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 28, 2023

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  • Active ingredient (in each tablet)

    Doxylamine succinate 25 mg

  • Purpose

    Nighttime sleep-aid

  • Use

    • helps to reduce difficulty in falling asleep
  • 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

    Stop use and ask a doctor if

    • sleeplessness persists continuously for more than two weeks. Insomnia may be a symptom of 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 right away.

  • Directions

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

    • use by expiration date on package
    • store at controlled room temperature 20°-25°C (68°-77°F)
  • Inactive ingredients

    dibasic calcium phosphate dihydrate, 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 63981-986-96
    ITM. / ART. 719940

    SLEEP AID
    Doxylamine Succinate Tablets, 25 mg
    Nighttime Sleep Aid

    Helps to Reduce Difficulty
    in Falling Asleep

    Just One Tablet per Dose

    2 x 96
    192 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 Chattem, Inc., owner of the
    registered trademark Unisom® SleepTabs®.
    50844     REV0123E38646

    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 44-386

    Kirkland 44-386

  • INGREDIENTS AND APPEARANCE
    SLEEP AID 
    doxylamine succinate tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63981-986
    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
    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
    ColorblueScoreno score
    ShapeOVALSize10mm
    FlavorImprint Code 44;386
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:63981-986-962 in 1 PACKAGE05/03/2019
    196 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    2NDC:63981-986-442 in 1 CARTON05/03/201905/16/2021
    296 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA04056405/03/2019
    Labeler - COSTCO WHOLESALE CORPORATION (103391843)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.038154464pack(63981-986)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.832867837manufacture(63981-986) , pack(63981-986)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.967626305pack(63981-986)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.117025878manufacture(63981-986)
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