Mucinex Children's Mighty Chews Cough Nighttime

Mucinex Children's Mighty Chews Cough Nighttime
SPL v1
SPL
SPL Set ID 156033ae-b16a-007b-e063-6294a90a7445
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
Fd&c Red No. 40 Maltodextrin Pectin Potassium Sodium Tartrate Water Malic Acid Corn Syrup Fd&c Blue No. 1 Sodium Chloride Anhydrous Trisodium Citrate Sucralose Sodium Polymetaphosphate Sucrose Anhydrous Citric Acid Glycerin

Identifiers & Packaging

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

Description

Dextromethorphan HBr 10 mg Doxylamine succinate 6.25 mg


Medication Information

Warnings and Precautions

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

■ excitability may occur, especially in children

■ marked drowsiness may occur

■ 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.

Dosage and Administration

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

Description

Dextromethorphan HBr 10 mg Doxylamine succinate 6.25 mg

Uses

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

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 72854-082-16

Children's

Mucinex®

Cough Suppressant

Antihistamine

Dextromethorphan HBr 10 mg

Doxylamine succinate 6.25 m

Age 6+

Mixed Berry Flavor

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.................................................Antihistamine

Section 55106-9

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)


Structured Label Content

Uses

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

Dosage and Administration (34068-7)

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

Warnings and Precautions (34071-1)

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

■ excitability may occur, especially in children

■ marked drowsiness may occur

■ 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)

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 72854-082-16

Children's

Mucinex®

Cough Suppressant

Antihistamine

Dextromethorphan HBr 10 mg

Doxylamine succinate 6.25 m

Age 6+

Mixed Berry Flavor

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.................................................Antihistamine

Section 55106-9 (55106-9)

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)


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)