NDC Code(s) : 63981-329-78
Packager : COSTCO WHOLESALE CORPORATION

Category : HUMAN OTC DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Allergy MedicineDiphenhydramine HCl TABLET, FILM COATED
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:63981-329
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DIPHENHYDRAMINE HYDROCHLORIDE(UNII: TC2D6JAD40)
(DIPHENHYDRAMINE - UNII:8GTS82S83M) 		DIPHENHYDRAMINE HYDROCHLORIDE25 mg
Inactive Ingredients
Ingredient Name Strength
STARCH, CORN(UNII: O8232NY3SJ)
D&C RED NO. 27 ALUMINUM LAKE(UNII: ZK64F7XSTX)
DIBASIC CALCIUM PHOSPHATE DIHYDRATE(UNII: O7TSZ97GEP)
MAGNESIUM STEARATE(UNII: 70097M6I30)
MICROCRYSTALLINE CELLULOSE(UNII: OP1R32D61U)
POLYETHYLENE GLYCOL, UNSPECIFIED(UNII: 3WJQ0SDW1A)
POLYVINYL ALCOHOL, UNSPECIFIED(UNII: 532B59J990)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
STEARIC ACID(UNII: 4ELV7Z65AP)
TALC(UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
Product Characteristics
Color pink Score no score
Shape OVAL Size 11 mm
Flavor Imprint Code 44;329
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:63981-329-78600 in 1 BOTTLE, PLASTIC Type 0: Not a Combination Product03/02/1990
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC Monograph Drug M012 03/02/1990

LABELER - COSTCO WHOLESALE CORPORATION(103391843)

Establishment
Name Address ID/FEI Business Operations
LNK International, Inc. 038154464 pack(63981-329)

Establishment
Name Address ID/FEI Business Operations
LNK International, Inc. 832867837 manufacture(63981-329), pack(63981-329)

Establishment
Name Address ID/FEI Business Operations
LNK International, Inc. 832867894 manufacture(63981-329)

Establishment
Name Address ID/FEI Business Operations
LNK International, Inc. 868734088 manufacture(63981-329)

Establishment
Name Address ID/FEI Business Operations
LNK International, Inc. 967626305 pack(63981-329)

PRINCIPAL DISPLAY PANEL

KIRKLAND
 Signature

COMPARE TO BENADRYL®
ALLERGY ULTRATAB® TABLETS
 active ingredient*

NDC 63981-329-78
ITM. / ART. 536099

ALLERGY
 MEDICINE

Diphenhydramine HCl 25 mg

Antihistamine • Allergy Relief

For Temporary Relief of:
Sneezing & Runny Nose
Itchy, Watery Eyes
Hay Fever Symptoms
Itching of Nose or Throat

Actual Size

600
Minitabs

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

*This product is not manufactured
or distributed by Johnson &
Johnson Corporation, owner of
the registered trademark
Benadryl® Allergy ULTRATAB®
Tablets.   50844 REV0721K32978

Manufactured by: LNK INTERNATIONAL, INC.
60 Arkay Drive, Hauppauge, NY 11788 USA
For: Costco Wholesale Corporation, P.O. Box 34535
Seattle, WA 98124-1535 USA    1-800-774-2678    www.costco.com

Kirkland 44-329Kirkland 44-329