Label: MELATONIN PHENOLIC- melatonin liquid

  • 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 16, 2021

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

View All Sections
  • ACTIVE INGREDIENT:

    (in each drop): 20% of Melatonin 6X, 12X, 30X, 12C, 30C.

  • INDICATIONS:

    May temporarily relieve symptoms associated with reactions to melatonin such as sleeplessness.**

    **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 for more than 7 days, consult your health care professional.

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

  • INDICATIONS:

    May temporarily relieve symptoms associated with reactions to melatonin such as sleeplessness.**

    **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
    PHENOLIC
    1 fl. oz. (30 ml)

    Melatonin Phenolic

  • INGREDIENTS AND APPEARANCE
    MELATONIN PHENOLIC 
    melatonin liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:44911-0247
    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:44911-0247-130 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product09/13/2016
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic08/14/2015
    Labeler - Energique, Inc. (789886132)
    Registrant - Apotheca Company (844330915)
    Establishment
    NameAddressID/FEIBusiness Operations
    Apotheca Company844330915manufacture(44911-0247) , api manufacture(44911-0247) , label(44911-0247) , pack(44911-0247)
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials, PubMed, Biochemical Data Summary

More Info on this Drug

View Labeling Archives, RxNorm, Get Label RSS Feed, View NDC Code(s)NEW!