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 10, 2024

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  • 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):
    o
    runny nose
    o
    sneezing
    o
    itchy, watery eyes
    o
    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)
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