NIGHTTIME SLEEP AID (DOXYLAMINE SUCCINATE) TABLET [WAL-MART STORES INC]

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NIGHTTIME SLEEP AID (DOXYLAMINE SUCCINATE) TABLET [WAL-MART STORES INC]
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NDC 49035-863-27, 49035-863-89
Set ID 5b0bf558-31e9-4b95-b946-84d160a73572
Category HUMAN OTC DRUG LABEL
Packager Wal-Mart Stores Inc
Generic Name
Product Class Antihistamine
Product Number
Application Number ANDA040564
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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

    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 20º-25ºC (68º-77ºF)
    • use by expiration date on package
  • Inactive ingredients

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

  • Questions or comments?

    Call 1-888-287-1915

  • Principal display panel

    NDC 49035-863-89

    equate™

    Compare to Unisom® SleepTabs® active Ingredient*

    Sleep Aid
    Doxylamine Succinate, 25 mg
    Nighttime Sleep-Aid


    One tablet per dose
    • Easy to swallow

    Actual Size
    32 TABLETS

    DISTRIBUTED BY: Walmart Inc., Bentonville, AR 72716
    PRODUCT OF ITALY

    *This product is not manufactured or distributed by Chattem, Inc., owner of the registered trademark Unisom® SleepTabs®.
    50844    REV0513A38627

    729665

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

    Equate 44-386

    Equate 44-386

  • INGREDIENTS AND APPEARANCE
    NIGHTTIME SLEEP AID 
    doxylamine succinate tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49035-863
    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
    CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS (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:49035-863-271 in 1 CARTON04/11/200205/05/2018
    132 in 1 BLISTER PACK; Type 0: Not a Combination Product
    2NDC:49035-863-8932 in 1 BOTTLE; Type 0: Not a Combination Product04/11/200208/01/2022
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA04056404/11/200208/01/2022
    Labeler - Wal-Mart Stores Inc (051957769)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.038154464PACK(49035-863)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.832867894MANUFACTURE(49035-863)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.832867837PACK(49035-863)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.967626305PACK(49035-863)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.868734088PACK(49035-863)
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