June 2023

Please note that there are currently 2 leaflets available for the BENADRYL ALLERGY ONE A
DAY 10MG Tablets licence (PL 15513/0118).

It is the same product licence number for both leaflets i.e PL 15513/0118.

The information contained within each leaflet is identical apart from the manufacturer details,
column format and leaflet dimensions.

The leaflets are differentiated by manufacturer, column format (either 4 column or 3 column) as
well as their respective dimensions.
1. PIL 1 (pages 2-3) - 4 column format, dimensions 305 x 148 mm
Product license holder and manufacturer: McNeil Products Limited, 50 -100 Holmers
Farm Way, High Wycombe, Buckinghamshire, HP12 4EG, UK.

or

2. PIL 2 (pages 4-5) - 3 column format, dimensions 160 x 800 mm mm

Manufacturer: Janssen-Cilag S.p.A., Via C. Janssen, 04010 Borgo San Michele, Latina,
Italy.

This is a combined pdf of both leaflets.

Both these PILs are from different manufacturers as mentioned above and it will be inserted in
carton as per its manufactured site.
 GB Benadryl Allergy One A Day 10mg Tablets 7s 14s 30s PIL MAH Update
06.12.2021 English
402438055_r1 TI006PIL_024_06
Brochure/Leaflet/Insert 305 x 148 mm
CTE LITE

CIA79546F UCB Farchim SA, Switzerland

CIA79546E N/A
2163 N/A 2 Before taking this medicine ! Special warnings about this medicine ! If anyone has too much
8714205 8714405 73805 N/A This medicine is suitable for most adults and ■ In most people this product does not cause If anyone has too much contact a doctor or
EMEA_2021_00051187_000 N/A children aged 12 years and over, but a few people drowsiness. However, there are rare your nearest Accident and Emergency
should not use it. If you are in any doubt, talk to exceptions and you should take care when department (Casualty) taking this leaflet and
your doctor or pharmacist. you use this product for the first time. If this pack with you.

Do not take this medicine...

product makes you feel drowsy, do not drive ! If you forget to take the medicine
or operate machinery. This may be worsened
■ If you have ever had a bad reaction to by alcohol, sedatives or tranquilisers (used to If you forget to take a dose, take the next dose
cetirizine dihydrochloride, to hydroxyzine treat anxiety or sleep disorders). when needed provided that you only take a
PANTONE PANTONE 10 mg TABLETS or piperazine derivatives or any other ■ As with all antihistamines, it is advisable to
maximum of 1 tablet in 24 hours. Do not take
287 C 167 C a double dose.
Cetirizine dihydrochloride ingredients of this medicine (See section 6). avoid alcohol consumption when taking this
 
If you have serious kidney problems. medicine.
4 Possible side-effects
■
REPRESENTATION: Colours represented with a diagonal line have been modified to aid PDF approval.
■ This medicine is used to relieve the symptoms of ! Talk to your doctor or pharmacist ■ You should stop taking this product for 3 days
hay fever and other allergic conditions such as before undergoing a skin allergy test because Like all medicines, this medicine can cause side
■ If you are an epileptic or at risk of antihistamines can affect the results of the test.
pet or dust allergies and skin reactions. effects, although not everybody gets them.
convulsions (fits).
This product contains lactose. If you have been
■ This medicine is for use by adults and children If this applies to you, talk to a doctor or told by your doctor that you have an
If you experience any of the following,
aged 12 years and over. pharmacist. stop taking this medicine and seek
intolerance to some sugars, contact your
■ A doctor must be contacted if symptoms worsen If you experience symptoms such as a sudden doctor before taking this medicinal product. immediate medical help:
or do not improve after 3 days onset of fever, reddening of the skin with blisters ■ Sudden onset of fever, reddening of the skin,
Read the leaflet carefully before use. Keep this containing pus, stop giving this medicine 3 How to take this medicine or many small pustules (possible symptoms
of Acute Generalised Exanthematous
leaflet, you might need it again. immediately and talk to a doctor or pharmacist ■ For oral use only.
Smallest Text Size (See section 4). Pustulosis - AGEP) may occur within the first
HelveticaNeue ■ Swallow with a glass of water.
MetaPlusBold-Roman 5.5pt 1 What the medicine is for ! Warnings and precautions ■ Do not take more than the stated dose shown in
2 days of treatment with this medicine (See
section 2).
MyriadPro-Regular the table.
Ave. Text Size Benadryl Allergy One a Day 10 mg Tablets is a If you are a patient with kidney problems, Sudden signs of allergy such as rash, itching
Fonts used

