NDC Code(s) : 0280-2100-32, 0280-2100-12, 0280-2100-20, 0280-2100-30, 0280-2100-40
Packager : Bayer HealthCare LLC.

Category : HUMAN OTC DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Bayer Aspirin TABLET
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:0280-2100
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ASPIRIN(UNII: R16CO5Y76E)
(ASPIRIN - UNII:R16CO5Y76E) 		ASPIRIN81 mg
Inactive Ingredients
Ingredient Name Strength
FERROSOFERRIC OXIDE(UNII: XM0M87F357)
CARNAUBA WAX(UNII: R12CBM0EIZ)
BROWN IRON OXIDE(UNII: 1N032N7MFO)
STARCH, CORN(UNII: O8232NY3SJ)
D&C YELLOW NO. 10(UNII: 35SW5USQ3G)
ALUMINUM OXIDE(UNII: LMI26O6933)
FD&C YELLOW NO. 6(UNII: H77VEI93A8)
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)
TRIACETIN(UNII: XHX3C3X673)
TRIETHYL CITRATE(UNII: 8Z96QXD6UM)
Product Characteristics
Color yellow Score no score
Shape ROUND Size 5 mm
Flavor Imprint Code 81
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:0280-2100-321 in 1 CARTON 07/12/2002
132 in 1 BOTTLE Type 0: Not a Combination Product
2NDC:0280-2100-121 in 1 CARTON 07/12/2002
2120 in 1 BOTTLE Type 0: Not a Combination Product
3NDC:0280-2100-201 in 1 CARTON 07/12/2002
3200 in 1 BOTTLE Type 0: Not a Combination Product
4NDC:0280-2100-301 in 1 CARTON 07/12/2002
4300 in 1 BOTTLE Type 0: Not a Combination Product
5NDC:0280-2100-401 in 1 CARTON 07/12/2002
5400 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 Drug M013 07/12/2002

LABELER - Bayer HealthCare LLC.(112117283)

Establishment
Name Address ID/FEI Business Operations
Bayer HealthCare LLC Consumer Care 072827066 manufacture(0280-2100), pack(0280-2100)

PRINCIPAL DISPLAY PANEL

N 0280-2100-32

ASPIRIN REGIMEN



BAYER ®



ASPIRIN (NSAID) PAIN RELIEVER

LOW DOSE

81mg

Safety Coated



Aspirin

32 ENTERIC COATED TABLETS

Carton 200 count