Label: CHILDRENS DIMETAPP MULTI-SYMPTOM COLD AND FLU- acetaminophen, diphenhydramine hydrochloride, phenylephrine hydrochloride liquid

  • NDC Code(s): 0031-2249-04
  • Packager: GlaxoSmithKline Consumer Healthcare Holdings (US) LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

DISCLAIMER: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

Drug Label Information

Updated June 9, 2021

If you are a consumer or patient please visit this version.

  • Active ingredients (in each 10 ml)

    Acetaminophen, USP 320 mg

    Diphenhydramine HCl, USP 12.5 mg

    Phenylephrine HCl, USP 5 mg

  • Purposes

    Pain reliever/Fever reducer

    Antihistamine/Cough suppressant

    Nasal decongestant

  • INDICATIONS & USAGE

    Uses

    temporarily relieves these symptoms associated with a cold, or flu:
    headache
    sore throat
    fever
    minor aches and pains
    temporarily relieves nasal congestion, and cough due to minor throat and bronchial irritation occurring with a cold
    temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:
    sneezing
    itching of the nose or throat
    itchy, watery eyes
    runny nose
    temporarily restores freer breathing through the nose
  • WARNINGS

    Warnings

    Liver warning

    This product contains acetaminophen. Severe liver damage may occur if user takes

    more than 5 doses in any 24-hour period, which is the maximum daily amount
    with other drugs containing acetaminophen
    3 or more alcoholic drinks every day while using this product

    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 use

    to sedate a child or to make a child sleepy
    in a child under 6 years of age
    if user is 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 this product.
    with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen ask a doctor or pharmacist.
    with any other product containing diphenhydramine, even one used on skin

    Ask a doctor before use if user has

    liver disease
    heart disease
    high blood pressure
    thyroid disease
    diabetes
    trouble urinating due to an enlarged prostate gland
    glaucoma
    cough that occurs with too much phlegm (mucus)
    a breathing problem or chronic cough that lasts or as occurs with smoking, asthma, chronic bronchitis, or emphysema

    Ask a doctor or pharmacist before use if user is

    taking the blood thinning drug warfarin
    taking any other oral nasal decongestant or stimulant
    taking any other pain reliever/fever reducer
    taking sedatives or tranquilizers

    When using this product

    do not use more than directed
    marked drowsiness may occur
    avoid alcoholic drinks
    alcohol, sedatives, and tranquilizers may increase drowsiness
    be careful when driving a motor vehicle or operating machinery
    excitability may occur, especially in children

    Stop use and ask a doctor if

    user gets nervous, dizzy, or sleepless
    pain, cough, or nasal congestion gets worse or lasts more than 5 days (children) or 7 days (adults)
    fever gets worse or lasts more than 3 days
    redness or swelling is present
    cough comes back or occurs with rash or headache that lasts. These could be signs of a serious condition.
    new symptoms occur

    If pregnant or breast-feeding, ask a health professional before use.

    Keep out of reach of children. In case of 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.

  • DOSAGE & ADMINISTRATION

    Directions

    do not take more than 5 doses in any 24-hour period
    do not exceed recommended dosage. Taking more than the recommended dose (overdose) may cause serious liver damage.
    measure only with dosage cup provided
    keep dosage cup with product
    ml = milliliter
    agedose

    adults and children 12 years and over

    20 ml every 4 hours

    children 6 to 12 years

    10 ml every 4 hours

    children under 6 years

    do not use

  • STORAGE AND HANDLING

    Other information

    each 10 ml contains: sodium 7 mg
    store at 20-25°C (68-77°F)
  • INACTIVE INGREDIENT

    Inactive ingredients

    anhydrous citric acid, artificial flavor, edetate disodium, FD&C red no. 40, glycerin, menthol, polyethylene glycol, propyl gallate, propylene glycol, purified water, sodium benzoate, sodium citrate, sorbitol solution, sucralose

  • QUESTIONS

    Questions or comments?

    Call weekdays from 9 AM to 5 PM EST at 1-800-762-4675

    For most recent product information, visit www.dimetapp.com

  • SPL UNCLASSIFIED SECTION

    Distributed by:
    Pfizer, Madison, NJ 07940 USA

  • PRINCIPAL DISPLAY PANEL - 118 ml Bottle Label

    Children's
    Dimetapp®

    Multi-Symptom
    Cold & Flu

    ACETAMINOPHEN (Pain Reliever/Fever Reducer)
    DIPHENHYDRAMINE HCl (Antihistamine/Cough Suppressant)
    PHENYLEPHRINE HCl (Nasal Decongestant)

    Relieves Nasal Symptoms

    Stuffy Nose
    Runny Nose
    Sneezing

    Plus Other Symptoms

    Itchy, Watery Eyes
    Cough
    Fever, Headaches
    Body Aches

    Packaged with Tamper-Evident
    bottle cap. Do Not Use if breakable
    ring is separated or missing.

    4 FL OZ (118 ml)

    Principal Display Panel - 118 ml Bottle Label
  • PRINCIPAL DISPLAY PANEL - 118 ml Bottle Carton

    NEW FORMULA

    Children's
    Dimetapp®

    ACETAMINOPHEN (Pain Reliever/Fever Reducer)
    DIPHENHYDRAMINE HCl (Antihistamine/Cough Suppressant)
    PHENYLEPHRINE HCl (Nasal Decongestant)

    Multi-Symptom
    Cold & Flu

    Relieves Nasal Symptoms

    Stuffy Nose
    Runny Nose
    Sneezing

    Plus Other Symptoms

    Itchy, Watery Eyes
    Cough
    Fever, Headaches
    Body Aches

    4 FL OZ (118 ml)
    alcohol-free • red grape flavor

    Principal Display Panel - 118 ml Bottle Carton
  • INGREDIENTS AND APPEARANCE
    CHILDRENS DIMETAPP MULTI-SYMPTOM COLD AND FLU 
    acetaminophen, diphenhydramine hydrochloride, phenylephrine hydrochloride liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0031-2249
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN320 mg  in 10 mL
    DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIPHENHYDRAMINE HYDROCHLORIDE12.5 mg  in 10 mL
    PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE5 mg  in 10 mL
    Inactive Ingredients
    Ingredient NameStrength
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    PROPYL GALLATE (UNII: 8D4SNN7V92)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)  
    SORBITOL (UNII: 506T60A25R)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    Product Characteristics
    ColorRED (red) Score    
    ShapeSize
    FlavorGRAPE (grape) Imprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0031-2249-041 in 1 CARTON01/01/202008/31/2022
    1118 mL in 1 BOTTLE; Type 1: Convenience Kit of Co-Package
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    Unapproved drug other01/01/202008/31/2022
    Labeler - GlaxoSmithKline Consumer Healthcare Holdings (US) LLC (079944263)