■
Optima medicine which is used to relieve the symptoms of please ask your doctor for advice; if necessary, Children under 12 years old
7.5pt or hives on the skin, swelling of the face,
Optima-Bold hay fever and other allergic conditions such as pet you will take a lower dose. The new dose will This medicine is not recommended for children lips, tongue or other parts of the body,
Optima-BoldItalic
Largest Text Size or dust allergies. The tablets contain 10 mg be determined by your doctor. If you have aged under 12 years old. shortness of breath, wheezing or trouble
ZapfDingbatsITC 14.0pt cetirizine dihydrochloride which is an antihistamine difficulty passing urine, you should ask your breathing
that helps relieve allergy symptoms such as doctor for advice. Adults and children aged 12 years
2021-06-30 13:20:50

■ Bruising or bleeding more easily than

sneezing, runny nose and watery eyes.
! If you are pregnant or breast-feeding and above normal
It can also be used to treat allergic skin reactions. Age Dose ■ Convulsions (fits) or hallucinations
These include urticaria, also known as hives, where ■ If you are pregnant or breast-feeding, think ■ Loss of consciousness
the skin looks blotchy, with white raised wheals you may be pregnant or are planning to Adults and children Take 1 tablet
(bumps) surrounded by redness. have a baby, ask your doctor or pharmacist aged 12 years and above once a day
This medicine is for use in adults and children aged for advice before taking this medicine. ■ Do not take more than 1 tablet in 24 hours.
12 years and over. You should not take Benadryl Allergy One a ■ If symptoms persist or worsen, stop use and
Day 10 mg Tablets during breast feeding consult your doctor or pharmacist.
because cetirizine passes into breast milk. turn over
 GB Benadryl Allergy One A Day 10mg Tablets 7s 14s 30s PIL MAH Update
06.12.2021 English
402438055_r1 TI006PIL_024_06
Brochure/Leaflet/Insert 305 x 148 mm
CTE LITE

CIA79546F UCB Farchim SA, Switzerland

CIA79546E N/A
2163 N/A If you experience any of the following, In very rare cases people have thought about The film coating contains
8714205 8714405 73805 N/A stop taking this medicine and talk to your committing suicide and if you feel this way then hydroxypropylmethylcellulose (E464), titanium
doctor: stop taking the tablets and see your doctor. dioxide (E171) and macrogol 400.
EMEA_2021_00051187_000 N/A
■ Confusion Cases of impotence in adults have also been What the medicine looks like and
■ Abnormal liver function tests reported. contents of the pack
■ Rapid heartbeat Benadryl Allergy One a Day 10 mg Tablets are
Reporting of side effects
Other effects which may occur include: white oblong film-coated tablets, with a break-line
If you get any side effects, talk to your doctor,
Common: affects 1 to 10 users in 100 and Y-Y logo available in packs of 7, 14 and 30.
pharmacist or nurse. This includes any possible
■ Headache or dizziness
Not all pack sizes may be marketed.
PANTONE PANTONE
side effects not listed in this leaflet. You can also
287 C 167 C ■ Drowsiness or tiredness report side effects directly via the Yellow Card Product licence holder and manufacturer:
 
■ Restlessness Scheme at: www.mhra.gov.uk/yellowcard or McNeil Products Limited, 50 -100 Holmers Farm
REPRESENTATION: Colours represented with a diagonal line have been modified to aid PDF approval. ■ Dry mouth, sore throat search for MHRA Yellow Card in the Google Play Way, High Wycombe, Buckinghamshire, HP12
■ Upset stomach, abdominal pain, diarrhoea, or Apple App Store. 4EG, UK.
nausea By reporting side effects you can help provide This leaflet was revised in Dec 2021.
■ Runny nose Benadryl is a registered trade mark.
more information on the safety of this medicine.
Uncommon: affects 1 to 10 users in 1,000
■ Agitation
■ Unusual weakness
5 Storing this medicine
■ Feeling of general discomfort or uneasiness Keep this medicine out of the sight and reach of
■ Pins & needles children.
Rarely: affects 1 to 10 users in 10,000 This medicine does not require any special storage
■ Aggression, depression conditions. Do not use this medicine after the
HelveticaNeue Smallest Text Size ■ Weight gain expiry date stated on the carton and blister. The
MetaPlusBold-Roman 5.5pt ■ Movement disorders including tremor, expiry date refers to the last day of that month.
MyriadPro-Regular Ave. Text Size muscle spasm and tics Do not throw away any medicines via wastewater
Fonts used

Optima ■ Sleeplessness or household waste. Ask your pharmacist how to

7.5pt
Optima-Bold Very rarely: affects less than 1 user in 10,000 throw away medicines you no longer use. These
Optima-BoldItalic
Largest Text Size measures will help protect the environment.
■ Taste disorder
ZapfDingbatsITC 14.0pt ■ Blurred vision, eye movement disorder
2021-06-30 13:20:50

