TOPCARE SLEEP AID (DOXYLAMINE SUCCINATE) TABLET [TOPCO ASSOCIATES LLC]

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TOPCARE SLEEP AID (DOXYLAMINE SUCCINATE) TABLET [TOPCO ASSOCIATES LLC]
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NDC 36800-441-64
Set ID 15dc89c4-b7ce-4d36-8107-f501daaf289b
Category HUMAN OTC DRUG LABEL
Packager Topco Associates LLC
Generic Name
Product Class Antihistamine
Product Number
Application Number ANDA040167
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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

    Do not use

    in children under 12 years of age

    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 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 right away. (1-800-222-1222)

  • Directions

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

    •
    store at 68°-77°F (20°-25°C)
    •
    retain in carton until time of use
    •
    see carton end panel for lot number and expiration date
  • Inactive ingredients

    anhydrous dibasic calcium phosphate, dibasic calcium phosphate dihydrate, FD&C blue no. 1 aluminum lake, magnesium stearate, microcrystalline cellulose, sodium starch glycolate

  • Questions or comments?

    1-888-423-0139

  • Principal Display Panel

    COMPARE TO UNISOM® SLEEPTABS® ACTIVE INGREDIENT

    NIGHTTIME

    Sleep Aid

    DOXYLAMINE SUCCINATE TABLETS, 25 mg

    NIGHTTIME SLEEP-AID

    OUR PHARMACISTS RECOMMEND

    Clinically Tested, Proven Effective

    One Tablet Per Dose

    32 TABLETS

    actual size

    Sleep Aid Carton Image 1
    Sleep Aid Carton Image 2
  • INGREDIENTS AND APPEARANCE
    TOPCARE SLEEP AID 
    doxylamine succinate tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:36800-441
    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
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    ANHYDROUS DIBASIC CALCIUM PHOSPHATE (UNII: L11K75P92J)  
    DIBASIC CALCIUM PHOSPHATE DIHYDRATE (UNII: O7TSZ97GEP)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    Product Characteristics
    ColorBLUEScoreno score
    ShapeOVALSize10mm
    FlavorImprint Code L441
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:36800-441-6432 in 1 CARTON01/29/1997
    11 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA04016701/29/1997
    Labeler - Topco Associates LLC (006935977)
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