Active Ingredient (In Each Tablet)
Guaifenesin 400 mg
Mucus Relief Tablet
FDA Label NDC 71335-1035
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Bryant Ranch Prepack for the product Mucus Relief (NDC 71335-1035). 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 (in each tablet), purpose, uses, warnings, otc - keep out of reach of children, directions, other information, inactive ingredients, 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 passageways
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)
- cough lasts more than 7 days or comes back
- cough occurs with fever, rash or persistent headache
- these could be signs of a serious illness.
Stop use and ask a doctor if
If pregnant or breast feeding, ask a health 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 right away.
Directions
- take with full glass of water
- do not exceed recommended dose
| adults and children 12 years
of age and over | 1 tablet, every 4 hours, while
symptoms persist • do not exceed 6 doses in 24 hours |
| children under 12 years of age
| do not use
|
Other Information
• Tamper Evident: do not use if imprinted safety seal under cap is broken or missing.
• store at controlled room temperature 20 °-25°C (68°-77°F)
Inactive Ingredients
cellulose, magnesium stearate, maltodextrin, povidone, silica, sodium starch glycolate, stearic acid.
How Supplied
Product: 71335-1035
NDC: 71335-1035-1 30 TABLET in a BOTTLE
NDC: 71335-1035-2 20 TABLET in a BOTTLE
NDC: 71335-1035-3 50 TABLET in a BOTTLE
NDC: 71335-1035-4 60 TABLET in a BOTTLE
NDC: 71335-1035-5 40 TABLET in a BOTTLE
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