Essentials of Nonprescription Medications and Devices

Essentials of Nonprescription
Medications and Devices

Essentials of
Nonprescription
Medications and
Devices
Elaine D Mackowiak BS Pharm, MS, PhD, RPh

Professor, Department of Pharmacy Practice, Temple University,
Philadelphia, PA, USA
To my children Jeffrey and Lisa, who had to tolerate my frequent late
days and evenings due to work related responsibilities. To my
late husband, Robert, and my parents, Veronica and the late
Stanley De Cusatis, for their encouragement in all my endeavors.
Published by the Pharmaceutical Press

An imprint of RPS Publishing
1 Lambeth High Street, London SE1 7JN, UK

1559 St Paul Avenue, Gurnee, IL 60031, USA
Ó Pharmaceutical Press 2010
is a trade mark of RPS Publishing
RPS Publishing is the publishing organisation of the Royal Pharmaceutical Society of

Great Britain
First published 2010
Typeset by Thomson Digital, Noida, India

Printed in Great Britain by TJ International, Padstow, Cornwall
ISBN 978 0 85369 861 6
All rights reserved. No part of this publication may be reproduced, stored in a retrieval
system, or transmitted in any form or by any means, without the prior written
permission of the copyright holder.
The publisher makes no representation, express or implied, with regard to the
accuracy of the information contained in this book and cannot accept any legal
responsibility or liability for any errors or omissions that may be made.
The right of Elaine D Mackowiak to be identified as the author of this
work has been asserted by her in accordance with the Copyright, Designs and
Patents Act, 1988.
A catalogue record for this book is available from the British Library.
Contents
Preface ix
About the author x
Acknowledgments xi
1 Regulation of the nonprescription drug market
by the US Food and Drug Administration 1
The US drug marketing system 1
The pharmacist’s role in self-care 7
Important sources of OTC drug information 7
References 8
2 Diagnostic home test kits 9
Blood pressure monitoring devices 10
Cholesterol tests 11
Diabetes monitoring devices 13
Fecal occult blood in the stool 16
Fertility test kits 17
Infectious disease kits 21
Drugs of abuse screening tests 24
Thermometers 26
Ear examination kits 28
Throat examination kits 28
Breast self-examination kit 29
Menopause detection kit 29
Paternity testing 29
Case study exercises 30
References 32
vi | Contents
3 Gastrointestinal system 33
Acid indigestion, heartburn, GERD, relief of upset stomach
associated with overindulgence in food and drink 34
Gas and bloating 39
Nausea and vomiting 42
Poison treatment drug products 45
Pinworms 48
Laxatives 49
Antidiarrheal agents 60
Lactose intolerance 63
Probiotics 63
Electrolyte solutions 64
Miscellaneous products 64
References 67
4 Respiratory system 69
Allergies 69
Common cold 77
Asthma 84
References 87
5 Central nervous system (including peripheral analgesics) 89
Oral analgesics 90
Sedatives 99
Stimulants 104
Antidepressant dietary supplements 106
References 109
6 Genitourinary system 111
Urinary-tract drugs 112
Products for men 115
Products for women 118
References 127
7 Topical ophthalmic, otic, and oral cavity conditions 129
Topical ophthalmic products 129
Otic products 135
Oral cavity products 137
Contents | vii
Canker sores or aphthous ulcers 143

Toothache and teething pain products 144
References 147
8 Topical dermatological products 149
Xerosis (dry skin) 151
Eczema (dermatitis) 153
Insect bites and stings 160
Musculoskeletal pain 167
Hemorrhoids 169
Antiperspirants 173
Sunscreens 174
Topical antimicrobial drugs 177
Topical antiviral drugs 182
Corn and callus removers 184
Ingrown toenail relief 185
Acne 186
Hyperproliferation skin conditions (scaly dermatitis) 188
References 194
9 Miscellaneous products 197
Weight loss products 197
Smoking cessation products 198
Osteoarthritis (arthritis) 202
Hair loss (alopecia) 203
Adaptogen 205
Memory loss and dementia 206
Coronary heart disease 207
References 209
Index 211
Preface
There is a large increase in the number of people assuming more responsibility

for their own healthcare by using nonprescription medications, especially for
many common conditions such as colds, allergies, and heartburn. Two impor-
tant factors contribute to this rise in self-care. First, the number of prescrip-
tion (Rx) drugs that have been switched to over-the-counter (OTC) status
(Rx–OTC switch) by the Food and Drug Administration (FDA) has increased,
making more effective medications available to consumers at reduced costs.
Second, the increased cost of medical care has prompted many people to go
without medical insurance, thus avoiding or delaying a visit to a physician.
Self-care may involve better nutrition, more physical activity, and use of
nonprescription drug products. Several different types of product are avail-
able, including home test kits and medical devices, OTC drugs, dietary supple-
ments and herbal remedies, and homeopathic products. There are important
distinctions among these products that pharmacists and consumers should
understand before choosing a product for use.
This text is intended to provide pharmacists, pharmacy students, and
individuals interested in self-care an easy to use reference for common condi-
tions and products available for prevention and treatment. The initial chapter
of this text describes the role the FDA exercises in controlling and monitoring
products for self-care in the USA. The chapters that follow provide brief
descriptions of common medical conditions amenable to self-care for specific
physiological systems and nonprescription products available for treatment.
Drug therapy discussions are based on the specific pharmacological cate-
gories of nonprescription products approved by the FDA through either its
monograph system for OTC drugs or its Rx–OTC switch program. Popular
dietary supplements, herbal products, and homeopathic products are dis-
cussed when appropriate. The format for each chapter includes the pharma-
cological drug category of the drug for therapy, indications for use, the mode
of action of the drug, warnings and precautions for the drug’s use, recom-
mended dose, and popular brand name products available in the USA. Sample
case scenarios are included at the end of the chapter.
Elaine D Mackowiak
September, 2009
About the author
Elaine D Mackowiak practiced briefly as a hospital pharmacist but has over

40 years of experience as a community pharmacist in both independent and
chain pharmacies. She joined the faculty of Temple University School of
Pharmacy in 1964 and has taught in ambulatory care and nonprescription
pharmacy courses for 35 years. She served as Chairperson of the Department
of Pharmacy Practice for 8 years. She has taught in the nuclear pharmacy
program since its inception, and became Director of the Nuclear Pharmacy
program in 1975, a position she continues to hold.
Her publications and presentations include the areas of nonprescription
medications, pharmaceutical education, medication management in geriatric
populations, nuclear pharmacy, radiation safety, diagnostic imaging drugs,
and health hazards of base metals in dental student populations.
She is a member of the American Pharmacists Association (Academy of
Pharmacy Practice and Nuclear Pharmacy), American Association of Colleges
of Pharmacy, the Health Physics Society, Sigma Xi, Rho Chi National Honor
Society, and Lambda Kappa Sigma Professional Pharmacy Fraternity.
Acknowledgments
The author thanks Ms Barbara Grissani, BA, technical support specialist, for
her friendship and assistance in preparation of this manuscript and many
other manuscripts over the years. The author thanks Albert Wertheimer,
PhD, Professor of Pharmacy Economics, for his encouragement during this
endeavor.
1
Regulation of the
nonprescription drug market
by the US Food and Drug
Administration
The US drug marketing system

Drug safety
In 1938, there was a major revision of the Food, Drug and Cosmetic Act of
1906 (FD&C), which formed the foundation for the current authority in
regulating drugs held by the Food and Drug Administration (FDA). One
major provision of the Act required manufacturers to submit to the FDA
information for all new drugs that provided proof of their safety in order to
be approved for marketing. Drugs used before the 1938 revision are not new
drugs and remain in the marketplace as GRAS (generally recognized as safe)
drugs, provided there is no substantial change in their formulations, recom-
mended doses, or use.1
Prescription and nonprescription drugs

There was no clear legal distinction between prescription (Rx) and nonpre-
scription drugs until the passage of the Durham–Humphrey Amendments in
1951. The amendments required all drugs that are habit forming or have
potentially severe toxicity to carry a printed statement on the label, known
as the Rx legend. The statement or legend is: ‘Caution: Federal law prohibits
dispensing without a prescription.’1 Drug products not fitting this description
do not have the statement on their labels and are known as ‘nonlegend’ or
over-the-counter (OTC) drugs.
Drug efficacy
The Kefauver–Harris amendments of the 1938 FD&C Act in 1962 required
manufacturers to submit information proving the efficacy (effectiveness) of a
2 | Essentials of Nonprescription Medications and Devices
new drug as well as safety data in order to be approved by the FDA.1 The
amendments included all drugs approved between 1938 and 1962, for which
data had to be submitted to prove their efficacy in order for the drug to remain
in the marketplace. This review process became the Drug Efficacy Study
Implementation program (DESI).
However, the many drugs in use before 1938 that had GRAS status were
not reviewed, creating the GRAE (generally recognized as effective) status.
The majority of dietary supplements, herbal remedies, and homeopathic
products are GRASE drugs (generally recognized as safe and effective). If
manufacturers of GRASE products change formulations, recommended doses
and/or intended use, the FDA considers these products to be new, unapproved
drugs. Since the manufacturers had not submitted a new drug application
(NDA) for their product, the FDA issues a guidance document discussing how
it intends to implement its policy for removing these marketed but unap-
proved products from the marketplace.2
Nonprescription or OTC drugs

FDA's monograph process
The DESI program involved all drugs with the exception of GRASE products,
and the FDA decided to review all the prescription drugs before beginning a
review of OTC drugs. This process began in 1972 with the creation of panels
of experts that reviewed OTC individual drugs or ingredients within a ther-
apeutic drug category. The panels published their reports to the FDA in the
Federal Register, identifying OTC drugs, active ingredients, determined to be
safe and effective and those that were not safe for OTC use. Some OTC drugs
deemed to be safe did not have sufficient evidence to prove efficacy. These
drugs were placed in a temporary category that allowed them to remain in the
marketplace while manufacturers were granted more time to submit data to
prove efficacy. All panels have submitted their reports.1–3
The FDA reviews each panel’s report and publishes an Advanced Notice of
Rulemaking in the Federal Register where all subsequent FDA actions are
reported. The FDA invites comments on its proposed rules, reviews them, and
publishes a Proposed Rule or Tentative Final Monograph. After another com-
ment period, the FDA publishes a Final Rule or Final Monograph. All OTC drugs
that have proved safety and efficacy are known as monograph drugs. Any drug
that is unsafe or remains in the temporary category (requiring more information
to prove efficacy) becomes a non-monograph drug once the Final Monograph
is published. Unsafe drugs must be removed from the marketplace. A drug that
has not proved efficacy cannot appear on the label as an active ingredient but
may remain in the product and must appear in the inactive ingredient.1,2
The OTC review process is quite long, and a few therapeutic categories
of drugs remain in the Proposed Rule or Tentative Final Monograph stage
Regulation of the nonprescription drug market by the US Food and Drug Administration | 3
at this time (2009). Monographs for OTC drugs contain the following
information: list of approved active ingredients, dosage formulations,
recommended doses, required labeling information, packaging informa-
tion, and/or testing information for some products. Some monographs also
contain labeling information for use of the active ingredients by healthcare
professionals. If a manufacturer wishes to market a drug in a monograph,
no prior approval from the FDA is needed if all the requirements in the
monograph are followed and if current good manufacturing practices are
followed.1,2
New OTC drug process

A new OTC drug may enter the market if the FDA approves an NDA sub-
mitted by the manufacturer, or if the manufacturer submits a supplemental
NDA for an Rx–OTC switch product. If the Rx–OTC switch process is
followed, the FDA may grant the manufacturer from one to three years of
exclusivity for marketing the product, but it may also grant no exclusivity.1,2
Once the exclusivity period has expired, another manufacturer may submit an
NDA to the FDA for approval if it wished to market the drug. If the FDA
places the drug in a monograph at some time after the exclusivity period
expires, a manufacturer must follow the monograph information if it wished
to market the drug and it does not have to file an NDA.
OTC product labels

If a product’s label cannot provide sufficient information for the public to use
the product safely, or if the condition for its use cannot be self-determined
and/or self-monitored, the product will not become an OTC drug. The OTC
drug labels must include the following information: name of active ingre-
dient(s), intended use of the product, warnings or precautions, potential
adverse effects and/or potential drug interactions, directions for use (dose
and frequency of administration based on age or weight), proper storage
information, and list of inactive ingredients. All products also have an
expiration date.
All OTC drugs contain the following warnings:
1 do not use the product if the individual is allergic to the ingredient(s) in

the product;
2 do not use the product if a woman is pregnant without the advice of her
physician;
3 do not use the product if a woman is breast feeding without the advice of
her physician; and
4 keep the product and all medication out of the reach of children.
Most OTC products are not recommended for use in children under 2
years of age without the advice of a physician or healthcare professional.
OTCs available from pharmacists only

Nearly all OTC drugs are available in any retail store in the US. However,
federal law restricts the sale of OTC drugs that have a potential for abuse,
such as codeine cough syrups and pseudoephedrine, to sale from pharma-
cies.1,4 An individual must provide identification and proof of age and sign a
form that the pharmacist is required to maintain of these sales. Because there
is significant abuse of dextromethorphan, a cough suppressant, by adoles-
cents, it may be included in this category in the near future. Individual states
may have more restrictive pharmacy laws than the federal law, and the reader
should become aware of the laws in the states where they reside; for example,
the Commonwealth of Pennsylvania requires a prescription for all cough
medications containing codeine.
Other drugs may also be restricted to sales by pharmacists. When the FDA
approved Plan B, the emergency contraceptive drug, as an OTC drug, it
became available only from the pharmacist.5 Products restricted to sale by a
pharmacist may be considered to be behind-the-counter (BTC) drugs but this
is not an official FDA drug category at this time.
OTCs for physician-diagnosed and chronic conditions

Although most OTC drugs are used for self-diagnosed, self-limiting condi-
tions, there are exceptions. An example is the use of OTC vaginal antifungal
drugs. If a woman had a previous vaginal candida (yeast) infection that was
diagnosed by a physician and the problem recurs, she may self-treat with
OTC drugs.
Another example is the use of OTC bronchodilating drugs. These products
are to be used only if a physician has diagnosed an individual with asthma and
the asthma is not a self-limiting condition.
OTC drugs are recommended for a specific period of time and all labels
contain statements advising individuals to see a healthcare professional if
symptoms are not relieved or have worsened within the recommended period
of use.
Relationship of OTC drug's active ingredient content and brand name

Manufacturers of OTC products may change the active ingredient without a
change being made in the product’s name. Kaopectate, a product used to treat
diarrhea, is an excellent example of this situation. The original Kaopectate
product contained kaolin and pectin as active ingredients. The final mono-
graph for antidiarrheal products concluded that neither was effective and they
were declared non-monograph drugs. The manufacturer reformulated the
product so that it contained attapulgite, which was classified as a monograph
drug. A revision of the final monograph for antidiarrheal drugs by the FDA
reclassified attapulgite as non-monograph and bismuth subsalicylate as a
monograph antidiarrheal. The present Koapectate product contains bismuth
subsalicylate. Therefore, an individual must read the labels carefully when

purchasing OTC drugs. This situation could never happen with prescription
drugs, because once a drug is given a brand name, the ingredient cannot be
changed.
Brand name and extended products

Manufacturers that have very successful brand name products which have
established brand loyalty among the public will market new products that
include the brand name but have different active ingredients. For example,
Dramamine, a product that is used for preventing and treating motion sick-
ness, has always contained dimenhydrinate as its active ingredient. The manu-
facturer markets Dramamine Less Drowsy, also a product that is used for
motion sickness, but containing meclizine. Another example is the popular
antacid Mylanta. As a suspension, this product contains aluminum hydroxide
and magnesium hydroxide, but as Children’s Mylanta tablets, it contains
calcium carbonate.
This situation is very confusing for both pharmacists and the public since
ingredient changes can be so easily altered by manufacturers. Product labels
should be read carefully by everyone purchasing or recommending an OTC
product for use.
Cost of OTC drugs

Manufacturers tend to price their products in a manner that is competitive
with other similar products. Popular brand name products must compete with
generic formulations of OTC products that are less expensive, in the same
manner as prescription drugs. If there are significant differences in costs
among products used for the same purpose, it is noted in the discussion here.
For example, electronic digital fever thermometers cost less than $10.00, but
infrared devices cost $35.00 or more. (Prices obtained from the internet;
www.drugstore.com)
Dietary supplements
Dietary supplements, primarily vitamins and herbal products, are not OTC
drugs because they are GRASE products and their manufacturers do not have
to prove safety and efficacy for them to remain in the marketplace. It is the
responsibility of the FDA to prove that a GRASE product is not safe in order
for it to be removed from the marketplace.
Specific information for regulation and sale of these products appears in
the Dietary Supplement and Education Act of 1994 (DSHEA).6 The labels for
these products must contain the following statements: ‘This product has not
been evaluated by the Food and Drug Administration.’ ‘This product is not
intended to diagnose, treat, cure or prevent any disease.’
The popularity of dietary supplements has grown in the last several years,
prompting the National Institutes of Health to establish a new division, the
National Institute on Complementary Alternative Medicine. The Institute has
sponsored several clinical trials of popular supplements for treating common
conditions such as the common cold, osteoarthritis, and several other com-
mon ailments. These trials have failed to establish efficacy for these products
at this time.
Homeopathic drugs
Certain homeopathic drugs that are claimed to treat a serious disease were
included in the 1938 FD&C Act and require a prescription by a homeopathic
physician. However, many homeopathic products are available OTC and the
labels for these must contain the statements: ‘This product has not been
evaluated by the Food and Drug Administration.’ ‘This product is not
intended to diagnose, treat, cure or prevent any disease.’
Homeopathy, an alternative medical practice, employs three basic princi-
ples. First, the ingredient used to treat an ailment should cause the same
symptoms as the individual’s complaint (like treats like); for example, a drug
that causes nausea should be used to treat individuals who complain of
nausea. Second, the ingredient should be as dilute as possible. Third, a process
of shaking must occur between dilutions (succussion). Homeopathic theory
states that succussion imparts an imprint in the solutions that increases its
effectiveness.7,8 Neither the American Medical Association nor the American
Pharmaceutical Association accept homeopathy as conventional therapy at
this time.
Information on the label of a homeopathic product differs from that
appearing on labels of OTC drugs or dietary supplements. The label of a
homeopathic product must contain the ingredient list, directions for use,
indication for use, and the dilution used in producing the product. All dilu-
tions are made from an original solution called the mother tincture. Dilutions
are expressed in Arabic numbers and Roman numerals. The Roman numeral
indicates the dilution, for example, X is a 1:10 dilution; C, a 1:100 dilution.
The Arabic number indicates how many times the dilution is performed. For
example, feverfew 3X on the label of a product means that a 1:10 dilution of a
sample of feverfew from the mother tincture is made and shaken. This prep-
aration is again diluted 1:10, shaken, and another 1:10 dilution is made, for a
total of three dilutions.
The OTC drugs and dietary supplement labels list the quantity of drug in
each tablet in units of mass or weight, such as grams (g) or milligrams (mg).
Labels of liquid products list the amount of active ingredient as a concentra-
tion, weight per unit of volume, or milligram per teaspoonful (5 mL). The
label of a homeopathic product does not provide the amount of drug in the
mother tincture, so the amount of drug is not known.
Healthcare professionals are well aware of the positive effect that may be
produced by a placebo, a formulation that contains no active ingredient. The
extreme dilution of homeopathic products may allow them to fit a definition
of placebo. This is one possible explanation for the efficacy attributed to
homeopathic products. Because of this dilution process used in homeopathic
products, very little drug is administered, which greatly reduces the possibility
of adverse effects. Allergic reactions remain as the most significant adverse
effect possible in sensitive individuals.
The pharmacist's role in self-care

When an individual consults a pharmacist about a medical problem, the
first decision by the pharmacist is to determine whether or not the problem
should be managed by self-care or should be referred to a physician. The
pharmacist should obtain information from the individual about the cur-
rent problem, including a description of the symptoms, the severity, onset,
and duration of symptoms. The pharmacist should ask about any treatment
or drug therapy the individual has tried and the success or failure of the
treatment. The pharmacist should review the medical history and use of
prescription and OTC drugs, dietary supplements, herbal products, and
homeopathic products.
The pharmacist accesses this information and develops a self-care plan for
the individual. This plan may include OTC drugs, dietary supplements,
homeopathic drugs, ancillary therapy (a healthy diet and/or mild exercise
program for weight loss), education and counseling, and follow-up monitor-
ing of the individual. Effective communication between the pharmacist and
the individual are essential for a successful outcome to result from their
interaction.
Important sources of OTC drug information

National phone number for Poison Control: 1–800–222–1222.
Reporting adverse drug effects: https://www.accessdata.fda.gov/scripts/
medwatch/medwatch_online.cfm.
Reporting adverse vaccine effects: www.vaers.hhs.gov.
General medical information: www.webmd.com; www.mayoclinic.com.
General medication safety information: www.consumermedsafety.org/.
National Center for Complementary and Alternative Medicine (NCCAM):
nccam.nih.gov.
Natural Medicine Comprehensive Database: www.naturalmedicine.com.
FDA center for Drug Evaluation and Research: www.fda.gov/cder.

FDA Office of In Vitro Diagnostic Devices: www.fda.gov/cdrh/oivd/.
References
1. Pray WS. A History of Nonprescription Product Regulations. New York: Haworth Press,
2003.
2. Frequently Asked Questions on the Regulatory Process of Over-the-Counter (OTC)
Drugs. www.fda.gov/cder/about/smallbiz/OTC_FAQ.htm (accessed October 28, 2008).
3. Guidance for FDA Staff and Industry Marketed Unapproved Drugs-Compliance Policy
Guide Sec.440.100. www.fda.gov/cder/guidance/6911fnl.htm (accessed September 8,
2008).
4. Legal Requirements for the Sale and Purchase of Drug Products Containing Pseudoeph-
edrine, Ephedrine, and Phenylpropanolamine. www.fda.gov/cder/news/methamphetamine.
htm (accessed October 28, 2008).
5. FDA Approves Over-the-Counter Access for Plan B for Women 18 and Older. Prescrip-
tion Remains Required for Those 17 and Under. www.fda.gov/bbs/topics/NEWS/2006/
NEW01436.html (accessed October 28, 2008).
6. Dietary Supplement Health and Education Act of 1994, Public Law 103-417. www.fda.
gov/opacom/laws/dshea.html (accessed October 28, 2008).
7. Stehlin I. Homeopathy: Real Medicine or Empty Promises? www.fda.gov/fdac/features/
096_home.html (accessed October 29, 2008).
8. Conditions Under Which Homeopathic Drugs May Be Marketed. www.fda.gov/ora/
compliance_ref/cpg/cpgdrg/cpg400-400.html (accessed October 29, 2008).
2
Diagnostic home test kits
The FDA amended the FD&C Act of 1938 in 1976 to include the following
definition for devices: ‘. . .an instrument, apparatus, implement, machine,
contrivance, implant, in vitro reagent, or other similar or related article,
including any component, part, or accessory, which is: (1) recognized in the
official National Formulary or the US Pharmacopeia, or any supplement to
them; (2) intended for use in the diagnosis of disease or other conditions, or in
the cure, mitigation, treatment or prevention of disease, in man or other
animals; or (3) intended to affect the structure or any function of the body
of man or other animals, and which does not achieve any of its principal
intended purposes through chemical action within or on the body of man or
other animals and which is not dependent upon being metabolized for
1
achievement of any of its principal intended purposes.’
An OTC home test kit must have proved that the device is able to produce
reliable results which are accurate when used by the population for whom the
2
test is intended before the FDA grants approval. The test device must dem-
onstrate sensitivity (test results are positive if the individual has the condition)
and accuracy (test results are negative if the individual does not have the
condition). An individual should be able to obtain the same results as a health
professional who uses the test, and the test should have some method that
indicates that the test is complete and has been performed correctly.
There are two types of OTC home test devices. One type gives the result of
the test once the directions for its use have been completed, for example a blood
glucose test meter. The other type of device requires the patient to follow
directions for obtaining a biological sample (a drop of blood or a urine sample),
which is then mailed to the manufacturer where a laboratory test is performed
to obtain the test’s result, for example a home test kit for the human immuno-
deficiency virus (HIV). The individual contacts the manufacturer at a specified
time after returning the test to obtain the laboratory’s result.
Congress, through the Health Care Financing Administration (HCFA),
regulates laboratory testing for humans by an act known as the Clinical
Laboratory Improvements Amendment (CLIA). CLIA-waived tests are
intended for use by individuals who have the least amount of training in
laboratory techniques. The FDA approves OTC home test kits that are CLIA
waived, but all not CLIA-waived tests are approved by the FDA for OTC use.
Potential errors in performing these tests are minimized, and even if an inac-
curate result occurs, it will not immediately endanger the health of the individ-
ual. The greater the number of steps in the test’s procedure, the more likely it is
that an individual will make a mistake that could give an erroneous result.
OTC home test kits are sold in pharmacies, other retail outlets, and on the
internet. Individuals should be cautious about purchasing test kits, especially
on the internet, because many devices are not FDA approved and there is no
way to determine their accuracy. The Office of In Vitro Diagnostic Devices
(OIVD) maintains a database of home test kits approved by the FDA available
3
at its website. One disadvantage of this site is that it only provides dates of
approval and does not have information about whether or not the kit is
currently available in the marketplace.
Users of home test kits should be aware of several important factors
regarding their use. First, it is important to be certain that the expiration date
of the kit has not passed and that the kit has been stored under proper
conditions. Reagents and other components of the kit may be subject to
degradation when stored improperly. All directions for use of the test kit must
be followed precisely in order to be sure that the result obtained is accurate.
However, not every test result will be correct 100% of the time, even when
tests are performed by skilled professionals. A second test should be done to
confirm the initial result. No important healthcare decision should be made
on the result of a single home test kit result. If the test result indicates a serious
medical condition, the result should be reported to the individual’s physician,
who will seek to verify the result and make appropriate recommendations for
treatment when it is necessary.
Blood pressure monitoring devices

Hypertension, or high blood pressure, is one of the most common medical
conditions in the USA and is an indication of cardiovascular disease. It is a
condition that rarely has any symptoms during its early stages and is detected
only by measurement with a blood pressure monitoring device. Uncontrolled
hypertension increases an individual’s risk of stroke, heart attacks, and kidney
disease. Many individuals diagnosed as having hypertension by their physi-
cian may want to monitor their blood pressure between visits to the physician
by purchasing blood pressure devices.
If the blood pressure values measured on the home blood pressure differ
from those taken in the physician’s office, no changes to medications should
be made by an individual unless directed to do so by the physician. The
individual should take the home device with them on the next visit to the
physician to check the device’s reading with those taken during the visit. If
the home reading is different, the monitor must be recalibrated.
Diagnostic home test kits | 11
Aneroid blood pressure monitors

Mode of action
An inflatable cuff connected to a meter is placed on the upper part of the arm
over the brachial artery and is inflated. An individual using a stethoscope
listens for the appearance of the pulse, the systolic blood pressure (pressure
against the artery wall when the heart contracts), while the pressure in the cuff
is slowly released. The disappearance of the pulse indicates the diastolic blood
pressure (arterial pressure when the heart ventricles relax and fill with blood).
Accepted values for normal blood pressure are a systolic reading of less than
120 and a diastolic reading of less than 80 mmHg.
Warnings and precautions
A healthcare provider must teach an individual how to use an aneroid blood
pressure monitor properly. The individual must have adequate dexterity to
release air slowly and adequate hearing to hear the sounds with the stetho-
scope. Aneroid devices usually require calibration yearly. Blood pressure cuffs
are available in different sizes and the individual must use the appropriate cuff
to obtain a valid blood pressure reading.
Electronic blood pressure monitors

Mode of action
An inflatable cuff connected to a device that automatically inflates and deflates
and has sensors that measure the systolic and diastolic blood pressure, display-
ing the values as a digital readout. These devices also display the pulse rate. The
devices are much easier to use than aneroid devices but may be less accurate.
These devices are battery operated and require replacement of the batteries.
Electronic blood pressure monitors are available for use on the upper arm,
wrist or finger, but the wrist and finger devices tend to be less accurate than
those using the upper arm for measurement.
Products
The following manufacturers make several different models of the aneroid
and electronic monitors: Omron, HoMedics, Luminiscope, Duro-Med and
Samsung.
Cholesterol tests
Elevated blood cholesterol levels are associated with an increase risk of car-
diovascular disease. A more precise evaluation of an individual’s risk may be
determined by measuring low-density lipoprotein cholesterol, high-density
lipoprotein cholesterol, and triglycerides, not just total cholesterol levels.
OTC home tests kits are available for measuring these various cholesterol
parameters.
Total cholesterol tests

Mode of action
A finger stick sample of capillary blood is placed in the well of a device that
contains a chromatographic stick impregnated with enzymes (cholesterol
esterase and cholesterol oxidase). Capillary attraction draws the sample over
the reagents, producing a color on a calibrated scale. The value from the
calibrated scale is compared with a test chart and the total cholesterol value
is read in milligrams per deciliter (mg/dL). Individuals are advised to consult a
physician if the value exceeds 200 mg/dL.
This test kit requires several timed steps that must be performed correctly to
obtain an accurate result. No acetaminophen (Tylenol) should be taken
within 4 hours of testing, and ingestion of 500 mg or more of ascorbic acid
(vitamin C) must be avoided. Both of these drugs may cause a falsely low
4
result during the test.
Products
CholesTrak, Home Access Instant Cholesterol Test, First Check Home
Cholesterol Test.
Cholesterol and lipid profile test card

Return mail test
Mode of action
A finger stick sample of capillary blood is placed on a test pad of a card and
returned to the manufacturer for laboratory analysis. The test kit consists of a
lancet, band-aid, test card with a code, and a return mailer. The individual
calls a toll free telephone number in a prescribed number of days after the test
and speaks with a trained counselor who provides the test’s results and
answers any questions the individual may have.
Product
BioSafe Cholesterol Test.
At home test
Mode of action
The device is a battery operated, photoreflectance meter that measures the
intensity of color produced on a reagent strip containing a drop of capillary
blood from a finger stick. The test result appears digitally on the meter. There
are three different types of strip, each with its own microchip, to determine
total cholesterol, high-density lipoprotein cholesterol, and triglycerides.
Directions provide information for the calculation of low-density lipoprotein
cholesterol levels.
Products
CardioChek, Landmark Full Lipid Panel Cholesterol Test. This type of detec-
tor provides more complete information and is more costly ($125) than total
cholesterol measurement kits, which cost less than $15.
Cholesterol and blood glucose meters

Mode of action
The device is a battery operated monitor that determines blood glucose levels
and total cholesterol levels from a finger stick of capillary blood by using two
different reagent strips.
Products
Accu-Chek Instant Plus, QSTEPS Biometer Dual Monitoring System.
Diabetes monitoring devices

Blood glucose monitors
Individuals who require injections of insulin (type 1 diabetes) must know the
concentration of glucose in their blood in order to control their diabetes. Some
individuals who have type 2 diabetes and control their diabetes with oral
medications may also measure their blood glucose levels. Individuals with
type 1 diabetes should measure blood glucose at least four times a day,
and adjust the amount of insulin required based on these measurements.
Lack of control of blood glucose increases the risk of cardiovascular disease,
kidney disease, neuropathy, and visual impairment in individuals who have
diabetes.
A small drop of capillary blood from a finger prick or an alternative site
(upper arm or forearm, thigh or palm) is placed on a reagent strip inserted into
a blood glucose monitor. Glucose reacts with the reagent strip, which contains
an enzyme, producing an electrochemical reaction. A biosensor in the monitor
converts the electrical signal to a digital value that displays the concentration
of glucose as milligrams per deciliter (mg/dL).
Accurate results depend on the following conditions:
* the meter is clean and calibrated if necessary (some newer meters do not
require calibration)
* the expiration date on the reagent strips is not exceeded
* the strips are compatible with the blood glucose meter
* the drop of blood covers the entire sample area on the strip (some meters
display a message or signal if there is not enough blood)
* the blood glucose level is not read until the test is complete
* there is no major change in temperature, hematocrit, motion, or
humidity, as this can affect some blood glucose monitors.
Most blood glucose meters require less than 1 to 2 microliters of blood and
give a result in less than 10 seconds. Meters have memories to save past
readings that are compatible with computer software programs for compar-
ing long-term blood glucose values to determine effectiveness of blood glucose
control. Table 2.1 compares features of some of popular meters.
Products
The following manufacturers make several models of glucose monitors:
Abbott, Bayer, Lifescan, and Roche Diagnostics.
Hemoglobin A1c monitors

Blood glucose monitors provide an immediate measure of glucose levels for an
individual so that insulin dosage can be adjusted. A better measurement of
long-term glucose control is glycoslated hemoglobin (HbA1c). Glucose enters
the red blood cell where it combines with hemoglobin and remains there for
the lifespan of the red blood cell, 120 days. Values for HbA1c of 7 or less
indicate good glucose control and minimize the risks of detrimental health
consequences associated with diabetes.
Return mail tests

Mode of action
A drop of blood from a finger stick is placed on a reagent pad on a card and is
sent to the manufacturer for analysis. The kit contains lancet, band-aid,
reagent card with code number, and return mailer. Several days later, the
individual calls the manufacturer on a toll free number and provides the code
to a trained counselor who discusses the test’s result with the individual.
Product
Appraise Diabetes A1c Test, Reli On A1c Test.
At home test
Mode of action
A drop of blood from a finger stick is placed on a test strip containing reagent.
The test strip is inserted into a photoreflectance meter and the result is digi-
tally displayed.
Table 2.1 Selected characteristics of popular blood glucose monitors
Meter Calibration code Blood Alternative site Special feature

(microliters) testing
Abbott
Free Style Lite Yes 0.3 Yes Blood may be

added to either
side of test strip
Free Style Yes 0.3 Yes

Freedom
Precision Xtra Automatic code 0.6 Yes Measures blood

chip glucose and
blood ketones;
two different
strips
Bayer Ascencia
Breeze 2 No 1.0 Yes Contains 10 strips

loaded in the
meter
Contour No 0.6 Yes Easy to use
Lifescan One Touch
Ultra mini Yes 1.0 Yes Smallest meter
Ultra Yes 1.0 Yes
Ultra Smart Yes 'Speck' Yes; finger Gives averages

preferred and graphs
results on meter
itself; does not
need separate
computer
Pfizer Accu-Chek
Compact Plus No 1.5 Yes Contains lancet

and preloaded 17
strip drum
Aviva Yes 0.6 Yes Use wide-mouth

strips
Rite Aid
True Track Smart No 1.0 Yes Disposable after

the 50 test strips
in kit are used
Products
A1cNow, A1c At-Home.
Fecal occult blood in the stool

Individuals who suddenly have very dark or black-looking bowel movements
may be experiencing blood loss from the gastrointestinal (GI) tract. A positive
result from an OTC fecal occult blood test cannot identify the cause of the
bleeding, just its presence. There are many possible causes of fecal blood loss
including many common conditions such as peptic ulcer disease, colon cancer,
ulcerative colitis, diverticulitis, fissures, and hemorrhoids. Many individuals
consider this test to be a cancer screening test, but it is not. Individuals who
have a positive test must contact their physician for a proper diagnosis.
Occult blood toilet bowl test

Mode of action
An individual drops a paper impregnated with a dye, tetramethylbenzidine,
into the toilet bowl after a bowel movement. The heme (iron) portion of
hemoglobin acts as an oxidizing agent, causing a blue-green color on the
paper if blood is present. Three successive bowel movements are tested and
the result from each is recorded by the individual. If the result is positive on
any part of the paper during any one of the three tests, the individual is
directed to contact a physician.
Women should avoid testing during menstruation. Irritating substances that
may cause GI bleeding should be avoided immediately before and during the
testing period. These substances include alcohol, aspirin, caffeine, ibuprofen,
naproxen sodium, and any prescription drugs that are gastric irritants. Use of
these substances during testing may produce false positive test results.
Products
EZ Detect, First Check Colorectal Test.
Antibody occult blood test

Mode of action
The antibody occult blood test uses the antibody–antigen reaction to detect
hemoglobin in a stool sample. A sample of feces is removed from the toilet
bowel using a collection stick provided in the kit. The stick is placed in a bottle
containing a buffer solution and shaken. Two drops of solution are placed in a
test cassette, and after 5 minutes the result is available. A positive result
5
requires consultation with a physician.

Women should avoid testing during menstruation. Irritating substances that
may cause GI bleeding should be avoided immediately before and during the
testing period. These substances include alcohol, aspirin, caffeine, ibuprofen,
naproxen sodium, and any prescription drugs that are gastric irritants.
Product
ColonCARE.
Fertility test kits

When conception is desired, several methods may be used to predict when a
mature ovum will be released into the fallopian tubes. Intercourse during this
time increases the probability of fertilization of a mature ovum by sperm.
These tests include use of monoclonal antibodies to detect hormones, mea-
surement of the body’s basal temperature, or monitoring of saliva for elec-
trolyte changes.
The morning’s first urine stream usually has the highest level of hormones
being tested and provides the best time for measurement when this type of test
is being used. Low sperm counts and failure to produce a mature ovum are
among the many possible causes of infertility. A physician should be consulted
if conception does not occur.
Women taking hormones or fertility drugs should not use these test devices
because of possible false results. Certain medical conditions will also produce
false results.
Ovulation tests
Monoclonal antibody tests
Mode of action
The pituitary gland releases a high concentration of luteinizing hormone (LH)
immediately before ovulation, LH surges. It stimulates the release of a mature
ovum into the fallopian tube. The excreted LH can be detected in the urine as
soon as this begins using an antibody–antigen reaction.
Since the exact day of the start of the LH surge is not known, the woman
must know the length of her menstrual cycle. Ovulation occurs 14 days prior
to menstruation and the woman should begin testing for LH a few days before
ovulation is expected to begin. A device with a stick at one end containing
monoclonal antibody is placed in the morning’s first urine stream. The sample
moves by capillary attraction to produce a color, a plus sign (þ), or some other
symbol on the device to indicate the presence of LH, a positive result. A
sample of morning’s first urine could be collected in a cup and the device
placed into the sample cup to do the test instead of using the urine stream.
Ovulation test kits contain multiple test sticks (five to nine sticks) because
several days of testing may be necessary to determine when the LH surge
begins. The cost of most kits is approximately $30.
Some prescription drugs and medical conditions may produce false positive
results.
Products
Clear Blue Easy Ovulation Test, First Response Ovulation Test, Answer
Quick and Simple One Step Test, Early Detect Ovulation Test, Accu-Clear
Early Ovulation Test.
Luteinizing hormone and estrogen hormone devices

Estrogen levels increase during the follicular stage of the menstrual cycle and
peak just before the LH surge occurs. Estrone 3-glucuronide, a metabolite of
estrogen, increases in the urine. The detection of both of these hormones may
increase the ability of the couple to predict ovulation more accurately.
Mode of action
The test uses antibody–antigen technology to detect LH and estrone 3-glucu-
ronide. A test stick in placed in the stream of the morning’s first urine daily
beginning on day five in the menstrual cycle and then inserted into the moni-
tor. The monitor displays one of three readings digitally: low, high, or peak
fertility.
The woman’s menstrual cycle should be between 21 and 42 days. If the
woman used birth control pills or was breast feeding, testing should not begin
until there have been two normal menstrual cycles. Menopause, liver or
kidney disease, polycystic ovarian syndrome, and use of tetracycline may give
6
inaccurate results.
Product
Clear Blue Easy Fertility Monitor. The initial cost of this device is $170 and
replacement reagent sticks cost approximately $44 for 30 sticks.
Basal temperature devices

Mode of action
Approximately 24 hours after the LH surge and before ovulation occurs, there
is a slight decrease in the body’s basal temperature that is followed by a slight
increase for a few days, which ranges approximately from 0.5 to 1.0 degrees
Fahrenheit ( F) (0.9–1.8 C).
This method is less accurate in predicting ovulation than the antibody–
antigen devices but is less costly. A digital thermometer that reads
temperature with 0.01 F differences is the only device needed. The woman
measures and records her basal body temperature at the same time daily,
usually in the morning before getting out of bed. Devices are available with
memories and some can be used with computer software packages that allow
comparison of temperature changes over multiple menstrual cycles.
Measurements should be after a restful sleep and must be made using the same
method. The temperature must be taken before the woman engages any
physical activity, like getting out of bed.
Products
Becton Dickinson Basal Thermometer; OvuQuick Basal Thermometer.
Electrolyte test devices

When estrogen levels increase during the menstrual cycle, there is a change in
concentration of sodium, potassium, and chloride in saliva and vaginal secre-
tions; this changes the viscosity of these secretions.
Saliva test devices

Mode of action
A sample of saliva from under the tongue is allowed to dry on a glass slide that
is viewed daily with a magnifying device provided in the kit. The pattern of
dried crystals changes from that of a series of dots or blobs to one that looks
7
like a branched fern.
Product
Fertile-Focus.
Mode of action
The test kit contains a device that is placed on the tongue. It uses an electro-
chemical reaction to determine sodium and potassium levels to indicate prob-
8
ability of ovulation.
Product
OvaCue.
Skin test devices

Mode of action
A watch-like device contains a biosensor pad that responds to chloride levels
on the skin. It is worn nightly for at least 6 hours approximately 4–5 days
before ovulation is expected. Chloride levels increase just before estrogen
levels peak during the menstrual cycle, providing another indication that
9
ovulation will occur.
Product
OV-Watch.
Male fertility tests

Sperm Count
Men who have low sperm counts or sperm with impaired motility may not be
able to impregnate their partners. Men are often reluctant to see a physician
and the use of an OTC home test to determine sperm counts may be helpful in
determining a possible cause for infertility.
Mode of action
Ejaculated semen is placed in a collection cup that alters the viscosity of the
semen for at least 15 minutes before performing the test. A sample of semen
and a control sample are placed in a cassette device. A blue dye is added to the
sample and control. If the color of the semen sample is the same as the control
sample or darker, the sperm count is at least 20 million per milliliter, a normal
value. A color that is less intense than the control indicates a sperm count that
is lower than normal. A physician should be consulted if a low sperm count is
10
indicated.
This multistep test may lead to errors during the procedure and produce
invalid results. The directions must be followed exactly. If the couple cannot
conceive a child, both should consult a physician even if the sperm count is
normal.
Products
FertilMARQ, PreConceive Plus Male Fertility Test.
Sperm count and sperm motility

Mode of action
The kit contains a microscope with a grid on the lens. A sample of semen is
placed on a slide and viewed through the microscope. Directions provide
information of interpreting the view of sperm on the grid and how to compare
11
it with a control sample to determine sperm count and motility.
Product
Micra.
Pregnancy test devices

Human chorionic gonadotropin (hCG) is produced by trophoblastic cells in
the corpus luteum within 8 to 10 days after conception and appears in the
urine. A morning’s first urine sample should contain the highest concentration
of hCG and provide the most accurate result. The secretion of hCG increases
and peaks at approximately 6 to 8 weeks after fertilization, but then decreases.
Performing the test too soon or too late may give an erroneous result.
Mode of action
This test is based on an antibody–antigen reaction. Most test devices will
detect hCG levels the first day after a missed menstrual cycle; some devices
may detect hCG as early as 5 days after fertilization. A stick impregnated with
reagents is placed in the urine stream or in a cup containing a urine sample.
Capillary attraction of the urine sample over the reaction area produces a
color, plus sign (þ), or digital readout to indicate a positive or negative test.

If the concentration of hCG is too low for detection when the test is first done,
a negative result will be obtained. The test should be repeated within a week if
the possibility of pregnancy exists. Women should consult with their phys-
ician if a positive test is obtained. There are some disease states that may
produce a false positive result.
Products
Test stick devices include Answer Pregnancy Test, First Response Early
Result, Clearblue Easy Earliest Result, e.p.t., Fact Plus, and AccuClear.
Infectious disease kits

Individuals who have unprotected sex or are intravenous drug users who do not
use sterile syringes are at high risk for acquiring hepatitis, HIV, and other
infections transmitted by biological fluids. Home tests are available for those
individuals who suspect that they may have been exposed to these agents. There
are no FDA approved home test kits for hepatitis A or hepatitis B at this time.
Hepatitis C
Mode of action
A sample of capillary blood obtained from a finger stick is placed on a reagent
pad on a card. The card is closed and sealed and returned to the manufacturer
for analysis. After a specified period of time, the individual calls a toll free
number, provides the code number from the test, and is given the result of the
test. A trained counselor responds to the telephone call and provides addi-
tional information to the individual regarding the meaning of the test result
and procedures that the individual should follow if the test result is positive.
The test kit contains directions, a lancet, antiseptic pad, band-aid, speci-
men card with a code number, and a return mailer.
Product
Home Access Hepatitis C Check Kit.
HIV-1
Mode of action
The HIV-1 test is an antibody–antigen test. A sample of capillary blood
obtained from a finger stick is placed on a reagent pad on a card. The card
is closed and sealed and returned to the manufacturer for laboratory analysis.
After a specified period of time, the individual calls a toll free number,
provides the code number from the test, and is given the result of the test. A
trained counselor responds to the telephone call and provides additional
information to the individual regarding the meaning of the test result and
procedures that the individual should follow if the test result is positive.
The test kit contains directions, a lancet, antiseptic pad, band-aid, speci-
men card with a code number, and a return mailer.
Product
Home Access HIV-1 test kit.
Vaginal pH tests
The normal pH of the vagina is acidic, usually around 3.5 to 4.5. If a woman has
a vaginal infection caused by bacteria, the vaginal pH usually increases. Women
who experience vaginal itching and/or vaginal discharge may have either a
bacterial or a fungal/yeast (candida) infection. If the woman had a previous
vaginal infection that was diagnosed as a candida infection by a physician, she
may purchase an OTC product to treat subsequent infections. OTC vaginal
antifungal products are not effective against vaginal bacterial infections.
Often a woman may be in doubt as to whether or not she has a candida
infection, and she should consult a physician. However, some women are
reluctant to see a physician, and an OTC test that measures vaginal pH may
help to distinguish between the two types of infection for these individuals.
Mode of action
Reagents on a test device will change color depending on the pH of the
specimen placed on the device. A sample of the vaginal secretion is obtained
and the color of the test device is compared with a color guide, indicating the
pH of vaginal secretions.
This test is intended for women who have a normal menstrual cycle, because
pH is dependent on a number of factors including normal hormone levels. The
test should not be performed during menses. Women who are pregnant or
have recently given birth should not use this test. Postmenopausal women
should not use this test because low estrogen levels may increase vaginal pH in
the absence of a bacterial infection.
The reagent area on the test device should not be touched and may be used
only once. If the test is positive, the vaginal pH is higher than normal and the
woman should consult a physician. If a negative result is obtained but the
woman has symptoms of vaginal itching and discharge, a physician should
be consulted regardless of the negative result.
Product
FEM-V. This test consists of a pantiliner that has an insert with reagent on
it. The woman uses the pantiliner and the vaginal secretions will wet the
insert and react with the reagent. The insert is removed from the pantiliner,
placed in a plastic tray and allowed to dry. If a blue–green color appears
after 10 minutes, the pH is increased, indicating that a bacterial infection is
probably present. This is a positive test and requires proper diagnosis and
treatment by a physician. If a yellow color appears after 10 minutes, a
candida infection is probably present, and the woman could begin self-care
12
with an OTC product or she could see a physician for a proper diagnosis.
Vagisil Screening Kit. This kit contains a hand-held device with a circle
containing pH paper. It is inserted into the vagina and the paper circle is
pressed against the vaginal wall for 5 seconds and removed. The color is
13
matched to a test chart, indicating the pH.
Urinary tract infections

Urinary frequency and urgency and/or discomfort during urination may indi-
cate the presence of a urinary-tract infection. If any blood appears in the urine,
a physician must be consulted because self-care is not appropriate even if there
are no other symptoms.
Urinary nitrate tests

Mode of action
The bacteria responsible for most urinary-tract infections convert urinary
nitrate compounds to nitrites. A test stick containing a reagent is placed in
a sample of a morning’s first urine stream for 10 seconds. The color produced
on the reagent pad is matched with a color chart provided with the kit to
14
determine if the test result is positive.
A positive test result, or a negative test result when the individual has
urinary-tract symptoms, requires consultation with a physician.
Products
UTI Home Screening Test Strips, Azo Test Strips.
Urinary nitrates and urinary protein test

Mode of action
Protein (albumin) in the urine may also indicate the presence of an infection.
The device contains a stick at one end that is placed in the urine stream.
Capillary attraction moves the urine sample to areas on the stick that have
reagents to indicate the nitrate to nitrite result in one window on the device
and the presence of protein in another window. If either or both tests
are positive, the individual should consult a physician. If the individual has
urinary-tract symptoms and both tests are negative, the individual should
consult a physician. The presence of protein in the urine but not nitrites could
14
indicate the presence of kidney disease.
Product
UTI Bladder Infection Test.
Drugs of abuse screening tests

Urine drug test kits
The FDA approves home test kits that use urine samples to determine the
presence of some prescription and illicit drugs. These tests do not provide
information about the amount of drug present, just whether or not the drug is
present. Prescription drugs in the following pharmacological classes can be
detected: barbiturates, benzodiazepines, methadone, opiates (codeine and
morphine, and oxycodone), and tricyclic antidepressants. Illicit substances
include amphetamine, methamphetamine, cocaine (crack), ecstasy (3,4-
methylenedioxymethamphetamine, also known as MDMA), heroin, mari-
15
juana (pot), and phencyclidine (PCP or angel dust). Table 2.2 provides
information as to how soon after using the drug it may be detected in the
urine and how long after use it can be detected.
Mode of action
The drug testing kits contain a urine collection cup with one or more strips,
each containing a reagent pad that is viewed for its result. If there is a positive
test result, the urine sample may be returned to the manufacturer to confirm
the test and determine the amount of drug present. Kits have a code number
and the individual either calls a toll free telephone number or goes to a
manufacturer’s website to obtain the results of laboratory tests.
Products
First Check: First Check 12 drug tests, First Check Marijuana Test, First
Check Cocaine Test.
Table 2.2 Drugs that are detected in home tests using urine samples
Drug Time for drug to appear in Time drug is detectable after

urine after use (h) ingestion (days)
Marijuana 1–3 1–7
Crack (cocaine) 2–6 2–3
Opiates (heroin) 2–6 1–3
Amphetamines 4–6 2–3
Phencyclidine (PCP or angel dust) 4–6 2–4
Ecstasy 2–7 2–4
Benzodiazepines 2–7 1–4
Barbiturates 2–4 1–3
Methadone 3–8 1–3
Tricyclic antidepressants 8–12 2–7
Oxycodone 1–3 1–2
At Home: At Home 12 drug tests; At Home 5 Drug test kit (marijuana,

amphetamine, methamphetamine, cocaine, opiates), At Home Single Test
(marijuana), At Home Single Test (cocaine).
Hair follicle test kits

Most drugs are detectable in urine samples for 1 to 3 days after the drug enters
the body. However, drugs are also deposited in hair follicles and remain there
until the hair grows out and is cut. A hair sample directly from the scalp may
contain traces of drugs used as much as 3 months earlier. These test kits have
code numbers and the hair sample is returned to the manufacturer for anal-
ysis. The individual calls the toll free number, provides the code number, and
16
is told the test’s result.
Mode of action
Hair samples are analyzed using gas chromatography and mass spectrometry.
Products
PDT-90, HairConfirm.
Alcohol test kits

Mode of action
An enzyme-based reaction of either a breath sample or a saliva sample con-
verts the alcohol in the sample to a blood alcohol level.

