Label: CHILDRENS ALLERGY RELIEF- diphenhydramine hcl solution

  • NDC Code(s): 50844-018-36
  • Packager: L.N.K. International, Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated December 8, 2023

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  • Active ingredient (in each 5 mL)

    Diphenhydramine HCl 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 (1-800-222-1222) right away.

  • Directions

    • find right dose on chart below
    • mL = milliliter; FL OZ = fluid ounce
    • use only enclosed dosing cup designed for use with this product. Do not use any other dosing device.
    • 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 yearsdo not use
    children 2 to 5 yearsdo not use unless
    directed by a doctor
    children 6 to 11 years5 mL to 10 mL

  • Other information

    • each 5 mL contains: sodium 4 mg
    • store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
    • see end flap for expiration date and lot number
  • Inactive ingredients

    anhydrous citric acid, flavor, glycerin, propylene glycol, purified water, sodium benzoate, sodium chloride, sodium citrate dihydrate, sucralose, xanthan gum

  • Questions or comments?

    1-800-426-9391

  • Principal display panel

    Quality 
         Plus

    NDC 50844-018-36

    Compare to active ingredient
    in Children’s Benadryl®
    Dye-Free Allergy*

    CHILDREN’S

    ALLERGY
    RELIEF

    Diphenhydramine HCl 12.5 mg
    Antihistamine

    Relieves
    • Sneezing
    • Runny nose
    • Itchy, Watery eyes
    • Itchy throat
      or nose

    Bubble Gum
    Flavor

    ALCOHOL FREE • DYE-FREE
    SUGAR FREE

    4 FL OZ (118 mL)

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

    50844     ORG121701836

    Distributed by
    LNK INTERNATIONAL, INC.
    60 Arkay Drive
    Hauppauge, NY 11788
    USA

    TAMPER EVIDENT: DO NOT USE IF IMPRINTED
    SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

    Quality Plus 44-018

    Quality Plus 44-018

  • INGREDIENTS AND APPEARANCE
    CHILDRENS ALLERGY RELIEF 
    diphenhydramine hcl solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50844-018
    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)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    TRISODIUM CITRATE DIHYDRATE (UNII: B22547B95K)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorBUBBLE GUMImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:50844-018-361 in 1 CARTON12/31/2018
    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 DrugM01212/31/2018
    Labeler - L.N.K. International, Inc. (038154464)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.967626305manufacture(50844-018) , pack(50844-018)
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