Label: MELATONIN FORTE (melatonin, nadidum, niacin, pyridoxinum hydrochloricum, zincum sulphuricum, hypophysis suis, hypothalamus (suis), lithium carbonicum, magnesia carbonica, pineal- suis spray

  • NDC Code(s): 43857-0020-1
  • Packager: BioActive Nutritional, 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 August 18, 2023

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  • ACTIVE INGREDIENTS:

    Melatonin 6X, Nadidum 6X, Niacin 6X, Pyridoxinum Hydrochloricum 6X, Zincum Sulphuricum 6X, Hypophysis Suis 8X, Hypothalamus (Suis) 8X, Lithium Carbonicum 8X, Magnesia Carbonica 8X, Pineal (Suis) 8X.

  • INDICATIONS:

    For temporary relief of imbalances in menstruation and ovulation, insomnia, dysmenorrhea and imbalance in menstrual cycle.

  • 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 a cool, dry place.

  • DIRECTIONS:

    Three sprays per day.  Hold in mouth for two minutes.

  • INACTIVE INGREDIENTS:

    Citric Acid, Demineralized Water, Ethanol 0.32%, Glycerin, Sodium Benzoate.

  • 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.

  • INDICATIONS:

    For temporary relief of imbalances in menstruation and ovulation, insomnia, dysmenorrhea and imbalance in menstrual cycle.

  • QUESTIONS:

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

  • PACKAGE LABEL DISPLAY:

    BIOActive Nutritional

    MELATONIN FORTE

    HOMEOPATHIC

    1 FL OZ (30 ml)

    Melatonin Forte

  • INGREDIENTS AND APPEARANCE
    MELATONIN FORTE 
    melatonin, nadidum, niacin, pyridoxinum hydrochloricum, zincum sulphuricum, hypophysis suis, hypothalamus (suis), lithium carbonicum, magnesia carbonica, pineal (suis) spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:43857-0020
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MELATONIN (UNII: JL5DK93RCL) (MELATONIN - UNII:JL5DK93RCL) MELATONIN6 [hp_X]  in 1 mL
    NADIDE (UNII: 0U46U6E8UK) (NADIDE - UNII:0U46U6E8UK) NADIDE6 [hp_X]  in 1 mL
    NIACIN (UNII: 2679MF687A) (NIACIN - UNII:2679MF687A) NIACIN6 [hp_X]  in 1 mL
    PYRIDOXINE HYDROCHLORIDE (UNII: 68Y4CF58BV) (PYRIDOXINE - UNII:KV2JZ1BI6Z) PYRIDOXINE HYDROCHLORIDE6 [hp_X]  in 1 mL
    ZINC SULFATE HEPTAHYDRATE (UNII: N57JI2K7WP) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION6 [hp_X]  in 1 mL
    SUS SCROFA PITUITARY GLAND (UNII: L0PFEMQ1DT) (SUS SCROFA PITUITARY GLAND - UNII:L0PFEMQ1DT) SUS SCROFA PITUITARY GLAND8 [hp_X]  in 1 mL
    SUS SCROFA HYPOTHALAMUS (UNII: N6R0856Z79) (SUS SCROFA HYPOTHALAMUS - UNII:N6R0856Z79) SUS SCROFA HYPOTHALAMUS8 [hp_X]  in 1 mL
    LITHIUM CARBONATE (UNII: 2BMD2GNA4V) (LITHIUM CATION - UNII:8H8Z5UER66) LITHIUM CARBONATE8 [hp_X]  in 1 mL
    MAGNESIUM CARBONATE (UNII: 0E53J927NA) (CARBONATE ION - UNII:7UJQ5OPE7D) MAGNESIUM CARBONATE8 [hp_X]  in 1 mL
    SUS SCROFA PINEAL GLAND (UNII: 050QZ2EDK7) (SUS SCROFA PINEAL GLAND - UNII:050QZ2EDK7) SUS SCROFA PINEAL GLAND8 [hp_X]  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    ALCOHOL (UNII: 3K9958V90M)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:43857-0020-130 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product01/12/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic05/04/2012
    Labeler - BioActive Nutritional, Inc. (624980496)
    Registrant - Apotheca Company (844330915)
    Establishment
    NameAddressID/FEIBusiness Operations
    Apotheca Company844330915manufacture(43857-0020) , api manufacture(43857-0020) , label(43857-0020) , pack(43857-0020)
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