Label: CHILDRENS ALLERGY RELIEF- diphenhydramine hcl solution

  • NDC Code(s): 70000-0701-1
  • Packager: Cardinal Health 110, LLC. DBA Leader
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated April 28, 2025

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  • 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

    • glaucoma
    • a breathing problem such as chronic bronchitis

    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.

  • Directions

    • do not take more than directed
    • do not take more than 6 doses in 24 hours
    • mL = milliliter
    • only use the dose cup provided 
    • find right dose on chart below 
    • take every 4 to 6 hours, or as directed by a doctor
     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
  • Other information

    • each 5 mL contains: sodium 4 mg
    • store at 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF)
    • see end flap for expiration date and lot number
  • Inactive ingredients

    anhydrous citric acid, flavor, glycerin, propylene glycol, purified water, sodium benzoate, sodium chloride, sodium citrate dihydrate, sucralose, xanthan gum

  • Questions or comments?

    1-800-426-9391

  • Principal Display Panel

    LEADER™

    NDC 70000-0701-1

    DYE-FREE

    Children's
    Allergy
    Relief
    Diphenhydramine HCl
    12.5 mg / 5 mL Oral Solution
    Antihistamine

    Clear
    Bubble Gum
    Flavored Liquid
    Ages 6 to 11 Years
    Relief of:
    Sneezing
    Runny Nose
    Itchy, Watery Eyes
    Itchy Throat
    or Nose
    Alcohol-Free
    Sugar-Free

    COMPARE TO
    CHILDREN’S
    BENADRYL®
    DYE-FREE
    ALLERGY LIQUID
    active ingredient*

    100% Money
    Back Guarantee

    4 FL OZ (118 mL)

    *This product is not manufactured or distributed by Kenvue Inc., owner
    of the registered trademark Children’s Benadryl® Dye-Free Allergy.
    50844                 ORG072401836

    ©2024 Cardinal Health. All Rights Reserved. CARDINAL
    HEALTH, the Cardinal Health LOGO, ESSENTIAL TO CARE,
    LEADER, and the LEADER LOGO are trademarks or registered
    trademarks of Cardinal Health. All other marks are the
    property of their respective owners.

    TAMPER EVIDENT: DO NOT USE IF IMPRINTED
    SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

    CardinalHealth™

    DISTRIBUTED BY CARDINAL HEALTH
    DUBLIN, OHIO 43017
    www.myleader.com 1-800-200-6313
    Essential to Care™ since 1979

    LEADER 44-018

    LEADER 44-018

  • INGREDIENTS AND APPEARANCE
    CHILDRENS ALLERGY RELIEF 
    diphenhydramine hcl solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70000-0701
    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)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    TRISODIUM CITRATE DIHYDRATE (UNII: B22547B95K)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorBUBBLE GUMImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70000-0701-11 in 1 CARTON12/19/2024
    1118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01212/19/2024
    Labeler - Cardinal Health 110, LLC. DBA Leader (063997360)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.967626305manufacture(70000-0701) , pack(70000-0701)
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