No food or drink should be ingested nor should the individual smoke for at
17
minimum of 10 minutes before the test is performed.
Products
Breath tests: AlcoHAWK Elite Breath Detector; Bactrack Breathalyzer and
Safe Drive Deluxe Detector.
Saliva test: Early Detect Blood Alcohol.
Thermometers
Fever thermometers are probably the most frequently purchased devices for
home use. Cost for these devices varies widely. Most electronic digital ther-
mometers cost $4.00–10.00; infrared ear thermometers cost $40.00, and
infrared temporal artery devices $50.00.
Oral, rectal, and underarm electronic thermometers

A rise in the normal body temperature is often associated with an infection or
some other medical condition. Although most people consider the normal
body temperature to be 98.6 F (37 C) an individual’s temperature may be as
much as one degree Fahrenheit higher or lower. The body temperature also
varies by approximately 1 F throughout the day. The lowest body tempera-
ture occurs just after awakening in the morning and increases to a maximum
level in the evening. Increased physical activity also causes an increase in body
temperature.
A persistent increase in body temperature indicates that a fever is present.
An oral temperature above 100 F (37.8 C) is considered a fever in adults, and
a rectal temperature over 100.4 F (38.0 C) is considered a fever in young
children. Rectal temperatures are preferred in young children because of their
inability to use an oral thermometer correctly. Rectal temperatures may also
be used if an individual is unconscious or not able to follow instructions for an
oral measurement.
Temperatures taken rectally are generally 1 F (1.8C) higher than tempera-
tures taken orally. However, rectal temperatures must be taken carefully in
order to avoid damaging the rectal mucosa. Rectal thermometers should be
coated with a lubricant before insertion. Taking a temperature rectally is not
esthetically acceptable to many people and other methods for taking tempera-
tures have been developed.
Temperatures taken under the arm (axillary temperature) are used in new-
borns and infants. This method is less reliable as the child gets older. The
thermometer must be placed in the axilla and the arm held against the body
for an accurate measurement. The measurements are approximately the same
as rectal measurements in infants less than 1 month old but may read as much
as 0.5 F or 1 F (0.9–1.8 C) less when used in older infants or children.
18
Electronic thermometers that have digital readouts reduce errors in mea-

suring body temperatures. Mercury thermometers are no longer sold because
of the environmental hazard associated with mercury, but many people may
still have mercury thermometers in their homes. These thermometers are safe
unless they are broken. The local health department should be consulted for
disposal of mercury-containing products.
Mode of action
Electronic thermometers provide reliable measurements in less than a minute
and the values are displayed digitally. Some devices require batteries but
disposable thermometers are also available.
Products
BD Musical SpongeBob Digital Thermometer, Vicks Comfortflex Therm-
ometer, Vicks Underarm Thermometer, HoMedics Underarm.
Tympanic membrane thermometers

Mode of action
The device is placed in the ear in such a manner that an infrared wave
generated by pressing a button strikes the tympanic membrane. The signal
returns to the device, which is calibrated and displays the temperature digi-
tally. The device must be held at the correct angle for the device to work
properly, and this is more difficult in young children than in older children
and adults. Tympanic membrane thermometers usually give readings that are
0.5–1 F (0.9–1.8 C) higher than an oral measurement.
18
Products
Thermoscan, Omron Ear Thermometer, Vicks Ear Thermometer.
Temporal artery forehead thermometers

Mode of action
The device is drawn across the forehead from its midline to the hair line while
an infrared sensor measures heat from the temporal artery. It may be more
accurate for infants than tympanic membrane devices. It generally gives a
reading that is 1 F (1.8 C) higher than oral body temperatures.
19

The device should be kept at room temperatures for 30 minutes before using;
it should not be used on scar tissue or injured skin; it should not be used out-
side or if sweat is present of the forehead. Temperature may also be measured
19
over the temporal artery behind the ear at about the level of the ear lobe.
Product
Exergen TAT-2000C.
Ear examination kits

Ear infections are frequent in children and are a leading cause of visits to
pediatricians. These devices are intended to help caregivers to determine
whether or not a physician should be consulted.
Visual examination of the inner ear

Mode of action
An ear examination kit consists of a user’s manual that has pictures of con-
ditions that may affect the middle ear and the tympanic membrane and a
medical quality device to see the inner ear. The device is similar to a medical
otoscope. The caregiver compares what is seen with photographs in the
manual. The pediatrician is called and the caregiver reports what was seen
when looking into the inner ear. The physician then provides the caregiver
with directions for care of the child.
Product
Dr. Dedo’s Ear Examination Kit.
Determination of fluid in the inner ear

Mode of action
Fluid frequently accumulates in the inner ear, which may result in ear pain. A
device that generates a sound wave (chirping) is inserted into the outer ear and
the signal is reflected from the tympanic membrane to the device. The sound is
converted by a microprocessor that indicates whether or not fluid has accu-
mulated. If the test indicates that it is likely that there is fluid present, the
20
caregiver should contact the child’s physician.
This device should not be used in children under 6 months of age, in children
who have tubes in their ears, in children with perforated ear drum or ear
20
deformities, or if there is any drainage from the ear.
Product
EarCheck Middle Ear Monitor.
Throat examination kits

Mode of action
This kit consists of a user’s manual, tongue depressor, and a penlight. The
manual contains photographs of the normal throat tissues and various
conditions that may occur in the throat. The caregiver compares the condi-
tions appearing in the throat with the photographs. The pediatrician is called
and the caregiver reports what was seen when looking into the throat. The
physician instructs the caregiver on the appropriate actions to follow.
Product
Dr. Dedo’s Throat Examination Kit.
Breast self-examination kit

Mode of action
A soft plastic, ultra-thin pad contains a lubricant inside to increase tactile
sensitivity to an abnormal mass in the breast. The pad is placed over the breast
and self-examination of the breast is performed. If any abnormality is
detected, a physician should be consulted.
Product
Sensability.
Menopause detection kit

Estrogen levels in women are controlled by the secretion of a hormone from
the posterior pituitary gland, follicle stimulating hormone (FSH). When estro-
gen blood levels fall, FSH is secreted to initiate synthesis of estrogen to return
circulating levels to the normal values. Once estrogen levels reach the normal
value, the pituitary gland stops secreting FSH.
As a woman approaches menopause, normal production of estrogen
decreases, causing the pituitary to continue secreting FSH. Since it is not
possible for more estrogen to be synthesized, the levels of FSH continue to
21
be higher than normal.
Mode of action
An antibody–antigen reaction detects the amount of FSH present in the urine.
A stick containing monoclonal antibodies is placed in the urine stream. The
sample moves along the stick, where the antibody–antigen reaction occurs
and produces a positive or negative result. If the test is positive, the woman is
advised to consult a physician.
Products
Menocheck, Early Detect Menopause Test Kit, Sure Step FSH Menopause.
Paternity testing
Mode of action
A male who wishes to verify if he is the biological father of a child may submit
a biological sample from himself and the child. The samples are sent to the
manufacturer and a DNA test is performed using the polymerase chain reac-
tion. The individual calls the toll free number after a specified period of time
for the test results.
Product
Paternity Test Kit.
Case study exercises

Case 1 A 48-year-old woman who has a hearing problem asks the
pharmacist to recommend a blood pressure monitor because she
doesn’t know the difference between an aneroid monitor and an elec-
tronic monitor.
The pharmacist recommends that she purchase an electronic blood
pressure monitor. The aneroid monitor requires that she use a stetho-
scope to hear the sounds needed for measurement of her blood pres-
sure. Her hearing difficulty may interfere with her ability to hear those
sounds. The electronic monitor has sensors in the blood pressure cuff
that automatically detects these sounds for measurement.
Case 2 A man asks the pharmacist to recommend a product that he can

use to check his cholesterol levels because he takes prescription drugs to
lower his triglycerides.
The pharmacist recommends that he consider purchasing CardioChek.
This device is able to measure total cholesterol, high-density lipopro-
tein cholesterol and triglycerides using a small finger stick sample of
blood on a reagent strip. He can also calculate his low-density lipopro-
tein cholesterol. Although he only wants a triglyceride measurement,
no home diagnostic tests are available for measuring only triglycerides.
Case 3 A patient who has diabetes wants to measure her hemoglobin

A1c and her blood glucose levels. She wants to know if there is a
monitor that does both.
The pharmacist tells the woman that there is no single product that can
do both; she will have to purchase each device separately.
Case 4 A 52-year-old man asks the pharmacist where the colon cancer
test kits are in the pharmacy. His mother had colon cancer and he
wants to do a home test because he is afraid to visit a doctor.
The pharmacist advises him that he made an excellent decision to want
to be tested for colon cancer because of his family history. However,
the home test kits only detect occult blood in the feces. Unfortunately,
this test is not specific for colon cancer. Many individuals who have
colon cancer may not have any rectally bleeding. The pharmacist
strongly recommends that he consult a doctor because of the potential
serious nature of his situation.
Case 5 A young woman asks the pharmacist to recommend a product

that will improve the chances of getting pregnant as she and her hus-
band have been trying to conceive a child for nearly 18 months and
have been unsuccessful; they do not want to see a physician because
their health insurance will not cover this type of expense.
The pharmacist suggests she consider purchasing the Clear Blue Easy
Fertility Monitor. Although this product is more expensive than most
of the other ovulation detecting devices, it measures both luteinizing
hormone and estrogen levels, which are used to detect ovulation.
The pharmacist also suggests they consider using an OTC diagnos-
tic test kit to determine whether or not her husband has a sufficient
number of sperm with appropriate motility. Several products are avail-
able for this purpose.
Case 6 The mother of a 14-year-old child is concerned that the child

maybe using drugs and asks the pharmacist to recommend a test product.
The pharmacist explains that she needs to have a discussion with the child
about this situation before resorting to a testing procedure. The phar-
macist explains that the at-home test kits require a urine sample from the
child. There are kits that are specific for certain drugs like marijuana or
cocaine or kits that detect drug use without identifying the specific drug.
Some test kits require the urine sample be sent to the manufacturer for
analysis. There is also a test kit that uses a hair sample for analysis. The
hair sample must be cut from near the scalp and returned to the manu-
facturer for analysis.
Case 7 A 34-year-old woman asks the pharmacist if there is a home test

for detecting menopause as her menstrual cycles have been irregular
and she gets some hot flashes occasionally, but she thinks she is too
young to be entering menopause and she can’t afford to go to the
doctor.
The pharmacist recommends that she consider purchasing either
Menocheck or Sure Step FSH Menopause test. Both of these products
determine the level of follicle-stimulating hormone present in the urine.
A high level of this hormone indicates that menopause may be occur-
ring, but the woman should consult a physician about her situation.
Case 8 The father of child tells the pharmacist that his wife told him to
buy a thermometer that is used in the ear; he says he doesn’t know what
to buy and he wants the pharmacist to make a recommendation.
The pharmacist explains that there is a device that measures the body
temperature by using ultrasound waves that are reflected from the
tympanic membrane in the ear. Several manufacturers make these
devices including Thermoscan, Omron and Vicks.
References
1. Public Law 94-295, U.S.C. x 321 (h).
2. FDA Review of Home-Use Devices. Updated February 1, 2003. www.fda.gov/cdrh/oivd/
doc-fdareview.html (accessed December 27, 2008).
3. Over the Counter Database. www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfIVD/Search.
cfm (accessed December 27, 2008).
4. Home Test Kits: Cholesterol. www.fda.gov/cdrh/oivd/homeuse-cholesterol.html (acces-
sed January 24, 2009).
5. ColonCare: Home Use Immunological FOB Test. www.careproductsonline.com/coloncare/
index.php (accessed January 24, 2009).
6. Clear Blue Easy Fertility Monitor. www.early-pregnancy-tests.com/clearblue.html
(accessed January 24, 2009).
7. Fertile-Focus. www.fertilefocus.com/ (accessed January 24, 2009).
8. OvaCue Fertility Monitor. www.zetek.net/ (accessed January 24, 2009).
9. Ov-Watch Fertility Predictor. www.ovwatch.com/ (accessed January 24, 2009).
10. Baby Start (Fertil MARKQ). www.testsymptomsathome.com/emb01.asp (accessed
January 24, 2009).
11. Micra. www.early-pregnancy-tests.com/spermtest.html (accessed January 24, 2009).
12. Fem-V. www.biospace.com/news_story.aspx?NewsEntityId¼59884 (accessed January
24, 2009).
13. Vagisil. www.vagisil.com/productinformation.shtml (accessed January 24, 2009).
14. UTI Home Screening Test Strip. www.utihometest.com/?OVRAW¼uti&OVKEY¼
uti&OVMTC¼standard&OVADID¼33566545512&OVKWID¼12424559012
15. Home-use Tests: Drugs of Abuse (First Check 12 Drug Test). Updates March 3, 2006.
www.fda.gov/cdrh/oivd/homeuse-drug-firstcheck 12.html (accessed January 12, 2009).
16. PDT-90 and Hair Confirm. www.testcountry.com/details.html?cat¼123 (accessed
January 27, 2009).
17. Alcohol tests. www.drugstore.com/search/search_results.asp?N¼0&Ntx¼mode%
2Bmatchallpartial&Ntk¼All&srchtree¼1&Ntt¼alcoholþtests&Go.x¼12&Go.y¼15
18. Body temperature. http://firstaid.webmd.com/body-temperature (accessed January 31,
2009).
19. Exergen. www.exergen.com/medical/TAT/2000c.htm (accessed January 31. 2009).
20. EarCheck. http://healthtestingathome.com/earcheckmiddleearmonitorec-2.aspx (acces-
sed January 31, 2009).
21. Menocheck. www.menocheck.com/pages/menochecknews.htm (accessed January 31,
2009).
3
Gastrointestinal system
The process of digestion begins when food enters the mouth and is chewed and
mixed with saliva from the salivary glands; this provides lubrication and
begins digestion by salivary enzymes. This bolus of food passes through the
pharynx and esophagus via the lower esophageal sphincter (LES) into the
stomach for further digestion. The LES closes, preventing reflux of the gastric
content into the esophagus, where it could cause irritation, and digestion
continues in the stomach.
The stomach wall contains cells that secrete acid, mucus, enzymes, and
hormones that affect digestion and motility. The bolus enters the small intes-
tine through the pyloric sphincter. Secretions from the intestinal mucosa
contain additional enzymes and hormones, affecting motility and enhancing
digestion. Secretions from the pancreas, liver, and gall bladder increase fluid
volume in the small intestine and further enhance digestion and absorption.
Nondigestible materials and metabolic waste products pass into the large
intestine for elimination.
Digestive problems affect a large number of people and produce a variety
of symptoms, including acid indigestion, upset stomach, sour stomach, heart-
burn, gastroesophageal reflux disease (GERD), nausea, vomiting, bloating,
intestinal gas, constipation, and diarrhea. When these symptoms are mild and
occur occasionally, self-care is appropriate. However, these symptoms also
occur in individuals who have peptic ulcer diseases, such as gastric ulcers,
duodenal ulcers, chronic gastritis, chronic GERD, and hiatus hernia; treat-
ment of these conditions requires supervision by a physician. Many of the
OTC drugs in this chapter may be used during treatment of these conditions
with prescription medications.
Other symptoms that may occur with the GI symptoms above require
immediate referral to a physician, including the presence of blood in the vomit
or stools, any difficulty in swallowing or breathing, or the presence of light-
headedness, sweating, or pain in the shoulder, arms, neck, or chest. These
symptoms indicate a serious condition that cannot be diagnosed by the indi-
vidual and are not amenable to self-care. Pregnant women and lactating
mothers should consult a physician before using any OTC drugs. OTC drugs
should not be administered to children 2 years of age or less unless a physician
has been consulted.
Acid indigestion, heartburn, GERD, relief of upset stomach

associated with overindulgence in food and drink
Antacids
Drug category and indications for use
Antacids provide relief from occasional heartburn, sour stomach, or acid
indigestion, and provide relief of upset stomach from food or drink.1,2
Monograph ingredients
Aluminum hydroxide, calcium carbonate, magaldrate, magnesium hydrox-
ide, magnesium oxide, sodium bicarbonate, and sodium citrate are the most
commonly used ingredients in antacid products.1 The neutralizing ability
varies among these drugs, with sodium bicarbonate, sodium citrate, and
calcium carbonate being the more effective neutralizers, followed by magne-
sium hydroxide and aluminum hydroxide.
All monograph antacids except sodium bicarbonate are approved for
symptoms related to upset stomach from overindulgence of food or drink
(hangover symptoms), and their use should be limited to 2 days for this
purpose. Sodium bicarbonate releases carbon dioxide, and if any undissolved
drug is ingested it can react with gastric acid, causing excessive distension of
the stomach and possible rupture.3 The Alka-Seltzer brand of sodium bicar-
bonate products is very popular, but the product intended for overindulgence
use, Alka-Seltzer Wake-Up Call, does not contain any sodium bicarbonate or
any antacid; it contains aspirin and caffeine.
Mode of action
Antacids chemically neutralize hydrochloric acid, an irritating substance
secreted into the stomach from cells in the gastric mucosa.
No more than the recommended dose should be taken within any 24 hour
period, or for more than 2 weeks without the supervision of a physician. If
symptoms are severe, occur frequently, or persist for more than 3 months,
referral to a physician is appropriate.
If the individual is taking a prescription drug, a physician or pharmacist
should be consulted because drug–drug interactions may occur. Many
antacids alter absorption of prescription drugs and should be administered
1 hour before or 2 hours after taking prescription drugs.1,4
Sodium bicarbonate and sodium citrate antacids exceed 5 milliequivalents
(140 mg) of sodium per daily dose and should not be used by individuals on
Gastrointestinal system | 35
salt-restricted diets. Tablets or powders containing sodium bicarbonate must

be added to at least 4 ounce (120 mL) of water and be dissolved before
ingestion.1 There may be some white residue at the bottom of the glass, but
this is not sodium bicarbonate and is safe to ingest. These products produce a
vigorous effervescence (bubbling) when carbon dioxide gas is produced; this
subsides when all the gas has been released.
Aluminum hydroxide has astringent properties and frequently causes con-
stipation. Magnesium compounds are soluble and frequently cause diarrhea.
Manufacturers combine aluminum hydroxide and magnesium hydroxide as
a mixture in an effort to balance the bowel effects of these two drugs, with
modest success. Magaldrate is a chemical compound of both aluminum and
magnesium hydroxides that does not have any particular advantage over
products that are physical mixtures. Calcium carbonate may cause consti-
pation and is also combined with magnesium antacids.1
Individuals with kidney disease should avoid magnesium antacids if they
contain more than 50 milliequivalents of magnesium unless under the super-
vision of a physician.1
Recommended doses
Antacids have a short duration of action. They should be administered 1 hour
after meals and as frequently as every 2 to 4 hours as needed. Doses vary
and depend on the acid-neutralizing capacity of the individual ingredients.
Table 3.1 contains dosage recommendations.
Products
Aluminum hydroxide (AlternaGEL), sodium bicarbonate (Alka-Seltzer Regu-
lar Strength, Alka-Seltzer Extra Strength, Alka-Seltzer Gold, Bromo-seltzer),
sodium citrate (Alka-Seltzer Heartburn Relief), calcium carbonate (Chooz,
Children’s Mylanta, Pepto-Bismol Children’s Chewable Tablets, Rolaids,
Tums, TumsEX, Tums Ultra, Tums Kids, Titralac), magaldrate (Riopan),
magnesium hydroxide (Milk of Magnesia), aluminum hydroxide and magne-
sium hydroxide mixtures (Maalox, Mylanta).
Table 3.1 Usual recommended doses for antacids
Antacid Over 12 years and 6–11 years 2–5 years

adult
Aluminum hydroxide 600–1200 mg Consult doctor Consult doctor
Calcium carbonate 500–1000 mg 400–800 mg 400 mg
Magnesium hydroxide/ 400–800 mg of each Consult doctor Consult doctor

aluminum hydroxide every 4 h
Sodium bicarbonate 2000 mg every 4 h 1000 mg ever 4 h Consult doctor

Some popular sodium bicarbonate products (Alka-Seltzer Original and

Alka-Seltzer Extra Strength) contain aspirin, a gastric irritant that may aggra-
vate an upset stomach and may cause gastric bleeding.
Some aluminum hydroxide and magnesium hydroxides contain alginic
acid and/or sodium alginate as a labeled inactive ingredient because neither
has any antacid activity. These substances float on top of the gastric contents
and block the LES to prevent acid reflux into the esophagus (GERD).
Gaviscon is an example of one of these products. Individuals who have
GERD should not lie down after eating as this will reduce the risk of devel-
oping heartburn symptoms.
Many individuals, especially women, purchase calcium carbonate formu-
lations that have a high calcium carbonate content, such as TumsEX (750 mg)
or Tums Ultra (1000 mg), for use as a source of calcium for bone health.
Viactiv Calcium Soft Chews contain calcium carbonate but it is marketed as a
source of calcium, not as an antacid.
Bismuth subsalicylate
Bismuth subsalicylate relieves symptoms of upset stomach caused by over-
indulgence in food and drink, including heartburn, nausea, fullness, belching,
and gas.5
Mode of action
Bismuth subsalicylate provides relief primarily by adhering to the mucosa of
the stomach and protecting it from direct contact with stomach acid. It has no
antacid ability.

Individuals taking anticoagulants (blood thinning drugs) should consult their
physicians before use; there may be a temporary darkening of the tongue and
stools from use of this drug. Bismuth subsalicylate products do not contain
aspirin but could cause an adverse effect in those allergic to aspirin. It should
not be used in children or teenagers who have or are recovering from chick-
enpox or flu-like symptoms (Reye’s syndrome warning).2,5,6
Reye’s syndrome occurs in children and adolescents under 18 years of age
after they have recovered from common viral infections. The risk of develop-
ing this condition is increased if aspirin and salicylate drugs are used.
Although Reye’s syndrome in relatively uncommon, it is a concern because
it affects the liver and brain and may cause death.
Recommended dose
Adults and children over age 12 may take 2 tablets (525 mg) every 30 to 60
minutes, but should not exceed eight doses within 24 hours; children aged 9 to
12 may take one-half the adult dose (1 tablet (262 mg); children aged 6 to 9
may take two-thirds of the adult dose (175 mg); children aged 3 to 6 may take
one-third of the adult dose (88 mg); children under age 3 require recommen-
dation by a physician.6
Products
Pepto-Bismol Caplets, Pepto-Bismol Chewable Tablets (Original), Pepto-
Bismol Suspension (Original). Names of products must be exact because
the manufacturer has similarly named products that have different active
ingredients. For example, Pepto-Bismol Children’s Chewable Tablets con-
tain the antacid calcium carbonate, while Pepto-Bismol Chewable Tablets
(Original) contain bismuth subsalicylate. All product labels for OTC drugs
must be read very carefully before choosing a particular product for use. This
situation occurs with many manufacturers and many OTC products.
Histamine H2-receptor blockers or antagonists

All H2-blockers take longer to relieve symptoms than antacids, but they have
a much longer duration of action. H2-blockers and antacids may be used
together.
The histamine H2-receptor blockers are used for temporary relief, or preven-
tion of symptoms of heartburn, indigestion, and sour stomach.
Rx–OTC switched drugs
Cimetidine, famotidine, nizatidine, and ranitidine are the H2-blockers avail-
able as OTC drugs. One formulation of famotidine combines it with calcium
carbonate and magnesium hydroxide, two antacids, to provide both fast and
prolonged relief. H2-blockers may be taken before or after meals to prevent or
treat GI symptoms.
Mode of action
The release of histamine in the body activates receptors, H2-receptors, on
parietal cells in the stomach to secrete a protein tyrosine kinase that activates
the enzyme hydrogen/potassium adenosine triphosphatase (Hþ/Kþ-ATPase).
This is an enzyme on the surface of the parietal cells that uses the energy
derived from ATP hydrolysis to drive the exchange of ions (hydrogen, chlo-
ride, and potassium ions) across the cell membrane. The net result is the
release of hydrogen ions into the stomach where they form hydrochloric acid.
The H2-blockers bind to the same receptors on the parietal cells as histamine,
preventing activation of these receptors and, ultimately, preventing the for-
mation of hydrochloric acid in the stomach. Since histamine is one of the most
potent stimulators of gastric acid in the body, H2-blockers are highly effective
drugs in relieving heartburn symptoms.
Table 3.2 Usual recommended doses for H2-receptor blocking drugs
Drug Dose (mg) Use
Cimetidine 200 Take with food or up to 30 min

before eating; maximum 2 doses
per day
Famotidine 10 or 20 Take 15–60 min before eating;

maximum 2 doses per day
Nizatidine 75 Take with meals or up to 60 min

before meal; maximum 2 doses
per day
Ranitidine 75 or 150 Take 30–60 min before eating;

maximum 2 doses per day

These drugs should not be taken for longer than 2 weeks or given to children
under 12 years of age. A physician should be consulted if the symptoms persist
or are more severe.
Cimetidine inhibits cytochrome P-450 enzymes and patients taking theo-
phylline, phenytoin, or warfarin should consult their physician before using
cimetidine.7 Pharmacists should probably recommend the other H2-antagonists
as a first choice instead of cimetidine because of its P-450 enzyme-inhibiting
action.
Recommended dose
Table 3.2 lists the dose for H2-blockers and their onset of action.
Products
Cimetidine (Tagamet HB), famotidine (Pepcid AC, 10 mg; Pepcid AC Maxi-
mum Strength, 20 mg), nizatidine (Axid AR), and ranitidine (Zantac 75 mg
and Zantac 150 mg), famotidine and calcium carbonate combination (Pepcid
Complete and Tums Dual Action).
Proton pump inhibitors

Proton pump inhibiting drugs (PPIs) are used for frequent heartburn, which is
defined as heartburn that occurs two or more days a week.
Omeprazole magnesium is the only OTC PPI available on the market at this
time; however, the FDA approved the switch of lansoprazole (Prevacid) from
Rx–OTC status in May 2009. It will probably be available in the near future.
Mode of action
The PPIs bind irreversibly to the Hþ/Kþ-ATPase pump in the parietal cell,
preventing secretion of acid into the stomach. Because the binding is irrevers-
ible, these drugs are the most effective acid reducers and are the preferred
drugs when heartburn symptoms are caused by GERD; however, it takes 1 to
4 days for them to achieve their maximum effect. The PPIs and H2-blockers
should not be taken together because both categories act by suppressing acid
secretion. Antacids may be used with PPIs.
The PPIs should not be taken for longer than 14 days or if symptoms persist
or worsen, without consulting a physician. They should not be used by
those under 18 years of age. PPIs may cause diarrhea, headache, abdomi-
nal pain, or a rash. Omeprazole magnesium inhibits the P-450 enzymes
CYP2C19 and CYP3A4 and should not be used without physician super-
vision by anyone taking warfarin, diazepam, digoxin, ketoconazole, or
itraconazole.8
Recommended dose
Omeprazole, 20 mg, should be taken daily with a glass of water for 14
consecutive days, 15 to 60 minutes before eating breakfast or the first meal
of the day. Omeprazole begins to produce its effect when parietal cells begin to
secrete hydrogen ions under stimulation by food; therefore, it is most effective
when taken before eating. This dosage regimen may be repeated once after 4
months if needed. If symptoms are not relieved after a second trial of 14 days
of treatment, a physician should be consulted.
The FDA is currently considering an Rx–OTC switch of the prescription
drug Zegerid. Zegerid combines omeprazole with sodium bicarbonate to
provide rapid heartburn relief from the antacid until the slower-acting omep-
razole reaches effective concentrations to produce a prolonged effect.
Product
Omeprazole magnesium (Prilosec OTC).
Gas and bloating

Antiflatulents
Antiflatulents are intended to relieve symptoms of gas, which include the
sensation of abdominal distention, pressure, bloating, feeling of fullness,
and belching. Swallowing of air during talking, eating or drinking is a fre-
quent cause of gas. Individuals who experience heartburn, acid indigestion,
and upset stomach problems complain that these symptoms are accompanied
by gas and belching.1
Simethicone is the only antiflatulent approved in the FDA’s monograph as a
single ingredient and as an ingredient that may be combined with antacid
formulations.1
Infant colic is a relatively common condition characterized by excessive
crying, passing of gas, and assumed gastric distress because the infant draws
its legs inward to the abdomen. Simethicone has been used together with
alterations in the infant’s diet to alleviate this condition. Unfortunately, con-
trolled studies have failed to prove the efficacy of simethicone over placebo in
treating infant colic. However, simethicone’s lack of adverse effects and the
lack of any other clear treatment for infant colic are reasons for its continued
use in this condition.9
Mode of action
Simethicone reduces the surface tension of gas bubbles present in the stomach,
causing them to break up into smaller ones that can be expelled from the GI
tract more easily. Simethicone has no antacid activity but it is combined with
antacids because gas is a frequent symptom that occurs when heartburn is
present.1

The only warnings for simethicone are not to exceed the recommended dosage
on the label in a 24 hour period unless directed to do so by a physician.
Recommended dose
Simethicone should be taken after meals and before bedtime. The dose for
infants under 2 years of age, or less than 24 lbs (10.9 kg) is 20 mg, with a
maximum of 240 mg daily; for infants over 2 years of age or 24 lbs, the dose is
40 mg with a maximum of 480 mg. The maximum daily dosage for adults and
children over 12 years is 500 mg per day, and single dose recommendations
range from 80 to 180 mg.10
Products
Simethicone (Mylicon Infant Drops, Phazyme Maximum Strength Chewable
Tablets and Softgel Capsules, Mylanta Gas Maximum Strength Chewable
Tablets and Softgel Capsules, and Gas X Thin Strips, Chewable Tablets and
Softgel Capsules).
Alternative therapy
Alpha-galactosidase
Alpha-galactosidase is an enzyme that the FDA has approved as a food
additive dietary supplement to treat bloating and intestinal gas.
Mode of action
Alpha-galactosidase helps to metabolize oligosaccharides, which are large
complex carbohydrate molecules that occur in high fiber foods such as beans,
to simpler sugar molecules before they reach the large intestine. Complex
carbohydrates are metabolized by bacteria present in the large intestine,
producing gas.11

One product that contains alpha-galactosidase, Beano, contains a small
amount of gluten, and individuals who are sensitive to gluten should consult
their physician before use.11
Recommended dose
Alpha-galactosidase should be taken immediately before meals or with
meals containing foods that produce gas symptoms. The amount of enzyme
to be taken depends on the amount of food to be eaten, and specific direc-
tions are on product labels. Alpha-galactosidase is available as oral tablets
or as powder or liquids to be added to foods before eating. Cooking foods
with alpha-galactosidase will reduce or destroy its enzyme activity. It is not
recommended for use in children under 12 years of age without a physician’s
supervision.
Products
Alpha-galactosidase (Beano tablets and liquid).
Peppermint oil
Peppermint oil is an aromatic oil that is a GRASE drug and has been used to
treat abdominal fullness and bloating.
Mode of action
Aromatic oils are thought to relax muscles in the GI tract to produce their
effect. Recent evidence demonstrated that peppermint oil relaxes muscle of
the LES and is thought to reduce tension created in the stomach from any gas
that is present. If this is indeed the mode of action of peppermint oil, it may
actually worsen symptoms of heartburn and indigestion caused by gastric
reflux (GERD). Peppermint oil is used as a flavoring agent in low doses,
including in many antacid and antiflatulent suspensions and tablets.
Peppermint oil as a flavoring agent probably has very little effect on LES
pressure.12

When peppermint oil is used in high doses, it may cause nausea, heartburn,
and perianal burning.
Recommended dose
Adult doses range from 0.2 to 0.4 mL up to three times a day; doses for
children over 8 years of age range from 0.1 to 0.2 mL up to three times
a day.
Product
Peppermint oil.
Nausea and vomiting

Nausea and vomiting have many causes, including local irritation of the gastric
mucosa, alterations of gastric motility, and stimulation of the brain by several
mechanisms. Several neurotransmitters are involved in producing emesis,
including acetylcholine, dopamine, and serotonin (5-hydroxytryptamine).
The common causes of nausea and vomiting that are self-diagnosed and
self-treated are motion sickness and local irritation from food and drink.
Vomiting causes both fluid and electrolyte loss; if it persists for more than
24 to 48 hours, an individual should consult a physician.
Antiemetics for motion sickness

Antiemetics are drugs that prevent or treat nausea, vomiting and/or dizziness
associated with motion sickness. Motion sickness involves stimulation of
nerves of the vestibular apparatus (semicircular canals) of the inner ear,
which are responsible for maintaining balance and equilibrium. Signals from
the vestibular nerves stimulate cholinergic centers in the vomiting center of
the medulla of the brain and this activates cranial nerves and causes muscles
in the GI tract to expel gastric content. Vertigo causes some symptoms that
are similar to motion sickness, but there are other causes of vertigo that
require diagnosis by a physician. Only motion sickness is a self-treatable
condition.13
Motion sickness is usually precipitated by riding in any type of motor
vehicle, train, boat, or airplane. Amusements rides, especially those with
circular motion, are likely to cause motion sickness.
All of the OTC antiemetics are antihistamines that have anticholinergic
activity. These drugs block the action of acetylcholine both centrally in the
brain and peripherally in the parasympathetic nervous system.
OTC antiemetics include cyclizine, dimenhydrinate, diphenhydramine, and
meclizine.

These antiemetics may cause drowsiness and should not be used with alcohol,
sedatives, or tranquilizers. Caution is required if driving a motor vehicle or
operating machinery when using these drugs. The degree of drowsiness
depends on the specific chemical structure of the drug, dimenhydrinate and
diphenhydramine causing the greatest degree of drowsiness. Meclizine causes
the least drowsiness and some of its products contain the words ‘less drowsy’
in their names.13
These drugs should not be taken unless directed by a physician by anyone
who has breathing problems (such as shortness of breath, emphysema or
chronic bronchitis), glaucoma, or difficulty in urination owing to enlargement
of the prostate gland.
Recommended dose
Antiemetics should be taken 30 to 60 minutes before engaging in the activity
that causes motion sickness. Recommended dosages for these drugs are listed
in table 3.3.
Products
Cyclizine (Marezine, Bonine for Kids), dimenhydrinate (Dramamine), diphen-
hydramine (Benadryl), and meclizine (Bonine, Dramamine Less Drowsy).
Alternative therapy: ginger

Ginger is a dietary supplement that is a GRAS drug and used to treat nausea
and vomiting; it may have some effect in preventing motion sickness. Ginger
Table 3.3 Usual recommended doses for motion sickness drugs
Drug Age (years) Dose
Cyclizine 6–12 25 mg, 6–8 h
Over 12 and adults 50 mg, 4–6 h
Dimenhydrinate 2–6 12.5–25 mg, 6–8 h
6–12 25–50 mg, 6–8 h
Over 12 and adults 50–100 mg, 4–6 h
Diphenhydramine 6–12 12.5–25 mg, 4–6 h
Over 12 and adults 25–50 mg, 4–6 h
Meclizine Adults only 25–50 mg, once daily

has demonstrated effectiveness for nausea and vomiting associated with

pregnancy, but no medications should be recommended for pregnant women
without the approval of their physician.
Mode of action
Ginger inhibits serotonin receptors in the GI tract and the brain and may
prevent both local and central stimulation of nerves that cause vomiting.14
Ginger may cause heartburn, diarrhea, or irritation of the oral mucosa. It may
increase the risk of bleeding if an individual is taking warfarin.
Recommended dose
Powered ginger 250–1000 mg up to four times a day.
Product
Ginger powder.
Phosphorylated carbohydrates
Concentrated carbohydrates may relieve nausea associated with upset stom-
ach or intestinal flu.
Mode of action
Phosphorylated carbohydrates are theorized to alter gastric emptying to
provide relief but the actual mode of action is unknown.13 A common home
remedy for nausea is the use of concentrated coke syrup and its use is based on
this same theory.
Phosphorylated carbohydrate products contain 1.87 g glucose and fruc-
tose (levulose) and 21.5 mg phosphoric acid per 5 mL. Individuals who
have diabetes should not use these products without consulting their
physicians; individuals who have fructose intolerance should not use these
products.15
Recommended dose
Children 2 to 12 years of age may take 5 to 10 mL every 15 minutes until
symptoms subside, but should not take more than five doses in an hour; adults
and children over 12 years of age may take 15 to 30 mL every 15 minutes until
symptoms subside, but also should not take more than five doses in an hour.
Phosphorylated carbohydrates should not be diluted with liquids before
ingestion.15
Products
Phosphorylated carbohydrates (Emetrol and Nausetrol).
Devices for preventing or treating nausea

Mechanical devices
Activation of certain pressure points in the body based on Chinese acupunc-
ture and acupressure, P6 or nei-kuan have demonstrated the ability to sup-
press nausea.16 The FDA approved two types of device for motion sickness
and for nausea associated with pregnancy (morning sickness).
Mode of action
Adjustable wrist bands containing a bead are placed on the underside of both
wrists to create acupressure by the bead. The amount of pressure is adjustable
and the bands should be used approximately 5 minutes before travel or mo-
tion begins.
Products
Sea-Band and Psi Band. These devices cost less than $10.00.
Electronic devices
Mode of action
A battery-powered wrist band provides an electronic pulse to the underside of
the wrist to prevent nausea. A conductivity gel must be applied to the wrist
before wearing the device. The device is adjusted so that a pulse or tingling
feeling is felt in the palm of the hand or in the middle fingers.17

The device should not be used if the individual has a cardiac pacemaker. The
device also contains latex and should not be used by anyone having a latex
allergy. Mild skin irration may occur. If the irritation is not relieved in 24
hours, a physician or pharmacist should be consulted. The device is not
waterproof and should not be submerged in water.17
Product
Relief Band. This device costs $130.00.
Poison treatment drug products

Ipecac syrup
Accidental oral ingestion of toxic substances has many potentially serious
adverse effects, including death. As long as the ingested substance remains in
the GI tract, it continues to be absorbed into the blood stream and will be
distributed to all body tissues. Emptying the stomach contents as soon as
possible, within 60 to 90 minutes at the latest, reduces the amount of toxin
available for absorption. Gastric lavage and vomiting are two mechanisms to
remove contents from the stomach.
There is considerable debate as to the overall effectiveness of ipecac within

the medical community. The FDA held a meeting of its advisory committee in
2003 to discuss continuing its general recommendation for using ipecac syrup
in poisoning situations. Discussions also considered continuing the OTC
availability of ipecac because of the potential for abuse by individuals who
have eating disorders like bulimia. The FDA has not issued any report or
recommendations based on this meeting, and its original approval of ipecac
syrup continues.
The American Association of Poison Control Centers issued guidelines in
2005 for using ipecac syrup in treating poisoning victims outside hospital
settings. Included among those recommendations were that universal recom-
mendations for ipecac use should be avoided except under the following
conditions: (1) there are no contraindications to its use; (2) the risk of injury
to the individual from the toxin is substantially greater than the risk associ-
ated with ipecac syrup use; (3) the individual would not be able to get emer-
gency treatment within an hour; (4) the ipecac syrup could be administered
within 90 minutes of ingestion of the toxin; and (5) no alternative treatment is
available for the individual. The Association was not in favor of promoting
households to maintain a supply of ipecac syrup. They did not take any
position regarding keeping ipecac syrup as an OTC or restricting its use.18
Ipecac syrup is intended for emergency use to cause vomiting of swallowed
poisons.18
Ipecac syrup is approved by the FDA and restricted for sale to 1 ounce con-
tainers for OTC use.
Mode of action
Ipecac syrup contains the alkaloids cephaeline and emetine, which cause local
irritation of the stomach mucosa and stimulate the vomiting center in the
brain via the chemoreceptor zone. Emetine has the potential to cause cardiac
and renal toxicity in excess dose or long-term use.
Ipecac syrup or other emetics should never be used in semiconscious or
unconscious individuals, nor should they be used in individuals who are
uncooperative or who have any blockage of their airway. Vomiting should
not be induced in individuals who have ingested caustic or corrosive substance
or products containing petroleum distillates, such as kerosene, gasoline, paint
thinner, cleaning fluid, furniture polish, or turpentine. Caustics and corro-
sives, include alkali (lye) and strong acids, produce damage to the mucosa of
the mouth, pharynx, and esophagus during swallowing that will be exacer-
bated during vomiting. Vomiting may result in aspiration of the vomitus
into the lungs and may result in lipid pneumonia if petroleum products are
aspirated. Milk should not be taken with ipecac syrup.19
Recommended dose
Before administering ipecac syrup, attempts should be made to contact a
poison control center, emergency medical facility, or health professional.
Infants under 6 months of age should not be given ipecac syrup unless
directed by a health professional. Infants aged 6 months to 1 year of age
may be given 5 mL of ipecac syrup mixed with 4 to 8 ounces (120–240 mL) of
water or clear liquid; children between age 1 and 12 years of age may be
given 15 mL of ipecac syrup mixed with 8 to 16 ounces (240–480 mL) of
water or clear liquid; children over 12 years of age and adults may be given
30 mL with 8 to 16 ounces (240–480 mL) of water or clear liquid. If indivi-
duals do not vomit within 20 minutes, a second dose of ipecac syrup may be
administered.19
Individuals should not be given activated charcoal until vomiting occurs.
Individual should be kept active and moving if possible.
Activated charcoal
Activated charcoal is used to adsorb swallowed poisons in emergency
situations.19
Mode of action
Activated charcoal particles possess a very large surface area. Toxins present
in the GI tract will adhere to its surface, preventing or reducing their absorp-
tion into the blood stream. The drug and adsorbed toxin are eliminated via the
feces. Not all toxins are absorbed by activated charcoal.

Activated charcoal should not be given to an individual until vomiting has
occurred unless directed by a health professional; it should not be adminis-
tered to individuals who are not fully conscious or individuals with an intes-
tinal blockage. It should not be used if the individual has ingested turpentine;
corrosives, such as alkali (lye); strong acids; petroleum distillates, such as
kerosene or gasoline; paint thinner; cleaning fluid; or furniture polish unless
directed by a health professional. Individuals should be informed that bowel
movements will be black in color.19
Recommended dose
Attempts should be made to contact a poison control center, emergency
medical facility or health professional before administering activated char-
coal. As soon after the toxin is ingested as possible or as directed by a health
professional, 20 to 30 g of powdered activated charcoal is given in a minimum

of 8 ounces (230 mL) of water. Activated charcoal remains as a suspension
and should be shaken well before use. Some products are flavored suspensions
that improve palatability, which may promote greater acceptance by indivi-
duals, especially children, to drink the product. Ipecac syrup and activated
charcoal should not be used at the same time.19
Products
Activated charcoal (ActiDose Aqua, ActiDose with Sorbitol, EZ-Char, Liqui
Char and Insta-Char).
Prevention
Some common sense actions can prevent accidental ingestion of drugs and
household substances by young children, who are the individuals involved
most frequently in accidental poisonings: all medications and household clean-
ing supplies should be stored out of reach of children (tall or locked cabinets);
children’s medications, including vitamins, should not be promoted as being
like or tasting like candy; the physician’s telephone should be posted in a
convenient place for emergency use; the local poison control center’s telephone
number should be posted in the same place, as should the number of the
national poison control number, 1–800–222–1222; the container of the prod-
uct should be in your hand when making telephone calls so that the product’s
exact name and ingredients can be readily identified; the product should be
taken with you to the emergency room once you have found out which hospital
in your area is best able to handle your specific problem.
Pinworms
Pryantel pamoate
An OTC anthelmintic drug is used to treat infestation by pinworms
(Enterobiasis vermicularis). No other worm infestation is amenable to OTC
treatment.20
Pinworms inhabit the small and large intestine after oral ingestion of the
larvae. The larvae mature and remain in the intestine for their lifetime. The
female pinworm migrates down the intestinal tract during the night and
deposits her eggs in the large intestine and around the anal sphincter. This
causes intense nocturnal anal itching, the characteristic symptom associated
with this condition. Female pinworms are approximately 0.25 to 0.5 inches
(0.63–1.25 cm) in length and can be seen at the anal sphincter area during the
night. They may also be present in the stools and appear as white, threadlike
contaminants.
Scratching because of the intense itching contaminates fingers and hands

and can be a source of re-entry into the body if hand and fingernail beds are
not thoroughly cleaned. Larvae may survive for up to 3 weeks in contami-
nated clothing, bedding, and bath towels, and on other surfaces.
Pinworms usually affect young children and it is not uncommon for an
entire family to become infected. Infected individuals should wear tight-fitting
underwear to reduce contamination, and clothing and bedding must be
washed in hot, soapy water. Items that are handled by individuals with pin-
worms must be disinfected, especially areas in the bathroom such as the toilet
seat, tub or shower, and all faucet and door handles.
Mode of action
Pyrantel pamoate acts as a depolarizing neuromuscular blocker in the pin-
worm. It prevents the worm from clinging to the intestinal mucosa to obtain
its nutrients and so it dies. There is no need to use laxative products to remove
the affected pinworms from the GI tract.20
Abdominal cramps, nausea, vomiting, diarrhea, headache, or dizziness may
occur after taking pyrantel pamoate, and a physician should be consulted if
the condition persists. The drug should not be taken by those with liver disease
unless directed by a physician.20
Recommended dose
The dose for adults and children aged 2 years and older is based on the
individual’s weight and is 11 mg per kilogram (5 mg per pound) body weight.
The maximum dose is 1 g. A single oral dose is required, and the entire family
should be treated at the same time. If there is a recurrence of pinworms, a
second dose should not be taken unless advised to do so by a physician.20
Products
Pyrantel pomoate (Reese’s Pinworm as capsules or liquid; Pin X as liquid and
chewable tablets).
Laxatives
Once digestion and absorption of food are completed, waste products move
through the small intestine into the large intestine, where the fecal mass is
temporarily stored until defecation occurs. This passage of waste material
through the GI tract depends on many factors, but the two most important
factors are GI motility and absorption of fluids, primarily water.
Gastric motility is affected by the physical bulk of foods in the diet, the
appropriate functioning of the autonomic nervous system, both sympathetic
and parasympathetic, hormones, and other substances secreted by the body.
If enough bulk, both solid and liquid, is not present in the lumen of the
intestines, receptors in the mucosal lining cannot be activated to move the

ingested mass along the GI tract.
The sympathetic nervous system controls slow segmental waves for mix-
ing materials that have been ingested, and the parasympathetic nervous sys-
tem controls peristaltic waves that move the ingested material through the GI
tract. The parasympathetic nervous system has a more prominent role in
overall GI motility than the sympathetic nervous system.
Hormones and other substances secreted by the body’s tissues and organs
may increase or decrease motility along the GI tract and may increase or
decrease secretions into the GI tract. The major GI hormones include gastrin,
which is secreted by the stomach and stimulates gastric acid and enzyme
secretions and increases GI motility; secretin, which is secreted by the small
intestine and stimulates the pancreas, gall bladder and liver to increase secre-
tions; and cholecystokinin, which is secreted by the small intestine and slows
gastric emptying. The intestine also produces gastric inhibitory peptide,
which inhibits gastric acid secretion and gastric motility, and motilin, which
stimulates intestinal motility.21
The normal balance of these substances allows movement through the GI
tract at a rate that permits adequate absorption of nutrients, water, and other
fluids. Contents from the stomach have a thin, liquid consistency as they enter
the small intestine, where secretions from the liver and gall bladder are added
to the duodenum, the first portion of the small intestine. As the mass contin-
ues through the duodenum into the jejunum and ilium, the other two portions
of the small intestine, most nutrients and fluids are absorbed. The mass be-
comes less liquid as it reaches the large intestine (colon), where excess water is
absorbed, and the semisolid feces remains in the colon until evacuation
occurs. The daily volume of fluid entering the GI tract is approximately
7000 mL, which is reduced to approximately 100–200 mL of feces ultimately
excreted.21
A bowel movement (defecation) is achieved by stimulation of stretch
receptors in the large intestine and activation of muscles that push the fecal
material through the anal sphincter to eliminate the body’s solid waste.
The process of digestion, absorption, and elimination of ingested nutrients
is a complicated process involving many factors that must be evaluated before
deciding the type of laxative appropriate for solving an individual’s problem
of constipation. The categories of drug used to treat constipation include
agents that provide bulk and agents that alter GI motility either directly or
indirectly. Table 3.4 describes general characteristics of the different types of
laxative.
Any abrupt change in eating habits may be a cause of constipation.
Traveling though different time zones changes the time that meals are con-
sumed as well as sleeping patterns, and changing the type of food eaten or the
volume of fluids ingested also affects bowel habits. Many prescription and
Table 3.4 Characteristics of laxatives
Laxative category Approximate onset of action Effect on electrolyte loss
Bulk formers 2–72 h Minimal
Lubricants 6–8 h Minimal
Hyperosmotics or saline laxatives 2–6 h Maximum
Osmotics (PEG 3350) 12–72 h Minimal to moderate
Stimulant (irritant or secretory) 6–12 h Moderate
Stool softeners (docusate) 12–72 h Minimal
Enemas 2–15 min Minimal
Suppositories
Glycerin 15–60 min Minimal
Carbon dioxide 5–30 min Minimal
Bisacodyl 15–60 min Minimal
OTC drugs reduce GI motility, including opioid analgesics, codeine cough

suppressants, antihypertensive medications, antihistamines, antidepressants,
diuretics, and antacids. Many common medical conditions may cause consti-
pation, including intestinal obstruction, hypothyroidism, diabetes, Parkinson’s
disease, spinal cord injuries, and multiple sclerosis.
Constipation is a common complaint among the elderly. Several factors
may contribute to constipation including an age-related decrease in GI motil-
ity, decline in physical activity and a more sedentary lifestyle, and dietary
choices.
Any change in normal bowel habits that causes persistent constipation or
diarrhea not associated with any of the previous situations warrants a recom-
mendation to a physician for evaluation. Sudden and persistent changes in
bowel habits are frequently the first symptoms of colon cancer in many
individuals.
Bulk laxatives
Monograph laxatives
Laxatives are drugs that are intended for the short-term relief, 1 week, of the
symptoms of constipation. A common misconception is in the definition
of constipation. The FDA monograph definition includes the following:
(1) infrequent bowel movements; (2) difficulty or pain in during defecation;

and (3) excessive dry or insufficient quantity of stools. A common misconcep-
tion is that a bowel movement is required daily. Medically, the frequency may
range from three bowel movements a day to three per week. If an individual
experiences a sudden change in bowel habit that lasts for 2 weeks or more, a
physician should be consulted because this is often a symptom associated with
a more serious condition such as obstruction or colon cancer.22
Mode of action
Bulk laxatives are replacements for lack of foods containing fiber, such as fruit
and vegetables, in an individual’s diet. The daily diet should contain approx-
imately 25 to 50 g fiber. The lack of bulk results in failure of activation of
receptors necessary for defecation. Dietary bran, guar gum, psyllium (plan-
tago seed), cellulose and methylcellulose, malt soup extract, polycarbophil,
and polycarbophil calcium are OTC monograph bulk laxatives.22
Psyllium also appears in many food products, especially cereals. Fiber
binds fats and lipids from foods, and soluble fiber such as oatmeal is more
effective than insoluble fiber like psyllium in this process. This reduction of fat
and lipid absorption in the GI tract may reduce cholesterol levels, and the FDA
allows fiber products in foods to make claims for heart health.
Bulk laxatives have a slow onset of action and may take 1 to 3 days for
maximum effect. Because they are replacing fiber normally consumed in the
diet, they may be used for more than the 7 days period of use recommended
for most other laxatives if the cause of constipation is lack of dietary fiber.
Some of the causes of lack of dietary fiber are poor food choices by indivi-
duals, inability to chew foods that have a high fiber content, inability to digest
fiber and/or the creation of intestinal gas, and the cost of some high fiber
foods.
Warning and precautions
Taking bulk laxatives without adequate fluid may cause them to swell and
block the throat or esophagus, causing choking. These products should not be
taken by individuals who have difficulty swallowing. Immediate medical
attention should be sought if chest pain, vomiting, or difficulty in swallowing
or breathing is experienced after taking these products; if there is no bowel
movement; or if abdominal discomfort and pain persist. Inadequate fluid
intake while using bulk laxatives may lead to intestinal blockage or ob-
struction.23
The bulk laxatives should not be used when abdominal pain, nausea, or
vomiting is present. If any blood appears in the stool or vomit, a physician
must be consulted because self-care is not appropriate.
Cellulose and methylcellulose should not be taken without consulting a
physician or pharmacist if an individual is taking salicylate drugs or prescrip-
tion drugs because of possible drug interactions.
Recommended dosage
All powdered products should be mixed with at least 6 ounces (170 mL) of
water or other fluid-like juices. If tablets or wafers containing bulk laxatives
are used, they should be followed by an increased intake of fluids. Doses for
bulk laxatives appear in table 3.5.
Table 3.5 Usual recommended doses for oral laxatives; all drugs are taken as one
single dose in a day
Drug Over 12 years and adult 6–11 years 2–5 years
Bulk laxatives
Bran 6–14 g Consult doctor Consult doctor
Methylcellulose 4–6 g 1–1.5 g Consult doctor
Malt soup extract 12–64 g 12–64 g 12–64 g
Polycarbophil 4–6 g 1.5–3 g 1–1.5 g
Psyllium 2.5–30 g 1.25–15 g Consult doctor
Lubricant laxatives
Mineral oil 15–45 mL 5 mL Consult doctor
Hyperosmotic/saline laxatives
Magnesium citrate 11–25 g 5.5–12.5 g 2.7–6.25 g
Magnesium 2.4–4.8 g 1.2–2.4 g 0.4–1.2 g

hydroxide (MOM)
Mixed sodium 20–45 mL Age 10 & 11: 10–20 mL; Consult doctor
phosphates age 5–9: 5–10 mL
Stimulant (irritant) laxatives
Bisacodyl 5–15 mg 5 mg Consult doctor
Castor oil 15–60 mL 5–15 mL 5–15 mL
Senna (sennosides A 12–50 mg 6–25 mg 3–12.5 mg

and B)
Stool softeners
Docusate calcium 50–360 mg 50–150 mg 50–150 mg
Docusate sodium 50–360 mg 50–150 mg 50–150 mg
Osmotic laxative
Polyethylene glycol 17 g restrict to age 18 and Consult doctor Consult doctor

(PEG) 3350 over
Products
Guar gum (Benefiber), malt soup extract (Maltsupex), methycellulose (Citrucel),
polycarbophil (Equalactin), polycarbophil calcium (Fiber Con tablets, Konsyl
Fiber caplets, and Perdiem fiber therapy caplets), and psyllium (Konsyl, Konsyl
for Kids and Metamucil).
Lubricant laxatives
Plain mineral oil or emulsified mineral oil emulsions are monograph laxatives
for short-term relief (1 week) of constipation.
Mode of action
Lubricant laxatives mix with the contents of the intestinal tract to make
elimination of the stool easier.
Lubricant laxatives should not be used in children under 6 years of age, in
pregnant women, in bedridden or aged individuals, in individuals who have
difficulty in swallowing, or individuals who are experiencing episodes of
vomiting or abdominal pain. If an individual has a problem with fecal incon-
tinence, leakage of stool through the anal sphincter may occur with use of
mineral oil laxatives. Mineral oil products should not be used with stool
softeners.22
Recommended dose
Emulsifier mineral may be administered during the day or at bedtime, but
plain mineral oil should only be administered at bedtime. See table 3.5 for
doses.
Products
Mineral oil (many generic manufacturers; Fleet Mineral Oil Enema), emulsi-
fied mineral oil (Kondremul). All enemas should be administered while the
individual is lying on their left side.
Hyperosmotic and/or saline laxatives

Hyperosmotic and saline laxatives may be used occasionally for relief of
constipation.
Mode of action
Hyperosmotic and saline laxatives greatly increase the osmotic pressure in the
lumen of the intestinal tract and water is drawn into the intestine to equalize
pressure. This causes a rapid response in stretch receptors that usually results
in watery bowel movements.
Glycerin is classified as a hyperosmotic laxative and is restricted to rectal

use. Magnesium citrate, magnesium hydroxide, magnesium and mixed phos-
phate salts (sodium phosphate and sodium biphosphate), all inorganic salts,
are classified as saline laxatives and are administered orally. Mixed phosphate
salts may also be used rectally.
Warnings and/precautions
Hyperosmotic and saline laxatives should not be used if abdominal pain,
nausea, or vomiting is present. If any blood appears in the stool, a physician
must be consulted because self-care is not appropriate.22
Excessive use of oral hyperosmotic laxatives may result in dehydration in
individuals who do not maintain an adequate intake of daily fluids; this can
lead to hospitalization and even death. The very young, the elderly, and gen-
erally frail individuals are at greatest risk for dehydration. An 8 ounce (230 mL)
glass of fluid should be taken with every oral dose of a hyperosmotic drug.
Magnesium citrate solution should be stored in a cold place (refrigerator)
to prevent degradation of the drug and to increase its palatability. Most
hyperosmotic laxatives have a disagreeable taste, which may limit their use-
fulness. If the daily dose of magnesium exceeds 600 mg and the individual has
kidney disease, a physician should be consulted before use.
If the individual has kidney disease, oral phosphate laxatives should not be
used without the supervision of a physician. If the daily dose contains more
than 115 mg of sodium, a physician should be consulted if the individual is on
a low sodium diet. The FDA restricts the packaging of oral phosphate solution
to 3 ounces (80 g) to prevent serious adverse effects.24
Oral phosphates were recommended frequently by physicians when a
thorough bowel cleansing before colonoscopy or bowel surgery was required.
The FDA issued a safety alert for both OTC and prescription oral phosphates
use for bowel cleansing in December 2008. The FDA received reports of acute
phosphate nephropathy and now requires a special warning on all oral phos-
phate prescription products.25 The FDA alert does not affect the status of
rectal phosphate products.
C.B. Fleet Laboratories, a major manufacturer of OTC oral phosphates
solution (Phospho-Soda), voluntarily removed its oral products from the
market except Fleet Phospho-Soda EZ Prep Bowel Cleansing. The FDA has
not issued any recall for oral phosphate products, either OTC or prescription
products. Some generic manufacturers may still have oral phosphate solutions
on the market.
Glycerin is restricted to rectal use as a suppository or enema, and it may
cause some rectal burning after insertion into the rectum.22
Recommended dose
Oral dosing for hyperosmotic drugs appears in table 3.5. Glycerin supposi-
tories should not be used in children under 2 years of age unless supervised by
a physician. Suppositories with 1 to 1.7 g glycerin may be used in children

aged between 2 and 6 years and are inserted rectally. (These suppositories are
referred to as infant suppositories.) Suppositories with 2 to 3 g of glycerin are
intended for use in children over 6 years of age and for adults. Glycerin
enemas containing 2 to 5 mL may be administered to children 2 to 5 years
of age, and enemas with 5 to 15 mL of glycerin may be used in children age
6 years or over and in adults.
A daily dose of mixed phosphate enemas may contain approximately 7 g of
dibasic sodium phosphate and 19 g of monobasic sodium biphosphate in 4
ounces (115 mL) of fluid for adults and children aged 12 years and older, and
doses of 3.5 g and 9.5 g, respectively, in 2 ounces (58 mL) of fluid for children
aged 2 to 11 years of age.22
Products
Glycerin suppositories and enemas (many generic manufacturers, Pedia-Lax
Liquid Glycerin Suppositories (formerly named BabyLax), and Pedia-Lax
Glycerin Suppositories), magnesium hydroxide (Philip’s Milk of Magnesia,
Freelax, and Pedia-Lax Chewable Tablets), and mixed phosphates (Fleet
Saline Enema and Fleet Pedia-Lax Enema).
Stimulant laxatives (secretory or irritant) laxatives

Stimulant laxatives are for short-term relief (1 week) of occasional consti-
pation.
Mode of action
Stimulant laxatives promote bowel movements by acting on the mucosal wall
of the intestine, hence the name irritant. They may increase secretions into the
intestine that stimulate stretch receptors to cause defecation, hence the name
secretory or stimulant. Bisacodyl, castor oil, and senna are classified as stim-
ulant laxatives. Castor oil acts on both the small and large intestine, causing a
more watery bowel movement, and should not be recommended because it is
more likely to cause dehydration than the other stimulant laxatives.

Stimulant laxatives should not be used when abdominal pain, nausea, or
vomiting is present. If any blood appears in the stool, a physician must be
consulted because self-care is not appropriate.
Bisacodyl tablets are enteric coated and should not be crushed or chewed;
they should not be taken with milk or within 1 hour of ingesting antacids or
milk (dairy) products. Abdominal discomfort or cramps may occur, and
burning may occur during defecation. The stimulant laxatives are stored at
temperatures lower than 86 F (30 C).
Recommended dose
Oral doses for stimulant laxatives appear in table 3.5. Bisacodyl may be used
as a single 10 mg suppository daily in children 6 to 12 years of age and in
adults; a 5 mg suppository may be used daily in children between 2 and 5 years
of age.
Products
Bisacodyl (Dulcolax tablets and suppositories, ExLax Ultra Stimulant
Laxative, Correctol, and Carter’s Laxative), senna (Senokot, ExLax Regular
Chocolate, and Pedia-Lax Quick Dissolve Strips).
Stool softeners
Stool softeners are intended for short-term relief (1 week) of constipation
unless supervised by a physician.
Many physicians recommend long-term use of stool softeners in geriatric
patients or patients who requires opiates for pain. Docusate calcium, docusate
potassium, and docusate sodium are classified as stool softeners.
Mode of action
Stool softeners act as surface active agents (detergents) that can penetrate dry,
hard stools in the large intestine to soften the stool for easier elimination.

