Label: MELATONIN- melatonin liquid 

  • Label RSS
  • NDC Code(s): 43742-0205-1
  • Packager: Deseret Biologicals, Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved homeopathic

NOTE: Most over the counter (OTC) are not reviewed and approved by the FDA. However, they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated 12/12

If you are a consumer or patient please visit this version.

  • ACTIVE INGREDIENTS

    Melatonin 6X, 12X, 30X, 200X, 12C, 30C, 60C, 200C

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  • INDICATIONS

    For temporary relief of symptoms related to sleep disorders, Seasonal Affective Disorder, jet lag, and depression.

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  • WARNINGS

    Keep out of reach of children. In case of overdose, contact physician or Poison Control Center right away.

    If pregnant or breast-feeding, seek advice of a health professional before use.

    Tamper seal: "Sealed for Your Protection." Do not use if seal is broken or missing.

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  • DIRECTIONS

    1-10 drops under the tongue, 3 times a day or as directed by a health professional. Consult a physician for use in children under 12 years of age.

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  • INACTIVE INGREDIENTS

    Demineralized water, 25% Ethanol.

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  • KEEP OUT OF REACH OF CHILDREN

    In case of overdose, contact physician or Poison Control Center right away.

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  • INDICATIONS AND USAGE

    For temporary relief of symptoms related to sleep disorders, Seasonal Affective Disorder, jet lag, and depression.

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  • QUESTIONS

    Dist. By: Deseret Biologicals, Inc.

    469 Parkland Drive

    Sandy, UT 84070

    www.desbio.com

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  • PRINCIPAL DISPLAY PANEL

    DESBIO

    NDC 43742-0205-1

    HOMEOPATHIC

    MELATONIN

    1 FL OZ (30 ml)

    Melatonin

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  • INGREDIENTS AND APPEARANCE
    MELATONIN 
    melatonin liquid
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:43742-0205
    Route of Administration ORAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    MELATONIN (MELATONIN) MELATONIN 6 [hp_X]  in 1 mL
    Inactive Ingredients
    Ingredient Name Strength
    WATER  
    ALCOHOL  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:43742-0205-1 30 mL in 1 BOTTLE, DROPPER
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    unapproved homeopathic 12/17/2012
    Labeler - Deseret Biologicals, Inc. (940741853)
    Registrant - Apotheca Company (844330915)
    Establishment
    Name Address ID/FEI Business Operations
    Apotheca Company 844330915 manufacture(43742-0205)
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