NDC 64578-0085 Hepatic-tone

Carduus Marianus, Ceanothus Americanus, Chelidonium Majus, Chionanthus Virginica, Citricum Acidum, Cysteinum, Hepar Suis, Leptandra Virginica, Magnesia Muriatica, Natrum Sulphuricum, Nux Vomica, Phosphorus, Quassia (amara), Taraxacum Officinale

NDC Product Code 64578-0085

NDC Code: 64578-0085

Proprietary Name: Hepatic-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: Carduus Marianus, Ceanothus Americanus, Chelidonium Majus, Chionanthus Virginica, Citricum Acidum, Cysteinum, Hepar Suis, Leptandra Virginica, Magnesia Muriatica, Natrum Sulphuricum, Nux Vomica, Phosphorus, Quassia (amara), 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
    • 64578-0085 - Hepatic-tone

NDC 64578-0085-1

Package Description: 59.1 mL in 1 BOTTLE, DROPPER

NDC Product Information

Hepatic-tone with NDC 64578-0085 is a a human over the counter drug product labeled by Energetix Corp. The generic name of Hepatic-tone is carduus marianus, ceanothus americanus, chelidonium majus, chionanthus virginica, citricum acidum, cysteinum, hepar suis, leptandra virginica, magnesia muriatica, natrum sulphuricum, nux vomica, phosphorus, quassia (amara), 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.

Hepatic-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.

  • MILK THISTLE 4 [hp_X]/mL
  • CEANOTHUS AMERICANUS LEAF 12 [hp_X]/mL
  • CHELIDONIUM MAJUS 4 [hp_X]/mL
  • CHIONANTHUS VIRGINICUS BARK 8 [hp_X]/mL
  • ANHYDROUS CITRIC ACID 8 [hp_X]/mL
  • CYSTEINE 8 [hp_X]/mL
  • PORK LIVER 9 [hp_X]/mL
  • VERONICASTRUM VIRGINICUM ROOT 12 [hp_X]/mL
  • MAGNESIUM CHLORIDE 8 [hp_X]/mL
  • SODIUM SULFATE 12 [hp_X]/mL
  • STRYCHNOS NUX-VOMICA SEED 12 [hp_X]/mL
  • PHOSPHORUS 12 [hp_X]/mL
  • QUASSIA AMARA WOOD 4 [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)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • 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: 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: 05-29-2014 What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.

Listing Expiration Date: 12-31-2019 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 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.

Hepatic-tone Product Label Images

Hepatic-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:

Carduus Marianus 4X; Ceanothus Americanus 12X; Chelidonium Majus 4X; Chionanthus Virginica 8X; Citricum Acidum 8X, 12X, 24X; Cysteinum 8X, 12X, 24X; Hepar Suis 9X, 12X, 30X, 6C; Leptandra Virginica 12X; Magnesia Muriatica 8X; Natrum Sulphuricum 12X; Nux Vomica 12X; Phosphorus 12X; Quassia (Amara) 4X; Taraxacum Officinale 4X.

Purpose:

Temporary relief of dull headache, itchy skin, belching, bitter taste.These statements have not been reviewed by the Food and Drug Administration.

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 or if symptoms worsen or persist.

Uses:

Temporary relief of dull headache, itchy skin, belching, bitter taste.These statements have not been reviewed by the Food and Drug Administration.

Inactive Ingredients:

Ethyl Alcohol, Glycerin, Purified Water

Questions:

Distributed by Energetix Corp.Dahlonega, GA 30533Questions? Comments?800.990.7085www.goenergetix.com

Package Label Display:

EnergetixHepatic-ToneHomeopathic RemedyDull headache, itchy skin, belching, bitter taste.2 fl oz (59.1 mL)

* Please review the disclaimer below.

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