Stool softeners should not be used when abdominal pain, nausea, or vomiting
is present. If any blood appears in the stool, a physician must be consulted
because self-care is not appropriate. Stool softeners should not be used with
mineral oil or prescription drugs without consulting a healthcare profes-
sional.22
Special warnings for docusate potassium include: ‘Do not use this drug if it
contains more than 975 mg of potassium in the daily dose if you have kidney
disease without supervision by a doctor.’
Special warnings for docusate sodium include: ‘Do not use this drug if it
contains more than 345 mg of sodium in the daily dose if you are on a low salt
diet without supervision by a doctor; do not use this drug if you have kidney
disease without supervision of a doctor.’
Recommended dose
See table 3.5.
Products
Docusate calcium (Kaopectate Stool Softener Liquigels), docusate potassium
(generic products), and docusate sodium (Colace, Pedia-Lax Liquid Stool
Softener, and Sof-Lax).
Carbon dioxide
Carbon dioxide suppositories are intended for short-term relief of consti-
pation.
Mode of action
When suppositories containing sodium biphosphate (1.2 to 1.5 g), sodium
acid phosphate (0.04 to 0.05 g), and sodium bicarbonate (1 to1.5 g) or sodium
bicarbonate (0.6 g) and potassium bitartrate (0.9 g) are used rectally, they
produce a chemical reaction that releases carbon dioxide gas. The carbon
dioxide gas expands, resulting in stimulation of stretch receptors to initiate a
bowel movement.
Recommended dose
Adults and children age 12 years and over may insert one suppository rectally
daily. The suppository should be moistened by dipping it in a cup of water for
10 seconds or holding it in under running water for at least 30 seconds before
insertion into the rectum.22
Product
Carbon dioxide suppositories (Ceo-Two Suppositories).
Bowel preparation kits

Bowel preparation kits contain a combination of laxatives that are intended
for use when medical procedures, such as colonoscopies and GI surgical
procedures, are to be performed. These procedures require the large intestine
be free of any fecal material. Physicians may use either prescription or OTC
products, which are taken the day before the scheduled procedure for bowel
cleansing. Only short-acting laxatives are used for the purpose.22 These pro-
ducts are not to be used unless directed to do so by a physician.
Mode of action
OTC laxatives that have a fast onset of action may be used alone or in
combinations. Saline laxatives (mixed phosphates and magnesium citrate)
and stimulant laxatives (bisacodyl and sennosides) are used for this purpose.
The mode of action for each appears earlier in this chapter. Oral phosphate
products may still be used by physicians for bowel cleansing, but the new
required labeling increase their awareness of the serious adverse effects to the
kidneys from acute phosphate nephropathy.25
Recommended dose
The products are used according to a physician’s directions as a bowel cleans-
ing preparation.
Product
Mixed phosphates (Fleet Phospho-Soda EZ Prep Bowel Cleansing). This is the
only Fleet oral phosphate product that remains on the OTC market at this
time, but it may not be on shelves available for consumers’ selection. Many
pharmacists have this product available as a behind-the-counter product so
that the consumers may be educated as to the proper use of the product and its
potential for serious adverse effects before purchasing it.
Combination laxatives
The monograph permits two laxatives to be combined in a single product,
providing that each laxative has a different mode of action.
Product
Senna and sodium docusate (PeriColace).
Osmotic laxatives
Polyethylene glycol 3350 (PEG 3350) is an osmotic laxative intended for
temporary relief of constipation.26
Rx–OTC switched drug

Polyethylene glycol 3350.
Mode of action
An osmotic laxative draws water into the intestines to mix with its contents
and cause swelling, thus initiating defecation. Unlike hyperosmotic laxatives,
which have a very fast action, osmotic laxatives have a slow effect because of
their lower osmolarity. While hyperosmotic laxatives are effective within
hours, osmotic laxatives take 1 to 3 days to achieve their effect. This slower
response also greatly reduces the possibility of dehydration and reduces the
risk of causing abdominal gas and cramping.26

If an individual has kidney disease, a physician should be contacted before
using the drug. Osmotic laxatives should not be used for more than 7 days.
Recommended dose
PEG 3350 is taken once daily as 17 g (one cap full) added to 4 to 8 ounces
(115–230 mL) of water or juice. It should not be used by individuals under 17
years of age.26
Product
PEG 3350 (MiraLax).
Antidiarrheal agents
When the contents of the intestines contain too much fluid, or movement
through the GI tract is too rapid, fluids cannot be absorbed and an excessive
volume reaches the large intestine. This results in sudden initiation of stretch
receptors and rapid evacuation of the colon, causing diarrhea. Thus, diarrhea
presents the opposite problems to those associated with constipation. When
fluid balance and GI motility are restored, bowel movements return to a
normal pattern. Diarrhea is usually defines as more than three loose or watery
bowel movements per day without any known cause. This rapid movement of
fluid through the GI tract is often accompanied by gas, cramping, or general
abdominal discomfort.
Traveler’s diarrhea is a common condition when an individual travels to
areas with relatively poor sanitation. It is most commonly caused by ingestion
of contaminated foods or water that contains fecal Escherichia coli, which
produces an endotoxin, but other bacteria or viruses are also known to cause
diarrhea. Uncooked foods and unpurified water should be avoided to lessen
the risk of accidental ingestion of contaminated substances.
Diarrhea that is suspected of being caused by bacterial organisms, other
than traveler’s diarrhea, requires referral to a physician for proper diagnosis
and treatment with prescription antibiotics. Diarrhea caused by viruses is
frequently of short duration, and oral fluids should be used to prevent dehy-
dration. Individuals who have profound diarrhea or diarrhea lasting more
than 48 to 72 hours should consult a physician.
Ingestion of substances that can create increased osmotic pressure in the
bowel may cause diarrhea if they are used in large quantities or for long
periods of time. Magnesium-containing dietary supplements and xylitol,
mannitol, and sorbitol sweeteners in candy, gums and foods are common
substances that may cause diarrhea.
Adsorbants
Antidiarrheal drugs reduce or stop symptoms associated with diarrhea.
Kaolin is the only monograph adsorbant and it helps to firm stools within
24 to 48 hours.27
Monograph ingredient
Kaolin suspension.
Mode of action
Adsorbant drugs adsorb water in the GI tract to create a semisolid mass, thus
lessening the amount of fluid that reached the large intestine. This may both
reduce the frequency of bowel movements and make them less watery.

Adsorbant drugs should not be used without consulting a physician if stools
are bloody or black or there is mucus in the stool, or if a fever is present. If
other medications are being taken, kaolin should be taken either 3 hours
before or 3 hours after the other drugs. A physician should be consulted if
the diarrhea gets worse or if it lasts for more than 48 hours. Plenty of fluids
should be drunk to prevent the dehydration caused by diarrhea.27
Electrolyte solutions or juices that do not contain an excess of glucose or
sugar are better sources of fluid than plain water. Caffeine and alcoholic
drinks should be avoided because they cause excess urination with additional
fluid loss.
Recommended dose
Adults and children over 12 years of age should take 26 g of the product after
each loose bowel movement or every 6 hours; it should not be taken for more
than 2 days. Children under 12 years of age should not take the product
without the supervision of a physician.27
Products
Kaolin suspension (generic products).
Bismuth subsalicylate
Bismuth subsalicylate may be used to control or relieve the symptoms of
diarrhea or traveler’s diarrhea; it reduces the number of bowel movements
and helps to firm stools.28
Mode of action
Bismuth subsalicylate is an astringent and coats the mucosa. It produces some
effect because it has adsorbant properties, but it also has antisecretory effects,
which reduces the amount of fluids entering the GI tract.
Bismuth subsalicylate should not be used without consulting a physician if
stools are bloody or black, if there is mucus in the stool, or if a fever is present.
There may be a temporary darkening of the tongue and stools from use of
this drug.
Bismuth subsalicylate does not contain aspirin, but it may cause an adverse
effect in an individual allergic to aspirin; it should not be used in children or
teenagers who have or are recovering from chickenpox or flu-like symptoms
(Reye’s syndrome warning); those taking anticoagulants (blood thinning
drugs) should consult their physician before use.
Those with diabetes, gout, or arthritis should ask a physician or pharma-
cist before using this product. If ringing in the ears or a loss of hearing
develops, stop using the drug. If symptoms get worse or diarrhea last for more
than 48 hours, a physician should be consulted. Plenty of fluids should be
drunk to prevent dehydration caused by diarrhea.28
Recommended dose
Adults and children over 12 years of age may take 1050 mg bismuth subsa-
licylate every 30 to 60 minutes but should not exceed 4200 mg in 24 hours;
bismuth subsalicylate should not be used for more than 2 days. Children aged
9 to 11 years may take one-half the adult dose (525 mg); children aged 6 to 8
years may take 350 mg; children aged 3 to 6 years may take one-sixth of the
adult dose (175 mg); children under 3 years of age require recommendation by
physician.28
Products
Bismuth subsalicylate (Pepto-Bismol, Kaopectate).
Loperamide
Drug category and indications
Loperamide is an anticholinergic drug that is used to reduce or stop diarrhea,
including traveler’s diarrhea.29
Rx–OTC switched drug

Loperamide.
Mode of action
Anticholinergic drugs block the action of the peripheral parasympathetic
nervous system and reduce GI motility. This allows more time for absorption
of fluid from the GI tract and reduces the watery stools.

Loperamide should not be used for more than 48 hours or in individuals who
have an elevated body temperature greater than 101 F (38.3 C); use of this
drug may cause a rash. Loperamide should not be used in children under 6
years of age.29
Recommended dose
The dose of loperamide for adults and children aged 12 years and over is 4 mg
after the first loose bowel movement and 2 mg after each loose bowel move-
ment thereafter. The maximum daily dose is 8 mg.
Children between 6 and 11 years of age may take 2 mg after the first loose
bowel movement and 1 mg after each loose bowel movement thereafter. The
maximum daily dose is 4 mg. When the liquid formulation is used, the mea-
suring device in the packaging should be used for exact measure for children’s
doses.
Products
Loperamide (Imodium A–D), loperamide with simethicone (Imodium Multi-
symptom Relief). The combination of simethicone and loperamide is permit-
ted because gas and abdominal distention occur frequently in individuals who
have diarrhea.
Lactose intolerance
Individuals who lack the enzyme lactase are not able to digest lactose, a sugar
common in milk and milk products. This causes symptoms of gas, bloating,
and diarrhea. Because lactose is not metabolized, it increases the osmotic
pressure in the intestines and, therefore, acts as a hyperosmotic laxative.
Eliminating lactose from the diet, or consuming it in small quantities will
generally prevent symptoms. Because a relatively large portion of the US
population has lactose intolerance, foods that have reduced lactose or are
lactose free are available in food markets. These include Lactaid Free Milk,
Dairy Ease Fat Free Milk, and soy milk products. Another alternative to
solving this problem relies on providing lactase enzyme as a dietary sup-
plement or a food by using products such as Lactaid. The FDA is considering
classifying lactase as an OTC drug but has not done so at this time.
Probiotics
The human GI tract contains a variety of bacteria known collectively as ‘gut
flora’; these have several important functions in the body, such as synthesizing
vitamin K and helping to maintain normal bowel balance and function. Bouts
of noninfectious diarrhea deplete the GI tract of these bacteria. The use of oral
preparations containing live strains of normal gut flora, probiotics, assists in
repopulating the GI tract, reducing the duration of diarrhea, and possibly
preventing other episodes of diarrhea. Individuals who are prescribed anti-
biotic drugs that affect a wide range of bacteria, including gut flora, often
develop diarrhea.
Lactobacillus and Bifidobacterium are the two most common species of
nonpathogenic bacteria used as probiotics; Saccharomyces boulardii, a yeast,
is another popular probiotic. The efficacy of the various strains of Lacto-
bacillus vary, and those with the most positive results in published studies
are L. acidophilus, L. bulgarius, L. casei, and L. reuteri. Several of these species
are present in yogurts, fermented milk and soy milk.30 Preparations of these
bacteria are available in capsule form and as granules. The FDA regulates these
products as dietary supplements and foods, not OTC drugs.
Products
Lactobacillus (Cultrelle, Probiotica), Bifidobacterium (Align), Saccharomyces
(Florastor).
Electrolyte solutions
The excessive watery stools that occur during diarrhea may result in dehy-
dration. Several OTC electrolyte solutions are available to help to prevent the
loss of both fluid volume and electrolytes during diarrhea. Most products are
formulated based on the recommendations of the World Health Organization
(WHO) oral rehydration solutions. Apple juice, other fruit juices, and car-
bonated beverages may contain a high quantity of carbohydrates and should
be avoided. Such high-carbohydrate drinks could worsen diarrhea because of
they would increase osmotic pressure in the GI tract, thus acting as osmotic
laxatives.
Products
Oral electrolyte products (Pedialyte and CeraLyte). Gatorade, a food product,
contains electrolytes and is a good substitute as a source of fluids instead of
fruit juices.
Miscellaneous products
Internal oral deodorants
Individuals who have ostomies (ileostomy or colostomy) or urinary and fecal
incontinence experience difficulty with control of odors.31
Chlorophyllin copper complex, bismuth subgallate.
Mode of action
No specific test for efficacy or mode of action is given in the FDA monograph
that recognizes chlorophyllin copper complex and bismuth subgallate as
monograph ingredients to help to reduce odor problems resulting from osto-
mies or incontinence problems. Individuals who have odor problems should
also avoid foods that are likely to cause odors, such as fish, eggs, garlic,
onions, and asparagus. Vitamin products and some prescription antibiotics
also cause odor problems.
If cramps or diarrhea occur with chlorophyllin copper complex, the recom-
mended dose should be reduced; if symptoms continue, consult your
physician.
Recommended dose
Chlorophyllin copper complex may be used by adults and children 12 years of
age or older in doses of 100 mg but should not exceed 300 mg per day.
Bismuth subgallate may be used by adults and children 12 years of age or
older in doses of 200 to 400 mg up to four times a day.
Products
Chlorophyllin copper complex (Nullo), bismuth subgallate (Devrom).

Case 1 GM, a 57-year-old male, was treated for gastric ulcers last year
and hasn’t had a prescription for a proton pump inhibiting drug for
the last 4 months. He asks the pharmacist whether he should take
PrilosecOTC or Zantac 150 mg because he has been experiencing
heartburn symptoms once a week for the past 3 weeks.
GM’s heartburn problem does not fit the criteria for use of
PrilosecOTC, which is frequent heartburn, two or more times a week.
However, because of his history of gastric ulcers he may be experienc-
ing a recurrence of ulcer disease. The pharmacist advises him to make
an appointment with his doctor and to use Zantac to relieve his symp-
toms until he sees his doctor.
Case 2 The mother of a 10-year-old child who just recovered from

chickenpox asks the pharmacist if Pepto Bismol is a good product to
relieve the child’s upset stomach. The mother says that the child has no
health problems and is not taking any type of medication except a daily
vitamin, which has never seemed to cause any problem.
The pharmacist advises the mother to avoid Pepto Bismol because it
contains a salicylate. Aspirin and salicylate products should not be used
in children who have had chickenpox or flu because of their association
with Reye’s syndrome. The pharmacist recommends a calcium carbon-
ate antacid such as Mylanta Children’s chewable tablets. The mother
should be advised to contact the doctor if the child’s symptoms are not
relieved within a day or two.
Case 3 JL, a 26-year-old female, asks the pharmacist if Regular Alka-

Seltzer is suitable for use for an upset stomach and hangover she has
from a weekend of partying that included a lot of food and alcoholic
beverages.
The pharmacist advises JL that sodium bicarbonate, which is in regular
Alka-Seltzer, is contraindicated for use when overindulgence is the
problem. Alka-Seltzer Wake-up Call, any of the other antacids and
Pepto Bismol are suitable for her symptoms.
Case 4 SB is a 60-year-old man who has a history of motion sickness.

He tells the pharmacist that the Dramamine that he has been using now
makes him very drowsy. He wants to know if there is a better product

for him to use. His only other medical problem is hypertension.
The pharmacist recommends that he try motion sickness products that
contain either cyclizine or meclizine, because they usually cause less
drowsiness than dimenhydrinate, the active ingredient in Dramamine.
He should be cautioned that these products also have to potential to
cause drowsiness.
Case 5 A pregnant woman who has ‘morning sickness’ symptoms asks

the pharmacist to recommend a product for her symptoms.
The pharmacist tells her that OTC drugs are not approved by the FDA
for use in pregnant women without supervision by a doctor. She should
also ask her doctor about the possible use of ginger, a food additive and
a dietary supplement, because there is evidence that it is of some benefit
in relieving nausea associated with pregnancy (See also p. 45).
Case 6 CY is a 45-year-old business man who has returned from a 6 day

trip to China. He explains that he normally has a daily bowel move-
ment but that he hasn’t had one in 4 days and his abdomen feels full and
uncomfortable.
The pharmacist recommends using a stimulant laxative like bisacodyl
or senna to relieve his constipation. If he doesn’t get relief from
these symptoms, he should consult his doctor. A single dose of a hyper-
osmotic such as magnesium citrate or milk of magnesia is a suitable
alternative. A laxative suppository or enema could also be recommended,
but these formulations are less likely to be used than oral laxatives.
Case 7 LM got new dentures (false teeth) 3 weeks ago and has been
eating soft foods and soups because she still has discomfort in chewing
foods. Her regular bowel movements have decreased from every other
day to about twice a week.
The pharmacist recommends that she increase bulk in her diet by using
a bulk laxative such as psyllium, bran, or methylcellulose. She should
also drink more fluids, especially if she chooses to use one of these
products. If she doesn’t have relief from her symptoms, she should
consult her doctor.
Case 8 A 45-year-old woman asks the pharmacist for Fleet’s Phospho-

Soda EZ Prep Bowel Cleansing because her doctor recommended it.
The pharmacist discusses this purchase with the individual and learns
that she is having a colonoscopy in 2 days and this product is part of her
preparation for the procedure. The pharmacist explains that the

Phospho-Soda product must be taken exactly as directed by her phys-
ician and must be taken with the recommended amount of fluid
because dehydration and possible kidney damage may occur if direc-
tions are not followed.
Case 9 KG has three children between 3 and 9 years old and one of
them has pinworms. She asks the pharmacist what to do.
The pharmacist tells her that everyone in the family, including all the
adults, should take a single dose of pryantel pamoate, and the dose is
based on body weight, 11 mg per kilogram (5 mg per pound). The
pharmacist also outlines cleaning and sanitary measures that must be
followed to prevent reoccurrence.
Case 10 A mother complains that her 5-year-old child has had diarrhea
for 3 days and won’t eat or drink. She asks the pharmacist if lopera-
mide (Imodium AD) by itself or combined with simethicone (Imodium
Multi-symptom) is better.
The pharmacist tells her to call the doctor immediately because diar-
rhea lasting for more than 48 hours without appropriate fluid intake
could lead to dehydration that must be managed by a doctor. She
should continue try to get the child to drink fluids. Loperamide is not
approved for use in children under 6 years of age and, therefore, neither
product should be used.
Case 11 KT has just returned from South America and is experiencing

diarrhea from fresh, unwashed fruit he bought at the airport. What
should he do?
The pharmacist recommends drinking fluids and using either lopera-
mide or bismuth subsalicylate according to the labeled directions. If
relief does not occur within 48 hours, he should consult his doctor.
References
1. Antacid products and antiflatulents for over-the-counter (OTC) human use; final mono-
graph. Fed Regist 1974; 39: 19862–19877.
2. Orally administered drug products for relief of symptoms associated with overindul-
gence in food and drink for over-the-counter human use; tentative final monograph;
notice of proposed rulemaking. Fed Regist 1991; 56: 66742–66751. www.fda.gov/cder/
otcmonographs/category_sort/overindulgence (accessed November 12, 2008).
3. Antacid drug products for over-the-counter human use; Proposed Amendment of Antacid
Final Monograph. Fed Regist 1994; 59: 5060–5065.
4. Antacid drug products for over-the-counter human use; amendment of antacid final
monograph; technical amendment. Fed Regist 1994; 59: 60555–60556.
5. Orally administered drug products for relief of symptoms associated with overindulgence
in food and drink for over-the-counter human use; proposed amendment of the tenta-
tive final monograph. Fed Regist 2005; 70: 741–746. www.fda.gov/cder/otcmonographs/
category_sort/overindulgence (accessed November 12, 2008).
6. Pepto Bismol. www.pepto-bismol.com/index.php (accessed November 18, 2008).
7. Tagamet. www.tagamethb.com/faqs.aspx (accessed November 17, 2008).
8. Questions and answers on Prilosec OTC (Omeprazole). www.fda.gov/cder/drug/infopage/
prilosecOTC/prilosecotcQ&A.htm (accessed November 17, 2008).
9. Cohen-Silver J, Ratnapalan S. Management of infantile colic. Clin Pediatr (Phil) 2009;
48: 14–17.
10. Mylicon. www.mylicon.com (accessed November 28, 2008).
11. Beanogas. www.Beanogas.com/UsingBeano.aspx (accessed November 17, 2008).
12. Kligler B, Chaudhary S. Peppermint oil. Am Fam Physician 2007; 75: 1027–1030.
13. Antiemetic drug products for over-the-counter human use: final rule. Fed Regist 1987; 52:
15886–15891.
14. White B. Ginger: an overview. Am Fam Physician 2007; 75: 1689–1691.
15. Emetrol. www.brands2liveby.com/product.aspx?id¼407 (accessed November 18, 2008).
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2009).
17. Relief Band. www.ReliefBand.com/answers.html (accessed May 26, 2009).
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management of ingested poisons. Clin Toxic (Phila) 2005; 43: 1–10.
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treatment drug products. Fed Regist 1985; 50: 2259–2262.
20. Anthelmintic drug products for over-the-counter human use; final monograph. Fed Regist
1986; 51: 27756–27760.
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htm (accessed November 14, 2008).
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Laxative/new_laxative.htm (accessed November 14, 2008).
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htm (accessed November 14, 2008).
25. Oral sodium phosphate (OSP) products for bowel cleansing (marketed as Visicol and
OsmoPrep, and oral sodium phosphate products available without prescription). www.
fda.gov/cder/drug/infopage/OSP_solution/default.htm (accessed May 20, 2009).
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November 17, 2008).
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4
Respiratory system
This chapter outlines the management of common respiratory symptoms that

affect either the upper respiratory or lower respiratory system. The upper
respiratory system includes the nose, throat, and sinuses. Allergies, the com-
mon cold, flu (influenza), and rhinosinusitis have many of the same symp-
toms and many drugs may be used in the treatment of these conditions.
Antihistamines and decongestants are the most commonly used drugs for
all these conditions. Some individuals may have headache or sinus discomfort
and pain, and OTC analgesics (see Chapter 5) may also be useful. These drugs
may used alone or combined in a single product.
The common cold and flu have additional symptoms, including coughs,
chest congestion, fever, and possible myalgia (muscle aches). Antitussives
(cough suppressants), expectorants, and antipyretics address these symptoms,
and they may be used alone or in combinations. All of the treatments for the
common cold and flu are symptomatic and provided limited relief. Several
dietary supplements and homeopathic products are very popular for treating
colds or flu, but there are few controlled clinical trials providing evidence of
their efficacy.
The lower respiratory system includes the trachea, bronchial tubes, and
lungs. The FDA only approved products for use in patients who have asthma,
provided that they had been previously diagnosed as having asthma by a
physician.
Allergies
Rhinorrhea (runny nose), nasal congestion, and sinusitis are symptoms
associated with allergic conditions and upper respiratory infections. Proper
treatment requires differentiation based on onset, duration, and severity of
symptoms plus the presence of additional symptoms such as fever or
headache.
Antihistamines
Antihistamines (H1-blockers or histamine antagonists) relieve the symptoms
of seasonal allergies (hay fever) and other upper respiratory allergies. They
temporarily reduce runny nose and relieve sneezing, itching of the nose or
throat, and itchy, watery eyes.1
Mode of action
Allergens (pollen, animal dandruff, foods, chemicals) produce changes that
are most noticeable in the upper respiratory track or the skin. Allergens bind
with immunoglobulin E (IgE) present in tissues and this reacts with surface
receptors on mast cells and basophils to cause the release of histamine, tryp-
tase, cysteinyl-leukotrienes, prostaglandin D, and cytokines (interleukins).
These inflammatory mediators cause changes in capillary permeability,
resulting in vasodilatation of blood vessels, edema, and thin, watery secre-
tions of the nose and eyes, and/or a rash or hives.2
The best and safest method to prevent symptoms from allergic reactions is
to avoid the allergen. Pharmacological treatment involves the use of oral
antihistamines. All antihistamines have the same mode of action. They occupy
the same receptors as histamine but do not cause its consequences, thereby
preventing or minimizing symptoms. Their onset of action may be delayed if
taken after symptoms occur because both histamine and the antihistamine
compete for the same receptor sites.
The hallmark symptoms of rhinitis are copious, thin, watery nasal secre-
tions, accompanied by itching, sneezing, and tearing, itchy eyes. Because the
lining of the paranasal sinuses are usually affected, the term rhinosinusitis is
frequently used instead of rhinitis. Rhinosinusitis may be allergic or non-
allergic (vasomotor rhinitis of unknown origin, rhinitis associated with preg-
nancy, and rhinitis associated with aging are not associated with IgE release)
and may be acute or chronic.3
Monograph drugs (first-generation, nonselective, or sedating antihistamines)

Mode of action
The first-generation monograph drugs cause drowsiness to a varying degree
depending on their specific chemical structure. They possess some lipid
solubility and are able to cross the blood–brain barrier to produce their
sedative effect.1 The alkylamine antihistamines include bromphenira-
mine maleate and its dextro form, chlorpheniramine maleate and its dextro
form, and triprolidine hydrochloride; these produce less sedation than the
ethanolamine-type drugs. The ethanolamine antihistamines include diphen-
hydramine hydrochloride and citrate, doxylamine succinate, and clemas-
tine fumarate.
Respiratory system | 71
All of these antihistamines have anticholinergic activity, contributing to

the reduction of secretions and providing a rationale for their use in cough/
cold products.

These products should not be taken for more than 7 days unless directed by a
physician. They should not be taken except under the advice and supervision
of a physician by those with asthma, narrow-angle glaucoma, or difficulty
urinating owing to enlargement of the prostate gland. These antihistamines
may cause drowsiness (alcohol, sedatives, and tranquilizers may increase
drowsiness) and should be used with caution when driving a motor vehicle
or operating machinery. They may cause excitability, especially in children.1
Recommended doses
Dosages for antihistamines are given in table 4.1.
Products
Chlorpheniramine (ChlorTrimeton Allergy), clemastine (Tavist Allergy),
diphenhydramine (Benadryl Allergy).
Rx–OTC switched drugs (second generation, peripherally selective or

nonsedating antihistamines)
Cetirizine and loratadine are the only antihistamines currently available as
OTC drugs in this category. Fexofenadine (Allegra) is a candidate for a future
Rx–OTC switch.
Table 4.1 Recommended doses for antihistamines
Drug Adult dose (dosing 6–12 years (dosing 2–5 years (dosing
frequency) frequency) frequency)
Brompheniramine 4 mg (4–6 h) 2 mg (4–6 h) 1 mg (4–6 h)
Cetirizine 10 mg (24 h); > 65 years, 5–10 mg (24 h) 2.5 mg (24 h)

5 mg (24 h)
Chlorpheniramine 4 mg (4–6 h) 2 mg (4–6 h) 1 mg (4–6 h)
Clemastine 1 mg (12 h) Consult physician Consult physician
Diphenhydramine 25–50 mg (4–6 h) 12.5–25 mg (4–6 h) Consult physician
Loratadine 10 mg daily 10 mg daily 5 mg daily
Triprolidine 2.5 mg (4–6 h) 1.25 mg (4–6 h) 4–5 years, 0.938 mg

(4–6 h); 2–3 years,
0.625 mg (4–6 h)
Mode of action
Cetirizine and loratadine bind to the receptor site for histamine in the same
manner as the FDA monograph antihistamines. They have less lipid solubility,
greatly reducing or preventing penetration into the brain and producing less
sedation. Both drugs lack the anticholinergic activity of the monograph anti-
histamines. They are available as tablets that dissolve on the tongue, provid-
ing an advantage over regular tablet formulations.
Cetirizine should not be used if an individual is allergic to hydroxyzine.
Cetirizine hydrochloride may cause drowsiness but it is much less severe than
with the first-generation antihistamines. Cetirizine products intended for
adults include a warning that individuals over the age of 65 years should
consult a physician before using this drug.4 However, labeling for cetirizine
children’s tablets and syrups, which contains 5 mg of cetirizine per dose,
recommends that adults over 65 years may take one dose per day.4 This is
somewhat confusing because adults would not ordinarily choose a product
intended for children for their use. The only adult products marketed at this
time are 10 mg tablets that cannot be broken in half. The dose of cetrizine for
adults over 65 is 5 mg once daily and, therefore, is only available in children’s
formulations at this time.
Cetirizine and loratadine should not be used without supervision of a
physician if the individual has kidney or liver disease.4,5
Products
Cetirizine (Zyrtec, Children’s Zyrtec Chewable Tablets, Children’s Zyrtec
Allergy Syrup, and Children’s Zyrtec Hives Relief Syrup), loratadine
(Alavert, Claritin, Claritin Hives Relief, Dimetapp Non-Drowsy Allergy,
Tavist ND, and Triaminic Allerchews).
Mast cell inhibitors

Mode of action
Nasal cromolyn sodium prevents the release of histamine from mast cells in
the presence of allergens. It must be used every 4 to 6 hours and is most
effective if used before exposure; it should be used continuously during expo-
sure.6 Maximum relief occurs after 1 to 2 weeks of use. Cromolyn sodium is
safe to use by individuals who should avoid antihistamines and it is a safe for
use in children.
Local irritation of nasal membranes may occur. Cromolyn sodium should not
be used for treating asthma, colds, rhinosinusitis, or if a fever or nasal dis-
charge is present.
Recommended dose
One spray is used in each nostril every 4 to 6 hours, but not more than 6 times
a day. Cromolyn sodium should not be used in children under 2 years of age.
Products
Cromolyn sodium (NasalCrom and BenaMist).
Decongestants
Oral decongestants
Decongestants are vasoconstrictors that relieve nasal congestion from all
causes of allergic or non-allergic rhinitis, the common cold, and other upper
respiratory conditions including sinusitis.7
Only phenylephrine and pseudoephedrine are available as OTC oral de-
congestants.7 Because pseudoephedrine can be used to make methamphet-
amine, it is only available from the pharmacist. Some states permit sales of
pseudoephedrine by a pharmacist or persons specifically trained by phar-
macists. Individuals must have photo identification, be 18 years of age or
older, and sign a register in order to purchase any product containing pseudo-
ephedrine.8
Phenylepherine replaced pseudoephedrine in most OTC oral decongestant
products. There is concern that the recommended minimum dose of 10 mg for
adults may lack effectiveness and the FDA is reviewing this dosing issue.
Mode of action
The nasal passages have a very extensive blood supply, and neuropeptides
released during the allergic or inflammatory process produce profound vaso-
dilatation, causing nasal congestion. Oral or topical vasoconstrictors effec-
tively relieve this nasal congestion.2

Decongestants may cause nervousness, dizziness, or insomnia and should not
be taken for more than 7 days. If symptoms do not improve or if a fever is
present, a physician should be consulted. Decongestants should not be taken
without consulting a physician by those with heart disease, high blood pres-
sure, thyroid disease, diabetes, or with difficulty in urinating owing to pros-
tate enlargement. They should not be taken with monoamine oxidase
inhibiting drugs (MAOIs) used for hypertension or depression (phenelizine,
tranylcypromine, isocarboxazid) or certain anti-Parkinson medications (e.g.
selegiline and rasagiline).7
Table 4.2 Recommended doses for decongestants for allergies
frequency) frequency) frequency)a
Oral
Phenylephrine 10 mg (4 h) 5 mg (4 h) 2.5 mg (4 h)
Pseudoephedrine 60 mg (4–6 h) 30 mg (4–6 h) 15 mg (4–6 h)
Topical
Levmetamfetamine 2 inhalations (2 h) 1 inhalation (2 h) Consult physician
Oxymetazoline spray or 0.05% (10–12 h) 0.05% (10–12 h) 0.025% (10–12 h)

drops
Phenylephrine spray or 0.25%, 0.5%, 1% (4 h) 0.25% (4 h) 0.125% (4 h)

drops
Propylhexedrine 2 inhalations (2 h) 2 inhalations (2 h) Consult physician
a
No recommended doses for children under 4 years of age if decongestants are included in cough/cold products.
Recommended dose
Dosages for decongestants appear in table 4.2.
Products
Pseudoephedrine (Sudafed), phenylephrine (Sudafed PE).
Topical nasal decongestants

Topical nasal decongestants are available as nasal drops, sprays, or inhalers,
and produce a quicker response than oral products. Overuse may cause
rebound congestion, commonly referred to as rhinitis medicamentosa.7
Topical nasal decongestants include levmetamfetamine, naphazoline hydro-
chloride, oxymetazoline, phenylepherine hydrochloride, and propylhexa-
drine, xylometazoline.
Mode of action
Topical nasal decongestants have the same vasoconstricting action on blood
vessels as oral decongestants but they have an immediate onset of action.
In addition to the warnings for oral decongestants, topical products may cause
nasal irritation, stinging, sneezing, or increased nasal discharge. The FDA’s
labeling restricts the use to 3 days to prevent rebound congestion. Products for
children should only be used with adult supervision.
Levmetamfetamine and propylhexadrine become vapors at normal tem-

perature and should be tightly closed after use; they should only be used for
3 months once they are opened.
Recommended dose
Table 4.2 has dosage recommendations.
Products
Levmetamfetamine (Vicks Vapor Inhaler), oxymetazoline hydrochloride
(Afrin, Vicks Sinex 12 Hour Nasal Spray, Zicam Intense Sinus Relief Nasal
Spray), phenylephrine hydrochloride (Neo-Synephrine, Vicks Sinex for Sinus
Relief), and propylhexadrine (Benzedrex Nasal Inhaler).
Nasal saline irrigation and cleansing

Mode of action
The discomfort accompanying nasal congestion may be relieved by the use of
saline nasal sprays or drops, saline irrigation, or antimicrobial sprays. These
products cleanse, moisturize, and soothe irritated nasal membranes. They are
safe for use by patients who have conditions that preclude the use of decon-
gestants, including women who are pregnant or breast feeding.

Nasal sprays and drops should not be used in children without adult
supervision.
Recommended dose
One or two sprays or drops are used in each nostril when needed.
Products
Ayr, Afrin Non-medicated, Little Noses, NaSal, Ocean, Pretz, Saline X, and
Simply Soothing For Child & Baby Nose.
Neti pots are a popular nasal irrigation system. They contain a reservoir
for either water or saline solution. The individual leans over a sink, tilts the
head, and pours the solution into one nostril and allows it to drain out of
the other nostril. Irritation of the nasal passages may result from this
procedure.
Antimicrobial sprays
Mode of action
Cetylpyridinium is an effective antiseptic against bacteria, but its primary
effect in treating nasal congestion and discomfort is by soothing dry and
irritated membranes.

Cetylpyridinium should not be used if nose bleeding is present. It should not
be used for more than 7 days and if the symptoms do not improve, or get worse
during use, a physician should be consulted.
Recommended dose
One to three sprays is used in each nostril twice a day. Cetylpyridinium should
not be used for children under 12 years of age.
Product
Cetylpyridinium (SinoFresh)
External nasal dilator strips

Mode of action
An adhesive strip is applied to dry skin on each side of the nose. This device
keeps the nostrils open, improving breathing in patients who have nasal
congestion.9 These devices may be safely used by individuals who cannot
use decongestants, including women who are pregnant or breast feeding.
Use of these nasal strips may be helpful in reducing snoring.
These strips should not be used on irritated or broken skin and should be
removed after 12 hours. Irritation from the adhesive may occur. The strips
contain latex and should not be used by individuals who have latex allergies.
Products
Breathe Right, Breath Right for kids (ages 5 to 12), Breath Right with
Menthol, Breatheasy, and Clear Passage.
Combination allergy drug therapy

Patients who have rhinitis, rhinosinusitis, or the common cold frequently
experience rhinorrhea, sneezing, nasal congestion, and headache or sinus pain
at the same time. Hence, the FDA permits numerous different drug combina-
tion products.10
Antihistamine and decongestant products
Alavert Allergy and Sinus, Allerest PE, Claritin D, Drixoral Cold and Allergy,
Sudafed Sinus and Allergy, Triaminic Cold and Allergy, and Dimetapp Cold
and Allergy.
Antihistamines and analgesic (usually acetaminophen) products
Coricidin HBP Cold and Flu, and Tylenol Severe Allergy. (These products are
suitable for patients who must avoid decongestants, especially patients with
hypertension, hyperthyroid and/or diabetes mellitus, a very large segment of
the US population.)
Decongestants and analgesics products

Advil Cold and Sinus Non-drowsy, Alka Seltzer Plus Cold and Sinus, DayQuil
Sinus, Sudafed Non-drowsy Sinus, and Tylenol Sinus Congestion and Pain
Daytime. (Products containing the word ‘non-drowsy’, generally do not con-
tain any antihistamine.)
Antihistamine, decongestant, and analgesic products
Advil Allergy and Sinus, Benadryl Allergy and Cold, Dristan Cold, NyQuil
Sinus, and Tylenol Sinus Congestion and Pain Night Time.
Common cold
The common cold is an upper respiratory tract infection, usually caused by
rhinoviruses or coronaviruses in adults. Parainfluenza virus and respiratory
syncytial virus are additional causes in children. Most colds are self-limiting,
lasting approximately 7 to 10 days, and treatment is purely symptomatic.
Viruses bind to intracellular adhesion molecule (ICAM-1) in the nasophar-
ynx, initiating the release of the same inflammatory neuropeptides produced
by allergens and causing the same upper respiratory symptoms.2 Irritation of
the throat from a postnasal drip associated with blockage of the nasal sinuses,
which frequently accompanies colds, results in a nonproductive cough. Cough
is the major symptom that distinguishes colds from other causes of rhino-
sinusitis.11 A sore throat (pharyngitis) and occasionally a mild fever or head-
ache may occur. Colds are differentiated from influenza (viral flu) infections
by the severe fatigue and generalized muscle aches and pain that accompany
flu infections.
Antitussives
Antitussives may provide mild, temporary symptomatic relieve by reducing or
suppressing nonproductive coughs.12
Coughing is a protective mechanism to eliminate irritating substances or
mucus from the lower respiratory tract. Cilia that line the airways move the
irritants upward until they reach the pharynx, where they are eliminated by
swallowing or expectorating (spitting). Individuals with lower respiratory
tract infections must cough to maintain clear airways and lungs and remove
excessive mucus to reduce the risk of pneumonia. This is a productive cough
and should not be suppressed nor self-treated.
Central acting antitussives

Mode of action
Oral antitussive drugs produce their effect by suppressing the cough center in
the brain.12 Codeine compounds, dextromethorphan, and diphenhydramine
are central-acting antitussives.12 Because of the potential for abuse of codeine,
Table 4.3 Recommended doses for antitussives, expectorants and bronchodilators
frequency) frequency) frequency)
Oral antitussives
Codeine 10–20 mg (4–6 h) 12.5 mg (4–6 h) Consult physician
Dextromethorphan 30 mg (6–8 h) 15 mg (6–8 h) 7.5 mg (6–8 h)a
Diphenhydramine HCl 25 mg (4 h) 12.5 mg (4 h) Consult physician
Topical antitussives
Camphor ointment 4.7–5.3% (3 times a day) 4.7–5.3% (3 times a day) 4.7–5.3% (3 times a day)
Menthol ointment 2.6–2.8% (3 times a day) 2.6–2.8% (3 times a day) 2.6–2.8% (3 times a day)
Menthol lozenge 5–10 mg (every hour) 5–10 mg (every hour) 5–10 mg (every hour)
Camphor steam 6.2% (3 times a day) 6.2% (3 times a day) 6.2% (3 times a day)
Menthol steam 3.2% (3 times a day) 3.2% (3 times a day) 3.2% (3 times a day)
Expectorants
Guaifenesin 200–400 mg (4 h) 100–200 (4 h) 50–100 mg (4 h)a
Bronchodilators
Ephedrine 12.5–25 mg (4 h) Consult physician Consult physician
Epinephrine 1% spray 1–3 inhalations (3 h) 1–3 inhalations (3 h) 4–6 years, 1–3

inhalations (3 h)
a
No recommended doses for children under 4 years of age for use in cough/cold products.
a narcotic, some states limit its sale to pharmacists only while other states
classify it as a prescription drug. Widespread abuse of dextromethorphan,
especially by adolescents, may result in it soon becoming a pharmacist only
available drug.13
See table 4.3.
Productive coughs associated with lower respiratory tract conditions that
produce excessive phlegm or mucus require treatment by a physician.
Chronic coughs associated with smoking, asthma, or emphysema should
not be self-treated. Cough persisting for more than 7 days in adults or 5 days
in children requires consultation with a physician.12
Codeine, dextromethorphan, and diphenhydramine may cause drowsiness,
and codeine may cause constipation. Diphenhydramine is an antihistamine
and its label must contain all the warning for antihistamines. Dextro-
methorphan should not be taken if individuals are taking a MAOI or for
2 weeks after stopping a MAOI, because high doses may cause increased
central nervous system depression, hypertension, hyperpyrexia, and seizures.
Recommended dose
Dosages for antitussives are given in table 4.3.
Products
Diphenhydramine: (Benadryl and Theraflu MultiSymptom), dextromethor-
phan: (Robitussin Cough Gels, Triaminic Long Acting Cough, DayQuil
Cough, Delsym, Robitussin Cough Gels, Robitussin DM (which also contains
guaifenesin), Triaminic Long Acting Cough, and Vicks Formula 44 Dry Cough).
Peripheral or local acting antitussives

Mode of action
Vapors from aromatic compounds (camphor and menthol) are inhaled, reach-
ing the mucous membranes of the mouth and nose. They produce a soothing
effect on irritated membranes, thus reducing coughs caused by stimulation of
peripheral nerves. Formulations include solutions for addition to vaporizers,
devices to be plugged into electrical outlets, and devices for placement in
showers. Ointments or patches may be applied to the chest and neck areas,
and clothing should be left loose around the neck to allow the vapors to reach
the nose and mouth.
Menthol as a lozenge formulation dissolves in the mouth, producing a
local, soothing effect on the irritated oropharyngeal membranes to reduce
coughs.
See table 4.3.
These compounds are for external use only and should not be taken by mouth,
except for menthol lozenges. Liquid products should only be added to a
vaporizer and not be left near an open flame. Ointments and chest rub pro-
ducts should not be used in the nose or under the nose, and should not be used
in children under 2 years of age. There are several reports of severe respiratory
effects from improper use of these products in infants and young children.
Recommended dose
Menthol cough drops, 5 to 10 mg, may be dissolved slowly in the mouth every
1 to 2 hours.
Products
Menthol lozenges (Hall’s cough drops, N’ice, Ricola, Vick’s cough drops).
Menthol and camphor topical combinations (Vicks VapoRub Ointment and
TheraFlu Vapor Patch), plug-in devices (PediaCare Gentle Vapors, SudaCare

Vapor-Plug Waterless Vaporizor, TheraFlu Flowing Vapors), or tablets to be
placed in the shower (SudaCare Shower Soothers).
Expectorants
An expectorant helps to loosen phlegm, and makes coughs more produc-
tive.14 Expectorants may relieve the congestion that frequently occurs with
colds.
Guaifenesin is the only FDA approved expectorant.
Mode of action
Expectorants may irritate the gastric mucosa, causing reflex stimulation of
respiratory secretions, reducing the viscosity of bronchial secretions.14
Guaifenesin should not be taken for a chronic cough; a cough associated with
asthma, chronic bronchitis, or emphysema; or a cough with excessive phlegm
or mucus without consulting a physician.14
Recommended dose
Table 4.3 gives dosage for guaifenesin.
Products
Guaifenesin (Robitussin Chest Congestion, and Mucinex).
Combination cold products

The efficacy of antitussive and expectorant combinations in treating upper
respiratory tract infections, especially when cough is present, appears to be a
paradox. Meta-analysis reviews of randomized controlled studies of most
combination cough and cold products in adults report only a slight positive
effect compared with placebo.15
The FDA has declared that no OTC cough/cold product should be used for
children under age 2 because of lack of efficacy and risk of adverse effects, and
it is evaluating their use for children aged 2 to 11 years.16 The Consumer
Healthcare Products Association, which represents most OTC drug manu-
facturers, announced a voluntary relabeling of pediatric cough/cold products
in October 2008. The new labels will instruct parents not to use cough/cold
products in children under 4 years of age without the advise of a physician.17
Products
Robitussin DM, Vick’s Formula 44 Custom Care Chesty Cough.
The number of products for cough/cold or flu treatment is somewhat

overwhelming and popular products are listed in table 4.4. All the pharma-
cological classes of drug discussed in this chapter (antihistamines, deconge-
stants, analgesics, antitussives, and expectorants) may be use alone or in
multiple combinations.10
Table 4.4 Ingredients in popular cough/cold and flu products
Product Analgesic Antihistamine Antitussive Decongestant Expectorant
Alka Seltzer Plus Yes Yes Yes

cold
Coricidin Yes Yes Yes

Maximum
Strength Flu
Dimetapp Cold Yes Yes Yes

& Cough
Dimetapp Yes Yes Yes Yes

Nighttime Flu
Robitussin Yes Yes Yes

Cough & Cold
Robitussin Yes Yes Yes Yes

Cough, Cold &
Flu
TheraFlu Cough Yes Yes Yes

& Cold
Theraflu Yes Yes Yes

Warming
Nighttime
Severe Cold
Triaminic Flu, Yes Yes Yes

Cough & Fever
Triaminic Chest Yes Yes

and Nasal
Congestion
Tylenol Cold Yes Yes Yes Yes

Multi-Symptom
Severe
Tylenol Cough, Yes Yes

Sore Throat Day
Tylenol Plus Yes Yes Yes Yes

Children's Flu
Table 4.4 (continued)

Vicks Formula Yes Yes Yes
44 Cough & Cold
PM
Vicks Formula Yes Yes

44 Congestion
Vicks Formula Yes Yes

44 Chesty
Cough
Vicks DayQuil Yes Yes Yes

Liquid
Vicks NyQuil Yes Yes Yes

Liquid
Vicks NyquilD Yes Yes Yes Yes
Vicks Children's Yes Yes

NyQuil
Alternative therapy for colds and flu

Many consumers prefer the use of natural products such as rose hips, echina-
cea, or zinc for a cold because they have fewer adverse effects. These products
do not have to prove safety or efficacy to the FDA before they appear in the
marketplace.
Vitamin C
Rose hips are a natural source of vitamin C. There is no evidence that high
doses of vitamin C prevent colds. Vitamin C in doses greater than 200 mg
daily may reduce the severity of cold symptoms.18
Echinacea
Echinacea species (E. angustifolia, E. purpurea, and E. pallida) are dietary
supplements promoted to prevent or treat colds. Lack of quality in the studies
and uncertainty of the purity of the products hinders a true evaluation of these
products. E. purpurea has been the most studied species and may have a mild
effect in reducing duration and symptoms of colds. Individuals allergic to
chrysanthemums may also be allergic to echinacea. Various parts of the plant
have been used, but root extracts seem to be more effective.19
Zinc products
Zinc compounds as either dietary supplements or homeopathic products
claim to bind to the ICAM-1 receptor present in nasal passages, preventing
or reducing the risk of viral infection. A structured review of 11 published

clinical trials demonstrated a slight positive effect in reducing cold symptoms,
but a nearly equal number of studies showed no effect.20 Limitations of most
zinc studies include use of zinc salts other than zinc gluconate or zinc acetate,
unknown concentrations of free zinc, and small numbers of study partici-
pants. The product’s taste seems to be the most frequent complaint, and it may
cause gastric upset. Many different flavors of lozenges are available to mask
its astringent taste.
A recent randomized, double-blind, placebo-controlled clinical trial of
individuals who began treatment within 24 hours of developing cold symp-
toms using zinc acetate lozenges (13.3 mg zinc) every 2 to 3 hours reported
that both the duration (nearly 3 day reduction) and the severity of cold
symptoms were significantly reduced. This study is important because it
measured the plasma concentration of zinc and several of the inflam-
matory factors involved in producing cold symptoms, including ICAM-1
concentrations.21
Application of zinc intranasally has also produced positive results in
reducing cold symptoms and duration, but there have been reports of indivi-
duals who have lost their sense of smell from this formulation.22
Products
Zinc gluconate (Cold-Eeze Lozenge, Zicam Lozenges contain zinc acetate and
gluconate salts, Zicam Nasal Gel Swabs).
Oscillococcinum
Oscillococcinum is one of the most popular homeopathic flu products. It
contains extracts from duck heart and liver, which are purported to be reser-
voir sites for the flu virus. There are relatively few placebo-controlled trials of
this product despite the fact that it has been used for over a century. The most
recent Cochrane Review notes that evidence of oscillococcinum’s efficacy is
lacking.23
Airborne
Airborne is a dietary supplement containing vitamins, herbs, and amino acids
that is labeled as supporting the immune system. Several years ago, Oprah
Winfrey and guests on her television show praised the ability of Airborne as a
product that would prevent colds. This endorsement led to the product
becoming a huge success. Closer examination of the product’s ingredients
and lack of supportive studies have seen its popularity decline. The product
originally claimed to prevent and cure colds, which, as a dietary supplement, it
cannot do. The company agreed to a $23.3 million settlement with refunds to
go to buyers.24
The product contains vitamins A, C, E, and riboflavin, several minerals,
amino acids, and echinacea. A single tablet contains 230 mg sodium and the
recommended dose of three tablets daily would greatly exceed the amount of
sodium permitted for individuals who are on a sodium-restricted diet. There is
no evidence of its effectiveness.
Asthma
Asthma is a lower respiratory system condition characterized by impaired
airflow in the bronchial tubes and lungs. The bronchi are hyper-responsive
to certain stimuli, producing an inflammatory response causing constriction
and narrowing of the airways accompanied by excessive secretions. The
respiratory system responds to these symptoms by increasing its release of
epinephrine, a neurotransmitter. Epinephrine activates specific receptors,
beta-2-adrenoceptors, in the sympathetic nervous system and these cause
the bronchi to dilate to make breathing easier.
Epinephrine
OTC bronchodilating drugs are used to provide symptomatic relief of wheez-
ing and shortness of breath only if the patient has been diagnosed by a phys-
ician as having asthma.25
Mode of action
Exogenous epinephrine binds to the beta-2-adrenoceptors in the bronchi in
the same manner as endogenously produced epinephrine, causing broncho-
dilatation and improving breathing.
Epinephrine and its salts are available for inhalation using hand-held nebuli-
zers or metered-dose inhalers.25
Epinephrine products should not be used by those with heart disease, high
blood pressure, thyroid disease, diabetes, or difficulty in urinating because of
an enlarged prostate unless directed by a physician. They also should not be
used by anyone taking a prescription drug for asthma, high blood pressure, or
depression (MAOIs). They may cause nervousness, tremors, insomnia, nausea,
rapid heart beat, or loss of appetite.25 The products should not be used if
cloudy or discolored. Epinephrine products should not be used in children
under 4 years of age; for children 4 years or older, one inhalation is used,
repeated if necessary after a wait of 1 minute; the inhaler should not be used
again for at least 3 hours and a physician should be consulted if symptoms are
not relieved. For adults, use should not continue if symptoms are not relieved
in 20 minutes or if they become worse and a physician should be consulted.
Recommended dose
Dosages for broncholdilators are listed in table 4.3.
Products
Epinephrine (micro Nephrin for nebulizers and Primatene Mist).
Oral inhalers may be removed from the OTC market because chloro-
fluorocarbon propellants currently in these products must be replaced under
regulations from the Environmental Protection Agency. Manufacturers would
have to reformulate their products and apply to the FDA for approval, a very
costly process.
Pharmacists should counsel and encourage patients who purchase OTC
bronchodilators that they should consult a physician. The OTC products have
limited use because optimum treatment for asthma patients requires prescrip-
tion corticosteroids, beta-2 sympathomimetics, or leukotriene receptor antag-
onist drugs.
Ephedrine
Mode of action
Ephedrine is a drug that mimics the action of epinephrine by binding to the
beta-2-adrenoceptors in the lungs, causing bronchodilatation. It is effective as
an oral drug, in contrast to epinephrine, which is destroyed in the stomach and
must be inhaled.
Ephedrine and its salts.
Ephedrine should not be used in children under 12 years of age. Use should not
be continued if symptoms are not relieved in 1 hour or become worse and a
physician should be consulted immediately.
Recommended dose
Dosage is given in table 4.3.
Products
Ephedrine (Bronkaid Dual Action Formula and Primatene).

