Cvs Children's Cold & Allergy

Cvs Children's Cold & Allergy
SPL v2
SPL
SPL Set ID 004e104b-d6ff-48d5-8685-cd1bff45399a
Route
ORAL
Published
Effective Date 2025-03-12
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Brompheniramine (2 mg)
Inactive Ingredients
Anhydrous Citric Acid Fd&c Blue No. 1 Fd&c Red No. 40 Glycerin Propyl Gallate Propylene Glycol Water Sodium Benzoate Sodium Citrate, Unspecified Form Sorbitol Sucralose

Identifiers & Packaging

Pill Appearance
Color: purple
Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-02-24

Description

Brompheniramine maleate, USP 2 mg

Purpose

Antihistamine


Medication Information

Purpose

Antihistamine

Description

Brompheniramine maleate, USP 2 mg

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

Antihistamine

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

Do Not Use
  • to sedate a child or to make a child sleepy
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

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.

Active Ingredients (in Each 10 Ml)

Brompheniramine maleate, USP 2 mg

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.
Principal Display Panel 118 Ml Bottle Label

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

NDC# 51316-693-04

Children's Cold& 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.

Ask A Doctor Or Pharmacist Before Use If You Are
  • taking sedatives or tranquilizers

Structured Label Content

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

Antihistamine

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

Do Not Use (Do not use)
  • to sedate a child or to make a child sleepy
Other Information (Other information)
  • each 10 ml contains:sodium 6 mg
  • store at room temperature
Inactive Ingredients (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? (Questions or comments?)

1-866-467-2748

When Using This Product (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, (If pregnant or breast-feeding,)

ask a health professional before use.

Keep Out of Reach of Children. (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.

Active Ingredients (in Each 10 Ml) (Active Ingredients (in each 10 mL))

Brompheniramine maleate, USP 2 mg

Ask A Doctor Before Use If You Have (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.
Principal Display Panel 118 Ml Bottle Label (PRINCIPAL DISPLAY PANEL - 118 ml Bottle Label)

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

NDC# 51316-693-04

Children's Cold& 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.

Ask A Doctor Or Pharmacist Before Use If You Are (Ask a doctor or pharmacist before use if you are)
  • taking sedatives or tranquilizers

Advanced Ingredient Data


Raw Label Data

All Sections (JSON)