Label: BENADRYL ALLERGY ULTRATAB- diphenhydramine hydrochloride tablet, film coated

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

Drug Label Information

Updated May 1, 2026

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  • Drug Facts

  • Active ingredient (in each tablet)

    Diphenhydramine HCl 25 mg

    Purpose

    Antihistamine

  • Uses

    ■ temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:

    ■runny nose ■sneezing ■itchy, watery eyes ■itching of the nose or throat

    ■temporarily relieves these symptoms due to the common cold:

    ■runny nose ■sneezing

  • Warnings

    Do not use

    ■ to make a child sleepy

    ■ with any other product containing diphenhydramine, even one used on skin

    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 drinks

    ■ alcohol, sedatives, and tranquilizers may increase drowsiness

    ■ be careful when driving a motor vehicle or operating machinery

    ■ excitability may occur, especially in children

    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. (1-800-222-1222)

  • Directions

    ■ take every 4 to 6 hours, or as directed by a doctor

    ■ do not take more than 6 times in 24 hours

    adults and children 12 years and over 1 to 2 tablets

    children 6 to under 12 years 1 tablet

    children under 6 years do not use

  • Other information

    ■ each tablet contains:calcium 15 mg

    ■ store between 20-25°C (68-77°F). Protect from light.

    ■ do not use if pouch is torn or damaged

  • Inactive ingredients

    carnauba wax, croscarmellose sodium, D&C red no. 27 aluminum lake, dibasic calcium phosphate, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, titanium dioxide

  • Questions or comments?

    call 1-877-717-2824(toll-free) or 215-273-8755(collect)

  • Package Label

    Package Label

  • INGREDIENTS AND APPEARANCE
    BENADRYL ALLERGY ULTRATAB 
    diphenhydramine hydrochloride tablet, film coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:73097-004(NDC:50580-226)
    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
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    D&C RED NO. 27 ALUMINUM LAKE (UNII: ZK64F7XSTX)  
    ANHYDROUS DIBASIC CALCIUM PHOSPHATE (UNII: L11K75P92J)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    ColorpinkScoreno score
    ShapeOVALSize11mm
    FlavorImprint Code B;WL;25
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:73097-004-5025 in 1 CARTON07/03/2019
    12 in 1 POUCH; Type 0: Not a Combination Product
    2NDC:73097-004-4020 in 1 CARTON07/03/2019
    22 in 1 POUCH; Type 0: Not a Combination Product
    3NDC:73097-004-021 in 1 CARTON07/03/2019
    32 in 1 POUCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01207/03/2019
    Labeler - Savings Distributors LLC (010527359)
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