Label: DIPHENHYDRAMINE HCL ORAL SOLUTION solution

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

Drug Label Information

Updated March 4, 2025

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  • Drug Facts

    Active Ingredients (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
    • itching of the nose or throat
    • itchy, watery eyes
  • WARNINGS

    Warnings

    Do not use

    • with any other products 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

    Ask a doctor or pharmacist before use if the child is taking sedastives 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.

    Overdose

    In case of overdose, get medical help or contact a Poison Control Center right away.

  • DIRECTIONS

    • do not take more than directed
    • find the right dose on the chart below
    • mL = milliliter
    • take every 4 to 6 hurs, or as directed by a doctor
    • do not take more than 6 doses in 24 hours

    Age (yr)Doses (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

    • store at 20ºC to 25ºC (68ºF to 77ºF). Protect from light.
    • do not refrigerate
    • Do not use this product if printed inner seal is broken or missing.
  • Inactive ingredients

    cherry flavor, citric acid, methylparaben, monoammonium glcyrrhizinate, potassium citrate, propylene glycol, polyparaben, purified water, sorbitol, sucralose.

  • Questions or comments?

    1-833-537-4679

  • SPL UNCLASSIFIED SECTION

    *This product is not manufactured by McNeil Consumer Healthcare, distributer of Benadryl Allergy.

    Distributed by:

    Kesin Pharma

    Oldsmar, FL 34677

    Revision 02/2025

    Kesin Pharma Logo

  • PRINCIPAL DISPLAY PANEL

    NDC 81033-029-16

    Diphenhydramine HCl

    Oral Solution, USP

    12.5 mg/5 mL

    Antihistamine

    Cherry Flavor

    16 fl oz. (473 mL)

    16 oz Bottle Label

  • INGREDIENTS AND APPEARANCE
    DIPHENHYDRAMINE HCL ORAL SOLUTION 
    diphenhydramine hcl oral solution solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:81033-029(NDC:84447-103)
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DIPHENHYDRAMINE HCL (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIPHENHYDRAMINE HCL12.5 mg  in 5 mL
    Inactive Ingredients
    Ingredient NameStrength
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    SORBITOL (UNII: 506T60A25R)  
    AMMONIUM GLYCYRRHIZATE (UNII: 3VRD35U26C)  
    POTASSIUM CITRATE (UNII: EE90ONI6FF)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorCHERRYImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:81033-029-16473 mL in 1 BOTTLE; Type 0: Not a Combination Product03/04/2025
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01203/04/2025
    Labeler - Kesin Pharma Corporation (117447816)
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