DIMETAPP- brompheniramine maleate, pseudoephedrine hydrochloride elixir 
GlaxoSmithKline Consumer Healthcare Holdings (US) LLC

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Dimetapp®

Active ingredients (in each 5 mL tsp)Purpose

Brompheniramine maleate, USP 1 mg

Antihistamine

Pseudoephedrine HCl, USP 15 mg

Nasal decongestant

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):
o
runny nose
o
sneezing
o
itchy, watery eyes
o
itching of the nose or throat
temporarily restores freer breathing through the nose

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.

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.

Directions

do not take more than 4 doses in any 24-hour period
agedose

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 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

Dimetapp®
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)

Principal Display Panel - 118 mL Bottle Carton
DIMETAPP 
brompheniramine maleate, pseudoephedrine hydrochloride elixir
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0031-2231
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
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
ColorPURPLEScore    
ShapeSize
FlavorGRAPEImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0031-2231-891 in 1 CARTON07/09/2015
1118 mL in 1 BOTTLE; Type 0: Not a Combination Product
2NDC:0031-2231-861 in 1 CARTON07/09/2015
2118 mL in 1 BOTTLE; Type 0: Not a Combination Product
3NDC:0031-2231-881 in 1 CARTON07/09/2015
3118 mL in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
Export only07/09/2015
Labeler - GlaxoSmithKline Consumer Healthcare Holdings (US) LLC (079944263)

Revised: 1/2024
Document Id: cbb620bd-e2a6-4d09-b050-8114699bbf20
Set id: 4f7b773b-950f-41fb-b024-689a89019fda
Version: 5
Effective Time: 20240110
 
GlaxoSmithKline Consumer Healthcare Holdings (US) LLC