Label: BENADRYL- diphenhydramine hydrochloride tablet, film coated

  • NDC Code(s): 50580-226-20, 50580-226-50, 50580-226-51, 50580-226-52, view more
    50580-226-53, 50580-226-54, 50580-226-56, 50580-226-62
  • Packager: Johnson & Johnson Consumer Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated January 29, 2024

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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:
      • 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 over1 to 2 tablets
    children 6 to under 12 years1 tablet
    children under 6 yearsdo 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 50580-226-51

    Benadryl ®

    ALLERGY

    Diphenhydramine HCl 25mg | Antihistamine

    ✓ Sneezing

    ✓ Runny Nose

    ✓ Itchy, Watery Eyes

    ✓ Itchy Throat

    ULTRATABS ®*

    *small tablet size

    actual size

    24 TABLETS

    PRINCIPAL DISPLAY PANEL

  • INGREDIENTS AND APPEARANCE
    BENADRYL 
    diphenhydramine hydrochloride tablet, film coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)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:50580-226-501 in 1 CARTON06/04/2012
    1100 in 1 BOTTLE; Type 0: Not a Combination Product
    2NDC:50580-226-512 in 1 CARTON06/04/2012
    212 in 1 BLISTER PACK; Type 0: Not a Combination Product
    3NDC:50580-226-532 in 1 POUCH; Type 0: Not a Combination Product06/04/2012
    4NDC:50580-226-5460 in 1 CARTON07/27/2015
    42 in 1 POUCH; Type 0: Not a Combination Product
    5NDC:50580-226-624 in 1 CARTON01/02/2017
    52 in 1 POUCH; Type 0: Not a Combination Product
    6NDC:50580-226-524 in 1 CARTON06/04/2012
    612 in 1 BLISTER PACK; Type 0: Not a Combination Product
    7NDC:50580-226-563 in 1 PACKAGE02/01/2013
    74 in 1 CARTON
    712 in 1 BLISTER PACK; Type 0: Not a Combination Product
    8NDC:50580-226-202 in 1 CARTON01/15/2024
    81 in 1 CARTON
    8100 in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01209/01/2008
    Labeler - Johnson & Johnson Consumer Inc. (878046358)
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