Label: SLEEP AID- doxylamine succinate tablet

  • 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

    • glaucoma
    • a breathing problem such as emphysema or chronic bronchitis
    • 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 antihistamines
    • any other drugs

    When using this product

    • avoid alcoholic beverages
    • do not drive a motor vehicle or operate machinery
    • 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 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

    • TAMPER EVIDENT: DO NOT USE IF OUTER PACKAGE IS OPENED OR BLISTER IS TORN OR BROKEN
    • store at controlled room temperature 20°-25°C (68°-77°F)
    • see end flap for expiration date and lot number
  • Inactive ingredients

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

  • Questions or comments?

    1-800-632-6900

  • Principal Display Panel

    COMPARE TO the active ingredient
    of UNISOM® SLEEPTABS® *See back panel

    NDC 30142-386-27

    Kroger®

    Nighttime Sleep-Aid

    Sleep Aid
    Doxylamine Succinate
    Tablets, 25 mg
    Nighttime Sleep-Aid

    actual
    size

    One Tablet
    Per Dose

    32 TABLETS

    TAMPER EVIDENT: DO NOT USE IF PACKAGE IS OPENED OR IF BLISTER
    UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING

    *Unisom® and SleepTabs® are registered trademarks of
    Chattem, Inc., Chattanooga, TN 37409. Chattem, Inc. is
    not affiliated with The Kroger Co. or this product.

    DISTRIBUTED BY THE KROGER CO.
    CINCINNATI, OHIO 45202
    FOR MORE PRODUCT INFORMATION, SCAN UPC
    USING YOUR KROGER APP OR CALL 800-632-6900

    50844 REV0123B38627

    Our Brands. Our Guarantee.
    Love It or Your Money Back.
    www.kroger.com

    Kroger 44-386

    Kroger 44-386

  • INGREDIENTS AND APPEARANCE
    SLEEP AID 
    doxylamine succinate tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:30142-386
    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
    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:30142-386-272 in 1 CARTON03/16/2021
    116 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA04056403/16/2021
    Labeler - Kroger Company (006999528)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.038154464pack(30142-386)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.832867837manufacture(30142-386) , pack(30142-386)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.967626305pack(30142-386)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.117025878manufacture(30142-386)
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