Neuralgo Rheum
Pseudognaphalium Obtusifolium, Causticum, Colchicum Autumnale Bulb, Citrullus Colocynthis Fruit Pulp, Iron, Lithium Benzoate, Toxicodendron Pubescens Leaf And Filipendula Ulmaria Root
Medinatura Inc
Human Prescription Drug
NDC 50114-7070Neuralgo Rheum also known as Pseudognaphalium Obtusifolium, Causticum, Colchicum Autumnale Bulb, Citrullus Colocynthis Fruit Pulp, Iron, Lithium Benzoate, Toxicodendron Pubescens Leaf And Filipendula Ulmaria Root is a human prescription drug labeled by 'Medinatura Inc'. National Drug Code (NDC) number for Neuralgo Rheum is 50114-7070. This drug is available in dosage form of Injection. The names of the active, medicinal ingredients in Neuralgo Rheum drug includes Causticum - 10 [hp_X]/1.1mL Citrullus Colocynthis Fruit Pulp - 10 [hp_X]/1.1mL Colchicum Autumnale Bulb - 10 [hp_X]/1.1mL Filipendula Ulmaria Root - 10 [hp_X]/1.1mL Iron - 10 [hp_X]/1.1mL Lithium Benzoate - 10 [hp_X]/1.1mL Pseudognaphalium Obtusifolium - 6 [hp_X]/1.1mL Toxicodendron Pubescens Leaf - 10 [hp_X]/1.1mL . The currest status of Neuralgo Rheum drug is Active.
Drug Information:
| Drug NDC: | 50114-7070 |
| 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: | Neuralgo Rheum |
| Also known as the trade name. It is the name of the product chosen by the labeler. |
| Product Type: | Human Prescription 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: | Pseudognaphalium Obtusifolium, Causticum, Colchicum Autumnale Bulb, Citrullus Colocynthis Fruit Pulp, Iron, Lithium Benzoate, Toxicodendron Pubescens Leaf And Filipendula Ulmaria Root |
| 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: | Injection |
| 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: | CAUSTICUM - 10 [hp_X]/1.1mL
CITRULLUS COLOCYNTHIS FRUIT PULP - 10 [hp_X]/1.1mL
COLCHICUM AUTUMNALE BULB - 10 [hp_X]/1.1mL
FILIPENDULA ULMARIA ROOT - 10 [hp_X]/1.1mL
IRON - 10 [hp_X]/1.1mL
LITHIUM BENZOATE - 10 [hp_X]/1.1mL
PSEUDOGNAPHALIUM OBTUSIFOLIUM - 6 [hp_X]/1.1mL
TOXICODENDRON PUBESCENS LEAF - 10 [hp_X]/1.1mL
|
| This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted. |
| Route Details: | INTRADERMAL
INTRAMUSCULAR
INTRAVENOUS
SUBCUTANEOUS
|
| 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: | 08 Jul, 2014 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 31 Aug, 2023 |
| 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: | 22 Jun, 2026 |
| 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: | DD5FO1WKFU
23H32AOH17
993QHL78E6
997724QNDS
E1UOL152H7
R9Z042Z19E
36XQ854NWW
6IO182RP7A
|
| 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: | Mood Stabilizer [EPC]
|
| 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 |
|---|
| 50114-7070-1 | 10 AMPULE in 1 CARTON (50114-7070-1) / 1.1 mL in 1 AMPULE | 08 Jul, 2014 | 31 Aug, 2023 | No |
| 50114-7070-2 | 3 AMPULE in 1 CARTON (50114-7070-2) / 1.1 mL in 1 AMPULE | 08 Jul, 2014 | 31 Aug, 2023 | 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. |
Product Elements:
Neuralgo rheum pseudognaphalium obtusifolium, causticum, colchicum autumnale bulb, citrullus colocynthis fruit pulp, iron, lithium benzoate, toxicodendron pubescens leaf and filipendula ulmaria root pseudognaphalium obtusifolium pseudognaphalium obtusifolium causticum causticum colchicum autumnale bulb colchicum autumnale bulb citrullus colocynthis fruit pulp citrullus colocynthis fruit pulp iron iron lithium benzoate lithium cation toxicodendron pubescens leaf toxicodendron pubescens leaf filipendula ulmaria root filipendula ulmaria root sodium chloride water
Indications and Usage:
Indications and usage neuralgo-rheum® injection solution is a homeopathic drug product indicated for the treatment of nerve pain, soft tissue rheumatism and symptoms of disc protrusion.
