Label: NIGHTTIME SLEEP AID- doxylamine succinate tablet

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

Drug Label Information

Updated 03/13

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

  • Active ingredient (in each tablet)

    Doxylamine succinate 25 mg

    Close
  • Purpose

    Nighttime sleep-aid

    Close
  • Use

    helps to reduce difficulty in falling asleep

    Close
  • 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.

    Close
  • 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 
    Close
  • 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 
    Close
  • Inactive ingredients

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

    Close
  • Questions?

    1-888-287-1915

    Close
  • Principal display panel

    NDC 49035-863-27

    equate®

    Compare to Unisom® SleepTabs® Active Ingredient*

    Doxylamine Succinate Tablets, 25 mg
    Nighttime
    Sleep Aid

    Safe and Proven Effective

    Fall Asleep Fast

    Just One Tablet Per Dose 

    25 mg
    32 TABLETS

    Distributed by: Wal-Mart Stores, Inc.,
    Bentonville, AR 72716 ©Wal-Mart Stores, Inc.

    *This product is not manufactured or distributed by McNeil Consumer Healthcare, owner of the registered trademark Unisom® SleepTabs®.
    50844    REV0513B38627

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

    Equate 44-386

    Equate 44-386

    Close
  • INGREDIENTS AND APPEARANCE
    NIGHTTIME SLEEP AID 
    doxylamine succinate tablet
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:49035-863
    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 CAPSULE Size 10mm
    Flavor Imprint Code 44;386
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:49035-863-27 1 in 1 CARTON
    1 32 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 - Wal-Mart Stores Inc (051957769)
    Establishment
    Name Address ID/FEI Business Operations
    LNK International, Inc. 038154464 PACK(49035-863)
    Establishment
    Name Address ID/FEI Business Operations
    LNK International, Inc. 832867894 MANUFACTURE(49035-863)
    Close