Label: SLEEP AID- doxylamine succinate tablet

  • NDC Code(s): 63981-386-46
  • Packager: COSTCO WHOLESALE CORPORATION
  • Category: HUMAN OTC DRUG LABEL

Drug Label Information

Updated January 23, 2020

If you are a healthcare professional or from the pharmaceutical industry please visit this version.

  • Active ingredient (in each tablet)

    Doxylamine succinate 25 mg

  • Purpose

    Nighttime sleep-aid

  • Use

    helps to reduce difficulty in falling asleep

  • 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

    Ask a doctor or pharmacist before use if you are

    taking any other drugs.

    When using this product

    • avoid alcoholic beverages
    • take only at bedtime

    Stop use and ask a doctor if

    sleeplessness persists continuously for more than two weeks. Insomnia may be a symptom of a serious underlying medical illness.

    If pregnant or breast-feeding,

    ask a health professional before use.

    Keep out of reach of children.

    In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

  • Directions

    • adults: take one tablet 30 minutes before going to bed; take once daily or as directed by a doctor
    • do not give to children under 12 years of age
  • Other information

    • store at controlled room temperature 20°-25°C (68°-77°F)
    • see end flap for expiration date and lot number
  • Inactive ingredients

    dicalcium phosphate, FD&C blue #1 aluminum lake, magnesium stearate, microcrystalline cellulose, sodium starch glycolate

  • Questions or comments?

    Call 1-800-426-9391 8:30 AM-4:00 PM ET, Monday-Friday

  • Principal display panel

    KIRKLAND
    Signature

    COMPARE TO
    UNISOM® SLEEPTABS®
    active ingredient*

    NDC 63981-386-46
    ITM. / ART. 719940

    SLEEP AID
    Doxylamine Succinate Tablets, 25 mg
    Nighttime Sleep Aid

    Actual
    Size

    Fall Asleep Fast!
    Safe, Proven Effective
    Just One Tablet per Dose

    2 x 96
    192 Tablets

    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 REV0513E38646

    This 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
    17V0283a

    CONTENTS NOT LABELED
    FOR INDIVIDUAL SALE

    Kirkland 44-386

    Kirkland 44-386



  • INGREDIENTS AND APPEARANCE
    SLEEP AID 
    doxylamine succinate tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63981-386
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DOXYLAMINE SUCCINATE (UNII: V9BI9B5YI2) (DOXYLAMINE - UNII:95QB77JKPL) DOXYLAMINE SUCCINATE25 mg
    Inactive Ingredients
    Ingredient NameStrength
    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
    ColorBLUEScore2 pieces
    ShapeOVALSize10mm
    FlavorImprint Code 44;386
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:63981-386-462 in 1 CARTON04/11/200208/01/2022
    196 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA04056404/11/200208/01/2022
    Labeler - COSTCO WHOLESALE CORPORATION (103391843)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.038154464PACK(63981-386)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.832867894MANUFACTURE(63981-386)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.832867837PACK(63981-386)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.967626305PACK(63981-386)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.868734088PACK(63981-386)