NDC 66096-176 Ohm Hepatic Terrain

Berberis Vulgaris, Carduus Marianus, Chelidonium Majus, China Officinalis, Cynara Scolymus, Taraxacum Officinale, Veratrum Album

NDC Product Code 66096-176

NDC Code: 66096-176

Proprietary Name: Ohm Hepatic Terrain 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: Berberis Vulgaris, Carduus Marianus, Chelidonium Majus, China Officinalis, Cynara Scolymus, Taraxacum Officinale, Veratrum Album 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

  • 66096 - Ohm Pharma Inc.
    • 66096-176 - Ohm Hepatic Terrain

NDC 66096-176-06

Package Description: 12 AMPULE in 1 BOX > 2.2 mL in 1 AMPULE

NDC Product Information

Ohm Hepatic Terrain with NDC 66096-176 is a a human over the counter drug product labeled by Ohm Pharma Inc.. The generic name of Ohm Hepatic Terrain is berberis vulgaris, carduus marianus, chelidonium majus, china officinalis, cynara scolymus, taraxacum officinale, veratrum album. The product's dosage form is liquid and is administered via oral form.

Labeler Name: Ohm Pharma 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.

Ohm Hepatic Terrain 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.

  • BERBERIS VULGARIS ROOT BARK 12 [hp_X]/mL
  • MILK THISTLE 6 [hp_X]/mL
  • CHELIDONIUM MAJUS 12 [hp_X]/mL
  • CINCHONA OFFICINALIS BARK 7 [hp_X]/mL
  • CYNARA SCOLYMUS LEAF 9 [hp_X]/mL
  • TARAXACUM OFFICINALE 7 [hp_X]/mL
  • VERATRUM ALBUM 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.

  • SODIUM CHLORIDE (UNII: 451W47IQ8X)

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: Ohm Pharma Inc.
Labeler Code: 66096
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: 04-23-2015 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.

Ohm Hepatic Terrain 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 (HPUS*): Equal amounts of: Berberis Vulgaris 12X, Carduus Marianus 6X, Chelidonium Majus 12X, China Officinalis 7X, Cynara Scolymus 9X, Taraxacum Officinale 7X, Veratrum Album 12X.

*The letters "HPUS" indicate the components in this product are officially monographed in the Homeopathic Pharmacopeia of the United States.

Indications & Usage

USES: Temporarily relieves primary and secondary functional hepatic disorders.**

Other

**This statement has not been evaluated by the FDA.It is based on documented Homeopathic Materia Medica.

Warnings

WARNINGS:IF PREGNANT OR BREAST-FEEDING, ask a health professional before use. If symptoms worsen or persist for more than 5 days, discontinue use and contact a health care professional.

Otc - Keep Out Of Reach Of Children

KEEP OUT OF THE REACH OF CHILDREN.

Dosage & Administration

DIRECTIONS: To open ampoule snap top up and away from you. Using pipette place entire content under the tongue, hold it for 30 seconds and swallow.POSOLOGY: Adults and children over 12 years: In acute conditions: 1 ampoule every 12 hours. In chronic conditions: 1 ampoule one to four times per week, or as directed by a health professional.Children under 12 years use 1/2 the adult dose.Discard unused solution. Solution does not contain any preservatives.Not for injection.

Other Safety Information

OTHER INFORMATION: Store at controlled room temperature. Tamper evident seal. Do not use if box seal is missing or broken.

Inactive Ingredient

INACTIVE INGREDIENTS: Isotonic sodium chloride solution.

Otc - Questions

Mfg. By: OHM PHARMA, INC. / Mineral Wells, TX 76067Made in USAwww.ohmpharma.com

Otc - Purpose

Primary and secondary functional hepatic disorders relief

* Please review the disclaimer below.

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