Active Ingredient
Guaifenesin 400mg
Mucus Relief Tablet
FDA Label NDC 69168-370
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Allegiant Health for the product Mucus Relief (NDC 69168-370). 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, purpose, uses, ask a doctor before use if you have, when using this product, stop use and ask a doctor if, pregnancy/breastfeeding, 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 make coughs more productive to rid the bronchial passageway of bothersome mucus
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 excessive phlegm (mucus)
When Using This Product
- do not exceed recommended dosage
- do not use for more than 7 days
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.
Pregnancy/Breastfeeding
If pregnant or breast-feeding, ask a health professional before use.
Keep Out Of Reach Of Children
Keep out of reach of children. In case of accidental overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.
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 Information
- store at 25°C (77°F) excursions between 15°-30°C (59°-86°F)
- keep in a dry place and do not expose to heat
- do not use if imprinted safety seal under cap is broken or missing
Inactive Ingredients
croscarmellose sodium, dicalcium phosphate, microcrystalline cellulose, silicon dioxide, stearic acid
Questions Or Comments?
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Principal Display Panel
Mucus Relief (370 Health A2z Mucus Relief 1)
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