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 November 11, 2019

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

  • 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

    • 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 
  • Inactive ingredients

    dicalcium phosphate, 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

    Compare to Unisom® SleepTabs® active ingredient*

    NDC 37808-986-27

    H-E-B®

    Nighttime
    Sleep-Aid
    Doxylamine Succinate
    25 mg

    Nighttime Sleep-Aid

    •Fall Asleep Fast And Safe
    •One Tablet Per Dose
    •Easy to Swallow

    actual size

    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., owner of the registered trademark
    Unisom® SleepTabs®.
    50844        ORG051338627

    MADE WITH PRIDE AND CARE FOR
    H-E-B®, SAN ANTONIO, TX 78204

    DOES NOT CONTAIN GLUTEN

                            H-E-B®
    100%
    GUARANTEE
    | If you aren't completely pleased
    promise           with this product, we'll be happy to
                             replace it or refund your money.
                             You have our word on it.

    HEB 44-386

    HEB 44-386

  • INGREDIENTS AND APPEARANCE
    NIGHTTIME SLEEP-AID 
    doxylamine succinate tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:37808-986
    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
    ANHYDROUS DIBASIC CALCIUM PHOSPHATE (UNII: L11K75P92J)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MICROCRYSTALLINE CELLULOSE (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:37808-986-272 in 1 CARTON04/11/200208/01/2022
    116 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA04056404/11/200208/01/2022
    Labeler - H E B (007924756)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.832867894MANUFACTURE(37808-986)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.832867837PACK(37808-986)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.967626305PACK(37808-986)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.038154464PACK(37808-986)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.868734088PACK(37808-986)