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

Drug Label Information

Updated July 18, 2024

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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 istaking 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 toactive 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

    1274 th49 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 DrugM01011/22/2021
    Labeler - RARITAN PHARMACEUTICALS INC (127602287)
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