NDC 44911-0293 Spleenex V

Aralia Quinquefolia, Magnesium Gluconicum, Dihydricum, Potassium Gluconate, Ginkgo Biloba, Pancreas Suis, Spleen (suis), Stomach (suis), Germanium Sesquioxide, Cuprum Metallicum, Zincum Metallicum, Alpha-ketoglutaricum Acidum, Citricum Acidum, Fumaricum Acidum, Magnesia Phosphorica, Malic Acid, Pyruvic Acid, Succinicum Acidum, Naphthoquinone, Aconiticum Acidum, Cis

NDC Product Code 44911-0293

NDC CODE: 44911-0293

Proprietary Name: Spleenex V What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.

Non-Proprietary Name: Aralia Quinquefolia, Magnesium Gluconicum, Dihydricum, Potassium Gluconate, Ginkgo Biloba, Pancreas Suis, Spleen (suis), Stomach (suis), Germanium Sesquioxide, Cuprum Metallicum, Zincum Metallicum, Alpha-ketoglutaricum Acidum, Citricum Acidum, Fumaricum Acidum, Magnesia Phosphorica, Malic Acid, Pyruvic Acid, Succinicum Acidum, Naphthoquinone, Aconiticum Acidum, Cis What is the Non-Proprietary Name?
The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.

Drug Use Information

Drug Use Information
The drug use information is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate. This information is not individual medical advice and does not substitute for the advice of a health care professional. Always ask a health care professional for complete information about this product and your specific health needs.

  • This medication is a mineral supplement used to prevent and treat low amounts of magnesium in the blood. Some brands are also used to treat symptoms of too much stomach acid such as stomach upset, heartburn, and acid indigestion. Magnesium is very important for the normal functioning of cells, nerves, muscles, bones, and the heart. Usually, a well-balanced diet provides normal blood levels of magnesium. However, certain situations cause your body to lose magnesium faster than you can replace it from your diet. These situations include treatment with water pills (diuretics such as furosemide, hydrochlorothiazide), a poor diet, alcoholism, or other medical conditions (e.g., severe diarrhea/vomiting, stomach/intestinal absorption problems, poorly controlled diabetes).
  • Drug uses not available
  • Drug uses not available

NDC Code Structure

  • 44911 - Energique, Inc.

NDC 44911-0293-1

Package Description: 30 mL in 1 BOTTLE, DROPPER

NDC Product Information

Spleenex V with NDC 44911-0293 is a a human over the counter drug product labeled by Energique, Inc.. The generic name of Spleenex V is aralia quinquefolia, magnesium gluconicum, dihydricum, potassium gluconate, ginkgo biloba, pancreas suis, spleen (suis), stomach (suis), germanium sesquioxide, cuprum metallicum, zincum metallicum, alpha-ketoglutaricum acidum, citricum acidum, fumaricum acidum, magnesia phosphorica, malic acid, pyruvic acid, succinicum acidum, naphthoquinone, aconiticum acidum, cis. The product's dosage form is liquid and is administered via oral form.

Labeler Name: Energique, Inc.

Dosage Form: Liquid - A dosage form consisting of a pure chemical in its liquid1 state. This dosage form term should not be applied to solutions.

Product Type: Human Otc Drug What kind of product is this?
Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.

Spleenex V Active Ingredient(s)

What is the Active Ingredient(s) List?
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.

