NDC 64578-0082 Gb-tone

Ammi Visnaga, Atropinum Sulphuricum, Boldo, Carduus Marianus, Chelidonium Majus, Echinacea, Fel Tauri, Hepar Suis, Hydrastis Canadensis, Leptandra Virginica, Magnesia Phosphorica, Natrum Phosphoricum, Podophyllum Peltatum, Taraxacum Officinale

NDC Product Code 64578-0082

NDC Code: 64578-0082

Proprietary Name: Gb-tone 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: Ammi Visnaga, Atropinum Sulphuricum, Boldo, Carduus Marianus, Chelidonium Majus, Echinacea, Fel Tauri, Hepar Suis, Hydrastis Canadensis, Leptandra Virginica, Magnesia Phosphorica, Natrum Phosphoricum, Podophyllum Peltatum, Taraxacum Officinale 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

  • 64578 - Energetix Corp
    • 64578-0082 - Gb-tone

NDC 64578-0082-1

Package Description: 59.1 mL in 1 BOTTLE, DROPPER

NDC Product Information

Gb-tone with NDC 64578-0082 is a a human over the counter drug product labeled by Energetix Corp. The generic name of Gb-tone is ammi visnaga, atropinum sulphuricum, boldo, carduus marianus, chelidonium majus, echinacea, fel tauri, hepar suis, hydrastis canadensis, leptandra virginica, magnesia phosphorica, natrum phosphoricum, podophyllum peltatum, taraxacum officinale. The product's dosage form is liquid and is administered via oral form.

Labeler Name: Energetix Corp

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.

Gb-tone 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.

  • AMMI VISNAGA FRUIT 12 [hp_X]/mL
  • ATROPINE SULFATE 12 [hp_X]/mL
  • PEUMUS BOLDUS LEAF 4 [hp_X]/mL
  • MILK THISTLE 4 [hp_X]/mL
  • CHELIDONIUM MAJUS 12 [hp_X]/mL
  • ECHINACEA ANGUSTIFOLIA 4 [hp_X]/mL
  • BOS TAURUS BILE 8 [hp_X]/mL
  • PORK LIVER 9 [hp_X]/mL
  • GOLDENSEAL 4 [hp_X]/mL
  • VERONICASTRUM VIRGINICUM ROOT 12 [hp_X]/mL
  • MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE 12 [hp_X]/mL
  • SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE 6 [hp_X]/mL
  • PODOPHYLLUM 12 [hp_X]/mL
  • TARAXACUM OFFICINALE 4 [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)
  • GLYCERIN (UNII: PDC6A3C0OX)

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: Energetix Corp
Labeler Code: 64578
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: 04-09-2014 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: 06-01-2021 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.

Gb-tone Product Label Images

Gb-tone 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:

Ammi Visnaga 12X, Atropinum Sulphuricum 12X, Boldo 4X, 12X, Carduus Marianus 4X, Chelidonium Majus 12X, Echinacea 4X, Fel Tauri 8X, 12X, 30X, Hepar Suis 9X, 12X, 30X, 6C, Hydrastis Canadensis 4X, Leptandra Virginica 12X, Magnesia Phosphorica 12X, 30X, Natrum Phosphoricum 6X, 12X, Podophyllum Peltatum 12X, Taraxacum Officinale 4X.

Purpose:

Abdominal pain, indigestion, headaches.

Warnings:

In case of overdose, get medical help or contact a Poison Control Center right away.If pregnant or breast feeding, ask a health professional before use.Keep out of reach of children.Other informationStore in a cool, dry place out of direct sunlight.Do not use if neck wrap is broken or missing.

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:

Take 30 drops orally twice daily or as directed by a healthcare professional.Consult a physician for use in children under 12 years of age.

Uses:

Temporary relief of abdominal pain, indigestion, headaches.

Inactive Ingredients:

Purified Water, Glycerin, 15% Ethanol.

Questions:

Distributed byEnergetix Corp.Dahlonega, GA 30533Questions? 800.990.7085www.goenergetix.com

Package Label Display:

EnergetixGB-ToneHomeopathic RemedyAbdominal pain, indigestion, headaches.DIN-HM 800397292 fl oz (59.1 mL)

* Please review the disclaimer below.

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