Label: NIGHTTIME SLEEP AID- doxylamine succinate tablet

  • NDC Code(s): 59779-441-01, 59779-441-64, 59779-441-67
  • Packager: CVS Pharmacy
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated October 24, 2022

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  • Active ingredient (in each tablet)

    Doxylamine succinate 25 mg

  • Purpose

    Nighttime sleep-aid

  • Use

    •
    helps to reduce difficulty in falling asleep
  • Warnings

    Do not use

    in children under 12 years of age

    Ask 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 68°-77°F (20°-25°C)
    •
    retain in carton until time of use
    •
    see carton end panel for lot number and expiration date
  • 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?

    1-800-719-9260

  • Principal Display Panel

    Compare to the active ingredient in Unisom® SleepTabs®

    Tablets

    Nighttime

    Sleep-Aid

    DOXYLAMINE SUCCINATE TABLETS, 25 mg

    Nighttime sleep-aid

    Helps to reduce difficulty in falling asleep

    Actual Size

    Actual Bottle Size on Side Panel

    96 TABLETS

    One tablet per dose

    sleep-aid-image

  • INGREDIENTS AND APPEARANCE
    NIGHTTIME SLEEP AID 
    doxylamine succinate tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59779-441
    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
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    ANHYDROUS DIBASIC CALCIUM PHOSPHATE (UNII: L11K75P92J)  
    DIBASIC CALCIUM PHOSPHATE DIHYDRATE (UNII: O7TSZ97GEP)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    Product Characteristics
    ColorBLUEScore2 pieces
    ShapeOVALSize10mm
    FlavorImprint Code L441
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:59779-441-642 in 1 CARTON07/23/199701/01/2016
    116 in 1 BLISTER PACK; Type 0: Not a Combination Product
    2NDC:59779-441-6748 in 1 CARTON04/18/201811/30/2022
    21 in 1 BLISTER PACK; Type 0: Not a Combination Product
    3NDC:59779-441-011 in 1 CARTON05/09/2018
    396 in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA04016707/23/1997
    Labeler - CVS Pharmacy (062312574)
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