NDC 57520-0535 Liver Tonic I

Carduus Marianus, Chelidonium Majus, Taraxacum Officinale, Chionanthus Virginica, Quassia Amara, Hepar Bovinum,

NDC Product Code 57520-0535

NDC Code: 57520-0535

Proprietary Name: Liver Tonic I 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, Chelidonium Majus, Taraxacum Officinale, Chionanthus Virginica, Quassia Amara, Hepar Bovinum, 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

  • 57520 - Apotheca Company
    • 57520-0535 - Liver Tonic

NDC 57520-0535-1

Package Description: 60 mL in 1 BOTTLE, DROPPER

NDC Product Information

Liver Tonic I with NDC 57520-0535 is a a human over the counter drug product labeled by Apotheca Company. The generic name of Liver Tonic I is carduus marianus, chelidonium majus, taraxacum officinale, chionanthus virginica, quassia amara, hepar bovinum,. The product's dosage form is liquid and is administered via oral form.

Labeler Name: Apotheca Company

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 I 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.

  • SILYBUM MARIANUM SEED 1 [hp_X]/mL
  • CHELIDONIUM MAJUS 1 [hp_X]/mL
  • TARAXACUM OFFICINALE 1 [hp_X]/mL
  • CHIONANTHUS VIRGINICUS BARK 3 [hp_X]/mL
  • QUASSIA AMARA WOOD 3 [hp_X]/mL
  • CEANOTHUS AMERICANUS LEAF 12 [hp_X]/mL
  • CITRULLUS COLOCYNTHIS FRUIT PULP 12 [hp_X]/mL
  • SODIUM SULFATE 12 [hp_X]/mL
  • STRYCHNOS NUX-VOMICA SEED 12 [hp_X]/mL
  • PHOSPHORUS 12 [hp_X]/mL
  • TEUCRIUM MARUM 12 [hp_X]/mL
  • BEEF LIVER 200 [hp_X]/mL
  • CULVER'S ROOT 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: Apotheca Company
Labeler Code: 57520
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: 07-14-2010 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: 12-31-2018 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: E 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 I Product Label Images

Liver Tonic I 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:  Carduus marianus 1X, Chelidonium majus 1X, Taraxacum officinale 1X, Chionanthus virginica 3X, Quassia amara 3X, Hepar bovinum 8X, 12X, 30X, 200X, Ceanothus americanus 12X, Colocynthis 12X, Leptandra virginica 12X, Natrum sulphuricum 12X, Nux vomica 12X, Phosphorus 12X, Teucrium marum 12X.

Otc - Purpose

INDICATIONS:  For temporary relief of sour, bitter taste after eating, fullness and soreness over the liver, coated tongue, flatulence and diarrhea alternating with constipation.

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 sour, bitter taste after eating, fullness and soreness over the liver, coated tongue, flatulence, and diarrhea alternating with constipation.

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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