Label: SLEEP AID 25MG- doxylamine succinate tablet

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated January 11, 2023

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  • Active ingredient (in each tablet)

    Doxylamine Succinate 25 mg

    Purpose

    Night sleep-aid

  • Uses

    Helps to reduce difficulty in falling asleep

  • Warnings

    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 glad
    • glucoma

    Ask a doctor or pharmacist before use if you are taking any other drugs.

    When usinf this product

    • avoid alcohol beverages
    • take only at bedtime

    Stop use and ask a doctor if sleeplessness persists continuosly for more than two weeks. Insomnia may be s symptom of serious underlying medical illness.

    If pregnant of breast-feeding, as a health professional before use.

  • KEEP OUT OF REACH OF CHILDREN

    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 and older:

    take one tablet 30 minutes before going to bed; take one daily or as directed by a doctor

    • children under 12 years:

    do not use

  • Other information

    • store between 20° and 25°C (68° and 77°F)
    • protect from excessive moisture
  • Inactive ingredients

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

  • Questions?

    call toll-free 1-866-933-6337

  • PRINCIPAL DISPLAY PANEL

    01b LBL_Sleep Aid Tablets_25mg.jpg

    01b DF1_Sleep Aid Tablets_25mg.jpg

    01b DF2_Sleep Aid Tablets_25mg.jpg

  • INGREDIENTS AND APPEARANCE
    SLEEP AID   25MG
    doxylamine succinate tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:73581-205
    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 (UNII: H8AV0SQX4D)  
    Product Characteristics
    ColorblueScoreno score
    ShapeOVALSize10mm
    FlavorImprint Code 44;386
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:73581-205-02200 in 1 BOTTLE; Type 0: Not a Combination Product08/03/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA04056408/03/2021
    Labeler - YYBA CORP (006339772)
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