Label: ALLERGY RELIEF CHILDRENS- diphenhydramine hydrochloride liquid

  • NDC Code(s): 33992-0292-4
  • Packager: ASSURED / DOLLAR TREE (Greenbrier International, Inc.)
  • 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 24, 2022

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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.
    • keep dosing cup with product
    • mL = milliliter
    • 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.
  • Inactive ingredients

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

  • Questions or comments?

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

  • Principal Display Panel

    COMPARE TO ACTIVE INGREDIENT IN CHILDREN'S BENADRYL ALLERGY*  

    CHILDREN'S

    Allergy Relief

    Oral Solution Diphenhydramine HCl 12.5 mg 

    Antihistamine

    • Alcohol Free

    Relieves: Sneezing, Runny Nose, Itchy, Watery Eyes, Itchy Nose or Throat

    FOR AGES 6-11 YEARS

    FL OZ (mL)

    Cherry Flavor 

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

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

    Distributed by: GREENBRIER INTERNATIONAL, INC.

    500 VOLVO PARKWAY, CHESAPEAKE, VA 23320

  • Product Label

    Diphenhydramine HCI 12.5 mg

    ASSURED Childrens Allergy Relief Cherry Liquid

  • INGREDIENTS AND APPEARANCE
    ALLERGY RELIEF  CHILDRENS
    diphenhydramine hydrochloride liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:33992-0292
    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
    FlavorCHERRYImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:33992-0292-4118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product06/30/201601/31/2025
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34106/30/201601/31/2025
    Labeler - ASSURED / DOLLAR TREE (Greenbrier International, Inc.) (610322518)
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