SLEEP AID (DOXYLAMINE SUCCINATE) TABLET [MCKESSON (SUNMARK)]

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SLEEP AID (DOXYLAMINE SUCCINATE) TABLET [MCKESSON (SUNMARK)]
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NDC 70677-0025-1
Set ID 069ab384-a664-430e-a0d8-cb47387b7000
Category HUMAN OTC DRUG LABEL
Packager McKesson (Sunmark)
Generic Name
Product Class Antihistamine
Product Number
Application Number ANDA040564
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  • 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 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

    sunmark®

    *COMPARE TO UNISOM® SLEEPTABS® ACTIVE INGREDIENT

    NDC 70677-0025-1

    sleep aid

    DOXYLAMINE SUCCINATE 25 MG
    Nighttime Sleep-Aid

    Fall asleep fast / safe
    One tablet per dose

    EASY TO SWALLOW

    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

    Another Quality Product Distributed by McKesson
    One Post Street, San Francisco, CA 94104
    Money Back Guarantee
    Please visit us at www.sunmarkbrand.com

    Sunmark 44-386

    Sunmark 44-386

  • INGREDIENTS AND APPEARANCE
    SLEEP AID 
    doxylamine succinate tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70677-0025
    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)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
    DIBASIC CALCIUM PHOSPHATE DIHYDRATE (UNII: O7TSZ97GEP)  
    Product Characteristics
    ColorBLUEScore2 pieces
    ShapeOVALSize10mm
    FlavorImprint Code 44;386
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70677-0025-12 in 1 CARTON04/11/200204/30/2022
    116 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA04056404/11/200204/30/2022
    Labeler - McKesson (Sunmark) (177667227)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.038154464PACK(70677-0025)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.832867894MANUFACTURE(70677-0025)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.967626305PACK(70677-0025)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.832867837PACK(70677-0025)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.868734088PACK(70677-0025)
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