NDC Code(s) : 0280-2020-10
Packager : Bayer HealthCare LLC.

Category : HUMAN OTC DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

BAYER Aspirin BAYER Aspirin Extra Strength TABLET
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:0280-2020
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ASPIRIN(UNII: R16CO5Y76E)
(ASPIRIN - UNII:R16CO5Y76E) 		ASPIRIN500 mg
Inactive Ingredients
Ingredient Name Strength
CARNAUBA WAX(UNII: R12CBM0EIZ)
STARCH, CORN(UNII: O8232NY3SJ)
D&C RED NO. 7(UNII: ECW0LZ41X8)
ALUMINUM OXIDE(UNII: LMI26O6933)
FD&C BLUE NO. 2(UNII: L06K8R7DQK)
FD&C RED NO. 40(UNII: WZB9127XOA)
HYPROMELLOSES(UNII: 3NXW29V3WO)
POWDERED CELLULOSE(UNII: SMD1X3XO9M)
PROPYLENE GLYCOL(UNII: 6DC9Q167V3)
SHELLAC(UNII: 46N107B71O)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
TRIACETIN(UNII: XHX3C3X673)
Product Characteristics
Color white Score no score
Shape OVAL Size 17 mm
Flavor Imprint Code Extra;Strength;BAYER
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:0280-2020-101 in 1 CARTON 23/12/2014
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 12/23/2014

LABELER - Bayer HealthCare LLC.(112117283)

Establishment
Name Address ID/FEI Business Operations
Bayer HealthCare LLC Consumer Care 072827066 manufacture(0280-2020), pack(0280-2020)

PRINCIPAL DISPLAY PANEL

Carton