Otc - Active Ingredient
Guaifenesin 400 mg.
Guiafenesin
FDA Label NDC 11534-164
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Sunrise Pharmaceutical Inc for the product Guiafenesin (NDC 11534-164). 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, indications and usage, ask a doctor before use if you have, otc - stop use and ask a doctor if, otc – if pregnant or breast feeding, otc - keep out of reach of children, directions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Expectorant.
Indications And Usage
Helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageway of bothersome mucus and make coughs more productive.
Ask A Doctor Before Use If You Have
Cough that lasts or chronic such as occurs with smoking, asthma, chronic bronchitis or emphysema.
Cough accompanied by too much phlegm (mucus)
Otc - Stop Use And Ask A Doctor If
Cough lasts for more than 7 days, comes back, or occurs with fever, rash or persistent headache. These could be signs of a serious illness.
Otc – If Pregnant Or Breast Feeding
Ask a health professional before use.
Otc - Keep Out Of Reach Of Children
In case of overdose, get medical help or contact a Poison Control Center right away.
Directions
Take with a glass of water
| Adults and children 12 years and over | 1 tablet every 4 hour. Max 6 doses |
| Children 6 to under 12 years | Do not use |
| Children under 6 years | Do not use |
Other Information
Store at 15(-30(C(59(-86(F)
Inactive Ingredient
Colloidal silicon dioxide, magnesium stearate, maltodextrin, microcrystalline cellulose, povidone, sodium starch glycolate, stearic acid.
* Please review the disclaimer below.
