Engystol
Vincetoxicum Hirundinaria Root, Sulfur
Medinatura Inc
Human Otc Drug
NDC 62795-9490Engystol also known as Vincetoxicum Hirundinaria Root, Sulfur is a human otc drug labeled by 'Medinatura Inc'. National Drug Code (NDC) number for Engystol is 62795-9490. This drug is available in dosage form of Tablet. The names of the active, medicinal ingredients in Engystol drug includes Sulfur - 10 [hp_X]/1 Vincetoxicum Hirundinaria Root - 30 [hp_X]/1 . The currest status of Engystol drug is Active.
Drug Information:
| Drug NDC: | 62795-9490 |
| The labeler code and product code segments of the National Drug Code number, separated by a hyphen. Asterisks are no longer used or included within the product code segment to indicate certain configurations of the NDC. |
| Proprietary Name: | Engystol |
| Also known as the trade name. It is the name of the product chosen by the labeler. |
| Product Type: | Human Otc Drug |
| Indicates the type of product, such as Human Prescription Drug or Human OTC Drug. This data element corresponds to the “Document Type” of the SPL submission for the listing. |
| Non Proprietary Name: | Vincetoxicum Hirundinaria Root, Sulfur |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Medinatura Inc |
| Name of Company corresponding to the labeler code segment of the ProductNDC. |
| Dosage Form: | Tablet |
| The translation of the DosageForm Code submitted by the firm. There is no standard, but values may include terms like `tablet` or `solution for injection`.The complete list of codes and translations can be found www.fda.gov/edrls under Structured Product Labeling Resources. |
| Status: | Active |
| FDA does not review and approve unfinished products. Therefore, all products in this file are considered unapproved. |
| Substance Name: | SULFUR - 10 [hp_X]/1
VINCETOXICUM HIRUNDINARIA ROOT - 30 [hp_X]/1
|
| This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted. |
| Route Details: | ORAL
|
| The translation of the Route Code submitted by the firm, indicating route of administration. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources. |
Marketing Information:
An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.
| Marketing Category: | UNAPPROVED HOMEOPATHIC |
| Product types are broken down into several potential Marketing Categories, such as New Drug Application (NDA), Abbreviated New Drug Application (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. |
| Marketing Start Date: | 12 Jan, 2022 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 09 May, 2026 |
| This is the date the product will no longer be available on the market. If a product is no longer being manufactured, in most cases, the FDA recommends firms use the expiration date of the last lot produced as the EndMarketingDate, to reflect the potential for drug product to remain available after manufacturing has ceased. Products that are the subject of ongoing manufacturing will not ordinarily have any EndMarketingDate. Products with a value in the EndMarketingDate will be removed from the NDC Directory when the EndMarketingDate is reached. |
| Listing Expiration Date: | 31 Dec, 2023 |
| This is the date when the listing record will expire if not updated or certified by the firm. |
OpenFDA Information:
An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.
| Manufacturer Name: | Medinatura Inc
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| Original Packager: | Yes
|
| Whether or not the drug has been repackaged for distribution. |
| UNII: | 70FD1KFU70
9R858U917W
|
| Unique Ingredient Identifier, which is a non-proprietary, free, unique, unambiguous, non-semantic, alphanumeric identifier based on a substance’s molecular structure and/or descriptive information. |
Packaging Information:
| Package NDC | Description | Marketing Start Date | Marketing End Date | Sample Available |
|---|
| 62795-9490-2 | 1 BOTTLE in 1 CARTON (62795-9490-2) / 100 TABLET in 1 BOTTLE | 12 Jan, 2022 | N/A | No |
| Package NDC number, known as the NDC, identifies the labeler, product, and trade package size. The first segment, the labeler code, is assigned by the FDA. Description tells the size and type of packaging in sentence form. Multilevel packages will have the descriptions concatenated together. |
Purpose:
Purpose immune support
Product Elements:
Engystol vincetoxicum hirundinaria root, sulfur vincetoxicum hirundinaria root cynanchum vincetoxicum root sulfur sulfur magnesium stearate lactose, unspecified form h
Indications and Usage:
Indications & usage section for immune support when experiencing minor cold & flu symptoms: body aches, fatigue, headache, nausea.
Warnings:
Warnings: if pregnant or breast-feeding, ask a health professional before use. keep out of reach of children. if symptoms persist or worsen, a healthcare provider should be consulted. do not use if known sensitivity to engystol® or any of its ingredients exists.
Dosage and Administration:
Directions adults and children 4 years and older: 1-2 tablets 3 times per day or as directed by a health practitioner. not to exceed 6 tablets per 24 hours. children under 4, as directed by a health professional. allow to completely dissolve in the mouth.
Package Label Principal Display Panel:
Engystol.jpg