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 July 15, 2020

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

  • 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
    7NDC:50580-226-524 in 1 CARTON
    712 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34109/01/2008
    Labeler - Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division (878046358)