Label: CHILDRENS DYE FREE ALLERGY- diphenhydramine hydrochloride liquid

  • NDC Code(s): 49580-0293-4
  • Packager: P & L Development, LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated April 15, 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 drug 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 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 chart below
     Age (yr) Dose (mL)
     children 6 to 11 years5mL to 10 mL
     children 2 to 5 years do not use unless directed by a doctor
     children under 2 yearsdo not use
  • Other information

    • each 5 mL contains: sodium 8 mg
    • store between 20°-25°C (68°-77°F). Do not refrigerate.
    • protect from light. Store in outer carton until contents are used
  • Inactive ingredients

     anhydrous citric acid,carboxymethyl cellulose sodium, flavor, glycerin, purified water, saccharin sodium, sodium benzoate, sodium citrate, sorbitol

  • 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

    dye-free​​

    allergy

    Diphenhydramine HCl 12.5 mg

    Antihistamine

    relieves:

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

    For Ages 6 to 11

    alcohol free

    dye-free

    bubblegum Flavor

    FL OZ (mL)

    Dosing Cup Included

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

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

    Manufactured by:

    PL Developments

    11865 S. Alameda St

    Lynwood, CA 90262

  • Package Label

    Diphenhydramine HCI 12.5 mg

    Readyincase Children's Dye-Free Allergy

  • INGREDIENTS AND APPEARANCE
    CHILDRENS DYE FREE ALLERGY 
    diphenhydramine hydrochloride liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49580-0293
    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)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    TRISODIUM CITRATE DIHYDRATE (UNII: B22547B95K)  
    CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    SORBITOL (UNII: 506T60A25R)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorBUBBLE GUMImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:49580-0293-41 in 1 BOX02/28/2015
    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 DrugM01202/28/2015
    Labeler - P & L Development, LLC (101896231)
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