DIMETAPP- brompheniramine maleate, pseudoephedrine hydrochloride elixir 
Haleon US Holdings 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

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

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

Directions

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 - Haleon US Holdings LLC (079944263)

Revised: 4/2024
Document Id: 16d88f5d-0ca6-17b2-e063-6394a90ae82f
Set id: 4f7b773b-950f-41fb-b024-689a89019fda
Version: 6
Effective Time: 20240424
 
Haleon US Holdings LLC