Label: DIMETAPP COLD AND ALLERGY- brompheniramine maleate solution
- NDC Code(s): 69536-305-04, 69536-305-08
- Packager: Foundation Consumer Healthcare
- Category: HUMAN OTC DRUG LABEL
Drug Label Information
Updated June 1, 2024
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- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENT
- Uses
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Warnings
Ask a doctor before use if you have
- 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
- Directions
- Other information
- Inactive ingredients
- Questions or comments?
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL - 118 mL Bottle Carton
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INGREDIENTS AND APPEARANCE
DIMETAPP COLD AND ALLERGY
brompheniramine maleate solutionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:69536-305 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BROMPHENIRAMINE MALEATE (UNII: IXA7C9ZN03) (BROMPHENIRAMINE - UNII:H57G17P2FN) BROMPHENIRAMINE MALEATE 2 mg in 10 mL Inactive Ingredients Ingredient Name Strength 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 Color purple Score Shape Size Flavor GRAPE Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:69536-305-04 1 in 1 CARTON 06/15/2024 1 118 mL in 1 BOTTLE; Type 0: Not a Combination Product 2 NDC:69536-305-08 1 in 1 CARTON 06/15/2024 2 237 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 OTC Monograph Drug M012 06/15/2024 Labeler - Foundation Consumer Healthcare (079675882)