Apo-dolor

Aconitum Napellus, Semecarpus Anacardium Fruit, Bryonia Dioica Root, Gelsemium Sempervirens Root, Menyanthes Trifoliata, Piper Methysticum Root, Schoenocaulon Officinale Seed, And Spigelia Anthelmia

Pekana Naturheilmittel Gmbh
Human Otc Drug
NDC 59469-130

Apo-dolor also known as Aconitum Napellus, Semecarpus Anacardium Fruit, Bryonia Dioica Root, Gelsemium Sempervirens Root, Menyanthes Trifoliata, Piper Methysticum Root, Schoenocaulon Officinale Seed, And Spigelia Anthelmia is a human otc drug labeled by 'Pekana Naturheilmittel Gmbh'. National Drug Code (NDC) number for Apo-dolor is 59469-130. This drug is available in dosage form of Solution/ Drops. The names of the active, medicinal ingredients in Apo-dolor drug includes Aconitum Napellus Whole - 12 [hp_X]/50mL Bryonia Dioica Root - 3 [hp_X]/50mL Gelsemium Sempervirens Root - 4 [hp_X]/50mL Macropiper Methysticum Root - 8 [hp_X]/50mL Menyanthes Trifoliata Whole - 3 [hp_X]/50mL Schoenocaulon Officinale Seed - 3 [hp_X]/50mL Semecarpus Anacardium Fruit - 6 [hp_X]/50mL Spigelia Anthelmia Whole - 3 [hp_X]/50mL . The currest status of Apo-dolor drug is Active.

Drug Information:

Drug NDC:	59469-130
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-dolor
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:	Aconitum Napellus, Semecarpus Anacardium Fruit, Bryonia Dioica Root, Gelsemium Sempervirens Root, Menyanthes Trifoliata, Piper Methysticum Root, Schoenocaulon Officinale Seed, And Spigelia Anthelmia
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:	ACONITUM NAPELLUS WHOLE - 12 [hp_X]/50mL BRYONIA DIOICA ROOT - 3 [hp_X]/50mL GELSEMIUM SEMPERVIRENS ROOT - 4 [hp_X]/50mL MACROPIPER METHYSTICUM ROOT - 8 [hp_X]/50mL MENYANTHES TRIFOLIATA WHOLE - 3 [hp_X]/50mL SCHOENOCAULON OFFICINALE SEED - 3 [hp_X]/50mL SEMECARPUS ANACARDIUM FRUIT - 6 [hp_X]/50mL SPIGELIA ANTHELMIA WHOLE - 3 [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:	10 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:	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.
UNII:	U0NQ8555JD 53UB5FH7CX 639KR60Q1Q BOW48C81XP 7H0QTZ446K 6NAF1689IO 7399B063X9 WYT05213GE
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
59469-130-10	1 BOTTLE, GLASS in 1 BOX (59469-130-10) / 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

Apo-dolor

Aconitum Napellus & more..

Solution/ Drops
PEKANA Naturheilmittel GmbH
NDC: 59469-130

Purpose:

For relief of minor headaches, and muscle pain. 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-dolor aconitum napellus, semecarpus anacardium fruit, bryonia dioica root, gelsemium sempervirens root, menyanthes trifoliata, piper methysticum root, schoenocaulon officinale seed, and spigelia anthelmia aconitum napellus whole aconitum napellus whole semecarpus anacardium fruit semecarpus anacardium fruit bryonia dioica root bryonia dioica root gelsemium sempervirens root gelsemium sempervirens root menyanthes trifoliata whole menyanthes trifoliata whole macropiper methysticum root macropiper methysticum root schoenocaulon officinale seed schoenocaulon officinale seed spigelia anthelmia whole spigelia anthelmia whole water alcohol

Indications and Usage:

Indications for relief of minor headaches, and muscle pain. 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 apo- dolor â¢ oral drops homeopathic medicine for relief of minor headaches, and muscle pain 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.