Label: BENADRYL ALLERGY LIQUI-GELS- diphenhydramine hydrochloride capsule, liquid filled

  • NDC Code(s): 50580-228-24, 50580-228-48, 50580-228-49
  • Packager: Kenvue Brands LLC
  • Category: HUMAN OTC DRUG LABEL

Drug Label Information

Updated November 8, 2024

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient (in each capsule)

    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
    • do not take more than 6 doses in 24 hours
      adults and children 12 years and over  1 to 2 capsules
      children 6 to under 12 years  1 capsule
      children under 6 years  do not use this product in children under 6 years of age
  • Other information

    • store between 20-25°C (68-77°F). Avoid high humidity and excessive heat. Protect from light.
    • do not use if carton is open or blister unit is broken
  • Inactive ingredients

    gelatin, glycerin, polyethylene glycol, purified water, sorbitol. Capsules are imprinted with edible dye-free ink.

  • Questions or comments?

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

  • PRINCIPAL DISPLAY PANEL

    NDC 50580-228-24

    Benadryl®

    ALLERGY

    LIQUI GELS ®*

    Diphenhydramine HCl 25 mg | Antihistamine

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

    DYE-FREE

    *liquid-filled capsules

    Actual Size

    24 CAPSULES

    PRINCIPAL DISPLAY PANEL

  • INGREDIENTS AND APPEARANCE
    BENADRYL ALLERGY LIQUI-GELS 
    diphenhydramine hydrochloride capsule, liquid filled
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50580-228
    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
    GELATIN, UNSPECIFIED (UNII: 2G86QN327L)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    WATER (UNII: 059QF0KO0R)  
    SORBITOL (UNII: 506T60A25R)  
    Product Characteristics
    Colorwhite (Clear) Scoreno score
    ShapeOVALSize15mm
    FlavorImprint Code BENADRYL
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:50580-228-242 in 1 CARTON03/01/2009
    112 in 1 BLISTER PACK; Type 0: Not a Combination Product
    2NDC:50580-228-482 in 1 PACKAGE02/01/2023
    24 in 1 CARTON
    26 in 1 BLISTER PACK; Type 0: Not a Combination Product
    3NDC:50580-228-493 in 1 PACKAGE06/19/2023
    34 in 1 CARTON
    312 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01203/01/2009
    Labeler - Kenvue Brands LLC (118772437)
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