DALAY MAXIMUM STRENGTH (DIPHENHYDRAMINE HCL 25 MG) TABLET [GENOMMA LABS USA, INC]

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  • DALAY MAXIMUM STRENGTH (DIPHENHYDRAMINE HCL 25 MG) TABLET [GENOMMA LABS USA, INC]

DALAY MAXIMUM STRENGTH (DIPHENHYDRAMINE HCL 25 MG) TABLET [GENOMMA LABS USA, INC]
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NDC 50066-247-24
Set ID 4792ae82-fa15-45ff-834f-f9231d272176
Category HUMAN OTC DRUG LABEL
Packager Genomma Labs USA, Inc
Generic Name
Product Class
Product Number
Application Number PART338
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  • Active ingredient (in each tablet)

    Diphenhydramine HCl 25 mg

  • Purpose

    Nighttime sleep aid

  • Uses

    • for relief of occasional sleeplessness
  • Warnings

    Do not use

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

    Ask a 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 a doctor or pharmacist before use if you are

    taking sedatives or tranquilizers

    When using this product

    • marked drowsiness may occur
    • avoid alcoholic beverages
    • 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 serious underlying medical illness.

    If pregnant or breast-feeding

    ask a health professional before use.

  • Keep out of reach of children

    In case of accidental overdose, get medical help or contact a Poison Control Center (1-800-222-1222) immediately

  • Directions

    Adults and children 12 years of age and older: take 2 tablets 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
    • do not use if imprinted safety seal under cap is broken or missing
  • Inactive ingredients

    croscarmellose sodium, dicalcium phosphate dihydrate, FD&C blue #1 aluminum lake, magnesium stearate, microcrystalline cellulose, silicon dioxide

    Questions or comments

    Call toll free 1-877-99 GENOM (43666)

  • Package/Label Principal Display Panel

    Dalay Sleep-Aid

    Dalay Sleep-Aid

  • INGREDIENTS AND APPEARANCE
    DALAY  MAXIMUM STRENGTH
    diphenhydramine hcl 25 mg tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50066-247
    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)  
    CALCIUM PHOSPHATE, DIBASIC, DIHYDRATE (UNII: O7TSZ97GEP)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    Product Characteristics
    ColorBLUEScoreno score
    ShapeROUNDSize10mm
    FlavorImprint Code AZ247
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:50066-247-241 in 1 CARTON04/21/2015
    124 in 1 BOTTLE; Type 0: Not a Combination Product
    Image of Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart33804/21/2015
    Labeler - Genomma Labs USA, Inc (832323534)
    Registrant - Allegiant Health (079501930)
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