Gut Brain Spectrum

Manufacturer
Energique, Inc. | Apotheca Company
Effective date
2024-09-27
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 02:28:06

Label at a glance#

ProductGut Brain Spectrum
Active ingredientARTEMISIA ABROTANUM FLOWERING TOP, AETHUSA CYNAPIUM WHOLE, BAPTISIA TINCTORIA ROOT, CICUTA VIROSA ROOT, COPPER, DAPHNE MEZEREUM BARK, BUFO BUFO CUTANEOUS GLAND, HUMAN MILK, SUCROSE, SEROTONIN HYDROCHLORIDE, ALUMINUM OXIDE, TRIBASIC CALCIUM PHOSPHATE, CANDIDA ALBICANS, HUMAN BREAST TUMOR CELL, HELIUM, CANIS LUPUS FAMILIARIS MILK, MERCURIUS SOLUBILIS, SODIUM CHLORIDE, SULFUR, THUJA OCCIDENTALIS LEAFY TWIG, FORMALDEHYDE SOLUTION, MEASLES VIRUS
Label structure9 sections

Dosage and administration

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.

Label contents#

Full prescribing information#

ACTIVE INGREDIENTS:

OTC - ACTIVE INGREDIENT SECTION

(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:

OTC - PURPOSE SECTION

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:

WARNINGS SECTION

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:

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

DIRECTIONS:

DOSAGE & ADMINISTRATION SECTION

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:

INDICATIONS & USAGE SECTION

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:

INACTIVE INGREDIENT SECTION

Demineralized Water, 20% Ethanol

QUESTIONS:

OTC - QUESTIONS SECTION

Dist. by Energique, Inc.

201 Apple Blvd.

Woodbine, IA 51579 800.869.8078

PACKAGE DISPLAY LABEL:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

ENERGIQUE

SINCE 1987

HOMEOPATHIC REMEDY

GUT BRAIN

SPECTRUM

1 fl. oz. (30 ml)

Gut Brain SpectrumGut Brain Spectrum

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
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FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
44911-0531-12024-09-27C16284748780-1f386c64a-4195-0266-e053-dadaa90a7c1aDRUG FACTS:
44911-0531-12023-01-30C16284748780-1f386c64a-4195-0266-e053-dadaa90a7c1aDRUG FACTS:

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
44911-0531-1Gut Brain Spectrum30 mL in 1 BOTTLE, DROPPERLIQUID303

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
44911-0531GUT 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 [ENERGIQUE, INC.]3Current NDC, Legacy NDC, 1 package rows20240928_cb1566a4-92d4-4f1a-9211-f0c538a83c27.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 30 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
44911-053144911-0531-1

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 24 matching rows.

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Gut Brain SpectrumABROTANUM (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, MORBILLINUMEnergique, Inc.cb1566a4-92d4-4f1a-9211-f0c538a83c272024-09-27WarningsExact identifier
ndc (package): 44911-0531-1
ndc (product): 44911-0531
ndc11 (package): 44911053101
spl id: 392e7f15-8de7-4e76-a684-29ca8bcf9268
spl set id: cb1566a4-92d4-4f1a-9211-f0c538a83c27

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.