NDC Code(s) : 61786-964-45
Packager : REMEDYREPACK INC.

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Rabofen DMGuaifenesin and Dextromethorphan Hydrobromide SOLUTION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:61786-964(NDC:0904-0053)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
GUAIFENESIN(UNII: 495W7451VQ)
(GUAIFENESIN - UNII:495W7451VQ) 		GUAIFENESIN100 mg in 5 mL
DEXTROMETHORPHAN HYDROBROMIDE(UNII: 9D2RTI9KYH)
(DEXTROMETHORPHAN - UNII:7355X3ROTS) 		DEXTROMETHORPHAN HYDROBROMIDE10 mg in 5 mL
Inactive Ingredients
Ingredient Name Strength
SODIUM BENZOATE(UNII: OJ245FE5EU)
SACCHARIN SODIUM(UNII: SB8ZUX40TY)
ANHYDROUS CITRIC ACID(UNII: XF417D3PSL)
GLYCERIN(UNII: PDC6A3C0OX)
MENTHOL, UNSPECIFIED FORM(UNII: L7T10EIP3A)
WATER(UNII: 059QF0KO0R)
CORN SYRUP(UNII: 9G5L16BK6N)
PRUNUS SEROTINA BARK(UNII: 5D48E975HA)
FD&C RED NO. 40(UNII: WZB9127XOA)
Product Characteristics
Color red (Reddish-Pink) Score
Shape Size
Flavor CHERRY Imprint Code
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:61786-964-45118 mL in 1 BOTTLE Type 0: Not a Combination Product31/10/2016
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part341 10/31/2016

PRINCIPAL DISPLAY PANEL

DRUG: Rabofen DM

GENERIC: Guaifenesin and Dextromethorphan Hydrobromide

DOSAGE: SOLUTION

ADMINSTRATION: ORAL

NDC: 61786-964-45

COLOR: red

FLAVOR: CHERRY

PACKAGING: 118 mL in 1 BOTTLE

ACTIVE INGREDIENT(S):

  • Dextromethorphan Hydrobromide 10mg in 5mL
  • Guaifenesin 100mg in 5mL

INACTIVE INGREDIENT(S):

  • Corn Syrup
  • FD&C Red no. 40
  • PRUNUS SEROTINA BARK
  • WATER
  • MENTHOL, UNSPECIFIED FORM
  • ANHYDROUS CITRIC ACID
  • Saccharin Sodium
  • Glycerin
  • Sodium Benzoate

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