Label: DIMETAPP- brompheniramine maleate, pseudoephedrine hydrochloride elixir
- NDC Code(s): 0031-2231-86, 0031-2231-88, 0031-2231-89
- 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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- ACTIVE INGREDIENT
-
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
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WARNINGS
Warnings
Do not useif 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
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
- STORAGE AND HANDLING
- DOSAGE & ADMINISTRATION
- INACTIVE INGREDIENT
- PRINCIPAL DISPLAY PANEL - 118 mL Bottle Carton
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INGREDIENTS AND APPEARANCE
DIMETAPP
brompheniramine maleate, pseudoephedrine hydrochloride elixirProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0031-2231 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 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 Color purple Score Shape Size Flavor GRAPE Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0031-2231-89 1 in 1 CARTON 07/09/2015 1 118 mL in 1 BOTTLE; Type 0: Not a Combination Product 2 NDC:0031-2231-86 1 in 1 CARTON 07/09/2015 2 118 mL in 1 BOTTLE; Type 0: Not a Combination Product 3 NDC:0031-2231-88 1 in 1 CARTON 07/09/2015 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 07/09/2015 Labeler - Haleon US Holdings LLC (079944263)