NDC 60986-1008 Cholenest

Rhamnus Purshiana, Carduus Marianus, Taraxacum Officinale, Chelidonium Majus, Leptandra Virginica, Myrica Cerifera, Berberis Vulgaris, Natrum Sulphuricum, Magnesia Phosphorica, Cuprum Metallicum

NDC Product Code 60986-1008

NDC Code: 60986-1008

Proprietary Name: Cholenest 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: Rhamnus Purshiana, Carduus Marianus, Taraxacum Officinale, Chelidonium Majus, Leptandra Virginica, Myrica Cerifera, Berberis Vulgaris, Natrum Sulphuricum, Magnesia Phosphorica, Cuprum Metallicum 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

  • 60986 - Marco Pharma International Llc.
    • 60986-1008 - Cholenest

NDC 60986-1008-3

Package Description: 50 mL in 1 BOTTLE, GLASS

NDC 60986-1008-4

Package Description: 100 mL in 1 BOTTLE, GLASS

NDC Product Information

Cholenest with NDC 60986-1008 is a a human over the counter drug product labeled by Marco Pharma International Llc.. The generic name of Cholenest is rhamnus purshiana, carduus marianus, taraxacum officinale, chelidonium majus, leptandra virginica, myrica cerifera, berberis vulgaris, natrum sulphuricum, magnesia phosphorica, cuprum metallicum. The product's dosage form is liquid and is administered via oral form.

Labeler Name: Marco Pharma International Llc.

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.

Cholenest 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.

  • FRANGULA PURSHIANA BARK 1 [hp_X]/100mL
  • SILYBUM MARIANUM SEED 1 [hp_X]/100mL
  • TARAXACUM OFFICINALE 1 [hp_X]/100mL
  • CHELIDONIUM MAJUS 1 [hp_X]/100mL
  • VERONICASTRUM VIRGINICUM ROOT 2 [hp_X]/100mL
  • MORELLA CERIFERA ROOT BARK 2 [hp_X]/100mL
  • BERBERIS VULGARIS ROOT BARK 2 [hp_X]/100mL
  • SODIUM SULFATE 6 [hp_X]/100mL
  • MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE 8 [hp_X]/100mL
  • COPPER 8 [hp_X]/100mL

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.

  • ALCOHOL (UNII: 3K9958V90M)
  • WATER (UNII: 059QF0KO0R)

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: Marco Pharma International Llc.
Labeler Code: 60986
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: 03-01-1992 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.

Cholenest Product Label Images

Cholenest 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

Cascara sagrada 1xHPUSMilk thistle 1xHPUSDandelion 1xHPUSCeladine 1xHPUSCulver's root 2xHPUSBayberry 2xHPUSBarberry 2xHPUSDisodium sulfate 6xHPUSMagnesium hydrogen phosphate 8xHPUSMetallic copper 8XHPUSThe letters HPUS indicates that the components in this product are officially monographed in the Homeopathic Pharmacopoeia of United Sates.

Purpose

Relief of constipation, difficulty digesting fat.

Otc - Keep Out Of Reach Of Children

Keep out of reach of children.

Suggested Use

Adults: 30-40 drops in tepid water 3 times daily before meals. Children, 10 drops in tepid water 3 times daily before meals.

Warnings

If pregnant or breast-feeding, consult a health professional before use.

Dosage & Administration

(Read Suggested Use Section)

Inactive Ingredients

Ethyl Alcohol (63.3% by vol.) and Water

* Please review the disclaimer below.

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