Label: NIGHTTIME SLEEP AID- doxylamine succinate tablet

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

NOTE: Most over the counter (OTC) are not reviewed and approved by the FDA. However, they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated 06/09

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  • Active ingredient (in each tablet)

    Doxylamine succinate 25 mg

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  • Purpose

    Nighttime sleep-aid

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  • Uses

    • helps to reduce difficulty in falling asleep
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  • 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

    Do not give

    to children under 12 years of age

    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.

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  • 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
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  • 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
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  • Inactive ingredients

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

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  • Questions or comments?

    1-800-719-9260

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  • Principal Display Panel

    Compare to the active ingredient in Unisom® SleepTabs®

    Nighttime

    Sleep Aid

    Doxylamine Succinate Tablets, 25 mg USP

    Nighttime Sleep Aid

    Fall Asleep Fast

    Safe. Proven Effective

    Just One Tablet Per Dose

    Actual Size

    Nighttime Sleep Aid Tablets Carton

    Nighttime Sleep Aid Tablets Carton

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  • INGREDIENTS AND APPEARANCE
    NIGHTTIME SLEEP AID 
    doxylamine succinate tablet
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:59779-441
    Route of Administration ORAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    DOXYLAMINE SUCCINATE (DOXYLAMINE) DOXYLAMINE SUCCINATE 25 mg
    Product Characteristics
    Color BLUE Score no score
    Shape OVAL Size 10mm
    Flavor Imprint Code L441
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:59779-441-64 2 in 1 CARTON
    1 16 in 1 BLISTER PACK
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    ANDA ANDA040167 07/23/1997
    Labeler - CVS Pharmacy (062312574)
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