Speci-chol

Chionanthus Virginicus Bark, Eichhornia Crassipes Whole, Hedera Helix Flowering Twig, Iberis Amara Seed, Iris Versicolor Root, Nutmeg, Phosphorus, And Glechoma Hederacea Flowering Top

Pekana Naturheilmittel Gmbh
Human Otc Drug
NDC 59469-123

Speci-chol also known as Chionanthus Virginicus Bark, Eichhornia Crassipes Whole, Hedera Helix Flowering Twig, Iberis Amara Seed, Iris Versicolor Root, Nutmeg, Phosphorus, And Glechoma Hederacea Flowering Top is a human otc drug labeled by 'Pekana Naturheilmittel Gmbh'. National Drug Code (NDC) number for Speci-chol is 59469-123. This drug is available in dosage form of Solution/ Drops. The names of the active, medicinal ingredients in Speci-chol drug includes Chionanthus Virginicus Root Bark - 3 [hp_X]/50mL Eichhornia Crassipes Whole - 2 [hp_X]/50mL Glechoma Hederacea Flowering Top - 698 mg/50mL Hedera Helix Flowering Twig - 6 [hp_X]/50mL Iberis Amara Seed - 3 [hp_X]/50mL Iris Versicolor Root - 3 [hp_X]/50mL Nutmeg - 4 [hp_X]/50mL Phosphorus - 10 [hp_X]/50mL . The currest status of Speci-chol drug is Active.

Drug Information:

Drug NDC:	59469-123
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:	Speci-chol
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:	Chionanthus Virginicus Bark, Eichhornia Crassipes Whole, Hedera Helix Flowering Twig, Iberis Amara Seed, Iris Versicolor Root, Nutmeg, Phosphorus, And Glechoma Hederacea Flowering Top
Also known as the generic name, this is usually the active ingredient(s) of the product.
Labeler Name:	Pekana Naturheilmittel Gmbh
Name of Company corresponding to the labeler code segment of the ProductNDC.
Dosage Form:	Solution/ Drops
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:	CHIONANTHUS VIRGINICUS ROOT BARK - 3 [hp_X]/50mL EICHHORNIA CRASSIPES WHOLE - 2 [hp_X]/50mL GLECHOMA HEDERACEA FLOWERING TOP - 698 mg/50mL HEDERA HELIX FLOWERING TWIG - 6 [hp_X]/50mL IBERIS AMARA SEED - 3 [hp_X]/50mL IRIS VERSICOLOR ROOT - 3 [hp_X]/50mL NUTMEG - 4 [hp_X]/50mL PHOSPHORUS - 10 [hp_X]/50mL
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:	11 Dec, 2008
This is the date that the labeler indicates was the start of its marketing of the drug product.
Marketing End Date:	24 Dec, 2025
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:	PEKANA Naturheilmittel GmbH
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.
NUI:	N0000185371 N0000185375 N0000175629 N0000184306 M0000728 M0016962 M0006342 M0008672 M0516536
Unique identifier applied to a drug concept within the National Drug File Reference Terminology (NDF-RT).
UNII:	S9Y4B22U2E 216V7S21BH 2458J91U39 3D10KUA6BM T90A7M66YF X43D4L3DQC AEE24M3MQ9 27YLU75U4W
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.
Pharmacologic Class EPC:	Non-Standardized Food Allergenic Extract [EPC] Non-Standardized Plant Allergenic Extract [EPC]
Established pharmacologic class associated with an approved indication of an active moiety (generic drug) that the FDA has determined to be scientifically valid and clinically meaningful. Takes the form of the pharmacologic class, followed by `[EPC]` (such as `Thiazide Diuretic [EPC]` or `Tumor Necrosis Factor Blocker [EPC]`.
Pharmacologic Class PE:	Increased Histamine Release [PE] Cell-mediated Immunity [PE]
Physiologic effect or pharmacodynamic effect—tissue, organ, or organ system level functional activity—of the drug’s established pharmacologic class. Takes the form of the effect, followed by `[PE]` (such as `Increased Diuresis [PE]` or `Decreased Cytokine Activity [PE]`.
Pharmacologic Class CS:	Allergens [CS] Plant Proteins [CS] Dietary Proteins [CS] Food Additives [CS] Seed Storage Proteins [CS]
Chemical structure classification of the drug product’s pharmacologic class. Takes the form of the classification, followed by `[Chemical/Ingredient]` (such as `Thiazides [Chemical/Ingredient]` or `Antibodies, Monoclonal [Chemical/Ingredient].
Pharmacologic Class:	Allergens [CS] Cell-mediated Immunity [PE] Dietary Proteins [CS] Food Additives [CS] Increased Histamine Release [PE] Non-Standardized Food Allergenic Extract [EPC] Non-Standardized Plant Allergenic Extract [EPC] Plant Proteins [CS] Seed Storage Proteins [CS]
These are the reported pharmacological class categories corresponding to the SubstanceNames listed above.

Packaging Information:

Package NDC	Description	Marketing Start Date	Marketing End Date	Sample Available
59469-123-10	1 BOTTLE, GLASS in 1 BOX (59469-123-10) / 50 mL in 1 BOTTLE, GLASS	11 Dec, 2008	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.

Other medicines with the same generic name

Speci-chol

Chionanthus Virginicus Bark & more..

Solution/ Drops
PEKANA Naturheilmittel GmbH
NDC: 59469-123

Purpose:

For relief of occasional abdominal bloating and flatulence. application of this homeopathic remedy for the designated usage is exclusively based on homeopathic experience. with severe forms of this disease, a clinically proven therapy is indicated.

Product Elements:

Speci-chol chionanthus virginicus bark, eichhornia crassipes whole, hedera helix flowering twig, iberis amara seed, iris versicolor root, nutmeg, phosphorus, and glechoma hederacea flowering top chionanthus virginicus root bark chionanthus virginicus root bark eichhornia crassipes whole eichhornia crassipes whole hedera helix flowering twig hedera helix flowering twig iberis amara seed iberis amara seed iris versicolor root iris versicolor root nutmeg nutmeg phosphorus phosphorus glechoma hederacea flowering top glechoma hederacea flowering top water alcohol

Indications and Usage:

Indications for relief of occasional abdominal bloating and flatulence. application of this homeopathic remedy for the designated usage is exclusively based on homeopathic experience. with severe forms of this disease, a clinically proven therapy is indicated.

Warnings:

Warning if symptoms persist, contact a licensed practitioner. if you have known sensitivity to any of the ingredients, please consult your licensed practitioner before use. if you are pregnant or nursing a baby, seek the advice of a health care professional before use. keep out of the reach of children. protect from light and heat. tamper evident do not use this product if tamper evident strip is broken or removed from base of cap.

Dosage and Administration:

Dosage unless otherwise prescribed, adults take 15-20 drops, 3 times per day. for pediatric dosages, consult your practitioner.

Package Label Principal Display Panel:

Principal display panel - 50 ml bottle box speci-chol â¢ oral drops homeopathic medicine for relief of occasional abdominal bloating and flatulence 1.7 fl oz (50 ml) pekana Â® principal display panel - 50 ml bottle box

Further Questions:

To report adverse events, contact bioresource at 321b blodgett street, cotati, ca 94931

Comments/ Reviews:

* Data of this site is collected from www.fda.gov. This page is for informational purposes only. Always consult your physician with any questions you may have regarding a medical condition.