Drug Facts:

Drug Facts:
SPL v5
SPL
SPL Set ID 8c3e961d-bc33-40cd-a282-a4fe5aa3f0ad
Route
ORAL
Published
Effective Date 2024-05-08
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
American Ginseng (6 [hp_X]) Arnica Montana (12 [hp_X]) Adenosine Triphosphate (16 [hp_X]) .alpha.-ketoglutaric Acid (30 [hp_X]) Ascorbic Acid (35 [hp_C]) .alpha.-lipoic Acid Oyster Shell Calcium Carbonate, Crude Anhydrous Citric Acid Copper Cysteine Iron Iodine Levothyroxine Magnesium Cation Malic Acid Manganous Cation Nadide Pyruvic Acid Niacinamide Pyridoxine Riboflavin Selenium Sulfur Thiamine Ion Ubidecarenone Zinc Aconitic Acid, (z)- Arsenic Cation (3+) Bryonia Alba Root Cinchona Officinalis Bark Conium Maculatum Flowering Top Gelsemium Sempervirens Root Mercurius Solubilis Silicon Dioxide Barium Cation
Inactive Ingredients
Water Alcohol

Identifiers & Packaging

Marketing Status
UNAPPROVED HOMEOPATHIC Completed Since 2023-12-28 Until 2029-05-08

Description

(in each drop) 2.86% of Aralia Quinquefolia 6X, Arnica Montana 6X; Alpha-Ketoglutaricum Acidum 12X, Alpha-Lipoicum Acidum 12X, Ascorbicum Acidum 12X, Adenosinum Triphosphoricum Dinatrum 12X, Calcarea Carbonica 12X, Citricum Acidum 12X, Cuprum Metallicum 12X, Cysteinum 12X, Ferrum Metallicum 12X, Iodium 12X, Levothyroxinum 12X, Magnesium Gluconicum Dihydricum 12X, Malicum Acidum 12X, Manganum Aceticum 12X, Nadidum 12X, Natrum Pyruvicum 12X, Nicotinamidum 12X, Pyridoxinum Hydrochloricum 12X, Riboflavinum 12X, Selenium Metallicum 12X, Sulphur 12X, Thiaminum Hydrochloricum 12X, Ubidecarenonum 12X, Zincum Metallicum 12X; Aconiticum Acidum, Cis- 16X; Arsenicum Album 30X, Bryonia 30X, Cinchona Officinalis 30X, Conium Maculatum 30X, Gelsemium Sempervirens 30X, Mercurius Solubilis 30X, Silicea 30X; Barium Oxalsuccinicum 35C.

Purpose

May temporarily relieve fatigue, weakness, loss of smell, and brain fog.** **Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.


Medication Information

Purpose

May temporarily relieve fatigue, weakness, loss of smell, and brain fog.** **Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.

Description

(in each drop) 2.86% of Aralia Quinquefolia 6X, Arnica Montana 6X; Alpha-Ketoglutaricum Acidum 12X, Alpha-Lipoicum Acidum 12X, Ascorbicum Acidum 12X, Adenosinum Triphosphoricum Dinatrum 12X, Calcarea Carbonica 12X, Citricum Acidum 12X, Cuprum Metallicum 12X, Cysteinum 12X, Ferrum Metallicum 12X, Iodium 12X, Levothyroxinum 12X, Magnesium Gluconicum Dihydricum 12X, Malicum Acidum 12X, Manganum Aceticum 12X, Nadidum 12X, Natrum Pyruvicum 12X, Nicotinamidum 12X, Pyridoxinum Hydrochloricum 12X, Riboflavinum 12X, Selenium Metallicum 12X, Sulphur 12X, Thiaminum Hydrochloricum 12X, Ubidecarenonum 12X, Zincum Metallicum 12X; Aconiticum Acidum, Cis- 16X; Arsenicum Album 30X, Bryonia 30X, Cinchona Officinalis 30X, Conium Maculatum 30X, Gelsemium Sempervirens 30X, Mercurius Solubilis 30X, Silicea 30X; Barium Oxalsuccinicum 35C.

Purpose:

May temporarily relieve fatigue, weakness, loss of smell, and brain fog.**

**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, 3 times 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 fatigue, weakness, loss of smell, and brain fog.**

**Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.

Active Ingredients:

(in each drop) 2.86% of Aralia Quinquefolia 6X, Arnica Montana 6X; Alpha-Ketoglutaricum Acidum 12X, Alpha-Lipoicum Acidum 12X, Ascorbicum Acidum 12X, Adenosinum Triphosphoricum Dinatrum 12X, Calcarea Carbonica 12X, Citricum Acidum 12X, Cuprum Metallicum 12X, Cysteinum 12X, Ferrum Metallicum 12X, Iodium 12X, Levothyroxinum 12X, Magnesium Gluconicum Dihydricum 12X, Malicum Acidum 12X, Manganum Aceticum 12X, Nadidum 12X, Natrum Pyruvicum 12X, Nicotinamidum 12X, Pyridoxinum Hydrochloricum 12X, Riboflavinum 12X, Selenium Metallicum 12X, Sulphur 12X, Thiaminum Hydrochloricum 12X, Ubidecarenonum 12X, Zincum Metallicum 12X; Aconiticum Acidum, Cis- 16X; Arsenicum Album 30X, Bryonia 30X, Cinchona Officinalis 30X, Conium Maculatum 30X, Gelsemium Sempervirens 30X, Mercurius Solubilis 30X, Silicea 30X; Barium Oxalsuccinicum 35C.

Inactive Ingredients:

Demineralized water, 20% Ethanol.

Package Label Display:

ENERGIQUE

SINCE 1987

HOMEOPATHIC REMEDY

MITOCHONDRIA

PRO

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 fatigue, weakness, loss of smell, and brain fog.**

**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, 3 times 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 fatigue, weakness, loss of smell, and brain fog.**

**Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.

Active Ingredients: (ACTIVE INGREDIENTS:)

(in each drop) 2.86% of Aralia Quinquefolia 6X, Arnica Montana 6X; Alpha-Ketoglutaricum Acidum 12X, Alpha-Lipoicum Acidum 12X, Ascorbicum Acidum 12X, Adenosinum Triphosphoricum Dinatrum 12X, Calcarea Carbonica 12X, Citricum Acidum 12X, Cuprum Metallicum 12X, Cysteinum 12X, Ferrum Metallicum 12X, Iodium 12X, Levothyroxinum 12X, Magnesium Gluconicum Dihydricum 12X, Malicum Acidum 12X, Manganum Aceticum 12X, Nadidum 12X, Natrum Pyruvicum 12X, Nicotinamidum 12X, Pyridoxinum Hydrochloricum 12X, Riboflavinum 12X, Selenium Metallicum 12X, Sulphur 12X, Thiaminum Hydrochloricum 12X, Ubidecarenonum 12X, Zincum Metallicum 12X; Aconiticum Acidum, Cis- 16X; Arsenicum Album 30X, Bryonia 30X, Cinchona Officinalis 30X, Conium Maculatum 30X, Gelsemium Sempervirens 30X, Mercurius Solubilis 30X, Silicea 30X; Barium Oxalsuccinicum 35C.

Inactive Ingredients: (INACTIVE INGREDIENTS:)

Demineralized water, 20% Ethanol.

Package Label Display: (PACKAGE LABEL DISPLAY:)

ENERGIQUE

SINCE 1987

HOMEOPATHIC REMEDY

MITOCHONDRIA

PRO

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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