Otc - Active Ingredient
Dextromethorphan HBr 10 mg
Doxylamine succinate 6.25 mg
Mucinex Childrens Mighty Chews Night Time Cold And Flu Tablet, Chewable
FDA Label NDC 72854-085
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Reckitt Benckiser Llc for the product Mucinex Childrens Mighty Chews Night Time Cold And Flu (NDC 72854-085). 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, dosage & administration, other safety information, inactive ingredient, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Dextromethorphan HBr 10 mg.......................... ...............Cough suppressant
Doxylamine succinate 6.25 mg.................................................Antihistamine
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
Warnings
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.
Otc - Keep Out Of Reach Of Children
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
Dosage & 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 |
Other Safety Information
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)
Inactive Ingredient
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
Otc - Questions
Questions? 1-866-MUCINEX (1-866-682-4639)
Package Label.Principal Display Panel
NDC 72854-085-16
Children's
Mucinex®
Cough Suppressant
Antihistamine
Dextromethorphan HBr 10 mg
Doxylamine succinate 6.25 m
Age 6+
Mixed Berry Flavor
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