SLEEP AID (DOXYLAMINE SUCCINATE) TABLET [ARMY AND AIR FORCE EXCHANGE SERVICE]

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SLEEP AID (DOXYLAMINE SUCCINATE) TABLET [ARMY AND AIR FORCE EXCHANGE SERVICE]
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NDC 55301-986-27
Set ID 009df4c9-a524-4b8f-be7a-52c521e68ff1
Category HUMAN OTC DRUG LABEL
Packager ARMY AND AIR FORCE EXCHANGE SERVICE
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

  • 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
    • difficulty in urination due to enlargement of the prostate gland
    • glaucoma

    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 and children 12 years and over: take one tablet 30 minutes before going to bed; take once daily or as directed by a doctor
    • children under 12 years: do not use
  • 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

    dibasic calcium phosphate dihydrate, 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

    exchange✔select™

    Compare To The Active Ingredient of Unisom® SleepTabs®*

    Sleep Aid
    Doxylamine succinate 25 mg

    Nighttime
    Sleep-Aid

    32 TABLETS

    Actual Size

    • For a restful sleep
    • Easy to swallow
    • One tablet per dose

    “SATISFACTION GUARANTEED OR YOUR MONEY BACK”
    Manufactured For Your Military Exchanges
    Distributed by: LNK International, Inc.,
    Hauppauge, NY 11788
    1-800-426-9391

    *This product is not manufactured or distributed by Chattem, Inc., owner of the registered trademark Unisom® SleepTabs®.
    50844 REV0718A38627

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

    Exchange Select 44-386

    Exchange Select 44-386

  • INGREDIENTS AND APPEARANCE
    SLEEP AID 
    doxylamine succinate tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55301-986
    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
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
    DIBASIC CALCIUM PHOSPHATE DIHYDRATE (UNII: O7TSZ97GEP)  
    Product Characteristics
    ColorBLUEScoreno score
    ShapeOVALSize10mm
    FlavorImprint Code 44;386
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:55301-986-272 in 1 CARTON04/01/2019
    116 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA04056404/01/2019
    Labeler - ARMY AND AIR FORCE EXCHANGE SERVICE (001695568)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.832867894MANUFACTURE(55301-986)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.038154464PACK(55301-986)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.832867837PACK(55301-986)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.868734088PACK(55301-986)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.967626305PACK(55301-986)
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