Label: TOPCARE SLEEP AID- doxylamine succinate tablet

  • NDC Code(s): 76162-159-62, 76162-159-67
  • Packager: Topco Associates LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated March 28, 2024

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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
    •
    with any other product containing doxylamine
    •
    unless you have time for a full night’s sleep

    Ask a doctor before use if you have

    •
    a breathing problem such as emphysema or chronic bronchitis
    •
    glaucoma
    •
    trouble urinating due to an enlarged prostate gland

    Ask a doctor or pharmacist before use if you are

    taking

    •
    a sedative or any other sleep-aid
    •
    tranquilizers
    •
    any other antihistamines
    •
    any other drugs

    When using this product

    •
    avoid alcoholic beverages
    •
    do not drive a motor vehicle or operate machinery
    •
    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 20-25◦C (68-77◦F)
    •
    keep carton. It contains important information.
  • 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

  • Package/Label Principal Display Panel

    TopCare® health

    COMPARE TO VICKS® ZZZQUIL® ULTRA ACTIVE INGREDIENT

    NIGHTTIME

    Sleep Aid

    ULTRA

    DOXYLAMINE SUCCINATE TABLETS, 25 mg

    NIGHTTIME SLEEP-AID

    Clinically Tested, Proven Effective

    24 TABLETS

    actual size

    1 Tablet Dose

    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:76162-159
    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
    ANHYDROUS DIBASIC CALCIUM PHOSPHATE (UNII: L11K75P92J)  
    DIBASIC CALCIUM PHOSPHATE DIHYDRATE (UNII: O7TSZ97GEP)  
    FD&C BLUE NO. 1 ALUMINUM LAKE (UNII: J9EQA3S2JM)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    SODIUM STARCH GLYCOLATE TYPE A (UNII: H8AV0SQX4D)  
    Product Characteristics
    ColorBLUEScore2 pieces
    ShapeOVALSize10mm
    FlavorImprint Code L441
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:76162-159-6224 in 1 CARTON06/16/2023
    11 in 1 BLISTER PACK; Type 0: Not a Combination Product
    2NDC:76162-159-6748 in 1 CARTON01/24/2024
    21 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA04016706/16/2023
    Labeler - Topco Associates LLC (006935977)
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