Label: SLEEP AID- diphenhydramine hcl 25 mg tablet

  • NDC Code(s): 69168-263-30, 69168-263-93, 69168-263-98
  • Packager: Allegiant Health
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated December 21, 2018

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  • Active ingredient (in each caplet)

    Diphenhydramine HCl 25 mg

  • Purpose

    Nighttime sleep aid

  • Uses

    relief of occasional sleeplessness

  • Warnings

    Do not use

    • in children under 12 years of age
    • with any other products containing diphenhydramine, including ones used on skin 

    Ask 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 Doctor or Pharmacist before use if you

    are taking sedatives or tranquilizers

    When using this product

    • avoid alcoholic beverages
    • drowsiness may occur
    • do not drive a motor vehicle or operating 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.

    If pregnancy or breast-feeding

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

  • Keep Out of Reach of Children

    Keep out of reach of children. In case of accidental overdose, contact a doctor or Poison Control Center (1-800-222-1222) 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 store between 20-25°C (68-77°F)
    • do not use if blister unit is torn or open
  • Inactive Ingredients

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

  • Package/Label Principal Display Panel

     Sleep Aid

    Sleep Aid

  • INGREDIENTS AND APPEARANCE
    SLEEP AID 
    diphenhydramine hcl 25 mg tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69168-263
    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
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    LACTOSE, UNSPECIFIED FORM (UNII: J2B2A4N98G)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    ColorblueScoreno score
    ShapeCAPSULESize12mm
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69168-263-9324 in 1 BOX; Type 0: Not a Combination Product03/03/2015
    2NDC:69168-263-3030 in 1 BOTTLE; Type 0: Not a Combination Product03/03/2015
    3NDC:69168-263-98200 in 1 BOTTLE; Type 0: Not a Combination Product07/23/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01203/03/2015
    Labeler - Allegiant Health (079501930)
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