Label: CHILDRENS BENADRYL ALLERGY- diphenhydramine hydrochloride solution

  • NDC Code(s): 50580-534-04, 50580-534-08, 50580-534-16, 50580-534-18
  • Packager: Johnson & Johnson Consumer Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated January 22, 2024

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient (in each 5 mL)

    Diphenhydramine HCl 12.5 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
  • 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 the child has

    • a breathing problem such as chronic bronchitis
    • glaucoma
    • a sodium-restricted diet

    Ask a doctor or pharmacist before use if the child is taking sedatives or tranquilizers

    When using this product

    • marked drowsiness may occur
    • sedatives and tranquilizers may increase drowsiness
    • excitability may occur, especially in children

    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

    • find right dose on chart below
    • mL = milliliter
    • take every 4 to 6 hours, or as directed by a doctor
    • do not take more than 6 doses in 24 hours
    Age (yr)Dose (mL)
    children under 2 yearsdo not use
    children 2 to 5 yearsdo not use unless directed by a doctor
    children 6 to 11 years5 mL to 10 mL

    Attention: use only enclosed dosing cup specifically designed for use with this product. Do not use any other dosing device.

  • Other information

    • each 5 mL contains: sodium 14 mg
    • store between 20-25°C (68-77°F). Protect from light. Store in outer carton until contents used.
    • do not use if bottle wrap or foil inner seal imprinted with “Sealed For Your Safety” is broken or missing
  • Inactive ingredients

    anhydrous citric acid, D&C red no. 33, FD&C red no. 40, flavors, glycerin, monoammonium glycyrrhizinate, poloxamer 407, purified water, sodium benzoate, sodium chloride, sodium citrate, sucrose

  • Questions or comments?

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

  • PRINCIPAL DISPLAY PANEL

    NDC 50580-534-04

    Children's

    Benadryl ®

    ALLERGY

    Diphenhydramine HCl/antihistamine

    12.5 mg/5 mL oral solution

    4-6 Hours/Dose

    RELIEF OF:

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

    Alcohol Free

    Cherry!

    Flavored

    4 fl oz (118 mL)

    benadryl-1

  • INGREDIENTS AND APPEARANCE
    CHILDRENS BENADRYL ALLERGY 
    diphenhydramine hydrochloride solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50580-534
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIPHENHYDRAMINE HYDROCHLORIDE12.5 mg  in 5 mL
    Inactive Ingredients
    Ingredient NameStrength
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    AMMONIUM GLYCYRRHIZATE (UNII: 3VRD35U26C)  
    POLOXAMER 407 (UNII: TUF2IVW3M2)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)  
    SUCROSE (UNII: C151H8M554)  
    Product Characteristics
    ColorredScore    
    ShapeSize
    FlavorCHERRYImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:50580-534-041 in 1 CARTON07/01/2008
    1118 mL in 1 BOTTLE; Type 1: Convenience Kit of Co-Package
    2NDC:50580-534-081 in 1 CARTON07/01/2008
    2236 mL in 1 BOTTLE; Type 1: Convenience Kit of Co-Package
    3NDC:50580-534-162 in 1 PACKAGE01/28/200912/28/2022
    31 in 1 CARTON
    3236 mL in 1 BOTTLE; Type 1: Convenience Kit of Co-Package
    4NDC:50580-534-182 in 1 PACKAGE04/12/2021
    41 in 1 CARTON
    4236 mL in 1 BOTTLE; Type 1: Convenience Kit of Co-Package
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01207/01/2008
    Labeler - Johnson & Johnson Consumer Inc. (878046358)
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