Case 1 A mother asks the pharmacist to recommend an antihistamine
for her 4-year-old child who is allergic to grass and tree pollens.
Several recommendations are possible, including sodium cromolyn,
but a loratadine tablet that dissolves on the tongue or a liquid
formulation is a good choice for this child. Sodium cromolyn must be

used 1 to 2 weeks before exposure to the allergen for maximum benefit,
and first-generation antihistamines may cause to much drowsiness.
Case 2 A 68-year-old man asks the pharmacist to recommend an

antihistamine because he is allergic to grasses. His prescription record
contains Flomax for a prostate problem.
Cromolyn sodium would have no effect on his benign prostatic hyper-
plasia (BPH); although it may not be as effective as antihistamine, it
will prevent or reduce his symptoms if used prophylactically accord-
ing to the directions. Cetirizine and loratadine are the only OTC anti-
histamines that do not contain BPH warnings and could be used.
However, the individual is over 65 and should consult his physician
before using cetirizine.
Case 3 GH, 15-year-old female, experiences nasal congestion and mild

rhinitis when she visits her friend who has a cat. She asks the pharma-
cist for Sudafed.
Because GH is under 18, the pharmacist recommends Sudafed PE,
which will help to reduce the nasal congestions and rhinitis. Sudafed
is pseudoephedrine and may only be sold to individuals 18 years of age
or older. However, an antihistamine such as loratadine taken approx-
imately 30 minutes before going to her friend’s house would be more
effective by preventing the histamine release that causes her symptoms.
The best recommendation is to avoid the cat and the areas that it
frequents.
Case 4 RT asks the pharmacist to recommend a sleeping tablet. He tells

the pharmacist that he began using Sinex spray approximately 3 weeks
ago because he gets nasal congestion during the evenings, and several
days later he began having sleeping problems.
The pharmacist explains that the phenylephrine in the Sinex is prob-
ably the cause of his problem and he should limit or stop using Sinex
before bedtime. No sedative is needed. The pharmacist advises RT to
limit his use of Sinex because excess use (more than 3 days in the
labeling) increases the risk of developing rebound congestion. The
pharmacist recommends trying Breathe Right Strips. If RT continues
to have problems sleeping, he could try using an OTC sedative or he
should consult his physician.
Case 5 A mother of a 3-year-old child asks the pharmacist for advice in

treating her child who has a cough from a cold.
The use of a steam vaporizer with camphor or menthol is the safest

choice because of lack of adverse effects. If the mother is concerned
about the child potentially getting burned by the heated water, a cool
mist humidifier or an ultrasonic humidifier without aromatic vapors
may be used. A plug-in vaporizer product is another alternative. The
FDA currently does not recommend OTC cough/cold products for
children under 4 years of age unless a physician has been consulted.
References
1. Cold, cough, allergy, bronchodilator, and antiasthmatic drug products for over-the-
counter human use; final monograph for OTC antihistamine drug products; final rule.
Fed Regist 1992; 57: 58356–58376.
2. Abbas AK. Diseases of immunity. In: Kumar V, Abbas AK, Fausto N, eds. Robbins and
Cotran: Pathologic Basis of Disease, 7th edn. Philadelphia, PA: Elsevier Saunders, 2005:
193–267.
3. Rosenfeld RM.Clinical practice guideline on adult sinusitis. Otolaryngol Head Neck Surg
2007; 137: 365–377.
4. Zyrtec. www.Zyrtec.com (accessed September 29, 2008).
5. Claritin. www.Claritin.com (accessed September 29, 2008).
6. www.NasalCrom.com (accessed September 29, 2008).
counter human use; final monograph for OTC nasal decongestant drug products; final
rule. Fed Regist 1994; 59: 43386–43412.
8. Legal requirements for the sale and purchase of drug products containing pseudoephed-
rine, ephedrine, and phenylpropanolamine. www.fda.gov/cder/news/methamaphetamine.
htm (accessed September 10, 2008).
9. Kirkness JP et al. Nasal airflow dynamics; mechanisms and responses with an external
nasal dilator strip. Eur Respir J 2000; 15: 929–936.
counter human use; final monograph for combination drug products. Final Rule. Fed
Regist 2002; 67: 78158–78172.
11. Bolser DC. Cough suppressant and pharmacologic protussive therapy ACCP Evidenced-
based clinical practice guidelines. Chest. 2006; 129(1Suppl):238S–249S.
counter human use; final monograph for OTC antitussive drug products; Final Rule.
Fed Regist 1987; 52: 30042–30057.
13. The National Survey on Drug Use and Health Report. January 2008. http://oas.samhsa.
gov/2k8/cough/cough.htm (accessed March 17, 2008).
counter human use; Expectorant drug products for over-the-counter human use; final
monograph; final rule. Fed Regist 1989; 54: 8494–8509.
15. Smith SM et al. OTC medications for acute cough in children and adults in ambulatory
settings. Cochrane Database Syst Rev 2008 (1): CD001831.
16. FDA News. FDA Releases Recommendations Regarding Use of OTC Cough and Cold
Products. www.fda.gov/bbs/topics/NEWS/2008/NEW01778.html (accessed January 18,
2008).
17. Transcript of Media Briefing on Pediatric Over-the-Counter Nonprescription Cough and
Cold Products. www.fda.gov/bbs/transcripts/2008/otc100708.pdf (accessed October 28,
2008).
18. Douglas RM. Vitamin C for preventing and treating the common cold. Cochrane
Database Syst Rev 2007; (3): CD000980.
19. Shah S et al. Evaluation of Echinacea for the prevention and treatment of the common
cold: a meta-analysis. Lancet Infect Dis 2007; 7: 473–480.
20. Caruso TJ et al. Treatment of naturally acquired common colds with zinc: a structured
review. Clin Infect Dis 2007; 45: 569–574.
21. Prasad AS et al. Duration and severity of symptoms and levels of plasma interleuleukin-1
receptor antagonist, soluble tumor necrosis factor receptor, and adhesion molecules in
patients with common cold treated with zinc acetate. J Infect Dis 2008; 197: 795–802.
22. Hirt M et al. Zinc nasal gel for treatment of common cold symptoms: a double-blind,
placebo-controlled trial. Ear Nose Throat J 2000; 79: 778–782.
23. Vickers A, Smith C. Homoeopathic oscillicoccinum for preventing and treating influenza
and influenza-like syndromes. Cochrane Database Syst Rev 2006; (3): CD001957.
24. Maker of Airborne will pay refunds for product that was marketed as a cold preventative.
www.webMD.com/cold-and-flu/news/20080304/coldremedy-airborne-settles-lawsuit?
page¼2 (accessed March 14, 2009).
counter human use; final monograph for OTC bronchodilator drug products; final rule.
Fed Regist 1986; 51: 35326–35340.
5
Central nervous system
(including peripheral
analgesics)
This chapter discusses oral analgesic/antipyretic drugs, sedatives, and stimu-

lants. Sedative and stimulant drugs act directly on receptors in various parts of
the brain while OTC internal analgesics first react in the periphery to inhibit
the synthesis of a series of compounds known as prostaglandins. All of the
OTC analgesics have an antipyretic effect, reducing an elevated body tem-
perature by acting on the hypothalamus in the brain. The brain and spinal
cord make up the central nervous system (CNS).
Many of the effects of prostaglandins are produced locally in tissues, but
some of their analgesic effects may be mediated by stimulating neurons in the
peripheral nervous system. Nerves from the peripheral nervous system prop-
agate signals to the spinal cord that reach the brain via afferent nerve path-
ways. Transmission of nerve impulses from the brain and spinal cord to the
peripheral tissues occurs via efferent nerve fibers.
Oral OTC analgesic drugs do not identify the cause of pain nor do they
correct it; they merely prevent or relieve mild to moderate pain. External
analgesics are drugs applied topically to the skin or mucous membranes to
block or prevent transmission from the peripheral nervous system. External
OTC analgesics are discussed separately Chapters 7 (topical OTC oral cavity
products) and 8 (topical OTC drugs for dermatological conditions).
OTC analgesics include acetaminophen and several drugs known as non-
steroidal anti-inflammatory drugs (NSAIDs), which include aspirin, other
salicylate drugs, ibuprofen, naproxen sodium, and ketoprofen. All of the
drugs produce analgesic and antipyretic effects, but acetaminophen has little
to no effect on inflammation.
The FDA has approved caffeine as a monograph analgesic adjuvant. An
adjuvant is a drug that does not have any analgesic activity but if combined
with an approved analgesic provides greater pain relief than the analgesic by
itself.1
Acetaminophen, aspirin, and ibuprofen may be used for all types of head-
ache including migraine headache. Manufacturers of products labeled exclus-
ively for migraine pain obtained FDA approval by submitting additional
data. Directions for use of these products differs from their use as ordinary
analgesic/antipyretic products.2
Oral analgesics
Acetaminophen
Acetaminophen is one of the most widely used analgesics in the USA. It is used
OTC for all age groups over the age of 2 years and is prescribed by healthcare
professionals for those under 2 years of age. It is the analgesic least likely to
cause GI symptoms, gastric irritation, GI bleeding, and ulcers, and it does not
affect blood platelets.
Acetaminophen is metabolized by the liver and is associated with liver
toxicity and death. This risk is increased if the use of acetaminophen involves
high daily doses, a long period of use, or the ingestion of three or more alcohol
beverages per day. Accidental ingestions by children or adults require imme-
diate treatment, even if there are no immediate symptoms of toxicity.
Acetaminophen is an analgesic and antipyretic. It may be used to reduce fevers
and provide temporary relief for minor aches and pains caused by the com-
mon cold, sore throat, toothache, headache, muscular aches and pain, pre-
menstrual and menstrual cramps (dysmenorrhea), and pain associated with
arthritis.1
Acetaminophen.
Mode of action
Acetaminophen is a weak inhibitor of prostaglandin synthesis in the periphery
but has a more pronounced effect in the brain; its full mechanism of action
remains uncertain. It has no true anti-inflammatory activity as NSAIDs have,
but it is recommended as a primary drug for relieving mild to moderate
arthritic pain. Two basic reasons for its use are that much of the pain asso-
ciated with osteoarthritis is not from an inflammatory process and its safety
profile for those over the age of 60 years is much better than that of the
NSAIDs.3
Adults and children over 12 years of age should not exceed the recommended
dose of 4 g per 24 hours because severe liver damage may occur at higher
dosage. Acetaminophen should not be used without consulting a physician if
Central nervous system (including peripheral analgesics) | 91
an individual has liver disease. If the individual consumes three or more

alcoholic drinks every day, a physician should be consulted before taking this
product. OTC acetaminophen should not be used with any other drugs,
prescription or nonprescription, containing acetaminophen. A physician or
pharmacist should be consulted by anyone unsure of the content of other
drugs they are taking.4,5
Acetaminophen should not be used for more than 10 days for temporary
relief of pain and for not more than 3 days if used for fever. If fever occurs or
swelling or redness occurs at the site of pain, a physician should be consulted.
Products labeled for sore throat pain are limited to 2 days of use. If the pain
worsens or a fever develops, a physician should be consulted.1,5,6
Children under 12 years of age should not take more than five doses of
acetaminophen in a 24 hour period because it could cause severe liver damage.
The drug should not be used without consulting a physician if the child has
liver damage or if the child is taking any other product that contains acet-
aminophen. If the caregiver is unsure of the content of other drugs the child is
taking, a physician or pharmacist should be consulted.
Acetaminophen products for children 2 to 12 years of age should not be
labeled for use of muscle aches and pains, premenstrual or menstrual cramps,
or arthritis.5,6
The FDA issued a final monograph for labeling of all internal analgesics on
April 29, 2009. Even though acetaminophen does not affect blood platelets,
all acetaminophen products must contain a warning by April 2010 that a
physician or pharmacist should be consulted if the individual is taking war-
farin.6 Maximum doses of acetaminophen taken for 1 week or more increase
the anticoagulant effect of warfarin by influencing its pharmacokinetics.7
NOTE: All these warnings about acetaminophen are required to be on the
product’s label when acetaminophen is combined in cough/cold products,
sinus pain relief products, premenstrual and menstrual pain relief products,
or sedative products.5,6
In June 2009, an FDA Advisory Committee recommended stronger warn-
ings or perhaps removal of acetaminophen from many combination prescrip-
tion products because of accidental overdoses.7 These recommendations may
extend to nonprescription products in the future, especially allergy/cough/
cold products. Such a change would affect many products on the market and
may result in formulation changes.
Recommended dose
Adults and children over 12 may take one or two 325 mg (regular strength) or
500 mg tablets (extra strength) every 4 to 6 hours, but should not exceed
4000 mg in 24 hours; sustained release acetaminophen is available as 650 mg
tablets and one to two tablets may be taken every 8 hours but must be
swallowed, not chewed or crushed.5,6
Table 5.1 Recommended doses of acetaminophen syrup or suspension (160 mg

per teaspoon (tsp) or 5 mL) for children 2–12 years of age
Weight (lbs) Weight (kg) Age (years) Oral dosea
Under 24 Under 11 Under 2 Consult doctor
24–35 11–16 2–3 1 tsp or 5 mL (160 mg)
36–47 16.3–21.3 4–5 1.5 tsp or 7.5 mL

(240 mg)
48–59 21.8–26.8 6–8 2 tsp or 10 mL (320 mg)
60–71 27.2–32.2 8–10 2.5 tsp or 12.5 mL

(400 mg)
72–95 32.7–43.2 11–12 3 tsp or 15 mL (480 mg)
a
Doses should be measured only with the measuring device enclosed in the package.
The recommended doses of acetaminophen syrup or suspension for chil-

dren between the ages of 2 and 12 years are given in table 5.1 and for con-
centrated infant acetaminophen drops in table 5.2.
Concentrated infants drops contain more acetaminophen per milliliter
than do syrup or suspension formulations and should only be measured with
the dropper that is packaged with the container. Failure to use the appropriate
measuring device may result in improper doses and is a frequent cause of
overdoses when the concentrated infant drops are used.
Products
Tylenol Regular Strength, Tylenol Extra Strength, Tylenol 8 hour, Tylenol
Arthritis, Feverall Suppositories, and Panadol.
NOTE: Tylenol 8 hour may be used in children over 12 years of age and
Tylenol Arthritis may be use in individuals over 18 years of age. Both contain
the same formula of sustained release acetaminophen, but arthritis products
may not be labeled for use in individuals under 18 years of age. Arthritis that
occurs in a child or adolescent requires physician treatment, not self-care.
Table 5.2 Recommended doses for concentrated acetaminophen infant drops

(concentration, 80 mg in 0.8 mL; 1 dropperful is 0.8 mL)
Weight (lbs) Weight (kg) Age (years) Dose
24–35 11–16 2–3 1.6 mL (use two

dropperful doses of
0.8 mL) (160 mg)
Nonsteroidal anti-inflammatory analgesic/antipyretic drugs

Monograph drugs
Aspirin (acetylsalicylic acid), carbaspirin calcium, choline salicylate, mag-
nesium salicylate, sodium salicylate, ibuprofen, naproxen sodium, and keto-
profen are all classified as NSAIDs.
NSAIDs may be used to reduce fever and provide temporary relief for minor
aches and pains caused by the common cold, sore throat, headache, muscular
aches and pain, backache, premenstrual and menstrual cramps (dysmenor-
rhea), and pain associated with arthritis.1,5,6
Low-dose aspirin (81 mg per day) may be recommended by a physician to
prevent the aggregation of blood platelets to reduce the risk of heart attacks
and strokes in certain individuals.
Mode of action
Aspirin and the other salicylates combine with cyclo-oxygenase enzymes
(COX-1 and COX-2), which are responsible for the first step in the formation
of prostaglandins and thromboxanes from arachidonic acid in the periphery.
Prostaglandins are produced in the inflammatory response and are involved
in the production of pain, especially pain associated with headache and
premenstrual and menstrual pain. The anti-inflammatory effect of aspirin
and salicylates derives from their ability to inhibiting prostaglandin synthe-
sis. Consequently, they are known as nonsteroidal anti-inflammatory drugs,
NSAIDs.3
Prostaglandin E2 (PGE2) produced in the periphery increases cyclic aden-
osine monophosphate (cyclic AMP), which causes the hypothalamus to
increase body temperature. Aspirin and the other NSAIDs inhibit PGE2 syn-
thesis, thus having an antipyretic effect.3
Prostaglandin H2 is converted to thromboxanes, which are involved in
platelet aggregation to stop bleeding. Because aspirin, but not other salicy-
lates, binds irreversibly to the acetyl site of COX-1, it is used for its antico-
agulant activity in individuals who are at risk for heart attacks and strokes
that are caused by blood clots. Individuals should consult their physician
before using aspirin for these cardiovascular uses.1,3,5–8
Aspirin, carbaspirin calcium, choline salicylate, magnesium salicylate,
sodium salicylate, and ibuprofen administered in recommended doses have
the same efficacy as analgesics and antipyretics.1,5
Individuals allergic to aspirin or any other pain or fever relief drug should not
take the drug as they may experience hives, asthma (wheezing), facial swell-
ing, or shock. The drug should be stopped immediately if any of these symp-
toms occur and a physician should be contacted.1,5,6
Children and teenagers should not use this drug if they have recovered, or
are recovering, from flu or chickenpox because they may develop Reye’s
syndrome, a serious condition associated with the use of aspirin and salicy-
lates.5,6,9 Reye’s syndrome occurs usually after a viral infection such as chick-
enpox or flu. Symptoms include persistent vomiting, fatigue, and confusion,
and the syndrome may progress to convulsions, unconsciousness, and death.
There is an increase in intracranial pressure and increased fatty deposits in the
liver and other organs. Immediate treatment minimizes the residual effects of
this condition.10
All NSAIDs may cause stomach bleeding and the risk of this event is
greater if individuals are over 60 years of age, have bleeding problems, peptic
ulcer disease, diabetes, gout, or arthritis, or if the individual is taking an
anticoagulant drug (blood thinner), steroids, or any other drugs containing
NSAIDs. Consuming three or more alcoholic beverages a day, taking more
than the recommended dose, or taking the drug for a longer period of time
than recommended increases the risk of bleeding.5,6
The appearance of blood or occult blood in any vomit or stool may
indicate stomach bleeding, and a physician should be consulted immediately.
If an individual experiences stomach pain or ringing in the ears, a physician
should be consulted.5,6
If NSAIDs do not relieve pain within 10 days, or fever within 3 days, a
physician should be consulted. If the symptoms worsen or redness develops in
the area of the pain, a physician should be consulted. If the product is labeled
for sore throat pain, its use should be limited to 2 days.1,5,6
NSAIDs should not be used during the last 3 months of pregnancy unless
directed by a physician because it may cause problems for the unborn child
and complications during delivery.1,5
Aspirin should not be used to reduce the risk of a heart attack unless
advised to do so by a physician.5
If a magnesium salicylate product has more than 50 milliequivalents of
magnesium in the recommended daily dose, it should not be used by individ-
uals with kidney disease without consulting a physician.1
If individuals have diabetes, high blood pressure, kidney disease or take a
diuretic drug, a physician should be consulted before using any NSAID.
NSAIDs may inhibit prostaglandins that produce vasodilatation of blood
vessels in the kidney, resulting in vasoconstriction and causing an increase
in blood pressure, further compromising kidney function in individuals who
have kidney disease.6,11,12
There are two special warnings for ibuprofen in addition to all the other
NSAIDs warnings.
Special ibuprofen warning for concomitant use with low-dose aspirin
(81 mg). There is competitive action between ibuprofen and aspirin for the
acetyl-binding site of cyclo-oxygenase when both drugs are administered

together. Since this is the site where aspirin acts to prevent platelet
aggregation for its cardiovascular effect, its effectiveness will be reduced.
If an individual uses both drugs, aspirin should be administered 8 hours
after ibuprofen.13 There is little evidence that naproxen sodium and
ketoprofen might have the same effect.
Special ibuprofen warning for migraine headache use. Individuals should
not use ibuprofen for a migraine headache if a physician has never
diagnosed their problem as a migraine headache. If the headache differs
from previous migraine headaches, is the worst headache of their life, is
accompanied by a fever and stiff neck, or has occurred after a head injury,
a physician should be consulted. If the headache is caused by bending,
coughing, or exertion, occurs daily, or is accompanied by vomiting, a
physician should be consulted before using ibuprofen. Ibuprofen is not
recommended for treating migraine headaches in individuals under 18
years of age unless a recommendation was made by a physician.14
Recommended dose
Aspirin for pain or fever relief. Adults and children over 12 years of age may
take two tablets of either 325 mg (regular strength) or 500 mg (extra
strength) aspirin per dose every 4 to 6 hours, not exceeding 12 tablets within
24 hours. Although the monograph permits aspirin use in children under
12 years of age, most healthcare professionals do not recommend its use;
acetaminophen is the preferred drug in children under 12 years of age.1,6
Aspirin for reduction of cardiovascular risk. The dose of aspirin
recommended is 81 mg per day for most individuals (a ‘baby’ aspirin), but
this use should be discussed with a physician. Doses higher than 81 mg
(325 to 500 mg) may be recommended by a physician for certain
individuals.
Salicylate drugs. Dose recommendations are given in table 5.3.
Table 5.3 Recommended adult doses of analgesic/antipyretic salicylate drugs

(maximum 4 times a day)
Drug Adult dose (mg)
Aspirin 325–1000
Carbaspirin calcium 414–828
Choline salicylate 435–870
Sodium salicylate 250–650
Magnesium salicylate 325–650

Table 5.4 Recommended doses of ibuprofen for children under 12 years of age
(100 mg in 1 teaspoon (tsp) or 5 milliliters (mL).
Weight (lbs) Weight (kg) Age (years) Dose
24–35 11–16 2 –3 1 tsp or 5 mL (100 mg)
36–47 16.3–21.3 4–5 1.5 tsp or 7.5 mL

(150 mg)
48–59 21.8–26.8 6–8 2 tsp or 10 mL (200 mg)
60–71 27.2–32.2 9–10 2.5 tsp or 12.5 mL

(250 mg)
72–95 32.7–43.2 11–12 3 tsp or 15 mL (300 mg)
Ibuprofen. Dose recommendation for adults and children over 12 years of

age is 200 to 400 mg per dose up to four times a day. Children’s ibuprofen
has a longer duration of action than acetaminophen and is given every 6
to 8 hours. Table 5.4 has the recommended doses for children aged between
2 and 12 years and table 5.5 for concentrated ibuprofen infants drops.
Products
Aspirin (Bayer Aspirin, Ascriptin, Anacin (contains caffeine as an adjuvant),
Bufferin, and Ecotrin (enteric coated aspirin), choline salicylate (Arthropan is
a liquid formulation), magnesium salicylate (Mobigesic, Backache Maximum
Strength, Extra Strength Doan’s, and Momentum Muscular Backache).
NOTE: There is no evidence that any of these products are more effective
in treating backache pain than any other aspirin or salicylate product, despite
the name of specific products.
Low-dose aspirin (81 mg) products: Bayer Low Dose ‘Baby’ Aspirin, St.
Joseph Adult Low Strength Aspirin.
Ibuprofen (Advil, Advil Infants’ Concentrated Drops, Advil Children’s
Suspension, Advil Migraine, and Motrin IB, Junior Strength Motrin, Con-
centrated Motrin Children’s Drops).
Table 5.5 Recommended doses for concentrated ibuprofen infant drops (50 mg in
1.25 mL; special measuring device included in package)
Weight (lbs) Weight (kg) Age (months) Dose
Under 6 Consult doctor
12–17 5.5–7.7 6–11 1.25 mL (50 mg)
18–23 8.2–10.5 12–23 1.875 mL (75 mg)

Rx–OTC switched NSAIDs

NSAIDs may be used to reduce fevers and provide temporary relief for minor
aches and pains caused by the common cold, sore throat, toothache, head-
ache, muscular aches and pain, backache, premenstrual and menstrual
cramps (dysmenorrhea), and pain associated with arthritis.
OTC NSAIDs
Ibuprofen, naproxen sodium and ketoprofen are available as analgesic/anti-
pyretic drugs because manufacturers submitted abbreviated new drug appli-
cations. These drugs are available as prescription products but in doses that
are higher than those in OTC products. The FDA included ibuprofen in the
OTC Internal Analgesic Monograph in 2002.15
Mode of action
NSAIDs inhibit the synthesis of prostaglandins in peripheral tissues and act in
the hypothalamus to reduce a fever in the same manner as aspirin. However,
NSAIDs competively inhibit cyclo-oxygenase in a reversible manner. These
NSAIDs cause somewhat less gastric irritation and bleeding than aspirin but
require the same warnings.5,6
If individuals are allergic to ibuprofen, naproxen sodium, ketoprofen, or
aspirin, or any other analgesic medication, they should not take theses prod-
uct, because they may cause hives, asthma (wheezing), or facial swelling. The
drug should be stopped immediately if any of these symptoms occur and a
physician contacted.
These products may cause stomach bleeding and the risk of this event is
greater if individuals are over 60 years of age, have bleeding problems or
peptic ulcer disease, take an anticoagulant drug (blood thinner), take steroids,
take any other drugs containing NSAIDs (either OTC or prescription), drink
three or more alcoholic beverages a day, take more than the recommended
dose, or take the drug for a longer period of time than recommended. A
physician or pharmacist should be consulted when taking other drugs if
individuals do not know the content of other medications.5,6
If blood appears in any vomiting or the stools have blood or are very black,
this may indicate stomach bleeding, and a physician should be consulted
immediately. If an individual experiences stomach pain or ringing in the ears,
a physician should be consulted.
If the product does not relieving pain within 10 days, or fever within
3 days, a physician should be consulted. If the symptoms worsen or
redness develops in the area of the pain, a physician should be consulted.
If the product is labeled for sore throat pain, its use should be limited to
2 days.1,5
A physician should be consulted before using these products if the indi-

vidual has diabetes, high blood pressure, liver cirrhosis, or kidney disease.6
These drugs should not be used during the last 3 months of pregnancy
unless told to do so by a physician, because they may cause problems for the
unborn child and complications during delivery.1,5
Recommended dose
Naproxen sodium. Individuals between the ages of 12 and 65 years of age
may take 220 mg (one tablet) every 8 to 12 hours and no more than three
tablets within 24 hours. Adults over 60 years of age should take 220 mg
(one tablet) every 12 hours. Children under 12 years of age should only
take naproxen sodium if recommended by a physician.16
Ketoprofen. Adults and children over 16 years of age may take 12.5 mg
ketoprofen every 8 hours. Children under 16 years of age should only take
ketoprofen if recommended by a physician.
Products
Naproxen sodium (Aleve), ketoprofen (marketed as Orudis KT but discon-
tinued by the manufacturer).
Analgesic combinations
The only permitted combination of analgesic drugs is acetaminophen and
aspirin.1
Acetaminophen and aspirin may be combined in a single product. The indica-
tions for use of each drug are the same, and the warnings and precautions for
each drug must appear on the label. The combination drug may not be labeled
for cardiovascular use even though it contains aspirin.
Special warnings for Excedrin Migraine
Individuals should not use Excedrin Migraine for a migraine headache if a
physician has never diagnosed their problem as a migraine headache. If this
headache is different from previous migraine headaches, is the worst headache
of their life, is accompanied by a fever and stiff neck, or has occurred after a
head injury, a physician should be consulted. If the headache is caused by bend-
ing, coughing or exertion, occurs daily, or is accompanied by vomiting, a phys-
ician should be consulted before using this product. Individuals under 18 years
of age should not use this product for a migraine headache unless a recommen-
dation has been made by their physician.16 These warnings are in addition to all
other acetaminophen and aspirin warnings that must appear on the label.
Products
Excedrin Extra Strength, Excedrin Migraine, Goody’s Headache Powders,
Vanquish.
Excedrin Extra Strength and Excedrin Migraine contain exactly the same
drugs, acetaminophen (250 mg), aspirin (250 mg) and caffeine (65 mg), but
the indications for use and labeled warnings are different. Excedrin Migraine
has only one indication, migraine headache, and is labeled for use by individ-
uals over 18 years of age; it has no other intended analgesic or antipyretic
use.17 Both drugs must have a warning for caffeine that states that the recom-
mended dose of this product has caffeine that is about equal to a cup of coffee.
Limit intake of caffeine from other sources to avoid nervousness, irritability,
increased heart rate, and insomnia that occurs from too much caffeine.17
Sedatives
Sleep is a dynamic process divided into two components, rapid eye movement
(REM) and nonrapid eye movement (NREM), which are easily distinguished
by electrophysiological patterns that can be measured using electroencephal-
ography (EEG) and electrooculography (EOG). These patterns vary depend-
ing on age of the individual and may be altered by environmental conditions
and/or by an individual’s mood, emotional state, drug therapy, or disease
state.
NREM sleep has four stages, each stage being considered to be a deeper
form of sleep. Stage 1 is the transition to sleep phase or the period for onset of
sleep. Stage 2 is an intermediate stage, which accounts for approximately 40
to 50% of sleep. Stages 3 and 4 are deep sleep stages where EEG measure-
ments show slow-moving waves. Stages 3 and 4 account for approximately
20% of sleep time and are primarily responsible for the restorative nature
of sleep, described by individuals as feeling more alert and energetic after
sleep. Stage 4 sleep becomes shorter in duration as people age and is partly
responsible for the early awakening experienced by elderly individuals.18
REM sleep patterns are more complex and less predictable than NREM
patterns and are associated with dreams. There is complete relaxation of
voluntary muscles during NREM sleep, and memory enforcement occurs
during this time. As the amount of REM sleep increases during the night,
there is a decrease in stages 3 and 4 of NREM sleep. Individuals usually
progress through four or five cycles of sleep (NREM and REM) during the
night, with each cycle lasting approximately 90 to 120 minutes.18
Sleep is not a period where all biological systems shift into a lower activity
level for a type of rest up or power up for the next day. Many important
activities occur during sleep, for example growth hormone and cortisol
(hydrocortisone) are secreted during sleep.
Insomnia is a general term that describes sleep disorders, and the most
common complaint by healthy individuals is that of not being able to fall
asleep readily, a sleep induction problem. The FDA’s definition of an OTC
sedative or nighttime sleep-aid is an agent that helps individuals who have
occasional difficulty in falling asleep.12 However, sleep is affected by external

and internal factors, and individuals as well as pharmacists should have an
understanding of the sleep process to determine when self-care may be
appropriate.
The internal or intrinsic control for sleep is the suprachiasmatic nucleus
(SCN) in the hypothalamus of the brain, which increases its neuronal signals
as evening approaches (diminishing light), stimulating the pineal gland to
secrete the hormone melatonin. Melatonin levels increase until about 2 to
4 a.m. and begin to diminish as dawn approaches. Estrogen and progester-
one levels in the brain also affect the SCN and are probably responsible for
the fact the women have a higher incidence of insomnia during menstru-
ation and menopause. Postpartum women also have more problems with
insomnia.18
The normal circadian rhythm in humans is slightly more than 24 hours.
However, external cues, primarily light and darkness and the daily activities
of individuals, entrain the daily rhythm to a 24 hour pattern and keep it at 24
hours. Light, either sunlight or bright artificial light, enters through the eyes,
activating neural pathways to the brain to promote wakefulness. Physical
activity, social interactions, and a busy or noisy environment also promote
wakefulness.
Individuals who experience occasional insomnia should be evaluated for
external causes of the problem before drug therapy is initiated. Behaviors that
enhance readiness for sleep in individuals include no napping during the day,
tapering down physical activity at the end of the day, having a regular pattern
of activity to prepare for sleep, having a regular time to go to sleep, reducing
distracting environmental factors such as too much light or noise, controlling
the temperature so it is not too hot or too cold, avoiding stimulating drugs
(caffeine in any form, pseudoephedrine or phenylephrine in allergy or cough/
cold medications) in the evening, avoiding alcohol, and avoiding smoking. If
these practices do not solve the individual’s insomnia, OTC sedative or diet-
ary supplements may help to alleviate the problem.
Common causes of sleep problems include shift work, jet travel, anxiety
and stressful situations, and medical conditions such as asthma, chronic
obstructive pulmonary disease, depression, sleep apnea, pain, dementia,
and rhinitis, among others. Treatment of the medical condition by a physician
should be the first attempt at solving sleep problems associated with medical
problems.
Shift workers and travelers who going through numerous time zones have
difficulties because each of these situations imposes new cues on the body’s
internal circadian rhythm. Melatonin has some positive effects in these situ-
ations, but prescription drugs are usually more effective. If shift work is a
long-term employment situation, altering circadian rhythm by entrainment
methods using light therapy and behavior modification may be successful.
Individuals who suffer from lack of sleep often complain of tiredness,

fatigue, lack of mental alertness, decreased motor skill, lack of concentration,
and irritability. Frequently, individuals try to compensate for these effects by
using stimulant drugs.
OTC drugs
Monograph drug: diphenhydramine
Nighttime sleep-aid or sedative relieves occasional sleeplessness for individ-
uals who have difficulty in falling asleep.19
Mode of action
Antihistamines classified as first generation or sedating antihistamines pro-
duce their effect by acting in the CNS.
If diphenhydramine does not provide relief of sleeplessness within 2 weeks, a
physician should be consulted because a more serious condition may be the
problem. If an individual has asthma, glaucoma, emphysema, chronic pul-
monary disease, shortness of breath, or difficulty in urinating because of an
enlarged prostate, a physician should be consulted. Alcoholic beverages
should not be consumed while taking diphenhydramine. If an individual is
taking other sedatives or tranquilizers, a physician should be consulted before
using this drug.19
Recommended dose
Adults and children over 12 years of age may take a single dose of 50 mg of
diphenhydramine 30 minutes before bedtime. This product should not be
used if any other product containing diphenhydramine is being used, even if
it is for topical use.20
NOTE: Diphenhydramine in used in many oral products for allergies,
sinus congestion, cough/colds, and itching, as well as topical products for
insect bites and itching. There are many reports of toxicity because of the use
of several products containing diphenhydramine.20
Products
Diphenhydramine: (Benadryl, Nytol, Simply Sleep, Sominex, Unisom Sleep
Gels, and Unisom Sleep Melts).
Rx–OTC switched drug: doxylamine

Doxylamine is an approved antihistamine with sedative actions similar to
diphenhydramine that was not included in the FDA’s nighttime sleep aid
monograph. The manufacturer filed an abbreviated new drug application
with the FDA and received approval for its use as a sedative.21

OTC sedatives relieve sleeplessness caused by difficulty in falling asleep.
Mode of action
Antihistamines classified as first generation or sedating antihistamines pro-
duce their effect by an action in the CNS.

If doxylamine does not provide relief of sleeplessness within 2 weeks, a
physician should be consulted because a more serious condition may be the
problem. If an individual has asthma, glaucoma, emphysema, chronic pul-
monary disease, shortness of breath, or difficulty in urinating because of an
enlarged prostate, a physician should be consulted. Alcoholic beverages
should not be drunk while taking doxylamine. If an individual is taking other
sedatives or tranquilizers, a physician should be consulted before using this
drug.21
Recommended dose
Adults and children over 12 years of age may take a single dose of 25 mg
doxylamine 30 minutes before bedtime.
Product
Doxylamine (Unisom Sleep Tabs).
Combination sedatives and analgesics

The FDA has approved the combination of nighttime sedatives with oral
analgesics to relieve occasional sleeplessness.
Mode of action
Mild discomfort and pain may prevent individuals from falling asleep easily,
and the combination of an analgesic and sedative may be more beneficial than
a sedative by itself.

Acetaminophen, aspirin, or ibuprofen may be combined with diphenhydra-
mine. Warnings and precautions for each active ingredient must appear on the
label of the product.
Recommended dose
Adults and children over 12 years of age may take a single dose of 1000 mg
acetaminophen with 50 mg diphenhydramine hydrochloride 30 minutes
before bedtime. Adults and children over 12 years of age may take a single
dose of 1000 mg aspirin with 72 mg diphenhydramine citrate 30 minutes
before bedtime. Adults and children over 12 years of age may take a single
dose of 400 mg ibuprofen with 72 mg diphenhydramine citrate 30 minutes
before bedtime.
Products
Acetaminophen and diphenhydramine (Tylenol PM), aspirin and diphenhy-
dramine (Bayer Aspirin PM), ibuprofen and diphenhydramine (Advil PM).
Dietary supplements
Melatonin
Although melatonin is a human hormone, it is not regulated as an OTC drug
by the FDA. It is available from animal sources or from a chemical synthetic
process as a dietary supplement. The body synthesizes melatonin through
several metabolic steps beginning with the conversion of the amino acid
tryptophan to serotonin and ultimately to melatonin.
Numerous studies have been conducted to determine the efficacy of mel-
atonin as a sleep aid. Although many clinical trials reported positive results
compared with placebos, the results were not statistically significant in many
studies.22 Most of the clinical trials had small numbers of patients and were
for short durations of use.
The evidence for the use of melatonin for jet lag in travelers has some
positive results for travel in an eastward direction if travel was through three
to five time zones, but the requirement for precise timing of dosing melatonin
for at least 3 days before the scheduled trip may limit its usefulness.22–24
Melatonin when combined with light therapy is more effective in altering
an internal circadian rhythm mechanism, but self-care is not appropriate
because it involves situations where insomnia is long term, not short term.24
Mode of action
Administration of exogenous melatonin elevates normal circulating levels of
melatonin, especially in individuals who have levels less than normal blood
concentrations, and it helps to relieve occasional insomnia. It acts at the same
receptor sites in the brain as endogenous melatonin.25
Melatonin has no serious adverse effects but may cause fatigue, headache,
dizziness, and irritability, especially when higher doses are used (more than
3 mg).
Recommended dose
Adult doses for falling asleep should be 1 to 3 mg 30 to 60 minutes before
bedtime. Adult doses for preventing jet lag are 1 to 3 mg taken at the projected
time of the new sleep pattern, beginning 3 days before travel.
Products
Melatonin (Melatonex and many generic manufacturers).
Valerian
Valeriana officinalis is the source of extracts that contain valepotriates, sesqui-
terpenes, and amino acids that are used in dietary supplements promoted
as sleep aids. However, the type of preparation used (tablets of valerian
extracts, teas or liquid preparation) vary greatly in the quantity of the com-
pounds that are in the product. There are many fewer studies reported on the
effectiveness of valerian, but the results, like those for melatonin, show slight
benefit for insomnia when compared with placebos.
Mode of action
The exact mechanism by which valerian causes sedation is not known, but it
may bind to gamma-aminobutyric acid (GABA) receptors, which normally
reduce brain stimulation. It does not exert its full effect unless it is taken for 2
to 4 weeks. This certainly exceeds recommendations for occasional drowsi-
ness, but it should be remembered that dietary supplements are not held to the
rigorous standards of OTC drugs because they are not approved for use by the
FDA.

Reported adverse effects include GI upset, headache, and morning
drowsiness.
Recommended dose
One cup of valerian tea made from a root extract is recommended several
times a day. Tablets containing 500 to 1000 mg valerian root extract may be
taken 1 hour before bedtime. An alcoholic liquid extract is available and the
recommended dose is 15 to 20 drops.26
Product
Valerian (Alluna).
Stimulants
The only OTC drug used as a stimulant is caffeine, but many brewed coffees
and teas, or energy drinks, may contain more caffeine than that permitted by
the FDA in OTC drugs. Guarana is a plant source of caffeine that appears in
many energy or natural products. Table 5.6 lists the amount of caffeine
available in some popular beverages and energy drinks.

Stimulant drugs produce an effect in the CNS that helps to alleviate occasional
drowsiness and fatigue and to increase mental alertness.27
Table 5.6 Caffeine content of popular beverages and energy drinksa
Product Usual size (ounces) Caffeine content (mg)
Plain, brewed coffee 8–12 60–120
Plain, brewed, decaf coffee 8–12 < 10
Dunkin' Donuts 16 143
MacDonald's Large 16 145
Starbucks Coffee Grande 16 330
Starbucks Grande Cappuccino 16 150
Starbucks Grande Caffe Latte 16 150
Starbucks Espresso 1.5 77
Plain, brewed tea 8–12 20–90
Lipton Brisk Ice Tea 20 50
Snapple Iced Tea 16 42
Starbucks Tazo Chai Tea 12 75
Nestea Ice Tea 16 34
Coca-Cola 12 35
Diet Coke 12 45
Barq's Root Beer 12 23
Mountain Dew 12 55
Dr. Pepper 12 41
Pepsi 12 38
Full Throttle 16 144
TAB Energy 10.5 95
Jolt 23.5 280
Vault 12 70
So-Be Adrenaline Rush 16 152
So-Be No Fear 16 174
Rockstar 16 160
Red Bull 8.3 80
Propel Invigorating Water 20 50
Vitamin Water Energy 20 40
a
Caffeine in drinks: http://www.energyfiend.com/the-caffeine-database (accessed: February 28, 2009).
Caffeine appears in many headache remedies because it increases the pain-

relieving effect of OTC analgesics (see earlier discussion in this chapter).
Caffeine also produces a mild diuretic effect and is used for this purpose in pro-
ducts that treat symptoms associated with premenstrual tension (Chapter 6).
Monograph drugs
Caffeine is the only approved monograph drug.
Mode of action
Caffeine stimulates the release of neurohormones, norepinephrine and epi-
nephrine, in the brain, which increase mental alertness and ward off feeling of
tiredness and fatigue.
Ingestion of caffeine from other sources should be limited when using a
caffeine product to prevent nervousness, irritability, insomnia, and rapid heart
beat. The product contains approximately as much caffeine as a cup of coffee.
If drowsiness or fatigue persists, a physician should be consulted.27
Recommend dose
Adults and children over 12 years of age may take 100 to 200 mg of caffeine
every 3 to 4 hours.
Products
Caffeine (NoDoz Maximum Strength, Ultra Pep-Back, Vivarin).
Antidepressant dietary supplements

St. John's wort
Diagnosis and treatment of depression is not a self-care problem and the FDA
has not approved any OTC drugs for depression. However, individuals who
think they are depressed may try taking OTC stimulants or dietary supple-
ments such as St. John’s wort. St. John’s wort is widely used in Europe as an
antidepressant, particularly in Germany. It is a dietary supplement in the USA
and its sale does not require FDA approval. It is commonly used to treat mild
to moderate depression.
Clinical trials comparing St. John’s wort with placebo and low-dose tri-
cyclic antidepressant drugs have demonstrated a positive effect, and it has
fewer adverse effects than the tricyclic antidepressants.28
St. John’s wort is a flowering plant or shrub whose extracts are used to
promote a positive mood.
Mode of action
Products of St. John’s wort are standardized based on the concentration of
hypercin present in the product. Hypericin has weak effects by inhibiting the
reuptake of several neurotransmitters in the brain, including serotonin, nor-

epinephrine and GABA. The plant also contains flavonoids, which contribute
to its effect.29,30 St. John’s wort affects liver enzymes, especially cytochrome
oxidase (CYP3A4).
If individuals are taking other medications physician should be consulted
because St. John’s wort has many drug interactions. It decreases the effect
of many drugs, including protease inhibitors and nonnucleoside reverse tran-
scriptase inhibitors (used to treat HIV infections), oral contraceptives, cyclo-
sporine, simvastatin, and warfarin. A sunscreen should be used when going
outdoors because this product causes photosensitivity reactions.29,30
Because this drug is a dietary supplement, it must contain the following
statement: ‘This product has not been evaluated by the Food and Drug
Administration. This product is not intended to diagnose, treat, cure, or
prevent any disease.’
Recommended dose
The daily dose for adults is 300 mg three times a day. This product is not
recommended for children. It may take up to 2 months for St. John’s wort to
produce its full effect.30

Case 1 A 48-year-old woman tells the pharmacist that she uses two
tablets of Tylenol Extra Strength (500 mg of acetaminophen per tablet)
four times a day because she fell and her back is sore. She wants to
know if she should use Tylenol PM to help her sleep better.
The pharmacist advises her not to use Tylenol PM because she is
already taking the maximum recommended daily dose of acetamino-
phen. If she exceeds the recommended daily dose, she increases the risk
of damaging her liver. If she is having trouble falling asleep, she could
take a nighttime sedative containing diphenhydramine, such as Nytol,
Sominex, or Simply Sleep.
Case 2 The mother of an 11-month-old infant asks the pharmacist

what dose of Tylenol Infant Drops she should give the baby because
the baby is teething and is cranking and crying.
The pharmacist tells the mother that Tylenol Infant Drops should not
be administered to a child less than 2 years of age unless the doctor has
advised her to do so. She could purchase a topical product such as
Anbesol, which contains a local anesthetic, that is rubbed on the gums
to relieve teething pain. (See Chapter 7.)
Case 3 A 56-year-old man who is not under the care of a doctor asks the
pharmacist what dose of aspirin he should take to reduce the risk that
he could have a heart attack. He is overweight like his father, who died
from a heart attack.
The pharmacist recommends that he see a physician because using
aspirin for a potential cardiovascular problem is not a decision that
should be made by an individual. There are risks associated with the
use of aspirin that must be evaluated before he should take aspirin on a
daily schedule. The pharmacist explains that he should see a physician
because he is overweight, and his father’s health history may increase
the risk he has for cardiovascular disease.
Case 4 A 44-year-old man had minor dental surgery done and the
dentist recommended that he take an OTC anti-inflammatory drug
such as ibuprofen for the moderate pain that he is having. He asks
the pharmacist if there is some other drug that he could take that does
not have to be taken every 4 hours because his job is such that he can’t
take the medication that frequently.
The pharmacist explains that naproxen sodium (Aleve) is the same type
of drug as ibuprofen and has a longer duration of action and would
solve his problem. It may be used twice a day.
Case 5 The mother of a 9-year-old girl tells the pharmacist that her
daughter has a dance performance in a week and she is too excited and
nervous to fall asleep. She asks if using valerian tablets (Alluna) would
be suitable because it’s a natural product.
The pharmacist advises her not to use any nighttime sedative because
sedatives should not be used in children under 12 years of age without a
doctor’s recommendation. He also tells her that valerian would not be
helpful because it takes approximately 2 weeks for it to have its opti-
mum effect. He discusses methods to have the child get ready for bed at
a set time and to have her avoid excitement and any beverages like cola
drinks that contain caffeine in the late afternoon and evenings.
Case 6 A worker has just had a job change and complains of problems
falling asleep at night. When he gets up in the morning, he feels tired
and has no energy. He wants to know if Vivarin will help to give him
energy during the day.
The pharmacist discusses the man’s use of coffee and tea during the
day. The man usually gets a 16 ounce Starbucks Grande Coffee on his
way to work but he doesn’t think it helps him with his fatigue. The
pharmacist explains that Vivarin contains 200 mg caffeine and the
Starbucks coffee he drinks contains 330 mg caffeine. The pharmacist

suggests that he not consume more caffeine since the coffee he drinks
doesn’t help him.
The pharmacist discusses an alternative of using a nighttime seda-
tive such as diphenhydramine (Nytol, Sominex or Simply Sleep) or
doxylamine (Unisom) for several nights. Perhaps he has some anxiety
because of his new job and a few nights of a more restful sleep will help
him. If this suggestion isn’t satisfactory, he should see his doctor.
Case 7 The mother of a 15-year-old girl asks the pharmacist which

OTC migraine drug would be best for her daughter.
The pharmacist discovers that the daughter has never seen a doctor
about her headaches. The pharmacist tells the mother that OTC
migraine products are only intended for use in individuals who are
over 18 years of age and who have been diagnosed as having migraine
headaches. The pharmacist recommends contacting the doctor and
suggests using acetaminophen or ibuprofen as soon as the headache
symptoms occur. The dosing directions on the product label should be
followed until the appointment with the doctor.
References
1. Internal analgesic, antipyretic, and antirheumatic drug products for over-the-counter
human use; tentative final monograph. Fed Regist 1988; 53: 46204–46260.
2. Managing Migraines. www.fda.gov/fdac/features/2006/206_migraines.html (accessed
February 21, 2009).
3. Burke A et al. Analgesic-antipyretic and anti-inflammatory agents; pharmacotherapy of
gout. In: Brunton LL et al. eds. Goodman & Gilman’s The Pharmacological Basis of
Therapeutics, 11th edn. New York: McGraw-Hill, 2006: 671–715.
4. Health Bulletin: Use Caution With Pain Relievers. Updates October 30, 2007. www.fda.
gov/cder/consumerinfo/acetaminophen.htm (accessed February 5, 2009).
5. Internal analgesics, antipyretics and antirheumatic drug products for over-the-counter
human use; proposed amendment of the tentative final monograph; required warnings
and other labeling. Fed Regist 2006; 71: 77314–77352.
6. Organ-specific warnings; internal analgesic, antipyretic, and antirheumatic drug products
for over-the-counter human use: final monograph. Fed Regist 2009; 74: 19385–19409.
7. FDA Panel Backs ‘Black Box’ Warnings for Acetaminophen Prescription Combos. http://
www.medpagetoday.com/ProductAlert/OTC/14922 (accessed July 12, 2009).
8. Schulman S. Hemorrhagic complications of anticoagulant and thrombolytic treatment:
American College of Chest Physicians Evidence-Based Clinical Practice Guidelines (8th
edition). Chest 2008; 133(Suppl 6): 257S–298S.
9. Labeling for oral and rectal over-the-counter drug products containing aspirin and non-
aspirin salicylates; Reye’s syndrome warning. Fed Regist 2003; 74: 18861–18869.
10. NINDA. Reye’s Syndrome Information Page. www.ninds.nih.gov/disorders/reyes_
syndrome/reyes_syndrome.htm (accessed May 26, 2009).
11. Bennett WM, DeBroe ME. Analgesic nephropathy: a preventable renal disease. N Engl
J Med 1989; 320: 1269–1271.
12. Naughton CA. Drug-induced nephrotoxicity. Am Fam Physician 2008; 78: 743–750.
13. New Information for Healthcare Professionals; Concomitant Use of Ibuprofen and
Aspirin. www.fda/gov/cder/drug/Infosheets/HCP/ibuprofen_aspirinHCP.htm (accessed
February 5, 2009).
14. Advil Migraine Product Information. www.Advil.com.products/migraine/migraine_
label.asp (accessed February 21, 2009).
15. Internal analgesic, antipyretic, and antirheumatic drug products for over-the-counter
human use; proposed amendment of the tentative final monograph, and related labeling.
Fed Regist 2002; 67: 54139–54159.
16. Aleve Labeling. www.aleve.com (accessed February 21, 2009).
17. Excedrin Migraine Product Information. www.excedrin.com/prodGuide-migraine-label.
shtml (accessed February 21, 2009).
18. Tibbitts GM. Sleep disorders: causes, effects, and solutions. Prim Care Clin Office Pract
2008; 35: 817–837.
19. Nighttime sleep-aid drug products for over-the-counter human use; final monograph; final
rule. Fed Regist 1989; 54: 6814–6827.
20. Labeling of diphenhydramine containing drug products for over-the-counter human use.
Fed Regist 2002; 67: 72555–72559.
21. Unisom Drug Facts. www.Unisom.com/DrugFacts.asp?product¼10 (accessed February
24, 2009).
22. Buscemi N et al. Melatonin for Treatment of Sleep Disorders. Summary, Evidence Report/
Technology Assessment: Number 108. [AHRQ Publication number 05-E002-1.] Rock-
ville, MD: Agency for Healthcare Research and Quality, 2004 http://ahrq.gov/clinic/
epcsums/melatsum.htm (accessed February 20, 2009).
23. Srinivasan V et al. Jet lag: therapeutic use of melatonin and possible application of
melatonin analogs. Travel Med Infect Dis 2008; 6: 17–28.
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lag disorders. Sleep 2007; 30: 1460–1483.
25. Gooneratne NS. Complementary and alternative medicine for sleep disturbances in older
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Comprehensive Database, 3rd edn. Stockton, CA: Therapeutic Research Faculty; 1999:
926–928, 1052–1054.
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6
Genitourinary system
This chapter discusses products affecting the urinary tract and gender-based
products. There are very few urinary-tract conditions that are amenable to
self-care because most require diagnosis by a physician, and appropriate
therapy requires prescription drugs. The most common symptom that affects
both men and women as they age is increased urinary frequency and the
discomfort that may accompany urination.
Men generally begin to experience symptoms of urinary frequency after
the age of 50 or 60 because of enlargement of the prostate gland. The urethra
passes through the prostate gland and as the prostate tissue increases in size it
causes obstruction of urine flow, causing incomplete emptying of the urinary
bladder. This leads to the need to empty the bladder frequently. There are
many other serious medical conditions, such as cancer, that cause similar
symptoms, and an appropriate diagnosis and treatment requires physician
supervision. However, many men are reluctant to see a physician and prefer to
try the dietary supplement saw palmetto to alleviate their symptoms.
Women are more likely to experience urinary-tract infections than men
because of the anatomic differences between the sexes. The urethra is much
shorter in women and the risk of bacteria entering the urinary tract is in-
creased. Many women have frequent reoccurrence of infections, and increas-
ing fluid intake and the use of dietary supplements or beverages containing
cranberries may provide symptomatic relief and prevent infection.
There are two drugs available for treatment of discomfort during urination
for which the FDA has not issued a final ruling. Phenazopyridine is classified
as a urinary analgesic drug, and methenamine is a urinary antiseptic (anti-
bacterial). The FDA plans to issue a ruling that will clarify its position on the
marketing of unapproved drugs that manufacturers will be required to follow.
Many women experience mild, temporary edema (fluid retention) along
with other symptoms, including premenstrual tension and dysmenorrhea,
during the menstrual cycle and the FDA has approved several OTC diuretics
in a monograph for this purpose.
Contraception may be a concern to both sexes and condoms for men and
women are available as OTC products. The use of condoms also reduces the
risk of sexually transmitted diseases. Spermicidal products for vaginal use are
also available as OTC products.
Many women are prone to develop a vaginal candida (yeast) infection,
especially those who have diabetes or are taking broad-spectrum anti-
biotics. The FDA permits the sale of OTC vaginal antifungal agents for
women who have been previously diagnosed as having a candida infection
by a physician.
Urinary-tract drugs
Urinary analgesics
Phenazopyridine
The FDA has not approved the efficacy claims of phenazopyridine as a
urinary-tract analgesic but it has not taken any action to call for its removal
from the marketplace at this time. The FDA has indicated that it intends to
declare any OTC products as misbranded or adulterated if they do not have
specifically approved drugs as active ingredients. These products will remain
on the market until FDA takes a final action on this proposed policy, or until a
manufacturer submits data proving efficacy. Phenazopyridine appears cur-
rently in several prescription drugs as a urinary analgesic in the USA.1
Drug category and indications of use
Phenazopyridine acts as a urinary analgesic to relieve the burning, discomfort,
and pain that occurs during urination; it may relieve symptoms of urinary
urgency and frequency.
Mode of action
The mechanism of action of phenazopyridine is not known, but it has no effect
as a urinary antiseptic or antibacterial agent.2

If an individual has kidney disease or glucose-6-phosphate dehydrogenase
deficiency, this drug should not be used without consulting a physician. If a
yellowing of the eyes or skin develops, or if fever, chills, confusion, back pain,
blood in the urine occur, a physician should be consulted. Use of this drug
should be limited to 2 days. If symptoms are not relieved or if they worsen, a
physician should be called. Phenazopyridine will cause a red–orange color in
the urine and may stain clothing. It will also stain soft contact lenses and these
should not be worn while taking this drug.2,3
Recommended dose
Adults may take two tablets after each meal for 2 days with a full glass of
water; not more than 12 tablets should be taken and the tablets should be
swallowed not chewed.3
Genitourinary system | 113
Products
Phenazopyridine (Azo-Standard, Uristat, UTI Relief, Uricalm).
Urinary-tract antiseptic (antibacterial)

Methenamine is bactericidal because of its antiseptic properties and helps to
relieve urinary frequency and urgency associated with urinary-tract infections.2
Methenamine.
Mode of action
In an acidic environment, menthenamine breaks down to form ammonia and
formaldehyde, which kill microorganisms.
A physician should be consulted the first time urinary pain, discomfort,
and/or frequency are experienced. Adverse effects include upset stomach,
vomiting, and diarrhea. The development of a skin rash or hives may indicate
an allergic reaction to methenamine, and the physician should be called
immediately.4
The product Cystex contains methenamine and sodium salicylate, which
requires the following additional warnings.5 ‘If you are allergic to aspirin or
any other analgesic drug do not take this product.’ ‘If you have peptic ulcer
disease or bleeding problems do not take this product.’ ‘If you are on a salt
restricted diet, do not take this drug.’ ‘If you are an adolescent who has
recently had chickenpox or the flu, do not take this drug because it increases
your risk of developing Reye’s syndrome.’
Recommended dose
Adults and individuals over 12 years of age may take two tablets up to four
times a day with food and a full glass of water. The tablets should not be
chewed. If pain and discomfort persist for 10 days or worsens, a physician
should be consulted.5
Products
Methenamine (Cystex, also contains sodium salicylate).
Dietary supplements
Cranberry
Indications for use
Cranberry juice or powered extracts may reduce the risk for urinary-tract
infections for individuals who are likely to have recurrent infections.6
Mode of action
Cranberry products are not antibacterial agents but studies revealed that they
reduce they ability of bacteria to adhere to the bladder wall. When fluid intake
is increased, the population of bacteria in the bladder is reduced, preventing
infections.

High doses of cranberry may cause stomach irritation and diarrhea.
Cranberries are very bitter and many natural cranberry drinks are sweetened
with large quantities of sugar, which should be avoided by individuals who
have diabetes and individuals who may be on weight-loss programs. Many
beverages are now prepared with artificial sweeteners to avoid these
problems.
There are reports that cranberry juice increases bleeding in patients taking
warfarin, an anticoagulant. Individuals should consult their physician before
consuming large quantities of cranberry juice if they are taking warfarin.
Large quantities of cranberry products may increase the risk of kidney stones
in individuals who previously had oxalate kidney stones.
Recommended dose
Adults and individuals over the age of 18 should drink 3 to 16 ounces (90–
480 mL) of cranberry juice daily to prevent urinary-tract infections. If 300 or
400 mg of powered cranberry extract as tablets or capsules are used, the dose
should be between one and six capsules twice a day with a large glass of water
1 hour before meals or 2 hours after meals.
Products
Ocean Spray Cranberry Juice and many others.
Urinary diuretics
Caffeine has mild diuretic activity and relieves mild edema (fluid retention)
associated with the menstrual cycle. It may be labeled to reduce the temporary
weight gain and breast tenderness associated with menstruation.7
Caffeine and pamabrom (8-bromotheophylline) are chemically methylxan-
thine compounds. Ammonium chloride (NH4Cl) is approved in the mono-
graph but does not appear in current products.
Mode of action
Methylxanthines cause vasodilatation and a slight increase in renal blood
flow and glomerular filtration rate. Sodium and chloride are excreted, in-
creasing urine volume and reducing edema.7

Caffeine’s label must state that the product contains about the same caf-
feine content as a cup of coffee and intake of beverages with caffeine should
be limited. Other caffeine-containing drugs should be limited because an
overdose of caffeine is possible. Adverse effects include gastric irritation,
rapid heart beat, increased blood pressure, irritability, nervousness, and
insomnia.7
Pamabrom’s label does not contain the same warnings because it does not
have a stimulant effect like caffeine on the CNS and the cardiovascular
system.7
Recommended dose
Caffeine may be used by adults and individuals over 12 years of age; 100 to
200 mg may be taken every 3 to 4 hours as long as symptoms persist.7
Pamabrom may be used by adults and individuals over 12 years of age as a
50 mg dose up to four times a day.
Products
Caffeine (used in many menstrual combination products); pamabrom (Aqua
Ban and Diurex Aquagels).
Products for men

Dietary supplement diuretics
Certain compounds in juniper berries, buchu, uva ursi, sandalwood, couch
grass, dandelion, and cubeb berries are claimed to have a diuretic action.
These herbs also appear in many homeopathic products in concentrations
much lower than those in dietary supplements.
Diurex For Men contains buchu, dandelion, juniper extract, and guarana,
a natural ingredient containing caffeine, and is described as helping to support
healthy fluid balance and aid in the elimination of excess body water and its
related discomforts.8
Mode of action
Many plant compounds are excreted by the kidney and may act on the bladder
to cause irritation, which may increase urination.
Product
Diurex Water Pills for Men.
Diurex can be used by healthy men over 18 years of age. If any other medica-
tions are being taken, a healthcare professional should be consulted before
using this product.8
As a dietary supplement, Diurex must contain the following statement on

the label. ‘These statements have not been evaluated by the FDA. This product
is not intended to diagnose, treat, cure or prevent any disease.’
Dietary supplement for benign prostate hyperplasia

The first symptoms of benign prostatic hyperplasia (BPH) are a weaker urine
stream, difficulty in initiating urine flow, and increased urinary frequency.
The incidence of BPH increases with age. The appropriate recommendation
for males who have these symptoms is an examination by a physician for a
diagnosis, because these symptoms are also associated with prostatitis and
cancer of the prostate.
BPH is most appropriately treated with prescription drugs. Relief of uri-
nary frequency and urgency is achieved by using drugs that specifically inhibit
alpha-adrenoceptors in the urinary tract so that the bladder can be more
completely emptied and the urine stream is more forceful.
Another way to manage this medical condition is to use drugs that block
the enzyme 5-alpha-reductase. This enzyme is in the pathway for production
of dihydrotestosterone, an androgenic hormone responsible for the growth of
the prostate gland. Finasteride and dutasteride are two prescription drugs that
inhibit this enzyme. Saw palmetto (Serenoa repens) produces the same effect
but its activity is much weaker than the prescription drugs. The enzyme-
inhibiting drugs may take up to 6 months to relieve BPH symptoms, and
the degree of their effectiveness is related to the actual size of the prostate
gland, which can only be determined by a physician. Comparison of saw
palmetto with finasteride in men with mild to moderate symptoms showed
similar relief of symptoms but no improvement in any objective measure of
urinary or prostate health. Saw palmetto did have fewer adverse effects than
finasteride. Saw palmetto has produced a positive effect in many placebo
trials.9,10
Indications of use
Saw palmetto may be useful in maintaining prostate and urinary health.
Herbal ingredient
Saw palmetto.
Mode of action
Saw palmetto contains plant sterols that are weak inhibitors of 5-alpha-
reductase and reduce the formation of dihydrotestosterone.
Saw palmetto should not be taken by pregnant women or women who plan to
become pregnant because of its potential antiandrogenic effect on the fetus.
Saw palmetto may cause gastric irritation, nausea, constipation, and diarrhea.
It should be used with caution if anticoagulants such as warfarin are being

used because it may increase bleeding. Bleeding has also been reported if it is
used with ginkgo biloba.10
Saw palmetto is not recommended by the American Urological Asso-
ciation for treatment of BPH. The product label must carry the standard
dietary supplement warning, ‘This product is not intended to diagnose, treat,
cure or prevent any disease.’
Male condoms
Condoms have a long history of use in the prevention of unwanted pregnancy,
but their importance as a device that prevents sexually transmitted disease is a
more recent development. Condoms made from natural rubber latex or poly-
urethane are effective in preventing infections that may be spread by contact
with the head of the penis, such as HIV (AIDS), syphilis, and gonorrhea. They
are less effective in preventing infections that are spread by contact with
infected skin, for example human papillomavirus (HPV) or herpes virus.
Condoms made from natural lamb intestines are effective in preventing preg-
nancy but not in preventing any sexually transmitted disease (STD). Condoms
may also be used to collect semen to determine sperm count during fertility
evaluations.
Condoms are effective because they are a physical barrier to sperm, bac-
teria, and viruses; they are unrolled over an erect penis, creating a sheath-like
cover. Condoms may be purchased with or without a reservoir tip. When a
condom without a reservoir tip is used, an area or space should remain at the
tip of the condom to prevent rupture of the condom during ejaculation.
Condoms are available with or without a lubricant, have varying thicknesses,
and many designed surfaces and colors that are intended to enhance the sexual
experience. Lubricants have not been evaluated or approved by the FDA.
If an individual or his partner is sensitive to latex, a polyurethane or lamb
skin condom should be used. Some condoms use a spermicidal lubricant, but
the amount of the lubricant is not deemed to be sufficient to kill all sperm.
Lubricants that are used with condoms should not be oil or petroleum based
(e.g. petrolatum (Vaseline)) because they may damage the condom.
Condoms should be stored in a cool, dry place. A condom that feels sticky
or appears damaged should not be used. The FDA requires that each condom
be tested to be certain that all standards are met during the manufacturing
process.11
General directions for effective use of a condom include the following.11
‘A condom should be used every time the individual has sex and may only be
used once. Condoms must be stored properly and should not be used after its
expiration date. Proper use of a condom requires that it be held at its base
when withdrawing the penis to prevent spillage of the ejaculate; dispose of the
Table 6.1 Pregnancy rate (percentage in one year) using no contraception and
common contraceptive methods
Contraceptive method Perfect use (%) Typical use (%)
None 85 85
OTC male condom 2 15
OTC female condom 5 21
OTC sponge no prior births (prior 9 (20) 16 (32)

births)
Rx estrogen/progesterone 0.3 8
Rx injection (Depo-Provera) 0.3 3
Rx transdermal (Evra Patch) 0.3 8
Diaphragm 6 16
OTC, over the counter; Rx, prescription.

