Otc - Active Ingredient
Dextromethorphan HBr 10 mg
Mucinex Childrens Mighty Chews Cold And Flu Tablet, Chewable
FDA Label NDC 72854-084
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Rb Health (us) Llc for the product Mucinex Childrens Mighty Chews Cold And Flu (NDC 72854-084). 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.
Label Section Quick Index
Otc - Purpose
Dextromethorphan HBr 10 mg.......................... ...............Cough suppressant
Uses
Uses
■ temporarily relieves cough due to minor throat and bronchial irritation as
may occur with a cold
Warnings
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.
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
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 |
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 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 72854-084-016
Children's
Mucinex®
Cough Suppressant
Dextromethorphan HBr 5 mg
Age 6+
Mixed Berry Flavor
Chewable Tablets
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