Drug Facts:

Drug Facts:
SPL v5
SPL
SPL Set ID 54e2c88e-2483-4c38-86e5-19e218e713ae
Route
ORAL
Published
Effective Date 2020-02-14
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
American Ginseng (3 [hp_X]) Ginkgo (6 [hp_X]) Sus Scrofa Pancreas (8 [hp_X]) Sus Scrofa Spleen (9 [hp_X]) Sus Scrofa Stomach (12 [hp_X]) Germanium Sesquioxide Cobalt Nickel Zinc .alpha.-ketoglutaric Acid Anhydrous Citric Acid Fumaric Acid Malic Acid Pyruvic Acid Succinic Acid Naphthoquine Barium Cation Phosphoric Acid Aconitic Acid, (z)- Magnesium Cation Strychnos Nux-vomica Seed Phosphorus
Inactive Ingredients
Water Alcohol

Identifiers & Packaging

Marketing Status
UNAPPROVED HOMEOPATHIC Active Since 2015-11-11

Description

(in each drop): 6.23% Baryta Carbonica 12X, Cobaltum Metallicum 12X, Niccolum Metallicum 12X, Phosphoricum Acidum 12X; Nux Vomica 12X, 30x, Phosphorus 12X, 30X. 1.85% of alpha-Ketoglutaricum Acidum 8X, 12X, 30X, Citricum Acidum 8X, 12X, 30X, Pyruvic Acid 8X, 12X, 30X; Aralia Quinquefolia 12X, Zincum Metallicum 12X; Fumaricum Acidum 12X, 30X, Magnesium Gluconicum Dihydricum 12X, 30X, Malic Acid 12X, 30X, Pancreas Suis 12X, 30X, Spleen (Suis) 12X, 30X, Stomach (Suis) 12X, 30X, Succinicum Acidum 12X, 30X; Aconiticum Acidum, Cis 30X, Naphthochinonum 30X. 0.10% of Cobaltum Metallicum 8X, Niccolum Metallicum 8X. 0.007% of Aralia Quinquefolia 3X, 6X; Ginkgo Biloba 6X, Pancreas Suis 6X, Spleen (Suis) 6X, Stomach (Suis) 6X; Fumaricum Acidum 8X, Germanium Sesquioxide 8X, Malic Acid 8X, Succinicum Acidum 8X, Zincum Metallicum 8X; Naphthochinonum 9X, 12X; Aconiticum Acidum, Cis 12X.


Medication Information

Description

(in each drop): 6.23% Baryta Carbonica 12X, Cobaltum Metallicum 12X, Niccolum Metallicum 12X, Phosphoricum Acidum 12X; Nux Vomica 12X, 30x, Phosphorus 12X, 30X. 1.85% of alpha-Ketoglutaricum Acidum 8X, 12X, 30X, Citricum Acidum 8X, 12X, 30X, Pyruvic Acid 8X, 12X, 30X; Aralia Quinquefolia 12X, Zincum Metallicum 12X; Fumaricum Acidum 12X, 30X, Magnesium Gluconicum Dihydricum 12X, 30X, Malic Acid 12X, 30X, Pancreas Suis 12X, 30X, Spleen (Suis) 12X, 30X, Stomach (Suis) 12X, 30X, Succinicum Acidum 12X, 30X; Aconiticum Acidum, Cis 30X, Naphthochinonum 30X. 0.10% of Cobaltum Metallicum 8X, Niccolum Metallicum 8X. 0.007% of Aralia Quinquefolia 3X, 6X; Ginkgo Biloba 6X, Pancreas Suis 6X, Spleen (Suis) 6X, Stomach (Suis) 6X; Fumaricum Acidum 8X, Germanium Sesquioxide 8X, Malic Acid 8X, Succinicum Acidum 8X, Zincum Metallicum 8X; Naphthochinonum 9X, 12X; Aconiticum Acidum, Cis 12X.

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 heaviness and fullness after eating little, stomach pain, and weak digestion.**

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

Active Ingredients:

(in each drop): 6.23% Baryta Carbonica 12X, Cobaltum Metallicum 12X, Niccolum Metallicum 12X, Phosphoricum Acidum 12X; Nux Vomica 12X, 30x, Phosphorus 12X, 30X. 1.85% of alpha-Ketoglutaricum Acidum 8X, 12X, 30X, Citricum Acidum 8X, 12X, 30X, Pyruvic Acid 8X, 12X, 30X; Aralia Quinquefolia 12X, Zincum Metallicum 12X; Fumaricum Acidum 12X, 30X, Magnesium Gluconicum Dihydricum 12X, 30X, Malic Acid 12X, 30X, Pancreas Suis 12X, 30X, Spleen (Suis) 12X, 30X, Stomach (Suis) 12X, 30X, Succinicum Acidum 12X, 30X; Aconiticum Acidum, Cis 30X, Naphthochinonum 30X. 0.10% of Cobaltum Metallicum 8X, Niccolum Metallicum 8X. 0.007% of Aralia Quinquefolia 3X, 6X; Ginkgo Biloba 6X, Pancreas Suis 6X, Spleen (Suis) 6X, Stomach (Suis) 6X; Fumaricum Acidum 8X, Germanium Sesquioxide 8X, Malic Acid 8X, Succinicum Acidum 8X, Zincum Metallicum 8X; Naphthochinonum 9X, 12X; Aconiticum Acidum, Cis 12X.

Inactive Ingredients:

Demineralized water, 20% Ethanol.

Package Label Display:

ENERGIQUE

SINDE 1987

HOMEOPATHIC REMEDY

SPLEENEX VH

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.


Structured Label Content

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 heaviness and fullness after eating little, stomach pain, and weak digestion.**

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

Active Ingredients: (ACTIVE INGREDIENTS:)

(in each drop): 6.23% Baryta Carbonica 12X, Cobaltum Metallicum 12X, Niccolum Metallicum 12X, Phosphoricum Acidum 12X; Nux Vomica 12X, 30x, Phosphorus 12X, 30X. 1.85% of alpha-Ketoglutaricum Acidum 8X, 12X, 30X, Citricum Acidum 8X, 12X, 30X, Pyruvic Acid 8X, 12X, 30X; Aralia Quinquefolia 12X, Zincum Metallicum 12X; Fumaricum Acidum 12X, 30X, Magnesium Gluconicum Dihydricum 12X, 30X, Malic Acid 12X, 30X, Pancreas Suis 12X, 30X, Spleen (Suis) 12X, 30X, Stomach (Suis) 12X, 30X, Succinicum Acidum 12X, 30X; Aconiticum Acidum, Cis 30X, Naphthochinonum 30X. 0.10% of Cobaltum Metallicum 8X, Niccolum Metallicum 8X. 0.007% of Aralia Quinquefolia 3X, 6X; Ginkgo Biloba 6X, Pancreas Suis 6X, Spleen (Suis) 6X, Stomach (Suis) 6X; Fumaricum Acidum 8X, Germanium Sesquioxide 8X, Malic Acid 8X, Succinicum Acidum 8X, Zincum Metallicum 8X; Naphthochinonum 9X, 12X; Aconiticum Acidum, Cis 12X.

Inactive Ingredients: (INACTIVE INGREDIENTS:)

Demineralized water, 20% Ethanol.

Package Label Display: (PACKAGE LABEL DISPLAY:)

ENERGIQUE

SINDE 1987

HOMEOPATHIC REMEDY

SPLEENEX VH

1 fl. oz. (30 ml)

Keep Out of Reach of Children: (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.


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