NDC 60512-9057 Digestion Relief

Dolichos Pruriens, Lycopodium Clavatum, Leptandra Virginica, Carduus Marianus, Chelidonium Majus, Boldo

NDC Product Code 60512-9057

NDC Code: 60512-9057

Proprietary Name: Digestion Relief 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: Dolichos Pruriens, Lycopodium Clavatum, Leptandra Virginica, Carduus Marianus, Chelidonium Majus, Boldo 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

  • 60512 - Homeolab Usa Inc.
    • 60512-9057 - Digestion Relief

NDC 60512-9057-1

Package Description: 80 PELLET in 1 TUBE

NDC Product Information

Digestion Relief with NDC 60512-9057 is a a human over the counter drug product labeled by Homeolab Usa Inc.. The generic name of Digestion Relief is dolichos pruriens, lycopodium clavatum, leptandra virginica, carduus marianus, chelidonium majus, boldo. The product's dosage form is pellet and is administered via oral form.

Labeler Name: Homeolab Usa Inc.

Dosage Form: Pellet - A small sterile solid mass consisting of a highly purified drug (with or without excipients) made by the formation of granules, or by compression and molding.

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.

Digestion Relief 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.

  • MUCUNA PRURIENS FRUIT TRICHOME 3 [hp_X]/1
  • LYCOPODIUM CLAVATUM SPORE 3 [hp_X]/1
  • VERONICASTRUM VIRGINICUM ROOT 3 [hp_X]/1
  • MILK THISTLE 3 [hp_X]/1
  • CHELIDONIUM MAJUS 1 [hp_X]/1
  • PEUMUS BOLDUS LEAF 1 [hp_X]/1

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.

  • SUCROSE (UNII: C151H8M554)
  • LACTOSE (UNII: J2B2A4N98G)

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: Homeolab Usa Inc.
Labeler Code: 60512
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: 10-18-2013 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.

Digestion Relief 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 Hpus

Dolichos pruriens 3XLycopodium clavatum 3XLeptandra virginica 3XCarduus marianus 3XChelidonium majus 1XBoldo 1X

References

Manufactured according to the Homeopathic Pharmacopoeia of the United States (HPUS)

Purpose

Helps relief digestive discomfort

Uses

This Homeopathic product of natural source helps relieve digestive discomfort, nausea, bloating and gas.

Otc - Ask Doctor

If symptoms persist or worsen, discontinue use and contact a health professional.

Otc - Pregnancy Or Breast Feeding

As with any drug, if you are pregnant or nursing a baby, seek the advice of a health professional before using this product.

Otc - Keep Out Of Reach Of Children

Keep this and all medications out of reach of children.

Directions

Adults: Allow 3 pellets to dissolve under the tongue three times a day or as directed by a health professional.Children under 12: Take 1/2 the adult dosage. Do not exceed recommended dosage.

Other Information

Do not use if cap seal is broken.Homeolab USA Inc., 3025 De L'Assomption Blvd., Montreal, QC H1N 2H2  CanadaPRODUCT OF CANADA

* Please review the disclaimer below.

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