Label: NOCTO SLEEP AID- doxylamine succinate tablet

  • Category: HUMAN OTC DRUG LABEL

Drug Label Information

Updated August 22, 2023

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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
    • 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 asthma, emphysema or chronic bronchitis
    • difficulty in urination due to enlargement of the prostate gland
    • glaucoma

    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

    • store at controlled room temperature 20°-25°C (68°-77°F)
    • see end flap for expiration date and lot number
  • Inactive ingredients

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

  • Questions or comments?

    Call 1-888-779-2877 M-F 9AM-5PM EST

  • Principal display panel

    Belmora LLC

    NDC 27854-375-01

    NOCTO®

    SLEEP AID
    Doxylamine Succinate Tablets 25 mg
    Nighttime Sleep-Aid

    24 Tablets

    Actual Size

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

    NOT TO BE SOLD IF PACKAGE IS TORN OR MISSING DOSAGE INFORMATION.

    Distributed by: Belmora LLC, 3033 Wilson Blvd. Suite 700, Arlington, VA 22201

    Nocto 44-386

    Nocto 44-386

  • INGREDIENTS AND APPEARANCE
    NOCTO SLEEP AID 
    doxylamine succinate tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:27854-375
    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 ALUMINUM LAKE (UNII: J9EQA3S2JM)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
    Product Characteristics
    ColorblueScoreno score
    ShapeOVALSize10mm
    FlavorImprint Code 44;386
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:27854-375-011 in 1 CARTON10/31/2019
    124 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA04056410/31/2019
    Labeler - Belmora LLC (112753244)
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