Childrens Cold And Cough 577

SPL v2

SPL

SPL Set ID 2bc3eae8-ffe6-bc96-e063-6394a90a2283

Route

ORAL

Published

Effective Date 2025-01-17

Document Type 34390-5 Human OTC Drug Label

Drug Facts

Composition & Product

Active Ingredients

Brompheniramine (2 mg) Dextromethorphan (10 mg) Phenylephrine (5 mg)

Inactive Ingredients

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

Identifiers & Packaging

Pill Appearance

Color: purple

Marketing Status

OTC MONOGRAPH DRUG Active Since 2025-01-17

Description

Brompheniramine maleate, USP 2 mg Dextromethorphan HBr, USP 10 mg Phenylephrine HCl, USP 5 mg

Purpose

Antihistamine Cough Suppressant Nasal decongestant

Medication Information

Purpose

Antihistamine Cough Suppressant Nasal decongestant

Description

Brompheniramine maleate, USP 2 mg Dextromethorphan HBr, USP 10 mg Phenylephrine HCl, USP 5 mg

Uses

temporarily relieves cough due to minor bronchial irritation as may occur with a cold, and nasal congestion due to the common cold, hay fever or other upper respiratory allergies

temporarily relieves these symptoms due to hay fever (allergic rhinitis):

sneezing
Itching of the nose or throat
runny nose
itchy, watery eyes

temporarily restores freer breathing through the nose

Purposes

Antihistamine

Cough Suppressant

Nasal decongestant

Warnings

Directions

do not take more than 6 doses in any 24-hour period
measure only with dosing cup provided
do not exceed recommended dosage
mL = milliliter

Age	Dose
adults & children 12 years & 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, or psychiatric, 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 10 mg
store at 20-25ºC (68-77ºF)
measuring cup provided

Inactive Ingredients

anhydrous citric acid, artificial flavor, FD&C blue #1, FD&C Red #40, glycerin, propylene glycol, propyl gallate, purified water, sodium benzoate, sodium citrate, sorbitol, sucralose

Principal Display Panel

CVS

Health ®

Compare to the active ingredients in Children's Dimetapp® Cold & Cough*

NDC 51316-578-03

Children's

Cold & Cough

BROMPHENIRAMIINE MALEATE

Antihistamine

DEXTROMETHORPHAN HYDROBROMIDE

Cough Suppressant

PHENYLEPHRINE HYDROCHLORIDE

Nasal Decongestant

DM Liquid

Relieves nasal congestion;

Stuffy nose; Runny nose;

Sneezes
Soothes Cough
Calm allergy symptoms

Alcohol free

6+ Years

Grape Flavor

Dosage Cup Included

4 FL OZ (118 mL)

When Using This Product

do not take more than directed
may cause drowsiness
alcohol, sedatives, and tranquillizers may increase drowsiness
avoid alcoholic beverages
be careful when driving a motor vehicle or operating machinery
excitability may occur, especially in children

Stop Use and Ask A Doctor If

nervousness, dizziness or sleeplessness occur
symptoms do not improve within 7 days or are accompanied by fever
cough lasts more than 7 days, comes back, or is accompanied by fever, rash, or persistent headache. These could be signs of a serious condition.

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.

Active Ingradients (in Each 10 Ml)

Brompheniramine maleate, USP 2 mg

Dextromethorphan HBr, USP 10 mg

Phenylephrine HCl, USP 5 mg

Ask A Doctor Before Use If You Have

heart disease
glaucoma
diabetes
thyroid disease
high blood pressure
difficulty in urination due to an enlarged prostate gland
cough that occurs with too much phlegm (mucus)
a breathing problem or persistent or chronic cough that lasts such as occurs with smoking, asthma, chronic bronchitis or emphysema

Ask A Doctor Or Pharmacist Before Use If You Are

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

Structured Label Content

Uses (USES)

temporarily relieves cough due to minor bronchial irritation as may occur with a cold, and nasal congestion due to the common cold, hay fever or other upper respiratory allergies

temporarily relieves these symptoms due to hay fever (allergic rhinitis):

sneezing
Itching of the nose or throat
runny nose
itchy, watery eyes

temporarily restores freer breathing through the nose

Purposes (PURPOSES)

Antihistamine

Cough Suppressant

Nasal decongestant

Warnings (WARNINGS)

Directions (DIRECTIONS)

do not take more than 6 doses in any 24-hour period
measure only with dosing cup provided
do not exceed recommended dosage
mL = milliliter

Age	Dose
adults & children 12 years & 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, or psychiatric, 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 10 mg
store at 20-25ºC (68-77ºF)
measuring cup provided

Inactive Ingredients (INACTIVE INGREDIENTS)

anhydrous citric acid, artificial flavor, FD&C blue #1, FD&C Red #40, glycerin, propylene glycol, propyl gallate, purified water, sodium benzoate, sodium citrate, sorbitol, sucralose

