Label: SLEEP AID- doxylamine succinate tablet
- NDC Code(s): 63981-986-44, 63981-986-96
- Packager: COSTCO WHOLESALE CORPORATION
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated August 24, 2024
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active ingredient (in each tablet)
- Purpose
- Use
-
Warnings
Do not use
- in children under 12 years of age
- with any other product containing doxylamine
- unless you have time for a full night’s sleep
Ask a doctor before use if you have
- a breathing problem such as emphysema or chronic bronchitis
- glaucoma
- trouble urinating due to an enlarged prostate gland
Ask a doctor or pharmacist before use if you are
taking
- sedatives or any other sleep-aid
- tranquilizers
- any other drugs
- any other antihistamines
When using this product
- avoid alcoholic beverages
- take only at bedtime
- do not drive a motor vehicle or operate machinery
- Directions
- Other information
- Inactive ingredients
- Questions or comments?
-
Principal display panel
KIRKLAND
SignatureCOMPARE TO
UNISOM® SLEEPTABS®
active ingredient*NDC 63981-986-96
ITM. / ART. 719940SLEEP AID
Doxylamine Succinate Tablets, 25 mg
Nighttime Sleep AidHelps to Reduce Difficulty
in Falling AsleepJust One Tablet per Dose
2 x 96
192 TabletsActual Size
TAMPER 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 REV0123E38646Manufactured 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.comKirkland 44-386
-
INGREDIENTS AND APPEARANCE
SLEEP AID
doxylamine succinate tabletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:63981-986 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 DIBASIC CALCIUM PHOSPHATE DIHYDRATE (UNII: O7TSZ97GEP) FD&C BLUE NO. 1 ALUMINUM LAKE (UNII: J9EQA3S2JM) MAGNESIUM STEARATE (UNII: 70097M6I30) MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U) SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2) Product Characteristics Color blue Score no score Shape OVAL Size 10mm Flavor Imprint Code 44;386 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:63981-986-96 2 in 1 PACKAGE 05/03/2019 1 96 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 2 NDC:63981-986-44 2 in 1 CARTON 05/03/2019 05/16/2021 2 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 05/03/2019 Labeler - COSTCO WHOLESALE CORPORATION (103391843) Establishment Name Address ID/FEI Business Operations LNK International, Inc. 038154464 pack(63981-986) Establishment Name Address ID/FEI Business Operations LNK International, Inc. 832867837 manufacture(63981-986) , pack(63981-986) Establishment Name Address ID/FEI Business Operations LNK International, Inc. 967626305 pack(63981-986) Establishment Name Address ID/FEI Business Operations LNK International, Inc. 117025878 manufacture(63981-986)