Olive Leaf Throat Flavored
Throat Spray
Vitality Works, Inc
Human Otc Drug
NDC 64616-038Olive Leaf Throat Flavored also known as Throat Spray is a human otc drug labeled by 'Vitality Works, Inc'. National Drug Code (NDC) number for Olive Leaf Throat Flavored is 64616-038. This drug is available in dosage form of Spray. The names of the active, medicinal ingredients in Olive Leaf Throat Flavored drug includes Baptisia Tinctoria - 4 [hp_X]/mL . The currest status of Olive Leaf Throat Flavored drug is Active.
Drug Information:
| Drug NDC: | 64616-038 |
| 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: | Olive Leaf Throat Flavored |
| Also known as the trade name. It is the name of the product chosen by the labeler. |
| Proprietary Name Base: | Olive Leaf Throat |
| The base of the Brand/Proprietary name excluding its suffix. |
| Proprietary Name Suffix: | Flavored |
| A suffix to the proprietary name, a value here should be appended to the ProprietaryName field to obtain the complete name of the product. This suffix is often used to distinguish characteristics of a product such as extended release (“XR”) or sleep aid (“PM”). Although many companies follow certain naming conventions for suffices, there is no recognized standard. |
| 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: | Throat Spray |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Vitality Works, Inc |
| 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: | BAPTISIA TINCTORIA - 4 [hp_X]/mL
|
| 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: | 27 Feb, 2003 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 09 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: | Vitality Works, 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. |
| UPC: | 0019277000408
|
| UPC stands for Universal Product Code. |
| UNII: | 5K1UO2888Y
|
| 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 |
|---|
| 64616-038-02 | 1 BOTTLE, SPRAY in 1 CARTON (64616-038-02) / 30 mL in 1 BOTTLE, SPRAY (64616-038-01) | 27 Feb, 2003 | 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:
Olive leaf throat spray raspberry spearmint throat redness and constriction, offensive discharge, painless sore throat, difficulty in swallowing, teeth and gums sore, ulcerated.
Product Elements:
Olive leaf throat flavored throat spray olea europaea leaf xylitol glycerin water raspberry seed oil spearmint oil baptisia tinctoria baptisia tinctoria
Indications and Usage:
Olive leaf throat spray raspberry spearmint a homeopathic remedy for the temporary relief of mouth and throat irritations.
Warnings:
Olive leaf throat spray raspberry spearmint do not exceed recommended dosage. this product may cause temporary discomfort such as mild burning and stinging in mouth and throat. the use of this container by more than one person may spread infection. for your safety there is a full body seal over bottle printed "sealed for you protection". do not use if seal is broken or missing.l
Dosage and Administration:
Olive leaf throat spray raspberry spearmint remove protective cap. with your head held upright, hold container close to mouth and depress pump completely. when finished, wipe nozzle clean and replace cap. adults and children 13 years and older - 1-3 sprays in mounth every 2-4 hours or as needed. children 3-12 - half the adult dose. children under 3 - consult healthcare professional.
Package Label Principal Display Panel:
Olive leaf throat spray raspberry spearmint label carton