Adapted from Trussell J. Contraceptive efficacy. In: Hatch RA et al. eds. Contraceptive Technology, 18th edn.
New York: Ardent Media, 2004.
used condom properly. If the condom breaks or leaks, the woman should use
emergency contraception to prevent pregnancy.’
Directions for use of latex and polyurethane condoms include: ‘Condoms
help to prevent pregnancy and reduce the risk of transmission of HIV infec-
tion, AIDS, and many other STDs.’
Directions for use of lamb’s skin condoms include: ‘Condoms help to
prevent pregnancy, but do not reduce the risk of STDs, including HIV and
AIDS.’
Condoms are not 100% perfect in preventing pregnancy even when used
properly. Both partners should use contraceptives to be more certain that
pregnancy does not occur. Women may use OTC spermicidal agents or pre-
scription devices such as a diaphragm, intrauterine device, cervical cap, or
oral, transdermal, or injectable contraceptive. If a male condom is being used,
the female should not use a female condom. Table 6.1 has the overall preg-
nancy rates expected with the various contraceptive measures.12
Products for women

Female condoms
The female condom is shaped like a cylinder; it is 7 inches (17 cm) long and has
one closed end and one open end. Both ends contain a soft, flexible ring. The
closed end is pushed together and inserted vaginally before intercourse so that
it covers the cervix and the ring on the open end remains outside the vagina. It
provides protection against pregnancy and STDs.13
The FDA has only approved one manufacturer of female condoms. There
are two types of female condoms available. The FC Female condom is made of
polyurethane and the FC2 is made of nitrile. If a lubricant is used, it should be
water soluble, the same as for male condoms.
Directions for use of the female condom includes the following.13 ‘Insert
the condom before intercourse, being certain the closed end covers the cervix
and be careful not to tear the condom with fingernails or jewelry. A new
condom is required each time the individual has intercourse, and do not use
the condom if the expiration date has passed. Squeeze the open end of the
condom together and twist it before removal to prevent spilling its content;
dispose of the condom properly. If the condom tears during intercourse or the
contents spill, consider using emergency contraception to prevent pregnancy.’
Vaginal spermicides
Vaginal spermicides are intended to prevent pregnancy.
Mode of action
Spermicides are nonionic surface-acting agents that disrupt the lipid mem-
branes of sperm. They may be used alone or with diaphragms and condoms.14
Monograph drug
Nonoxynol 9 is the only monograph spermicide.
Spermicides are intended for vaginal use only. The product does not protect
against infections by HIV or other STDs. Nonoxynol 9 may cause irritation of
vaginal tissue, which may increase the risk of getting HIV from an infected
partner. If the individual or her partner has HIV/AIDS, another form of birth
control is recommended (male latex or polyurethane condoms). The product
may cause vaginal irritation, burning, or itching. If a rash develops in the
individual or her partner, use of the product should be stopped and a phys-
ician should be consulted. A douche product should not be used for at least 6
hours after intercourse.14
Recommended dose
Directions for vaginal inserts. ‘The woman should use one vaginal insert
10 minutes before sexual intercourse; each insert provides one hour of
protection.’
Directions for cream, jelly, or foam. ‘Insert the contents of one applicator
into the vagina 10 minutes before intercourse; each dose provides one hour
of protection.’
Directions for vaginal films. ‘Use your finger to insert one contraceptive
film vaginally so that it covers the cervix before intercourse; one film will
provide up to 3 hours of protection.’
The contraceptive sponge has been available in the USA for varying per-
iods of time. Its unavailability has never been caused by problems of safety or
efficacy, but rather with problems in the manufacturing process, lack of
approval of an abbreviated new drug application, or financial decisions made
by the manufacturer. The sponge is scheduled to appear in the US market in
the summer of 2009. The sponge is inserted vaginally to cover the cervix and
may be left in place for 24 hours.
Products
Nonoxynol 9 (Ortho Options Delfen Vaginal Contraceptive Foam, Ortho
Options Conceptrol Prefilled Vaginal Contraceptive Applicators, Encare Vag-
inal Contraceptive Inserts, VCF Vaginal Contraceptive Film, Today Sponge).
Emergency contraception
Levonorgestrel (Plan B)
The FDA originally approved OTC status for the sale of a package containing
two tablets, each containing 0.75 mg levonorgestrel, as emergency contra-
ception if purchased by someone 18 years of age or older.15 The federal courts
in the USA ordered the FDA to make Plan B available to those aged 17 years of
age in spring 2009 because women of that age were included in the clinical
trials. The FDA indicated that it intends to comply with the order.16
Progestin only tablets reduce the chance of pregnancy when a woman has
unprotected intercourse or if there is failure of some form of contraception.
Rx–OTC switched drug: levonorgestrel

The FDA approved the switch of levonorgestrel, a progestin, to OTC status,
but it may only be purchased from a pharmacist as a behind-the-counter
drug.
Mode of action
Progestin therapy may prevent release of the ovum if taken before ovulation
or it may prevent fertilization from occurring. It may also prevent implan-
tation of a fertilized ovum in the uterus.15
Women who are pregnant should not use levonorgestrel because it is not
effective if they are already pregnant. It should not be used as a routine form
of contraception. The woman’s next menstrual cycle should occur within
3 days of the expected date. If menstruation is more than a week late, the
woman should consider taking a pregnancy test.
Levonorgestrel does not provide any protection from STDs. Adverse

effects include nausea, vomiting, abdominal discomfort or pain, fatigue,
headache, alteration in the amount of bleeding during the period, and breast
tenderness.16
Recommended dose
Levonorgestrel is most effective when taken within 72 hours after unprotected
intercourse. One tablet of levonorgestrel 0.75 mg should be taken as soon as
possible and the second tablet should be taken 12 hours later. The greater the
time elapsed between intercourse and taking the first dose, the less effective
the drug is in preventing pregnancy.
If vomiting occurs within 1 to 2 hours after taking the first tablet, the dose
must be repeated and a second dose must be taken 12 hours later. (Since the
package contains only two tablets, if the woman vomits after the first tablet, a
second purchase may be necessary because two doses of levonorgestrel are
necessary for the drug to be effective.) The cost of Plan B (two tablets) is
around $40.00.
Product
Levonorgestrel (Plan B: Next Choice (available in Fall 2009; newly approved
generic)). NOTE. On July 16, 2009 the FDA approved Plan B One Stage
which contain 1.5 mg of levonorgestrel in one tablet instead of the two tablet
dose.
Vaginal antifungal drugs

Vaginal infections are not unusual in women once menarche occurs.
Overgrowth of Candida albicans, a normal inhabitant of the vagina, is the
most frequent cause of vaginal infections. Women who have diabetes mellitus
are at greater risk for infection, as are women who are immunosuppressed or
who take broad-spectrum antibiotics or oral contraceptives. Sanitary pads
should be changed frequently during menstruation and tampons should not
be used.17
Cleansing the vaginal area and keeping it dry are helpful in preventing
candida infections. Many women cleanse the vagina by using douche pro-
ducts. There are no specific medical recommendations for using douches in
normal healthy women. These products are not evaluated by the FDA; they
contain surfactants for cleansing and may have buffers and pH adjuster to
help to maintain the normal environment in the vagina.
There is some evidence that ingestion of probiotic nutrients in yogurts,
those having live lactobacilli or bifidobacteria, may help to prevent vaginal
yeast infections. The FDA has not approved the use of the probiotics for this
purpose.
The symptoms associated with yeast infections include vaginal itching and
a thick, white, discharge that looks like cottage cheese. Once a woman has had
a candida infection that was diagnosed by a physician, she may choose to treat
her next candida infection with an OTC vaginal antifungal drug.

Candida or yeast infections are treated with topical, vaginal antifungal drugs.
Vaginal antifungal drugs relieve itching and irritation caused by the vaginal
yeast infections.

Butoconazole, clotrimazole, miconazole, and tioconazole are all approved for
use as vaginal antifungal drugs.
Mode of action
All of the OTC antifungal drugs are classified chemically as imidazoles. They
bind to sterols in the fungal membrane, causing changes in its permeability
that result in fungal cell death.18

These products should not be used if a woman is pregnant. A woman should
not use this product if she has never had a vaginal yeast (candida) infection
diagnosed by a physician. The product should not be used if lower abdominal,
back or shoulder pain is present; if fever or chills, nausea, or vomiting develop;
or if a foul-smelling vaginal discharge is present.17
A woman should not have vaginal intercourse when using a vaginal anti-
fungal drug. This product may damage condoms and diaphragms and should
not be used with tampons, douches, spermicides, or other vaginal products.
These drugs provide no protection against STDs.
If there is no relief of symptoms within 3 days of using this product,
or if the symptoms last longer than 7 days, the woman should consult a
physician.17
Recommended dose
Adults and children over 12 years of age may use vaginal antifungal drugs.
Products are available that are to be used for 1, 3, or 7 days. The concentration
of the active drug differs for each type of product, with the single-day treat-
ments having the highest concentrations and the 7-day treatments having the
lowest concentration. Vaginal products may be suppositories (inserts) or
vaginal creams that are to be used once daily before bedtime. Formulations
consisting of a vaginal cream come with an applicator that is inserted vagi-
nally, depressing a plunger delivers the cream to the vagina. Some products
come in prefilled, disposable applicators.
Products are also available as a topical cream for application to the skin
around the vagina that may be irritated and itchy, and they may be used twice
a day. Topical creams are to be used in addition to the formulation that is
inserted vaginally.
Products
Clotrimazole (Gyne-Lotrimin 3 Vaginal Cream and Gyne-Lotrimin 7 Vaginal
Cream), tioconazole (Monistat 1 Day Treatment and Vagistat-1), and miconazole
(Monistat 1 Day Treatment Day or Night Combination Pack, Monistat 3 as vaginal
suppositories (ovule inserts) or combination pack with inserts and topical cream,
Monistat 7 Day Treatment with disposable applicators or as a combination with
applicators and topical cream, Vagistat 3 as vaginal suppositories (inserts)).
Premenstrual and menstrual symptoms

Premenstrual syndrome comprises multiple symptoms, including bloating or
edema, cramps, headache, backache, fatigue, and feelings of irritability,
depression, and anxiety.
OTC drugs
The symptoms of cramps (lower abdominal pain) and headache may be treated
using OTC analgesics, as discussed in Chapter 5. Bloating and edema may be
treated using OTC diuretics, as discussed earlier in this chapter. Irritability,
depression, and anxiety may be treated by using pyrilamine, an antihistamine.
Since this is not a final monograph, pyrilamine, is permitted in products be-
cause the FDA has not made a final decision on its efficacy, but, it may only be
used in a combination product to treat premenstrual or menstrual symptoms.
All of the above drugs have already been discussed, and table 6.2 contains
a list of combination products available for premenstrual or menstrual
symptoms.
Table 6.2 Content of combination products for relief of premenstrual or menstrual

symptomsa
Product name Analgesic Diuretic Pyrilamine
Diurex Advanced Water Pills Magnesium salicylate Caffeine None
Diurex PMS Formula Acetaminophen Pamabrom Yes
Pamprin Cramp Acetaminophen and Pamabrom None

magnesium salicylate
Pamprin Max Acetaminophen and aspirin Caffeine None
Pamprin Max Multisymptom Acetaminophen Pamabrom Yes
Premsyn pms Acetaminophen Pamabrom Yes
Midol Max Strength Menstrual Complete Acetaminophen Caffeine Yes
Tylenol Women's Menstrual Relief Acetaminophen Pamabrom No
a
Information obtained from product labels.
Menopausal symptoms
Perimenopause and menopause are associated with a series of symptoms that
includes hot flushes (hot flashes), irritability, and difficulty in concentrating
and sleeping. These symptoms are associated with the decrease in estrogen
and progesterone as women reach their 40s and 50s. Many women use
prescription hormone replacement therapy, but doing so slightly increases
the risk of breast cancer. Many women seek alternatives, and herbal products
are among these choices.
Dietary supplements
The National Center for Complementary and Alternative Medicine and the
National Institute on Aging sponsored a study to evaluate the effect of black
cohosh (Actaea racemosa and Cimicifuga racemosa) on the vasomotor symp-
toms associated with menopause, hot flashes, and night sweats. Black cohosh
was used alone or combined with other herbal ingredients and compared with
conjugated equine estrogens (with and without progesterone) and placebo.
There was no difference between black cohosh alone or with other herbal
ingredients and the placebo in relieving menopausal symptoms. The conju-
gated equine estrogen drugs did have a positive effect.19,20
Phytoestrogens (plant estrogens) are used to support the healthy, natural
changes that occur during menopause.
Herbal ingredients
Black cohosh, soy and red clover are promoted for menopause health.
Mode of action
Phytoestrogens are purported to act at estrogen receptors in the body and to
replace natural estrogen, which is declining. Phytoestrogens have a weaker
action than human estrogens and are assumed to be safer than prescription
drug hormone replacement therapy. A more recent placebo-controlled
study reported that black cohosh, botanical products and dietary soy had
no effect on vaginal epithelium, endometrium, or reproductive hormones
when compared with hormonal replacement.21 This finding adds doubt
as to whether or not phytoestrogens act as true estrogenic substances in
humans.
Black cohosh may cause gastric irritation and headache. Soy and red clover
contain phytoestrogens, which may act at human estrogen receptors; there-
fore, women at increased risk of diseases associated with estrogen adminis-
tration (e.g. breast, uterine, or ovarian cancer; endometriosis; or uterine
fibroids) should not use these products without consulting their physicians.
Recommended dose
There are no true recommended doses for these products, but they should not
be used in children. Doses are based on those used in studies or products that
are commercially available. A usual dose of black cohosh is 20 mg of root
extract, which contains 1 to 2 mg triterpenes, once or twice a day.
Soy and red clover contain isoflavones and concentrations vary from
50 mg to approximately 120 mg. Soy is available in many foods, including
soy milk, tofu, and soy noodles. Daily soy intake may vary from 25 to 50 g.22
Products
Black cohosh (Remifemin and generic products are available from many
generic companies), phytoestrogens (Promensil and Estroven).

Case 1 Allison is 17 years old and asks the pharmacist to recommend a
product because she experiences swelling of her hands and feet and
some breast tenderness during her menstrual cycle.
The pharmacist asks about her use of caffeine products and learns that
she usually drinks a cup of coffee in the morning, but has no other
caffeine. The pharmacist explains that products containing caffeine
and pamabron would be helpful. The pharmacist explains that both
act in the same manner so she should use only one product during her
next menstrual cycle to determine if she has any relief. The pharmacist
recommends Aqua Ban or Diurex Aquagels; both products contain
pamabron.
Case 2 Charles, a 67-year-old man, asks the pharmacist to recommend

a product because he is experiencing urinary frequency and has to get
up two or three times a night to urinate and this is disturbing his sleep.
The pharmacist discusses Charles’ problem and recommends that he
consult a doctor. Charles has had these symptoms for about 8 months,
but until a couple of weeks ago he only got up once during the night to
urinate. The pharmacist tells Charles that since his problem increased
in severity, there are no OTC products that will provide immediate
relief. The dietary supplement that many men use, saw palmetto, may
provide some symptomatic relief but it takes a few months before it
really has an effect. Only prescription medications can provide Charles
with a more timely relief. Charles is also at an age when he should have
a prostate examination by a doctor to be certain that he doesn’t have a
more serious problem than the expected enlargement of the prostate
that occurs with age.
Case 3 A 15-year-old girl asks the pharmacist whether she should use
Tylenol Tablets or Motrin IB for the cramps and back pain that she gets
when she has her menstrual period.
The pharmacist recommends Motrin IB because it has been shown to
be more effective for menstrual-related pain. Motrin IB contains ibu-
profen, a nonsteroidal anti-inflammatory drug, which has a greater
effect on inhibiting the peripheral prostaglandin synthesis that is
responsible for most of the symptoms she is experiencing. Although
Tylenol also affects prostaglandin synthesis, it has very little anti-
inflammatory effect.
Case 4 Scott asks the pharmacist what he should do about skin irri-
tation he experiences on his penis and genital area after he uses a condom.
The pharmacist discusses the issue with Scott and learns that he is using
a latex condom. The pharmacist suggests that he might be sensitive to
the latex and that he should use a polyurethane condom. If Scott still
has a skin irritation problem he should consult a physician.
Case 5 Gina tells the pharmacist she wants to purchase Plan B but she
can’t find it on any of the shelves in the pharmacy.
The pharmacist informs Gina that Plan B is only available from the
pharmacist and cannot be put on the store’s shelves with other products.
Case 6 Miriam asks the pharmacist to recommend a product because

she has vaginal itching and a thin vaginal discharge that has a bad
smell.
The pharmacist asks Miriam if she ever had this problem before and if
she saw a doctor. Miriam replies that she has not. Miriam needs a
proper diagnosis for her problem. The pharmacist recommends that
Miriam should consult a physician because the only OTC drugs avail-
able for vaginal infections are for a yeast (candida) infection that was
previously diagnosed by a physician. The pharmacist also explains that
the symptoms she describes are not those usually associated with a
yeast infection.
Case 7 Rachael is a 47-year-old woman who asks the pharmacist to

recommend a sleeping product because she gets up several times during
the night because of sweating, which disturbs her sleep. She also experi-
ences similar symptoms during the day but they are less bothersome.
The pharmacist discusses the fact that she is probably having these
symptoms because of normal decreases in her hormone levels that
occur during menopause. An OTC sedative may or may not help her
sleeping problem, but it certainly would have no effect of the cause of
her night sweats. The pharmacist suggests that she discuss the problem
with her physician because she may want to consider hormone replace-
ment therapy.
Rachael asks about herbal therapy because she is aware that hor-
mone therapy could increase her cancer risks. The pharmacist suggests
that she could increase soy in her diet or purchase dietary supplements
of soy or red clover, which contain phystoestrogens, plant estrogens.
Black cohash is another product that has been used for normal meno-
pausal symptoms. He also tells Rachael that controlled clinical trials
have not shown that these dietary supplements produce significant
relief of night sweats, but they may provide some relief that could help
her problem. If Rachael does not obtain relief, she should discuss the
issue with her physician.
References
1. Phenazopyridine. www.nlm.nih.gov/medlineplus/druginfo/meds/a682231.html. Last review-
ed September 1, 2008 (accessed March 3, 2009).
2. Petri WA. Sulfonamides, trimethoprim–sulfamethoxazole, quinolones, and agents for uri-
nary tract infections. In: Brunton LL et al. eds. Goodman & Gilman’s The Pharmacological
Basis of Therapeutics, 11th edn. New York: McGraw-Hill, 2006: 1111–1126.
3. Uricalm Label Information. www.drugstore.com:80/products/prod.asp?pid¼152874&
catid¼11647 (accessed March 3, 2009).
4. Methenamine Information. www.nlm.nih.gov/medlineplus/druginfo/meds/a682296.html
(accessed March 3, 2009).
5. Cystex Label. http://drugstore.com.products/prod.asp?pid¼159288catid¼11647 (access-
ed March 7, 2009).
6. Cranberry (Vaccinium macrocarpon) Information. www.nlm.nih.gov/medlineplus/druginfo/
natural/patient-cranberry.html (accessed March 5, 2009).
7. Orally administered menstrual drug products for over-the-counter human use; tentative
final monograph; notice of proposed rulemaking. Fed Regist 1988; 46194–46202.
8. Diurex Pills for Men. www.Diurex.com (accessed March 5, 2009).
9. Edwards JL. Diagnosis and management of benign prostatic hyperplasia. Am Fam
Physician 2008; 77: 1403–1410.
10. Saw palmetto. (Serenoa repens [Bartram] Small) Information. www.nlm.nih.gov/
medlineplus/druginfo/natural/patient-sawpalmetto.html (accessed March 5, 2009).
11. Labeling Guidance for Latex Condoms. www.fda.gov/cdrh/comp/guidance/1688.html
12. Trussell J. Contraceptive efficacy. In: Hatch RA et al. Contraceptive Technology, 18th
edn. New York: Ardent Media, 2004: 221–252.
13. FC & FC2 Female Condom Label Information. www.femalehealth.com/theproduct.html
14. Over-the-counter vaginal contraceptive and spermicide drug products containing nonox-
ynol 9; required labeling. Fed Regist 2007; 72: 71769–71785.
15. Vaginal contraceptive drug products for over-the-counter human use; establishment of a
monograph; proposed rulemaking. Fed Regist 1980; 82014–82049.
16. Plan B information. www.fda.gov/cder/drug/infopage/planB/default.htm (accessed
March 9, 2009).
17. Guidance for Industry. Labeling Guidance for OTC Topical Drug Products for the
Treatment of Vaginal Yeast Infections (Vulvovaginal Candidiasis). www.fda.gov/cder/
guidance/2483dft.pdf (accessed March 9, 2009).
18. Bennett, JE. Antifungal agents. In: Brunton LL et al. eds. Goodman & Gilman’s The
Pharmacological Basis of Therapeutics, 11th edn. New York: McGraw-Hill, 2006: 1225–
1241.
19. Menopausal Symptoms and CAM. www.nccam.nih.gov/health/menopause/menopausesym
[toms.htm (accessed February 19, 2009).
20. Newton KM et al. Treatment of vasomotor symptoms on menopause with black cohosh,
multibotanicals, soy, hormonal therapy or placebo: a randomized trial. Ann Intern Med
2006; 145: 869–879.
21. Reed S et al. Vaginal, endometrial, and reproductive hormone findings: randomized,
placebo-controlled trial of black cohash, multibotanical herbs, and dietary soy for vaso-
motor symptoms: the Herbal Alternatives for Menopause (HALT) Study. Menopause
2008; 15: 51–58.
22. Product Review: Supplements for Menopausal Symptoms (Soy and Red Clover
Isoflavones, Black Cohash, and Progesterone Cream). www.ConsumerLab.com (accessed
March 3, 2009).
7
Topical ophthalmic, otic,
and oral cavity conditions
Topical ophthalmic products

There are several different OTC pharmacological products available to relieve
common ophthalmic conditions, including dry eyes (artificial tears), irritated
red eyes (astringents, vasoconstrictors, and antihistamines), cleansing (eye
washes), and contact lens products. All ophthalmic products are sterile and
buffered so that the osmotic pressure between ophthalmic fluids and the
product are equal.
Single-use ophthalmic containers should be discarded after use. The tip of
a multiuse container should not touch the eye, eyelid, or any other surface and
should be capped immediately after use. Multiuse products contain preserv-
atives that may cause irritation or allergic reactions in some individuals.
Single-use containers should be used in these situations.
Certain symptoms are not amenable to self-care and require referral to a
physician. These symptoms include eye pain, blurred or distorted vision,
sensitivity to light, presence of foreign objects that cannot be removed by
using eye washes, a copious thick discharge, and irritation and redness that
worsen or persist for more than 72 hours.1
Conjunctivitis is a general term describing inflammation of the conjunc-
tiva, the mucous membrane that lines the inner surface of the eye. This may
result from irritation or from a viral or bacterial infection. There are no OTC
products for ophthalmic infections.2
Blepharitis is an inflammation of the eyelids, and the most common causes
are inflammation of hair follicles, irritation or blockage of sebaceous glands,
and localized infection with Staphlococcus aureus, commonly referred to as a
stye. These conditions are usually self-limiting, but some of the discomfort
they cause may be relieved by applying warm compresses to the affected eye
for 5 to 10 minutes several times a day. An ophthalmic lubricant ointment
may also be useful.
Age-related macular degeneration, a serious eye disease, may be treated

with high doses of antioxidants, eye vitamins, but these are oral products, not
ophthalmic products.
Dry eye products (artificial tears)

The eye is constantly exposed to environmental conditions, such as wind,
heat, and low humidity, causing the eyes to lose moisture. Tears are secreted
by the lacrimal glands and act as both lubricant and cleansing agent. Tears are
composed of lipids (cholesterol esters, phospholipids, triglycerides, and fatty
acids) secreted mainly by sebaceous glands on the eyelids, aqueous com-
pounds (electrolytes, primarily sodium and chloride, and other salts that act
as buffering agents), and mucus (glycoproteins and mucopolysaccharides).
These compounds protect the eyes from abrupt changes in osmotic pressure
and pH. Lipids and mucus add viscosity to tears, which helps to retard
evaporation and soothe mildly irritated eyes. Infrequent blinking causes dry-
ness, and mild irritation and is frequently associated with wearing contact
lenses for excessive periods of time or staring at computer or video screens.
Aging may be accompanied by decreased activity of the lacrimal glands
and an alteration of the various components of tears. Medications such as
anticholinergic drugs, antihistamines, diuretics, and some antidepressants
also cause a decrease in tears. People who wear contact lenses may be both-
ered by dry eyes. Smoking may cause dry eyes and irritation and redness.
Treatment for dry eyes is the use of artificial tear products, which are either
demulcents or emollients.
Artificial tear solutions (demulcents)

Demulcents are water-soluble drugs that are instilled as liquid drops in the
eyes to relieve dryness and mild irritation.
Monograph demulcent drugs
Cellulose derivatives (carboxymethylcellulose, hydroxyethylcellulose, hydroxy-
propylcellulose, and methylcellulose), dextran 70 (a water-soluble polymer),
gelatin, polyols (polyethylene glycol (PEG) 300, PEG 400, polysorbate 80, and
propylene glycol), and polyvinyl alcohol.1
Mode of action
Artificial tear solutions replace normal tears and provide lubrication to the
eye, relieving discomfort.
Liquid demulcents should not be used if they contain particulate matter or if
the solution is cloudy or changed in color. If the condition worsens or persists
Topical ophthalmic, otic, and oral cavity conditions | 131
for more than 72 hours, use of the demulcents should be stopped and a
physician consulted.
Recommended dose
One or two drops should be instilled in the affected eye as needed. Hands
should be washed before using eye drop preparations. The proper method of
using eye drops involves tilting the head backward, pulling the lower lid
forward and placing one drop in the pouch-like area of the lower lid.
Slowly return the lower lid to its normal position and close the eye for 1 to
2 minutes. Dry with a clean tissue if necessary. Repeat if a second drop is
needed.
Products
Akwa Tears, GenTeal, Hypotears, Refresh, Systane, Tears Naturale, and
Visine Tears.
Artificial tear ointments (emollients)

Emollients are lipid ophthalmic ointments applied to the lower eyelid to
relieve dry eyes and minor irritations.
Lanolin, anhydrous lanolin, light mineral oil, mineral oil, paraffin, petrola-
tum, white ointment, white petrolatum, white wax, and yellow wax.1
Mode of action
Emollients replace the normal lipid secretions from the sebaceous glands of
the eyelids.
If the condition worsens or persists for more than 72 hours, use of the emol-
lient should be stopped and a physician consulted.
Recommended dose
Apply a thin amount of ointment to the lower eyelid. Wash hands, pull the
lower eyelid down and apply a small amount of ointment (approximately one-
quarter of an inch (0.5 cm)) to the inside of the lower eyelid.
Products
GenTeal Eye Ointment, Refresh P.M., and Stye Eye Ointment.
Eyewash solutions
An eyewash solution is intended to cleanse the eye and remove loose foreign
matter and/or to relieve minor eye irritations, such as stinging and burning
associated with dust, air pollution, and chlorinated water.

Eyewash solutions contain no pharmacologically active ingredients.1
Monograph drugs
Eyewashes or eye lotion contain water, agents to restore osmotic pressure, pH
adjusters, buffers, and preservatives.
Mode of action
Washing the eye with a solution contained in an eyecup or flushing the eye
with a solution that from a nozzle removes debris, liquid or solid, that acci-
dentally enters the eye and causes discomfort. Eyewash solutions may be used
to cleanse the eye of excess mucous secretions.
Immediate medical treatment should be sought for all open wounds in or near
the eyes or if noxious chemicals accidentally enter the eye.
Recommended dose
Products that have nozzles should be used while the individual bends over a
sink and flushes the affected eye by squeezing the bottle gently with contin-
uous pressure. When eye washes are used with eye cups, a clean eye cup should
be filled half-way with solution. The cup is pressed against the skin surround-
ing the eye to prevent leakage of the eye wash. The eyelids should be opened to
bath the entire eye.
Products
Collyrium, B&L Advanced Eye Relief, OcuFresh.
Hypertonic eye drops

A hypertonic solution contains a concentration of sodium chloride between
2% and 5%; this is greater than the 0.9% that is isotonic to the eye. It is used
to reduce corneal edema.
Sodium chloride solutions of 2% to 5% are approved drugs.
Mode of action
Addition of hypertonic sodium chloride to the eye causes a higher osmotic
pressure in the eye, and excessive fluid in the cornea is removed as the eye
attempts to equalize the osmotic pressures.
These products should not be used except with the advice and supervision of a
physician. If eye pain or changes in vision occur, or if the condition worsens or
persists, a physician should be consulted. Temporary stinging and burning
may occur.
Recommended dose
One or two drops are instilled in the affected eye as recommended by the
physician.
Product
Muro-128.
Ophthalmic astringents
An astringent is instilled in the eye to help clear excess mucus, reducing
irritation and discomfort.
Zinc sulfate (0.25%) is the only approved astringent.
Mode of action
Astringents combine with protein, causing it to precipitate so that it may be
removed from fluids in the eye.
The product should not be used if it is cloudy or has changed color. A
physician should be consulted if eye pain or changes in vision occur, or if
the condition worsens or persists.
Recommended dose
One or two drops are instilled into the affected eye up to four times a day.
Product
Zincfrin (astringent, zinc sulfate, plus a vasoconstrictor, phenylephrine).
Ophthlamic vasoconstrictors
Vasoconstrictors act to reduce redness of the eye resulting from minor
irritation.1,3
Ephedrine, naphazoline, oxymetazoline, phenylephrine, and tetrahydro-
zoline.1,3
Mode of action
Small blood vessels in the eye dilate and cause redness. Topical application of
ophthalmic sympathomimetic drugs constricts these blood vessels, reducing
or eliminating the redness.1,3
These products should not be used if they are cloudy or have changed color.
The solutions may cause the eyes to dilate and should not be used by those
with narrow-angle glaucoma unless advised by a physician. Excessive use of

these products may increase redness of the eye.3
Recommended dose
One or two drops are instilled in the affected eye up to four times a day. The
product should not be used in children under 6 years of age.
Products
Naphazoline (Clear Eyes and B&L Moisturizing Drops), oxymetazoline
(Visine LR), phenylephrine (generic), and tetrahydrozoline (Visine, Visine
Advanced Relief, and Murine Tears Plus).
Ophthalmic antihistamines
Antihistamine ophthalmic products are intended to relieve irritation, itchy
eyes, watery secretions, and redness caused by an allergic response.
Pheniramine and ketotifen have been approved for use as ophthalmic anti-
histamine drugs to alleviate the symptoms associated with allergic conjuncti-
vitis. Pheniramine is only used when it is combined with the vasoconstrictor
naphazoline.3
Mode of action
The release of inflammatory products, especially histamine, from the antigen–
antibody immune reaction produces increased tearing, redness, and irritation.
The antihistamine in the ophthalmic drops binds to the receptors where
histamine normal binds. This blocks histamine from activating these recep-
tors, preventing tearing, vasodilatation of small blood vessels, and redness.
Ketotifen is used alone and acts by blocking the receptor for histamine and
by preventing histamine release from mast cells.
The products should not be used if they are cloudy or have changed color.
These products should not be used if eye pain or changes in vision occur, or
if the condition worsens or persists for more than 72 hours.
Pheniramine products.3 ‘Individuals who have narrow-angle glaucoma

should not use vasoconstrictors because the pupils may dilate and become
enlarged, worsening vision. This is a temporary condition. Do not use in
children under 6 years of age.’
Ketotifen products.4 ‘Do not use for redness associated with contact lens
use. If you wear contact lenses, remove the lenses and wait for at least
10 minutes before reinserting lenses after using ketoifen. Do not use in
children under 3 years of age.’
Directions for use

Pheniramine is used as one to two drops up to three or four times a day.
Ketotifen is used as one drop every 8 to 12 hours, but not more than twice
a day.
Products
Pheniramine (Naphcon A, Opcon A, and Vasocon A), ketotifen (Zaditor).
Contact lens products

Contact lens and the solutions used for their disinfection are consider as
devices and not drugs by the FDA. Contact lenses are made of polymers that
correct vision and should be fitted by an eye physician. Lenses are classified as
either soft or rigid gas permeable (RGP). The polymers used are different for
each type of lens and the disinfecting solutions must be chemically compatible
with the lenses. Several different manufacturers make contact lenses and
products that are compatible with the lenses.
Improper cleaning and disinfection of contact lenses may lead to serious
eye problems, including infections that may cause blindness. These conditions
include acanthameoba keratitis, giant papillary conjunctivitis, and fusarium
keratitis. General procedures to be followed to minimize the risk of infection
include the following: (1) always wash hands before inserting or removing
lenses; (2) do not use nonsterile water or saline solutions for cleaning or
storage of the lenses; (3) use sterile disinfecting solutions for cleaning and
storing lenses and do not reuse the solution; (4) do not use products if the
expiration date has passed; (5) clean the lens case and allow it to air dry
between uses; (5) clean lenses by gently rubbing the surfaces, rinse, and then
store in lens case; (6) store the lenses in the appropriate solution for the
recommended period of time needed for proper disinfection before using
the lenses.5
Products
Soft contact lenses: ReNu Multipurpose Daily Disinfecting Solution, Opti-
FreeRepleniSH Multipurpose Disinfecting Solution, CIBA Vision Clean Care
H2O2 Cleaning and Disinfection Solution.
RGP contact lenses: Boston Multiaction Solution w/Daily Protein
Remover, Boston Conditioning Advance Solution.
Otic products
The external ear is a blind canal that is lined with epithelial skin. Cerumen (ear
wax) is produced as the secretions from the sebaceous and sweat glands
combined with epithelial skin cells that are being shed and replaced.
Cerumen has a light-yellowish color and becomes darker when it is exposed
to air and is oxidized. Exposure to air also causes cerumen to lose moisture
and become harder, causing discomfort and impaired hearing if it is not
removed.
NOTE: There are no FDA approved drugs for topical use for earache (ear
pain). Ear pain should be evaluated by a physician, but use of an oral analgesic
such as acetaminophen, aspirin, or ibuprofen may relieve pain symptoms
temporarily. There are homeopathetic earache drops that contain chamo-
milla, sulfur, and mercury solubilis sold as Similasan products. As homeo-
pathic products they do not have to prove safety or efficacy to the FDA
(see Chapter 1.)
Ear wax removal aid

Ear wax softeners are intended to help in removing ear wax by softening and
loosening excessive ear wax.6
Carbamide peroxide (6.5%) and anhydrous glycerin drops are placed in the
ear and remain there for a period of time to soften excessive ear wax in the
external ear canal.
Mode of action
Ear wax softening agents absorb moisture, which lubricates hardened ear wax
for easier removal from the external ear canal.
These products should not be used unless directed by a physician if there is
drainage or discharge from the ear, tinnitus, ringing or buzzing in the ear,
dizziness, ear pain, a perforated ear drum, ear tubes, or ear surgery. Cotton
swabs should not be used in the ear.6
Directions for use
The head is tilted and 5 to 10 drops of solution are added to the affected ear in
adults and children over 12 years of age; ear wax softeners should not be used
in children under 12 years of age unless directed by a physician. The solution is
kept in the ear by inserting cotton in the ear. Drops may be used twice a day
and for a maximum of 4 days. If the earwax is not removed, a physician
should be consulted.6
The excess wax is removed by flushing the ear with water at room tem-
perature or warm, using an ear syringe. Water that is too cold or too hot may
cause nausea and vomiting and/or dizziness.
Products
Carbamide peroxide (Debrox, Murine Wax Removal System; this product
contains an ear syringe with the drug product).
Prevention of swimmer's ear

Water that remains in the external ear canal may causes discomfort, a feeling
of fullness in the ear, and may impair hearing. Drugs that dry water-clogged
ears may be used to relieve these symptoms and may help to prevent infections
in the external ear.7
Isopropyl alcohol (95%) in anhydrous glycerin is approved for drying water-
clogged ears.
Mode of action
If water remains trapped in the external ear canal from swimming or shower-
ing, it may create conditions causing discomfort in the ear and favor the
growth of microorganisms that cause infections. Drugs that absorb the water
or change the environment of the external ear reduce the risk of an infection.

Isopropyl alcohol is flammable and should be kept away from flames and fire.
It should not be used without consulting a physician if there is pain, drainage/
discharge from the ear, or dizziness, or by anyone who has had ear surgery.7
Directions for use

The head is tilted and four to five drops are instilled in the affected ear. A plug
of cotton may be used to keep the solution in the external ear canal.
Products
Isopropyl alcohol and anhydrous glycerin (Swim Ear and Auro Ear).
Oral cavity products

Tooth decay, gingivitis, periodontitis, aphthous ulcers, and fever blisters are
the most common problems that affect the oral cavity and frequently these
cause a great discomfort and pain. There are a variety of products that can
relieve the discomfort associated with these conditions, but maintaining good
oral hygiene is the best way to prevent their occurrence.
Anticaries drugs
Dental caries (tooth decay) may be prevented by daily brushing and flossing of
the teeth. There are several other factors that are important in maintaining
healthy teeth. There is a genetic component that provides greater resistance to
tooth decay in some individuals, but the environment in the oral cavity is very
important.
The presence of food debris, especially sugars, enhances the growth of

bacteria that constitute the normal flora in the oral cavity. A sticky film,
plaque, is formed in the mouth and adheres to the teeth. Bacteria in the plaque
remain in close contact with the teeth, producing acidic waste products that
can demineralize the calcium hydroxyapatite in the teeth’s hard enamel
surface.
The enamel protects the softer dentin, which contains the blood supply
and nerve structure, beneath its surface from bacteria. Once the enamel loses
its hardness through demineralization, bacteria invade the dentin, causing
destruction and producing pain and tooth loss.
The salivary glands secrete saliva, which contains buffers to keep the pH
slightly acidic, usually between 6.5 and 7.0 in healthy adults; enzymes neces-
sary for initiating the digestion of certain foods; and electrolytes (minerals) to
maintain the integrity of the teeth’s enamel surface. Saliva helps to protect the
teeth from decay by diluting and neutralizing acids produced by bacteria in
the oral cavity.
Secretion of saliva is controlled primarily by activation of the parasym-
pathetic (cholinergic) nervous system. If there is impairment in the produc-
tion of saliva, the incidence of tooth decay increases. Anticholinergic drugs
inhibit salivary secretion, causing dry mouth (xerostomia) as an adverse
effect. There are many artificial saliva products that may alleviate this
condition, but they are not considered to be drugs in the monograph system.
Oasis Dry Mouth, Biotene Dry Mouth and OraMoist are popular saliva
substitutes.

An anticaries drug helps to prevent dental caries, a disease of the calcified
enamel of the tooth that results in demineralization and destruction of the
dentin and its structures.8
Sodium fluoride, stannous fluoride, and sodium monofluorophosphate
applied topically to the teeth through the use of mouth rinses or dentifrices
(toothpastes) act as anticaries drugs.8
Oral supplements containing fluorides are prescription drugs. Com-
munities with a public water supply that serves over 25 000 people may add
fluoride to the drinking water supplies. The optimum concentration of fluor-
ide in drinking water ranges from 0.7 to 1.0 parts per million.
Mode of action
The ingestion or topical application of fluoride ion to the enamel of teeth
results in the formation of fluoroapatite, a substance that increases the hard-
ness of the enamel, making it more resistant to demineralization from the
action of bacteria.

These products should be kept out of the reach of children under 6 years of
age. Anticaries toothpastes and oral fluoride rinse formulations should not be
swallowed after use but should be spit out. When an oral fluoride rinse is used,
food and drink should not be consumed for at least 30 minutes after rinsing.
Anticaries products have size limitations depending on the specific fluoride
ingredient present. The purpose of this limit is to reduce the risk of toxicity
from the fluoride component in case of accidental ingestion. Toothpastes are
limited to 276 mg of total fluoride, and oral rinses to 120 mg.8
Stannous fluoride products may produce surface staining, which is not
harmful and can be removed by a dentist.
Directions for use
Adults and children over 2 years of age should brush the teeth thoroughly with
toothpaste after every meal or at least twice a day. Children under 6 years of
age should be supervised until they are capable of using the products properly.
Adults and children over 6 years of age should use an oral fluoride rinse
once a day after thoroughly brushing their teeth. They should swish 10 mL of
fluoride rinse around the teeth for 1 minute and then spit it out. Fluoride rinses
are used in children under 6 years of age only if recommended by the physician
or dentist.
Products
All toothpastes that are labeled as anticaries products contain fluoride.
Popular brands include Crest, Colgate, Aquafresh, Rembrandt, Tom’s of
Maine Natural Product Toothpaste, Ultra Brite.
The teeth should be flossed with regular dental floss or tape after brushing
to remove debris from around the gums line and between the teeth. Dental
floss and dental tape are not reviewed in the FDA’s monograph system.
NOTE: Toothbrushes are available in many styles, sizes, and bristle
designs. The American Dental Association recommends using a soft, multi-
tufted, nylon bristle brush.9 Electric toothbrushes with timers may help some
individuals, especially children, to brush for the proper amount of time to
thoroughly clean the teeth. Electric toothbrushes are recommended for indi-
viduals who have motor impairment and cannot use a hand brush properly.
Anticaries oral rinses
ACT, Listerine Tooth Defense, Listerine Smart Rinse, Phos-flur, and Tom’s of
Maine Natural Anticavity Rinse.
Antiplaque and antigingivitis mouth rinses

Brushing and flossing the teeth are the most effective ways to remove plaque
and other debris from the teeth. If plaque is not removed from the teeth, it
will become calcified and harden. This harden plaque (calculus or tartar)
should be removed by a dental health professional. Accumulation of plaque

and calculus cause the gums to become inflamed and bleed, especially when
brushing the teeth. The gum around the tooth is loosened and recedes,
allowing penetrate of bacteria under the gum where they can attack the
periodontal ligaments that are responsible for holding the teeth in place
(periodontitis).

Drugs applied to the oral cavity as mouth rinses or dentifrices to retard or
prevent gingivitis and plaque are antigingivitis and antiplaque agents. These
claims include removal of plaque, prevention of gum disease, and reduction in
swelling and redness of gums, and bleeding gums.10
Stannous fluoride toothpaste, cetylpyridinium chloride rinse (0.045 to 0.1%),
triclosan, and a combination of volatile oils in a mouth rinse (eucalyptol,
menthol, methyl salicylate, and thymol) may make antiplaque and antigingi-
vitis claims.
Mode of action
Antigingivitis and antiplaque agents inhibit the growth of bacteria in the oral
cavity.

If gingivitis, bleeding, or redness lasts for more than 2 weeks, the product
should be stopped and a dentist consulted. Pain, swollen gums, pus from the
gums, loose teeth, and increasing space between the teeth are symptomatic of
serious gum disease and require consultation with a dentist. These products
should be kept out of reach of children under 6 years of age.10
Recommended dose
Stannous fluoride and triclosan toothpastes can be used by adults and children
over 2 years of age for brushing the teeth after every meal or at least twice a
day. Children under 6 years of age should be supervised until they are capable
of using the product properly.
Adults and children over 12 years of age should swish 20 mL of cetylpyr-
idinium chloride or 20 mL of combined volatile oils mouth rinse around the
teeth twice a day for 30 seconds and then spit out. The rinse is not swallowed.
Children between 6 and 12 years of age should follow the same directions but
must be supervised. Children under 6 years of age should not use this product
unless advised to do so by the dentist or physician.
Products
Cetylpyridinium (Cepacol, Crest Pro-Health), triclosan (Total), combined
volatile oils (Listerine).
Tooth desensitizers
A tooth desensitizer is a gel or toothpaste applied to teeth that helps to relieve
pain or build resistance to pain caused by cold, heat, sweets, acids, or
contact.11
Potassium nitrate (5%).
Mode of action
A tooth desensitizer acts on the dentin in the tooth to block pain and discom-
fort from stimuli that do not normally elicit a painful response in individuals
with normal teeth.
Sensitive teeth may be an indication of a more serious problem that should be
treated by a dentist. If relief is not experienced within 4 weeks, or if the
problem gets worse, a dentist or physician should be consulted.11
Directions for use
Adults and children over 12 years of age should use 1 inch (2.5 cm) of tooth-
paste on a soft bristle toothbrush and brush for 1 minute twice a day. Consult
a dentist for use in children under 12 years of age.
Products
Potassium nitrate (Denquel, Sensodyne, Promise).
Fever blister or cold sore

Fever blisters or cold sores (herpes labialis) are an infection caused by the virus
herpes simplex type 1 (HSV-1). Herpes labialis is characterized by the erup-
tion of a lesion along the lips or nose where the epithelial cells meet the
mucous membrane of the mouth or nose, causing irritation, swelling, and
pain. Once an individual has contracted the virus, there is always the risk of
additional episodes because the virus migrates and remains dormant in the
nerve ganglia until a stressful situation arises.12
Stressful triggers include such factors as ultraviolet light exposure (sun-
light), poor nutrition, fatigue, fever, extremes of hot or cold weather, and
other infections. The most common trigger is the common cold, hence, the
name ‘cold sore.’ The virus is easily transmitted by kissing or by using objects
contaminated with virus, such as lip balms or lipsticks.
Frequently, the individual experiences a prodromal event, such as tingling
or a feeling of burning, before the lesion appears. The lesion fills with fluid,
gets larger, forms a blister that finally ruptures to create an ulcerous area on
the lip that forms a crust.12
The FDA has not approved any prescription antiviral drugs for OTC
use because it believes that their indiscriminate use may lead to resist-
ance, creating the same type of problems seen with many antibiotic drugs.
OTC treatment relies on the use of drugs classified as skin protectants and
oral cavity anesthetics/external oral analgesics for symptomatic relief of
irritation, discomfort, and pain. The FDA also approved 10% docosanol
as an OTC drug through a new drug application (NDA)13 but rejected the
use of the amino acid lysine as an effective for the treatment of fever
blisters.14
Oral protectant and external analgesic (anesthetic) combinations

Skin protectants are applied topically to fever blisters to relieve dryness and
soften crusts to relieve discomfort.15
Allantoin, calamine, petrolatum, zinc oxide, and cocoa butter are used to-
gether or combined with external analgesics for treatment of fever blisters.15
Mode of action
Oral skin protectants are pharmacologically inert and provide a continuous
film over irritated or injured tissue.
If symptoms persist for more than 7 days or worsen, a dentist or physician
should be consulted.
Products
Skin protectants plus external analgesics for the treatment of fever blisters
(Anbesol Cold Sore Therapy, Campho-Phenique Cold Sore Scab Relief).
Table 7.1 lists the ingredients in these products.
Table 7.1 Fever blister/cold sore products containing skin protectants and/or oral
anesthetics/analgesics
Product Skin protectant Anesthetic/external analgesics
Anbesol Cold Sore Therapy Allantoin, petrolatum Benzocaine, camphor
Carmex Cold Sore Menthol, camphor, phenol
Campho-Phenique Cold Sore Camphor, phenol

Treatment
Campho-Phenique Cold Sore Petrolatum Pramoxime

Scab Relief
Zilactin L Cold Sore Relief Benzyl alcohol

Oral external analgesics

External analgesics are applied topically to fever blisters for temporary relief
of pain and itching.15
External analgesic drugs are predominately local anesthetics. Benzocaine,
benzyl alcohol, camphor, dyclonine, lidocaine, menthol, phenol, phenolate
sodium, pramoxine, and resorcinol all have local anesthetic activity.15
Mode of action
Topical external analgesics block nerve transmission from noxious stimulus
of the peripheral system.
Products should not be used if there is an allergy to any ingredient.
Products
See table 7.1.
Docosanol
Docosanol is used to treat fever blisters and shortens healing time.13
Mode of action
Docosanol applied topically as soon as symptoms of a fever blister occur
prevents the herpes virus from entering epithelial cells.16
New drug application drug
The FDA has approved 10% docosanol for shortening the time required for
treatment of fever blisters.
Docosanol is applied topically only to the affected area; it should not be used
in or near the eyes and or inside of the mouth. If the fever blister gets worse or
does not heal in 10 days, a physician should be consulted.13
Directions for use
Adults and children over 12 years of age should apply docosanol on the
affected area as soon as the first symptom of a fever blister occurs. It should
be applied five times a day until the fever blister is completely healed.
Product
Docosanol 10% (Abreva).
Canker sores or aphthous ulcers

Minor injury to the oral mucosa may cause irritation, inflammation, and
ulceration of the mucosa, resulting in discomfort and pain, especially when
acid, salty, or spicy foods or beverages are ingested. Most of these injuries are
self-healing and do not require further treatment, but good oral hygiene is
necessary to prevent a more serious condition, such as infection, from occur-
ring. Oral wound cleansing agents are available for this purpose. If an indi-
vidual has recurrent aphthous ulcer stomatitis, referral to a physician or
dentist is appropriate.
External anesthetic/analgesic monograph drugs are also useful in relieving
discomfort and pain associated with canker sores.

Oral wound cleansers temporarily clean minor wounds or inflamed gums
caused by dentures, dental appliances, dental procedures, or accidental injury.
They also may be used to remove phlegm, mucus, or other secretion associ-
ated with a sore mouth.17
Carbamide peroxide in anhydrous glycerin, hydrogen peroxide, sodium
bicarbonate, and sodium perborate are approved drugs.
Mode of action
Oral wound cleansers release oxygen when used as oral mouth rinses, loos-
ening debris that is removed when the solutions are expectorated.

If symptoms are not relieved in 7 days, or worsen, a dentist or physician
Directions for use

Adults and children over 2 years of age may use these products as a mouth
rinse. The solution should be swirled around the mouth for 1 minute and then
spat out for up to four times a day. Use of this product by children between 2
and 12 years of age requires supervision by a caregiver.17
Products
Carbamide peroxide (Gly-oxide, Cankaid), hydrogen peroxide (Peroxyl Gel),
sodium bicarbonate (many generic products), sodium perborate.
Toothache and teething pain products

Local anesthetics, primarily benzocaine, are used topically to relieve sore
throat and toothache pain, and gum pain associated with teething in infants.
Benzocaine, benzyl alcohol, dyclonine, hexylrescorcinol, menthol, phenol,
phenolate sodium, and salicyl alcohol (resorcinol) are used for toothache
pain. Only benzocaine, phenol, and phenolate sodium are approved for relief
of teething pain.17
Mode of action
Local anesthetics prevent and relieve pain by blocking nerve transmission
from noxious stimuli that activate peripheral nerves.

These products should not be used by anyone allergic to any ingredient.
Products used for sore throat pain should not be used for more than 2 days;
if symptom are not relieved or worsen, or if a headache or a fever develops, a
physician should be consulted. If gum or toothache pain is not relieved,
worsens, or lasts longer than 7 days, a dentist or physician should be
consulted.17
Directions for use

Oral anesthetic/analgesic products used as ointments or gels for toothache
pain by adults and children over 2 years of age should be rubbed along the
gums of the affected tooth up to four times a day. Children between 2 and 12
years old should be supervised by a caregiver.
Benzocaine, phenol, and phenolate sodium are used for teething pain in
infants over 4 months of age. Under that age, a physician should be consulted.
Benzocaine may be rubbed on the gums up to four times a day. Fever and nasal
congestion are not symptoms of teething and may be symptoms of some other
condition, and a physician should be consulted.11
Products
Products for adult and children over 2 years of age: benzocaine (Zilactin B,
Kanka), phenol (Campho-Phenique, Carmex), benzyl alcohol (Zilactin L and
Kanka). Baby teething products: benzocaine (Baby Anbesol, Orajel Baby and
Orajel Baby Nighttime).

Case 1 A 52-year-old woman with narrow-angle glaucoma works at a
computer everyday and complains of irritated, red eyes. She asks the
pharmacist whether regular Visine or Visine A is better for her
problem.
The pharmacist notes that the woman is taking a prescription drug to
treat narrow-angle glaucoma. Both products the woman asked about
contain a vasoconstrictor that should not be used when an individual
has glaucoma. Vasoconstrictors are sympathomimetic amine drugs
that constrict small blood vessels in the eye to reduce the redness, but
they also cause the pupils of the eyes to dilate. This may worsen the
glaucoma the woman has and impair her vision. The pharmacist
recommends the use of an artificial tear solution or ointment. She
should also take occasional breaks from looking at the computer mon-
itor and be sure that she blinks more often to keep her eyes moist. If this
doesn’t solve her problem, she should consult her doctor.
Case 2 A young man has allergies to dust and molds. There is renova-
tion construction going on in his apartment building and his eyes are
itchy and watery.
This person would benefit most from an ophthalmic solution that
contains an antihistamine. Two types of product are available, vaso-
constrictor with an antihistamine (Naphcon A, Visine A, or Opcon A)
or an ophthalmic solution containing only an antihistamine (Zaditor).
The young man has no other medical condition, and could choose to
use either product.
Case 3 A man asks the pharmacist to help him to select a disinfecting

solution for contact lenses that his son wears because he doesn’t know
what to purchase.
The pharmacist asks the man what type of contact lenses his son wears,
soft lenses or rigid gas permeable lenses. The man doesn’t know. The
pharmacist explains that she can’t make any recommendation because
each type of contact lens requires a different solution and they cannot
be used interchangeably.
Case 4 A young woman who swims on the high school team asks for
some type of product to get rid of the water in her ears.
The pharmacist recommends either Auro Ear or Swim Ear. Each prod-
uct contains isopropyl alcohol in anhydrous glycerin and she should
use four to five drops in each ear.
Case 5 The mother of a 7-year-old child asks the pharmacist for vita-
mins with fluoride.
The pharmacist tells the mother that vitamins or supplements with
fluorides are prescription drugs and she should contact her dentist or
physician. However, she could be sure that the toothpaste she buys is
an anticaries (anticavity) product because it would contain fluoride.
She should also purchase a topical fluoride rinse product like Phos-flur,
Act or Listerine’s Tooth Defense or Smart Rinse. The mother should be
told that these products are to be swished around the teeth and then
spat out. They are not intended to be swallowed.
Case 6 A young woman wants a mouth rinse that will help to reduce the
build-up of plaque that she gets on her teeth.
The pharmacist discusses the need for thorough brushing and flossing
of teeth as the best preventative for removing plaque rather than rely-
ing solely on a mouth rinse. A mouth rinse will be most effective if it is
used after brushing the teeth. Suitable products are Listerine, Scope,
Cepacol or Crest Pro-Health rinses.
Case 7 A 23-year-old woman who went to a tanning salon complains

to the pharmacist that she thinks she has a cold sore, but she doesn’t
have a cold. She wants to know what to do.
The pharmacist explains that ultraviolet light from the tanning salon
probably activated the herpes simplex virus that causes cold sores.
There are two possible ways to treat her problem. The use of 10%
docosonal (Abreva) applied topical five times a day could reduce the
healing time for the cold sore. She could also apply topical oral anes-
thetics/external analgesics to relieve pain and discomfort. Products
include benzocaine (Zilactin B or Anbesol), phenol (Carmex or
Campho-Phenique), or benzyl alcohol (Zilactin L).
Case 8 The mother of an 11-month-old child wants to purchase a baby

teething product but isn’t sure how to use it.
The pharmacist explains that the solution or ointment should be
rubbed along the gum where the tooth is going to erupt. If the product
contains benzocaine, it may be used up to four times a day. Suitable
products are Baby Anbesol, Orajel Baby and Orajel Baby Nighttime.
References
1. Ophthalmic drug products for over-the-counter human use; final monograph; final rule.
Fed Regist 1988; 53: 7076–7093.
2. Ophthalmic drug products for over-the-counter human use; ophthalmic anti-infective
drug products for over-the-counter human use. Fed Regist 1992; 57: 60416–60423.
3. Ophthalmic drug products for over-the-counter human use; amendment of final mono-
graph. Fed Regist 2000; 65: 38426–38429.
4. Zaditor Label. www.zaditor.com/info/answers/drug-facts.jsp (accessed February 3, 2009).
5. Contact Lens Solutions and Products. Updated November 6, 2008. www.fda.gov/cder/
contactlenses/solutions.html (accessed February 4, 2009).
6. Topical otic drug products for over-the-counter human use; final monograph: final rule.
Fed Regist 1986; 51: 28656–28661.
7. Topical otic drug products for over-the-counter human use; products for drying water-
clogged ears; amendment of monograph; lift of partial stay of effective date. Fed Regist
2000; 48902–48905.
8. Anticaries drug products for over-the-counter human use; final monograph. Fed Regist
1995; 60: 53474–52510.
9. Toothbrushing. www.ada.org/public/topics/cleaning_faq.asp (accessed February 4, 2009).

