NDC 44911-0539 Spleenex V

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

NDC Product Code 44911-0539

NDC CODE: 44911-0539

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, Potassium Gluconate, Ginkgo Biloba, Magnesium Gluconicum Dihydricum, Pancreas Suis, Spleen (suis), Stomach (suis), Germanium Sesquioxide, Cuprum Metallicum, Zincum Metallicum, Alpha-ketoglutaricum Acidum, Citricum Acidum, Fumaricum Acidum, Magnesia Phosphorica, Malicum Acidum, Pyruvic Acid, Succinicum Acidum, Naphthochinonum, Aconiticum Acidum, Cis-, Natrum Oxalaceticum 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.

NDC Code Structure

  • 44911 - Energique, Inc.

NDC 44911-0539-1

Package Description: 30 mL in 1 BOTTLE, DROPPER

NDC Product Information

Spleenex V with NDC 44911-0539 is a a human over the counter drug product labeled by Energique, Inc.. The generic name of Spleenex V is aralia quinquefolia, potassium gluconate, ginkgo biloba, magnesium gluconicum dihydricum, pancreas suis, spleen (suis), stomach (suis), germanium sesquioxide, cuprum metallicum, zincum metallicum, alpha-ketoglutaricum acidum, citricum acidum, fumaricum acidum, magnesia phosphorica, malicum acidum, pyruvic acid, succinicum acidum, naphthochinonum, aconiticum acidum, cis-, natrum oxalaceticum. 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
  • POTASSIUM GLUCONATE 3 [hp_X]/mL
  • GINKGO 6 [hp_X]/mL
  • MAGNESIUM GLUCONATE 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
  • SODIUM DIETHYL OXALACETATE 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.

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: 03-19-2020 What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.

Listing Expiration Date: 12-31-2021 What is the Listing Expiration Date?
This is the date when the listing record will expire if not updated or certified by the product labeler.

Exclude Flag: N - NO 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 ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".

* 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:

(in each drop): 2.47% of Ginkgo Biloba 6X; Aralia Quinquefolia 6X, 12X, 30X; Alpha-Ketoglutaricum Acidum 8X, 12X, 30X, Citricum Acidum 8X, 12X, 30X, Fumaricum Acidum 8X, 12X, 30X, Pyruvic Acid 8X, 12X, 30X, Succinicum Acidum 8X, 12X, 30X; Cuprum Metallicum 12X, Zincum Metallicum 12X; Magnesia Phosphorica 12X, 30X, Magnesium Gluconicum Dihydricum 12X 30X, Malicum Acidum 12X, 30X, Naphthoquinone 12X, 30X, Natrum Oxalaceticum 12X, 30X, Pancreas Suis 12X, 30X, Potassium Gluconate 12X, 30X, Spleen (Suis) 12X, 30X, Stomach (Suis) 12X, 30X; Aconiticum Acidum, Cis 30X. 0.10% of Aralia Quinquefolia 3X, Potassium Gluconate 3X; Magnesium Gluconicum Dihydricum 6X, Pancreas Suis 6X, Potassium Gluconate 6X, Spleen (Suis) 6X, Stomach (Suis) 6X; Cuprum Metallicum 8X, Germanium Sesquioxide 8X, Magnesia Phosphorica 8X, Malicum Acidum 8X, Zincum Metallicum 8X; Naphthoquinone 9X; Aconiticum Acidum, Cis 12X.

Indications:

May temporarily reliee stomach discomfor, diarrhea, and fever.****Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.

May temporarily reliee stomach discomfor, diarrhea, and fever.****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.

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 for more than 2 days, 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 Blvd.Woodbine, IA 51579 800-869-8078

Package Label Display:

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

* Please review the disclaimer below.