Mucus Relief
FDA Label NDC 68210-4173
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Spirit Pharmaceuticals Llc for the product Mucus Relief (NDC 68210-4173). 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 drug facts, active ingredient (in each tablet), purpose, uses, warnings, ask a doctor before use if you have, stop use and ask a doctor, 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
Active Ingredient (In Each Tablet)
Guaifenesin 400 mg
Purpose
Expectorant
Uses
• helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive
Warnings
Do not use for children under 12 years of age
Ask A Doctor Before Use If You Have
• with persistent or chronic cough such as occurs with smoking,
asthma, chronic bronchitis, or emphysema • cough accompanied by
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 • adults and children 12 years of age and over: take 1 tablet every 4 hours with a full glass of water while symptoms persist. Do not exceed 6 tablets in 24 hours. • children under 12 years of age: do not use
Other Information
• store between 20-25°C (68-77°F)
Inactive Ingredients
Colloidal silicon dioxide, magnesium stearate, maltodextrin, microcrystalline cellulose, polyvinyl pyrrolidone, sodium starch glycolate, stearic acid
Questions Or Comments?
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