NDC Code(s) : 37205-757-76, 37205-757-87
Packager : Cardinal Health (Leader) 37205

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Aspirin Aspirin TABLET, COATED
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:37205-757
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
POLYSORBATE 80(UNII: 6OZP39ZG8H)
DIMETHICONE(UNII: 92RU3N3Y1O)
SODIUM HYDROXIDE(UNII: 55X04QC32I)
SODIUM LAURYL SULFATE(UNII: 368GB5141J)
TALC(UNII: 7SEV7J4R1U)
TRIETHYL CITRATE(UNII: 8Z96QXD6UM)
ANHYDROUS LACTOSE(UNII: 3SY5LH9PMK)
FERROSOFERRIC OXIDE(UNII: XM0M87F357)
BROWN IRON OXIDE(UNII: 1N032N7MFO)
CROSCARMELLOSE SODIUM(UNII: M28OL1HH48)
D&C YELLOW NO. 10(UNII: 35SW5USQ3G)
FD&C YELLOW NO. 6(UNII: H77VEI93A8)
HYPROMELLOSES(UNII: 3NXW29V3WO)
METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:1)(UNII: 74G4R6TH13)
CELLULOSE, MICROCRYSTALLINE(UNII: OP1R32D61U)
MINERAL OIL(UNII: T5L8T28FGP)
POTASSIUM HYDROXIDE(UNII: WZH3C48M4T)
STARCH, CORN(UNII: O8232NY3SJ)
PROPYLENE GLYCOL(UNII: 6DC9Q167V3)
WATER(UNII: 059QF0KO0R)
SHELLAC(UNII: 46N107B71O)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
SODIUM BICARBONATE(UNII: 8MDF5V39QO)
STEARIC ACID(UNII: 4ELV7Z65AP)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
FERRIC OXIDE YELLOW(UNII: EX438O2MRT)
Product Characteristics
Color YELLOW Score no score
Shape ROUND Size 7 mm
Flavor Imprint Code E;T81;1
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:37205-757-761 in 1 BOX 13/04/2013
1120 in 1 BOTTLE, PLASTIC Type 0: Not a Combination Product
2NDC:37205-757-87300 in 1 BOTTLE, PLASTIC Type 0: Not a Combination Product13/04/2013
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC MONOGRAPH FINAL part343 04/13/2013 03/31/2018

PRINCIPAL DISPLAY PANEL

Compare to Bayer® Low Dose Aspirin† active ingredient

‡Aspirin Regimen

Aspirin 81 mg

Pain Reliever (NSAID)

Low Dose Safety Coated

ENTERIC COATED TABLETS

†This product is not manufactured or distributed by Bayer HealthCare LLC, owner of the registered trademark Bayer® Low Dose Aspirin.

‡Aspirin is not appropriate for everyone, so be sure you talk to your doctor before you begin an aspirin regimen.

KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.

TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING.

PRINCIPAL DISPLAY PANEL

Aspirin 81 mgLeader Aspirin 81 mg Low Dose Safety Coated Tablet