Active Ingredient (In Each Teaspoonful (5 Ml))
Guaifenesin USP 100 mg
Robafen Cough Formula
FDA Label NDC 53217-024
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Aidarex Pharmaceuticals Llc for the product Robafen Cough Formula (NDC 53217-024). 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 teaspoonful (5 ml)), purpose, uses, ask a doctor before use if, directions, other information, inactive ingredients, questions?, 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
Ask A Doctor Before Use If
- you have a cough that lasts or a chronic cough such as occurs with smoking, asthma, chronic bronchitis or emphysema
- cough occurs with too much phlegm (mucus)
Directions
do not take more than 6 doses in any 24 hour period
| adults and children 12 years and over | 2 - 4 teaspoons every 4 hours or as directed by a doctor |
| children under 12 years | do not use |
Other Information
- each teaspoonful (5 mL) contains: sodium 3 mg
- store at room temperature 15°-30°C (59°-86°F)
Inactive Ingredients
caramel powder, citric acid, corn syrup, FD&C Red #40, glycerin, menthol, propylene glycol, purified water, sodium benzoate, sodium saccharin
Questions?
Adverse Drug Event Call: (800) 616-2471
Principal Display Panel
NDC 53217-0024-01
TAMPER-EVIDENT
Robafen™
Syrup
(brand of Guaifenesin syrup USP
100 mg per 5 mL)
EXPECTORANT
Each teaspoonful (5 mL) contains:
Guaifenesin
(Glyceryl Guaiacolate), USP 100 mg
TAMPER-EVIDENT: Do not use this product
if inner foil seal over the mouth of the
bottle is cut, torn, broken or missing.
For Dispensing Purpose Only
Distributed by
MAJOR PHARMACEUTICALS
31778 Enterprise Drive
Livonia, MI 48150 USA
Repackaged By :
Aidarex Pharmaceuticals LLC,
Corona, CA 92880
Image Label (Robafen 120 mL For Major 1) 
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