Label: MELATONIN liquid

  • NDC Code(s): 43742-0771-1
  • Packager: Deseret Biologicals, Inc.
  • Category: HUMAN OTC DRUG LABEL

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 8, 2016

If you are a healthcare professional or from the pharmaceutical industry please visit this version.

  • ACTIVE INGREDIENT:

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

  • HOMEOPATHIC INDICATIONS:

    For temporary relief of symptoms related to sleep issues and jet lag.**

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

  • WARNINGS:

    Keep out of reach of children. In case of overdose, contact physician or a 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.

  • KEEP OUT OF REACH OF CHILDREN:

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

  • 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.

  • HOMEOPATHIC INDICATIONS:

    For temporary relief of symptoms related to sleep issues and jet lag.**

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

  • INACTIVE INGREDIENTS:

    Demineralized water, 25% Ethanol

  • QUESTIONS:

    Dist. By: Deseret Biologicals, Inc.
    469 W. Parkland Drive
    Sandy, UT 84070    www.desbio.com

  • PACKAGE LABEL DISPLAY:

    DESBIO

    NDC 43742-0771-1

    HOMEOPATHIC

    MELATONIN

    1 FL OZ (30 ml)

    Melatonin

  • INGREDIENTS AND APPEARANCE
    MELATONIN 
    melatonin liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:43742-0771
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MELATONIN (UNII: JL5DK93RCL) (MELATONIN - UNII:JL5DK93RCL) MELATONIN6 [hp_X]  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    ALCOHOL (UNII: 3K9958V90M)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:43742-0771-130 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product06/08/2016
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic06/08/2016
    Labeler - Deseret Biologicals, Inc. (940741853)
    Registrant - Apotheca Company (844330915)
    Establishment
    NameAddressID/FEIBusiness Operations
    Apotheca Company844330915manufacture(43742-0771) , api manufacture(43742-0771) , label(43742-0771) , pack(43742-0771)