NDC 43857-0056 Liver Tonic II

Boldo, Carduus Marianus, Curcuma Longa, Echinacea, Taraxacum Officinale, Magnesia Phosphorica, Gallbladder (bovine), Hepar Bovine, Ammi Visnaga, Atropinum Sulphuricum, Chelidonium Majus, Leptandra Virginica, Podophyllinum,

NDC Product Code 43857-0056

NDC Code: 43857-0056

Proprietary Name: Liver Tonic II 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: Boldo, Carduus Marianus, Curcuma Longa, Echinacea, Taraxacum Officinale, Magnesia Phosphorica, Gallbladder (bovine), Hepar Bovine, Ammi Visnaga, Atropinum Sulphuricum, Chelidonium Majus, Leptandra Virginica, Podophyllinum, 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.


Code Structure
  • 43857 - Bioactive Nutritional, Inc.
    • 43857-0056 - Liver Tonic

NDC 43857-0056-1

Package Description: 60 mL in 1 BOTTLE, DROPPER

NDC Product Information

Liver Tonic II with NDC 43857-0056 is a a human over the counter drug product labeled by Bioactive Nutritional, Inc.. The generic name of Liver Tonic II is boldo, carduus marianus, curcuma longa, echinacea, taraxacum officinale, magnesia phosphorica, gallbladder (bovine), hepar bovine, ammi visnaga, atropinum sulphuricum, chelidonium majus, leptandra virginica, podophyllinum,. The product's dosage form is liquid and is administered via oral form.

Labeler Name: Bioactive Nutritional, 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.


Liver Tonic II 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.

  • PEUMUS BOLDUS LEAF 1 [hp_X]/mL
  • SILYBUM MARIANUM SEED 1 [hp_X]/mL
  • TURMERIC 1 [hp_X]/mL
  • ECHINACEA, UNSPECIFIED 1 [hp_X]/mL
  • TARAXACUM OFFICINALE 1 [hp_X]/mL
  • MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE 8 [hp_X]/mL
  • BOS TAURUS GALLBLADDER 8 [hp_X]/mL
  • BEEF LIVER 8 [hp_X]/mL
  • AMMI VISNAGA FRUIT 12 [hp_X]/mL
  • ATROPINE SULFATE 12 [hp_X]/mL
  • CHELIDONIUM MAJUS 12 [hp_X]/mL
  • VERONICASTRUM VIRGINICUM ROOT 12 [hp_X]/mL
  • PODOPHYLLUM 12 [hp_C]/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: Bioactive Nutritional, Inc.
Labeler Code: 43857
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: 08-17-2012 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: 06-18-2019 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.

Liver Tonic II Product Label Images

Liver Tonic II 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

Otc - Active Ingredient

ACTIVE INGREDIENTS: Boldo 1X, Carduus Marianus 1X, Curcuma Longa 1X, Echinacea 1X, Taraxacum Officinale 1X, Magnesia Phosphorica 8X, Gallbladder (Bovinum) 8X, 12X, 30X, 200X, Hepar Bovinum 8X, 12X, 30X, 200X, Ammi Visnaga 12X, Atropinum Sulphuricum 12X, Chelidonium Majus 12X, Leptandra Virginica 12X, Podophyllinum 12C.

Otc - Purpose

INDICATIONS:​ ​For temporary relief of bitter taste in mouth, nausea, pain through the stomach to the back and right shoulder, and abdominal distention with liver region painful.

Warnings

WARNINGS: If pregnant or breast-feeding, ask a health care 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.

Dosage & Administration

DIRECTIONS: 10 drops orally, 3 times a day. Consult a physician for use in children under 12 years of age.

Inactive Ingredient

INACTIVE INGREDIENTS: Demineralized water, 25% Ethanol.

Otc - 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.

Indications & Usage

INDICATIONS: For temporary relief of bitter taste in mouth, nausea, pain through the stomach to the back and right shoulder, and abdominal distention with liver region painful.

Otc - Questions

Distributed by:BIOACTIVE NUTRITIONALMelbourne, FL 32935For Nutritional Information write:BioActive Nutritional, Inc.1803 N. Wickham Rd,Melbourne, FL 32935

* Please review the disclaimer below.

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