Otc - Active Ingredient
Active ingredient (in each immediate-release tablet)
Guaifenesin 400 mg
Guaifenesin
FDA Label NDC 11822-7836
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Rite Aid for the product Guaifenesin (NDC 11822-7836). 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, indications & usage, warnings, otc - ask doctor, otc - when using, otc - stop use, otc - pregnancy or breast feeding, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Purpose
Expectorant
Indications & Usage
Uses
- helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive to rid the bronchial passageway of bothersome mucus
Warnings
Warnings
Otc - Ask Doctor
Ask a doctor before use if you have
- persistant or chronic cough such as occurs with smoking , asthma, chronic bronchitis, or emphysema
- cough accompanied by excessive phlegm (mucus)
Otc - When Using
When using this product
- do not exceed recommended dosage
- do not use for more than 7 days
Otc - Stop Use
Stop use and ask a doctor if
- cough lasts for more than 7 days, recurs, or is accompanied by fever, rash, or persistent headache. These could be signs of a serious condition.
Otc - Pregnancy Or Breast Feeding
If pregnant or breast-feeding, ask a healthcare 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 (1-800-222-1222) right away.
Dosage & Administration
Directions
- adults and children 12 years of age and older: take 1 tablet every 4 hours with a full glass of water while symptoms persist. Do not exceed 6 doses in 24 hours.
- children under 12 years of age: do not use
Other Safety Information
Other information
- store at 25°C (77°F) excursions permitted between 15°-30°C (59°- 86°F)
- keep in a dry place and do not expose to excessive heat
Inactive Ingredient
Inactive ingredients colloidal silicon dioxide, magnesium stearate, maltodextrin, microcrystalline cellulose, povidone, silicon dioxide, sodium starch glycolate, stearic acid
Otc - Questions
Questions or comments? Call 1-877-290-4008
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