FDA Label for Robafen Cough Formula
View Indications, Usage & Precautions
Robafen Cough Formula Product Label
The following document was submitted to the FDA by the labeler of this product Aidarex Pharmaceuticals Llc. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Active Ingredient (In Each Teaspoonful (5 Ml))
Guaifenesin USP 100 mg
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
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