Children's Dimetapp Cold & Allergy Brompheniramine Maleate And Phenylephrine Hcl

SPL v6

SPL

SPL Set ID f4020c08-29f6-4609-834e-191ce6885130

Route

ORAL

Published

Effective Date 2025-12-09

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Brompheniramine (2 mg) Phenylephrine (5 mg)

Inactive Ingredients

Anhydrous Citric Acid Fd&c Blue No. 1 Fd&c Red No. 40 Glycerin Propylene Glycol Propyl Gallate Water Sodium Benzoate Sodium Citrate, Unspecified Form Sorbitol Sucralose

Identifiers & Packaging

Pill Appearance

Color: purple

Marketing Status

OTC MONOGRAPH DRUG Active Since 2020-03-30

Description

Brompheniramine maleate, USP 2 mg Phenylephrine HCl, USP 5 mg

Purpose

Antihistamine Nasal Decongestant

Medication Information

Purpose

Antihistamine Nasal Decongestant

Description

Brompheniramine maleate, USP 2 mg Phenylephrine HCl, USP 5 mg

Uses

temporarily relieves nasal congestion due to the common cold, hay fever or other upper respiratory allergies
temporarily relieves these symptoms due to hay fever (allergic rhinitis):
- runny nose
- sneezing
- itchy, watery eyes
- itching of the nose or throat
temporarily restores freer breathing through the nose

Purposes

Antihistamine

Nasal Decongestant

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
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.

Other Information

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

Inactive Ingredients

anhydrous 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 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 or contact a Poison Control Center right away at 1-800-222-1222.

Active Ingredients (in Each 10 Ml)

Brompheniramine maleate, USP 2 mg

Phenylephrine HCl, USP 5 mg

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, asthma, or chronic bronchitis

Principal Display Panel 118 Ml Bottle Label

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

NDC# 69842-639-04

Children's Cold& Allergy

Brompheniramine Maleate USP (Antihistamine)

Phenylephrine HCl USP (Nasal Decongestant)

Stuffy Nose
Runny Nose
Sneezing
Itchy, Watery Eyes

Alcohol-Free • Sugar Free

Ages 6 Years and Over

Grape Flavor

Naturally and Artificially Flavored

4 FL OZ (118 ml)

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

Distributed by:

CVS Pharmacy, Inc.

One CVS Drive, Woonsocket, RI 02895

CVS.com 1-800-SHOP CVS

V12431

CVS Quality

Money Back Guaranteed

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

Ask A Doctor Or Pharmacist Before Use If You Are

taking any other oral nasal decongestant or stimulant
taking sedatives or tranquilizers

Structured Label Content

Uses (USES)

temporarily relieves nasal congestion due to the common cold, hay fever or other upper respiratory allergies
temporarily relieves these symptoms due to hay fever (allergic rhinitis):
- runny nose
- sneezing
- itchy, watery eyes
- itching of the nose or throat
temporarily restores freer breathing through the nose

Purposes (PURPOSES)

Antihistamine

Nasal Decongestant

Directions (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
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.

Other Information (OTHER INFORMATION)

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

Inactive Ingredients (INACTIVE INGREDIENTS)

anhydrous 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 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 (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, (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

Phenylephrine HCl, USP 5 mg

Ask A Doctor Before Use If You Have (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, asthma, 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# 69842-639-04

Children's Cold& Allergy

Brompheniramine Maleate USP (Antihistamine)

Phenylephrine HCl USP (Nasal Decongestant)

Stuffy Nose
Runny Nose
Sneezing
Itchy, Watery Eyes

Alcohol-Free • Sugar Free

Ages 6 Years and Over

Grape Flavor

Naturally and Artificially Flavored

4 FL OZ (118 ml)

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

Distributed by:

CVS Pharmacy, Inc.

One CVS Drive, Woonsocket, RI 02895

CVS.com 1-800-SHOP CVS

V12431

CVS Quality

Money Back Guaranteed

*This product is not manufactured or distributed by Pfizer, 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 any other oral nasal decongestant or stimulant
taking sedatives or tranquilizers

Advanced Ingredient Data

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Raw Label Data

All Sections (JSON)

{"USES": "temporarily relieves nasal congestion due to the common cold, hay fever or other upper respiratory allergies temporarily relieves these symptoms due to hay fever (allergic rhinitis): runny nose sneezing itchy, watery eyes itching of the nose or throat temporarily restores freer breathing through the nose", "PURPOSES": "Antihistamine Nasal Decongestant", "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 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.", "OTHER INFORMATION": "each 10 ml contains: sodium 6 mg store at room temperature", "INACTIVE INGREDIENTS": "anhydrous 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 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 or contact a Poison Control Center right away at 1-800-222-1222.", "Active Ingredients (in each 10 mL)": "Brompheniramine maleate, USP 2 mg Phenylephrine HCl, USP 5 mg", "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, asthma, or chronic bronchitis", "PRINCIPAL DISPLAY PANEL - 118 ml Bottle Label": "Compare to the active ingredients in Children’s Dimetapp® Cold & Allergy* NDC# 69842-639-04 Children's Cold & Allergy Brompheniramine Maleate USP (Antihistamine) Phenylephrine HCl USP (Nasal Decongestant) Stuffy Nose Runny Nose Sneezing Itchy, Watery Eyes Alcohol-Free • Sugar Free Ages 6 Years and Over Grape Flavor Naturally and Artificially Flavored 4 FL OZ (118 ml) IMPORTANT: Keep this carton for future reference on full labeling. Distributed by: CVS Pharmacy, Inc. One CVS Drive, Woonsocket, RI 02895 © 2020 CVS/pharmacy CVS.com 1-800-SHOP CVS V12431 CVS Quality Money Back Guaranteed *This product is not manufactured or distributed by Pfizer, the distributor of Children’s Dimetapp® Cold & Allergy.", "Ask a doctor or pharmacist before use if you are": "taking any other oral nasal decongestant or stimulant taking sedatives or tranquilizers"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:07:34.740591 · Updated: 2026-03-14T23:11:10.262850