NDC Code(s) : 59741-201-06
Packager : Bio-Pharm, Inc.

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Assured Day time Cold and CoughDextromethorphan Hydrobromide and Phenylephrine Hydrochloride LIQUID
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:59741-201
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Dextromethorphan Hydrobromide(UNII: 9D2RTI9KYH)
(Dextromethorphan - UNII:7355X3ROTS) 		Dextromethorphan Hydrobromide5 mg in 5 mL
Phenylephrine Hydrochloride(UNII: 04JA59TNSJ)
(Phenylephrine - UNII:1WS297W6MV) 		Phenylephrine Hydrochloride2.5 mg in 5 mL
Inactive Ingredients
Ingredient Name Strength
saccharin sodium(UNII: SB8ZUX40TY)
Citric Acid Monohydrate(UNII: 2968PHW8QP)
FD&C Red no. 40(UNII: WZB9127XOA)
benzoic acid(UNII: 8SKN0B0MIM)
Water(UNII: 059QF0KO0R)
Edetic Acid(UNII: 9G34HU7RV0)
Sodium Citrate(UNII: 1Q73Q2JULR)
Sorbitol(UNII: 506T60A25R)
Propylene Glycol(UNII: 6DC9Q167V3)
Prunus Serotina Bark(UNII: 5D48E975HA)
Product Characteristics
Color PINK Score
Shape Size
Flavor CHERRY Imprint Code
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:59741-201-06118 mL in 1 BOTTLE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC MONOGRAPH FINAL part341 11/01/2011

PRINCIPAL DISPLAY PANEL

NDC 59741-201-06

ASSURED ®

Day Time
Cold & Cough*

Cough Suppressant:
Dextromethorphan HBr

Nasal Decongestant:
Phenylephrine HCl

Relief for:

• Cough• Stuffy Nose

Cherry
Flavor

4 FL OZ (118 mL)

Principal Display Panel - 118 mL Bottle Label