DIMETAPP COLD AND ALLERGY- brompheniramine maleate solution 
Foundation Consumer Healthcare

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Dimetapp ®
Cold and Allergy

Drug Facts

Active ingredient (in each 10 mL)Purpose
Brompheniramine maleate, 2 mgAntihistamine

Uses

Warnings

Do not use

  • to sedate a child or to make a child sleepy

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

When using this product

  • do not use more than directed
  • drowsiness may occur
  • avoid alcoholic drinks
  • alcohol, sedatives, and tranquilizers may increase drowsiness
  • be careful when driving a motor vehicle or operating machinery
  • excitability may occur, especially in children

If pregnant or breast-feeding,ask a health professional before use.

Keep out of reach of children.In case of overdose, get medical help or contact a Poison Control Center right away.

Directions

agedose
adults and children 12 years and over20 mL every 4 hours
children 6 to under 12 years10 mL every 4 hours
children under 6 yearsdo not use

Other information

Inactive ingredients

anhydrous citric acid, artificial flavor, FD&C blue no. 1, FD&C red no. 40, glycerin, propylene glycol, purified water, sodium benzoate, sodium citrate, sorbitol solution, sucralose

Questions or comments?

Call 1-888-594-0828weekdays 9 AM to 5 PM EST

Distributed by:
Foundation Consumer Brands, LLC
Pittsburgh, PA 15212

PRINCIPAL DISPLAY PANEL - 118 mL Bottle Carton

CHILDREN'S
Dimetapp ®

BROMPHENIRAMINE MALEATE (Antihistamine)

PHARMACIST
RECOMMENDED

Cold &
Allergy

Relieves + comforts:

6+
YRS

4 FL OZ
(118 mL)

Grape Flavor • Alcohol Free

Dimetapp 4oz Carton

DIMETAPP  COLD AND ALLERGY
brompheniramine maleate solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69536-305
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BROMPHENIRAMINE MALEATE (UNII: IXA7C9ZN03) (BROMPHENIRAMINE - UNII:H57G17P2FN) BROMPHENIRAMINE MALEATE2 mg  in 10 mL
Inactive Ingredients
Ingredient NameStrength
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
ColorpurpleScore    
ShapeSize
FlavorGRAPEImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:69536-305-041 in 1 CARTON06/15/2024
1118 mL in 1 BOTTLE; Type 0: Not a Combination Product
2NDC:69536-305-081 in 1 CARTON06/15/2024
2237 mL in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01206/15/2024
Labeler - Foundation Consumer Healthcare (079675882)

Revised: 6/2024
Document Id: 15c37689-3815-0c21-e063-6394a90a2666
Set id: 15c3570c-bd00-8e43-e063-6294a90a8683
Version: 1
Effective Time: 20240601
 
Foundation Consumer Healthcare