Label: CHILDRENS DIMETAPP COLD AND ALLERGY- brompheniramine maleate, phenylephrine hcl liquid

  • NDC Code(s): 0031-2235-13, 0031-2235-19
  • Packager: GlaxoSmithKline Consumer Healthcare Holdings (US) LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

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.

Drug Label Information

Updated June 9, 2021

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

  • ACTIVE INGREDIENTS (IN EACH 10 ML)

    Brompheniramine maleate, USP 2 mg

    Phenylephrine HCl , USP 5 mg

  • PURPOSES

    Antihistamine

    Nasal decongestant

  • USES

    temporarily relieves nasal congestion due to the common cold, hay fever or other upper respiratory allergies
    temporarily relieves these symptoms due to hay fever (allergic rhinitis):
    runny nose
    sneezing
    itchy, watery eyes
    itching of the nose or throat
    temporarily restores freer breathing through the nose
  • WARNINGS

    Do not use

    to sedate a child or to make a child sleepy
    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 this product.

    Ask a doctor before use if you have

    heart disease
    high blood pressure
    thyroid disease
    diabetes
    trouble urinating due to an enlarged prostate gland
    glaucoma
    a breathing problem such as emphysema, asthma, or chronic bronchitis

    Ask a doctor or pharmacist before use if you are

    taking any other oral nasal decongestant or stimulant
    taking sedatives or tranquilizers

    When using this product

    do not use more than directed
    drowsiness may occur
    avoid alcoholic beverages
    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

    you get nervous, dizzy, or sleepless
    symptoms do not get better within 7 days or are accompanied by fever

    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.

  • DIRECTIONS

    do not take more than 6 doses in any 24-hour period
    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 under 12 years

    10 ml every 4 hours

    children under 6 years

    do not use

  • OTHER INFORMATION

    each 10 ml contains: sodium 6 mg
    store at 20-25°C (68-77°F)
  • INACTIVE INGREDIENTS

    anhydrous citric acid, artificial flavor, FD&C blue no. 1, FD&C red no. 40, glycerin, propylene glycol, purified water, sodium benzoate, sodium citrate, sorbitol solution, sucralose

  • QUESTIONS OR COMMENTS?

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

  • PRINCIPAL DISPLAY PANEL

    NDC 0031-2235-13

    Children's
    Dimetapp®

    BROMPHENIRAMINE MALEATE (Antihistamine)
    PHENYLEPHRINE HCl (Nasal Decongestant)

    Cold
    & Allergy

    Relieves Nasal Symptoms

    Stuffy Nose
    Runny Nose
    Sneezing

    Plus Other Symptoms

    Itchy, Watery Eyes

    For Ages
    6 Yrs.
    & Over

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

    PRINCIPAL DISPLAY PANEL - 118 ml Bottle Carton
  • INGREDIENTS AND APPEARANCE
    CHILDRENS DIMETAPP COLD AND ALLERGY 
    brompheniramine maleate, phenylephrine hcl liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0031-2235
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BROMPHENIRAMINE MALEATE (UNII: IXA7C9ZN03) (BROMPHENIRAMINE - UNII:H57G17P2FN) BROMPHENIRAMINE MALEATE1 mg  in 5 mL
    PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE2.5 mg  in 5 mL
    Inactive Ingredients
    Ingredient NameStrength
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    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
    ColorPURPLE (purple liquid) Score    
    ShapeSize
    FlavorGRAPE (grape flavor and odor) Imprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0031-2235-131 in 1 CARTON02/07/200704/30/2022
    1118 mL in 1 BOTTLE; Type 1: Convenience Kit of Co-Package
    2NDC:0031-2235-191 in 1 CARTON02/07/200704/30/2022
    2237 mL in 1 BOTTLE; Type 1: Convenience Kit of Co-Package
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34102/07/200704/30/2022
    Labeler - GlaxoSmithKline Consumer Healthcare Holdings (US) LLC (079944263)