Label: DIMETAPP PAEDIATRIC- brompheneramine maleate, pseduephedrine hydrochloride elixir

  • NDC Code(s): 0031-2251-04, 0031-2251-05, 0031-2251-12
  • 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

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  • PRINCIPAL DISPLAY PANEL - 118 ml Bottle Carton

    READ DIRECTIONS CAREFULLY

    37/5.8/0406

    S2

    Dimetapp®

    Paediatric
    Elixir

    Relieves:

    1.
    Nasal Congestion
    2.
    Sneezing
    3.
    Runny Nose
    4.
    Sniffing

    GREAT
    GRAPE TASTE

    ALCOHOL-FREE

    4 FL OZ 118 ml

    PRINCIPAL DISPLAY PANEL - 118 ml Bottle Carton
  • PRINCIPAL DISPLAY PANEL - 118 mL Bottle Carton - Adult

    Dimetapp®
    Elixir
    NASAL DECONGESTANT
    ANTIHISTAMINE

    GREAT GRAPE TASTE
    FOR CHILDREN & ADULTS

    RELIEVES COLD AND
    ALLERGY SYMPTOMS

    NASAL CONGESTION

    RUNNY NOSE

    ITCHY, WATERY EYES

    SNEEZING

    4 FL. OZ. (118 mL)

    PRINCIPAL DISPLAY PANEL - 118 mL Bottle Carton - Adult
  • INGREDIENTS AND APPEARANCE
    DIMETAPP PAEDIATRIC 
    brompheneramine maleate, pseduephedrine hydrochloride elixir
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0031-2251
    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
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SORBITOL (UNII: 506T60A25R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    TRISODIUM CITRATE DIHYDRATE (UNII: B22547B95K)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    WATER (UNII: 059QF0KO0R)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    Product Characteristics
    ColorPURPLEScore    
    ShapeSize
    FlavorGRAPEImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0031-2251-121 in 1 CARTON09/14/2015
    1118 mL in 1 BOTTLE; Type 0: Not a Combination Product
    2NDC:0031-2251-041 in 1 CARTON08/08/2016
    2118 mL in 1 BOTTLE; Type 0: Not a Combination Product
    3NDC:0031-2251-051 in 1 CARTON08/08/2016
    3118 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    Export only09/14/2015
    Labeler - GlaxoSmithKline Consumer Healthcare Holdings (US) LLC (079944263)