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., 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 January 23, 2023

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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 finalpart34107/01/2008
    Labeler - Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division (878046358)
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