Active Ingredient (In Each Extended-Release Tablet)
Guaifenesin 600 mg
Guaifenesin Tablet
FDA Label NDC 73581-400
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Yyba Corp for the product Guaifenesin (NDC 73581-400). 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 ingredient (in each extended-release tablet), purpose, uses, warning, do not use, ask a doctor before use if you have, stop use and ask a doctor if, if pregnant or breast-feeding, 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
Warning
.
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 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.
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 (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 and over: 1 or 2 tablets every 12 hours. Do not exceed 4 tablets in 24 hours.
• children under 12 years: do not use.
Other Information
• tamper evident: Do not use if seal on bottle printed "SEALED for YOUR PROTECTION" is broken or missing.
• store between 20 to 25°C (68 to 77°F).
Inactive Ingredients
Carbomer homopolymer, hypromellose, microcrystalline cellulose, povidone.
Questions?
call 1-866-933-6337
You may also report side effects to this phone number.
Package Label.Principal Display Panel
Guaifenesin (Guaifenesin)
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