Label: GUT BRAIN SPECTRUM (abrotanum (artemisia abrotanum), aethusa cynapium, baptisia tinctoria, cicuta virosa, cuprum metallicum, mezereum, bufo rana, lac materna humanum, saccharum officinale, serotonin- hydrochloride, alumina, calcarea phosphorica, candida albicans, carcinosin, helium, lac caninum, mercurius solubilis, natrum muriaticum, sulphur, thuja occidentalis, formalinum, morbillinum 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 October 19, 2021

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  • ACTIVE INGREDIENTS:

    (in each drop): 4.55% of Abrotanum (Artemisia Abrotanum) 6X, Aethusa Cynapium 6X, Alumina 12C, Baptisia Tinctoria 6X, Bufo Rana 15X, Calcarea Phosphorica 12C, Candida Albicans 12C, Carcinosin 12C, Cicuta Virosa 12X, Cuprum Metallicum 12X, Formalinum 15C, Helium 12C, Lac Caninum 12C, Lac Materna Humanum 30X, Mercurius Solubilis 12C, Mezereum 12X, Morbillinum 15C, Natrum Muriaticum 12C, Saccharum Officinale 30X, Serotonin (Hydrochloride) 30X, Sulphur 12C, Thuja Occidentalis 12C.

  • INDICATIONS:

    May temporarily relieve symptoms of dullness with gastro-intestinal discomfort, feeling unconnected to others, and minor symptoms following vaccination.**

    **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 of dullness with gastro-intestinal discomfort, feeling unconnected to others, and minor symptoms following vaccination.**

    **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 DISPLAY LABEL:

    ENERGIQUE

    SINCE 1987

    HOMEOPATHIC REMEDY

    GUT BRAIN

    SPECTRUM

    1 fl. oz. (30 ml)

    Gut Brain Spectrum

  • INGREDIENTS AND APPEARANCE
    GUT BRAIN SPECTRUM 
    abrotanum (artemisia abrotanum), aethusa cynapium, baptisia tinctoria, cicuta virosa, cuprum metallicum, mezereum, bufo rana, lac materna humanum, saccharum officinale, serotonin (hydrochloride), alumina, calcarea phosphorica, candida albicans, carcinosin, helium, lac caninum, mercurius solubilis, natrum muriaticum, sulphur, thuja occidentalis, formalinum, morbillinum liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:44911-0531
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ARTEMISIA ABROTANUM FLOWERING TOP (UNII: QG07G580U0) (ARTEMISIA ABROTANUM FLOWERING TOP - UNII:QG07G580U0) ARTEMISIA ABROTANUM FLOWERING TOP6 [hp_X]  in 1 mL
    AETHUSA CYNAPIUM WHOLE (UNII: M6936L953C) (AETHUSA CYNAPIUM - UNII:M6936L953C) AETHUSA CYNAPIUM WHOLE6 [hp_X]  in 1 mL
    BAPTISIA TINCTORIA ROOT (UNII: 5EF0HWI5WU) (BAPTISIA TINCTORIA ROOT - UNII:5EF0HWI5WU) BAPTISIA TINCTORIA ROOT6 [hp_X]  in 1 mL
    CICUTA VIROSA ROOT (UNII: YEA9P21S8N) (CICUTA VIROSA ROOT - UNII:YEA9P21S8N) CICUTA VIROSA ROOT12 [hp_X]  in 1 mL
    COPPER (UNII: 789U1901C5) (COPPER - UNII:789U1901C5) COPPER12 [hp_X]  in 1 mL
    DAPHNE MEZEREUM BARK (UNII: X2N6E405GV) (DAPHNE MEZEREUM BARK - UNII:X2N6E405GV) DAPHNE MEZEREUM BARK12 [hp_X]  in 1 mL
    BUFO BUFO CUTANEOUS GLAND (UNII: Q59QU6N72Q) (BUFO BUFO CUTANEOUS GLAND - UNII:Q59QU6N72Q) BUFO BUFO CUTANEOUS GLAND15 [hp_X]  in 1 mL
    HUMAN MILK (UNII: 1XCH439UQR) (HUMAN MILK - UNII:1XCH439UQR) HUMAN MILK30 [hp_X]  in 1 mL
    SUCROSE (UNII: C151H8M554) (SUCROSE - UNII:C151H8M554) SUCROSE30 [hp_X]  in 1 mL
    SEROTONIN HYDROCHLORIDE (UNII: GKN429M9VS) (SEROTONIN - UNII:333DO1RDJY) SEROTONIN HYDROCHLORIDE30 [hp_X]  in 1 mL
    ALUMINUM OXIDE (UNII: LMI26O6933) (ALUMINUM OXIDE - UNII:LMI26O6933) ALUMINUM OXIDE12 [hp_C]  in 1 mL
    TRIBASIC CALCIUM PHOSPHATE (UNII: 91D9GV0Z28) (CALCIUM CATION - UNII:2M83C4R6ZB) CALCIUM CATION12 [hp_C]  in 1 mL
    CANDIDA ALBICANS (UNII: 4D7G21HDBC) (CANDIDA ALBICANS - UNII:4D7G21HDBC) CANDIDA ALBICANS12 [hp_C]  in 1 mL
    HUMAN BREAST TUMOR CELL (UNII: C62OO7VD9K) (HUMAN BREAST TUMOR CELL - UNII:C62OO7VD9K) HUMAN BREAST TUMOR CELL12 [hp_C]  in 1 mL
    HELIUM (UNII: 206GF3GB41) (HELIUM - UNII:206GF3GB41) HELIUM12 [hp_C]  in 1 mL
    CANIS LUPUS FAMILIARIS MILK (UNII: G39P120JQT) (CANIS LUPUS FAMILIARIS MILK - UNII:G39P120JQT) CANIS LUPUS FAMILIARIS MILK12 [hp_C]  in 1 mL
    MERCURIUS SOLUBILIS (UNII: 324Y4038G2) (MERCURIUS SOLUBILIS - UNII:324Y4038G2) MERCURIUS SOLUBILIS12 [hp_C]  in 1 mL
    SODIUM CHLORIDE (UNII: 451W47IQ8X) (CHLORIDE ION - UNII:Q32ZN48698) SODIUM CHLORIDE12 [hp_C]  in 1 mL
    SULFUR (UNII: 70FD1KFU70) (SULFUR - UNII:70FD1KFU70) SULFUR12 [hp_C]  in 1 mL
    THUJA OCCIDENTALIS LEAFY TWIG (UNII: 1NT28V9397) (THUJA OCCIDENTALIS LEAFY TWIG - UNII:1NT28V9397) THUJA OCCIDENTALIS LEAFY TWIG12 [hp_C]  in 1 mL
    FORMALDEHYDE SOLUTION (UNII: T0H3L6C7I5) (FORMALDEHYDE SOLUTION - UNII:T0H3L6C7I5) FORMALDEHYDE SOLUTION15 [hp_C]  in 1 mL
    MEASLES VIRUS (UNII: HT3R7C012Q) (MEASLES VIRUS - UNII:HT3R7C012Q) MEASLES VIRUS15 [hp_C]  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    ALCOHOL (UNII: 3K9958V90M)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:44911-0531-130 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product03/05/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic03/05/2020
    Labeler - Energique, Inc. (789886132)
    Registrant - Apotheca Company (844330915)
    Establishment
    NameAddressID/FEIBusiness Operations
    Apotheca Company844330915manufacture(44911-0531) , api manufacture(44911-0531) , label(44911-0531) , pack(44911-0531)
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