10. Oral health care drug products for over-the-counter human use; antigingivitis/antiplaques
products; establishment of a monograph. Fed Regist 2003; 68: 32232–32287.
11. Oral health care products for over-the-counter human use: tentative final monograph;
notice of proposed rulemaking. Fed Regist 1991; 56: 48302–48347.
12. Hirsh MS. Herpes simplex virus. In: Mandell GL et al. eds. Principles and Practices of
Infectious Diseases, 4th edn. New York: Churchill Livingstone, 1995: 1336–1345.
13. Docosanol. www.fda.gov/cder/foi/nda/2000/20-941_Abreva.htm, (accessed February 7,
2009).
14. Orally administered drug products for the treatment of fever blisters for over-the-counter
human use; final monograph. Fed Regist 1992; 57: 29166–29173.
15. Skin protection and external analgesic drug products for fever blister and cold sore
treatment drug products. Fed Regist 1990; 55: 3362–3383.
16. Pope LE et al. The anti-herpes simplex virus activity of n-docosanol includes inhibition of
the viral entry process. Antiviral Res 40: 1998; 85–94.
8
Topical dermatological
products
The skin is the largest organ of the body and its main functions are to provide
protection to the other organs and to regulate body temperature. It also has a
cosmetic or esthetic purpose; it is the image that an individual first sees of
another person and creates the first impression of that person. The FDA
regulates products that affect the function and structure of the skin as drugs
and those that affect its appearance as cosmetics, by the authority granted by
the passage of the FD&C Act of 1938 and its amendments.
Labels for products that are cosmetics have major differences from labels
of drugs. Products that are purely cosmetic have no active ingredients list, just
a list of ingredients. All ingredients in the product are listed in the order of
highest concentration of the ingredients first and the lowest concentrations
last. The label does not contain the specific concentration of the ingredient,
making the comparisons among products a nearly impossible task. Manu-
facturers may use either the chemical name or the trade name of the ingredi-
ent. Trade names do not provide a clear identity of the ingredient, making
product comparisons even more difficult.1
Dermatological products that contain a drug and cosmetic ingredients must
list the drug component as an active drug ingredient providing its approved
drug name, the quantity of drug present, and any warnings or precautions. The
cosmetic components are listed as inactive ingredients. Examples of this are
many cosmetic skin moisturizers, which now contain a sunscreen. The sun-
screen is an OTC drug approved by the FDA and must be listed as an active
ingredient, and the remaining moisturizing components are listed as the inac-
tive ingredients. Another example is hair shampoos. If the shampoo claims to
eliminate or prevent dandruff, a drug claim, it must list the antidandruff
ingredient as the active ingredient, and the other shampoo ingredients become
inactive ingredients.
The skin is composed of two separate layers, the epidermis and the dermis.
The epidermis has five separate layers, with the stratum germinativum, the
basal layer, separating the epidermis from the dermis. Epithelial cells have a
relatively uniform shape and high water content. As the cells grow upward
toward the surface, they become more irregular in shape and lose moisture,
becoming more flattened or packed together. The other layers of the skin are
the stratum spinosum, the stratum granulosum, the stratum lucidum (a special
band of tightly packed cells only found on the palms of the hands and soles of
the feet), and the stratum corneum, the outermost layer.2 The stratum spino-
sum contains melanocytes, which produce melanin when stimulated by the
ultraviolet rays of sunlight to protect the skin.
The stratum corneum is a rather thin layer of keratinized cells (basically
dead cells with the lowest water content, approximately 10 to 20%) forming a
continuous, uniform layer that is continuously shed. These keratinized cells
protect the layers of cells beneath by preventing the penetration of many
compounds, especially those that are water soluble, to which the skin is
exposed. The pH of the surface of the skin is slightly acidic, approximately
4.5 to 5.5, which prevents the growth of most microorganisms. Once the skin
is damaged and this continuous layer of protection is broken, the risk of
infection is greatly increased.
The dermis is a much thicker layer of cells, collagen, and elastin that
separates the epidermis from the subcutaneous layer of tissue. It contains
many vital structures, including nerves, the capillary network of the circula-
tory system, hair follicles, sebaceous glands, and sweat glands. The subcuta-
neous layer, hypodermis, consists of connective tissue, adipose tissues, and
blood vessels and is responsible for providing nutrition to the layers above and
for regulating body temperature.2
When the body temperature increases, the blood vessels dilate, and blood
from the core of the body moves to the periphery or skin surface where cooling
can occur. The sweat glands are innervated by the peripheral sympathetic
nervous system, which stimulates the active secretion of water, causing heat
loss by evaporation from the skin surface.
The moisture and lipid content of skin change with age and other condi-
tions. Babies have a thinner epidermis with a higher water content and this
allows greater absorption of many topical drugs. The epidermis becomes
thicker in children and the secretion from the sebaceous glands increases
during puberty, primarily as a result of increased hormone secretion, increas-
ing the risk of acne in this age group.
Normal aging produces a great number of changes in the skin. The skin
becomes thinner and loses moisture more readily, and there is a decrease in
sebaceous gland and sweat gland secretions. These changes may produce dry
skin (xerosis), one of the most common skin conditions in both men and
women over the age of 65. The problem is exacerbated in women as they
reach menopause because of the dramatic decrease in estrogen secretion; it
occurs in men at a slightly older age as their testosterone levels decrease.3
Collagen and elastin deteriorate and wrinkles develop, primarily as a
consequence of damage to the skin from environmental conditions (wind
Topical dermatological products | 151
and sun), smoking, and other environmental or occupational chemicals,

which may cause oxidation in skin cells. Skin damage also makes the skin
more susceptible to flaking and cracking, causing a loss of continuity of the
skin barrier and increasing susceptibility to infection.
There are disorders in skin cell turnover rates that cause dandruff, sebor-
rhea, and psoriasis. This chapter discusses OTC drug therapy used to prevent
or treat these conditions. This chapter also includes products used to treat
dermatitis resulting from a variety of sources, insect bites and stings, and mild
to moderate conditions causing itching, irritation, or pain to the skin, mucous
membranes, or superficial muscles.
All of the products in this chapter are topical dermatological products and
every product must bear a statement that indicates the product is for external
use only.
Xerosis (dry skin)

When the water content of the epidermis falls below 10%, changes in the skin
become very prominent, including chaffing, flaking, itching, redness (ery-
thema), and roughness. As the skin becomes thinner and secretions from
the sebaceous glands decrease, the permeability of the skin changes, allowing
moisture from the lower layers of the skin to penetrate through the stratum
corneum to the surface. Excessive bathing and harsh soaps remove lipids from
the skin and exacerbate the problem.3
Bathing with tepid water rather than hot water and using super-fatted
soaps such as glycerin soaps or nonsoap cleansers such as Aquanil Lotion or
Cetaphil Lotion helps to prevent xerosis.
Environmental conditions of wind and low humidity increase loss of moist-
ure. Xerosis is commonly referred to as alligator or lizard skin by individuals
who have this problem because of the appearance of deep wrinkles.
Treatment of xerosis includes the use of skin protectants that have lipid
characteristics to act as occlusive agents and prevent loss of moisture from the
epidermis. Glycerin is generally considered to be a humectant type of skin
protectant. It absorbs moisture and keeps it on the skin. Occlusive protectants
are more effective in preventing loss of moisture but their greasy texture may
be undesirable for some individuals. Most products used to moisturize the
skin contain several different protective ingredients.3
Emollients and humectants (moisturizers)

Emollients and humectants are protective drugs applied to the epidermis to
retard loss of moisture and to relieve symptoms associated with dry skin. They
are used to protect chapped hands or lips, and to provide protection from the
drying effects of wind and cold weather.4
Skin protectants are used in treating numerous conditions depending on the
specific concentration and product formulation. Most products contain more
than one ingredient. The most commonly used protectants are beeswax,
cocoa butter, dimethicone, glycerin, hard fat, lanolin, mineral oil, petrolatum,
and white petrolatum. Table 8.1 lists the concentrations of each protectant
that must be used to have it listed as an active ingredient in a drug product.4
When the concentration of a protectant in a product is less than those in table
8.1, the label lists it as an inactive ingredient, not an active ingredient.
Mode of action
Emollients act as a barrier to prevent evaporation of moisture from the
epidermal layers of the skin. The greater the lipid characteristic of the drug,
the more effective it is as an occlusive agent. Emollients themselves contain no
moisture.
Humectants are hygroscopic drugs that absorb water and hold it on the
surface of the skin, allowing the epidermal keratin to become soft and supple.
Glycerin is a true humectant.
Table 8.1 Protectants and concentrations required to be monograph or active

ingredients for xerosis (dry skin): over-the-counter drug products and other topical
dermatological products
Protectant Monograph concentrations (%)
Cocoa butter 50–100
Cod liver oil 5–13.56
Colloidal oatmeal > 0.007
Dimethicone 1–30
Glycerin 20–45
Hard fat 50–100
Lanolin 12.5–50
Mineral oil 50–100
Petrolatum 30–100
Topical starch 10–98
White petrolatum 30–100
Zinc acetate 0.1–2
Zinc carbonate 0.2–2
Zinc oxide 1–25

Product formulations include creams, ointments, gels, or lip balms, specifi-

cally for chapped lips.
These products are intended for external use only and should not be used in or
near the eyes. If the condition worsens or the product does not provide relief
within 7 days, a physician should be consulted.4
Recommended use
Products intended for application to the skin should be applied at least twice a
day. Products are most effective if applied after bathing. The skin should be
patted dry and the protectant applied while the skin is still moist. Products
intended as hand moisturizers should be applied as necessary. Products
intended as lip protectants should be applied as necessary.3,4
Products
Beeswax (Burt’s Bees Beeswax Lip Balm), dimethicone (Aveeno Skin Relief
Moisturizing Cream, Aveeno Daily Moisturizing Lotion, Blistex Medicated
Lip Balm, Chap Stick Overnight Lip Treatment, Natural Ice Medicated Lip
Protectant), white petrolatum (Aveeno Lip Protectant, Vaseline Petroleum
Jelly, Vaseline Lip Therapy, Chap Stick Lip Balm Original).
Popular moisturizing products that contain multiple protective ingredients
include AmLactin, Eucerin, Keri Lotion, Alpha Keri, Jergens, Curel, Corn
Huskers, Lubriderm, Moisturel, and Neutragena. Personal preference based
on the texture or feel of the product on the skin is usually the deciding factor in
choice of a product by most individuals who use skin protectant products.
Eczema (dermatitis)
Eczema is a general term used to describe an inflammatory condition of the
skin that is characterized by redness, a rash, and/or itching. All of these
symptoms may be considered to be some form of dermatitis. The most com-
mon form of eczema is atopic dermatitis. It has a genetic component and there
is an increase in immunoglobulin E. It usually affects other members of the
family, all of whom tend to have sensitive skin and other allergies, such as
seasonal rhinitis (hay fever). Atopic individuals also tend to have a higher
incidence of asthma.5
The incidence of atopic dermatitis is approximately 10 to 20% in children
and decreases to less than 3% in adults. It is characterized by intense itchy, dry
skin and may progress to papules or vesicles, with or without exudates, that
occur primarily on the forehead, cheeks, chin, upper arms, wrists, ankles, and
trunk of the body. Scratching may increase the risk of infection, and treatment
includes the use of emollients (moisturizers) and antipruritic drugs. Oral
antihistamines may be used to relieve the itching and topical corticosteroids
are used because of their anti-inflammatory action.5
Other common skin problems include allergic dermatitis. The best treat-
ment for these conditions is avoidance of the agent responsible for the der-
matitis if it can be identified. Common allergens include soaps, detergents,
fragrances, fabrics like wool, foods, drugs, metals like chromium or nickel (in
jewelry), and plants, especially those in the Toxicodendron family (poison ivy,
poison oak, poison sumac).
Irritant dermatitis results from continued contact of irritants on the skin;
the most common causes are diaper rash and occupational exposure to chemi-
cals. Symptoms include irritation, erythema, discomfort, and pain; the skin
reaction may progress to breakdown of the skin, increasing susceptibility to
infection. Treatment includes avoidance of the irritant: changing baby’s dia-
per frequently and keeping the area clean and dry, or wearing protective
clothing and/or gloves for occupational exposures. The use of skin protectants
(discussed above) is the first line of treatment for these conditions, along with
topical corticosteroids and antipruritic drugs.
Atopic dermatitis
Monograph drugs
Protectants
All protectants listed for xerosis in table 8.1 are approved for use in atopic
dermatitis.
Rx–OTC switch drug: hydrocortisone

Hydrocortisone was initially introduced to the OTC market as a Rx–OTC
switched drug in concentrations of 0.25 to 0.5%. The FDA added hydrocor-
tisone to the External Analgesic Monograph and increased the permitted
OTC concentration to 1%.
Drug category and indication for use
Topical hydrocortisone is a corticosteroid used to relieve the itch, redness and
rash in eczema, psoriasis, insect bites and stings, and allergic skin reactions
from soaps, detergents, cosmetics, jewelry, poison ivy, poison oak, and poison
sumac.6,7
Mode of action
Hydrocortisone acts to suppress the immune system, reducing the symptoms
associated with allergic reactions. It also prevents the inflammatory response
and suppresses erythema and itching.
Topical hydrocortisone is for external use only. It should not be used in the
vagina or rectum. It may be used for itching on the skin area around the
vagina, but it should not be use if a vaginal discharge is present. It should not
be used for external anal or genital itching in children under 12 years of age.
Topical hydrocortisone should not be used in children under 2 years of age
without consulting a physician. It should not be used for diaper rash without
consulting a physician.
If the condition gets worse, if there is no relief in 7 days, or if the condition
returns, a physician should be consulted.6,7
Recommended use
Hydrocortisone 0.25 or 1% may be applied to affected area three to four
times a day by adults or children over 2 years of age.
Products
Hydrocortisone 1% (Cortaid and Cortizone10).
Irritant dermatitis: diaper rash

Diaper rash or diaper dermatitis has several causes, including excess moisture
retention on the buttocks, perineum, lower abdomen and back and inner
thighs and irritation from urine and/or feces. Changing the diaper frequently
and use of protectants are recommended. If the skin becomes macerated and
broken, infection is possible and a physician should be consulted.
Application of protectants to the affected area may prevent diaper rash and
provide protection against wetness.8
Cod liver oil (5 to 13.56%), lanolin (15.5%), mineral oil (50 to 100%), talc
(45 to 100%), topical starch (10 to 98%), and zinc oxide (25 to 40%) are the
only protectants recognized for diaper rash.7,8 These drugs may be used alone
or combined in a single product.
Mode of action
Topical protectants provide a physical barrier against wetness and irritants
and prevent skin damage.
If the diaper rash worsens or persists for longer than 7 days, or if it clears up
but reoccurs in a few days, a physician should be consulted.
Cod liver oil is a source of vitamin A and D and no more than 10 000 units
of vitamin A or 400 units of vitamin D (cholecalciferol) should be used in a 24
hour period.
Powdered topical starch should not be applied to broken skin and should
not be used near the face to avoid inhalation.
Table 8.2 Selected popular diaper rash products containing protectants
Producta Lanolin Petrolatum Cod liver oil Zinc oxide

(vitamins A and D)
A and D Original Ointment M M I
Aveeno Baby Soothing Relief M
Balmex Extra Protective M
Boudreaux's Butt Paste I M
Desitin Original Ointment I I I M
Desitin Multi-Purpose I M I
Palmer's Bottom Butter M I
Triple Paste M M M
M, monograph concentrations; I, listed as inactive ingredients (concentration less than the required amount
for monograph status).
a
Products contain additional inactive ingredients.
Recommended use
The diaper area is cleaned and the product applied liberally with each diaper
change, especially at bedtime.
Products
Table 8.2 lists popular diaper rash ointments or creams and lists the ingredi-
ents in each. Baby powder products include protectants but not in con-
centrations high enough to be classified as monograph ingredients. Talc is
available in Johnson’s Original Baby Powder, and corn starch is available in
Johnson’s Cornstarch Baby Powder and Burt’s Bees Baby Powder.
Allergic contact dermatitis: poison ivy, poison oak, poison sumac

The best approach to allergic dermatitis is preventing the allergen from
touching the skin or mucous membranes. The symptoms associated with
allergic dermatitis include itching, erythema, rash, or blister formation. All
of the protectants discussed earlier in this chapter will provide temporary
relief for the symptoms associated with allergic contact dermatitis. Poison
ivy, poison oak, and poison sumac are the most common plant causes of
allergic dermatitis, and specific products have been developed for their treat-
ment that usually include more than one monograph ingredient because of the
intense itch that they cause.
These plants belong to the genus Toxicodendron, and they all produce an
oleoresin, urushiol, that quickly and tenaciously binds to skin proteins (hence
the names of urushiol-induced dermatitis and Toxicodendron dermatitis). All

of these plants have green leaves that are in clusters of three, and they may
have white, waxy-like berries. The leaves of poison ivy usually turn red in the
fall. Poison ivy may act like a vine, wrapping itself on tree trunks. Herbicides
are available that will kill the plants, but plants should not be burned because
they may release oleoresin into the air, allowing for its further dispersion and
increasing the risk of exposure. The oleoresin may remain on garden tools and
clothing for months or years, causing re-exposure to individuals. All contam-
inated objects should be thoroughly cleaned. Pets may carry the resin on their
fur and remain an additional source of exposure to those allergic to the
oleoresin.9
Washing the contaminated skin within 5 to 10 minutes may remove the
resin, but if more than an hour has elapsed, washing will not be effective.
Several manufacturers make cleansing products that are not drug products
for removing the oleoresin from the skin, but avoidance or wearing clothing
and gloves that fully protects the skin is the best prevention.
Products promoted for removal of the oleoresin from the skin may contain
surfacants (e.g. Zanfel Poison Ivy Wash and Cortaid Poison Ivy Care Toxin
Removal Cloths) or may combine surfactants with microfine beads (e.g.
IvyStat). The combination products act like very mild abrasives, causing
exfoliation of the epidermis to eliminate the bound oleoresin. Most products
recommend washing the contaminated skin as soon as possible, usually within
a few hours of exposure. Products containing skin protectants, topical hydro-
cortisone, or external analgesics may be applied after their use.
Technu is also a product promoted for removal of oleoresin from the skin;
it is a petroleum-based product, deodorized mineral spirits, and contains
surfactants. However, it should not be used on skin if hydrocortisone pro-
ducts were used within the previous 3 days.10
Exposure of the skin to urushiol usually results in intense itching as the initial
symptom, with erythema and a rash developing with a day or two. The inten-
sity of rash depends on the amount of resin deposited on the skin. If an individ-
ual just brushed by the plant, the erythema and rash forms a linear or jagged
path. Intense exposure produces a continuous, redden patch on the skin. The
rash progresses to form papules, bullae, and vesicles that fill with fluid, but the
fluid does not contain resin and is not contagious, contrary to popular belief.
How quickly the rash forms depends on the amount of resin on the skin. The
ruptured vesicles form a crust and complete healing may take 2 or 3 weeks.9
Self-care may be appropriate if the exposed area is relatively small, but
widespread exposure is best treated by oral corticosteroids prescribed by a
physician. Exposure around the eyes, the mucous membranes of the nose and
mouth, or the genitals warrants consultation with a physician. Scratching the
intense itch increases the risk of infection; if a fever develops or pus forms in
the blisters, a physician must be consulted.9
Prevention of urushiol exposure: bentoquatum

Drug category and directions for use
Bentoquatum, an inert, silicate clay (quaternium-18 bentonite), is applied to
the skin to prevent exposure to urushiol oleoresin.
FDA approved new drug application
Bentoquatum 5%.
Mode of action
Topical application of bentoquatum to the skin creates a physical barrier. The
oleoresin adheres to the clay, protecting the skin from direct contact with the
allergen.11
Bentoquatum should not be used on broken skin or open rash or in children
under 6 years of age. The product should be shaken well before use.12
Recommended use
Bentoquatum is applied topically to the exposed area of skin 15 minutes
before risk of exposure to plants and reapplied every 4 hours, or sooner if
sweating profusely.12
Product
Bentoquatum 5% (Ivy Block).
Treatment of urushiol exposure: protectants

Several different pharmacological agents are used to treat the rash and itch
associated with poison ivy. Colloidal oatmeal and sodium bicarbonate are
skin protectants that soothe the irritated and erythematous skin. Itching is an
irritating, cutaneous sensation than causes an individual to scratch. Topical
analgesics have local anesthetic activity, blocking the nerves that are respon-
sible for producing the itching sensation. Combinations of protectants and
external analgesics are found in nearly all products for treating poison ivy.13

Skin protectants provide temporary relief from minor irritation and itching
caused by poison ivy, poison oak, or poison sumac.
Colloidal oatmeal and sodium bicarbonate (1 to 100%) are the most fre-
quently used skin protectives. Calamine is frequently used. It contains zinc
oxide with 1% or less of ferric oxide to produce a pink tint to lotions, creams,
or ointments; colorless calamine products have no ferric oxide.4
Mode of action
Skin protectants prevent drying and itching of the skin from harmful stimuli.

All products are for external use only.
Colloidal oatmeal contains the following warnings.13 ‘Use a mat in the tub
or shower to prevent slipping when use as a soaking preparation; soaking too
long may cause excessive drying of the skin; stir any colloidal oatmeal that
may settle on the bottom of the tub; use only once and discard solution.’
Recommended use
Adults and children over 2 years of age should soak the affect areas for 15 to
30 minutes when colloidal oatmeal is used. The area should be patted dry, and
the process may be repeated as needed or as directed by a physician. Colloidal
oatmeal used as a wet compress should be applied for 15 to 30 minutes and
may be repeated as needed. A freshly prepared compress should be prepared
each time it is needed.
Sodium bicarbonate may be used by adults and children over 2 years of age
as a paste and applied to the affected area as needed or directed by a physician.
If it is to be used as a soak, 1 to 2 cupfuls should be dissolved in warm water
and the individual should soak the affected area for 15 to 30 minutes and the
area should be patted dry. It should only be used once and a fresh solution
should be prepared each time it is needed.13
Treatment of urushiol exposure: external analgesics

External analgesics may temporarily relieve itch and discomfort caused by
skin rashes, including those from poison ivy, poison oak, poison sumac, insect
bites and stings, and minor skin irritations.
Diphenhydramine is the antihistamine used in most topical analgesic
products.
Local anesthetics drugs include benzyl alcohol, phenol, phenolate sodium,
benzocaine, dibucaine, lidocaine, and proxamine.4,13
Mode of action
The FDA definition of topical external analgesics includes topical antihista-
mines and topical local anesthetics. Topical antihistamines prevent the hista-
mine produced by the allergic reaction from binding to cutaneous receptors,
thus preventing or reducing redness and itching. Topical anesthetics affect the
cutaneous nerves in the skin, blocking transmission of stimuli that cause
itching and pain.
Diphenhydramine should not be used over a large area of the skin and it
should not be used when other topical or oral products containing diphenhyd-
ramine are used. It should not be used to treat itching and discomfort
Table 8.3 Monograph drug products for treating symptoms of poison ivy, poison
oak and poison sumac, and insect bites
Product Protectant External analgesic
Aveeno Anti Itch Cream and Lotion Colloidal oatmeal Proxamine
Benadryl Itch Stopping Cream, Spray Zinc acetate Diphenhydramine
Calamine Lotion Calamine (zinc oxide)
Caladryl Clear Lotion Zinc acetate Diphenhydramine
Calagel Anti Itch Lotion Zinc acetate Diphenhydramine
Gold Bond Medicated Itch Relief Proxamine
Ivarest Anti-Itch Cream Calamine (zinc oxide) Dephenhydramine
Itch-X Spray and Gel Benzyl alcohol and pramoxine
Itch-X Anti-Itch Lotion Hydrocortisone
Sarna Original Anti Itch Lotion Camphor and menthol
associated with measles or chickenpox without consulting a physician. Both

conditions may produce a rash over the entire body, increasing the risk of
toxicity. There have been reports of confusion and psychosis in children from
excess absorption of diphenhydramine.14 Oral products containing diphen-
hydramine include those used for allergies, coughs, colds, sinus relief, motion
sickness, and sedatives.
Local anesthetics should not be used if the individual has an allergy toward
the specific ingredient, and lidocaine is not recommended for children under 2
years of age.4,13
If itching and discomfort are not relieved, or worsen within 7 days, a
physician should be contacted.
Recommended dose
Topical products for poison ivy, poison oak, and poison sumac may be used
three or four times a day as needed.
Products
Most products for poison ivy, poison oak and poison sumac contain a com-
bination of external analgesics and skin protectants (table 8.3).
Insect bites and stings

Arthropods, a phylum of invertebrate animals that includes insects, com-
monly bite or sting humans and produce a burning, stinging sensation
immediately or within a brief period of time; the area around the bite or sting
becomes swollen, red, and itchy. The most serious effect an individual can
experience is an anaphylactic allergic reaction, which may cause death
through acute hypotension, circulatory collapse, bronchoconstriction, and
respiratory arrest. These sensitive individuals should have a prescription for
an epinephrine pen that they should carry at all times. The most common
stinging arthropods are bumblebees, honey bees, yellow jackets, hornets,
wasps, and scorpions. Bees leave their stinger in the skin and it should be
removed carefully.
Ants, bed bugs, chiggers, fleas, black flies, gnats, lice, mosquitoes, scabies,
spiders, and ticks are the most common biting arthropods. Ticks and mos-
quitoes are of special concern because they may transmit diseases.
Ticks, especially ticks whose main host are deer, transmit several serious
diseases, the most common being Lyme disease and Rocky Mountain spotted
fever. Ticks are parasites that remain on the skin and should be carefully
removed by gently grasping the tick with forceps or tweezers and tugging
until it is released from the skin. It should be kept for proper identification;
deer ticks are much smaller than other ticks.
Mosquitoes are also common carriers of disease, and are responsible
primarily for West Nile virus in the USA. Chiggers and scabies are parasitic
mites that remain on the skin; their bites and secretions cause intense itching,
inflammation, and skin irritation. Scabies burrow under the skin and may
require physician treatment for their eradication.
Insect repellants
Prevention is the best solution to arthropod bites and stings. Avoid the use of
perfumes or products that may attract arthropods. When going outdoors,
especially in high grass or wooded areas, wear tight fitting clothing that is
not brightly colored and covers as much of the skin as possible. Exposed skin
surfaces may be protected by the application of topical insect repellents. The
Environmental Protection Agency (EPA) regulates insect repellents.
EPA approved chemicals for human use

DEET (N,N-diethyl-m-toluamide), picaridin (KBR 3023 or 2-(2-hydroxy-
ethyl)-1-piperidinecarboxylic acid 1-methylpropyl ester) and oil of lemon
eucalyptus (PMD or para-menthane-3,8-diol) are approved for use on both
human skin and clothing. These chemicals are effective against the most
common arthropods, including flies, gnats, mosquitoes, and ticks.15
Mode of action
Insect repellents interfere with pheromone detection used by the insect to
locate its prey.
Warnings and precautions for all products

Products should be applied only to exposed skin or clothing, and not on
underclothing. Repellents should not be used on skin that has cuts, wounds,
or is burned or irritated. They should be used sparingly around the eyes and
mucous membranes of the nose and mouth. Application to the face is by
spraying the product on the hands and then applying to the face, not by
directly spraying the face with an aerosol. Adults should apply insect repel-
lents for children and not allow them to handle products.16
Treated skin should be washed with soap and water when returning
indoors. All clothing should also be washed before it is worn again. If the
product causes skin irritation or a rash, it should be washed off immediately
with soap and water. If product is ingested, the local poison control center
should be called. The container of the product should be taken if a visit to the
physician’s office or the emergency center is needed. Empty containers should
be disposed of properly and the container not reused.16
DEET has an odor and a greasy feel and may stain clothes. It should not be
applied on or near fabrics containing acetates, rayon, spandex or other syn-
thetic materials (excluding nylon), furniture, plastics, watch crystals, leather,
or painted or varnished surfaces, including cars.
Warnings specifically for DEET. ‘Excessive application may cause ataxia,
confusion, blurred vision, and seizures. The higher the concentration of DEET
applied to the skin, and the greater the area of application on the skin, the
greater the risk of adverse effects. Do not use in children under 2 years of age
without consulting a physician.’
Recommended use
DEET should be applied to exposed skin according to the EPA directions and
may be re-applied if the insects begin to bite. DEET should not be used in
children under 2 years of age without consulting a physician. The American
Academy of Pediatrics does not recommend the use of DEET on infants
younger than 2 months of age.17 DEET should be used in concentrations less
than 10% for children under 12 years of age. Adults may use concentrations
of DEET as high as 100%. As the concentration of DEET applied to the skin
increases, it provides a longer duration of protection.
Picaridin has fewer adverse effects and is preferred for use on children. It is
nearly as effective as DEET against most insects. Effective concentrations
range from 5 to 20%. It should be applied to exposed skin surfaces and
may be re-applied if the insects begin to bite.15
Oil of lemon eucalyptus is effective against mosquitoes and ticks but it is
not as effective as DEET or picaridin. It should be applied to exposed skin in
concentrations of 30 to 40%. Oil of lemon eucalyptus is not recommended for
use in children under 3 years of age.15
Products
DEET (Off! Deep Woods Sportsman, Off! Skintastic, Off! Deep Woods Insect
Repellent, Off! Deep Woods Towelettes, Ben’s Tick and Insect Repellent, and
Ultrathon), picaridin (Cutter Advanced Insect Repellent and Natrapel 8 Hour
DEET Free), oil of lemon eucalyptus (Repel Plant Based Lemon Eucalyptus
Insect Repellent).
Insect bite and sting treatment

Oral antihistamines (Chapter 4) are also effective in relieving itch and inflam-
mation associated with insect bites and stings. All arthropod bites and sites
may be treated with topical hydrocortisone and external analgesics (antipru-
ritics and local anesthetics, as discussed earlier in this chapter) used as single
agents or combination products. The products listed in table 8.3 are also
approved by the FDA for relief of itching and skin irritation from insect bites.
Counterirritants are also used for treating insect bites and stings, either alone
or combined with a protectant, an antipruritic, or a local anesthetic.
Counterirritants are used for the temporary relief of pain and itching caused
by minor aches and pains.
Allyl isothiocynate (0.05 to 5%), ammonia water (1 to 2.5%), camphor (3 to
11%), capsaicin (0.025 to 0.05%), histamine (0.025 to 0.1%), menthol (1.25
to 16%), methyl nicotinate (0.25 to 1%), methyl salicylate (10 to 60%), and
turpentine oil (6 to 50%) are monograph counterirritants.18
Mode of action
Counterirritants are external analgesics that stimulate cutaneous sensory
nerves for the purpose of relieving pain in deeper layers of the skin.18
Counterirritants are for external use only and should not be used around the
eyes, on wounds or damaged skin. The affected area should not be covered or
bandaged. If the condition worsens or does not improve in 7 days, a physician
Recommended use
Counterirritants are applied to the affected area three to four times a day.
They should not be used in children under 2 years of age without consulting a
physician.
Products
Table 8.4 lists the external analgesic products available to treat insect bites
and stings.
Table 8.4 Products containing external analgesic monograph ingredients for

insect bites and stings
Product Counterirritant Local anesthetic Protectant
After Bite Fast Itch Eraser Sodium bicarbonate
After Bite Ammonia
Burt's Bees Bug Bite Relief Camphor and menthol
Mitigator Sting and Bite Scrub Sodium bicarbonate
Sting Eze Benzocaine
Swab Plus Pre-filled Swabs Benzocaine
Pediculosis (lice infestations)

Lice are blood-sucking parasites that infest the head, body, or pubic area and
are the only organisms amenable to self-treatment. They can cause intense
itching and rashes. Head lice are the most common infestation problem in the
USA and occur predominately in children. Female lice lay their eggs, com-
monly called nits, on the hair shaft near the scalp. The nits are bound to the
hair by chitin and may be removed by combing with a fine-toothed comb or
washing with medicated shampoos. The nits normally hatch in 7 to 10 days
and the life cycle is repeated if the lice are not eradicated. Head lice are spread
from one person to another by using objects that are contaminated, such as
sharing combs, brushes, hats, or pillows.
Body lice occur less frequently and tend to inhabit clothing that is worn
close to the skin. The lice feed off blood in the skin and eradication involves
improving personal hygiene by bathing more frequently and washing contam-
inated clothing more frequently in hot water. Wearing contaminated clothing
is the usual method for transmitting body lice from one person to another.
Pubic lice (crabs) physically resemble crabs and infest hair in the pubic
area. Spread of pubic lice is usually through sexual contact. Underwear or
other contaminated clothing should be washed in hot water and dried using
the hot cycle for 20 minutes.
Treatment of lice includes the use of pediculicides and physical removal of
nits by combing. Inanimate objects should be washed in hot water and dried
for 20 minutes using the hot cycle in a dryer. Objects that cannot be cleansed
in this manner may be dry-cleaned or stored in a plastic bag for 2 weeks. Adult
lice may only survive for a couple of days without feeding, but the nits, if
present, may not hatch for up to 10 days. The monograph recommends
storage of the items for 2 weeks.19
There is a concern that resistance to the OTC products may have devel-
oped in lice. If all directions are not carefully followed and the treatment is not
repeated in 7 to 10 days, reinfestation may occur. It is also possible that some
type of genetic change may have occurred in lice, but this has not been clearly
established. If lice remain after a second treatment, referral to a physician is
necessary. Antibiotics or prescription pediculicides may be necessary to suc-
cessfully treat the individual.
Monograph drugs
OTC pediculicide, pyrethrum extract, refers only to treatment for lice and
includes head lice, body lice, and pubic lice.20
Pyrethrum extract, formerly known as pyrethrins, combined with piperonyl
butoxide is the only monograph drug.
Mode of action
Pyrethrum extract is derived from chrysanthemums and is absorbed by the
lice, causing paralysis of the nervous system and death. These compounds are
not absorbed by humans. Piperonyl butoxide is combined with pyrethrins
because it inhibits the normal oxidative enzymes in lice from metabolizing
pyrethrins to inactive compounds.19

Pyrethrum extract should not be used near the eyes, on the eyebrows or
eyelashes, or in the nose, mouth, or vagina. Pyrethrum extract should not
be used without consulting a physician by anyone allergic to ragweed or
chrysanthemums, because they may have difficulty breathing or an asthma
attack. If breathing becomes difficult, or if irritation of the skin or eyes occurs,
the product should be washed off and a physician consulted.
Recommended use
Products used as shampoos are applied to dry hair and remain on the hair for
10 minutes before being lathered with warm water to wash the hair. The hair
is towel dried and any tangles combed out. A fine-toothed comb is then used
to remove nits that remain on the hair shaft near the scalp. The hair should be
treated again in 7 to 10 days. This product should not be used in children
under 2 years of age without consulting a physician.19
Products
Pyrethrum extract with pipronyl butoxide (RID Shampoo and Pronto Lice
Killing Mousse Shampoo).
New drug application: permethrin

An OTC pediculicide refers only to treatment for lice and includes head lice,
body lice, and pubic lice.
Mode of action
Permethrin is a synthetic pyrethrin absorbed by lice that paralyses the nervous
system, resulting in death.
Permethrin should not be used near the eyes, on the eyebrows or eyelashes, or
in the nose, mouth or vagina. Permethrin should not be used without consult-
ing a physician by anyone allergic to ragweed. (Although permethrin is not
derived from chrysanthemums, it is chemically related to natural pyrethrum
and the individual may experience a sensitivity reaction.) Stop using permeth-
rin if it causes a rash on the skin or scalp.21
Recommended use
The hair is washed with any shampoo that does not contain a conditioner and
towel dried so it remains damp before applying the product. The product is
kept on the hair for 10 minutes before rinsing with warm water and towel
drying. Once tangles have been combed from hair, a fine-toothed comb is used
to remove nits. A second treatment may be applied in 7 or more days if live lice
remain. Permethrin should not be used in children under 2 months of age.21
Product
Permethrin (Nix).
Alternative therapy
Parents who do not want to use chemicals on their children have several other
choices available for treating head lice. Products that moisten and add lubri-
cation to the hair are available to make combing the nits from the hair easier.
LiceMD contains dimethicone, and RID Egg & Nit Comb-Out Gel contains
glycerin and cellulose derivatives. These products are not pediculicides. They
are applied to the hair before combing with a fine-toothed comb and then
washing the hair with warm water.22
Homeopathic pediculicide
Licefreee! is a homeopathic product that contains sodium chloride. The prod-
uct forms a thick, gel that immobilizes the lice until they die. This product may
create a hypertonic condition that affects the lice, but there is no explanation
provided for its mechanism of action in the company’s literature.23
The product is applied to dry hair and then covered with a plastic cap
(shower cap), which is included with the product. The product is kept on the
hair for at least 60 minutes and then the hair is washed with warm water. After
towel drying and combing out tangles, the hair is combed with a fine-toothed
comb. The treatment may be repeated in 7 to 10 days. Since most cases of head
lice are in children, it may be difficult to persuade them to keep a wet gel on
their head for 60 minutes, and this may limit the potential usefulness of this
product.
Musculoskeletal pain
Mild to moderate pain and discomfort affecting the muscles, ligaments, ten-
dons, and joints may occur after repetitive use or after minor injury and are
frequently treated with topical analgesics. Osteoarthritis joint pain is fre-
quently treated with topical analgesics. OTC oral analgesics (Chapter 5)
may be successful in relieving pain for many individuals, but many others
prefer to treat localized musculoskeletal problems by applying an external
analgesic to the affected area.
The counterirritant drugs that were discussed earlier in this chapter are the
drugs of choice for topical pain relief. The use of a cold or hot compress is
useful in mitigating musculoskeletal pain. When a minor injury, such as
twisting an ankle or knee, occurs, the body responds by increasing the blood
supply to the area and inflammatory mediators are released, which may cause
swelling and inflammation. This response may be reduced by resting the
affected area, applications of ice, wrapping the injury with an elastic-type
bandage to produce compression, and elevation of the injured area if possible
to reduce swelling. The acronym RICE describes this process.
Application of a cold compress, ice, or cold packs to the area will reduce
the inflammatory response, providing temporary relief of pain. Cold applica-
tions should last for approximately 10 or 15 minutes and may be used three or
four times within the first 24 hours after the injury.
There are products available containing chemicals that produce an endo-
thermic reaction, producing a cold compress for immediate use. These pro-
ducts can be used only one time. Reusable gel packs that are stored before use
in a freezer or ice may be used. If ice is used, it should not be placed on bare
skin. It may be placed in an ice bag or a plastic bag and wrapped in a towel
before applying it to the skin.
There are also products available containing chemicals that produce an
exothermic reaction, providing an immediate source of heat when needed.
Warm compresses, heating pads, moist steam packs, reusable gel packs, and
heat wraps (ThermaCare Heat Wraps) or patches are all available as sources
of heat. Heat wraps may only be used only once and are discarded. After
24 hours, the application of heat may be more appropriate than cold to relieve
discomfort. Heat should never be applied to the skin if a counterirritant has
been used on the skin because it will increase absorption of the counterirritant
and may damage the skin.
Some counterirritant drugs such as camphor and menthol may cause a

feeling of coolness of the skin, while others like methyl salicylate (oil of
wintergreen) cause warmth. Capsaicin and trolamine (triethanolamine sal-
icylate) have no noticeable effect on the skin’s temperature. Most products
used as topical analgesics contain more than one counterirritant and may
contain a local anesthetic and/or a protectant.

Counterirritants are topical external analgesics that may be used for the
temporary relief of minor aches and pains of muscles and joints caused by a
simple backache, lumbago (an old term referring to lower back pain), arthri-
tis, neuralgia, strains, bruises, and sprains.18
Monograph counterirritants
Camphor, capsaicin, menthol, and methyl salicylate are monograph drugs.
Mode of action
Counterirritants stimulate cutaneous sensory nerve fibers by causing mild
irritation or inflammation and in doing so mask the pain in the deeper layer
of the tissue that was caused by the injury or other noxious stimuli.18
Menthol and camphor produce a cooling sensation on the skin initially
that is followed by a feeling of warmth, which may be mediated by inhibition
of cutaneous catecholamines.24
Capsaicin, a compound derived from peppers, causes the depletion of
substance P, a neuropeptide present in peripheral sensory nerve fibers. This
occurs only with repeated application for 7 to 14 days. Capsaicin causes no
feelings of either coolness or warmth.24
Methyl salicylate produces a feeling of warmth on the skin and is presumed
to act by inhibiting local prostaglandins that sensitize nerve receptors to
pain.18 Trolamine may produce a similar effect because it is also a salicylate.
However, the FDA has not issued a final ruling on the efficacy of trolamine at
this time, and it appears in several products.

These products are for external use only and should not be used around the
eyes or on mucous membranes. If the condition worsens or persists for more
than 7 days, a physician should be consulted. The products should not
be applied to wounds or damaged skin and the treated area should not be
bandaged or covered.18
Recommended dose
These products are applied to the affected area three to four times a day. They
should not be used for children under 2 years of age without consulting a
physician.
Table 8.5 Products containing monograph-listed counterirritant combinations

(external analgesics) for musculoskeletal pain and osteoarthritis
Product Camphor Menthol Methyl salicylate Capsaisin
Banalag Yes Yes Yes
Ben Gay Pain Relieving Cream Yes Yes Yes
Biofreeze Roll on Yes Yes
Pain Bust-R Yes Yes
Salonpas Pain Patch Yes Yes Yes Yes
Salonpas Gel Patch Yes Yes
Salonpas Arthritis Patch Yes Yes
Salonpas Pain Relief Patch-Ultra Thin Yes Yes
Thera-Gesic Yes Yes
Tiger Balm and Tiger Balm Arthritis Yes Yes
Zen Sports Balm Yes Yes Yes
Products
Menthol (Absorbine Jr Spray, Aspercreme Heat Pain Relieving Gel, Ben Gay
Gel and Patch, Biofreeze Gel and Spray, Icy Hot Lotion and Patch, Mineral Ice
and Ultra Blue), capsaicin (Capzasin-P and Zostrix); trolamine (Myoflex,
Sportscreme, and Mobisyl). Table 8.5 contains the list of topical counter-
irritants products that are combinations and their monograph ingredients.
Hemorrhoids
Hemorrhoids, a common anorectal condition, are frequently treated with
OTC products if there is no rectal bleeding. Hemorrhoids are swollen veins
in the anorectal area. These veins have thin walls and become dilated and
bleed. Hemorrhoids are either internal, above the anorectal line covered with
mucous membranes that lack pain receptors, or external, below the anorectal
line and covered with epithelial skin that has pain receptors. The anorectal
line is the area where the upper anal canal merges with the rectum.25,26 A
commonly used term used to describe hemorrhoids is piles.
Symptoms associated with hemorrhoids include irritation, itching, dis-
comfort, pain, and rectal bleeding, occurring most frequently during bowel
movements. If rectal bleeding occurs, it is usually bright red, and further

diagnosis and treatment require consultation with a physician. If the diagnosis
of hemorrhoids was made previously, a physician should again be consulted
because some other condition may now be present. Many serious conditions
may cause rectally bleeding, including colon cancer, cirrhosis of the liver,
obstructions, fissures, and tumors.
The cause of hemorrhoids in many individuals may be unknown, but
certain situations are associated with the development of hemorrhoids, such
as excessive straining during defecation, frequent diarrhea, and pregnancy.
The weight of the fetus on the blood vessels in the membranes lining the floor
of the pelvis and the pressures exerted during normal vaginal delivery of the
baby may cause hemorrhoids in women. Often, after delivery, the condition
may resolve or it could return at some later stage of life.25
Individuals should be take measures to prevent constipation by having
some bulk or fiber in their diets, drinking plenty of fluids, and by taking a
stool softener. The anal area should be carefully cleansed after a bowel move-
ment, and should be patted dry, not vigorously rubbed. Premoistened anor-
ectal wipes with or without medication or baby wipes can be used for cleansing
the area. Application of topical OTC astringents, external analgesics, skin
protectants, keratolytics, and vasoconstrictor drugs approved by the FDA
are available for self-treatment of hemorrhoids. External analgesics and skin
protectants discussed previously in this chapter are used to treat hemorrhoids.
Dosage formulations for anorectal products include cream, ointments,
medicated wipes or pads for cleansing, and suppositories. Some products
may be inserted intrarectally with an applicator or a ‘hemorrhoid pipe’.
Astringents
Astringents provide a coagulant effect on skin or mucous membranes to
provide relief from itching and discomfort associated with hemorrhoids and
aids in protecting irritated anorectal areas.
Calamine (5 to 25%), witch hazel (10 to 50%), formerly Hamamelis water,
and zinc oxide (5 to 25%) are monograph astringents. Note that calamine and
zinc oxide are also classified as skin protectants.
Mode of action
Astringents reduce the amount of mucus and other secretions that may irritate
and inflame the affected area.26,27
If the condition worsens or does not improve within 7 days, the individual
should consult a physician. If bleeding occurs, a physician should be consulted
promptly.
Recommended use
The individual should apply these products to the affected area after proper
cleansing. These products should not be used on children less than 12 years
of age.
Products
Calamine, witch hazel and zinc oxide are available as single products from
many generic manufacturers. Table 8.6 lists combination products including
these ingredients when they are used for hemorrhoid relief.
Table 8.6 Hemorroidal relief products that contain a combination of monograph

astringents, external analgesics, protectants or vasoconstrictors
Product Astringent External Protectant Vasoconstrictor Usea

analgesic
Americaine Benzocaine E
Ointment
Lanacane Hydrocortisone E
Nupercainal Dibucaine E
Ointment
Preparation H Hydrocortisone E
Anti-itch
Preparation H Pramoxine Glycerin, Phenylephrine E

Cream, Maximum petrolatum,
Strength shark liver oil
Preparation H Cocoa butter, Phenylephrine I

suppository shark liver oil
Preparation H Witch hazel Mineral oil, Phenylephrine I and E

ointment petrolatum,
shark liver oil
Preparation H Witch hazel E

Wipes
Tronolane Cream Pramoxine Zinc oxide I and E
Tronolane Hard fat Phenylephrine I

Suppository
Tucks pads Witch hazel E
Tucks Anti-itch Hydrocortisone E

Ointment
Tucks Oint-ment Pramoxine Mineral oil, zinc E

(Anusol) oxide
a
Use for internal (I) or external (E) hemorrhoids.
Keratolytics
Keratolytics debride surface cells of the epidermis to relieve the itching and
discomfort associated with hemorrhoids.
Alcloxa (0.2 to 2%) and resorcinol (1 to 3%) are the only kertolytics consid-
ered mild enough in their action to be used on the anorectal tissues.
Mode of action
Keratolytics act on keratin to loosen its attachment to epidermal cells so that
the cells slough off.26
If the individual’s condition worsens or does not improve within 7 days, a
physician should be consulted. If bleeding occurs, a physician should be
consulted promptly. These products should not be used in the rectum.
Products
There are no keratolytic drugs available in the most popular anorectal pro-
ducts sold in the USA at this time, but they may appear in store or generic
brands.
Vasoconstrictors
Vasoconstrictors are used to temporarily relieve the swelling of hemorrhoids.
Epinephrine (0.005 to 0.01%), ephedrine (0.1 to 1.25%), and phenylephrine
(0.25%) are vasoconstrictor drugs.
Mode of action
Vasoconstrictors are drugs that act on the alpha-adrenoceptors in the smooth
muscle of blood vessel walls to shrink or constrict the vasodilated blood
vessels.
Individuals who have heart disease, high blood pressure, thyroid disease,
diabetes, or difficulty in urination because of enlargement of the prostate
gland should not use these products without consulting a physician. If an
individual is taking drugs for high blood pressure or depression, a physician
should be consulted before using these products.26,27
Ephedrine may cause insomnia, nervousness, nausea, loss of appetite,
and tremor. The individual should consult a physician if these symptoms
occur.26,27
Recommended dose
The products are applied to the affected area up to four times a day.
Products
See table 8.6.
Antiperspirants
The purpose of the eccrine sweat glands in the dermal layer of the skin is to
provide a means of controlling body temperature. When conditions result in
the core body temperature rising, there is an increase in secretions from the
sweat glands. As the sweat evaporates from the skin, it causes cooling.
Some individuals may have overactive sweat glands, while others perceive
the appearance of any moisture under the arms as an embarrassment.
The FDA has approved certain salts of aluminum, which are astringents, as
antiperspirants. Most individuals use antiperspirants daily, and these pro-
ducts have a minimum of adverse affects, the most common being skin
irritation.

Antiperspirants are used to prevent or reduce the amount of sweat.28
Aluminum chloride, aluminum chlorohydrate, aluminum chlorohydrex salts,
and aluminum zirconium chlorohydrate salts are monograph antiperspirants.
There are a total of 18 different aluminum salts approved in the monograph.28
Mode of action
Astringents precipitate (shrink or constrict) proteins within the sweat gland to
reduce, lessen, or decrease secretions.

Antiperspirants should not be applied on broken skin. If skin irritation or a
rash occurs, use of the the product should stop. If the irritation or rash does
not improve, the individual should contact a physician. Those with kidney
disease should consult a physician before using these products. Users of spray
products should avoid inhalation or contact with the eyes.
A popular internet myth links use of antiperspirants with breast cancer. A
study published in the Journal of the National Cancer Institute29 showed no
such relationship and has been supported by a more recent study.30
Recommended use
The antiperspirant is applied topically to the underarms only. Products that
reduced sweating by 20% may claim a 24 hour effect; products that reduce
sweating by 30% may claim extra-effective protection.28
Products
All popular antiperspirants are aluminum salts in varying concentrations and
may or may not contain a fragrance and are formulated for men or women.
Products labeled as deodorants only are cosmetics not drugs.
Sunscreens
Many of the changes in the skin that are attributed to aging, especially in the
epidermal layers, are really effects from damage caused by ultraviolet rays
in sunlight (photoaging). Sun damage includes sunburn, photoaging, actinic
keratoses, and skin cancer.
Ultraviolet in sunlight is divided into three categories depending on wave-
length: UVA is 320–400 nanometers (nm), UVB 290–320 nm, and UVC 200–
290 nm. There are two subdivisions of UVA: UVA-1 is 340–400 nm (long
UVA) and UVA-2 is 320–340 nm (short UVA). The earth’s natural ozone
layer absorbs UVC. Artificially produced UVC is used for germicidal purposes
in sterilizing inanimate objects.31
UVB is responsible for most of the damage referred to as sunburn, causing
erythema or reddening and blistering. UVB strikes the earth primarily
between 10:00 a.m. and 2:00 p.m. when the USA is using standard time. It
is able to penetrate cloud cover and water and is reflected off water, snow, and
sand. The best protection against exposure is to remain indoors or in the shade
during this time period, or to cover the skin with clothing or sun-protective
drugs.
The monograph sunscreens have a different degree of effectiveness in
protecting the epidermis against ultraviolet light, and they are primarily
effective against UVB. The FDA developed a method to describe the relative
effectiveness of sunscreens to provide people with a tool to help them to decide
which product would provide the degree of protection they need. The sun
protection factor (SPF) is determined by using a standard source of ultraviolet
light and exposing protected skin (skin with sunscreen applied) and unpro-
tected skin to produce the same amount of erythema (redness) on the skin. The
amount of energy required to produce erythema in protected skin divided by
the energy required to produce erythema in unprotected skin determines the
SPF value.31
A rating of SPF 4 provides the least amount of protection and is recom-
mended for use primarily for individuals who have a high concentration of
melanin in the skin. A product that has an SPF of 8 means that it takes twice as
long to produce the same amount of skin damage, or it provides twice the
protection as a product with SPF 4. The maximum SPF value has been
increased from SPF 30þ to SPF 50þ.32
Melanin is a pigment produced in the skin in response to exposure to
sunlight to protect the skin from further damage, and is responsible for
‘tanning’ of the skin. Individuals who have fair skin have less melanin, espe-
cially if they are of Celtic origin, and should use products with SPF 30þ or
higher for protection. Cosmetic products that produce an artificial tan on the
skin provide no sun protection.
Many individuals believe that it is cosmetically more attractive to have a
tanned skin and go to a tanning salon where they are exposed to artificial
ultraviolet light to maintain a tan all year long. Artificial ultraviolet is just as
damaging to the skin as sunlight.
The FDA approved an NDA for ecamsule, which protects the skin against
UVA, which penetrates the dermal layer of the skin and causes long-term
damage.32 The use of SPF factors provides consumers with a way to compare
sunscreens that protect against UVB, and the FDA is considering establishing
a new system for consumers to use when choosing a sunscreen product for
protection against UVA. The system would use stars, 1 star for minimal
protection and 4 stars for the highest degree of protection.33
If the skin is not protected and sunburn occurs, temporary relief can be
obtained from OTC products containing external analgesics (hydrocortisone
and local anesthetics, as discussed earlier in this chapter), which will reduce
irritation and minor pain of the skin. Sunburn that covers an extensive area or
a sensitive area of the skin, or results in blistering of the skin, should be treated
by a physician.18
Products
Most sunscreens have a combination of drugs to provide protection against
UVA and UVB. Popular combinations include Aveeno Continuous Protection
Sunblock, Bull Frog Quik Gel, Coppertone Sport, PreSun Ultra, Neutrogena
Healthy Defense Oil-free Sunblock, and Sea & Ski Advanced Sunscreen.
Monograph sunscreens
Drugs that are sunscreens are topical dermatological products that protect
the skin against sunburn.
Monograph drugs
Several different chemical classifications of drug are monograph sun-
screens. Table 8.7 lists the specific FDA approved drugs and includes the type
of ultraviolet light protection of each and the mode of action of each.
Mode of action
Sunscreens that are derived from organic chemicals must absorb at least 85%
of the ultraviolet light between 290 and 320 nm. These drugs absorb the
energy of the light, resulting in a change in the actual chemical composition
of the drug and a decrease in the amount of drug available for protection as the
Table 8.7 Categories of FDA approved drugs for sun protection, classified as
absorbers or reflectors for specific ranges of ultraviolet (UV) light protection
Drug category Range of UV protection
Para-aminobenzoic acid derivatives: PABA, padimate O (octyldimethyl UVB absorber

PABA), glyceryl aminobenzoate, ethyl-[bis(hydroxypropyl)] aminobenzoate
Benzophenones derivatives: dioxybenzone, oxybenzone, sulisobenzone UVB and UVA absorber
Cinnamate derivatives: cinoxate, diethanolamine methoxycinnamate, UVB absorber

octinoxate (formerly octyl methoxycinnamate)
Salicylate derivatives: homosalate, octisalate (formerly octyl salicylate), UVB absorber

trolamine salicylate.
Other organic chemical compounds
Octocrylene UVB absorber
Ensulizole UVB absorber
Avobenzone (Parsol 1789) UVA-1 absorber
Ecamsule UVB and UVA-1 absorber
Meradimate UVA-2 absorber
Inorganic chemical compounds
Titanium dioxide UVB, UVA reflecting agent
Zinc oxide UVB, UVA blocking agent
length of time exposed to the sun increases. These products should be reap-
plied every 2 to 3 hours.
Titanium dioxide, an inorganic drug, acts by reflecting the ultraviolet light
away from the skin, and there is no change in its chemical composition. Zinc
oxide, another inorganic drug, acts by physically blocking the ultraviolet light
from reaching the skin and is also not affected by the ultraviolet light. Both of
these products do not deteriorate with sun exposure and should be reapplied
after the individual goes swimming or sweats profusely.31
These products are for external use only and individuals should avoid contact
with the eyes. If irritation or a skin rash develops, individuals should stop use
of the product; if the irritation or rash does not improve, a physician should be
consulted.
Recommended use
Suncreens may be applied liberally to the skin of adults and infants over 6
months of age before exposure to sunlight; a physician should be consulted if
the infant is less than 6 months old. Sunscreens should be reapplied after
swimming or extensive sweating. If the product is labeled as water resistant,
it should be reapplied after 40 minutes in the water; if labeled as very water
resistant, it is reapplied after 80 minutes.31
New drug application sunscreens

Suncreens prevent epidermal and/or dermal damage from sunlight.
New drug application
Avobenzone and ecamsule.
Mode of action
Avobenzone absorbs UVA-1 rays and ecamsule absorbs UVA-2 rays in sun-
light to prevent skin damage.
An individual using a sunscreen should keep the product out of eyes and stop
use if irritation or a skin rash develops. If the irritation or rash does not
improve, a physician should be consulted.
Recommended use
Sunscreens should be applied to the skin of adults and infants over 6 months of
age before exposure to sunlight and reapplied as necessary, especially after
swimming or perspiring. Consult a physician for use in infants less than 6
months old.
Products
Avobenzone and ecamsule are combined with octocrylene in Anthelios SX.
Avobenzone appears in many other sunscreen products.
Topical antimicrobial drugs

When the integrity of the skin is damaged, the risk of infection is increased.
The FDA has approved the use of antiseptics and antibiotics as topical OTC
drugs to reduce the risk of infection. If a skin infection does occur, it requires
treatment by a physician. Diagnosis of the cause of the infection is beyond the
capabilities of untrained individuals, and inappropriate use of antibiotics
would increase the risk of creating resistant strains of bacteria.
The first step in proper wound care is cleaning the area with non-irritating
skin cleansers, drying the area, application of a topical first aid cream, and
protecting the damaged skin by covering it with a sterile bandage. The manu-
facturer of Band-Aid bandages makes a sterile bandage that contains topical
antibiotics in the protective pad, which eliminates the need for applying an
antibiotic cream or ointment to minor wounds.
First aid topical antiseptics

Monograph antiseptics
Topical antiseptics are used to clean the skin or minor cuts, scrapes, or burns.
Products containing alcohol, isopropyl alcohol, phenol, and iodine tincture
will cause pain if applied to broken skin. If the injured skin is to be cover-
ed, antiseptics should be removed from the skin by washing or should be
thoroughly dried on the skin before a bandage is applied.
First aid antiseptics are used topically to inhibit microbial growth on the intact
skin and reduce the risk of infection in minor cuts, scrapes, and burns.34
Alcohol (48 to 95% ethyl alcohol), isopropyl alcohol (50 to 91.3%; 70%
isopropyl alcohol is known as rubbing alcohol), hexylresorcinal (0.1%)
hydrogen peroxide (3%), iodine tincture, povidone-iodine (5 to 10%), phenol
(0.5 to 1.5%), benzalkonium chloride (0.1 to 0.13%), benzethonium chloride
(0.1 to 0.2%), and methylbenzethonium chloride (0.13 to 5%).34
Mode of action
Antiseptics are drugs that are either microbiostatic or microbiocidal if they
remain on the skin for a sufficient amount of time.
General warnings for these drugs include the following:34 ‘this product is for
external use only and should not be used around the eyes or mucous mem-
branes, on animal bites, deep or puncture wounds, serious burns, or a large
area of the body. If the individual’s condition worsens or has not improved
within 7 days, a physician should be consulted.’
Specific warnings for specific drugs include the following:34 (1) alcohol
and isopropyl alcohol should not be used near an open flame or fire because
they are flammable; (2) phenol containing products should not be ban-
daged; and (3) iodine containing products should not be used by individuals
who are allergic to iodine and they may temporarily stain the skin and
clothing.
Recommended use
Antimicrobial drugs should be applied topically to the affected area to clean
the skin or minor wound, or they may be applied to the wound after cleaning
with water to prevent infection. The area should be allowed to dry before ap-
plying a sterile bandage. The product may be applied one to three times a day.
Products
Alcohol, isopropyl alcohol and hydrogen peroxide are available from many
generic manufacturers, benzalkonium chloride (Bactine Original First Aid
Liquid with lidocaine, Band-Aid Antiseptic Hurt Free with lidocaine, Neo-
sporin Neo To Go Spray with proxamine), and povidone iodine (Betadine).
NOTE: Lidocaine in not recommended for use in children under 2 years of age.
Rx–OTC switched antimicrobial drugs

Chlorhexidine is a topical antiseptic used to inhibit microbial growth on
intact skin or on minor cuts.

