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
  • 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 March 7, 2019

If you are a consumer or patient please visit this version.

  • 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 FINALpart34102/28/2019
    Labeler - Cardinal Health (Leader) 70000 (097537435)