Label: CHILDRENS ALLERGY- diphenhydramine hydrochloride liquid

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

Drug Label Information

Updated November 28, 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:
      • sneezing 
      • runny nose
      • itchy, watery eyes
      • itching of the nose or throat
  • Warnings

    Do not use

    • with any other product containing diphenhydramine, even one used on skin
    • to make a child sleepy

    Ask a doctor before use if the child has

    • a breathing problem such as chronic bronchitis
    • glaucoma
    • a sodium-restricted diet

    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 the reach of children.

    In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

  • Directions

    • do not take more than 6 doses in 24 hours
    • take every 4 to 6 hours, or as directed by a doctor
    • measure only with dosing cup provided. Do not use any other dosing device.
    • mL = milliliter
    • keep dosing cup with product
    • find the right dose on the chart below 
    age (yr)dose (mL)
     children 6 to 11 years 5 mL to 10 mL
     children 2 to 5 years do not use unless directed by a doctor
     children under 2 years do not use

  • Other information

    • each 5 mL contains: sodium 6 mg
    • store between 20-25ºC (68-77ºF). Do not refrigerate
    • Protect from light. Store in outer carton until contents are used
  • Inactive ingredients

    anhydrous citric acid, D&C red #33, FD&C red#40, flavors, glycerin, poloxamer 407, purified water, sodium benzoate, sodium chloride, sodium citrate, sucrose

  • Questions or comments?

     Call 1-877-753-3935 Monday-Friday 9AM-5PM EST

  • Principal Display Panel

    *Compare to the Active Ingredient in Children's Benadryl® Allergy

    CHILDREN'S ALLERGY

    Diphenhydramine HCI 12.5 mg

    ANTIHISTAMINE

    RELIEVES:

    • Sneezing
    • Runny Nose
    • Itchy, Watery Eyes
    • Itchy Nose or Throat

    Alcohol Free

    4-6 Hours per Dose

    CHERRY Flavored Liquid

    FL OZ (mL)

    Dosing Cup Included

    *This product is not manufactured or distributed by McNeil Consumer Healthcare, distributors of Benadryl® Allergy

    TAMPER EVIDENT: DO NOT USE IF CARTON IS OPENED OR IF PRINTED SAFETY SEAL AROUND BOTTLE OR UNDER CAP IS BROKEN OR MISSING.

    DISTRIBUTED BY: fred's Inc.

    4300 NEW GETWELL RD, MEMPHIS, TN 38118

    www.fredsinc.com

  • Product Label

    Diphenhydramine HCI 12.5 mg

    FRED'S PHARMACY Children's Allergy Cherry Flavor

  • INGREDIENTS AND APPEARANCE
    CHILDRENS ALLERGY 
    diphenhydramine hydrochloride liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55315-092
    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)  
    POLOXAMER 407 (UNII: TUF2IVW3M2)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    TRISODIUM CITRATE DIHYDRATE (UNII: B22547B95K)  
    SUCROSE (UNII: C151H8M554)  
    D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorCHERRYImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:55315-092-041 in 1 BOX04/30/201504/30/2024
    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 DrugM01204/30/201504/30/2024
    Labeler - Freds Inc (005866116)
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