Chlorhexidine 4% and chlorhexidine with isopropyl alcohol are approved
skin wound cleansers and general skin cleansing agents.35

Wounds involving more than superficial layers of the skin should not be
treated with chlorhexidine. Chlorohexidine should not be used repeatedly
as a skin cleanser unless directed by a physician.35
Products
Chlorhexidine (Hibiclens Liquid), chlorhexidine and isopropyl alcohol
(Hibistat).
First aid topical antibiotics

An antibiotic drug contains a chemical substance produced by a micro-
organism that is used topically to inhibit the growth or to kill bacteria on
the skin.36
Bacitracin 500 Units, neomycin 3.5 mg, and polymyxin B sulfate 10 000 Units
are monograph antibiotics.
Mode of action
Bacitracin interferes with amino acids needed for synthesis of bacterial cell
walls of Gram-positive bacteria. Neomycin inhibits protein synthesis by bind-
ing to the 30S subunit of microbial transfer ribonucleic acid (tRNA), which is
found in Gram-negative bacteria and several types of Gram-positive bacteria
but not in humans. Polymyxin B is a microcidal surface active agent that alters
phospholipids in the cell wall of Gram-negative bacteria.37

The individual should not use these products around the eyes, on mucous
membranes, or on a large area of the body. If the individual’s condition
worsens or does not improve in 7 days, a physician should be consulted. If
the individual develops skin irritation or a rash, use of the product should
be stopped; if the problem does not improve, a physician should be con-
sulted. Deep puncture wounds, bites, or serious burns require treatment by
a physician.
If an individual is allergic to the antibiotic or any ingredient in the product,
it should not be used. Neomycin has the greatest risk of causing an allergic
response.36
Recommended use
Apply a small amount of the product on the skin up to three times a day. A
sterile bandage may be applied after application to keep the wound clean.
Products
Bacitracin and neomycin are available from generic manufacturers. Bacitracin
is usually combined with neomycin or polymyxin B, or both, because it does
not affect Gram-negative bacteria. The monograph does not permit use of
polymyxin B as a single ingredient product.
Combination products: Bacitracin and polymyxin B (Polysporin Ointment
and Band-Aid Plus Antibiotic Adhesive Bandage), neomycin and polymyxin B
(Neosporin Maximum Strength Plus; also contains proxamine, a local anes-
thetic), bacitracin, neomycin, and polymyxin B (Neosporin First Aid Anti-
biotic Ointment).
Topical antifungal drugs

Dermatophytes are fungal organisms that depend on keratin, the dead
surface layers of the epidermis, for their sustenance. They also infect hair
and nails, which are keratin structures. Tinea pedis (athlete’s foot), tinea
corporis (ringworm), and tinea cruris (jock itch) are the most common
fungal infections affecting the epidermis and they are amenable to self-
care. Tinea can be spread by direct contact or contact with contaminated
surfaces, such as a wet shower room floors, one of the most common sites
for spreading tinea pedis. Good personal hygiene practices that keep the
skin clean and dry are important in preventing and treating fungal infec-
tions.
Conditions favoring the growth of fungi include moisture and heat, which
accounts for the sites of the body affected. Symptoms include itching, ery-
thema, flaking, and cracking of the skin. Infections of the scalp and body
usually produce a circular pattern, hence the name ringworm. Individuals
who are immunosuppressed or taking immunosuppressing drugs are at
greater risk of fungal infections than normal individuals. OTC topical hydro-
cortisone should not be used for treating symptoms of these infections because
it will make the problem worse.
Monograph drugs
Topical antifungal drugs are used to relieve itching, scaling, redness, and
burning associated with athlete’s foot, jock itch and ringworm.38
Clotrimazole (1%), miconazole (2%), tolnaftate (1%), undecylenic acid and
its salts (10 to 25%).38
Mode of action
Tolnaftate and undecylenic acid and its salts (calcium, copper, and zinc
undecylenate) inhibit fungal growth. Miconazole and clotrimazole inhibit
synthesis of ergosterol, a component specific to the cell wall of fungi.37–39

These products should not be used around the eyes or on mucous membranes.
Recommended use
The individual should apply the product daily on the skin around the toes for
up to 4 weeks for athlete’s foot. If there is no improvement within 2 weeks, a
physician should be consulted. The individual should apply the product daily
to the affected area for 2 weeks for jock itch and ringworm. These products
should not be used in children under 2 years of age without consulting a
physician. These products are not effective for tinea infections on the scalp
or nails.38
Products
Tolnaftate (Tinactin Foot Powder and Spray and Tinactin Antifungal Jock Itch
Powder, Ting Foot and Jock Itch Cream, and Lamisil AF Defense Powder);
undecylenic acid (Tineacide Cream, FungiCure Anti-Fungal Liquid).
Rx–OTC switched antifungal drugs

Topical antifungal drugs are used to relieve itching, scaling, redness, and
burning associated with athlete’s foot, jock itch, and ringworm.40
Active ingredients
Terbinafine and butenafine.
Mode of action
Terbinafine and butenafine inhibit synthesis of ergosterol, a component
specific to the fungal cell wall.37

Terbinafine 1% and butenafine 1% products have the same warnings. These
products should not be used on the nails or scalp and should not be used
around the eyes. If the product gets in the individual’s eye or eyes, thorough
washing with water is necessary. These products are not to be used by women
for vaginal yeast infections. If skin irritation occurs, the individual should stop
using the products. If the irritation does not improve, the individual should
consult a physician.
Recommended use
Terbinafine and butenafine may be applied twice a day for 7 days or once a
day for 4 weeks for treatment of athlete’s foot. They should be applied to the
skin or genital area daily for 2 weeks for treatment of jock itch. These pro-
ducts should not be used by individuals under 12 years of age.40
Products
Clotrimazole (Lotrimin AF Anti Jock Itch Powder, Lotrimin AF Anti Fungal
Cream), miconazole (Desenex Powder and Spray, Lotrimin AF Spray,
Micatin Spray), terbinafine (Lamisil AT Cream, Lamisil AT for Women),
butenafine (Lotrimin Ultra AF Antifungal Cream).
Topical antiviral drugs

Warts are caused by human papillomaviruses, which affect the basal layer of
skin cells, causing hyperproliferation of epidermal skin cells. Most warts on
the skin have a rough, cauliflower appearance and are located predominately
on the hands, fingers, feet, knees, and genital areas. There is no OTC treat-
ment for genital warts, or warts on the face or lips.41
Warts are contagious and may be spread by direct skin to skin contact, or
by skin contact with contaminated inanimate objects. The virus has an incu-
bation period that ranges from 1 to 9 months. Normal shedding of the keratin
layer of the epidermis carries the virus with it.
OTC treatment of warts includes the use of keratolytic drugs that remain
on the skin for prolonged periods of time. Flexible collodion is the usual
pharmaceutical vehicle for keratolytic drug solutions used to treat warts,
corns, or calluses. It is a solution of nitrocellulose (pyroxylin) in either ether
or acetone, which quickly evaporates after application to the affected area of
the skin, leaving a transparent film on the skin.
Keratolytics may also be applied to the skin in the form of a plaster, a pad
with a keratolytic drug on a synthetic material that uses adhesive to keep the
pad on the skin for a prolonged period of time.
OTC home products that produce a cryotherapeutic type condition are
now available for the treatment of warts. Their main advantage is a much
shorter treatment time compared with keratolytic therapy. If OTC treatment
is unsuccessful, a physician may use liquid nitrogen cryotherapy or some other

technique to remove warts.
Monograph drugs (keratolytics)

Wart removers cause a softening of the keratin in the epidermal layers of the
skin to remove common or plantar warts.41
Salicylic acid is the only monograph drug. The concentration of salicylic acid
varies depending on the formulation used in the product. Products that are
plasters contain 12 to 40% salicylic acid and flexible collodion solutions
contain 5 to 17%.41
Mode of action
A keratolytic drug destroys the integrity of the intracellular matrix of cell
walls, causing a softening that increases the shedding of the epidermis. As the
keratolytic reaches the basal layer, the virus is also affected and shed with the
epidermal cells.

These products should not be used around the eyes or on mucous membranes;
broken, irritated, or reddened skin; or the genitals. This product should not be
used if the individual has diabetes or poor circulation, and it should not be
used on birthmarks, moles (nevi), or warts that have hair growing from them.
If the wart becomes very red, sore, or drains fluid, or if numbness or a tingling
sensation develops, the product should be stopped and a physician
consulted.41
Flexible collodion products should not be inhaled and should not be used
near an open flame. The bottle should be capped tightly when not in use and
not stored near flames or a heated area.
Recommended use
The products are applied only to the wart and not the surrounding skin, after
it has been washed, soaked in or with warm water for 5 minutes, and patted
dry. Salicylic acid solution may be applied once or twice a day after washing
the area. Salicylic acid in plaster formulations may be reapplied in 48 hours
after removing the old plaster and cleaning the area. Most warts are removed
within 1 to 2 weeks, but the product may be used up to a maximum of 12
weeks.41
Products
Salicylic acid: (Compound W, Curad Mediplast, Duo Film Wart Remover,
Dr. Scholl’s Clear Away Wart Remover, Transversal, Wart Care, Wartner
Wart Remover).
New drug application (cryotherapy)

Drug therapy and indications for use
Cryotherapy uses extreme cold temperature to remove warts.
Dimethyl ether packages with butane have received FDA approval as a wart
removal system.42
Mode of action
Application of extreme cold causes a blister to form under the wart to disrupt
and free it from the epidermal layer. The destroyed epidermal tissue sloughs
off, removing the virus.
These products are extremely flammable. Do not smoke while applying them
and do not use near an open flame; store away from heat. They should be used
in a well-ventilated area and inhalation should be avoided. An aerosol prod-
uct is not sprayed directly on to the skin; it is sprayed on the applicator
supplied with the product and then applied to the wart.43
Recommended use
Individuals should apply the drug to the skin using applicators that are sup-
plied in the package. Applicators should not be reused. Product may be
reapplied but should not be used on the same wart more than four times.43
Products
Dimethyl ether (DME) and butane (Compound W Freeze Off, Dr. Scholl’s
Freeze Away, and Wartner’s Plantar Wart Removal System).
Corn and callus removers

Corns and calluses are excessive thickness or growth of the keratinized outer
layer of the epidermis. They are usually caused by excessive or continuous
pressure on the same area of the skin. They occur most frequently on the feet
from improperly fitting footwear or on the palms of the hands or fingers from
repetitive pressure. Tissues becomes firm or hardened to protect the lower
layers of the epidermis.
Keratolytics soften and remove the excess keratinized layers of skin.44
Monograph drugs
Salicylic acid 12 to 40% is used in a plaster formulation and 12 to 17.6% is
used in a flexible collodion solution.44
Mode of action
A keratolytic drug destroys the integrity of the intracellular matrix of cell
walls, causing a softening that increases the shedding of the epidermis.

The warnings and precautions for salicylic acid used as a corn or callus
remover are the same as those described above for wart removal.
Recommended use
The affected area is washed and dried before topical application of the prod-
uct to the corn or callus. The product may be reapplied in 48 hours for a period
up to 14 days. If the condition gets worse or does not improve, a physician or
podiatrist should be consulted.44
Products
Salicylic acid (Dr. Scholl’s Corn Cushions, Dr. Scholl’s Maximum Strength
Corn Remover, Dr. Scholl’s Corn/Callus Remover, Dr. Scholl’s Callus pads.)
Ingrown toenail relief

Ingrown toenails are primarily the result of improper trimming or clipping of
the nails. Proper grooming should include trimming the nail straight across
and not rounding the edges. If the nail is improperly trimmed, the edges of the
nail can grow into the skin tissue and may cause pain, inflammation, and
swelling. Improperly fitted shoes can also cause this condition through undue
pressure on the side of the toe. There is no OTC cure for an ingrown toenail,
but the FDA has approved sodium sulfide (1%) to help to relieve pain and
discomfort.
Sodium sulfide
An ingrown toenail relief product relieves pain or discomfort when applied to
the toenail.45
Sodium sulfide (1%) in a gel vehicle is a monograph drug.
Mode of action
A toenail relief product softens the nail or hardens the nail bed, producing
relief from pressure on the tissue around the nail and relieving pain.45

This product is for external use only and should not be applied to any open
sore or broken skin. Individuals with diabetes, gout, or poor circulation
should consult a physician before using this product. This product must be
used with the retainer ring provided in the package. If redness or swelling of
the toe occurs, if a discharge is present around the nail, or if there is no relief of
symptoms within 7 days, the product should be stopped and a physician
consulted.11
Recommended use
The affected toe is washed and dried before placing the retainer ring on the toe
with the open slot over the area where the ingrown toenail and the skin meet.
The ring should be smoothed down firmly and the gel applied to the slot in the
ring. The round center section of a bandage strip should be applied directly
over the gel-filled ring and placed around the toe. This procedure should be
performed in the morning and evening for up to 7 days or until the pain and
discomfort are relieved. This product should not be used on children under 12
years of age.45
Product
Dr. Scholl’s Ingrown Toenail Pain Reliever
Acne
Acne is a condition involving the sebaceous glands and hair follicles (pilose-
baceous unit), which arise in the dermal layer of the skin and pass through the
epidermis to the surface of the skin. Sebum, an oily secretion, remains on
the skin, acting as a retardant to moisture loss and providing lubrication of
the skin to prevent chapping. Sebum that is not cleansed from the skin may
act as an irritant or may block the gland’s opening, resulting in blemishes or
comedones (pimples) on the skin. Bacteria normally present on the skin,
Propionibacterium acnes, use the lipids in sebum for nutrition and growth,
causing further irritation of the skin and development of papules, pustules,
nodules or cysts. Topical antibiotic preparations are available as prescription
drugs to control the growth of bacteria.46
Acne is rated from grade 1 to grade 4, increasing in severity as the values
increase. Mild to moderate acne may respond to OTC products; more severe
acne, characterized by pustules and cysts, requires treatment by a physician.
Acne predominately affects adolescents because of the increase in
hormone production during this period, especially androgenic compounds.
Testosterone and dihydrotestosterone stimulate sebum production. Heat and
humidity contribute to the problem, as does the use of oily substances in facial
lotions, sunscreens, and cosmetics. Working in kitchens of restaurants, espe-
cially fast-food establishments, where the atmosphere is humid and cooking
oils are present in the environment exacerbates the problem. The face, upper
chest, and back are the areas most commonly affected.
The skin must be cleaned and dried frequently, but harsh soaps and
vigorous scrubbing are to be discouraged because the irritation they cause
may worsen acne. Numerous acne face-washes or scrubs, and cleansing pads
containing salicylic acid or benzoyl peroxide, are available as the initial step in
acne treatment. Some products are tinted to mask blemishes, making them
less obvious.
Manufacturers of acne products are now marketing a combination of

three products as a single system or treatment package for acne. These treat-
ment packages contain a medicated skin wash, which may contain an active
drug; a skin toner (a liquid rinse with no active ingredient); and a medicated
therapy treatment to be applied after washing and drying the skin.
Rosacea is a dermatological condition inaccurately referred to as adult
acne because of its general appearance. It is characterized by vasodilatation of
small blood vessels in the skin of the face around the nose, cheeks, chin and
forehead, producing redness and skin blemishes. Individuals with rosacea do
not have comedones. There is no OTC treatment for this condition.
Acne products reduce the number of acne blemishes, acne pimples, black-
heads (open comedones), and whiteheads (closed comedones).47
Salicylic acid (0.5 to 2%), sulfur (3 to 10%) when it is used as a single
ingredient in a product, sulfur (3 to 8%) when it is used in a combination
product, and resorcinol (2%) or resorcinol monoacetate (3%) when it is
combined with sulfur.47
Benzoyl peroxide (2.5 to 10%) is not included in the final monograph, but
the FDA allows it to continue in OTC products while it evaluates reports of an
increase in risk of skin tumors in some animals. The FDA’s advisory group did
not find evidence that benzoyl peroxide caused skin tumors or caused skin
tumors to grow faster in human studies.48
Mode of action
Salicylic acid has a keratolytic effect and removes the epidermal layer of the
skin, the site of acne blemishes. Sulfur has mild antibacterial and antifungal
activity, which may prevent microbial growth. Resorcinol may be combined
with sulfur to improve the efficacy of sulfur, but it is not used alone. Benzoyl
peroxide has antimicrobial activity through its ability to release oxygen in
human tissues.47,48
If the individual uses more than one acne medication at the same time, the skin
may become excessively dry, causing skin irritation. If this occurs, only one
medication should be used. If the individual has discomfort from a combina-
tion of products recommended by a physician, the physician should be
consulted.
If excessive skin irritation occurs when using a sulfur product, use should
be stopped and a physician consulted. Sulfur products containing resorcinol
should not be used on broken skin or on a large area of the body.47
Benzoyl peroxide may irritate the skin and produce erythema and dryness.
It increases the skin’s sensitivity to sunlight and individuals are advised to use
a sunscreen if they go outdoors. Benzoyl peroxide may cause bleaching and

discoloration of clothing.
Recommended use
The individual should clean the skin thoroughly before using any acne prod-
uct, and apply a thin coating to the affected areas up to three times a day. It is
recommended that benzoyl peroxide treatment begins by using it once a day,
increasing the number of daily applications if no skin irritation occurs.
Products
Salicylic acid (Biore Blemish Cleanser, Bye Bye Blemish Antiacne Wash, Clean
& Clear Continuous Control Acne Wash, Clean & Clear Advantage Acne
Cleanser, Clearasil Ultra Daily Face Wash, Clearasil Deep Pore Cleaning
Pads, Cuticura Treatment Foaming Face Wash, Neutragena Oil Free Wash,
Neutragena Acne Stress Control, Oxy Face Wash, Oxy Face Scrub, Oxy
Cleansing Pads, Zapzyt Adult Acne Clearing Gel), salicylic acid and resor-
cinol (Clearasil Acne Control Adult Cream), benzoyl peroxide (Clean & Clear
Persa Gel, Clearsil Ultra, Clearasil Daily Acne Control Vanishing Cream,
Neutragena On the Spot Vanishing Formula, Oxy Spot Treatment, Proactiv
Renewing Cleanser, Proactiv Repairing Solution, Zapzyt Treatment Bar,
Zapzyt Maximum Strength Acne Gel).
Hyperproliferation skin conditions (scaly dermatitis)

Dandruff, seborrhea, and psoriasis are skin conditions in which there is an
excessive rate of skin growth or turnover that results in noticeable thickening
or shedding of the outer keratinized layer of the skin. These conditions are
also referred to as scaly dermatitis. The rate of epidermal turnover in dandruff
is approximately twice the normal, in seborrhea it is around five times greater
than normal, and in psoriasis it is much greater. Psoriasis has aspects of being
an immune disorder, and severe cases require referral to a physician for proper
treatment.49
Dandruff affects the scalp, the excess epidermal cells appearing as dry,
white flakes. The higher levels of a fungus, Pityrosporum ovale, on the scalp of
individuals with dandruff contribute to the condition because it converts
sebum lipids in free fatty acids, which act as skin irritants.
Seborrhea occurs around the scalp, ears, eyebrows, or other areas of the
body. The flaking epidermal cells are oily and have a yellow color, and the
skin is irritated, itchy, and red. Infant seborrhea is referred to as cradle cap
because it occurs on the top of the head of infants. It is only treated by washing
the scalp with baby shampoo and generally is a temporary condition that
tends to resolve itself as the infant gets a little older.
Psoriasis may occur anywhere on the body, but the wrists, elbows, and
knees are the areas that are most frequently affected. The skin appears thick
and scaly, with redness and itching. Severe psoriasis appears as white scales or
thick plaques and the skin is itchy and inflamed. When the scales break off, the
capillaries in the skin and are visible and bleeding can occur. This condition is
known as the Auspitz sign.50
Shampoos with surface-active agents disperse the epidermal flakes for easy
removal when the hair is washed. Shampoos may contain keratoplastic,
keratolytic, or cytostatic drugs to treat these conditions.
Dandruff
Antidandruff drugs may be used to reduce or eliminate the scaling associated
with dandruff.51
Monograph drugs
Sulfur (2 to 5%) is a keratoplastic drug; salicylic acid (1.8 to 3%) is a kera-
tolytic drug; and pyrithione zinc (0.95 to 2%), selenium sulfide (1%), micron-
ized selenium sulfide (0.6%), coal tar (0.5 to 5%), and coal tar (1.8%) plus
menthol (1.5%) are cytostatic drugs.51,52
Mode of action
Keratoplastics (sulfur) and keratolytic drugs (salicylic acid) soften the epider-
mal skin by affecting the intercellular matrix of cell walls. Keratolytics are
more effective and cause the epidermal cells to be sloughed off. Cytostatic
drugs inhibit cell turnover but the mechanism is not fully understood.51
The products should not be used around the eyes, but if contact occurs, the
area should be rinsed thoroughly with water. If the individual’s condition
does not improve or gets worse after regular use, a physician should be
consulted. If the condition affects a large portion of the body, a physician
should be consulted. These products should not be used in children under 2
years of age without consulting a physician.51,52
Coal tar products sensitize the skin to sunlight and the individual should
use a sunscreen before going outdoors. Coal tar products should not be used
for prolonged periods of time without consulting a physician. If a cream or
ointment formulation is used, it should not be used around the rectum or
genital area unless directed by a physician. If an individual uses OTC psoriasis
products, the individual should notify the physician if treatment with ultra-
violet light is being prescribed.51
Recommended use
Products that are used as shampoos should be applied to the scalp and then
washed off, and may be used twice a week. Products formulated as lotions,
creams, or ointments may be applied to the affected scalp from one to four
times a day.
Products
Coal tar (Denorex Dandruff Shampoo and Conditioner Therapeutic), sulfur
and salicylic acid (Sebulex Medicated Dandruff Shampoo), salicylic acid
(Denorex Shampoo), selenium sulfide (Selsun Blue), zinc pyrithione (AXE
Anti-Dandruff Shampoo, Garnier Fructis Hair Care Fortifying 2 in 1 Sham-
poo, Gillette Anti-Dandruff Shampoo, Head & Shoulders Classic Clean
Dandruff Shampoo, Head & Shoulders Dry Scalp Care Shampoo, Head &
Shoulders Refresh Dandruff Shampoo, Matrix Men Anti-Dandruff Shampoo,
Neutragena T-Gel Dandruff Shampoo, Pert Plus Dandruff Away Shampoo,
Suave for Men 2 in 1 Shampoo).
Rx–OTC switch: ketoconazole

Ketoconazole, an antifungal drug, helps to control flaking, scaling, and itch-
ing caused by dandruff.53
Rx–OTC switch drug
Ketaconazole 1%.
Mode of action
Ketaconazole has antifungal activity and inhibits the growth of P. ovale,
which is present on the scalp and contributes to the symptoms associated
with dandruff. If a rash appears, the product should be stopped. If the con-
dition gets worse or does not improve within 2 to 4 weeks, the a physician
should be consulted.48,53
Ketaconazole should not be used on broken or inflamed skin. Contact with
the eyes should be avoided; if contact occurs, the eyes should be washed
thoroughly with water.53
Recommended use
The hair is washed thoroughly with the shampoo and rinsed with water. This
is repeated in 3 to 4 days for up to 8 weeks. The product should not be used on
children under 12 years of age.53
Product
Ketaconazole (Nizoral A-D Shampoo).
Seborrhea
Antiseborrhea products help to control and relieve the irritation and itching
of seborrheic dermatitis.51
Keratoplastics (sulfur), keratolytics (salicylic acid), and cytostatic drugs
(pyrithione zinc, selenium sulfide, and coal tar).
Mode of action
Keratoplastics and keratolytics soften epidermal skin, allowing cells to slough
off easily when the hair and skin are washed. Cytostatic drugs inhibit cell
turnover to prevent build-up of excess keratinized epithelial cells.
Contact with the eyes should be avoided. If the condition affects a large area of
the body, a physician should be consulted before using any of these products.
If the condition does not improve or if it gets worse, a physician should be
consulted. These products are not recommended for use in children under 2
years of age.
Infant seborrhea (cradle cap) should not be treated with these products; a
shampoo formulated for babies should be used. If baby shampoo does not
improve infant seborrhea, the caregiver should consult a physician.
Products
Salicylic acid (Denerox Shampoo), zinc pyrithione (SkinZinc Spray for
Seborrhea; the product label for this drug recommends that it be used in
individuals 18 years of age or older), coal tar (Neutragena T-Gel).
Psoriasis
Drugs for treating psoriasis relieve the itching, flaking, and inflammation
associated with psoriasis.51,52
Only coal tar and salicylic acid are monograph drugs for treating the symp-
toms associated with psoriasis.50–52
Mode of action
Coal tar and salicylic acid act in the manner described for dandruff.
If psoriasis affects a large area of the body, a physician should be consulted
before using these products. Contact with the eyes should be avoided. If the
condition does not improve or gets worse, the individual should contact a
physician.
Coal tar products sensitize the skin to sunlight and the individual should
use a sunscreen before going outdoors. Coal tar products should not be used
for prolonged periods of time without consulting a physician. If a cream or
ointment formulation is used, it should not be used around the rectum or
genital area unless directed by a physician. If an individual uses OTC psoriasis
products, the individual should notify the physician if treatment with ultra-
violet light is being prescribed.51 Product labels for psoriasis products con-
taining coal tar recommend that they be used by individuals 18 years of age or
older.
Products
Coal tar (Psoriasin has several formulations, including Psoriasin
MultiSymptom Psoriasis Relief Ointment, Liquid, Scalp Liquid, and Gel),
salicylic acid (Dermarest Psoriasis Medicated Moisturizer and Dermarest
Psoriasis Shampoo, SkinZinc Cream for Psoriasis (this product is recom-
mended for individuals 18 years of age or older)).

Case 1 KM, a 78-year-old man, tells the pharmacist that the skin on his
arms is dry, flaking, and itching. He used hydrocortisone lotion for
itching when he had a case of poison ivy and wanted to know if he
should buy some for this problem.
The pharmacist asked if he used any moisturizing cream on his arms.
KM replied that he never used any skin lotions. The pharmacist sug-
gested that the KM’s problem could be caused by dry skin (xerosis),
explaining that without any other cause, this was most likely his prob-
lem. KM is at risk for dry skin based on his age. Although hydrocor-
tisone will relieve itching, it has no benefit for dry, flaky skin.
The pharmacist recommended that he try using a product like
Eucerin or Aveeno twice a day for several days and avoids using ordi-
nary soaps for bathing, trying Cetaphil, a nonsoap skin cleansing agent.
He also recommended that warm water rather than hot water be used
for bathing. If these suggestions do not relieve KM’s symptoms, the
pharmacist recommended that he call his doctor.
Case 2 JR, a 17-year-old man, was helping a neighbor to clear some

brush from the yard yesterday. He wore gloves but took his shirt off
because it was a very hot day. Now he has a rash on his arms and chest
that is red, very itchy, and has small skin blisters filled with fluid. The
neighbor said there was poison ivy in the yard.
The pharmacist suggests that JR call his doctor because the area of skin
exposed to the poison ivy is relatively large and OTC products may not
be the most effective manner to treat this problem. However, if JR
wanted to try an OTC product, he should use an antipruritic lotion or
spray that contained either hydrocortisone, like Cortaid, or a local
anesthetic, like Gold Bond Medicated Itch Relief.
Case 3 A 56-year-old woman asks the pharmacist to recommend a

product because she has arthritis in her right knee that has been painful
for the last 5 days. She has been taking Tylenol to relieve the pain and it
provides some relief but her knee pain still limits her activities. Her
sister told her to buy capsaisin cream and she wants to know if this is
appropriate.
The pharmacist explains that capsaisin is used to relief pain associated
with arthritis but that it does not produce its maximum effect for
approximately 7 to 10 days. The pharmacist suggests a topical cream
that contains external analgesic such as BenGay Cream (camphor,
menthol, and methyl salicylate) or Salonpas Arthritis Patch (menthol
and methyl salicylate) for more immediate relief.
Case 4 A mother asks the pharmacist if Off Skintastic could be used on

her 4-year-old child. She lives in the neighborhood where there are deer
and she afraid the child will be bitten by a deer tick.
The pharmacist tells the woman that Skintastic has a high concentra-
tion of DEET, an insect repellent that is not recommended for use in
young children. He suggests that she use picaridin, an insect repellent
that is as effective as DEET for ticks but does not have the same
dangerous adverse effects as DEET. The pharmacist also reminds the
mother that once the child comes indoors, the insect repellent should be
washed off, regardless of the product that is used.
Case 5 A mother asks the pharmacist to recommend a product because

her child has head lice.
The pharmacist recommends the mother use Nix or RID lice sham-
poos. Both must remain on the hair for 10 minutes and should be
thoroughly washed from the hair. The hair should be patted dry and
a fine-toothed comb should be used to remove nits (larvae) from the
base of the hair follicle. The hair should be checked and the process
repeated in 7 days if all the lice have not been killed or removed. If the
lice remain after the second treatment, the mother should consult the
child’s doctor because the lice may be resistant to this topical therapy.
There are prescription medications that are effective for resistant
strains of lice. All other members of the family should be checked to
see if they are infected with head lice and should be treated in the same
manner if infested.
The mother must be reminded to wash all contaminated clothing in
hot water, placing them in the dryer on the hot cycle for 20 minutes.
Items that cannot be washed may be sprayed with a pediculicide spray,
or they could be stored in a closed, plastic bag for 2 weeks to be certain
that both adult lice and the larvae have died.
Case 6 GB cut his hand 3 days ago while working. It is getting swollen
and red. He asks the pharmacist for an antibiotic ointment.
The pharmacist tells GB that he must see a physician because the
symptoms he describes indicates that the wound could be infected.
None of the antibiotic ointments available OTC are for treating an
infection. They are only to be used on minor wounds to prevent
infections.
Case 7 YT asks the pharmacist what to do about several warts on her

hands because they are embarrassing to her. She tried Compound W
but the warts came back.
The pharmacist suggests she try home cryotherapy for the warts, a
procedure that should destroy the tissue that virus has infected. If this
procedure does not rid her of the warts, she should a consult a physician
for a more effective treatment.
Case 8 NS is 16 years old and works as a cook in a fast-food restaurant.

He asks the pharmacist to recommend a product for his acne. NS has
only a few pustules and comedones on his face.
The pharmacist recommends that he should be sure to keep the skin on
his face clean and apply an acne product every morning and evening.
The pharmacist suggests using a medicated pad to wipe his face during
working hours to reduce the amount of oil on the skin surface. NS
could use Clear & Clean Persa Gel morning and evening, but he must
use a sunscreen if he will be exposed to the sun because the benzoyl
peroxide will increase his sensitivity to the sun. He could use Clearsil
pads for cleaning his skin at work.
Case 9 CK, a 77-year-old man, complains that his dandruff is getting

very bad. He complains that his scalp along his hairline is itching, red,
and feels oily. When he combs his hair, there are yellow-looking flakes.
The pharmacist asks CK if he has talked to his doctor about the
problem, but CK says he didn’t and doesn’t like going to see the doctor.
The pharmacist suggests that CK may have seborrhea and he should try
a medicated shampoo with salicylic acid, such as Denorex Shampoo,
twice a week for several weeks to see if it helps his symptoms. If CK
doesn’t experience any relief, he could try a coal tar shampoo or call his
doctor.
References
1. Decoding the Cosmetic Label. www.cfsan.fda.gov/dms/cos-labl.html (accessed March
19, 2009).
2. Marks Jr., JG, Miller JJ, Lookingbill & Marks’ Principles of Dermatology, 4th edn.
Philadelphia, PA: Saunders Elsevier, 2006.
3. Robert WE. Dermatologic problems of older women. Dermatol Clin 2006; 24: 271–280.
4. Skin protectant drug products for over-the-counter human use; final monograph. Fed
Regist 2003; 68: 33362–33381.
5. Wasserbauer N, Ballow M. Atopic dermatitis. Am J Med 2009; 122: 121–125.
6. Hydrocortisone; History of Rule Making. www.fda.gov/ohms/dockets/ac/05/slides/2005-
4099S1_02_FDA-Koenig.ppt (accessed March 18, 2009).
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final monograph; notice of proposed rulemaking. Fed Regist 1990; 55: 6931–6951.
8. Skin protectant drug products for over-the-counter human use; diaper rash products;
proposed rule. Fed Regist 1990; 55: 25204–25232.
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10. Technu Information. www.teclabsinc.com/products.cfm?id¼1F5604C8-9D05-4675-
56129F6D83DF2417&section¼1 (accessed March 22, 2009).
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quaternium-18 bentonite. J Am Acad Dermatol 1995; 33: 212–216.
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proposed rulemaking for poison ivy, poison oak, poison sumac, and insect bites drug
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14. Labeling of diphenhydramine containing drug products for over-the-counter human use;
final rule. Fed Regist 2002; 67: 72555–72559.
15. Active Ingredients Found in Insect Repellents. Last updates September 8, 2008. www.eps.
gov/pesticides/hea;th/mosquitoes/ai_insectrp.htm. (accessed March 22, 2009).
16. Updated Information Regarding Insect Repellents. www.cdc.gov/ncidod/dvbid/westnile/
RepellentUpdates.htm (accessed March 22, 2009).
17. Follow Safety Precautions When Using DEET on Children. www.aap.org/family/wnv-
jun03.htm (accessed March 22, 2009).
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monograph and notice of proposed rulemaking. Fed Regist 1979; 44: 69768–69866.
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1993; 58: 65452–65456.
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S15–S28.
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April 4, 2009).
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Fed Regist 1980; 45: 35576–35677.
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Regist 1990; 55: 31776–31783.
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Regist 2003; 68: 34273–34293.
29. Mirick DK et al. Antiperspirant use and risk of breast cancer. J Natl Cancer Inst 2002; 94:
1578–1580.
30. Namer M et al. [The use of deodorants/antiperspirants does not constitute a risk fac-
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871–880.
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Regist 1993; 58: 28194–28302.
32. FDA Approves A New Over-the-counter Sunscreen Product. www.fda.gov/bbs/topics/
NEWS/2006/NEW01417.html (accessed February 12, 2009).
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2007?NEW01687.html (accessed March 27, 2009).
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33644–33680.
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OTC first aid antibiotic drug products; final rule. Fed Regist 1987; 52: 47312–47324.
37. Feldman SR et al. Handbook of Dermatologic Drug Therapy. London: Taylor & Francis,
2005.
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Regist 1993; 58: 49890–49899.
39. Topical antifungal drug products for over-the-counter human use; amendment of final
monograph. Fed Regist 2002; 67: 5942–5943.
40. Comparison of Labeling for All Topical Antifungals Treating Athlete’s Foot. http://fda.
gov/ohrms/dockets/ac/04/briefing/4036B1_08_Product%20Labeling.htm (accessed April
3, 2009).
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Regist 1990; 55: 33246–33256.
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(accessed April 4, 2009).
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2003; 68: 24347–24349.
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clinical applications. Dermatol Clin 2007; 25: 137–146.
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Regist 1991; 56: 41008–41020.
48. Topical drug products containing benzoyl peroxide; required labeling. Fed Regist 1995;
60: 9554–9558.
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use; final rule. Fed Regist 1991; 56: 63554–63569.
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2007; 72: 9849–9852.
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.jhtml (accessed April 4, 2009).
9
Miscellaneous products
Weight loss products

Orlistat
Obesity is a major health concern not only in the USA but worldwide because
it is a major risk factor for heart disease and diabetes mellitus. Many untested
and ineffective products are widely promoted. The FDA banned ephedra, a
drug that stimulates the sympathetic nervous system to suppress appetite
centers in the brain, from the marketplace in 2004 because of its serious
adverse effects, which included many deaths.1 Unfortunately, ephedra still
appears in many weight-loss supplement products that may be obtained from
sources outside the USA via internet purchases.
Bitter orange (Citrus aurantium) contains synephrine, a sympathomimetic
drug that produces many of the same effects as ephedra and is in many dietary
supplements still promoted for weight loss. There is little evidence of its
effectiveness as a weight-loss product and it has the same risks of ephedra.
It may cause nervousness, irritability, and insomnia and it increases heart rate
and blood pressure, increasing the risk of heart attacks and stroke.2
Healthy eating habits and physical activity are the most reliable methods
that produce weight loss. Many different diets are available, such as low
carbohydrates or high protein, but the most significant weight loss occurs
when total caloric intake is reduced. Mild exercise increases the expenditure
of calories and if used with reduced calorie intake provides the more reliable
method for losing weight.
The FDA approved the switch of the prescription drug orlistat to OTC
status, and it is the only OTC drug available at this time for weight loss.
Orlistat will increase weight loss by as much as 25% when combined with a
healthy eating plan.3
Mode of action
Orlistat inhibits the action of lipases in the stomach and small intestines; these
enzymes metabolize dietary fats to forms that can be absorbed, hence orlistat
prevents fat absorption and reduces caloric intake.
Transplant recipients should not use orlistat because it interferes with the
action of drugs used to prevent organ rejection, particularly cyclosporine.
Individuals who have gall bladder problems, kidney stones, pancreatitis,
problems with absorbing foods, or who take other weight-loss medications
should not use orilstat. Individuals who are not overweight should not take
this drug.3
Individuals taking warfarin, a blood thinner, or medicines for thyroid
disease or diabetes should consult a physician or pharmacist before taking
orlistat.3
When taking orlistat, a multiple vitamin product containing vitamins A,
D, E, K, and beta-carotene should be used daily at bedtime. These vitamins are
fat-soluble vitamins and the use of orilstat will affect their absorption from
foods.
A well-balanced reduced calorie diet should be eaten while taking orlistat
because it produces its effect in the GI tract to prevent fat absorption.
Individuals may experience bowel changes, gas, oil spotting, loose stools,
and more frequent stools, which may be hard to control. Eating a low-fat
diet will reduce these effects.
Recommended dose
Adults and adolescents over 18 years of age should take one capsule with each
meal containing fat but not more than three capsules a day.3 Orlistat is not
recommended for individuals under 18 years of age.
Product
The starter package for Alli contains the following: an eating guide and
discussion of healthy food choices for a weight-reducing diet; a calorie and
fat chart to assist the individual make better choices; and a daily journal that
assists the individual in keeping a record of their caloric intake.
Smoking cessation products

The use of tobacco products places a large burden on the healthcare system
because of all the deleterious effects it has on the human body. These effects
include increasing the risk of heart disease and stroke, bronchitis, chronic
obstructive pulmonary disease, emphysema, increased risk of infections such
as pneumonia, reduced fertility in women, increased risk to the fetus during
the pregnancy and low birthweight infants, and increased cancer risk of the
oral cavity, esophagus, stomach, pancreas, lung, and bladder.
Miscellaneous products | 199
Tobacco use is a learned behavior and, like weight control, changing

behavior is very difficult for many people. Nicotine is an addictive drug and
its effects in the central nervous system are similar to those of other addictive
drugs. Nicotine’s effects on dopamine receptors is primarily responsible for its
pleasurable effects, but it also acts at other neurotransmitter sites to cause
arousal, appetite suppression, and suppression of anxiety. The most success-
ful programs to stop smoking have several components. The most important
component is the decision on the part of the individual to stop smoking. Once
the individual makes this decision and chooses a stop date, the individual must
decide the method to employ to insure success.4,5
The ‘cold turkey’ method may work for some people, but unpleasant
withdrawal symptoms occur when nicotine use is abruptly stopped, leading
many individuals to resume their tobacco habit. Withdrawal symptoms
include irritability, anxiety, difficulty in concentration, depression, insomnia,
weight gain, and a craving or increased desire to smoke.
The use of nicotine replacement alleviates many of these symptoms, help-
ing the individual to continue with the program to stop smoking. If the
individual works with a counselor in a one-on-one situation or with a group
of individuals who have the same goal, the chance of succeeding is greatly
improved. There are programs where a counselor or health coach is available
by toll free phone anytime the individual feels that he or she needs encour-
agement or help to overcome the desire to resume smoking.
The US Public Health Service published a reference guide of strategies for
smoking cessation programs. The guidelines recommend the ‘5 A’s’ approach.6
Healthcare providers should ask, advise, assess, assist, and arrange a program
for the individual who decides to quit smoking.
OTC nicotine replacement products are available in several dosage forms:
gum, lozenge, and transdermal patches. Each type of product has different
rates of onset of action and duration of action, and individuals choose the
product type that most appeals to them. Many individuals may have made
previous attempts to stop smoking and been unsuccessful with OTC products.
The individual should always be encouraged to try again. If OTC product use
is not successful, the individual should consult a physician because there are
several prescription drugs available that may be appropriate for them to try.
Nicotine replacement products

OTC nicotine products act on sites in the central nervous system to relieve
symptoms of nicotine withdrawal when tobacco use is stopped.4,5
Rx–OTC drug
Nicotine
Mode of action
When tobacco use is stopped, the levels of nicotine present in the nervous
system decline and this produces withdrawal symptoms that are physically
unpleasant. Nicotine replacement products are used in decreasing doses over
a period of time to wean the person away from smoking on a precise schedule
to minimize symptoms. When the planned doses are stopped, the individual
should not experience any unpleasant effects and will stop smoking. Unfor-
tunately, the craving feeling for tobacco that an individual has remains to
some degree in most individuals.
No nicotine replacement product may be sold to persons under the age of 18
years of age, and proof of age is required. Prescriptions are required if indi-
viduals are under 17 years of age. These products should not be used if a
woman is pregnant or breast feeding because they may cause an increased
heart rate in the child. Individuals should not continue to smoke if these
products are being used. Individuals who have heart disease, a recent heart
attack, high blood pressure, or irregular heart rhythms should consult a
physician before using these products.
Any individual who experiences a rapid heart rate, nausea, vomiting or
dizziness should stop using the product and a physician should be consulted.
Individuals should stop using this product when the schedule for tapering
doses has reached its scheduled conclusion.
Products that are gums slowly release nicotine from a polacrilex, flavored
formulation, and should not be used in individuals who have problems chewing
or temporomandibular joint problems. An individual who has dentures, braces,
or other dental appliances could consult with the dentist before using a gum.
Irritation of oral mucous membrane, hiccups, or gastric upset can occur from use
of the gum. Do not eat or drink for 15 minutes before or while using the gum.
Products that are lozenges should not be chewed or swallowed. Individ-
uals may experience nausea, hiccups, or heartburn while using lozenges. Do
not eat or drink for 15 minutes before or while using the lozenge.
Products that are transdermal patches should be placed on clean, dry, hair-
free, intact skin on the upper body or the upper outside portion of the arm.
Patches should be rotated on different parts of the body to reduced possible skin
irritation, which could be caused either by the drug or by the adhesive on the
patch. A new patch should be used every 24 hours. If vivid dreams occur, remove
the patch at bedtime and apply new patch in the morning. The patches may not
be cut into separate pieces. All used patches should be disposed of safely.
Recommended dose
When the gum is used, it should be chewed slowly until the individual feels a
tingling or flavor sensation. The gum is then placed between the cheek and
gum until the sensation subsides, and then the gum is again slowly chewed
Table 9.1 Weekly schedules for doses of Nicorette gum and Committ lozenges
Weeks Nicorette guma Committ lozengeb
1 through 6 1 piece every 1–2 h 1 lozenge every 1–2 h
Maximum 24 h dose 24 pieces 20 lozenges
a
If 25 or more cigarettes are smoked per day, use the 4 mg dose; if less than 25 cigarettes per day, use 2 mg dose.
b
If the first cigarette is smoked within 30 min of waking up after sleeping, use the 4 mg lozenge; if 30 min or more
elapse, use the 2 mg dose.
again and the process is repeated. This is known as the ‘chew and park’
technique. The gum should be ‘parked’ in different areas to avoid irritation
of the oral tissue. The nicotine is absorbed during this time. It should take
approximately 30 minutes until the full dose of nicotine is released. If the gum
is continually chewed without these periods for absorption, the nicotine is
swallowed and is not absorbed from the stomach because of its acid environ-
ment. Therefore, the product will not be effective.
The gum is available in 2 and 4 mg doses. The starting dose depends on the
number of cigarettes smoked per day. Table 9.1 provides the number of pieces
of gum to be used, and the schedule for use.
When the lozenge is used, it should be allowed to fully dissolve in the
mouth and it should be moved to different areas to prevent irritation of
the oral tissue. The lozenge is available in 2 mg and 4 mg strengths and the
strength and number of lozenges to be used is determined by in the amount of
time that elapses before the individual smokes the first cigarette of the day
after awakening from sleep. See table 9.1 for dose schedule.
When a transdermal patch is used, nicotine is absorbed through the skin at
a slower rate than the gum or lozenge, and is released over a longer period of
time. It does not act quickly to satisfy the immediate need that an individual
may desire. Patches are available in varying strengths: 7 mg, 14 mg, and
21 mg. Starting dosage depends on the number of cigarettes smoke per
day. Table 9.2 provides the schedule for use of the patch formulations.
Table 9.2 Recommended dose schedule for Nicoderm CQ and Habitrol

Transdermal patches
Smoke 10 cigarettes per day Smoke < 10 cigarettes per day
Step 1 (21 mg patch) 1 patch daily, weeks 1–6 Do not use
Step 2 (14 mg patch) 1 patch daily, weeks 7–8 1 patch daily, weeks 1–6
Step 3 (7 mg patch) 1 patch daily, weeks 9–10 1 patch daily, weeks 7–8
Products
Nicotine gum (Nicorette and generic formulations), nicotine lozenges (Com-
mitt), nicotine patches (Nicoderm, Habitrol and generic formulations).
Osteoarthritis (arthritis)
Osteoarthritis (arthritis) is a chronic, progressive disease that primarily affects
the aging population. It is often considered to be a phenomenon resulting from
‘wearing out’ of the body’s bone and cartilage structures, but many factors are
involved in the disease, including genetic factors, inflammation, obesity, pre-
vious injury, and metabolic or endrocrine disorders. Joints in the knees, hips,
and hands are most commonly affected.
Articular cartilage in joints allows for smooth pain-free movement and
absorbs and distributes pressures resulting primarily from the weight of the
body. As cartilage becomes thinner, it is no longer able to function properly,
and the joint’s synovial fluid becomes less viscous and elastic. The joint space
decreases and eventually movement becomes stiff and painful.7
Physical therapy with nonweight-bearing exercises helps to relieve stiff-
ness in some individuals. Pharmacotherapy for arthritis involves the use of
OTC drugs, acetaminophen, and the nonsteroidal anti-inflammatory drugs
(NSAIDs) (see Chapter 5), and prescription NSAIDs. Intra-articular injection
of corticosteroids, which have anti-inflammatory properties, provides relief
that lasts for a limited time. Injection of hyaluronic acid, a normal constituent
of synovial fluid, may restore some normal function for a limited period of
time, providing some pain relief.7
Glucosamine and glucosamine with chrondroitin are dietary supplements
that have demonstrated pain relief without the adverse effects associated with
the OTC or prescription drugs. Maximum benefit with glucosamine requires
several weeks of continuous use. Current studies have not provided evidence
that glucosamine or its combined use with chondroitin have any significant
effect on cartilage loss when compared with placebo.8
Dietary supplements
Glucosamine
Glucosamine is an aminoglycan protein used to maintain cartilage.
Mode of action
Glucosamine stimulates synthesis of mucopolysaccharides, components of
articular cartilage and synovial fluid. Supplements of glucosamine hydrochlo-
ride or glucosamine sulfate may help to restore damaged cartilage and/or may
prevent further degradation of cartilage.9,10

Glucosamine that is prepared from the exoskeletons of shellfish such as
shrimp and crab may precipitate an allergic reaction and should be avoided.
It may cause nausea, vomiting, and heartburn.9,10
Recommended dose
Glucosamine is recommended in daily doses of 500 to 1500 mg for adults and
individuals over the age of 18. The dose may be given as a single dose or it may
be divided into two or three doses per day.
Products
Glucosamine hydrochloride or glucosamine sulfate (available from many
generic manufacturers).
Chrondroitin sulfate
Chrondroitin is an aminoglycan that is used to maintain cartilage.
Mode of action
Chrondroitin stimulates synthesis of mucopolysaccharides, components of
articular cartilage and synovial fluid. Supplements of chrondition sulfate or
chrondroitin combined may help to restore damaged cartilage and/or may
prevent further degradation of cartilage.

Chrondroitin may cause gastric irritation and nausea.
Recommended dose
Chrondroitin sulfate may be used in adults or individuals over the age of 18 in
doses of 200 mg to 400 mg two or three times a day.
Products
Chrondroitin sulfate (available from many generic manufacturers).
NOTE: Glucosamine (500 mg) and chrondroitin (400 mg) are frequently
used together (Cosamin DS and Osteo BiFlex). There is no evidence that the
combination is superior to using glucosamine alone.8,9
Hair loss (alopecia)

Hair is protein keratin and may be vellous hair, soft, fine usually unpigmen-
ted, or terminal hair, thicker and pigmented. Terminal hair has three stages of
growth: anagen (approximately 2 to 6 years), catagen (2 to 3 weeks), and
telogen (approximately 12 weeks), a resting stage. As telogen hair is lost, a
new cycle of hair growth begins. The anagen stage becomes shorter with each
new cycle of growth.11
Normal hair is shed at a rate from 50 to 100 hairs a day because telogen
hair becomes more loosely connected to the hair follicle. Hair growth and hair
loss (alopecia) are affected by many factors including genetic predisposition,
nutrition, age, stress, gender, diseases, and drug therapy. Androgenic hor-
mones have the greatest influence on hair growth and loss. Androstenedione
and dihydroepiandrosterone from the adrenal gland in men and women, and
testosterone and 5-alpha-dihydrotestosterone in men are the principal circu-
lating human androgens. 5-Alpha-dihydrotestosterone is the most potent
androgen in the skin and is the major factor that causes androgenic alopecia,
male pattern baldness.
Male pattern baldness begins on the crown of the head and extends over a
greater portion of the scalp, and in some individuals covers the entire scalp.
Terminal hair begins to lose its thickness and becomes finer and is then shed. It
is replaced by thinner, vellous hair, which is colorless and much shorter. Male
pattern baldness also occurs in women but with a much lower incidence.
Women usually lose hair from all areas of the scalp, not just the crown of
the head. Male pattern baldness is the only type of alopecia amenable to
treatment with OTC drugs.
Minoxidil
Topical minoxidil is used to regrow hair on the scalp.
Rx–OTC switch drug ingredients

Minoxidil 2% and 5%.
Mode of action
The exact mode of action is unknown but several actions could contribute to
hair growth, opeing of potassium channels, through inhibition of normal
calcium entry into cells, and possibly increasing the blood supply through
its vasodilating action. However, other drugs that cause vasodilatation of the
blood vessels in the scalp have not increased hair growth.11

Minoxidil carries the following warnings.12 ‘If hair loss is greater than the
amount shown on the side of this product’s label or if hair loss is on the front
of the scalp, the product should not be used because it will not be effective. If
the individual has no family history of hair loss, or if hair loss is sudden and
patchy, or if it occurs for an unknown reason, minioxidil should not be used. It
should not be used on any part of the body except the scalp. Do not use if the
scalp is inflamed, irritated, infected, or if any other medication are being used
on the scalp. Individual’s who have heart disease should not use minoxidil
without consulting a phyician. Contact with the eyes should be avoided.’
If an individual experiences chest pain, rapid heart rate, faintness, dizzi-

ness, sudden unexplained weight gain, swelling of the hands or feet or if
redness and irritation of the scalp occurs, use of the product should be stopped
and a physician consulted.
Recommended use
Minoxidil 2% topical solution may be applied to the affected area of the
scalp twice a day. Results may not be noticeable for 2 to 4 months, and hair
texture and color may change. This product will not produce the same
amount of hair growth for all individuals. Continued use is required for
continued hair growth. This product is not for use by individuals under 18
years of age.12,13
Minoxidil 5% is for use by men only and should not be used by women.
Men should stop use and a physician should be consulted if hair growth
does not occur in 12 months. Women using 2% minoxidil should stop
use and a physician should be consulted if hair growth does not occur in
8 months.12,13
Products
Minoxidil (Women’s Rogaine 2% Solution, Men’s Rogaine 5% Solution and
5% foam).
Adaptogen
An adaptogen is considered to be a nontoxic substance that allows the body
to respond to a variety of stresses, including emotional and physical factors.
Most adaptogens have a long history of use in Chinese medicine. The best
known and most frequently studied is ginseng. Panax ginseng, also known
as Asian ginseng, Chinese ginseng, or Korean red ginseng, has been pro-
moted for a great number of conditions. There is evidence that it may have a
positive effect on cholesterol metabolism through its antioxidant actions. It
may improve the immune system’s response in some respiratory conditions,
and it may reduce blood glucose levels in individuals who have type 2
diabetes.14
American ginseng, Panax quinquefolius, is an alternative to Chinese
ginseng and contains the same ginsenosides that are considered to be the
active constituents in the plant. Siberian or Russian ginseng is Eleuthero-
coccus senticosus, a less-expensive alternative that does not contain
ginsenosides.14,15
In addition to ginseng products available as dietary supplements, many
consumer beverages and multivitamin products are marketed that contain
ginseng, including bottled water and energy or sports drinks. These products
are promoted to improve an individual’s immunity and to increase a feeling
of well-being and stamina.
Ginseng
Ginseng is a dietary supplement that may improve lipid metabolism, blood
glucose levels, and immunity, increase energy and stamina, improve memory,
reduce GI problems, reduce inflammation, improve a cancer patient’s general
health, and improve heart disease.14
Mode of action
The mechanism of action for the various effects of these ginsenosides remains
unclear.

