Mucinex Children's Mighty Chews Cough

Mucinex Children's Mighty Chews Cough
SPL v4
SPL
SPL Set ID 155e07b3-0a08-3be8-e063-6394a90a7635
Route
ORAL
Published
Effective Date 2024-06-03
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Dextromethorphan (10 mg)
Inactive Ingredients
Corn Syrup Glycerin Water Pectin Potassium Sodium Tartrate Sucrose Anhydrous Citric Acid Anhydrous Trisodium Citrate Sucralose Malic Acid Maltodextrin Sodium Chloride Sodium Polymetaphosphate Fd&c Red No. 40

Identifiers & Packaging

Pill Appearance
Imprint: M Shape: round Color: red Size: 23 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-06-03
Description

Dextromethorphan HBr 10 mg

Medication Information

Warnings and Precautions

Warnings

Do not use

■ 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.

Ask a doctor before use if you have

■ a sodium-restricted diet

■ persistent or chronic cough such as occurs with smoking, asthma, or emphysema

■ cough that occurs with too much phlegm (mucus)

When using this product

■ do not exceed recommended dosage

Stop use and ask a doctor if

■ cough lasts more than 7 days, comes back, or occurs with fever, rash, or

headache. These could be signs of a serious condition.

Description

Dextromethorphan HBr 10 mg

Uses

Uses

■ temporarily relieves cough due to minor throat and bronchial irritation as

may occur with a cold

Section 50565-1

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

Section 51727-6

Inactive ingredients

anhydrous citric acid, corn syrup, FD&C red no. 40, flavors, glycerin, malic acid,

maltodextrin, pectin, potassium sodium tartrate, purified water, sodium chloride, trisodium citrate (anhydrous), sodium polymetaphosphate, sucralose, sucrose

Section 51945-4

NDC 72854-061-16

Children's

Mucinex®

Cough Suppressant

Dextromethorphan HBr 5 mg

Age 6+

Mixed Berry Flavor

Chewable Tablets

Section 53413-1

Questions? 1-866-MUCINEX (1-866-682-4639)

Section 55105-1

Dextromethorphan HBr 10 mg.......................... ...............Cough suppressant

Section 55106-9

Dextromethorphan HBr 10 mg

Section 60561-8

Other information

■ each chewable tablet contains: potassium 5 mg and sodium 15 mg

■ store in a cool dry place at 20-25°C (68-77°F)

Directions

Directions

■ take every 4 hours or as directed by a doctor

■ chew thoroughly before swallowing

adults and children 12 years

of age and over 		2 chewable tablets every 4 hours, not to exceed

12 chewable tablets in any 24-hour period
children 6 to under 12 years

of age 		1 chewable tablet every 4 hours, not to exceed

6 chewable tablets in any 24-hour period
children under 6 years of age do not use

Structured Label Content

Uses

Uses

■ temporarily relieves cough due to minor throat and bronchial irritation as

may occur with a cold

Warnings and Precautions (34071-1)

Warnings

Do not use

■ 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.

Ask a doctor before use if you have

■ a sodium-restricted diet

■ persistent or chronic cough such as occurs with smoking, asthma, or emphysema

■ cough that occurs with too much phlegm (mucus)

When using this product

■ do not exceed recommended dosage

Stop use and ask a doctor if

■ cough lasts more than 7 days, comes back, or occurs with fever, rash, or

headache. These could be signs of a serious condition.

Section 50565-1 (50565-1)

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

Section 51727-6 (51727-6)

Inactive ingredients

anhydrous citric acid, corn syrup, FD&C red no. 40, flavors, glycerin, malic acid,

maltodextrin, pectin, potassium sodium tartrate, purified water, sodium chloride, trisodium citrate (anhydrous), sodium polymetaphosphate, sucralose, sucrose

Section 51945-4 (51945-4)

NDC 72854-061-16

Children's

Mucinex®

Cough Suppressant

Dextromethorphan HBr 5 mg

Age 6+

Mixed Berry Flavor

Chewable Tablets

Section 53413-1 (53413-1)

Questions? 1-866-MUCINEX (1-866-682-4639)

Section 55105-1 (55105-1)

Dextromethorphan HBr 10 mg.......................... ...............Cough suppressant

Section 55106-9 (55106-9)

Dextromethorphan HBr 10 mg

Section 60561-8 (60561-8)

Other information

■ each chewable tablet contains: potassium 5 mg and sodium 15 mg

■ store in a cool dry place at 20-25°C (68-77°F)

Directions

Directions

■ take every 4 hours or as directed by a doctor

■ chew thoroughly before swallowing

adults and children 12 years

of age and over 		2 chewable tablets every 4 hours, not to exceed

12 chewable tablets in any 24-hour period
children 6 to under 12 years

of age 		1 chewable tablet every 4 hours, not to exceed

6 chewable tablets in any 24-hour period
children under 6 years of age do not use

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:03:18.087529 · Updated: 2026-03-14T23:03:18.838207