NDC Code(s) : 41163-945-32, 41163-945-06
Packager : United Natural Foods, Inc. dba UNFI

Category : HUMAN OTC DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Aspirin Aspirin TABLET, DELAYED RELEASE
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:41163-945
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
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
STARCH, CORN(UNII: O8232NY3SJ)
FD&C RED NO. 40(UNII: WZB9127XOA)
FD&C YELLOW NO. 6(UNII: H77VEI93A8)
HYPROMELLOSE, UNSPECIFIED(UNII: 3NXW29V3WO)
METHACRYLIC ACID(UNII: 1CS02G8656)
MICROCRYSTALLINE CELLULOSE(UNII: OP1R32D61U)
POLYDEXTROSE(UNII: VH2XOU12IE)
POLYETHYLENE GLYCOL, UNSPECIFIED(UNII: 3WJQ0SDW1A)
SHELLAC(UNII: 46N107B71O)
DIMETHICONE(UNII: 92RU3N3Y1O)
WATER(UNII: 059QF0KO0R)
SODIUM BICARBONATE(UNII: 8MDF5V39QO)
SODIUM LAURYL SULFATE(UNII: 368GB5141J)
TALC(UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
TRIACETIN(UNII: XHX3C3X673)
TRIETHYL CITRATE(UNII: 8Z96QXD6UM)
Product Characteristics
Color pink Score no score
Shape ROUND Size 6 mm
Flavor Imprint Code L
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:41163-945-321 in 1 CARTON 25/07/2014
1120 in 1 BOTTLE, PLASTIC Type 0: Not a Combination Product
2NDC:41163-945-061 in 1 CARTON 25/07/2014
2200 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 07/25/2014

LABELER - United Natural Foods, Inc. dba UNFI(943556183)

Establishment
Name Address ID/FEI Business Operations
LNK International, Inc. 038154464 pack(41163-945)

Establishment
Name Address ID/FEI Business Operations
LNK International, Inc. 832867837 manufacture(41163-945)

Establishment
Name Address ID/FEI Business Operations
LNK International, Inc. 832867894 manufacture(41163-945)

Establishment
Name Address ID/FEI Business Operations
LNK International, Inc. 868734088 manufacture(41163-945)

Establishment
Name Address ID/FEI Business Operations
LNK International, Inc. 967626305 pack(41163-945)

Establishment
Name Address ID/FEI Business Operations
LNK International, Inc. 117025878 manufacture(41163-945)

PRINCIPAL DISPLAY PANEL

EQUALINE®

compare to
St. Joseph® Low Dose
Safety Coated 81 mg Aspirin
active ingredient**

NDC 41163-945-32

low dose
aspirin 81 mg

pain reliever (NSAID)

• safety coated
• aspirin regimen

TALK TO YOUR DOCTOR OR OTHER
HEALTHCARE PROVIDER BEFORE
USING THIS PRODUCT FOR YOUR HEART

120 enteric coated tablets

actual size

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

**This product is not manufactured or distributed
by Foundation Consumer Healthcare, LLC,
owner of the registered trademark St. Joseph®
Low Dose Safety Coated 81 mg Aspirin.
50844 REV0122B64532

DISTRIBUTED BY UNFI
PROVIDENCE, RI 02908 USA

855-423-2630

Equaline 44-645Equaline 44-645