UNISOM SLEEPTABS (DOXYLAMINE SUCCINATE) TABLET [CHATTEM, INC.]

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UNISOM SLEEPTABS (DOXYLAMINE SUCCINATE) TABLET [CHATTEM, INC.]
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NDC 41167-0063-5, 41167-0063-6, 41167-0063-7, 41167-0063-8
Set ID f591d52f-5610-4517-a96f-1ed63deb00bc
Category HUMAN OTC DRUG LABEL
Packager Chattem, Inc.
Generic Name
Product Class Antihistamine
Product Number
Application Number ANDA040167
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  • SPL UNCLASSIFIED SECTION

    Unisom® SleepTabs®

    Doxylamine succinate tablets Nighttime Sleep-Aid

    Drug Facts

  • Active ingredient (in each tablet)

    Doxylamine succinate 25 mg

  • Purpose

    Nighttime sleep-aid

  • Uses

    • 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 68º to 77ºF (20º to 25ºC)
    • retain in carton until time of use
  • 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: 1-866-844-2798

  • 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

  • INGREDIENTS AND APPEARANCE
    UNISOM SLEEPTABS 
    doxylamine succinate tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:41167-0063
    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 (UNII: H3R47K3TBD)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
    Product Characteristics
    ColorBLUEScore2 pieces
    ShapeOVALSize13mm
    FlavorImprint Code Unisom;ST
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:41167-0063-51 in 1 CARTON01/15/2016
    116 in 1 BLISTER PACK; Type 0: Not a Combination Product
    2NDC:41167-0063-61 in 1 CARTON01/15/2016
    232 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    3NDC:41167-0063-71 in 1 CARTON01/15/2016
    348 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    4NDC:41167-0063-81 in 1 CARTON01/15/2016
    480 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA04016701/15/2016
    Labeler - Chattem, Inc. (003336013)
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