NDC Code(s) : 68016-142-06
Packager : Chain Drug Consortium, LLC

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Day Time Acetaminophen, Dextromethorphan Hydrobromide, Phenylephrine Hydrochloride LIQUID
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68016-142
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ACETAMINOPHEN(UNII: 362O9ITL9D)
(ACETAMINOPHEN - UNII:362O9ITL9D) 		ACETAMINOPHEN325 mg in 15 mL
DEXTROMETHORPHAN HYDROBROMIDE(UNII: 9D2RTI9KYH)
(DEXTROMETHORPHAN - UNII:7355X3ROTS) 		DEXTROMETHORPHAN HYDROBROMIDE10 mg in 15 mL
PHENYLEPHRINE HYDROCHLORIDE(UNII: 04JA59TNSJ)
(PHENYLEPHRINE - UNII:1WS297W6MV) 		PHENYLEPHRINE HYDROCHLORIDE5 mg in 15 mL
Inactive Ingredients
Ingredient Name Strength
CITRIC ACID MONOHYDRATE(UNII: 2968PHW8QP)
GLYCERIN(UNII: PDC6A3C0OX)
POLYETHYLENE GLYCOL 300(UNII: 5655G9Y8AQ)
PROPYLENE GLYCOL(UNII: 6DC9Q167V3)
WATER(UNII: 059QF0KO0R)
SACCHARIN SODIUM ANHYDROUS(UNII: I4807BK602)
TRISODIUM CITRATE DIHYDRATE(UNII: B22547B95K)
SUCROSE(UNII: C151H8M554)
FD&C YELLOW NO. 6(UNII: H77VEI93A8)
Product Characteristics
Color Score
Shape Size
Flavor ORANGE Imprint Code
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:68016-142-06177 mL in 1 BOTTLE, PLASTIC 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 11/03/2009

PRINCIPAL DISPLAY PANEL

Premier Value

Day-Time

Non-Drowsy Cold/flu Relief

Acetaminophen

6 FL OZ (177 mL)

PRINCIPAL DISPLAY PANEL

Acetaminophen 325 mg, Dextromethorphan HBr 10 mg, Phenylephrine HCl 5 mgPremier value Daytime with PE