Oleander 4x
Avila Herbals
Human Otc Drug
NDC 80732-304Oleander 4x is a human otc drug labeled by 'Avila Herbals'. National Drug Code (NDC) number for Oleander 4x is 80732-304. This drug is available in dosage form of Tincture. The names of the active, medicinal ingredients in Oleander 4x drug includes Nerium Oleander Leaf - 4 [hp_X]/30U . The currest status of Oleander 4x drug is Active.
Drug Information:
| Drug NDC: | 80732-304 |
| 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: | Oleander 4x |
| 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: | Oleander 4x |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Avila Herbals |
| Name of Company corresponding to the labeler code segment of the ProductNDC. |
| Dosage Form: | Tincture |
| 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: | NERIUM OLEANDER LEAF - 4 [hp_X]/30U
|
| This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted. |
| Route Details: | SUBLINGUAL
|
| 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: | 19 Oct, 2020 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 14 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: | Avila Herbals
|
| 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: | 7KV510R6H6
|
| 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 |
|---|
| 80732-304-11 | 1 U in 1 BOX (80732-304-11) | 19 Oct, 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. |
Purpose:
Purpose flu symptoms
Product Elements:
Oleander 4x oleander 4x water orange oil terpeneless alcohol nerium oleander leaf nerium oleander leaf
Indications and Usage:
Uses temporary relief of symptoms of fever, aches, and pains associated with flu, colds, and respiratory distress of flu-like symptoms.
Warnings:
Warnings ask a doctor before use if you are: experiencing worsening symptoms or if symptoms persist more than 7 days, have a diagnosed heart arrythmia, under 12 yrs. when using this product you may get drowsy avoid alcoholic drinks alcohol, sedatives, and tranquilizers may increase drowziness be careful when driving a motor vehicle or operating machinery if pregnant or breast-feeding, ask a health professional before use keep out of reach of chldren. in case of overdose, get medical help or contact posion control center right away
Dosage and Administration:
Dosage and directions take 1ml every 6 hours; not more than 4 ml in a 24 hour period
Package Label Principal Display Panel:
Oleander 4x oleander 4x, incubation temporary relief of symptoms of fever, aches and pains associated with flu, colds, and respiratory distress of flu-like symptoms. hpus homeopathic contents: 15 ml, 20% alcohol. package.label principal display planel