NDC Code(s) : 0603-0169-21, 0603-0169-32
Packager : Qualitest Pharmaceuticals

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Enteric Coated Aspirin Regular Strength TABLET
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0603-0169
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
STARCH, CORN(UNII: O8232NY3SJ)
DIMETHICONE(UNII: 92RU3N3Y1O)
CROSCARMELLOSE SODIUM(UNII: M28OL1HH48)
D&C YELLOW NO. 10(UNII: 35SW5USQ3G)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
TALC(UNII: 7SEV7J4R1U)
TRIETHYL CITRATE(UNII: 8Z96QXD6UM)
SODIUM HYDROXIDE(UNII: 55X04QC32I)
FD&C YELLOW NO. 6(UNII: H77VEI93A8)
POLYSORBATE 80(UNII: 6OZP39ZG8H)
HYPROMELLOSES(UNII: 3NXW29V3WO)
CELLULOSE, MICROCRYSTALLINE(UNII: OP1R32D61U)
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A(UNII: NX76LV5T8J)
SODIUM LAURYL SULFATE(UNII: 368GB5141J)
MINERAL OIL(UNII: T5L8T28FGP)
Product Characteristics
Color orange Score no score
Shape ROUND Size 11 mm
Flavor Imprint Code T
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:0603-0169-21100 in 1 BOTTLE
2NDC:0603-0169-321000 in 1 BOTTLE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part343 02/04/2011

PRINCIPAL DISPLAY PANEL

ID="inv-219a916a-9e93-4624-9c63-326b13090376">

Product Label

Pain Reliever for Arthritis Pain

Made in the USA for

Qualitest Pharmaceuticals

130 Vintage Drive, Huntsville, AL 35811

EntericAspirin325mg100

EntericAspirin325mg100