Label: DYE FREE CHILDRENS ALLERGY RELIEF- diphenhydramine hydrochloride solution

  • Category: HUMAN OTC DRUG LABEL

Drug Label Information

Updated December 12, 2023

If you are a healthcare professional or from the pharmaceutical industry please visit this version.

  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient (in each 5 mL)

    Diphenhydramine HCl USP 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
    Itchy of the throat or Nose
  • 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

    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)

  • Directions

    find right dose on chart below
    take every 4 to 6 hours, or as directed by a doctor
    do not take more than 6 doses in 24 hours
    mL = milliliter

    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

    5mL to 10 mL

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

  • Other information

    each 5 mL contains: sodium 3 mg
    store at room temperature
    see bottom panel for lot number and expiration date
    protect from light
    contains low sodium
  • Inactive ingredients

    anhydrous citric acid, carboxymethylcellulose sodium, flavors, glycerin, potassium citrate, purified water, sodium benzoate, sorbitol, sucralose.

    Questions or comments?

    1-888-287-1915

  • PRINCIPAL DISPLAY PANEL

    *Compare to Children'sBenadryl® Dye-Free active ingredient**

    NDC 49035-600-04

    Dye-Free

    Children’s Allergy Relief

    Diphenhydramine HCl USP 12.5 mg ǀ Antihistamine
    Oral solution

    For Relief of:

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

    Sugar-Free | Dye-Free

    6-11 YEARS

    Natural Cherry Flavor

    4 FL OZ (118 mL)
    TAMPER EVIDENT: DO NOT USE IF PRINTED INNER SEAL UNDER CAP IS TORN OR MISSING

    *This product is not manufactured or distributed by Johnson and Johnson, owner of the registered trademark Children’s Benadryl® Dye–Free.

    IMPORTANT: Keep this carton for the future reference on full labeling.

    DISTRIBUTED BY:

    Walmart Inc.,

    Bentonville, AR 72716

    Satisfaction guaranteed- Or we’ll replace it or give you your money back. For question or comments or to report an undesired reaction or side effect, please call 1-888-287-1915

    Equate Children's Allergy Relief Cherry Flavor
  • INGREDIENTS AND APPEARANCE
    DYE FREE CHILDRENS ALLERGY RELIEF 
    diphenhydramine hydrochloride solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49035-600
    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)  
    CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED (UNII: K679OBS311)  
    glycerin (UNII: PDC6A3C0OX)  
    POTASSIUM CITRATE (UNII: EE90ONI6FF)  
    water (UNII: 059QF0KO0R)  
    sodium benzoate (UNII: OJ245FE5EU)  
    sorbitol (UNII: 506T60A25R)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    Product Characteristics
    ColorWHITE (Clear, colorless) Score    
    ShapeSize
    FlavorCHERRY (Natural) Imprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:49035-600-041 in 1 CARTON03/09/2020
    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 DrugM01203/09/2020
    Labeler - WAL-MART STORES INC. (051957769)