NDC 62106-1201 Chelidonium Plex

Chelidonium Majus, Carduus Marianus, Solidago Virgaurea, Berberis Vulgaris, Dolichos Pruriens, Iris Versicolor, Ptelea Trifoliata, Taraxacum Officinale

NDC Product Code 62106-1201

NDC Code: 62106-1201

Proprietary Name: Chelidonium Plex 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: Chelidonium Majus, Carduus Marianus, Solidago Virgaurea, Berberis Vulgaris, Dolichos Pruriens, Iris Versicolor, Ptelea Trifoliata, 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

  • 62106 - Seroyal Usa
    • 62106-1201 - Chelidonium Plex

NDC 62106-1201-0

Package Description: 1 BOTTLE, GLASS in 1 BOX > 30 mL in 1 BOTTLE, GLASS

NDC Product Information

Chelidonium Plex with NDC 62106-1201 is a a human over the counter drug product labeled by Seroyal Usa. The generic name of Chelidonium Plex is chelidonium majus, carduus marianus, solidago virgaurea, berberis vulgaris, dolichos pruriens, iris versicolor, ptelea trifoliata, taraxacum officinale. The product's dosage form is liquid and is administered via oral form.

Labeler Name: Seroyal Usa

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.

Chelidonium Plex 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.

  • PTELEA TRIFOLIATA BARK 10 [hp_X]/30mL
  • TARAXACUM OFFICINALE 10 [hp_X]/30mL
  • BERBERIS VULGARIS ROOT BARK 10 [hp_X]/30mL
  • MUCUNA PRURIENS FRUIT TRICHOME 10 [hp_X]/30mL
  • IRIS VERSICOLOR ROOT 10 [hp_X]/30mL
  • CHELIDONIUM MAJUS 10 [hp_X]/30mL
  • MILK THISTLE 3 [hp_X]/30mL
  • SOLIDAGO VIRGAUREA FLOWERING TOP 3 [hp_X]/30mL

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: Seroyal Usa
Labeler Code: 62106
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: 12-17-2014 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.

Chelidonium Plex Product Label Images

Chelidonium Plex 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 ingredientsEach drop contains:Berberis vulgaris (Barberry) Bark 10X

Carduus marianus (Milk thistle) Fruit 3X

Chelidonium majus (Greater celandine) Rhizome and Root 10X

Dolichos pruriens (Cowhage) Dried Fruit Hairs 10X

Iris versicolor (Blue flag) Underground Parts 10X

Ptelea trifoliata (Hop tree) Leaf and Twig Bark 10X

Solidago virgaurea (Goldenrod) Inflorescences 3X

Taraxacum officinale (Common dandelion) Whole Plant 10X

Otc - Purpose

UsesHelps promote and maintain healthy liver and kidney functions and alleviatessymptoms associated with overindulgence of food and alcohol.

Warnings

Warnings

Stop use and ask a doctor if symptoms persist or worsen.

If pregnant or breastfeeding, ask a health professional before use.

Keep out of reach of children.
In case of overdose, get medical help or contact a Poison Control Center right away.

Otc - Pregnancy Or Breast Feeding

If pregnant or breastfeeding, ask a health professional before use.

Otc - Keep Out Of Reach Of Children

Keep out of reach of children.

Overdosage

In case of overdose, get medical help or contact a Poison Control Center right away.

Inactive Ingredient

Inactive Ingredients:Ethanol (beet),

purified water

Dosage & Administration

Directions:To be taken ten minutes away from food.Children: Divided dosage by half and follow adult directions.Invert bottle and shake lightly allowing for drops to fall directly under the tongue or into 1/4 oz. of water.Hold contents for about 20 seconds and swallow.To promote drop flow, invert bottle and shake before each use.Adults and adolescents (12 years and older)Take 10 drops three times daily or as recommended by your healthcare practitioner.Children (under 12 years)Take under the direction of your healthcare practitioner.

Indications & Usage

UsesHelps promote and maintain healthy liver and kidney functions and alleviates symptoms associated with overindulgenceof food and alcohol.Directions:To be taken ten minutes away from food.Invert bottle and shake lightly allowing for drops to fall directly under the tongue or into 1/4 oz. of water.Hold contents for about 20 seconds and swallow.To promote drop flow, invert bottle and shake before each use.Adults and adolescents (12 years and older)Take 10 drops three times daily or as recommended by your healthcare practitioner.Children (under 12 years)Take under the direction of your healthcare practitioner.

Other Safety Information

Other information

Do not use if seal is missing or broken.

Store in a cool, dry place.

* Please review the disclaimer below.

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