Label: NIGHTTIME SLEEP AID- doxylamine succinate tablet

  • NDC Code(s): 21130-386-27
  • Packager: Better Living Brands, LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated 06/15

If you are a consumer or patient please visit this version.

  • Active ingredient (in each tablet)

    Doxylamine succinate 25 mg

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  • Purpose

    Nighttime sleep-aid

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  • Use

    helps to reduce difficulty in falling asleep

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  • Warnings

    Ask a doctor before use if you have

    • a breathing problem such as asthma, emphysema or chronic bronchitis
    • glaucoma
    • 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.

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  • 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 
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  • Other information

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

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

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  • Questions or comments?

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

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  • Principal display panel

    NDC 21130-386-27

    Signature
    Care
    Quality Guaranteed

    COMPARE TO
    Unisom
    ® SleepTabs® active ingredient*

    Nighttime
    Sleep Aid
    DOXYLAMINE SUCCINATE 25 mg
    Nighttime Sleep-Aid
    • Fall asleep fast/safe
    • Easy to swallow
    • 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

    *This product is not manufactured or distributed by Chattem, Inc., distributors of Unisom® SleepTabs®.
    50844     REV0513C38627

    DISTRIBUTED BY BETTER LIVING BRANDS LLC
    P.O. BOX 99, PLEASANTON, CA 94566-0009
    1-888-723-3929

    OUR PROMISE
    QUALITY SATISFACTION
    100% GUARANTEED
    OR YOUR MONEY BACK.SignatureCare 44-386

    SignatureCare 44-386


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  • INGREDIENTS AND APPEARANCE
    NIGHTTIME SLEEP AID 
    doxylamine succinate tablet
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:21130-386
    Route of Administration ORAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    DOXYLAMINE SUCCINATE (UNII: V9BI9B5YI2) (DOXYLAMINE - UNII:95QB77JKPL) DOXYLAMINE SUCCINATE 25 mg
    Inactive Ingredients
    Ingredient Name Strength
    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
    Color BLUE Score 2 pieces
    Shape OVAL Size 10mm
    Flavor Imprint Code 44;386
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:21130-386-27 4 in 1 CARTON
    1 8 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    ANDA ANDA040564 04/11/2002
    Labeler - Better Living Brands, LLC (009137209)
    Establishment
    Name Address ID/FEI Business Operations
    LNK International, Inc. 038154464 PACK(21130-386)
    Establishment
    Name Address ID/FEI Business Operations
    LNK International, Inc. 832867894 MANUFACTURE(21130-386)
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