Label: ALLERGY RELIEF CHILDRENS ALLERGY- diphenhydramine hydrochloride liquid

  • NDC Code(s): 70000-0492-1
  • Packager: Cardinal Health (Leader) 70000
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated March 4, 2024

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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:
      • sneezing
      • runny nose
      • itchy, watery eyes
      • itching of the nose or throat
  • Warnings

    Do not use

    • with any other product containing diphenhydramine, even one used on skin
    • to make a child sleepy

    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 the reach of children.

    In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

  • Directions

    • do not take more than 6 doses in 24 hours
    • take every 4 to 6 hours, or as directed by a doctor
    • measure only with dosing cup provided. Do not use any other dosing device.
    • mL = milliliter
    • keep dosing cup with product
    • find the right dose on the chart below
    age (yr)dose (mL)
     children 6 to 11 years 5 mL to 10 mL
     children 2 to 5 years do not use unless directed by a doctor
     children under 2 years do not use

  • Other information

    • each 5 mL contains: sodium 6 mg
    • store between 20-25ºC (68-77ºF). Do not refrigerate
    • Protect from light. Store in outer carton until contents are used
  • Inactive ingredients

    anhydrous citric acid, D&C red #33, RD&C red#40, flavors, glycerin, poloxamer 407, purified water, sodium benzoate, sodium chloride, sodium citrate, sucrose

  • Questions or comments?

     Call 1-877-753-3935 Monday-Friday 9AM-5PM EST

  • Principal Display Panel

    COMPARE TO CHILDREN'S BENADRYL® ALLERGY active ingredient*

    Children's

    Allergy Relief

    Diphenhydramine HCI

    Oral Solution, 12.5 mg/5mL

    Antihistamine

    Bubble Gum Flavor

    Ages 6 to 11 years

    Relieves

    Sneezing

    Runny Nose

    Itchy, Watery Eyes

    Itching of the Nose or Throat

    Alcohol-Free

    Dosing Cup included

    FL OZ (mL)

    *This product is not manufactured or distributed by McNeil Consumer Healthcare, distributor of Benadryl® Allergy

    TAMPER EVIDENT: DO NOT USE IF CARTON IS OPENED OR IF PRINTED SAFETY SEAL AROUND BOTTLE OR UNDER CAP IS BROKEN OR MISSING.

    DISTRIBUTED BY CARDINAL HEALTH

    DUBLIN, OHIO 43017

    www.myleader.com

  • Product Label

    Diphenhydramine HCI 12.5 mg

    LEADER Children's Allergy Relief

  • INGREDIENTS AND APPEARANCE
    ALLERGY RELIEF  CHILDRENS ALLERGY
    diphenhydramine hydrochloride liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70000-0492
    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)  
    POLOXAMER 407 (UNII: TUF2IVW3M2)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    TRISODIUM CITRATE DIHYDRATE (UNII: B22547B95K)  
    SUCROSE (UNII: C151H8M554)  
    D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorBUBBLE GUMImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70000-0492-11 in 1 BOX02/28/2019
    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 DrugM01202/28/2019
    Labeler - Cardinal Health (Leader) 70000 (063997360)
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