Individuals who have allergic reactions to any Panax species should not use
ginseng. Ginseng may reduce the effectiveness of warfarin in individuals
requiring anticoagulation therapy. Individuals who have type 2 diabetes
should consult their physician before using ginseng.14
Recommended dose
Adults doses of 100 to 200 mg of ginseng extract (4% ginsenosides) may be
taken once or twice a day for 12 weeks. Ginseng is not recommended for use in
individuals under 18 years of age.14
Products
Ginsana and many generic forms of ginseng are available.
Memory loss and dementia

Ginkgo biloba
Ginkgo biloba extracts are dietary supplements that have been promoted as
memory enhancers for many years. Forgetfulness is associated frequently
with normal aging, and more severe memory loss and dementia are associated
with a number of serious medical conditions such as Parkinson’s and
Alzheimer’s diseases. Studies of short duration (6–12 weeks) have produced
contradictory results in randomized clinical trials.16–19 However, a study
lasting over 6 years and involving more than 3000 individuals over the age
of 75 who had normal cognition or mild cognitive impairment failed to
prevent dementia from all causes or from Alzheimer’s disease with standard-
ized ginkgo or placebo.20

Ginkgo biloba may be helpful in preventing memory loss. It may also help to
relieve pain associated with claudication (impaired circulation that causes
pain when walking).21
Mode of action
The flavone glycosides and terpene lactones present in ginkgo may increase
blood supply to tissues through their ability to reduce the viscosity of blood
and cause vasodilatation.17
Bleeding has been reported with the use of ginkgo, and excessive bleeding may
occur if an individual is taking anticoagulant drugs such as aspirin or warfa-
rin. Indiviuals taking anticoagulant drugs should consult a physician before
using ginkgo. Individuals may experience headache and nausea.
Recommended doses
Adults may take 80–240 mg of standardized ginkgo leaf extract two to three
times a day. Gingko is not recommended for those under 18 years of age. The
standardized extract (EGb-761) contains 24–45% flavone glycosides and 6%
terpine lactones.21
Products
Ginkoba and many generic formulations.
Coronary heart disease

Coronary heart (artery) disease (CHD) is a major cause of morbidity and
death in the USA. Risks factors such as age, gender, and family history cannot
be controlled, but obesity, high serum lipids, and smoking may be controlled
or modified. A healthy diet, moderate exercise, and no smoking are behaviors
that can reduce the risk of CHD. The American Heart Association and the
American Dietetic Association recommend reducing saturated animals fats in
the daily diet and increasing polyunsaturated fats (PUFAs) obtained from
certain fish (salmon, mackerel, herring, trout, sardine, and tuna), nuts and
seeds (walnuts, flaxseed), and plant oils (soy and canola).22,23 These foods
contain omega-3 fatty acids (eicosapentaenoic acid (EPA) and docosahexae-
noic acid (DHA)).
The FDA recommended that individuals increase omega-3 fatty acids in
their diets, and also permitted dietary supplements EPA and DHA to claim
that their use may reduce the risk of CHD.24 Both EPA and DHA are available
in higher concentrations than permitted in OTC dietary supplements in a
prescription drug, omega-3-acid ethyl esters (Lovaza), for the treatment of
high serum triglycerides.
Omega-3 fatty acids

Drugs and indications for use
Omega-3 fatty acids (fish oils) may reduce the risk of CHD.
Mode of action
Omega-3 fatty acids reduce levels of triglycerides, decrease platelet adhesion,
decrease sympathetic nervous system overactivity (vasoconstriction), reduce
inflammation associated with arachidonic acid-derived mediators, reduce
insulin resistance, and may decease ventricular arrhythmias.23,25
Individuals who are taking anticoagulant drugs or who have bleeding prob-
lems should consult a physician before using omega-3 products. Individuals
may experience a fishy taste and may have diarrhea.
Recommended dose
There is no specific recommendation for the daily amount of omega-3 fatty
acids. However, the FDA recommends that adults and those over 18 years
of age should not take more than 2000 mg of EPA and DHA daily.24
Formulations based on FDA’s standard for menhaden fish contain 1000 mg
of fish oil that has 180 mg EPA and 120 mg DHA. Concentrated formulations
of fish oil products contain twice the amount of EPA and DHA.
The American Heart Association recommends that individuals without
risk factors eat two servings (3 ounces (80 g) per serving) of fish per week, and
those who have risk factors should eat four servings of fish per week.22 The
American Heart Association also recommends that not more than 3000 mg of
fish oil supplements be taken daily without consulting a physician.
Products
Omega-3 fish oils are available from many generic manufacturers.

Case 1 A young woman who has discussed the use Alli for weight loss
with the pharmacist is getting ready to leave the pharmacy. She asks the
pharmacist if there is anything else she needs to do to successfully
complete the scheduled weight-loss program.
The pharmacist asks if she has any vitamin products at home that
contain vitamins A, D, E, and K. Alli will prevent the absorption of
these fat-soluble vitamins and they must be replaced in the diet. These
vitamins should be taken every evening as long as she uses Alli.
Case 2 HY is a 59-year-old man who has been smoking two packs of

cigarettes a day for 20 years. He has decided to stop smoking and
doesn’t want to use any gum or lozenges because he is having extensive
periodontal dental work done. He asks the pharmacist to recommend a
product.
The pharmacist recommends that he use the dermal patch system for
his nicotine replacement program. He should use begin with the high
dose, the 21 mg patch, and follow the directions for tapering in the
product’s instructions. The pharmacist suggests that he consider join-
ing a smoking cessation program because individuals in these programs
tend to have greater success when they have a support group.
Case 3 MJ asks the pharmacist why the glucosamine tablets she bought
last week and has taken for 5 days did not help relieve her arthritis pain.
The pharmacist explains that glucosamine helps to increase growth of
cartilage tissue in the joints and that it may take a month or more before
it exerts its maximum effect. She should continue taking 1500 mg of
glucosamine daily and if she has pain she should take acetaminophen.
If she feels no improvement after taking glucosamine for 4 to 6 weeks,
she may decide to stop taking it. She could also consult her doctor if the
pain becomes worse.
Case 4 MR, a 49-year-old woman, asks the pharmacist if she should

use 5% minoxidil because she is beginning to lose hair on the crown of
her head.
The hair loss MR described fits that of male pattern baldness, andro-
genic alopecia. She may want to try using minoxidil 2% solution, but
should not use minoxidil 5% because is not approved for use by
women.
Case 5 KN is a 56-year-old man who had a stroke and is taking a baby

aspirin daily as prescribed by his doctor. He tells the pharmacist that he
is getting forgetful and wants to know if ginkgo will help him.
The pharmacist tells KN that some clinical studies show positive results
of ginkgo in preventing memory loss when compared with a placebo,
while other studies show no effect. However, ginkgo increases the risk
of excessive bleeding in individuals who are taking anticoagulant drugs
like aspirin. The pharmacist recommends that KN consult his doctor
about this situation before he takes any ginkgo product.
References
1. Final Rule Declaring Dietary Supplements Containing Ephedrine Alkaloids Adulterated
Because They Present an Unreasonable Risk. Rockville, MD: US Department of Health
and Human Services, Food and Drug Administration, 2004: 1–363. www.fda.gov/
OHRMS/DOCKETS/98fr/1995n-0304-nfr0001.pdf (accessed March 4, 2009).
2. Bent S et al. Safety and efficacy of citrus aurantium for weight loss. Am J Cardiol 2004; 94:
1359–1361.
3. Orlistat Information. www.fda.gov/cder/drug/infopage/orlistat_otc/ (accessed March 4,

2009).
4. Treating Tobacco Use and Dependence: 2008 Update. www.ahrq.gov/path/tobacco.htm
5. Corelli RL, Hudman KS. Tobacco use and dependence. In: Koda-Kimble MA et al. eds.
Applied Therapeutics: The Clinical Use of Drugs, 9th edn. Philadelphia, PA: Wolters
Kluwer Lippincott Williams & Wilkins, 2009: 85-1–89-30.
6. Fiore MC et al. Treating Tobacco Use and Dependence. Quick Reference Guide for
Clinicians. Rockville, MD: US Department of Health and Human Services, Public
Health Service, 2000. www.surgeongeneral.gov/tobacco/tobaqrg.htm (accessed May
28, 2009).
7. Buys LM, Elliott E. Osteoarthritis. In: DiPiro JT et al. eds. Pharmacotherapy: A
Pathophysiologic Approach, 7th edn. New York: McGraw Hill, 2008: 1519–1550.
8. Dietary Supplements Glucosamine and/or Chondroitin Fare No Better Than Placebo in
Slowing Structural Damage of Knee Osteoarthritis. www.nih.gov/news/newsletter/
2009_january/gait.htm (accessed March 13, 2009).
9. Jellin JM et al. Glucosamine hydrochoride. In: Pharmacist’s Letter/Prescriber’s Letter
Natural Medicines Comphrehensive Database, 3rd edn. Stockton, CA: Therapeutic
Research Faculty; 2000: 492–496.
10. Product Review: Joint Supplements (Glucosamine, Chrondroitin, and MSM). www.
consumerLab.com (accessed March 12, 2009).
11. Otberg N et al. Androgenic alopecia. Endrinol Metab Clin North Am 2007; 36: 379–398.
12. Guidance for Industry Labeling OTC Human Drug Products Updating Labeling in
ANDAs. www.fda.gov/cder/guidance/3954dft.htm (accessed March 31, 2009).
13. Rogaine. www.Rogaine.com (accessed March 31, 2009).
14. Ginseng (American ginseng, Asian ginseng, Chinese ginseng, Korean red ginseng, Panax
ginseng: Panax spp. including P. ginseng, C.C.Meyer and P. quinquefolius L., excluding
Eleutherococcus senticosus). www.nlm.nih.gov/medlineplus/druginfo/natural/patient-
ginseng.html (accessed May 27, 2009).
15. Asian ginseng. http://nccam.nih.gov/asianginseng.html (accessed May 27, 2009).
16. Solomon PR et al. Ginkgo for memory enhancement: a randomized controlled trial. JAMA
2002; 288: 835–840.
17. Birks J. Ginkgo biloba for cognitive impairment and dementia. Cochrane Database Syst
Rev 2007; (2): CD003120.
18. Mix JA. An examination of the efficacy of Ginkgo biloba extract EGb761 on the
neuropsychologic functioning of cognitively intact older adults. J Alt Complement Med
2000; 6: 219–229.
19. van Dongen MC et al. The efficacy of ginkgo for elderly people with dementia and age-
associated memory impairment: new results of a randomized clinical trial. J Am Geriatr
Soc 2000; 48: 1183–1194.
20. DeKosky ST et al. Ginkgo biloba for prevention of dementia: a randomized controlled
trial. JAMA 2008; 300: 2253–2262.
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ginkgo.html (accessed May 27, 2009).
22. Fish and Omega-3 Fatty Acids. http://216.185.112.5/presenter.jhtml?identifier¼4632
(accessed May 30, 2009).
23. van Horn L et al. The evidence for dietary prevention and treatment of cardiovascular
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24. Omega-3 Fatty Acids and Coronary Heart Disease. [Docket No. 2003Q-0401.] www.fda.
gov/Drugs/ResourcesForYou/Consumers/ucm073992.html#omega3 (accessed June 1,
2009).
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Index
A and D Original Ointment 156 skin 150

Abbott, blood glucose monitors 15 sunlight 174
abuse, drugs with potential for 4 see also elderly people
pseudoephedrine 4, 73, 74 Airborne (dietary supplement) 83
see also antitussives; drugs of abuse, albumin, urine 24
screening tests Alcloxa, for hemorrhoids 172
Accu-Chek (Pfizer), blood glucose alcohol
monitors 15 antiseptic 178
accuracy, diagnostic home test kits 9 dehydration and 61
acetaminophen 90, 107 fecal occult blood test and 16
antihistamine products with 76 liver toxicity of acetaminophen 90
aspirin with 98 NSAIDs and 94
children 91, 92, 107 test kits 25
dosages 92 alginic acid 36
cholesterol tests and 12 Alka-Seltzer 34, 65
concentrated infant drops 92 Alka Seltzer Plus cold 81
dosages 92 Alka-Seltzer Wake-Up Call 34
diphenhydramine with 102 alkylamine antihistamines 70
acid indigestion 34 allergens 70
acne 186, 194 allergic dermatitis 154, 156, 192
activated charcoal 47 allergies 86
active ingredients analgesics 93, 97
brand names and 4 antihistamines for 85
dermatological products 149 combination drug therapy for 76
acupuncture, antiemetic devices 45 decongestants for, dosages 74
adaptogens 205 echinacea 82
adhesive strips, external nasal dilator 76 glucosamine 202
adjuvants 89 latex condoms 126
adsorbents 60 ophthalmic 146
adulterated products, FDA policy 112 pyrethrum extract 165
Advanced Notice of Rulemaking, Federal upper respiratory system 69
Register 2 Alli (orlistat) 198
afferent nerve pathways 89 alopecia 203
After Bite 164 alpha-galactosidase 40
After Bite Fast Itch Eraser 164 5-alpha-reductase blockers 116
age-related macular degeneration 130 aluminum hydroxide 5, 35
ageing 70 dosages 35
212 | Index
aluminum salts, antiperspirant 173 see also platelets; warfarin

Americaine Ointment 171 antidepressant dietary supplements 106
American Association of Poison Control antidiarrheal agents 60
Centers, on ipecac syrup 46 antiemetics see vomiting
American ginseng 205 antiflatulents 39
American Heart Association, on fish antifungal drugs
consumption 208 topical 180
ammonium chloride 114 vaginal 4, 121
amphetamines, times appearing and staying antihistamines
in urine 25 for allergies 85
anagen hair 203 analgesic products with 76
anal itching, pinworms 48 cold/cough products containing 81
analgesics 89, 90 decongestant and analgesic products
antihistamine products with 76 with 76
cold/cough products containing 81 decongestant products with 76
decongestant and antihistamine dosages
products with 76 insect bites and stings 163
decongestant products with 76 for motion sickness 42
external 89, 164 ophthalmic 134, 146
hemorrhoidal relief products 171 as sedatives 101
for musculoskeletal pain 167 see also sedating antihistamines
oral 143 topical 159
for urushiol exposure 157, 159 upper respiratory system 69
with sedatives 102 see also H2-receptor antagonists
urinary 112 antimicrobial drugs
anaphylaxis, insect bites and stings 161 topical 177
Anbesol, for teething 107 see also antibiotics
Anbesol Cold Sore Therapy 142 antimicrobial nasal sprays 75
androgenic hormones 203 antiperspirants 173
aneroid blood pressure monitors 11, 30 antipyretic effect, analgesics 89
angel dust, times appearing and staying in antiseptics
urine 25 first aid topical 178
anhydrous glycerin drops 136 urinary, methenamine 111, 113
anorectal line 169 see also disinfectants
antacids 34 antitussives 69
dosages 34 cold/cough products containing 81
proton pump inhibitors and 39 combinations with expectorants 80
antibiotics dosages 78
first aid topical 179, 194 topical, dosages 78
see also antimicrobial drugs antivirals, topical 182
antibody occult blood test 16 anus
anticholinergic activity, antihistamines 70 anorectal line 169
anticholinergic drugs itching, pinworms 48
loperamide as 62 aphthous ulcers (canker sores) 143
for motion sickness 42 Aqua Ban 125
anticoagulants arthritis
bismuth subsalicylate and 36 acetaminophen 90
Gingko biloba and 207 see also osteoarthritis
omega-3 fatty acids and 208 articular cartilage 202
saw palmetto and 117 artificial saliva products 138
Index | 213
artificial tan 175 Benadryl Itch Stopping Cream, Spray 160

artificial tears 130 BenGay Cream 193
ascorbic acid, cholesterol tests and 12 benign prostatic hyperplasia see prostatism
aspirin 93 bentoquatam 158
acetaminophen with 98 benzalkonium chloride 178
allergy, bismuth subsalicylate and benzocaine, for toothache and teething pain
36, 61 144, 145
in antacid preparations 36 benzodiazepines, times appearing and
diphenhydramine with 102 staying in urine 25
dosages 95 benzoyl peroxide 187, 188, 194
fecal occult blood test and 16 Bifidobacterium 63
Gingko biloba and 207 Biofreeze Roll On 169
low-dose 93, 94, 95, 108 BioSafe Cholesterol Test 12
ibuprofen, warnings 94 bisacodyl
platelets 93 oral dosage 51
asthma 69, 84 suppositories 57
bronchodilators for 4, 84 time of action 51
astringents tablets 56
antiperspirant 173 bismuth subgallate 64
for hemorrhoids 170, 171 bismuth subsalicylate 36
ophthalmic 133 in Kaopectate 4
athlete’s foot 180 bitter orange 197
atopic dermatitis 153, 154 black cohosh 124, 127
attapulgite, in Kaopectate 4 bleeding
Auro Ear 146 rectal 170
Auspitz sign 189 see also occult blood
Aveeno Anti Itch Cream and Lotion 160 stomach, NSAIDs 94
Aveeno Baby Soothing Relief 156 urinary 23
Aviva, blood glucose monitor 15 blepharitis 129
avobenzone 177 bloating, gas and 39
axillary thermometers 26 blood, in urine 23
blood glucose monitors 14
bacitracin 179, 180 blood pressure, normal value 11
backache, NSAIDs 96 blood pressure monitoring devices 10, 30
bacteria, gastrointestinal commensal 63 body lice 164
baldness 203 Boudreaux’s Butt Paste 156
Balmex Extra Protective 156 bowel cleansing, oral phosphates 55
Banalag 169 bowel movement 50
Band-Aid bandages 177 bowel preparation kits 58
barbiturates, times appearing and staying in bran, dosage 53
urine 25 brand names
basal temperature devices 18 active ingredients and 4
baths, dry skin prevention 151 extended products and 5
Bayer Ascencia, blood glucose monitors 15 breast
beads, microfine, skin products cancer, antiperspirants and 173
containing 157 self-examination kit 29
Beano (alpha-galactosidase preparation) 41 breast feeding, LH and estrogen ovulation
beeswax 153 tests 18
behind-the-counter drugs 4 breath tests, alcohol 26
Ben Gay Pain Relieving Cream 169 Breeze 2, blood glucose monitor 15
214 | Index
8-bromotheophylline (pamabrom) 114, Carmex Cold Sore 142

115, 125 cartilage, articular 202
brompheniramine, dosage 71 castor oil 56
bronchodilators dosage 53
for asthma 4, 84 catagen hair 203
dosages 78 cellulose
buchu 115 artificial tears 130
bulk laxatives 51, 66 fiber 52
choking 52 central nervous system 89
dosages 53 cephaeline 46
Burt’s Bees Bug Bite Relief 164 cerumen 135
butane, cryotherapy 184 softeners 136
butenafine 181, 182 cetirizine 71, 86
dosage 71
caffeine 104, 108 cetylpyridinium
as adjuvant 89 mouth rinse 140
dehydration and 61 nasal spray 75
as diuretic 114 charcoal, activated 47
drinks listed showing content 105 chest rubs, vaporizing 79
Excedrin Migraine, warning 99 ‘chew and park’ technique, nicotine
fecal occult blood test and 16 replacement gums 200
premenstrual tension 106, 125 chickenpox, aspirin and 93
Caladryl Clear Lotion 160 chiggers 161
Calagel Anti Itch Lotion 160 children
calamine 158 acetaminophen 91, 92, 107
for hemorrhoids 170 dosages 92
calcium carbonate 35, 36 aspirin 36, 95
dosages 35 cetirizine 72
calculus, dental 139 cough/cold products 80
callus removers 184 epinephrine 84
Campho-Phenique Cold Sore Scab Relief ibuprofen, dosage 95, 96
142 mouth rinses 140
Campho-Phenique Cold Sore Treatment OTC drugs and 3
142 skin 150
camphor 79, 168 topical hydrocortisone 155
ointment, dosage 78 Children’s Mylanta 5
products for musculoskeletal pain 160 chlorhexidine 179
steam, dosage 78 chlorophyllin copper complex 64
candida infections, vagina 112, 121 chlorpheniramine, dosage 71
pH tests 22 choking, bulk laxatives 52
canker sores (aphthous ulcers) 143 cholecystokinin 50
capsaicin 168, 169, 193 cholesterol
carbamide peroxide 136 dietary fiber and 52
carbaspirin calcium 93 ginseng and 205
dose 95 tests 11, 12, 13, 30
carbon dioxide suppositories 58 choline salicylate, dose 95
time of action 51 chondroitin 202, 203
CardioChek, cholesterol test 30 chronic conditions, OTC drugs for 4
caries, prevention 137, 146 cimetidine 38
Index | 215
dose and instructions 38 dosages 92

circadian rhythm 100 condoms
see also diurnal variation female 118
claims (false), for Airborne 83 pregnancy rates 118
claudication, Gingko biloba 206 latex
Clear Blue Easy Fertility Monitor 18, 31 allergy 126
clemastine, dosage 71 directions 118
Clinical Laboratory Improvements male 117
Amendment (CLIA) 9 pregnancy rates 118
clothes, storage for louse contamination conjugated equine estrogens, black
164 cohosh vs 124
clotrimazole 123, 181, 182 conjunctivitis 129
coal tar 189, 190 constipation 50, 66, 170
psoriasis 191, 192 Consumer Healthcare Products
seborrhea 191 Association, on children’s cough/cold
cocaine (crack), times appearing and products 80
staying in urine 25 contact (allergic) dermatitis 154, 156, 192
cocoa butter 152 contact lenses 135
cod liver oil (topical) 152, 155, 156 disinfectants 135, 146
codeine 4, 77, 78 dry eyes 130
coke syrup, concentrated 44 ketotifen and 134
cold compresses 167 phenazopyridine and 112
cold sores 141, 142, 147 Contour, blood glucose monitor 15
collodion, flexible 182, 183 contraceptives 111
colloidal oatmeal 152, 158, 159 with condoms 118
colon cancer 30, 51 emergency 120
colostomy, odors 64 Plan B 4, 120, 126
Comb-Out Gel, Egg & Nit (RID) 166 LH and estrogen ovulation tests 18
combination treatments pregnancy rates 118
acetaminophen in 91 sponges 120
acne 187 pregnancy rates 118
allergies 76 see also condoms
analgesics 98 Coricidin Maximum Strength Flu 81
colds 80 corn removers 184
first aid topical antibiotics 180 coronary heart disease 207
glucosamine and chondroitin 203 corticosteroids, intra-articular
laxatives 59 injection 202
commensal bacteria 63 cosmetics 149
Committ lozenges, dose schedules 201 cost, OTC drugs 5
common cold 69, 77, 81 couch grass 115
cough 77, 86 cough 77, 81
Compact Plus, blood glucose monitor 15 common cold 77, 86
compresses see also codeine; dextromethorphan
cold 167 counseling, smoking cessation 199
colloidal oatmeal 159 counterirritants 168
warm 167 heat therapy and 167
concentrated coke syrup 44 insect bites 163, 164
concentrated infant drops, acetaminophen musculoskeletal pain 167, 169
92 crabs (pubic lice) 164
216 | Index
crack (cocaine), times appearing and seborrhea 188, 190, 194

staying in urine 25 dermatological products, topical 149
cradle cap 188, 191 dermatophytes 180
cranberries 111, 113 dermis 150
craving, tobacco 200 desensitizers, teeth 141
creams, antifungal 122 DESI (Drug Efficacy Study Implementation)
cromolyn sodium 72, 86 Program 2
cryotherapy, warts 182, 184 Desitin Multi-Purpose 156
cubeb berries 115 Desitin Original Ointment 156
cyclizine 43 dextromethorphan 4, 77, 78, 79
cyclo-oxygenase enzymes 93 dosages 78
Cystex 113 diabetes
cytochrome P-450 enzymes ginseng 205, 206
cimetidine and 38 monitoring devices 13, 30
omeprazole magnesium and 39 hemoglobin A1c monitors 14, 30
cytostatic drugs NSAIDs 94
pyrithione zinc 189, 190, 191 phosphorylated carbohydrates 44
seborrhea 190 diagnostic home test kits 9
selenium sulfide 189 CLIA-waived 9
see also coal tar diaper rash 154, 155, 156
diaphragm contraceptives, pregnancy
dandelion 115 rates 118
dandruff 188, 189, 194 diarrhea 60, 67
Debrox Wax Removal System 136 diastolic blood pressure 11
decongestants 73, 74 dietary supplements
for allergies, dosages 74 antidepressant 106
analgesic products with 76 arthritis 202
antihistamine and analgesic products diuretics 115
with 76 melatonin as 103
antihistamine products with 76 prostatism 116
cold/cough products containing 81 regulation 5
deer ticks 161 diets 197
DEET (insect repellent) 161, 162, 193 orlistat with 198
defecation 50 digestion 33
definitions, diagnostic home test kits 9 digital thermometer, basal temperature 18
dehydration 5-alpha-dihydrotestosterone 204
hyperosmotic laxatives 55 dilutions, homeopathic products 6
treatments for 61 dimenhydrinate 43
dementia 206 Dimetapp Cold & Cough 81
demulcents 130 Dimetapp Nighttime Flu 81
dental products 137 dimethicone 152, 153
see also oral rinses dimethyl ether, cryotherapy 184
deodorants, internal oral 64 diphenhydramine 77, 78, 79
Depo-Provera, pregnancy rates 118 with analgesics 102
depression 106 as antiemetic 43
dermal patches see transdermal patches as antitussive, dosages 78
dermatitis dosage 71
eczema 153 as sedative 101
hyperproliferation skin conditions 188 topical 159
Index | 217
disinfectants ecamsule 175, 177

contact lenses 135, 146 eccrine sweat glands 173
see also antiseptics echinacea 82
diuretics 114 ecstasy, times appearing and staying in
dietary supplements 115 urine 25
NSAIDs and 94 eczema 153
Diurex Advanced Water Pills 123 edema, menstrual cycle 111
Diurex Aquagels 125 efferent nerve fibers 89
Diurex For Men 115 efficacy 1
Diurex PMS Formula 123 Egg & Nit Comb-Out Gel (RID) 166
diurnal variation eicosapentaenoic acid (EPA) 207
normal body temperature 26 elderly people
see also circadian rhythm constipation 51
docosahexaenoic acid (DHA) 207 see also ageing
docosanol 142, 143, 147 electric toothbrushes 139
docusate, dosage 53 electrolyte solutions (for rehydration) 61
docusate potassium 57 electrolyte test devices, ovulation 19
douches 121 electronic acupuncture devices 45
Nonoxynol 9 and 119 electronic blood pressure monitors 11, 30
doxylamine 101 electronic thermometers 26
Dramamine 5, 65 basal temperature 18
Dramamine Less Drowsy, meclizine in 5 prices 5
dreams, nicotine replacement products 200 emergency contraceptives 120
drowsiness Plan B 4, 120, 126
antiemetics 43, 66 emetine 46
sedating antihistamines 70, 71 emollients 151, 152
Drug Efficacy Study Implementation artificial tears 131
Program 2 emulsified mineral oil 54
drug interactions enamel, dental 138
orlistat 198 enemas 54
St. John’s wort 107 action time 51
drugs of abuse glycerin 56
screening tests 24, 31 energy drinks, listed showing caffeine
see also intravenous drug users content 105
see also abuse, drugs with potential for Enterobiasis vermicularis (pinworms)
dry eye products (artificial tears) 130 48, 67
dry mouth 138 Environmental Protection Agency, insect
dry skin 150, 151, 152, 192 repellents 161
Durham--Humphrey amendments, FD&C ephedra 197
Act 1 ephedrine 78, 85, 172
dutasteride 116 epidermis 149
dysmenorrhea 111 epinephrine 78, 84
epithelium, skin 149
ear equine estrogens, black cohosh vs 124
examination kits 28 ergosterol, synthesis inhibition 181
infrared thermometers 26, 27, 32 estrogens
products for 135 conjugated equine, black cohosh vs 124
see also cerumen see also luteinizing hormone and
earache 136 estrogen hormone devices
218 | Index
estrone 3-glucuronide 18 flora, gut 63

ethanolamine antihistamines 70 flossing, teeth 139
Evra Patch 118 flu 69, 81
Excedrin Migraine, warning 98 aspirin and 93
exclusivity, granted by FDA 3 common cold vs 77
exercise, weight control 197 fluid absorption, gastrointestinal system 50
expectorants 79 fluid in the inner ear 28
antitussives and, combinations 80 fluorides 138, 139
cold/cough products containing 81 follicle stimulating hormone, menopause
dosages 78 detection kits 29, 31
extended products, brand names and 5 Food and Drugs Administration, regulation
external analgesics 89, 164 by 1
hemorrhoidal relief products 171 Food, Drugs and Cosmetics Act (1906),
for musculoskeletal pain 167 amendments 1, 9
oral 143 food supplements see dietary supplements
for urushiol exposure 157, 159 forehead thermometers, temporal
external nasal dilator strips 76 artery 26, 27
eye cups 132 Free Style Freedom, blood glucose
eye drops, method of applying 131 monitor 15
eyewash solutions 131 Free Style Lite, blood glucose monitor 15
frequency, urinary 111, 125
famotidine 37, 38 fructose, antiemetic preparations 44
fat-soluble vitamins 198, 208 fruit juices 64
fecal occult blood 16 fungi
antibody test 16 dermatophytes 180
Federal Register, Advanced Notice of see also antifungal drugs
Rulemaking 2
FEM-V, vaginal pH test 23 gas and bloating 39
ferric oxide, calamine 158 gastric inhibitory peptide 50
Fertile-Focus, ovulation test 19 gastrin 50
fertility tests gastro-esophageal reflux disease
kits 17, 31 (GERD) 34, 36
male 20 gastrointestinal system 33
fever motility 49
acetaminophen and 91 Gatorade 64
temperature 26 Gaviscon 36
fever blisters 141, 142, 147 GERD (reflux disease) 34, 36
fexofenadine 71 ginger 43, 66
fiber 52 gingivitis 140
Final Monograph (Final Rule) 2 Gingko biloba 206, 209
finasteride 116 saw palmetto and 117
first aid topical antibiotics 179, 194 ginseng 205
first aid topical antiseptics 178 glaucoma, vasoconstrictors and 134, 145
fish, polyunsaturated fats from 207 glucosamine 202, 209
flatulence 39 glucose see diabetes, monitoring devices
flavonoids 106 glucose-6-phosphate dehydrogenase
Fleet Phospho-Soda EZ Prep Bowel deficiency, phenazopyridine and 112
Cleansing 55, 59, 66 glycerin
flexible collodion 182, 183 anhydrous, drops 136
Index | 219
for dry skin 151, 152 pediculicide 166

suppositories 55 human chorionic gonadotropin, pregnancy
time of action 51 test devices 20
glycosylated hemoglobin, monitors 14, 30 human immunodeficiency virus see HIV-1
Gold Bond Medicated Itch Relief 160 humectants 151, 152
GRAE drugs (‘generally recognized as glycerin as 151
effective’ drugs) 2 humidifiers 87
GRAS drugs (‘generally recognized as safe’ hyaluronic acid, intra-articular
drugs) 1 injection 202
GRASE drugs 2 hydrocortisone
dietary supplements as 5 for atopic dermatitis see Rx-OTC
guaifenesin 80 switch products, atopic dermatitis
dosage 78 fungal infections and 180
guarana 104, 115 Hþ/Kþ ATPase 37
gums, nicotine replacement products 200 proton pump inhibitors on 39
gut flora 63 hypericin 106
hyperosmotic laxatives 51, 54
H2-receptor antagonists 37 dosages 53
dosages 38 osmotic laxatives vs 59
proton pump inhibitors and 39 hyperproliferation skin conditions 188
Habitrol Transdermal patches, dose hypertension 10
schedules 201 NSAIDs and 94
hair follicle test kits, drugs of abuse 25, 31 hypertonic eye drops 132
hair loss 203 hypodermis 150
hangovers 34
hard fat 152 ibuprofen 93
head lice 164, 193 diphenhydramine with 103
headache 90, 109 dosages 95
see also migraine children 95, 96
heartburn 34, 65 concentrated infant drops 96
heat therapy (compresses) 167 fecal occult blood test and 16
hemoglobin A1c monitors 14, 30 menstrual period pain 126
hemorrhage OTC Internal Analgesic Monograph 97
see also bleeding; occult blood warnings 94
hemorrhoids 169, 171 ice compresses 167
hepatitis C, infectious disease kits for 21 ileostomy, odors 64
heroin, times appearing and staying in imidazoles 122
urine 25 immune system, ginseng and 205
herpes labialis 141, 142, 147 immunoglobulin E, allergy mechanism 70
histamine receptor antagonists see immunosuppressants, orlistat and 198
antihistamines; H2-receptor antagonists indigestion 34
history-taking, by pharmacists 7 infant colic, simethicone and 40
HIV-1 infant suppositories 56
infectious disease kits for 22 infants, ipecac syrup 47
Nonoxynol 9 and 119 infections, contact lenses 135
home test kits, diagnostic 9 infectious disease kits 21
CLIA-waived 9 inflammatory mediators 70
homeopathy 6 influenza see flu
earache drops 136 infrared thermometers
220 | Index
ear 26, 27, 32 Kefauver--Harris amendments, FD&C

prices 5 Act 1
temporal artery 26, 27 keratinized cells, stratum corneum 150
ingrown toenail relief 185 keratolytics
inhalers, epinephrine 85 corns 184
inner ear hemorrhoids 172
fluid in 28 seborrhea 190
visual examination 28 warts 182, 183
insect bites and stings 160, 163 see also salicylic acid
insect repellents 161, 193 keratoplastics
insomnia 99, 108 seborrhea 190
phenylephrine 86 see also sulfur
Internal Analgesic Monograph (OTC), ketoconazole, dandruff 190
ibuprofen 97 ketoprofen, dosage 98
internal oral deodorants 64 ketotifen 134, 135
internet, diagnostic home test kits kidney disease
purchased 10 antiperspirants 173
intestinal obstruction, bulk laxatives 52 docusate potassium 57
intra-articular injection 202 magnesium hydroxide 35
intracellular adhesion molecule-1 NSAIDs 94
(ICAM-1) phenazopyridine 112
saline laxatives 55
common cold 77
kidney stones, cranberry and 114
zinc products on receptor 82
intravenous drug users, infectious disease
labels 3
kits for 21
analgesics 91
iodine 178
children’s cough/cold products 80
ipecac syrup 45
cosmetics 149
irrigation and cleansing, nasal 75
dietary supplements 5
irritant dermatitis 154
homeopathic products 6
diaper rash 155
St. John’s wort 107
irritant laxatives see stimulant laxatives
lactase 63
isopropyl alcohol 178
Lactobacillus 63
chlorhexidine with 179
lactose intolerance 63
swimmer’s ear prevention 137
lamb intestines, condoms from 117
Itch-X Anti-Itch Lotion 160
lamb’s skin condoms, directions 118
Itch-X Spray and Gel 160
Lanacane 171
itching 158 lanolin, 152, 155
pinworms 48 lansoprazole 38
Ivarest Anti-Itch Cream 160 latex
condoms
jet lag, melatonin for 103 allergy 126
jock itch 180 directions 118
juniper berries 115 wrist acupressure devices 45
laxatives, 49, 51, 53
kaolin 60 see also suppositories
Kaopectate LDL cholesterol, BioSafe Cholesterol
formulation changes 4 Test 13
see also bismuth subsalicylate levmetamfetamine 74
Index | 221
levonorgestrel (Plan B) 4, 120, 126 dosages 35

lice 164 kidney disease and 35
Licefreee! 166 magnesium hydroxide/aluminum
LiceMD 166 hydroxide, dosages 35
lidocaine, children 179 magnesium salicylate 94
Lifescan One Touch, blood glucose dose 95
monitors 15 male fertility tests 20
lifestyle behaviours male pattern baldness 204, 209
healthy sleep 100 malt soup extract, dosage 53
weight control 197 marijuana, times appearing and staying in
light therapy, melatonin with 103 urine 25
lipases, inhibition 197 mast cell inhibitors 72
lipid profile, test card 12 meclizine 43
lists of ingredients, cosmetics 149 in Dramamine Less Drowsy 5
liver toxicity, acetaminophen 90, 91 melanin 174
local anesthetics melanocytes 150
fever blisters 143, 147 melatonin 100
insect bite products 164 memories (data storage)
toothache and teething pain 144 basal temperature thermometers 18
for urushiol exposure 159, 160 diabetes monitoring devices 14
loperamide 62, 67 memory loss 206, 209
loratadine 71, 85, 86 menhaden fish standard, omega-3 fatty
dosage 71 acids and 208
Lovaza (omega-3-acid ethyl esters) 207 Menocheck 31
low-density lipoprotein cholesterol, BioSafe menopause 124
Cholesterol Test 13 detection kit 29, 31
low-dose aspirin 93, 94, 95, 108 insomnia 100
ibuprofen, warnings 94 night sweats 126
lower esophageal sphincter 33 menstrual cycle, vaginal pH tests 22
peppermint oil on 41 menstrual symptoms 126
lower respiratory system 69 insomnia 100
see also asthma see also premenstrual syndrome
lozenges menthol 168, 169
menthol 78, 79 coal tar with 189
nicotine replacement products 200, 201 cough drops 79
lubricant laxatives, 51, 53, 54 lozenges 78, 79
lubricants, condoms 117 musculoskeletal pain, products 169
lungs 69 ointment, dosage 78
see also asthma steam, dosage 78
luteinizing hormone, ovulation tests 17 vapor 79
luteinizing hormone and estrogen hormone mercury thermometers 26
devices, ovulation tests 18 methadone, times appearing and staying in
lysine, fever blisters and 142 urine 25
methenamine 111, 113
macular degeneration, age-related 130 methyl salicylate 168, 169
Magladrate 35 methylcellulose 52
magnesium, salts, laxatives 55 dosage 53
magnesium citrate, dosages 35 methylxanthines 114
magnesium hydroxide 5, 35 miconazole 123, 181, 182
222 | Index
microfine beads, skin products nasal saline irrigation and cleansing 75

containing 157 National Institute on Complementary
micronized selenium sulfide 189 Alternative Medicine 6
microscope, sperm count and sperm nausea 42
motility 20 neomycin 179, 180
Midol Max Strength Menstrual Neti pots 75
Complete 123 new drug application sunscreens 177
migraine 90, 109 new drug applications (NDA) 3
Excedrin Migraine, warning 95 see also cryotherapy
ibuprofen, warnings 95 new OTC drugs, regulatory process 3
mineral oil Nicoderm CQ, dose schedules 201
lubricant laxatives 53, 54 Nicorette gum, dose schedules 201
topical 152, 155 nicotine 198
minoxidil 204 replacement therapy 199
misbranded products, FDA policy 112 as Rx-OTC drug 199
mites night sweats, menopause 126
chiggers 161 nitrate tests, urine 23
scabies 161 nitrocellulose 182
Mitigator Sting and Bite Scrub 164 nits 164, 165, 166
mixed phosphate salts 55, 59 Nix lice shampoo 193
dosages 53 nizatidine, dose and instructions 38
enemas 56 nocturnal anal itching, pinworms 48
moisturizers 151 non-legend drugs 1
sunscreens in 149 non-monograph drugs 2
monoclonal antibody fertility test kits 17 non-steroidal anti-inflammatory drugs 89,
monograph drugs 2 93, 97
antiflatulents 34 long-acting 108
laxatives 51 stomach bleeding 94
monograph ingredients, antacids 34 see also ibuprofen; naproxen sodium
monograph process (FDA) 2 nonoxynol 9 119
monographs, contents 3 nonrapid eye movement sleep 99
mosquitoes 161 normal body temperature 26
motilin 50 nozzles, use applying eyewash solutions 132
motility, gastrointestinal system 49 NREM sleep 99
motion sickness 42, 43, 65 Nupercainal Ointment 171
Motrin IB 126
mouth, products for 137 oatmeal, colloidal 152, 158, 159
mouthwashes see oral rinses obesity 197
multiuse products, ophthalmic 129 occult blood, fecal 16
Murine Wax Removal System 136 antibody test 16
musculoskeletal pain 167, 192 occupational exposure, irritant
counterirritants 167, 169 dermatitis 154
Mylanta (antacid) 5 Office of In Vitro Diagnostic Devices
(OIVD), website 10
naphazoline 134 oil of lemon eucalyptus 161, 162
naproxen sodium 108 oil of wintergreen (methyl salicylate)
dosage 98 168, 169
fecal occult blood test and 16 ointments
nasal dilator strips, external 76 applying to eyes 131
Index | 223
vaporizing 79 paternity testing 29

oleoresin (urushiol) 156 PCP (phencyclidine), times appearing and
oligosaccharides, alpha-galactosidase on 41 staying in urine 25
omega-3-acid ethyl esters (Lovaza) 207 pediculosis 164
omega-3 fatty acids 207 Pennsylvania, law on cough medicines 4
omeprazole magnesium 38, 39 peppermint oil 41
ophthalmic products, topical 129 peptic ulcer disease 65
oral cavity products 137 Pepto-Bismol 65
oral deodorants, internal 64 variety of products 37
oral electronic digital thermometers 26 see also bismuth subsalicylate
oral rehydration solutions 61 periodontitis 140
oral rinses 147 permethrin 166
anticaries 139 petrolatum 152
antiplaque and antigingivitis 139 diaper rash products 152
fluoride limits 139 white 152, 153
organic sunscreens 175 Pfizer Accu-Chek, blood glucose
orlistat 197 monitors 15
Oscillococcinum 83 pH, skin surface 150
osmotic laxatives, 51, 53, 59 phenazopyridine 111, 112
osteoarthritis 202 phencyclidine, times appearing and staying
acetaminophen 90 in urine 25
counterirritants 169 pheniramine 134, 135
pain treatment 167 phenol 144, 145, 178
otic products 135 phenolate sodium 144, 145
over-the-counter drugs 1 phenylephrine, 73, 74, 86
children 3 phenytoin, cimetidine and 38
chronic conditions 4 phosphate salts 55, 56, 59
new, regulatory process 3 phosphorylated carbohydrates 44
for physician-diagnosed conditions 4 photoreflectance meter, BioSafe
ovulation tests 17 Cholesterol Test 12
oxalate kidney stones, cranberry and 114 photosensitivity, St. John’s wort 107
oxycodone, times appearing and staying in physician-diagnosed conditions, OTC
urine 25 drugs for 4
oxymetazoline 134 phytoestrogens 124, 127
dosages 74 black cohosh 124, 127
picaridin 161, 162, 193
Pain Bust-R 169 pilosebaceous units 186
Palmer’s Bottom Butter 156 pinworms 48, 67
pamabrom 114, 115, 125 piperonyl butoxide 165
Pamprin Cramp 123 Pityrosporum ovale 188
Pamprin Max 123 placebo effect 7
Pamprin Max Multisymptom 123 Plan B (emergency contraceptive) 4,
Panax ginseng 205 120, 126
panels of experts, monograph process plaque, dental 138, 147
(FDA) 2 hardening 139
pantiliner, FEM-V vaginal pH test 23 platelets, aspirin on 93
parasympathetic nervous system, PMD (oil of lemon eucalyptus) 161, 162
gastrointestinal motility 49 poison ivy 156, 160, 192
‘parking,’ nicotine replacement gums 200 poison oak 156, 160
224 | Index
poison sumac 156, 160 H2 93

poisoning prostatism 111
prevention 48 antihistamines and 86
treatments for 45 dietary supplements for 116
polycarbophil, dosage 53 protectants see moisturizers; skin
polyethylene glycol 3350 53, 59 protectants
polymyxin B 179, 180 protein see urine, nitrates and protein test
polyols, artificial tears 130 proton pump inhibitors 38
polyunsaturated fats (PUFAs) 207 pseudoephedrine 4, 73, 74
polyurethane condoms, directions 118 Psoriasin (products) 192
postmenopausal women, vaginal pH tests psoriasis 188, 191
and 22 psyllium 52
postpartum period, insomnia 100 dosage 53
potassium, in docusate potassium 57 pubic lice 164
potassium nitrate, tooth desensitizer 141 pyrantel pamoate 48, 67
Precision Xtra, blood glucose monitor 15 pyrethrum extract 165
pregnancy pyrilamine 123
ginger 43, 66 pyrithione zinc 189, 190, 191
NSAIDs 94, 98
rates, contraceptives 118
ranitidine 38
rhinitis 70
rapid eye movement sleep 99
saw palmetto and 116
rashes
test devices 20
allergic dermatitis 157
premenstrual syndrome 111, 114, 123, 125
see also diaper rash
caffeine for 106, 125
rebound nasal congestion 74
combination products 123
rectal bleeding 170
see also menstrual symptoms
see also occult blood
Premsyn PMS 123
rectal electronic digital thermometers 26
Preparation H Anti-itch 171
red clover 124, 127
Preparation H Cream, Maximum
Strength 171 referral to physician
Preparation H suppository 171 allergic dermatitis 157
Preparation H Wipes 171 diaper rash 155
prescription drugs, non-prescription gastrointestinal conditions requiring 33
drugs vs 1 hemorrhoids 170
prevention ophthalmic conditions requiring 129
caries 137, 146 reflux disease, gastro-esophageal
poisoning 48 (GERD) 34, 36
sexually transmitted infections 117 regulation, by Food and Drugs
swimmer’s ear 137, 146 Administration 1
prices, OTC drugs 5 rehydration solutions, oral 61
PrilosecOTC 65 REM sleep 99
probiotics 63, 121 resin (urushiol) 156
progestins, Plan B 4, 120, 126 resistance to OTC products, lice 165
Propionibacterium acnes 186 resorcinol
Proposed Rule 2 acne 187, 188
propylhexedrine 74 hemorrhoids 172
prostaglandins 89, 93 resorcinol monoacetate, acne 187
E2 93 respiratory system 69
Index | 225
return mail tests, hemoglobin A1c saliva 138

monitors 14 saliva tests
Reye’s syndrome 36, 93 alcohol 26
RGP (rigid gas permeable) contact lenses, ovulation 19
products 135 Salonpas Arthritis Patch 169, 193
rhinitis 70, 86 Salonpas Gel Patch 169
rhinitis medicamentosa 74 Salonpas Pain Patch 169
rhinosinusitis 69, 70 Salonpas Pain Relief Patch-Ultra Thin 169
RICE (acronym), treatment of samples, diagnostic home test kits
musculoskeletal pain 167 providing 9
RID Egg & Nit Comb-Out Gel 166 sandalwood 115
RID shampoo 193 Sarna Original Anti Itch Lotion 160
rigid gas permeable contact lenses 135 saw palmetto 116, 125
ringworm 180 scabies 161
Rite Aid, blood glucose monitor 15 scaly dermatitis 188
Robitussin Cough, Cold & Flu 81 screening tests
rosacea 187 drugs of abuse 24, 31
rose hips 82 see also intravenous drug users
rubbing alcohol see isopropyl alcohol urinary tract infections 23
Russian ginseng 205 vaginal infections 23
Rx legend 1 seborrhea 188, 190, 194
Rx-OTC switch products 3 sebum 186
antifungals 181 secretin 50
antihistamines 71 secretory laxatives see stimulant laxatives
ophthalmic 134 sedating antihistamines 70
antimicrobials 179 sedatives 99
atopic dermatitis 154 selenium sulfide 189
dandruff 190 self-care, pharmacists and 7
H2-receptor antagonists 37 self-examination kit, breast 29
nicotine as 199 senna, dosage 53
NSAIDs 97 sensitive teeth 141
orlistat 197 sensitivity, diagnostic home test kits 9
proton pump inhibitors 37 sexually transmitted infections
for vaginal candidiasis 122 condoms preventing 117
infectious disease kits 21
Saccharomyces boulardii 63 shampoos
St. John’s wort 106 antidandruff 149, 189
salicylates 93 antilouse 165
Cystex 113 shift workers, insomnia 100
dosages 95 simethicone 40
salicylic acid loperamide with 63
acne 187, 188 skin 149
corns 184 topical products 149
dandruff 189 skin protectants 152
psoriasis 191, 192 diaper rash 156
seborrhea 191 fever blisters 142
warts 183 hemorrhoidal relief products 171
saline irrigation and cleansing, nasal 75 insect bite products 152
saline laxatives 54 see also moisturizers
226 | Index
skin test devices, ovulation test 19 stratum corneum 150

SkinZinc Spray for Seborrhea 191 stratum lucidum 150
sleep 99 strips, external nasal dilator 76
smoking cessation products 198, 208 stye 129
sodium subcutaneous layer 150
in Airborne 83 substance P, depletion 168
in antacids 34 succussion 6
sodium bicarbonate 34 Sudafed PE 86
dosages 35 sugar, cranberry juice 114
as skin protectant 158, 159 sulfur
in Zegerid 39 acne 187
sodium chloride dandruff 189
hypertonic eye drops 132 see also keratoplastics
Licefreee! 166 sun protection factor (SPF) 174
sodium salicylate, dose 95 sunburn 174, 175
sodium sulfide 185
sunscreens 174, 176
soft contact lenses, products 135
in moisturizers 149
softeners, for cerumen 136
St. John’s wort and 107
soluble fiber 52
supplemental NDA (new drug
sore throat
applications) 3
local anesthetics 144
suppositories
period of self-medication 91, 94
carbon dioxide 51, 58
sound wave device, fluid in the inner ear 28
laxative 51
soy 124, 127
suprachiasmatic nucleus (SCN) 100
sperm count 20
Sure Step FSH Menopause test 31
sperm motility 20
surfactants, skin products
spermicides 117, 119
containing 157
sponge contraceptives 120
sustained release acetaminophen 91
pregnancy rates 118
Swab Plus Pre-filled Swabs 164
St. John’s wort 106
sweat glands, eccrine 173
stannous fluoride products 139
stannous fluoride toothpaste, claims Swim Ear 146
allowed 140 swimmer’s ear, prevention 137, 146
star system, sunscreens 175 sympathetic nervous system,
starch, topical 152, 155, 156 gastrointestinal motility 49
steam vaporizers 87 sympathomimetic drugs see
steroids, intra-articular injection 202 vasoconstrictors
stimulant laxatives 51, 56 synephrine 197
dosages 53 syringing, ear 136
stimulants, central nervous system 104 systolic blood pressure 11
Sting Eze 164
stings see insect bites and stings talc 155, 156
stomach bleeding, NSAIDs 94 tanning 175
stool softeners 57 tartar, dental 139
dosages, 51 tears 130
see also docusate Technu 157
storage teething
clothes, for louse contamination 164 Anbesol for 107
diagnostic home test kits 10 products for 144, 147
Index | 227
telephone counseling, cholesterol and lipid Triaminic Chest and Nasal Congestion 81
profile test card 12 Triaminic Flu, Cough & Fever 81
telogen hair 203 triclosan toothpastes 140
temperature tricyclic antidepressants
normal body temperature 26 St. John’s wort vs 106
regulation, skin 150 times appearing and staying in urine 25
temporal artery forehead thermometers triethanolamine salicylate (trolamine)
26, 27 168, 169
Tentative Final Monograph 2 triglyceride measurement 30
terbinafine 181, 182 Triple Paste 156
terminal hair 203 triprolidine, dosage 71
tetracycline, LH and estrogen ovulation trolamine 168, 169
tests 18 Tronolane Cream 171
tetrahydrozoline 134 Tronolane Suppository 171
tetramethylbenzidine, fecal occult blood True Track Smart, blood glucose
test 16 monitor 15
theophylline, cimetidine and 38 Tucks Anti-itch Ointment 171
Thera-Gesic 169 Tucks Ointment (Anusol) 171
TheraFlu Cough & Cold 81 Tucks pads 171
Theraflu Warming Nighttime Severe Tums Ultra 36
Cold 81 TumsEX 36
thermometers 26 Tylenol Arthritis 92
see also electronic thermometers; Tylenol Cold Multi-Symptom Severe 81
infrared thermometers Tylenol Cough, Sore Throat Day 81
throat examination kits 28 Tylenol 8 hour 92
thromboxanes 93 Tylenol Infant Drops 107
ticks 161 Tylenol Plus Children’s Flu 81
Tiger Balm 169 Tylenol Women’s Menstrual Relief 123
tinea 180 tympanic membrane thermometers 26,
tioconazole 123 27, 32
titanium dioxide 176
toenails, ingrown toenail relief 185 Ultra, blood glucose monitors 15
toilet bowl test, fecal occult blood 16 ultraviolet light
tolnaftate 181 psoriasis treatment 189
toothache and teething pain products types 174
144, 147 unapproved drugs 2
toothbrushes 139 undecylenic acid 181
toothpastes underarm electronic digital
brands containing fluoride 139 thermometers 26
fluoride limits 139 units, drug quantities 6
transdermal patches upper respiratory system 69
contraceptives, pregnancy rates 118 urinary analgesics 112
nicotine replacement products, 200, urinary antiseptics, methenamine 111, 113
201, 209 urinary tract infections 111
transplant recipients, orlistat and 198 home tests 23
travelers urine
diarrhea 60, 67 blood in 23
insomnia 100 drug test kits 24
melatonin for 103 drugs detected 24
228 | Index
human chorionic gonadotropin 20 cimetidine and 38

nitrate tests 23 cranberry and 114
nitrates and protein test 23 Gingko biloba and 207
ovulation tests 17 ginseng and 206
urushiol 156 warm compresses 167
uva ursi 115 warnings 3
colloidal oatmeal 159
vagina Cystex 113
antifungal drugs 4, 121 DEET (insect repellent) 162
discharge, hydrocortisone and 154 minoxidil 204
infections 126 warts 182, 194
candida 22, 112, 121 water resistant sunscreens 177
pH tests 22 water supplies, fluoride 138
spermicides 119 wax, ear see cerumen
Vagisil Screening Kit 23 weight loss products 197
valerian 104, 108 white petrolatum 152, 153
vapors Winfrey, Oprah (TV show hostess), on
antitussives 79 Airborne 83
see also steam vaporizers wintergreen, oil of (methyl salicylate) 168,
vasoconstrictors 169
glaucoma and 134, 145 witch hazel, for hemorrhoids 170
for hemorrhoids 171, 172 withdrawal symptoms, nicotine 199
ophthalmic 133 women, minoxidil and 205
see also decongestants wound care 177, 194
vasomotor rhinitis 70 wound cleansers, oral 144
vertigo 42 wrinkles 150
‘very water resistant’ sunscreens 177 wrist bands, antiemetic 45
Viactiv Calcium Soft Chews 36
Vicks Children’s NyQuil 82
xerosis (dry skin) 150, 151, 152, 192
Vicks DayQuil Liquid 82
Vicks Formula 44 Chesty Cough 82
Vicks Formula 44 Congestion 82 Zantac 65
Vicks Formula 44 Cough & Cold Zegerid 39
PM 82 Zen Sports Balm 169
Vicks NyQuil Liquid 82 Zilactin L Cold Sore Relief 142
Vicks NyquilD 82 zinc
Visine, Visine A 145 intranasal 83
visual examination of the inner ear 28 products 82
vitamin(s), fat-soluble 198, 208 zinc acetate, skin products 152
vitamin C 82 zinc carbonate, skin products 152
vitamin D, daily limit 155 zinc oxide 152, 155
volatile oils, mouth rinse 140 diaper rash products 152
vomiting 42 for hemorrhoids 170
induction, ipecac syrup for 45 as sunscreen 176
Plan B and 121 zinc pyrithione 189, 190, 191
zinc sulfate, ophthalmic 133
warfarin Zincfrin 133
acetaminophen and 91

Essentials of Nonprescription Medications and Devices

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What is the book about?

What is the book about?

What topics are covered in the book?

What topics are covered in the book?

Essentials of Nonprescription

Medications and Devices

Elaine D Mackowiak BS Pharm, MS, PhD, RPh

Published by the Pharmaceutical Press

1 Lambeth High Street, London SE1 7JN, UK

Ó Pharmaceutical Press 2010

is a trade mark of RPS Publishing

RPS Publishing is the publishing organisation of the Royal Pharmaceutical Society of

First published 2010

Typeset by Thomson Digital, Noida, India

ISBN 978 0 85369 861 6

Canker sores or aphthous ulcers 143

There is a large increase in the number of people assuming more responsibility

Elaine D Mackowiak practiced briefly as a hospital pharmacist but has over

The US drug marketing system

Prescription and nonprescription drugs

Nonprescription or OTC drugs

New OTC drug process

OTC product labels

1 do not use the product if the individual is allergic to the ingredient(s) in

OTCs available from pharmacists only

OTCs for physician-diagnosed and chronic conditions

Relationship of OTC drug's active ingredient content and brand name

subsalicylate. Therefore, an individual must read the labels carefully when

Brand name and extended products

Cost of OTC drugs

The pharmacist's role in self-care

Important sources of OTC drug information

FDA center for Drug Evaluation and Research: www.fda.gov/cder.

Blood pressure monitoring devices

Aneroid blood pressure monitors

Electronic blood pressure monitors

Total cholesterol tests

Cholesterol and lipid profile test card

Cholesterol and blood glucose meters

Diabetes monitoring devices

Hemoglobin A1c monitors

Return mail tests

Table 2.1 Selected characteristics of popular blood glucose monitors

Meter Calibration code Blood Alternative site Special feature

Free Style Lite Yes 0.3 Yes Blood may be

Free Style Yes 0.3 Yes

Precision Xtra Automatic code 0.6 Yes Measures blood

Breeze 2 No 1.0 Yes Contains 10 strips

Contour No 0.6 Yes Easy to use

Lifescan One Touch

Ultra mini Yes 1.0 Yes Smallest meter

Ultra Yes 1.0 Yes

Ultra Smart Yes 'Speck' Yes; finger Gives averages

Compact Plus No 1.5 Yes Contains lancet

Aviva Yes 0.6 Yes Use wide-mouth

True Track Smart No 1.0 Yes Disposable after

Fecal occult blood in the stool

Occult blood toilet bowl test

Antibody occult blood test

Warnings and precautions