Label: CHILDRENS DYE FREE ALLERGY RELIEF- diphenhydramine hcl liquid

  • NDC Code(s): 21130-563-05
  • Packager: BETTER LIVING BRANDS LLC.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated April 27, 2026

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredient (in each 5 mL)

    Diphenhydramine HCl 12.5 mg

  • PURPOSE

    Purpose

    Antihistamine

  • INDICATIONS & USAGE

    Uses

    • temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:

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

  • WARNINGS

    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).

  • DOSAGE & ADMINISTRATION

    Directions

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

    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 years5 mL to 10 mL

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

  • OTHER SAFETY INFORMATION

    Other information

    • each 5 mL contains: sodium 5 mg
    • store at no greater than 25°C
  • INACTIVE INGREDIENT

    Inactive ingredients anhydrous citric acid, flavors, glycerin, purified water, sodium benzoate, sodium carboxymethylcellulose, sodium citrate dihydrate, sodium saccharin, sorbitol solution, sucralose

  • QUESTIONS

    Questions or comments? Call 1-877-290-4008

  • PRINCIPAL DISPLAY PANEL

    653L Children's Dye Free Allergy Relief - Bubblegum flavor - Label

    653L label

    653L Children's Dye Free Allergy Relief - Bubblegum flavor - Carton

    653L carton

  • INGREDIENTS AND APPEARANCE
    CHILDRENS DYE FREE ALLERGY RELIEF 
    diphenhydramine hcl liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:21130-563
    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
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    TRISODIUM CITRATE DIHYDRATE (UNII: B22547B95K)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    SORBITOL SOLUTION (UNII: 8KW3E207O2)  
    CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED (UNII: K679OBS311)  
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    WATER (UNII: 059QF0KO0R)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorBUBBLE GUMImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:21130-563-051 in 1 CARTON05/01/2026
    1118 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01205/01/2026
    Labeler - BETTER LIVING BRANDS LLC. (009137209)
    Registrant - TIME CAP LABORATORIES, INC. (037052099)
    Establishment
    NameAddressID/FEIBusiness Operations
    MARKSANS PHARMA LIMITED677604129manufacture(21130-563)
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