Label: ROBAFEN COUGH FORMULA- guaifenesin syrup
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Contains inactivated NDC Code(s)
NDC Code(s): 61786-963-45 - Packager: REMEDYREPACK INC.
- 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 5, 2017
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- Active ingredient (in each 2 TSP (10 mL) )
- Purpose
- Uses
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Warnings
Ask a doctor before use if you have
- a persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis or emphysema
- a cough occurs with too much phlegm (mucus)
- Directions
- Other information
- Inactive ingredients
- Questions or comments?
- SPL UNCLASSIFIED SECTION
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PRINCIPAL DISPLAY PANEL
DRUG: ROBAFEN COUGH FORMULA
GENERIC: Guaifenesin
DOSAGE: SYRUP
ADMINSTRATION: ORAL
NDC: 61786-963-45
COLOR: brown
FLAVOR: MENTHOL
PACKAGING: 118 mL in 1 BOTTLE
ACTIVE INGREDIENT(S):
- Guaifenesin 100mg in 5mL
INACTIVE INGREDIENT(S):
- Corn Syrup
- FD&C Red no. 40
- Menthol, Unspecified Form
- Caramel
- Water
- Glycerin
- Sodium Benzoate
- Propylene Glycol
- Anhydrous Citric Acid
- Saccharin Sodium
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INGREDIENTS AND APPEARANCE
ROBAFEN COUGH FORMULA
guaifenesin syrupProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:61786-963(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, UNSPECIFIED FORM (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:61786-963-45 118 mL in 1 BOTTLE; Type 0: Not a Combination Product 10/31/2016 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part341 10/31/2016 Labeler - REMEDYREPACK INC. (829572556)