Label: CHILDRENS ALLERGY RELIEF DYE FREE BUBBLE GUM- diphenhydramine hydrochloride liquid

  • NDC Code(s): 81522-293-04
  • Packager: FSA Store Inc. (Caring Mills)
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated April 2, 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 8 mg
    • store between 20-25ºC (68-77ºF). Do not refrigerate
    • Protect from light. Store in outer carton until contents are used.
  • Inactive ingredients

    carboxymethylcellulose sodium, citric acid, 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 the active ingredient in Children's Benadryl® Allergy

    For Ages 6-11 Years

    Children's Allergy Relief

    Diphenhydramine HCI 125 mg/5 mL

    Antihistamine Oral Solution

    Bubble Gum Flavor

    Dye-Free

    Alcohol-Free

    Relieves:

    • Sneezing
    • Runny nose
    • Itchy, watery eyes
    • Itching of the nose or throat

    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.

    Manufactured for FSA Store Inc.

    240 W. 37th St., 6th Floor

    New York, NY  10018

  • Packaging Label

    Diphenhydrame HCl 12.5 mg

    Caring Mills Children's Allergy Dye Free Bubble Gum Liquid

  • INGREDIENTS AND APPEARANCE
    CHILDRENS ALLERGY RELIEF  DYE FREE BUBBLE GUM
    diphenhydramine hydrochloride liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:81522-293
    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)  
    CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    TRISODIUM CITRATE DIHYDRATE (UNII: B22547B95K)  
    SORBITOL (UNII: 506T60A25R)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorBUBBLE GUMImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:81522-293-041 in 1 CARTON04/18/2022
    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 DrugM01204/18/2022
    Labeler - FSA Store Inc. (Caring Mills) (049283340)
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