CVS PHARMACY CHILDRENS COLD AND ALLERGY- brompheniramine maleate liquid

CVS PHARMACY by

Drug Labeling and Warnings

CVS PHARMACY by is a Otc medication manufactured, distributed, or labeled by CVS PHARMACY, INC.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active Ingredients (in each 10 mL)

Brompheniramine maleate, USP 2 mg

Purposes

Antihistamine

Uses

• temporarily relieves:
  • runny nose
  • sneezing
  • itchy, watery eyes due to hay fever
  • itching of the nose or throat

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, 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 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 at 1-800-222-1222.

Directions

• do not take more than 6 doses in any 24-hour period
• measure only with dosage cup provided
• keep dosage cup with product
• ml = milliliter

age	Dose
adults and children 12 years and over	20 ml every 4 hours
children 6 to under 12 years	10 ml every 4 hours
children under 6 years	do not use

Other information

• each 10 ml contains:sodium 6 mg
• store at room temperature

Inactive ingredients

citric acid, FD&C Blue No. 1, FD&C Red No. 40, flavor, glycerin, propylene glycol, propyl gallate, purified water, sodium benzoate, sodium citrate, sorbitol liquid, sucralose

Questions or comments?

1-866-467-2748

PRINCIPAL DISPLAY PANEL - 118 ml Bottle Label

Compare to the active ingredients in Children’s Dimetapp® Cold & Allergy*

NDC# 51316-693-04

Children'sCold& Allergy

Brompheniramine Maleate USP (Antihistamine)
Relieves + comforts:

• Runny Nose
• Itchy, Watery Eyes
• Sneezing
• Itchy throat

For Ages 6 Years and Over

Grape Flavor

Naturally and Artificially Flavored

No Added Alcohol

No Added Sugar

4 FL OZ (118 ml)

IMPORTANT:Keep this carton for future reference on full labeling.

Distributed by:

*This product is not manufactured or distributed by Foundation Consumer Healthcare, LLC, the distributor of Children’s Dimetapp® Cold & Allergy.

INGREDIENTS AND APPEARANCE

CVS PHARMACY   CHILDRENS COLD AND ALLERGY
brompheniramine maleate liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 51316-693
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BROMPHENIRAMINE MALEATE (UNII: IXA7C9ZN03) (BROMPHENIRAMINE - UNII:H57G17P2FN)	BROMPHENIRAMINE MALEATE	2 mg  in 10 mL

Inactive Ingredients
Ingredient Name	Strength
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
FD&C RED NO. 40 (UNII: WZB9127XOA)
GLYCERIN (UNII: PDC6A3C0OX)
PROPYL GALLATE (UNII: 8D4SNN7V92)
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
Color	purple (purple liquid)	Score
Shape		Size
Flavor	GRAPE	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 51316-693-04	1 in 1 CARTON	02/24/2025
1		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
OTC Monograph Drug	M012	02/24/2025

Labeler - CVS PHARMACY, INC. (062312574)