Warnings and Cautions:
Warnings and precautions none
Dosage and Administration:
Dosage and administration general considerations the dosage schedules listed below can be used as a general guide for the administration of neuralgo-rheum injection solution. ⢠neuralgo-rheum injection solution may be administered s.c., i.d., i.m., or i.v.. ⢠if co-administration with a local anesthetic is desired, neuralgo-rheum injection solution may be mixed with lidocaine or similar agents at the discretion of the physician. ⢠the interval between injections is left to the discretion of the hcp, but should not exceed 1 ampule in 24 hours. ⢠parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. ⢠draw up required dose into syringe. ⢠discard any unused ampule contents. do not reuse ampule. ⢠only licensed practitioners with sufficient expertise in injecting drugs, including the respective route of administration, should administer the product.
Read more...standard dosage: adults and children 12 years and older: 1 ml 1 to 3 times per 7 days. children 6 to 11 years: 0.7 ml 1 to 3 times per 7 days. children 2 to 5 years: 0.5 ml 1 to 3 times per 7 days. acute dosage: adults and children 12 years and older: 1 ml daily, and then continue with standard dosage. children 6 to 11 years: 0.7 ml daily, and then continue with standard dosage. children 2 to 5 years: 0.5 ml daily, and then continue with standard dosage.
Dosage Forms and Strength:
Dosage 1 ampule containing 1.1 ml solution for injection each containing the active ingredients in the strengths listed under description.
Contraindications:
Contraindications neuralgo-rheum injection solution is contraindicated in patients with known hypersensitivity to neuralgo-rheum or any of its ingredients.
Adverse Reactions:
Adverse reactions post-marketing experience no adverse events have been reported with a causal relationship to neuralgo-rheum injection solution. to report suspected adverse reactions, contact medinatura. at 1.844.633.4628 or info@medinatura.com or fda at 1-800-fda-1088 or www.fda.gov/medwatch .
Overdosage:
Overdosage no negative effects of an overdose have been reported and none are expected due to the homeopathic dilutions.
Description:
Description each 1.1 ml solution for injection ampule contains: active ingredients: ingredient name potency quantity final dilution causticum 10x 1.1 µl 12.99 causticum 30x 1.1 µl 32.99 causticum 200x 1.1 µl 203.00 colchicum autumnale 10x 1.1 µl 12.99 colchicum autumnale 30x 1.1 µl 32.99 colchicum autumnale 200x 1.1 µl 203.00 colocynthis 10x 1.1 µl 12.99 colocynthis 30x 1.1 µl 32.99 ferrum metallicum 10x 1.1 µl 12.99 ferrum metallicum 30x 1.1 µl 32.99 gnaphalium polycephalum 6x 3.3 µl 8.52 gnaphalium polycephalum 10x 3.3 µl 12.52 gnaphalium polycephalum 30x 3.3 µl 32.52 lithium benzoicum 10x 1.1 µl 12.99 lithium benzoicum 30x 1.1 µl 32.99 rhus toxicodendron 10x 1.1 µl 12.99 rhus toxicodendron 30x 1.1 µl 32.99 spiraea ulmaria 10x 1.1 µl 12.99 spiraea ulmaria 30x 1.1 µl 32.99 list of excipients: water for injection 1,072.5 μl sodium chloride 10.3 μl
Clinical Pharmacology:
Clinical pharmacology mechanism of action the exact mechanism of neuralgo-rheum injection solution is not fully understood. pharmacodynamics not applicable for homeopathic medicinal products.
Package Label Principal Display Panel:
Neuralgo-rheum 1.1ml injection.jpg
Neuralgo-rheum 1.1ml injection.jpg