Label: UNISOM SLEEPTABS- doxylamine succinate tablet

  • NDC Code(s): 41167-0608-0, 41167-0608-1, 41167-0608-2, 41167-0608-3, view more
    41167-0608-4
  • Packager: Chattem, Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated March 25, 2026

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient (in each tablet)         

    Doxylamine succinate 25 mg

  • Purpose

    Nighttime sleep-aid

  • Use   

    ■ helps to reduce difficulty in falling asleep

  • Warnings   

    See carton for complete 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

    ■ sedatives 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. 

  • 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

    ■ TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING  

    ■ TAMPER EVIDENT: DO NOT USE IF OUTER PACKAGE IS OPENED OR BLISTER IS TORN OR BROKEN   

    ■ store at controlled room temperature 20º-25ºC (68º-77ºF) 

    ■ see end flap for expiration date and lot number 

    ■ use by expiration date on package 

  • Inactive Ingredients

    dibasic calcium phosphate dihydrate, FD&C blue #1 aluminum lake, magnesium stearate, microcrystalline cellulose, sodium starch glycolate

  • Questions or comments?

    1-866-844-2798 Monday - Friday 8am-6pm ET

  • Principal Display Panel

    Unisom
    SleepTabs
    Doxylamine succinate     tablets, 25 mg
    NI    GHTTIME SLEEP-AID

    Unisom SleepTabs Doxylamine succinate tablets, 25 mg NIGHTTIME SLEEP-AID

  • INGREDIENTS AND APPEARANCE
    UNISOM SLEEPTABS 
    doxylamine succinate tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:41167-0608
    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
    DIBASIC CALCIUM PHOSPHATE DIHYDRATE (UNII: O7TSZ97GEP)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
    Product Characteristics
    Colorblue (Light Blue) Score2 pieces
    ShapeOVALSize13mm
    FlavorImprint Code Unisom;ST
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:41167-0608-41 in 1 CARTON03/16/2026
    14 in 1 BLISTER PACK; Type 0: Not a Combination Product
    2NDC:41167-0608-01 in 1 CARTON03/16/2026
    216 in 1 BLISTER PACK; Type 0: Not a Combination Product
    3NDC:41167-0608-11 in 1 CARTON03/16/2026
    332 in 1 BOTTLE; Type 0: Not a Combination Product
    4NDC:41167-0608-21 in 1 CARTON03/16/2026
    448 in 1 BOTTLE; Type 0: Not a Combination Product
    5NDC:41167-0608-31 in 1 CARTON03/16/2026
    580 in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA04056403/16/2026
    Labeler - Chattem, Inc. (003336013)
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