Drug Facts:

Drug Facts:
SPL v1
SPL
SPL Set ID adfee6ce-05b0-4955-bf5f-9612b8db4c78
Route
ORAL
Published
Effective Date 2024-12-26
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Artemisia Abrotanum Flowering Top (6 [hp_X]) Aethusa Cynapium (12 [hp_X]) Baptisia Tinctoria Root (15 [hp_X]) Cicuta Virosa Root (30 [hp_X]) Bronze Powder (12 [hp_C]) Daphne Mezereum Bark (15 [hp_C]) Bufo Bufo Cutaneous Gland Human Milk Sucrose Serotonin Alumina Calcium Cation Candida Albicans Human Breast Tumor Cell Canis Lupus Familiaris Milk Mercurius Solubilis Chloride Ion Propionic Acid Sulfur Thuja Occidentalis Leafy Twig Formaldehyde Solution Measles Virus
Inactive Ingredients
Water Alcohol

Identifiers & Packaging

Marketing Status
UNAPPROVED HOMEOPATHIC Active Since 2024-12-26

Description

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

Purpose

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.


Medication Information

Purpose

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.

Description

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

Purpose:

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.

Questions:

Dist. by Energique, Inc.

201 Apple Blvd.

Woodbine, IA 51579

800.869.8078

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.

Active Ingredients:

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

Inactive Ingredients:

Demineralized water, 20% Ethanol

Package Display Label:

ENERGIQUE

SINCE 1987

HOMEOPATHIC REMEDY

GUT BRAIN

SPECTRUM

1 fl. oz. (30 ml)

Keep Out of Reach of Children:

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


Structured Label Content

Purpose: (PURPOSE:)

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:)

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.

Questions: (QUESTIONS:)

Dist. by Energique, Inc.

201 Apple Blvd.

Woodbine, IA 51579

800.869.8078

Directions: (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: (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.

Active Ingredients: (ACTIVE INGREDIENTS:)

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

Inactive Ingredients: (INACTIVE INGREDIENTS:)

Demineralized water, 20% Ethanol

Package Display Label: (PACKAGE DISPLAY LABEL:)

ENERGIQUE

SINCE 1987

HOMEOPATHIC REMEDY

GUT BRAIN

SPECTRUM

1 fl. oz. (30 ml)

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.


Advanced Ingredient Data


Raw Label Data

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