Active Ingredient(S)
Guaifenesin 400 mg
Mucus Relief Tablet
FDA Label NDC 69168-916
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 69168-916). 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(s), purpose, use(s), ask a doctor before use if, 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
Use(S)
- 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
- 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
ask a healthcare professional before use
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 children12 years of age and older: Take 1 caplet every 4 hours with a full of 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
- do not use if imprinted safety seal under cap is broken or missing
Storage
- store at 25°C (77°F) excursions between 15° to 30°C (59° to 86°F)
- keep in a dry place and do not expose to heat
Inactive Ingredients
croscarmellose sodium, dicalcium phosphate, microcrystalline cellulose, silicon dioxide, stearic acid
Questions
Call 1-888-952-0050
Monday through Friday 9AM - PM EST.
Principal Display Panel
Mucus Relief (Sound Body Mucus Relief 1)
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