  • AMERICAN GINSENG 3 [hp_X]/mL
  • MAGNESIUM GLUCONATE 3 [hp_X]/mL
  • POTASSIUM GLUCONATE 3 [hp_X]/mL
  • GINKGO 6 [hp_X]/mL
  • SUS SCROFA PANCREAS 6 [hp_X]/mL
  • SUS SCROFA SPLEEN 6 [hp_X]/mL
  • SUS SCROFA STOMACH 6 [hp_X]/mL
  • GERMANIUM SESQUIOXIDE 8 [hp_X]/mL
  • COPPER 8 [hp_X]/mL
  • ZINC 8 [hp_X]/mL
  • OXOGLURIC ACID 8 [hp_X]/mL
  • ANHYDROUS CITRIC ACID 8 [hp_X]/mL
  • FUMARIC ACID 8 [hp_X]/mL
  • MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE 8 [hp_X]/mL
  • MALIC ACID 8 [hp_X]/mL
  • PYRUVIC ACID 8 [hp_X]/mL
  • SUCCINIC ACID 8 [hp_X]/mL
  • NAPHTHOQUINE 9 [hp_X]/mL
  • ACONITIC ACID, (Z)- 12 [hp_X]/mL

Inactive Ingredient(s)

About the Inactive Ingredient(s)
The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product.

  • WATER (UNII: 059QF0KO0R)
  • ALCOHOL (UNII: 3K9958V90M)

Administration Route(s)

What are the Administration Route(s)?
The translation of the route code submitted by the firm, indicating route of administration.

  • Oral - Administration to or by way of the mouth.
  • Oral - Administration to or by way of the mouth.

Product Labeler Information

What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Energique, Inc.
Labeler Code: 44911
Marketing Category: UNAPPROVED HOMEOPATHIC - What is the Marketing Category?
Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.

Start Marketing Date: 11-11-2015 What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.

End Marketing Date: 12-02-2020 What is the End Marketing Date?
This is the date the product will no longer be available on the market. If a product is no longer being manufactured, in most cases, the FDA recommends firms use the expiration date of the last lot produced as the EndMarketingDate, to reflect the potential for drug product to remain available after manufacturing has ceased. Products that are the subject of ongoing manufacturing will not ordinarily have any EndMarketingDate. Products with a value in the EndMarketingDate will be removed from the NDC Directory when the EndMarketingDate is reached.

Exclude Flag: N What is the NDC Exclude Flag?
This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA’s requests for correction to deficient or non-compliant submissions. Values = ‘Y’ or ‘N’.

* Please review the disclaimer below.

Spleenex V Product Label Images

Spleenex V Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Labeling Index

Active Ingredients:

Aralia Quinquefolia 3X, 6X, 12X, 30X, Magnesium Gluconicum Dihydricum 3X, 6X, 12X 30X, Potassium Gluconate 3X, 6X, 12X, 30X, Ginkgo Biloba 6X, Pancreas Suis 6X, 12X, 30X, Spleen (Suis) 6X, 12X, 30X, Stomach (Suis) 6X, 12X, 30X, Germanium Sesquioxide 8X, Cuprum Metallicum 8X, 12X, Zincum Metallicum 8X, 12X, Alpha-Ketoglutaricum Acidum 8X, 12X, 30X, Citricum Acidum 8X, 12X, 30X, Fumaricum Acidum 8X, 12X, 30X, Magnesia Phosphorica 8X, 12X, 30X, Malic Acid 8X, 12X, 30X, Pyruvic Acid 8X, 12X, 30X, Succinicum Acidum 8X, 12X, 30X, Naphthoquinone 9X, 12X, 30X, Aconiticum Acidum, Cis 12X, 30X

Indications:

Spleen, Pancreas, Stomach support.****These statements are based upon traditional homeopathic practice. They have not been reviewed by the Food and Drug Administration.

Spleen, Pancreas, Stomach support.****These statements are based upon traditional homeopathic practice. They have not been reviewed by the Food and Drug Administration.

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.

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.

Directions:

Adults and children 5 to 10 drops orally, 3 times daily or as otherwise directed by a health care professional. If symptoms persist, consult your health care professional. Consult a physician for use in children under 12 years of age.

Inactive Ingredients:

Demineralized water, 20% Ethanol.

Questions:

Dist. by Energique, Inc.201 Apple BlvdWoodbine, IA 51579   800-869-8078

Package Label Display:

ENERGIQUESINCE 1987HOMEOPATHIC REMEDYSPLEENEX V1 fl. oz. (30 ml)

* Please review the disclaimer below.