Active Ingredients (In Each Extended-Release Bi-Layer Tablet)
Guaifenesin 600 mg
Guaifenesin Tablet, Extended Release
FDA Label NDC 69848-017
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Granules Usa, Inc. for the product Guaifenesin (NDC 69848-017). 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 active ingredients (in each extended-release bi-layer tablet), purpose, uses, do not use, ask a doctor before use if you have, stop use and ask doctor if, if pregnant or breat-feeding,, keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Expectorant
Uses
■ helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive
Do Not Use
■ for children under 12 years of age
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)
Stop Use And Ask 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.
If Pregnant Or Breat-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 (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 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
■ Tamper evident: Do not use if carton is open or if printed seal on blister is broken or missing.
■ store between 20-25°C (68-77°F)
Inactive Ingredients
carbomer homopolymer type B; hypromellos, magnesium stearate, microcrystalline cellulose, sodium starch glycolate
Questions?
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