Nauzene Grape
Lactic Acid, Wild Hops
Denison Pharmaceuticals Inc.
Human Otc Drug
NDC 0295-7208Nauzene Grape also known as Lactic Acid, Wild Hops is a human otc drug labeled by 'Denison Pharmaceuticals Inc.'. National Drug Code (NDC) number for Nauzene Grape is 0295-7208. This drug is available in dosage form of Liquid. The names of the active, medicinal ingredients in Nauzene Grape drug includes Bryonia Alba Root - 3 [hp_X]/15mL Lactic Acid - 3 [hp_X]/15mL . The currest status of Nauzene Grape drug is Active.
Drug Information:
| Drug NDC: | 0295-7208 |
| 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: | Nauzene Grape |
| 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: | Lactic Acid, Wild Hops |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Denison Pharmaceuticals Inc. |
| Name of Company corresponding to the labeler code segment of the ProductNDC. |
| Dosage Form: | Liquid |
| 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: | BRYONIA ALBA ROOT - 3 [hp_X]/15mL
LACTIC ACID - 3 [hp_X]/15mL
|
| 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: | 18 Jan, 2019 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 24 Dec, 2025 |
| 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: | Denison Pharmaceuticals 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: | 0072959010218
|
| UPC stands for Universal Product Code. |
| UNII: | T7J046YI2B
33X04XA5AT
|
| 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 |
|---|
| 0295-7208-17 | 1 BOTTLE, PLASTIC in 1 CARTON (0295-7208-17) / 118 mL in 1 BOTTLE, PLASTIC | 18 Jan, 2019 | 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 nausea reliever
Product Elements:
Nauzene grape lactic acid, wild hops corn syrup high fructose corn syrup glycerin phosphoric acid water potassium sorbate bryonia alba root bryonia alba root lactic acid lactic acid
Indications and Usage:
Uses for the relief of upset stomach and nausea, including that due to "stomach flu", "car sickness" or overindulgence in food or drink.
Warnings:
Warnings
Do Not Use:
Warnings
When Using:
When using this product do not take more than 6 tablespoons in a 24-hour period.
Dosage and Administration:
Directions read all package directions and warnings before use and use only as directed. children under 2 yrs ask a doctor children 2 yrs and up adults 1 - 2 tablespoons (15 - 30 ml) use only with enclosed dosing cup. dosage may be repeated after 30 minutes not to exceed 6 tablespoons in a 24-hour period unless advised by a doctor. for maximum effectiveness never dilute nauzene kids or drink fluids of any kind immediately before or after taking nauzene kids. nauzene kids is intended for use by normally healthy persons only.
Stop Use:
Stop use and ask a doctor if nausea lasts more than two weeks or recurs frequently.
Information for Patients:
Other information sodium content: 5 mg/tablespoon (15-ml) potassium content: 10 mg/tablespoon (15-ml) store at room temperature. **contents sealed: each bottle of nauzene kids has a tamper evident seal around the cap and a safety seal under the cap. do not use if either of these seals appears broken. you may report serious side effectes to the phone number provided under questions? below.
Package Label Principal Display Panel:
Label
Further Questions:
Questions? 1-800-792-2582