Cold And Flu Relief


Clineva Management Services, Llc
Human Otc Drug
NDC 71409-304
Cold And Flu Relief is a human otc drug labeled by 'Clineva Management Services, Llc'. National Drug Code (NDC) number for Cold And Flu Relief is 71409-304. This drug is available in dosage form of Pellet. The names of the active, medicinal ingredients in Cold And Flu Relief drug includes Aconitum Napellus - 14 [hp_X]/1 Allium Cepa Whole - 8 [hp_X]/1 Arnica Montana - 8 [hp_X]/1 Eupatorium Cannabinum Whole - 8 [hp_X]/1 Gelsemium Sempervirens Root - 18 [hp_X]/1 Solanum Dulcamara Whole - 8 [hp_X]/1 . The currest status of Cold And Flu Relief drug is Active.

Drug Information:

Drug NDC: 71409-304
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: Cold And Flu Relief
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: Cold And Flu Relief
Also known as the generic name, this is usually the active ingredient(s) of the product.
Labeler Name: Clineva Management Services, Llc
Name of Company corresponding to the labeler code segment of the ProductNDC.
Dosage Form: Pellet
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:ACONITUM NAPELLUS - 14 [hp_X]/1
ALLIUM CEPA WHOLE - 8 [hp_X]/1
ARNICA MONTANA - 8 [hp_X]/1
EUPATORIUM CANNABINUM WHOLE - 8 [hp_X]/1
GELSEMIUM SEMPERVIRENS ROOT - 18 [hp_X]/1
SOLANUM DULCAMARA WHOLE - 8 [hp_X]/1
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.
Route Details:ORAL
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: 14 Jul, 2017
This is the date that the labeler indicates was the start of its marketing of the drug product.
Marketing End Date: 19 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:Clineva Management Services, 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:U0NQ8555JD
8P2VLG2456
O80TY208ZW
1UEC056CS0
639KR60Q1Q
G72JA9DHK5
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
71409-304-8080 PELLET in 1 VIAL, DISPENSING (71409-304-80)14 Jul, 2017N/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:

Uses: *for the temporary relief of minor fever, chills, runny nose, congestion, body aches adn fatigue due to the common cold or the flu.

Product Elements:

Cold and flu relief cold and flu relief allium cepa whole allium cepa whole aconitum napellus aconitum napellus arnica montana arnica montana sucrose solanum dulcamara whole solanum dulcamara whole lactose gelsemium sempervirens root gelsemium sempervirens root eupatorium cannabinum whole eupatorium cannabinum whole

Indications and Usage:

Uses: for the temporary relief of minor fever, chills, runny nose, congestion, body aches and fatigue due to the common cold or the flu

Warnings:

Warnings if symptoms persist or worsen, or if pregnant or nursing, consult a doctor. keep out of reach of children. do not use if cap seal is broken or missing.

Dosage and Administration:

Directions: turn tube upside down, twist cap to break seal & release pellets. using clear cap, place 3 pellets to dissilve under your tongue 3 times a day or as needed. take apart from food or drinks. to preserve purity avoid touching pellets with fingers.

Package Label Principal Display Panel:

Cold and flu label.jpg

Further Questions:

Question, comments? call 1-844-254-6382


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.