NDC Code(s) : 0280-2110-10
Packager : Bayer HealthCare LLC.

Category : HUMAN OTC DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Bayer Aspirin Regimen Aspirin TABLET, COATED
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:0280-2110
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ASPIRIN(UNII: R16CO5Y76E)
(ASPIRIN - UNII:R16CO5Y76E) 		ASPIRIN325 mg
Inactive Ingredients
Ingredient Name Strength
FERROSOFERRIC OXIDE(UNII: XM0M87F357)
BROWN IRON OXIDE(UNII: 1N032N7MFO)
HYPROMELLOSES(UNII: 3NXW29V3WO)
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A(UNII: NX76LV5T8J)
POLYSORBATE 80(UNII: 6OZP39ZG8H)
POWDERED CELLULOSE(UNII: SMD1X3XO9M)
PROPYLENE GLYCOL(UNII: 6DC9Q167V3)
SHELLAC(UNII: 46N107B71O)
SODIUM LAURYL SULFATE(UNII: 368GB5141J)
STARCH, CORN(UNII: O8232NY3SJ)
TRIACETIN(UNII: XHX3C3X673)
TRIETHYL CITRATE(UNII: 8Z96QXD6UM)
CARNAUBA WAX(UNII: R12CBM0EIZ)
ALUMINUM OXIDE(UNII: LMI26O6933)
D&C YELLOW NO. 10(UNII: 35SW5USQ3G)
FD&C YELLOW NO. 6(UNII: H77VEI93A8)
Product Characteristics
Color yellow Score no score
Shape OVAL Size 15 mm
Flavor Imprint Code BAYER;325
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:0280-2110-101 in 1 CARTON 01/12/2015
1100 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 Drug M013 01/11/2015

LABELER - Bayer HealthCare LLC.(112117283)

PRINCIPAL DISPLAY PANEL

BayerAspirinRegimen325