Label: MELATONIN CORD- 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 25, 2022

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  • ACTIVE INGREDIENT:

    Melatonin 6C, 12C, 30C.

  • INDICATIONS:

    May temporarily relieve symptoms such as altered sleep patterns.**

    **Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.

  • WARNINGS:

    If pregnant or breast-feeding, ask a health 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 a 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:

    Adults and children 5 to 10 drops orally, 1 time daily or as otherwise directed by a health care professional. If symptoms persist, consult your health care professional.

    Consult a physician for use in children under 12 years of age.

  • INDICATIONS:

    May temporarily relieve symptoms such as altered sleep patterns.**

    **Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.

  • INACTIVE INGREDIENTS:

    Demineralized water, 20% Ethanol.

  • QUESTIONS:

    Dist. by Energique, Inc.

    201 Apple Blvd

    Woodbine, IA 51579  800.869.8078

  • PACKAGE LABEL DISPLAY:

    ENERGIQUE
    SINCE 1987
    HOMEOPATHIC REMEDY
    MELATONIN
    CORD
    1 fl. oz. (30 ml)

    Melatonin Cord

  • INGREDIENTS AND APPEARANCE
    MELATONIN CORD 
    melatonin liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:44911-0194
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MELATONIN (UNII: JL5DK93RCL) (MELATONIN - UNII:JL5DK93RCL) MELATONIN6 [hp_C]  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    ALCOHOL (UNII: 3K9958V90M)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:44911-0194-130 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product07/09/2015
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic07/09/2015
    Labeler - Energique, Inc. (789886132)
    Registrant - Apotheca Company (844330915)
    Establishment
    NameAddressID/FEIBusiness Operations
    Apotheca Company844330915manufacture(44911-0194) , api manufacture(44911-0194) , label(44911-0194) , pack(44911-0194)
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