NDC | 63981-386-46 |
Set ID | 01bc2491-4deb-4f4c-990e-9bc7783120ae |
Category | HUMAN OTC DRUG LABEL |
Packager | COSTCO WHOLESALE CORPORATION |
Generic Name | |
Product Class | Antihistamine |
Product Number | |
Application Number | ANDA040564 |
- Active ingredient (in each tablet)
- Purpose
- Use
-
Warnings
Ask a doctor before use if you have
- glaucoma
- a breathing problem such as asthma, emphysema or chronic bronchitis
- trouble urinating due to an enlarged prostate gland
- Directions
- Other information
- Inactive ingredients
- Questions or comments?
-
Principal display panel
KIRKLAND
Signature™COMPARE TO
UNISOM® SLEEPTABS®
active ingredient*NDC 63981-386-46
ITM. / ART. 719940SLEEP AID
Doxylamine Succinate Tablets, 25 mg
Nighttime Sleep AidActual
SizeFall Asleep Fast!
Safe, Proven Effective
Just One Tablet per Dose2 x 96
192 TabletsTAMPER EVIDENT: DO NOT USE IF
IMPRINTED SAFETY SEAL UNDER
CAP IS BROKEN OR MISSING*This product is not manufactured or distributed by
Chattem, Inc., owner of the registered trademark
Unisom® SleepTabs®. 50844 REV0513E38646This product does not contain gluten.
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
www.costco.com 1-800-774-2678
17V0283aCONTENTS NOT LABELED
FOR INDIVIDUAL SALEKirkland 44-386
-
INGREDIENTS AND APPEARANCE
SLEEP AID
doxylamine succinate tabletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:63981-386 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength DOXYLAMINE SUCCINATE (UNII: V9BI9B5YI2) (DOXYLAMINE - UNII:95QB77JKPL) DOXYLAMINE SUCCINATE 25 mg Inactive Ingredients Ingredient Name Strength ANHYDROUS DIBASIC CALCIUM PHOSPHATE (UNII: L11K75P92J) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) MAGNESIUM STEARATE (UNII: 70097M6I30) CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2) Product Characteristics Color BLUE Score 2 pieces Shape OVAL Size 10mm Flavor Imprint Code 44;386 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:63981-386-46 2 in 1 CARTON 04/11/2002 08/01/2022 1 96 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 ANDA ANDA040564 04/11/2002 08/01/2022 Labeler - COSTCO WHOLESALE CORPORATION (103391843) Establishment Name Address ID/FEI Business Operations LNK International, Inc. 038154464 PACK(63981-386) Establishment Name Address ID/FEI Business Operations LNK International, Inc. 832867894 MANUFACTURE(63981-386) Establishment Name Address ID/FEI Business Operations LNK International, Inc. 832867837 PACK(63981-386) Establishment Name Address ID/FEI Business Operations LNK International, Inc. 967626305 PACK(63981-386) Establishment Name Address ID/FEI Business Operations LNK International, Inc. 868734088 PACK(63981-386)