Prevencia
Fucus Vesiculosus, Bovine Colostrum
Core Consumer Healthcare Llc
Human Otc Drug
NDC 82506-100Prevencia also known as Fucus Vesiculosus, Bovine Colostrum is a human otc drug labeled by 'Core Consumer Healthcare Llc'. National Drug Code (NDC) number for Prevencia is 82506-100. This drug is available in dosage form of Spray. The names of the active, medicinal ingredients in Prevencia drug includes Bos Taurus Colostrum - .015 mg/15mL Fucus Vesiculosus - .015 mg/15mL . The currest status of Prevencia drug is Active.
Drug Information:
| Drug NDC: | 82506-100 |
| 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: | Prevencia |
| 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: | Fucus Vesiculosus, Bovine Colostrum |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Core Consumer Healthcare Llc |
| Name of Company corresponding to the labeler code segment of the ProductNDC. |
| Dosage Form: | Spray |
| 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: | BOS TAURUS COLOSTRUM - .015 mg/15mL
FUCUS VESICULOSUS - .015 mg/15mL
|
| This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted. |
| Route Details: | NASAL
|
| 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: | 17 Oct, 2022 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 04 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: | Core Consumer Healthcare LLC
|
| 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: | S256WJ3OFQ
535G2ABX9M
|
| 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 |
|---|
| 82506-100-15 | 15 mL in 1 BOTTLE, SPRAY (82506-100-15) | 17 Oct, 2022 | 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:
Otc purpose reduce risk of cold and flu infections
Product Elements:
Prevencia fucus vesiculosus, bovine colostrum benzalkonium chloride fucus vesiculosus fucus vesiculosus bos taurus colostrum bos taurus colostrum
Indications and Usage:
Indications and usage use to reduce risk of cold and flu infections
Warnings:
Warnings warnings for nasal use only do not use if you have a sensitivity or allergy to any of the ingredients. if an allergic reaction occurs, stop use and ÂÂÂseek medical help right away. ask a doctor before use if you have ear, nose, or throat sensitivity or susceptibility to nosebleeds. when using this product if accidental eye contact, skin irritation, or rash occurs, rinse with water and discontinue use use of this container by more than one person may spread infection temporary discomfort such as burning, stinging, sneezing, or an increase in nasal discharge may occur stop use and ask a doctor if symptoms get worse or last more than 7 days or accompanied by fever redness or swelling is present * new symptoms occur if pregnant or breast feeding, ask a health professional before use. keep out of reach of children. if swallowed, get medical help or contact a poison control center.
Dosage and Administration:
Directions for use directions adults and children 12 years of age and older: shake well before using. remove cap and clip. before using for the first time, prime pump by depressing the rim a few times for the fine mist to appear. without tilting head, place tip of nozzle in the nostril. without inhaling, depress the rim and pump once into each nostril. do not overspray. wipe away any excess. use every 4 to 6 hours.
Package Label Principal Display Panel:
Prevencia nasal spray front panel