Label: SLEEP AID- doxylamine succinate tablet

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated April 5, 2024

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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 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

    • 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?

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

  • Principal display panel

    Walgreens 

    Compare to the active ingredient
    in Unisom® SleepTabs®††

    Sleep Aid
    DOXYLAMINE SUCCINATE TABLETS,
    25 mg / NIGHTTIME SLEEP-AID
    Nighttime

    80
    TABLETS

    ONE TABLET PER DOSE                ACTUAL SIZE

    TAMPER EVIDENT: DO NOT USE IF
    IMPRINTED SAFETY SEAL UNDER CAP IS
    BROKEN OR MISSING

    †Our pharmacists recommend the
    Walgreens brand. We invite you to
    compare to national brands.
    ††This product is not manufactured
    or distributed by Chattem, Inc.,
    owner of the registered trademark
    Unisom® SleepTabs®.

    DISTRIBUTED BY: WALGREEN CO.
    DEERFIELD, IL 60015
    100% SATISFACTION GUARANTEED
    walgreens.com ©2023 Walgreen Co.

    50844 ORG012338631                NDC 0363-0386-31

    WALGREENS 44-386

    WALGREENS 44-386

  • INGREDIENTS AND APPEARANCE
    SLEEP AID 
    doxylamine succinate tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0363-0386
    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:0363-0386-311 in 1 CARTON04/05/2024
    180 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA04056404/05/2024
    Labeler - Walgreen Company (008965063)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.038154464pack(0363-0386)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.832867837manufacture(0363-0386) , pack(0363-0386)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.967626305pack(0363-0386)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.117025878manufacture(0363-0386)
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