Apo-pulm

Onion, Bryonia Dioica Root, Hedera Helix Flowering Twig, Hyoscyamus Niger, Phosphorus, Polygala Senega Root, Antimony Potassium Tartrate, And Pulmonaria Officinalis Whole

Pekana Naturheilmittel Gmbh
Human Otc Drug
NDC 59469-101

Apo-pulm also known as Onion, Bryonia Dioica Root, Hedera Helix Flowering Twig, Hyoscyamus Niger, Phosphorus, Polygala Senega Root, Antimony Potassium Tartrate, And Pulmonaria Officinalis Whole is a human otc drug labeled by 'Pekana Naturheilmittel Gmbh'. National Drug Code (NDC) number for Apo-pulm is 59469-101. This drug is available in dosage form of Syrup. The names of the active, medicinal ingredients in Apo-pulm drug includes Antimony Potassium Tartrate - 6 [hp_X]/125mL Bryonia Dioica Root - 4 [hp_X]/125mL Hedera Helix Flowering Twig - 8 [hp_X]/125mL Hyoscyamus Niger - 4 [hp_X]/125mL Onion - 4 [hp_X]/125mL Phosphorus - 10 [hp_X]/125mL Polygala Senega Root - 4 [hp_X]/125mL Pulmonaria Officinalis Whole - 4 [hp_X]/125mL . The currest status of Apo-pulm drug is Active.

Drug Information:

Drug NDC:	59469-101
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:	Apo-pulm
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:	Onion, Bryonia Dioica Root, Hedera Helix Flowering Twig, Hyoscyamus Niger, Phosphorus, Polygala Senega Root, Antimony Potassium Tartrate, And Pulmonaria Officinalis Whole
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:	Syrup
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:	ANTIMONY POTASSIUM TARTRATE - 6 [hp_X]/125mL BRYONIA DIOICA ROOT - 4 [hp_X]/125mL HEDERA HELIX FLOWERING TWIG - 8 [hp_X]/125mL HYOSCYAMUS NIGER - 4 [hp_X]/125mL ONION - 4 [hp_X]/125mL PHOSPHORUS - 10 [hp_X]/125mL POLYGALA SENEGA ROOT - 4 [hp_X]/125mL PULMONARIA OFFICINALIS WHOLE - 4 [hp_X]/125mL
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:	10 Jun, 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:	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 N0000175629 N0000184306 M0000728 M0006342 M0022575
Unique identifier applied to a drug concept within the National Drug File Reference Terminology (NDF-RT).
UNII:	DL6OZ476V3 53UB5FH7CX 3D10KUA6BM 4WRK2153H3 492225Q21H 27YLU75U4W M7T6H7D4IF 483B0A2Y00
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]
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] Dietary Proteins [CS] Vegetable 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] Increased Histamine Release [PE] Non-Standardized Food Allergenic Extract [EPC] Vegetable 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
59469-101-50	1 BOTTLE, GLASS in 1 BOX (59469-101-50) / 250 mL in 1 BOTTLE, GLASS	03 Feb, 2020	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

Apo-pulm

Onion & more..

Syrup
PEKANA Naturheilmittel GmbH
NDC: 59469-101

Purpose:

For relief of minor chest congestion with mucus. 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:

Apo-pulm onion, bryonia dioica root, hedera helix flowering twig, hyoscyamus niger, phosphorus, polygala senega root, antimony potassium tartrate, and pulmonaria officinalis whole onion onion bryonia dioica root bryonia dioica root hedera helix flowering twig hedera helix flowering twig hyoscyamus niger hyoscyamus niger phosphorus phosphorus polygala senega root polygala senega root antimony potassium tartrate antimony cation (3+) pulmonaria officinalis whole pulmonaria officinalis whole water alcohol

Indications and Usage:

Indications for relief of minor chest congestion with mucus. 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 1 teaspoon up to 6 times per day. for pediatric dosages, consult your practitioner.

Package Label Principal Display Panel:

Principal display panel - 250 ml bottle box apo-pulmâ¢ homeopathic expectorant syrup homeopathic medicine for relief of minor chest congestion with mucus 8.5 fl. oz. (250ml) pekana Â® principal display panel - 250 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.