NDC Code(s) : 59741-116-06, 59741-116-10
Packager : Bio-Pharm, Inc.

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Tussin DMGuaifenesin and Dextromethorphan Hydrobromide SOLUTION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:59741-116
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:59741-116-101 in 1 CARTON
1NDC:59741-116-06118 mL in 1 BOTTLE Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC MONOGRAPH FINAL part341 01/01/2004

PRINCIPAL DISPLAY PANEL

COMPARE TO ACTIVE INGREDIENTS IN
ROBITUSSIN ® DM*

NDC 59741-116-10

ASSURED™

ADULT

Tussin DM

Dextromethorphan HBr USP

- Cough Suppressant

Guaifenesin USP

- Expectorant

AGES 12+

  • Alcohol Free
  • Non-Drowsy

Relieves Cough, Chest
Congestion & Mucus

4 FL OZ
(118 mL)

Principal Display Panel - 118 mL Bottle Carton