Label: DIPHENHYDRAMINE HCL 25MG- sleep aid tablet, coated

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated November 23, 2021

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  • Active ingredient(s)

    Diphenhydramine HCl 25 mg

  • Purpose

    Nighttime sleep aid

  • Use(s)

    for relief of occasional sleeplessness

  • Warnings

    Do not use

    • In children under 12 years of age
    • With any other product containing diphenydramine, even one used on skin

    Ask a doctor before use if

    • 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 tranquilizers

    When using this product

    • avoid alcoholic beverages
    • drowsiness will occur
    • do not drive a motor vehicle or operate machinery

    Stop use and ask a doctor if

    sleeplessness persists continuously for more than 2 weeks. Insomnia may be a symptom of
    a serious underlying medical illness.

    Pregnancy/Breastfeeding

    If pregnant or breast-feeding, ask a health professional before use.

    Keep out of reach of children

    In case of accidental overdose, contact a doctor or Poison Control Center right away. 

  • Directions

    adults and children 12 years and over: take 2 caplets at bedtime if needed or as directed by a doctor

    children under 12 years of age: do not use

  • Other information

    • store at room temperature 20°– 25°C (68°– 77°F)
    • do not use if blister unit is torn or open 
    • you may report side effects to 1-888-952-0050
  • Inactive ingredients

    croscarmellose sodium, FD&C blue #1 aluminum lake, hypromellose, lactose, magnesium
    stearate, microcrystalline cellulose, polyethylene glycol, silicon dioxide, titanium dioxide

  • Principal Display Panel

    Sleep Aid

    Sleep Aid


  • INGREDIENTS AND APPEARANCE
    DIPHENHYDRAMINE HCL 25MG 
    sleep aid tablet, coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69168-002
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIPHENHYDRAMINE HYDROCHLORIDE25 mg
    Inactive Ingredients
    Ingredient NameStrength
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    FD&C BLUE NO. 1 ALUMINUM LAKE (UNII: J9EQA3S2JM)  
    HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
    LACTOSE, UNSPECIFIED FORM (UNII: J2B2A4N98G)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    ColorblueScoreno score
    ShapeOVALSize12mm
    FlavorImprint Code 263;arch
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69168-002-9324 in 1 CARTON; Type 0: Not a Combination Product11/23/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01011/23/2021
    Labeler - Allegiant Health (079501930)
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