Label: MELATONIN- melatonin liquid

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

DISCLAIMER: This homeopathic product has not been evaluated by the Food and Drug Administration for safety or efficacy. FDA is not aware of scientific evidence to support homeopathy as effective.

Drug Label Information

Updated June 28, 2016

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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  • HOMEOPATHIC INDICATIONS:

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

    **These statements are based upon traditional homeopathic principles. They have not been reviewed by the Food and Drug Administration.

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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, ask 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

    KEEP OUT OF REACH OF CHILDREN.  In case of overdose, contact physician or Poison Control Center right away.

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  • HOMEOPATHIC INDICATIONS:

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

    **These statements are based upon traditional homeopathic principles. They have not been reviewed by the Food and Drug Administration.

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  • QUESTIONS

    Dist. By: Deseret Biologicals, Inc.

    469 W. Parkland Drive

    Sandy, UT 84070

    www.desbio.com

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  • PACKAGE LABEL DISPLAY:

    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 Item Code (Source) NDC:43742-0205
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    MELATONIN (UNII: JL5DK93RCL) (MELATONIN - UNII:JL5DK93RCL) MELATONIN 6 [hp_X]  in 1 mL
    Inactive Ingredients
    Ingredient Name Strength
    WATER (UNII: 059QF0KO0R)  
    ALCOHOL (UNII: 3K9958V90M)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:43742-0205-1 30 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product 12/17/2012
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    unapproved homeopathic 12/17/2012 04/21/2021
    Labeler - Deseret Biologicals, Inc. (940741853)
    Registrant - Apotheca Company (844330915)
    Establishment
    Name Address ID/FEI Business Operations
    Apotheca Company 844330915 manufacture(43742-0205) , api manufacture(43742-0205) , label(43742-0205) , pack(43742-0205)
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