Mucinex Childrens Mighty Chews Cough Daytime And Nighttime Combo Pack

Mucinex Childrens Mighty Chews Cough Daytime And Nighttime Combo Pack
SPL v2
SPL
SPL Set ID 16637d54-8049-d3ce-e063-6394a90aafc9
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) Doxylamine (6.25 mg)
Inactive Ingredients
Anhydrous Citric Acid Sodium Chloride Sucrose Sodium Polymetaphosphate Water Anhydrous Trisodium Citrate Sucralose Fd&c Red No. 40 Maltodextrin Potassium Sodium Tartrate Pectin Corn Syrup Glycerin Malic Acid Fd&c Blue No. 1

Identifiers & Packaging

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

Mucinex Children's Mighty Chews Cough Daytime: Active ingredient (in each chewable tablet) Dextromethorphan HBr 10 mg . Mucinex Children's Mighty Chews Cough Nighttime: Active ingredient (in each chewable tablet) Dextromethorphan HBr 10 mg Doxylamine succinate 6.25 mg

Medication Information

Warnings and Precautions

Mucinex Children's Mighty Chews Cough Daytime:

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

■ cough that occurs with too much phlegm (mucus)

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

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.

Mucinex Children's Mighty Chews Cough Nighttime:

Warnings



Do not use

■ 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.



Ask a doctor before use if you have

■ a sodium-restricted diet

■ glaucoma

■ trouble urinating due to an enlarged prostate gland

■ a breathing problem such as emphysema or chronic bronchitis

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

■ cough that occurs with too much phlegm (mucus)



Ask a doctor or pharmacist before use if you are taking sedatives or

tranquilizers

When using this product

■ do not exceed recommended dosage

■ marked drowsiness may occur

■ exciteability may ocur, especial in chidren

■ alcohol, sedatives, and tranquilizers may increase drowsiness

■ avoid alcoholic drinks

■ use caution when driving a motor vehicle or operating machinery

Stop use and ask a doctor if cough lasts more than 7 days, comes back, or

occurs with fever, rash, or headache that lasts. These could be signs of a

serious condition.

Description

Mucinex Children's Mighty Chews Cough Daytime: Active ingredient (in each chewable tablet) Dextromethorphan HBr 10 mg . Mucinex Children's Mighty Chews Cough Nighttime: Active ingredient (in each chewable tablet) Dextromethorphan HBr 10 mg Doxylamine succinate 6.25 mg

Uses

Mucinex Children's Mighty Chews Cough Daytime:

Uses temporarily relieves cough due to minor throat and bronchial irritation

as may occur with a cold

Mucinex Children's Mighty Chews Cough Nighttime:

Uses

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

may occur with a cold

■ controls cough to help you get to sleep

■ temporarily relieves these symptoms due to hay fever or other upper

respiratory allergies:

■ runny nose

■ sneezing

■ itching of the nose or throat

■ itchy, watery eyes

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

Mucinex Children's Mighty Chews Cough Daytime:

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

Mucinex Children's Mighty Chews Cough Nighttime:

Inactive ingredients anhydrous citric acid, corn syrup, FD&C blue

no. 1, 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 72854-083-32

DAY & NIGHT MIGHTY CHEWS COUGH



Mucinex®Childrens

Dextromethorphan HBr – Cough Suppressant

Doxylamine succinate - Antihistamin

16 Chewable Tablets each

Section 53413-1

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

Section 55105-1

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

Doxylamine succinate 6.25 mg.................................................Antihistamin

Section 55106-9

Mucinex Children's Mighty Chews Cough Daytime:

Active ingredient (in each chewable tablet)

Dextromethorphan HBr 10 mg.

Mucinex Children's Mighty Chews Cough Nighttime:

Active ingredient (in each chewable tablet)

Dextromethorphan HBr 10 mg

Doxylamine succinate 6.25 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

Mucinex Children's Mighty Chews Cough Daytime+Mucinex Children's Mighty Chews Cough Nighttime::

■ 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

Mucinex Children's Mighty Chews Cough Daytime:

Uses temporarily relieves cough due to minor throat and bronchial irritation

as may occur with a cold

Mucinex Children's Mighty Chews Cough Nighttime:

Uses

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

may occur with a cold

■ controls cough to help you get to sleep

■ temporarily relieves these symptoms due to hay fever or other upper

respiratory allergies:

■ runny nose

■ sneezing

■ itching of the nose or throat

■ itchy, watery eyes

Warnings and Precautions (34071-1)

Mucinex Children's Mighty Chews Cough Daytime:

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

■ cough that occurs with too much phlegm (mucus)

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

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.

Mucinex Children's Mighty Chews Cough Nighttime:

Warnings



Do not use

■ 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.



Ask a doctor before use if you have

■ a sodium-restricted diet

■ glaucoma

■ trouble urinating due to an enlarged prostate gland

■ a breathing problem such as emphysema or chronic bronchitis

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

■ cough that occurs with too much phlegm (mucus)



Ask a doctor or pharmacist before use if you are taking sedatives or

tranquilizers

When using this product

■ do not exceed recommended dosage

■ marked drowsiness may occur

■ exciteability may ocur, especial in chidren

■ alcohol, sedatives, and tranquilizers may increase drowsiness

■ avoid alcoholic drinks

■ use caution when driving a motor vehicle or operating machinery

Stop use and ask a doctor if cough lasts more than 7 days, comes back, or

occurs with fever, rash, or headache that lasts. 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)

Mucinex Children's Mighty Chews Cough Daytime:

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

Mucinex Children's Mighty Chews Cough Nighttime:

Inactive ingredients anhydrous citric acid, corn syrup, FD&C blue

no. 1, 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 72854-083-32

DAY & NIGHT MIGHTY CHEWS COUGH



Mucinex®Childrens

Dextromethorphan HBr – Cough Suppressant

Doxylamine succinate - Antihistamin

16 Chewable Tablets each

Section 53413-1 (53413-1)

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

Section 55105-1 (55105-1)

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

Doxylamine succinate 6.25 mg.................................................Antihistamin

Section 55106-9 (55106-9)

Mucinex Children's Mighty Chews Cough Daytime:

Active ingredient (in each chewable tablet)

Dextromethorphan HBr 10 mg.

Mucinex Children's Mighty Chews Cough Nighttime:

Active ingredient (in each chewable tablet)

Dextromethorphan HBr 10 mg

Doxylamine succinate 6.25 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

Mucinex Children's Mighty Chews Cough Daytime+Mucinex Children's Mighty Chews Cough Nighttime::

■ 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

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Raw Label Data

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Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:04:27.532020 · Updated: 2026-03-14T23:05:12.885917