Label: BENADRYL- diphenhydramine hydrochloride tablet, film coated

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

Drug Label Information

Updated December 1, 2023

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  • SPL UNCLASSIFIED SECTION

    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:
    o
    runny nose
    o
    sneezing
    o
    itchy, watery eyes
    o
    itching of the nose or throat
    •
    temporarily relieves these symptoms due to the common cold:
    o
    runny nose
    o
    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 carton is opened or if blister unit is broken
  • 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)

  • PRINCIPAL DISPLAY PANEL

    NDC 71205-521-06

    Benadryl®

    ALLERGY

    Diphenhydramine HCl 25mg | Antihistamine

    ✓ Sneezing
    ✓ Runny Nose
    ✓ Itchy, Watery Eyes
    ✓ Itchy Throat

    ULTRATABS®*
    *small tablet size

    actual size

    6 TABLETS

    71205-521-06
  • INGREDIENTS AND APPEARANCE
    BENADRYL 
    diphenhydramine hydrochloride tablet, film coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71205-521(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)  
    Dibasic Calcium Phosphate Dihydrate (UNII: O7TSZ97GEP)  
    Hypromellose, Unspecified (UNII: 3NXW29V3WO)  
    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:71205-521-063 in 1 BAG01/01/2021
    12 in 1 POUCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01209/01/2008
    Labeler - Proficient Rx LP (079196022)
    Establishment
    NameAddressID/FEIBusiness Operations
    Proficient Rx LP079196022REPACK(71205-521) , RELABEL(71205-521)
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