NIGHTTIME SLEEP AID (DOXYLAMINE SUCCINATE) TABLET [BETTER LIVING BRANDS, LLC]

  • Home
  • NIGHTTIME SLEEP AID (DOXYLAMINE SUCCINATE) TABLET [BETTER LIVING BRANDS, LLC]

NIGHTTIME SLEEP AID (DOXYLAMINE SUCCINATE) TABLET [BETTER LIVING BRANDS, LLC]
PDF | XML
NDC 21130-386-22, 21130-386-27
Set ID c7dea3ea-c9f5-4903-859b-3b7a3762f07e
Category HUMAN OTC DRUG LABEL
Packager Better Living Brands, LLC
Generic Name
Product Class Antihistamine
Product Number
Application Number ANDA040564
View All Sections
  • 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

    • 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.

  • 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

    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

    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., 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.

    Signature Care 44-386

    Signature Care 44-386


  • INGREDIENTS AND APPEARANCE
    NIGHTTIME SLEEP AID 
    doxylamine succinate tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:21130-386
    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:21130-386-272 in 1 CARTON04/11/200208/01/2022
    116 in 1 BLISTER PACK; Type 0: Not a Combination Product
    2NDC:21130-386-223 in 1 CARTON04/11/200208/01/2022
    216 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 - Better Living Brands, LLC (009137209)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.038154464PACK(21130-386)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.832867894MANUFACTURE(21130-386)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.832867837PACK(21130-386)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.967626305PACK(21130-386)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.868734088PACK(21130-386)
View All Sections

Related Drugs

Search DailyMed Drugs