Label: MELATONIN liquid

  • 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 March 22, 2019

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  • ACTIVE INGREDIENT:

    Melatonin 6X.

  • INDICATIONS:

    For temporary relief of fatigue, irritability, insomnia, and exhaustion.

  • WARNINGS:

    If pregnant or breast-feeding, ask a health care professional before use.

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

    Do not use if tamper evident seal is broken or missing.

    Store in cool, dry place.

  • KEEP OUT OF REACH OF CHILDREN:

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

  • DIRECTIONS:

    10 drops orally, 3 times a day. Consult a physician for use in children under 12 years of age.

  • INDICATIONS:

    For temporary relief of fatigue, irritability, insomnia, and exhaustion.

  • INACTIVE INGREDIENTS:

    Demineralized Water, 25% Ethanol

  • QUESTIONS:

    Distributed by:
    BioActive Nutritional, Inc.
    1803 N. Wickham Rd.
    Melbourne, FL 32935
    bioactivenutritional.com

  • PACKAGE LABEL DISPLAY:

    BIOActive Nutritional

    MELATONIN 6X

    HOMEOPATHIC

    1 FL OZ (30 ml)

    Melatonin 6X

  • INGREDIENTS AND APPEARANCE
    MELATONIN 
    melatonin liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:43857-0511
    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:43857-0511-130 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product03/22/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic03/22/2019
    Labeler - BioActive Nutritional, Inc. (624980496)
    Registrant - Apotheca Company (844330915)
    Establishment
    NameAddressID/FEIBusiness Operations
    Apotheca Company844330915manufacture(43857-0511) , api manufacture(43857-0511) , label(43857-0511) , pack(43857-0511)
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