Label: MAX ALLERGY KIDS- diphenhydramine hcl solution

  • NDC Code(s): 71399-0023-4, 71399-0023-6, 71399-0023-8
  • Packager: Akron Pharma 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:
      • sneezing
      • runny nose
      • itchy, watery eyes
      • itchy 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
    • excitabillty 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

    • do not take more than 6 doses in any 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 8 mg
    • store between 20°- 25°C (68°-77°F). Do not refrigerate
    • protect from light
  • Inactive ingredients

    anhydrous citric acid, bubble gum flavor, purified water, sodium benzoate, sodium citrate, saccharin sodium, sorbitol solution, sucrose.

  • Questions or comments?

    Please Call 1(877) 225-6999

    Manufactured for:
    Akron Pharma, Inc,
    Fairfield, NJ 07004
    Manufactured in U.S.A

  • PRINCIPAL DISPLAY PANEL

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  • INGREDIENTS AND APPEARANCE
    MAX ALLERGY KIDS 
    diphenhydramine hcl solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71399-0023
    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)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SODIUM CITRATE (UNII: 1Q73Q2JULR)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    SORBITOL (UNII: 506T60A25R)  
    SUCROSE (UNII: C151H8M554)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorBUBBLE GUMImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71399-0023-4118 mL in 1 BOTTLE; Type 0: Not a Combination Product11/24/2023
    2NDC:71399-0023-8236 mL in 1 BOTTLE; Type 0: Not a Combination Product11/15/2023
    3NDC:71399-0023-6473 mL in 1 BOTTLE; Type 0: Not a Combination Product11/24/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01211/15/2023
    Labeler - Akron Pharma Inc. (067878881)
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