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    Acetaminophen Combined

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    loreabreu1003
    This document provides information about a medication containing acetaminophen, dextromethorphan, guaifenesin, and phenylephrine. It lists the active ingredients and strengths, describes the intended uses, warnings, directions, and other details.

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    © All Rights Reserved
    Download as PDF, TXT or read online from Scribd

    Acetaminophen Combined

    Uploaded by

    loreabreu1003
    19 views5 pages
    This document provides information about a medication containing acetaminophen, dextromethorphan, guaifenesin, and phenylephrine. It lists the active ingredients and strengths, describes the intended uses, warnings, directions, and other details.

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    acetaminophen combined PI

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    acetaminophen combined

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    This document provides information about a medication containing acetaminophen, dextromethorphan, guaifenesin, and phenylephrine. It lists the active ingredients and strengths, describes the intended uses, warnings, directions, and other details.

    Copyright:

    © All Rights Reserved
    Download as PDF, TXT or read online from Scribd
    Download as pdf or txt
    19 views5 pages

    Acetaminophen Combined

    Uploaded by

    loreabreu1003
    This document provides information about a medication containing acetaminophen, dextromethorphan, guaifenesin, and phenylephrine. It lists the active ingredients and strengths, describes the intended uses, warnings, directions, and other details.

    Copyright:

    © All Rights Reserved
    Download as PDF, TXT or read online from Scribd
    Download as pdf or txt
    of 5

    ACETAMINOPHEN 500MG, DEXTROMETHORPHAN HBR 10MG, GUAIFENESIN 200MG,

    PHENYLEPHRINE HCL 5MG- acetaminophen 500mg, dextromethorphan hbr 10mg,


    guaifenes in 200mg, phenylephrine hcl 5mg tablet
    Strive Pharmaceuticals Inc
    Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they
    comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
    ----------
    Cold & Flu - Gripa (Acetaminophen 325mg; Dextromethorphan HBr 10mg, Guaifenes in 200mg,
    Phenylephrine HCl 5mg)
    Acetaminophen 325mg; Dextromethorphan HBr 10mg; Gauifenesin 200mg; Phenylephrine HCl 5mg
    colloidal silicon dioxide, croscarmellose sodium, dibasic calcium phosphate, FD&C yellow#6,
    magnesium staerate, mica, microcrystalline cellulose, polyethylene glycol, polysorbate 80, polyvinyl
    alcohol, stearic acid, talc
    take with a full glass of water
    do not take more than directed
    do not exceed 8 caplets per 24 hours

    adults & children 12 years of age & over 2 caplets with water every 4 hours
    children 4 to 12 years of age ask a doctor
    children under 4 years of age do not use

    *temporarily relief of occasional heaches and minor aches and pains with accompanying sleeplessness
    Liver warning:
    This product contains acetaminophen. Severe liver damage may occur if you take:
    more than 8 caplets in 24 hours, which is the maximum daily amount for this product
    with other drugs containing acetaminophen
    3 or more alcoholic drinks every day while using this product

    Allergy alert:
    Acetaminophen may cause severe skin reactions. Symptoms may include:
    skin reddening
    blisters
    rash

    if a skin reaction occurs, stop use and seek medical help right away
    Sore throat warning:
    If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache,
    rash, nausea, or vomiting, consult a doctor promptly
    Do not us e
    with any other drug containing acetaminophen (prescription or non prescription). If you are not sure
    whether a drug contains acetaminophen, ask a doctor or pharmacist
    if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for
    depression, psychiatric or emotional conditions, or Parkinson's disease), or for 2 weeks after
    stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a
    doctor or pharmacist before taking ths product
    if you have ever had an allergic reaction to this product or any of its ingredients
    As k a doctor before us e if you have
    liver disease
    heart disease
    high blood pressure
    thyroid disease
    diabetes
    trouble urinating due to an enlarged prostrate gland
    cough that occurs with too much phlegm (mucus)
    persistent or chronic cough such as occurs with smoking, asthama, chronic bronchitis, or
    emphysema

    As k a doctor or a pharmacis t before us e if you are


    taking the blood thinning drug warfarin

    When us ing this product


    do not use more than directed

    Stop us e and as k a doctor if


    you get nervous, dizzy or sleepless
    pain, nasal congestion, or cough gets worse or lasts more than 7 days
    fever gets worse or lasts more than 3 days
    redness or swelling is present
    new symptoms occur
    cough comes back or occurs with rash or headache that lasts

