Label: CHILDRENS DYE FREE ALLERGY RELIEF- diphenhydramine hcl solution

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

Drug Label Information

Updated May 11, 2024

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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

    • glaucoma
    • a breathing problem such as chronic bronchitis

    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.

  • Directions

    • do not take more than directed
    • find right dose on chart below
    • mL = milliliter
    • only use the dose cup provided 
    • 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 years 5 mL to 10 mL
  • Other information

    • each 5 mL contains: sodium 4 mg
    • store at 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF)
    • 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

    FREE
    FROM
    SUGAR FREE
    ALCOHOL FREE

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

    NDC 11822-0918-1

    AGES 6-11

    CHILDREN’S
    DYE-FREE
    ALLERGY     RELIEF

    DIPHENHYDRAMINE
    HCl 12.5 mg / 5 mL
    Oral Solution
    ANTIHISTAMINE

    for relief of:
    sneezing,
    runny nose,
    itchy throat or nose,
    itchy, watery eyes

    CLEAR BUBBLE
    GUM FLAVOR

    DOSAGE CUP INCLUDED

    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              ORG012301836

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

    OUR PROMISE
    Dye Free

    DOSAGE CUP INCLUDED

    DISTRIBUTED BY:
    RITE AID
    200 NEWBERRY COMMONS
    ETTERS, PA 17319
    www.riteaid.com

    SATISFACTION
    GUARANTEE
    If you’re not satisfied, we’ll
    happily refund your money.

    Rite Aid 44-018

    Rite Aid 44-018

     

  • INGREDIENTS AND APPEARANCE
    CHILDRENS DYE FREE ALLERGY RELIEF 
    diphenhydramine hcl solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11822-0918
    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:11822-0918-11 in 1 CARTON05/01/2023
    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 DrugM01205/01/2023
    Labeler - Rite Aid Corporation (014578892)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.967626305manufacture(11822-0918) , pack(11822-0918)
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