■ Difficult, painful or involuntary urination 6 Further Information

Other effects which may occur but it is unknown What's in this medicine?
how often:
The active ingredient in Benadryl Allergy One a
■ Vertigo, increased appetite
Day 10 mg Tablets is: 10 mg Cetirizine
■ Amnesia, memory impairment
dihydrochloride in each tablet.
■ Inability to pass urine
■ Eye pain
Other ingredients are: Microcrystalline cellulose,
■ Joint pain.
lactose, colloidal anhydrous silica and magnesium
■ Pruritus (intense itching) when you stop
stearate. 19-0127
giving this medicine. CIA79546F
 CHILD

2023-01-13 11:19:58
Fonts used

Coding (Silent Zone)

Dimensions
Component

Substrate
Reference

Product / Eurocode / Mat. ID Code 90099400 / 90099300 / 90099500

Old Component / Item Code
New Component / Item Code
Project Name / Design GB_Benadryl Allergy One A Day 10mg Tablets 7s 14s 30s_PIL
REPRESENTATION:
TECHNICAL DETAILS

MANUFACTURING SITE

LITHO OFFSET LITHO OFFSET

PANTONE
287 C
Braille Grid

Profile
Optima-Regular
Optima-BoldItalic
Optima-Bold
Optima
MyriadPro-Regular
MetaPlusBold-Roman
HelveticaNeue

PANTONE
167 C
160 x 800 mm
Leaflet

WHITE
Latina/Insert/016/V2

Colours represented with a diagonal line have been modified to aid PDF approval.
Print & Varnish Free

Text Limit

N/A
758803
Print Free

Bleed
ZapfDingbatsITC

Master Dieline
Plant

PC-Spec
Technical Code

Job / Version No.

Languages
ArtWorks ID
Fold/Technical
Varnish Free

402531534_r5
English
EMEA_2021_00051187_001
JJSC_00282_V1
Latina

N/A
3758
Perforation
Seal Area
20.92pt
Largest Text Size
11.5pt
Ave. Text Size
8.74pt
Smallest Text Size

Date 30-11-2021

Date 20-02-2023
Tamper Evident Label Area

Stamping Area
3758
3758

to your doctor or pharmacist. This product contains lactose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor
before taking this medicinal product.
Do not take this medicine...
■ If you have ever had a bad reaction to cetirizine dihydrochloride, to hydroxyzine or piperazine derivatives or any other ingredients of this This medicine contains less than 1 mmol sodium (23 mg) per 10 mg, that is to say essentially ‘sodium-free".
medicine (See section 6). 3 How to take this medicine
■ If you have serious kidney problems. ■ For oral use only.
! Talk to your doctor or pharmacist ■ Swallow with a glass of water.
■ Do not take more than the stated dose shown in the table.
■ If you are an epileptic or at risk of convulsions (fits).
10 mg TABLETS If this applies to you, talk to a doctor or pharmacist. Children under 12 years old
If you experience symptoms such as a sudden onset of fever, reddening of the skin with blisters containing pus, stop giving this medicine immediately This medicine is not recommended for children aged under 12 years old.
Cetirizine dihydrochloride and talk to a doctor or pharmacist (See section 4).
Adults and children aged 12 years and above
■ This medicine is used to relieve the symptoms of hay fever and other allergic conditions such as pet or dust allergies and skin reactions. ! Warnings and precautions Age Dose
■ This medicine is for use by adults and children aged 12 years and over.
If you are a patient with kidney problems, please ask your doctor for advice; if necessary, you will take a lower dose. The new dose will be
■ A doctor must be contacted if symptoms worsen or do not improve after 3 days determined by your doctor. If you have difficulty passing urine, you should ask your doctor for advice. Adults and children Take 1 tablet
Read the leaflet carefully before use. Keep this leaflet, you might need it again. aged 12 years and above once a day
! If you are pregnant or breast-feeding
1 What the medicine is for ■ If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice
■
■
Do not take more than 1 tablet in 24 hours.
If symptoms persist or worsen, stop use and consult your doctor or pharmacist.
before taking this medicine.
Benadryl Allergy One a Day 10 mg Tablets is a medicine which is used to relieve the symptoms of hay fever and other allergic conditions such
You should not take Benadryl Allergy One a Day 10 mg Tablets during breast feeding because cetirizine passes into breast milk.
as pet or dust allergies. The tablets contain 10 mg cetirizine dihydrochloride which is an antihistamine that helps relieve allergy symptoms ! If anyone has too much
such as sneezing, runny nose and watery eyes.
It can also be used to treat allergic skin reactions. These include urticaria, also known as hives, where the skin looks blotchy, with white raised
! Special warnings about this medicine If anyone has too much contact a doctor or your nearest Accident and Emergency department (Casualty) taking this leaflet and pack with
wheals (bumps) surrounded by redness. ■ In most people this product does not cause drowsiness. However, there are rare exceptions and you should take care when you use this you.
product for the first time. If this product makes you feel drowsy, do not drive or operate machinery. This may be worsened by alcohol, sedatives or
This medicine is for use in adults and children aged 12 years and over. tranquilisers (used to treat anxiety or sleep disorders). ! If you forget to take the medicine
2 Before taking this medicine ■ As with all antihistamines, it is advisable to avoid alcohol consumption when taking this medicine. If you forget to take a dose, take the next dose when needed provided that you only take a maximum of 1 tablet in 24 hours. Do not take

