Label: TARGET DYE FREE CHILDRENS ALLERGY RELIEF- diphenhydramine hydrochloride syrup

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated April 23, 2024

If you are a consumer or patient please visit this version.

View All Sections
  • 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
    ▪
    itching of the nose or throat
  • 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 (tsp)

    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, flavors, glycerin, potassium citrate, purified water, sodium benzoate, sorbitol, sucralose.

  • PRINCIPAL DISPLAY PANEL

    NDC 82442-710-08

    Compare to active ingredient in Children's
    Benadryl® Dye-Free

    Dye-Free

    Children’s Allergy Relief

    Diphenhydramine HCl / Antihistamine

    Oral solution

    For Relief of:

     
    Runny nose
     
    Itchy throat or Nose
     
    sneezing
     
    itchy, watery eyes

    Sugar Free

    Natural Cherry Flavor
    8 fl oz (236 mL)

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

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

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

    Distributed by:

    Target Dye-free childrens allergy Relief
  • INGREDIENTS AND APPEARANCE
    TARGET DYE FREE CHILDRENS ALLERGY RELIEF 
    diphenhydramine hydrochloride syrup
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:82442-710
    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
    ColorRED (Clear, colorless) Score    
    ShapeSize
    FlavorCHERRYImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:82442-710-081 in 1 CARTON04/05/2024
    1236 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 DrugM01204/05/2024
    Labeler - Target Corporation (006961700)
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials, PubMed, Biochemical Data Summary

More Info on this Drug

View Labeling Archives, RxNorm, Get Label RSS Feed, View NDC Code(s)NEW!