Label: 7 SELECT SLEEP AID- doxylamine succinate tablet

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

Drug Label Information

Updated March 6, 2015

If you are a consumer or patient please visit this version.

  • Active ingredient (in each tablet)

    Doxylamine succinate 25 mg

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  • Purpose

    Nighttime sleep-aid

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  • Use

    helps to reduce difficulty in falling asleep
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  • 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)

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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

    anhydrous dibasic calcium phosphate, dibasic calcium phosphate dihydrate, 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 Unisom® Sleep Tabs® active ingredient

    Sleep Aid Tablets

    Doxylamine Succinate Tablets, 25 mg

    Night Time Sleep-Aid

    Clinically Tested, Proven Effective

    One Tablet Per Dose

    16 TABLETS

    Actual Size

    7 Select Sleep Aid Tablets Image 1
    7 Select Sleep Aid Tablets Image 2
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  • INGREDIENTS AND APPEARANCE
    7 SELECT SLEEP AID 
    doxylamine succinate tablet
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:10202-441
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    DOXYLAMINE SUCCINATE (UNII: V9BI9B5YI2) (DOXYLAMINE - UNII:95QB77JKPL) DOXYLAMINE SUCCINATE 25 mg
    Inactive Ingredients
    Ingredient Name Strength
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: L11K75P92J)  
    CALCIUM PHOSPHATE, DIBASIC, DIHYDRATE (UNII: O7TSZ97GEP)  
    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:10202-441-73 16 in 1 CARTON
    1 1 in 1 BLISTER PACK
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    ANDA ANDA040167 08/05/2014
    Labeler - 7-Eleven (007347602)
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