Otc - Active Ingredient
ACTIVE INGREDIENT: Each immediate-release tablet contains – Guaifenesin 400 mg
Mucus Relief
FDA Label NDC 58118-9896
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Clinical Solutions Wholesale for the product Mucus Relief (NDC 58118-9896). 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, otc - keep out of reach of children, indications & usage, warnings, dosage & administration, inactive ingredient, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
PURPOSE: Expectorant
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 right away
Indications & Usage
Helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive to rid the bronchial passageway of bothersome mucus.
Warnings
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)
Dosage & Administration
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.
Inactive Ingredient
Colloidal Silicon Dioxide, Magnesium Stearate, Maltodextrin, Microcrystalline Cellulose, Povidone, Silicon Dioxide, Sodium Starch Glycolate, Stearic Acid
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