Label: ROBAFEN COUGH FORMULA- guaifenesin syrup
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Contains inactivated NDC Code(s)
NDC Code(s): 53217-024-01 - Packager: Aidarex Pharmaceuticals LLC
- This is a repackaged label.
- Source NDC Code(s): 0904-0061
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Drug Label Information
Updated October 3, 2013
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- Active ingredient (in each teaspoonful (5 mL))
- Purpose
- Uses
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Warnings
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
- Other information
- Inactive ingredients
- Questions?
- SPL UNCLASSIFIED SECTION
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PRINCIPAL DISPLAY PANEL
NDC 53217-0024-01
TAMPER-EVIDENTRobafen™
Syrup(brand of Guaifenesin syrup USP
100 mg per 5 mL)EXPECTORANT
Each teaspoonful (5 mL) contains:
Guaifenesin
(Glyceryl Guaiacolate), USP 100 mgTAMPER-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 USARepackaged By :
Aidarex Pharmaceuticals LLC,
Corona, CA 92880
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INGREDIENTS AND APPEARANCE
ROBAFEN COUGH FORMULA
guaifenesin syrupProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:53217-024(NDC:0904-0061) Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN 100 mg in 5 mL Inactive Ingredients Ingredient Name Strength PROPYLENE GLYCOL (UNII: 6DC9Q167V3) SODIUM BENZOATE (UNII: OJ245FE5EU) SACCHARIN SODIUM (UNII: SB8ZUX40TY) ANHYDROUS CITRIC ACID (UNII: XF417D3PSL) GLYCERIN (UNII: PDC6A3C0OX) MENTHOL (UNII: L7T10EIP3A) CORN SYRUP (UNII: 9G5L16BK6N) WATER (UNII: 059QF0KO0R) CARAMEL (UNII: T9D99G2B1R) FD&C RED NO. 40 (UNII: WZB9127XOA) Product Characteristics Color BROWN (Reddish-Brown) Score Shape Size Flavor MENTHOL Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:53217-024-01 118 mL in 1 BOTTLE, PLASTIC Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH FINAL part341 08/15/2012 Labeler - Aidarex Pharmaceuticals LLC (801503249)