Label: NIGHTTIME SLEEP AID- doxylamine succinate tablet 

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

NOTE: Most over the counter (OTC) are not reviewed and approved by the FDA. However, they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated 09/13

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

    • 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.

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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 USP]
    • see end flap for expiration date and lot number 
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  • Inactive ingredients

    dicalcium phosphate, FD&C blue #1 aluminum lake, magnesiums 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 21130-326-01

    Compare to Unisom® SleepTabs® active ingredient*

    Nighttime
    Sleep Aid
    Doxylamine Succinate Tablets, 5 mg
    Nighttime Sleep-Aid
    • Safe. Proven Effective.
    • Contains No Pain Reliever
    • Just One Tablet Per Dose

    32 TABLETS

    SAFEWAY®

    *this product is not manufactured or distributed by Chattem, Inc., distributors of the registered trademark Unisom® SleepTabs®.
    50844     REV0512B38627

    DISTRIBUTED BY SAFEWAY INC., P.O. BOX 99, PLEASANTON, CA 94566-009
    1-888-SAFEWAY / www.safeway.com

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

    Safeway 44-386

    Safeway 44-386

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  • INGREDIENTS AND APPEARANCE
    NIGHTTIME SLEEP AID 
    doxylamine succinate tablet
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:21130-386
    Route of Administration ORAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    DOXYLAMINE SUCCINATE (DOXYLAMINE) DOXYLAMINE SUCCINATE 25 mg
    Inactive Ingredients
    Ingredient Name Strength
    CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS  
    FD&C BLUE NO. 1  
    MAGNESIUM STEARATE  
    CELLULOSE, MICROCRYSTALLINE  
    SODIUM STARCH GLYCOLATE TYPE A POTATO  
    Product Characteristics
    Color BLUE Score 2 pieces
    Shape CAPSULE Size 10mm
    Flavor Imprint Code 33;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
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    ANDA ANDA040564 04/11/2002
    Labeler - Safeway (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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