Label: DIMETAPP- brompheniramine maleate, pseudoephedrine hydrochloride elixir

  • NDC Code(s): 0031-2231-86, 0031-2231-88, 0031-2231-89
  • Packager: GlaxoSmithKline Consumer Healthcare Holdings (US) LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Export only

Drug Label Information

Updated January 25, 2021

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

  • ACTIVE INGREDIENT

    Active ingredients (in each 5 mL tsp)Purpose

    Brompheniramine maleate, USP 1 mg

    Antihistamine

    Pseudoephedrine HCl, USP 15 mg

    Nasal decongestant

  • INDICATIONS & USAGE

    Uses

    temporarily relieves nasal and sinus congestion due to the common cold, hay fever or other upper respiratory allergies, or associated with sinusitis
    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

    Warnings

    Do not use 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 or chronic bronchitis

    Ask a doctor or pharmacist before use if you are 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.

  • STORAGE AND HANDLING

    Other information

    store at 20-25°C (68-77°F)
    not a USP elixir
    dosage cup provided
    Pleasant tasting – children find its great grape taste easy to take.
    Adults like it, too – especially those who have difficulty swallowing tablets or capsules.
  • DOSAGE & ADMINISTRATION

    Directions

    do not take more than 4 doses in any 24-hour period
    agedose

    adults and children 12 years and over

    4 tsp every 4 hours

    children 6 to under 12 years

    2 tsp every 4 hours

    children under 6 years

    Do not use

  • INACTIVE INGREDIENT

    Inactive ingredients

    artificial flavor, citric acid, FD&C blue no. 1, FD&C red no. 40, glycerin, high fructose corn syrup, propylene glycol, saccharin sodium, sodium benzoate, sorbitol, purified water

  • PRINCIPAL DISPLAY PANEL - 118 mL Bottle Carton

    Dimetapp®
    Elixir
    NASAL DECONGESTANT
    ANTIHISTAMINE

    GREAT GRAPE TASTE
    FOR CHILDREN & ADULTS

    RELIEVES COLD AND
    ALLERGY SYMPTOMS

    NASAL CONGESTION

    RUNNING NOSE

    ITCHY, WATERY EYES

    SNEEZING

    4 FL. OZ. (118 mL)

    Principal Display Panel - 118 mL Bottle Carton
  • INGREDIENTS AND APPEARANCE
    DIMETAPP 
    brompheniramine maleate, pseudoephedrine hydrochloride elixir
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0031-2231
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BROMPHENIRAMINE MALEATE (UNII: IXA7C9ZN03) (BROMPHENIRAMINE - UNII:H57G17P2FN) BROMPHENIRAMINE MALEATE1 mg  in 5 mL
    PSEUDOEPHEDRINE HYDROCHLORIDE (UNII: 6V9V2RYJ8N) (PSEUDOEPHEDRINE - UNII:7CUC9DDI9F) PSEUDOEPHEDRINE HYDROCHLORIDE15 mg  in 5 mL
    Inactive Ingredients
    Ingredient NameStrength
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    HIGH FRUCTOSE CORN SYRUP (UNII: XY6UN3QB6S)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SORBITOL (UNII: 506T60A25R)  
    WATER (UNII: 059QF0KO0R)  
    Product Characteristics
    ColorPURPLEScore    
    ShapeSize
    FlavorGRAPEImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0031-2231-891 in 1 CARTON07/09/2015
    1118 mL in 1 BOTTLE; Type 0: Not a Combination Product
    2NDC:0031-2231-861 in 1 CARTON07/09/2015
    2118 mL in 1 BOTTLE; Type 0: Not a Combination Product
    3NDC:0031-2231-881 in 1 CARTON07/09/2015
    3118 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    Export only07/09/2015
    Labeler - GlaxoSmithKline Consumer Healthcare Holdings (US) LLC (079944263)