Cold And Infection Defense

Nasal Throat Spray


Vitality Works, Inc
Human Otc Drug
NDC 64616-041
Cold And Infection Defense also known as Nasal Throat Spray is a human otc drug labeled by 'Vitality Works, Inc'. National Drug Code (NDC) number for Cold And Infection Defense is 64616-041. This drug is available in dosage form of Liquid. The names of the active, medicinal ingredients in Cold And Infection Defense drug includes Belladonna Leaf - 5 [hp_X]/mL Echinacea Purpurea - 4 [hp_X]/mL Echinacea Purpurea Root - 4 [hp_X]/mL . The currest status of Cold And Infection Defense drug is Active.

Drug Information:

Drug NDC: 64616-041
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: Cold And Infection Defense
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: Nasal 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: 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:BELLADONNA LEAF - 5 [hp_X]/mL
ECHINACEA PURPUREA - 4 [hp_X]/mL
ECHINACEA PURPUREA ROOT - 4 [hp_X]/mL
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: 16 Dec, 2003
This is the date that the labeler indicates was the start of its marketing of the drug product.
Marketing End Date: 08 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:0038518001059
UPC stands for Universal Product Code.
UNII:6GZW20TIOI
QI7G114Y98
OS64WTR4KU
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 NDCDescriptionMarketing Start DateMarketing End DateSample Available
64616-041-0130 mL in 1 BOTTLE, SPRAY (64616-041-01)16 Dec, 2003N/ANo
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:

Cold and infection defense temporary relief of syptoms associated with common cold, flu, sinusitis, and sore throat.

Product Elements:

Cold and infection defense nasal throat spray water silver xylitol sodium chloride citrus paradisi seed sodium hydroxide echinacea purpurea echinacea purpurea echinacea purpurea root echinacea purpurea root belladonna leaf belladonna leaf

Indications and Usage:

Cold and infection defense temporary relief of symptoms associated with common cold, flu, sinusitis and sore throat.

Warnings:

Cold and infection defense if pregnant or nursing, seek advice from a health care professional. not for use by more that 1 person. for safety finish the bottle within 60 days after opening. keep out of reach of children.

Dosage and Administration:

Cold and infection defense kee head upright, spray 1-3 times in each nostril and/or throat. repeat 1-4 times per day as needed.

Package Label Principal Display Panel:

Cold and infection defense cold & infection defense


Comments/ Reviews:

* Data of this site is collected from www.fda.gov. This page is for informational purposes only. Always consult your physician with any questions you may have regarding a medical condition.