Label: BENADRYL - diphenhydramine hydrochloride tablet, film coated

  • NDC Code(s): 50580-226-50, 50580-226-51, 50580-226-52, 50580-226-53, view more
    50580-226-54, 50580-226-56, 50580-226-62
  • Packager: Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division
  • 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 November 20, 2017

If you are a consumer or patient please visit this version.

  • SPL UNCLASSIFIED SECTION

    Drug Facts

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  • Active ingredient (in each tablet)

    Diphenhydramine HCl 25 mg

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  • Purpose

    Antihistamine

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  • 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
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  • 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)

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  • 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
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  • 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
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  • 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

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  • Questions or comments?

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

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  • 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
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  • INGREDIENTS AND APPEARANCE
    BENADRYL  
    diphenhydramine hydrochloride tablet, film coated
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:50580-226
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    Diphenhydramine Hydrochloride (UNII: TC2D6JAD40) (Diphenhydramine - UNII:8GTS82S83M) Diphenhydramine Hydrochloride 25 mg
    Inactive Ingredients
    Ingredient Name Strength
    Carnauba Wax (UNII: R12CBM0EIZ)  
    Croscarmellose Sodium (UNII: M28OL1HH48)  
    D&C Red no. 27 (UNII: 2LRS185U6K)  
    Aluminum Oxide (UNII: LMI26O6933)  
    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
    Color PINK Score no score
    Shape OVAL Size 11mm
    Flavor Imprint Code B;WL;25
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:50580-226-50 1 in 1 CARTON 06/04/2012
    1 100 in 1 BOTTLE; Type 0: Not a Combination Product
    2 NDC:50580-226-51 2 in 1 CARTON 06/04/2012
    2 12 in 1 BLISTER PACK; Type 0: Not a Combination Product
    3 NDC:50580-226-53 2 in 1 POUCH; Type 0: Not a Combination Product 06/04/2012
    4 NDC:50580-226-54 60 in 1 CARTON 07/27/2015
    4 2 in 1 POUCH; Type 0: Not a Combination Product
    5 NDC:50580-226-62 4 in 1 CARTON 01/02/2017
    5 2 in 1 POUCH; Type 0: Not a Combination Product
    6 NDC:50580-226-52 4 in 1 CARTON 06/04/2012
    6 12 in 1 BLISTER PACK; Type 0: Not a Combination Product
    7 NDC:50580-226-56 3 in 1 PACKAGE 02/01/2013
    7 NDC:50580-226-52 4 in 1 CARTON
    7 12 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part341 09/01/2008
    Labeler - Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division (878046358)
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