Hevert Pain Relief
Arnica Montana Root And Toxicodendron Pubescens Shoot
Hevert Arzneimittel Gmbh & Co Kg
Human Otc Drug
NDC 54532-0014Hevert Pain Relief also known as Arnica Montana Root And Toxicodendron Pubescens Shoot is a human otc drug labeled by 'Hevert Arzneimittel Gmbh & Co Kg'. National Drug Code (NDC) number for Hevert Pain Relief is 54532-0014. This drug is available in dosage form of Tablet. The names of the active, medicinal ingredients in Hevert Pain Relief drug includes Arnica Montana Root - 4 [hp_X]/1 Toxicodendron Pubescens Shoot - 6 [hp_X]/1 . The currest status of Hevert Pain Relief drug is Active.
Drug Information:
| Drug NDC: | 54532-0014 |
| 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: | Hevert Pain Relief |
| 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: | Arnica Montana Root And Toxicodendron Pubescens Shoot |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Hevert Arzneimittel Gmbh & Co Kg |
| 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: | ARNICA MONTANA ROOT - 4 [hp_X]/1
TOXICODENDRON PUBESCENS SHOOT - 6 [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: | 15 Feb, 2013 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 21 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: | Hevert Arzneimittel GmbH & Co KG
|
| 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: | MUE8Y11327
46PYZ1F82M
|
| 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 |
|---|
| 54532-0014-4 | 10 BLISTER PACK in 1 CARTON (54532-0014-4) / 10 TABLET in 1 BLISTER PACK | 15 Feb, 2013 | N/A | No |
| 54532-0014-5 | 2 BLISTER PACK in 1 CARTON (54532-0014-5) / 10 TABLET in 1 BLISTER PACK | 15 Feb, 2013 | 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:
Active ingredients purpose "x" indicates a homeopathic dilution. for more information visit: www.hevertusa.com arnica montana, radix 4x muscle pain and stiffness, bruising and swelling due to injuries and overexertion rhus toxicodendron 6x muscle pain and stiffness, overexertion
Product Elements:
Hevert pain relief arnica montana root and toxicodendron pubescens shoot arnica montana root arnica montana root toxicodendron pubescens shoot toxicodendron pubescens shoot lactose monohydrate magnesium stearate h
Indications and Usage:
Uses for temporary relief of muscle pain and stiffness reduces bruising and minor swelling due to injuries and overexertion claims based on traditional homeopathic practice, not accepted medical evidence. not fda evaluated.
Warnings:
Warnings do not use if you are allergic to arnica montana or other plants from the daisy family (compositae) you are allergic to rhus toxicodendron or other plants from the cashew family stop use and ask a doctor if pain gets worse or lasts for more than 7 days new symptoms occur redness or swelling is present these could be signs of a serious condition. if pregnant or breast-feeding, ask a health professional before use. keep out of reach of children. in case of overdose, get medical help or contact a poison control center right away.
Do Not Use:
Warnings do not use if you are allergic to arnica montana or other plants from the daisy family (compositae) you are allergic to rhus toxicodendron or other plants from the cashew family stop use and ask a doctor if pain gets worse or lasts for more than 7 days new symptoms occur redness or swelling is present these could be signs of a serious condition. if pregnant or breast-feeding, ask a health professional before use. keep out of reach of children. in case of overdose, get medical help or contact a poison control center right away.
Dosage and Administration:
Directions adults and children over 12 years of age: dissolve 2 tablets in mouth 3 times daily. in acute cases, dissolve 2 tablets in mouth 6 times daily. children 6 to 12 years of age: dissolve 1 tablet in mouth 3 times daily. in acute cases, dissolve 1 tablet in mouth 6 times daily.
Stop Use:
Stop use and ask a doctor if pain gets worse or lasts for more than 7 days new symptoms occur redness or swelling is present these could be signs of a serious condition.
Package Label Principal Display Panel:
Principal display panel - 100 tablet blister pack carton ndc 54532-0014-4 hevert ® pain relief homeopathic medicine relieves muscular pain and swelling from injuries quick dissolving tablets made in germany with the power of arnica! 100 tablets hevert principal display panel - 100 tablet blister pack carton
Further Questions:
Questions? 1-855-387-6466