Label: ADWE DYE-FREE CHILDRENS ALLERGY- diphenhydramine hydrochloride syrup

  • NDC Code(s): 68163-710-08
  • Packager: RARITAN PHARMACEUTICALS INC
  • 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 16, 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 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 (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)
    •
    protect from sunlight
    •
    see bottom panel for lot number and expiration date
    •
    contains low sodium
  • Inactive ingredients

    anhydrous citric acid, carboxymethylcellulose sodium, flavors, glycerin, potassium citrate, purified water, sodium benzoate, sorbitol, sucralose.

  • PRINCIPAL DISPLAY PANEL

    NDC 68163-710-08

    Compare to active ingredient in Children'sBenadryl® Dye-Free*

    Children’s Allergy Relief

    Antihistamine

    Diphenhydramine HCl

    For Relief Of:

    •
    Runny nose
    •
    sneezing
    •
    itchy, watery eyes
    •
    Itchy Throat or Nose
     
    Natural Cherry Flavor

    8 fl oz (236 mL)

    Manufactured for:

    Adwe Laboratories

    1274th 49 Street

    Brooklyn, NY 11219

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

     
    ADWE dye-free childrens allergy
  • INGREDIENTS AND APPEARANCE
    ADWE DYE-FREE CHILDRENS ALLERGY 
    diphenhydramine hydrochloride syrup
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68163-710
    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
    ColorWHITE (Clear, colorless) Score    
    ShapeSize
    FlavorCHERRYImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:68163-710-081 in 1 CARTON11/22/2021
    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 finalpart34111/22/2021
    Labeler - RARITAN PHARMACEUTICALS INC (127602287)
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