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

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated July 10, 2019

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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 finalpart34107/03/2019
    Labeler - Savings Distributors LLC (010527359)
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