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Drug Facts
Childrens Mucinex Chest Congestion
FDA Label NDC 63824-280
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 Childrens Mucinex Chest Congestion (NDC 63824-280). 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 other, active ingredient (in each 5 ml), purpose, uses, ask a doctor before use if the child has, otc - stop use, otc - keep out of reach of children, directions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Active Ingredient (In Each 5 Ml)
Guaifenesin, USP 100 mg
Purpose
Expectorant
Uses
helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive
Ask A Doctor Before Use If The Child Has
- cough that occurs with too much phlegm (mucus)
- persistent or chronic cough such as occurs with asthma
Otc - Stop Use
Stop use and ask a doctor if cough lasts more than 7 days, comes back, or occurs with fever, rash, or persistent headache. These could be signs of a serious illness.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.
Directions
- do not take more than 6 doses in any 24-hour period
- measure only with dosing cup provided
- do not use dosing cup with other products
- mL = milliliter
| Age | Dose |
|---|---|
| children 6 years to under 12 years | 5 mL – 10 mL every 4 hours |
| children 4 years to under 6 years | 2.5 mL – 5 mL every 4 hours |
| children under 4 years | do not use |
Other Information
- tamper evident: do not use if printed neckband on bottle cap is broken or missing
- store between 20-25°C (68-77°F)
- do not refrigerate
- dosing cup provided
Inactive Ingredients
acesulfame potassium, anhydrous citric acid, FD&C blue #1, FD&C red #40, flavor, glycerin, maltitol, propylene glycol, purified water, saccharin sodium, sodium benzoate, sorbitol, sucralose, xanthan gum
Questions?
1-866-MUCINEX (1-866-682-4639)
You may also report side effects to this phone number.
Principal Display Panel - 118 Ml Bottle Carton
NDC 63824-280-64
Children's
Mucinex®
Chest
Congestion
Guaifenesin Oral Solution, USP
Expectorant
✓ Chest Congestion✓ Breaks up Mucus✓ Alcohol-free
Grape
Flavor Liquid
4 FL OZ
(118 mL)
Principal Display Panel (118 mL Bottle Carton)
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