Drug Facts:

Drug Facts:
SPL v1
SPL
SPL Set ID 5cd31e1d-0312-48d1-9ecd-d01c6fe3b672
Route
ORAL
Published
Effective Date 2024-12-12
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Goldenseal (5 [hp_X]) Ascorbic Acid (6 [hp_X]) Cinchona Officinalis Bark (12 [hp_X]) Pork Kidney (30 [hp_X]) Thiamine Ion (15 [hp_C]) Urtica Dioica Apis Mellifera Arsenic Cation (3+) Lycoperdon Utriforme Fruiting Body Phenol Arabica Coffee Bean Histamine Lachesis Muta Venom Ledum Palustre Twig Strychnos Nux-vomica Seed Oxalic Acid Phosphorus Toxicodendron Pubescens Leaf Lactic Acid, L- Claviceps Purpurea Sclerotium Sepia Officinalis Juice Serotonin Sulfur Thuja Occidentalis Leafy Twig Northern Quahog Aconitum Napellus Dieffenbachia Seguine Strychnos Ignatii Seed Chloride Ion Loxosceles Reclusa
Inactive Ingredients
Water Alcohol

Identifiers & Packaging

Marketing Status
UNAPPROVED HOMEOPATHIC Active Since 2024-12-11

Description

(in each drop): 3.33% of Hydrastis Canadensis 5X; Ascorbicum Acidum 6X, Cinchona Officinalis 6X, Kidney 6X, Thiaminum Hydrochloricum 6X, Urtica Dioica 6X; Apis Mellifica 12X, Arsenicum Album 12X, Bovista 12X, Carbolicum Acidum 12X, Coffea Cruda 12X, Histaminum Hydrochloricum 12X, Lachesis Mutus 12X, Ledum Palustre 12X, Nux Vomica 12X, Oxalicum Acidum 12X, Phosphorus 12X, Rhus Tox 12X, Sarcolacticum Acidum 12X, Secale Cornutum 12X, Sepia 12X, Serotonin 12X, Sulphur 12X, Thuja Occidentalis 12X, Venus Mercenaria 12X; Aconitum Napellus 30X, Caladium Seguinum 30X, Ignatia Amara 30X, Natrum Muriaticum 30X; Loxosceles Reclusa 15C.

Purpose

May temporarily relieve itching, flushing, rash, abdominal discomfort, fatigue, and brain fog.** **Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.


Medication Information

Purpose

May temporarily relieve itching, flushing, rash, abdominal discomfort, fatigue, and brain fog.** **Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.

Description

(in each drop): 3.33% of Hydrastis Canadensis 5X; Ascorbicum Acidum 6X, Cinchona Officinalis 6X, Kidney 6X, Thiaminum Hydrochloricum 6X, Urtica Dioica 6X; Apis Mellifica 12X, Arsenicum Album 12X, Bovista 12X, Carbolicum Acidum 12X, Coffea Cruda 12X, Histaminum Hydrochloricum 12X, Lachesis Mutus 12X, Ledum Palustre 12X, Nux Vomica 12X, Oxalicum Acidum 12X, Phosphorus 12X, Rhus Tox 12X, Sarcolacticum Acidum 12X, Secale Cornutum 12X, Sepia 12X, Serotonin 12X, Sulphur 12X, Thuja Occidentalis 12X, Venus Mercenaria 12X; Aconitum Napellus 30X, Caladium Seguinum 30X, Ignatia Amara 30X, Natrum Muriaticum 30X; Loxosceles Reclusa 15C.

Purpose:

May temporarily relieve itching, flushing, rash, abdominal discomfort, fatigue, 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 itching, flushing, rash, abdominal discomfort, fatigue, and brain fog.**

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

Active Ingredient:

(in each drop): 3.33% of Hydrastis Canadensis 5X; Ascorbicum Acidum 6X, Cinchona Officinalis 6X, Kidney 6X, Thiaminum Hydrochloricum 6X, Urtica Dioica 6X; Apis Mellifica 12X, Arsenicum Album 12X, Bovista 12X, Carbolicum Acidum 12X, Coffea Cruda 12X, Histaminum Hydrochloricum 12X, Lachesis Mutus 12X, Ledum Palustre 12X, Nux Vomica 12X, Oxalicum Acidum 12X, Phosphorus 12X, Rhus Tox 12X, Sarcolacticum Acidum 12X, Secale Cornutum 12X, Sepia 12X, Serotonin 12X, Sulphur 12X, Thuja Occidentalis 12X, Venus Mercenaria 12X; Aconitum Napellus 30X, Caladium Seguinum 30X, Ignatia Amara 30X, Natrum Muriaticum 30X; Loxosceles Reclusa 15C.

Inactive Ingredients:

Demineralized water, 20% Ethanol.

Package Label Display:

ENERGIQUE

SINCE 1987

HOMEOPATHIC REMEDY

MAST CELL 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 itching, flushing, rash, abdominal discomfort, fatigue, 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 itching, flushing, rash, abdominal discomfort, fatigue, and brain fog.**

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

Active Ingredient: (ACTIVE INGREDIENT:)

(in each drop): 3.33% of Hydrastis Canadensis 5X; Ascorbicum Acidum 6X, Cinchona Officinalis 6X, Kidney 6X, Thiaminum Hydrochloricum 6X, Urtica Dioica 6X; Apis Mellifica 12X, Arsenicum Album 12X, Bovista 12X, Carbolicum Acidum 12X, Coffea Cruda 12X, Histaminum Hydrochloricum 12X, Lachesis Mutus 12X, Ledum Palustre 12X, Nux Vomica 12X, Oxalicum Acidum 12X, Phosphorus 12X, Rhus Tox 12X, Sarcolacticum Acidum 12X, Secale Cornutum 12X, Sepia 12X, Serotonin 12X, Sulphur 12X, Thuja Occidentalis 12X, Venus Mercenaria 12X; Aconitum Napellus 30X, Caladium Seguinum 30X, Ignatia Amara 30X, Natrum Muriaticum 30X; Loxosceles Reclusa 15C.

Inactive Ingredients: (INACTIVE INGREDIENTS:)

Demineralized water, 20% Ethanol.

Package Label Display: (PACKAGE LABEL DISPLAY:)

ENERGIQUE

SINCE 1987

HOMEOPATHIC REMEDY

MAST CELL 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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