The following Structured Product Label (SPL) was submitted to the FDA by Reckitt Benckiser Llc for the product Mucinex Childrens Mighty Chews Cough Nighttime (NDC 72854-082). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding otc - active ingredient, otc - purpose, uses, warnings, otc - keep out of reach of children, directions, other safety information, inactive ingredient, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
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
Dextromethorphan HBr 10 mg.......................... ...............Cough suppressant
Doxylamine succinate 6.25 mg.................................................Antihistamin
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
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.
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
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 |
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)
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
Questions? 1-866-MUCINEX (1-866-682-4639)
NDC 72854-083-32
DAY & NIGHT MIGHTY CHEWS COUGH
Mucinex®Childrens
Dextromethorphan HBr – Cough Suppressant
Doxylamine succinate - Antihistamin
16 Chewable Tablets each
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