Label: DIMETAPP PAEDIATRIC- brompheneramine maleate, pseduephedrine hydrochloride elixir
- NDC Code(s): 0031-2251-04, 0031-2251-05, 0031-2251-12
- Packager: Haleon US Holdings LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: Export only
Drug Label Information
Updated April 24, 2024
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- Official Label (Printer Friendly)
- PRINCIPAL DISPLAY PANEL - 118 ml Bottle Carton
- PRINCIPAL DISPLAY PANEL - 118 mL Bottle Carton - Adult
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INGREDIENTS AND APPEARANCE
DIMETAPP PAEDIATRIC
brompheneramine maleate, pseduephedrine hydrochloride elixirProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0031-2251 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BROMPHENIRAMINE MALEATE (UNII: IXA7C9ZN03) (BROMPHENIRAMINE - UNII:H57G17P2FN) BROMPHENIRAMINE MALEATE 1 mg in 5 mL PSEUDOEPHEDRINE HYDROCHLORIDE (UNII: 6V9V2RYJ8N) (PSEUDOEPHEDRINE - UNII:7CUC9DDI9F) PSEUDOEPHEDRINE HYDROCHLORIDE 15 mg in 5 mL Inactive Ingredients Ingredient Name Strength 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 Color purple Score Shape Size Flavor GRAPE Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0031-2251-12 1 in 1 CARTON 09/14/2015 1 118 mL in 1 BOTTLE; Type 0: Not a Combination Product 2 NDC:0031-2251-04 1 in 1 CARTON 08/08/2016 2 118 mL in 1 BOTTLE; Type 0: Not a Combination Product 3 NDC:0031-2251-05 1 in 1 CARTON 08/08/2016 3 118 mL in 1 BOTTLE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date Export only 09/14/2015 Labeler - Haleon US Holdings LLC (079944263)