GB - 758803
■ You should stop taking this product for 3 days before undergoing a skin allergy test because antihistamines can affect the results of the test. a double dose.
This medicine is suitable for most adults and children aged 12 years and over, but a few people should not use it. If you are in any doubt, talk turn over

3758
3758
4 Possible side-effects ■
■
Feeling of general discomfort or uneasiness
Pins & needles
5 Storing this medicine
Like all medicines, this medicine can cause side effects, although not everybody gets them. Rarely: affects 1 to 10 users in 10,000 Keep this medicine out of the sight and reach of children.
If you experience any of the following, stop taking this medicine and seek immediate medical help: ■ Aggression, depression This medicine does not require any special storage conditions. Do not use this medicine after the expiry date stated on the carton and blister.
■ Weight gain The expiry date refers to the last day of that month.
■ Sudden onset of fever, reddening of the skin, or many small pustules (possible symptoms of Acute Generalised Exanthematous
■ Movement disorders including tremor, muscle spasm and tics Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use.
Pustulosis - AGEP) may occur within the first 2 days of treatment with this medicine (See section 2).
■ Sleeplessness These measures will help protect the environment.
■ Sudden signs of allergy such as rash, itching or hives on the skin, swelling of the face, lips, tongue or other parts of the body,
shortness of breath, wheezing or trouble breathing Very rarely: affects less than 1 user in 10,000
■ Bruising or bleeding more easily than normal ■ Taste disorder 6 Further Information
■ Blurred vision, eye movement disorder
■ Convulsions (fits) or hallucinations What's in this medicine?
■ Difficult, painful or involuntary urination
■ Loss of consciousness
Other effects which may occur but it is unknown how often: The active ingredient in Benadryl Allergy One a Day 10 mg Tablets is: 10 mg Cetirizine dihydrochloride in each tablet.
If you experience any of the following, stop taking this medicine and talk to your doctor: ■ Vertigo, increased appetite Other ingredients are: Microcrystalline cellulose, lactose monohydrate, colloidal anhydrous silica, crosscarmellose sodium and magnesium stearate.
■ Confusion ■ Amnesia, memory impairment The film coating contains hydroxypropylmethylcellulose (E464), titanium dioxide (E171) and polyethylene glycol.
Abnormal liver function tests ■ Inability to pass urine
■
■ Rapid heartbeat ■ Eye pain What the medicine looks like and contents of the pack
■ Joint pain. Bendadryl Allergy One a Day 10mg Tablets are white oblong film-coated tablets, with the letters ‘CTZ’ on one side and the characters
Other effects which may occur include: ■ Pruritus (intense itching) when you stop giving this medicine. ‘10 MG’ on the other side with a break-line between ‘10’ and ‘MG’ available in packs of 7, 14 and 30. Not all pack sizes may be marketed.
Common: affects 1 to 10 users in 100 In very rare cases people have thought about committing suicide and if you feel this way then stop taking the tablets and see your doctor. MA holder: McNeil Products Limited, 50 – 100 Holmers Farm Way, High Wycombe, Buckinghamshire, HP12 4EG, UK.
■ Headache or dizziness Cases of impotence in adults have also been reported. Manufacturer: Janssen-Cilag S.p.A., Via C. Janssen, 04010 Borgo San Michele, Latina, Italy.
■ Drowsiness or tiredness
■ Restlessness Reporting of side effects This leaflet was revised in September 2022.
■ Dry mouth, sore throat Benadryl is a registered trade mark.
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible
■ Upset stomach, abdominal pain, diarrhoea, nausea
side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard or search for
■ Runny nose
MHRA Yellow Card in the Google Play or Apple App Store.
Uncommon: affects 1 to 10 users in 1,000 By reporting side effects you can help provide

GB - 758803
■ Agitation
more information on the safety of this medicine.
■ Unusual weakness