Label: CHILDRENS BENADRYL ALLERGY- diphenhydramine hydrochloride solution

  • NDC Code(s): 50580-534-04, 50580-534-08, 50580-534-16
  • 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 October 19, 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 5 mL)

    Diphenhydramine HCl 12.5 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
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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 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)

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  • 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 years do not use
    children 2 to 5 years do not use unless directed by a doctor
    children 6 to 11 years 5 mL to 10 mL

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

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  • 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 "SAFETY SEAL®" is broken or missing
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  • 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

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  • Questions or comments?

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

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  • 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)

    Principal Display Panel
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  • INGREDIENTS AND APPEARANCE
    CHILDRENS BENADRYL ALLERGY 
    diphenhydramine hydrochloride solution
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:50580-534
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    Diphenhydramine hydrochloride (UNII: TC2D6JAD40) (diphenhydramine - UNII:8GTS82S83M) Diphenhydramine hydrochloride 12.5 mg  in 5 mL
    Inactive Ingredients
    Ingredient Name Strength
    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
    Color RED Score     
    Shape Size
    Flavor CHERRY Imprint Code
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:50580-534-04 1 in 1 CARTON 07/01/2008
    1 118 mL in 1 BOTTLE; Type 1: Convenience Kit of Co-Package
    2 NDC:50580-534-08 1 in 1 CARTON 07/01/2008
    2 236 mL in 1 BOTTLE; Type 1: Convenience Kit of Co-Package
    3 NDC:50580-534-16 2 in 1 PACKAGE 01/28/2009
    3 1 in 1 CARTON
    3 236 mL in 1 BOTTLE; Type 1: Convenience Kit of Co-Package
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC MONOGRAPH FINAL part341 07/01/2008
    Labeler - Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division (878046358)
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