Label: UNISOM SLEEPTABS- doxylamine succinate tablet

  • NDC Code(s): 41167-0063-5, 41167-0063-6, 41167-0063-7, 41167-0063-8
  • Packager: Chattem, Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated January 20, 2016

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  • SPL UNCLASSIFIED SECTION

    Unisom® SleepTabs®

    Doxylamine succinate tablets Nighttime Sleep-Aid

    Drug Facts

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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

    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 68º to 77ºF (20º to 25ºC)
    • retain in carton until time of use
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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

    Questions or comments: 1-800-633-1610

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  • PRINCIPAL DISPLAY PANEL

    Unisom Sleeptabs
    Doxylamine succinate
    25 mg

    Nighttime Sleep-Aid
    80 Tablets

    PRINCIPAL DISPLAY PANEL 
Unisom Sleeptabs
Doxylamine succinate
25 mg
80 Tablets

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  • INGREDIENTS AND APPEARANCE
    UNISOM SLEEPTABS 
    doxylamine succinate tablet
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:41167-0063
    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
    ANHYDROUS DIBASIC CALCIUM PHOSPHATE (UNII: L11K75P92J)  
    DIBASIC CALCIUM PHOSPHATE DIHYDRATE (UNII: O7TSZ97GEP)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
    Product Characteristics
    Color BLUE Score 2 pieces
    Shape OVAL Size 13mm
    Flavor Imprint Code Unisom;ST
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:41167-0063-5 2 in 1 CARTON
    1 8 in 1 BLISTER PACK; Type 0: Not a Combination Product
    2 NDC:41167-0063-6 1 in 1 CARTON
    2 32 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    3 NDC:41167-0063-7 1 in 1 CARTON
    3 48 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    4 NDC:41167-0063-8 1 in 1 CARTON
    4 80 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    ANDA ANDA040167 01/15/2016
    Labeler - Chattem, Inc. (003336013)
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