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Drug Facts
12 Hour Mucus Relief Tablet, Extended Release
FDA Label NDC 63868-149
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Chain Drug Marketing Association Inc for the product 12 Hour Mucus Relief (NDC 63868-149). 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 extended-release tablet), purpose, uses, warnings, otc - do not use, otc - ask doctor, otc - stop use, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Active Ingredient (In Each Extended-Release Tablet)
Guaifenesin 600 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
Warnings
Warnings
Otc - Do Not Use
Do not use
■ for children under 12 years of age
Otc - Ask Doctor
Ask a doctor before use if you have
■ persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema
■ cough accompanied by too much phlegm (mucus)
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 - Pregnancy Or Breast Feeding
If pregnant or breast-feeding, ask a health professional before use.
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 (1-800-222-1222).
Directions
■ do not crush, chew, or break tablet
■ take with a full glass of water
■ this product can be administered without regard for the timing of meals
■ adults and children 12 years of age and over: 1 or 2 tablets every 12 hours. Do not exceed 4 tablets in 24 hours.
■ children under 12 years of age: do not use
Other Information
■ store between 20-25°C (68-77°F)
■ retain carton for complete product information and warnings
Inactive Ingredients
carbomer homopolymer type B, hypromellose, magnesium stearate, microcrystalline cellulose, sodium starch glycolate
Principal Display Panel
QUALITY CHOICE®
NDC 63868-149-20
†Compare to the Active Ingredient in MUCINEX®
12 Hour
Mucus Relief
Expectorant
Guaifenesin Extended-Release Tablets, 600 mg
• Relieves Chest Congestion
• Thins & Loosens Mucus
• Immediate and Extended Release
Actual Size
20 EXTENDED-RELEASE TABLETS
Image Description (F1203a02qch R0)
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