NDC Code(s) : 0280-0044-12
Packager : Bayer HealthCare LLC.

Category : HUMAN OTC DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

ANTIFLUAcetaminophen, Phenylephrine HCl, Chlorpheniramine Maleate TABLET, COATED
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:0280-0044
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PHENYLEPHRINE HYDROCHLORIDE(UNII: 04JA59TNSJ)
(PHENYLEPHRINE - UNII:1WS297W6MV) 		PHENYLEPHRINE HYDROCHLORIDE5 mg
CHLORPHENIRAMINE MALEATE(UNII: V1Q0O9OJ9Z)
(CHLORPHENIRAMINE - UNII:3U6IO1965U) 		CHLORPHENIRAMINE MALEATE2 mg
ACETAMINOPHEN(UNII: 362O9ITL9D)
(ACETAMINOPHEN - UNII:362O9ITL9D) 		ACETAMINOPHEN325 mg
Inactive Ingredients
Ingredient Name Strength
CROSCARMELLOSE SODIUM(UNII: M28OL1HH48)
D&C YELLOW NO. 10(UNII: 35SW5USQ3G)
MAGNESIUM SILICATE(UNII: 9B9691B2N9)
MAGNESIUM STEARATE(UNII: 70097M6I30)
Product Characteristics
Color yellow Score no score
Shape OVAL Size 16 mm
Flavor Imprint Code AntiFlu
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:0280-0044-121 in 1 CARTON 04/02/2015
112 in 1 BLISTER PACK Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
Export only 04/02/2015

LABELER - Bayer HealthCare LLC.(112117283)

PRINCIPAL DISPLAY PANEL

antiflutab