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

CVS

Health ®

Compare to the active ingredients in Children's Dimetapp® Cold & Cough*

NDC 51316-578-03

Children's

Cold & Cough

BROMPHENIRAMIINE MALEATE

Antihistamine

DEXTROMETHORPHAN HYDROBROMIDE

Cough Suppressant

PHENYLEPHRINE HYDROCHLORIDE

Nasal Decongestant

DM Liquid

Relieves nasal congestion;

Stuffy nose; Runny nose;

Sneezes
Soothes Cough
Calm allergy symptoms

Alcohol free

6+ Years

Grape Flavor

Dosage Cup Included

4 FL OZ (118 mL)

When Using This Product (WHEN USING THIS PRODUCT)

do not take more than directed
may cause drowsiness
alcohol, sedatives, and tranquillizers may increase drowsiness
avoid alcoholic beverages
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)

nervousness, dizziness or sleeplessness occur
symptoms do not improve within 7 days or are accompanied by fever
cough lasts more than 7 days, comes back, or is accompanied by fever, rash, or persistent headache. These could be signs of a serious condition.

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.

Active Ingradients (in Each 10 Ml) (ACTIVE INGRADIENTS (in each 10 mL))

Brompheniramine maleate, USP 2 mg

Dextromethorphan HBr, USP 10 mg

Phenylephrine HCl, USP 5 mg

Ask A Doctor Before Use If You Have (ASK A DOCTOR BEFORE USE IF YOU HAVE)

heart disease
glaucoma
diabetes
thyroid disease
high blood pressure
difficulty in urination due to an enlarged prostate gland
cough that occurs with too much phlegm (mucus)
a breathing problem or persistent or chronic cough that lasts such as occurs with smoking, asthma, chronic bronchitis or emphysema

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 sedative or tranquilizers

Advanced Ingredient Data

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Raw Label Data

All Sections (JSON)

{"USES": "temporarily relieves cough due to minor bronchial irritation as may occur with a cold, and nasal congestion due to the common cold, hay fever or other upper respiratory allergies temporarily relieves these symptoms due to hay fever (allergic rhinitis): sneezing Itching of the nose or throat runny nose itchy, watery eyes temporarily restores freer breathing through the nose", "PURPOSES": "Antihistamine Cough Suppressant Nasal decongestant", "WARNINGS": ".", "DIRECTIONS": "do not take more than 6 doses in any 24-hour period measure only with dosing cup provided do not exceed recommended dosage mL = milliliter Age Dose adults & children 12 years & 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, or psychiatric, 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 10 mg store at 20-25ºC (68-77ºF) measuring cup provided", "INACTIVE INGREDIENTS": "anhydrous citric acid, artificial flavor, FD&C blue #1, FD&C Red #40, glycerin, propylene glycol, propyl gallate, purified water, sodium benzoate, sodium citrate, sorbitol, sucralose", "PRINCIPAL DISPLAY PANEL": "CVS Health ® Compare to the active ingredients in Children's Dimetapp ® Cold & Cough* NDC 51316-578-03 Children's Cold & Cough BROMPHENIRAMIINE MALEATE Antihistamine DEXTROMETHORPHAN HYDROBROMIDE Cough Suppressant PHENYLEPHRINE HYDROCHLORIDE Nasal Decongestant DM Liquid Relieves nasal congestion; Stuffy nose; Runny nose; Sneezes Soothes Cough Calm allergy symptoms Alcohol free 6+ Years Grape Flavor Dosage Cup Included 4 FL OZ (118 mL) ", "WHEN USING THIS PRODUCT": "do not take more than directed may cause drowsiness alcohol, sedatives, and tranquillizers may increase drowsiness avoid alcoholic beverages be careful when driving a motor vehicle or operating machinery excitability may occur, especially in children", "STOP USE AND ASK A DOCTOR IF": "nervousness, dizziness or sleeplessness occur symptoms do not improve within 7 days or are accompanied by fever cough lasts more than 7 days, comes back, or is accompanied by fever, rash, or persistent headache. These could be signs of a serious condition.", "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.", "ACTIVE INGRADIENTS (in each 10 mL)": "Brompheniramine maleate, USP 2 mg Dextromethorphan HBr, USP 10 mg Phenylephrine HCl, USP 5 mg", "ASK A DOCTOR BEFORE USE IF YOU HAVE": "heart disease glaucoma diabetes thyroid disease high blood pressure difficulty in urination due to an enlarged prostate gland cough that occurs with too much phlegm (mucus) a breathing problem or persistent or chronic cough that lasts such as occurs with smoking, asthma, chronic bronchitis or emphysema", "ASK A DOCTOR OR PHARMACIST BEFORE USE IF YOU ARE": "taking any other oral nasal decongestant or stimulant taking sedative or tranquilizers"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:05:22.215485 · Updated: 2026-03-14T23:07:03.829205