    These could be signs of a serious condition


    If pregnant or breas t-feeding,
    ask a health professional before use
    Keep out of reach of children
    Overdos e warning: In case of accidental overdose, get medical help or contact a Poison Control
    Center right away. Prompt medical attention is critical for adults as well as for children even if you do
    not notice any signs or symptoms.
    Keep out of reach of children
    Overdos e Warning: In case of accidental overdose, get medical help or contact a Poison Control
    Center right away. Prompt medical attention is critical for adults as well as for children even if you do
    not notice any signs or symptoms.
    Pain reliever / fever reducer, cough suppressant, expectorant, nasal decongestant
    store at room temperature between 20 º C - 25 º C (68 º F - 77 º F)
    avoid excessive heat and humidity
    ACETAMINOPHEN 500MG, DEXTROMETHORPHAN HBR 10MG,
    GUAIFENESIN 200MG, PHENYLEPHRINE HCL 5MG
    acetaminophen 500mg, dextromethorphan hbr 10mg, guaifenesin 200mg, phenylephrine hcl 5mg tablet

    Product Information
    Prod uct T yp e HUMAN O TC DRUG Ite m Cod e (S ource ) NDC:70 6 9 2-10 8

    Route of Ad minis tration O RAL

    Active Ing redient/Active Moiety


    Ing redient Name Basis o f Streng th Streng th
    GUAIFENESIN (UNII: 49 5W7451VQ ) (GUAIFENESIN - UNII:49 5W7451VQ ) GUAIFENESIN 20 0 mg
    PHENYLEPHRINE HYDRO CHLO RIDE (UNII: 0 4JA59 TNSJ) (PHENYLEPHRINE - PHENYLEPHRINE
    5 mg
    UNII:1WS29 7W6 MV) HYDRO CHLO RIDE
    DEXTRO METHO RPHAN HYDRO BRO MIDE (UNII: 9 D2RTI9 KYH) DEXTRO METHO RPHAN
    10 mg
    (DEXTRO METHO RPHAN - UNII:7355X3RO TS) HYDRO BRO MIDE
    ACETAMINO PHEN (UNII: 36 2O 9 ITL9 D) (ACETAMINO PHEN - UNII:36 2O 9 ITL9 D) ACETAMINO PHEN 325 mg

    Inactive Ing redients


    Ing redient Name Streng th
    STEARIC ACID (UNII: 4ELV7Z6 5AP)
    CRO SCARMELLO SE SO DIUM (UNII: M28 O L1HH48 )
    PO LYETHYLENE GLYCO L 4 0 0 (UNII: B6 9 78 9 4SGQ )
    FD&C YELLO W NO . 6 (UNII: H77VEI9 3A8 )
    DIBASIC CALCIUM PHO SPHATE DIHYDRATE (UNII: O 7TSZ9 7GEP)
    MICRO CRYSTALLINE CELLULO SE (UNII: O P1R32D6 1U)
    SILICO N DIO XIDE (UNII: ETJ7Z6 XBU4)
    MICA (UNII: V8 A1AW0 8 8 0 )
    MAGNESIUM STEARATE (UNII: 70 0 9 7M6 I30 )
    PO LYSO RBATE 8 0 (UNII: 6 O ZP39 ZG8 H)
    TALC (UNII: 7SEV7J4R1U)
    PO LYVINYL ALCO HO L, UNSPECIFIED (UNII: 532B59 J9 9 0 )

    Product Characteristics
    Color o ra nge S core no sc o re
    S hap e CAPSULE S iz e 19 mm
    Flavor Imp rint Cod e S70 1
    Contains

    Packag ing
    # Item Co de Packag e Descriptio n Marketing Start Date Marketing End Date
    1 NDC:70 6 9 2-10 8 -41 4 in 1 PACKAGE; Type 0 : No t a Co mbina tio n Pro duc t 12/20 /20 18

    Marketing Information
    Marke ting Cate gory Ap p lication Numb e r or Monograp h Citation Marke ting S tart Date Marke ting End Date
    O TC mo no gra ph fina l pa rt341 12/20 /20 18

    Labeler - Strive Pharmaceuticals Inc (080028013)

    Revised: 11/2020 Strive Pharmaceuticals Inc

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