DIMETAPP- brompheniramine maleate, pseudoephedrine hydrochloride elixir

Dimetapp by

Drug Labeling and Warnings

Dimetapp by is a Otc medication manufactured, distributed, or labeled by GlaxoSmithKline Consumer Healthcare Holdings (US) LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

age	dose
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

Dimetap®
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)

INGREDIENTS AND APPEARANCE

DIMETAPP 
brompheniramine maleate, pseudoephedrine hydrochloride elixir

Product 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 - Wyeth Consumer Healthcare LLC (828831730)