Label: MAX SLEEP JUNIOR CHILDRENS SLEEP AID- melatonin solution/ drops

  • Category: DIETARY SUPPLEMENT
  • DEA Schedule: None
  • Marketing Status: Dietary Supplement

Drug Label Information

Updated June 23, 2024

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  • STATEMENT OF IDENTITY

    facts

  • HEALTH CLAIM

    • Drug-Free
    • Easy to use dropper
    • Safe, gentle and effective

    * This statement has not been evaluated by the Food and Drug Administration.  This product is not intended to diagnose, treat, cure, or prevent any disease.

  • SAFE HANDLING WARNING

    Store at room temperature 

  • WARNINGS

    Caution: This product may cause drowsiness. Do not exceed recommended serving. Do not take or combine with other products containing melatonin or products that cause sedation or drowsiness. Consult a doctor if you or your child is experiencing long-term sleep difficulties.
    Do not use if you or your child is allergic to any of the ingredients.

  • PRECAUTIONS

    Do not drive or operate machinery while taking melatonin

  • DOSAGE & ADMINISTRATION

    SUGGESTIONS FOR USE: Using the enclosed dropper, administer 30-60 minutes before bedtime.
    Take only as directed. For occasional use only. May be administered directly into the mouth or into a liquid that will be consumed immediately. After administration, a slight warming sensation in the mouth is normal. Talk with your doctor's care for a medicine or are under a doctor's care for medical condition. Do not use if safety seal is broken. Clean dropper and reclose cap tightly after each use.

    Manutactured lor:
    Akron Pharma, Inc.
    Fairtield, NJ 07004
    www.akronpharma.com

  • PRINCIPAL DISPLAY PANEL

    label

  • INGREDIENTS AND APPEARANCE
    MAX SLEEP JUNIOR CHILDRENS SLEEP AID 
    melatonin solution/ drops
    Product Information
    Product TypeDIETARY SUPPLEMENTItem Code (Source)NHRIC:71399-0128
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MELATONIN (UNII: JL5DK93RCL) (MELATONIN - UNII:JL5DK93RCL) MELATONIN1 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    GLYCERIN (UNII: PDC6A3C0OX)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NHRIC:71399-0128-11 in 1 CARTON
    130 mL in 1 BOTTLE, DROPPER
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    dietary supplement06/21/2024
    Labeler - Akron Pharma (067878881)
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