Label: BEST CHOICE CHILDRENS ALLERGY RELIEF BUBBLEGUM FLAVOR- diphenhydramine hcl liquid

  • NDC Code(s): 63941-710-04
  • Packager: BEST CHOICE (VALU MERCHANDISERS COMPANY)
  • 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 August 18, 2023

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  • 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
    ▪
    itching 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 at (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

    5 mL 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, flavor, glycerin, potassium citrate, purified water, sodium benzoate, sorbitol, sucralose.

  • Questions or comments?

    1-866-467-2748

  • Principal display panel

    Best Choice®

    NDC 63941-710-04

    COMPARE TO THE ACTIVE INGREDIENT IN CHILDREN’S BENADRYL® DYE-FREE *

    DYE-FREE

    Children’s

    Allergy Liquid

    Diphenhydramine HCl/Antihistamine Oral Solution

    For Relief of:

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

    SUGAR FREE

    BUBBLEGUM FLAVOR

    Naturally and artificially flavored

    4 FL OZ (118 mL)

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

    www.StopMedicineAbuse.org

    *This product is not manufactured or distributed by Johnson & Johnson owner of the registered trademark Children’s Benadryl® Dye-Free

    TEMPER EVIDENT: DO NOT USE IF PRINTED INNER SEAL UNDER CAP IS TORN OR MISSING

    Children's allergy liquid Bubblegum Flavor
  • INGREDIENTS AND APPEARANCE
    BEST CHOICE CHILDRENS ALLERGY RELIEF  BUBBLEGUM FLAVOR
    diphenhydramine hcl liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63941-710
    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
    Color    Score    
    ShapeSize
    FlavorBUBBLE GUMImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:63941-710-041 in 1 CARTON06/07/2021
    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 finalpart34106/07/2021
    Labeler - BEST CHOICE (VALU MERCHANDISERS COMPANY) (868703513)
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