SLEEP AID NIGHTTIME (DOXYLAMINE SUCCINATE) TABLET [MCKESSON (HEALTH MART)]

  • Home
  • SLEEP AID NIGHTTIME (DOXYLAMINE SUCCINATE) TABLET [MCKESSON (HEALTH MART)]

SLEEP AID NIGHTTIME (DOXYLAMINE SUCCINATE) TABLET [MCKESSON (HEALTH MART)]
PDF | XML
NDC 62011-0344-1
Set ID 9c03a879-6b67-486b-b23c-e9d84678a031
Category HUMAN OTC DRUG LABEL
Packager McKesson (Health Mart)
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

  • Uses

    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

    • take only at bedtime
    • avoid alcoholic beverages

    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 20°-25°C (68°-77°F)
    • 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

    Health Mart®

    NDC 62011-0344-1

    Compare to Unisom®
    SleepTabs® active ingredient*

    Sleep Aid Tablets

    Doxylamine Succinate 25 mg
    Nighttime Sleep Aid

    Fall Asleep Fast/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        REV0513A38627

    McKESSON

    Another Quality Product
    Distributed by McKesson
    One Post Street, San Francisco, CA 94104
    Money Back Guarantee
    healthmart.com

    Health Mart 44-386

    Health Mart 44-386

  • INGREDIENTS AND APPEARANCE
    SLEEP AID  NIGHTTIME
    doxylamine succinate tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62011-0344
    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
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    ANHYDROUS DIBASIC CALCIUM PHOSPHATE (UNII: L11K75P92J)  
    Product Characteristics
    ColorBLUEScore2 pieces
    ShapeOVALSize10mm
    FlavorImprint Code 44;386
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:62011-0344-12 in 1 CARTON04/11/200205/20/2022
    116 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA04056404/11/200205/20/2022
    Labeler - McKesson (Health Mart) (177667227)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.038154464PACK(62011-0344)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.832867894MANUFACTURE(62011-0344)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.832867837PACK(62011-0344)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.967626305PACK(62011-0344)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.868734088PACK(62011-0344)
View All Sections

Related Drugs

Search DailyMed Drugs