Febriplex

Aconitum Napellus, Arnica Montana, Belladonna, Eupatorium Perfoliatum, Gelsemium Sempervirens, Mercurius Solubilis, Rhus Toxicodendron


Seroyal Usa
Human Otc Drug
NDC 62106-9911
Febriplex also known as Aconitum Napellus, Arnica Montana, Belladonna, Eupatorium Perfoliatum, Gelsemium Sempervirens, Mercurius Solubilis, Rhus Toxicodendron is a human otc drug labeled by 'Seroyal Usa'. National Drug Code (NDC) number for Febriplex is 62106-9911. This drug is available in dosage form of Tablet. The names of the active, medicinal ingredients in Febriplex drug includes Aconitum Napellus - 6 [hp_X]/1 Arnica Montana Root - 8 [hp_X]/1 Atropa Belladonna - 8 [hp_X]/1 Eupatorium Perfoliatum Flowering Top - 10 [hp_X]/1 Gelsemium Sempervirens Root - 12 [hp_X]/1 Mercurius Solubilis - 10 [hp_X]/1 Toxicodendron Pubescens Shoot - 8 [hp_X]/1 . The currest status of Febriplex drug is Active.

Drug Information:

Drug NDC: 62106-9911
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: Febriplex
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: Aconitum Napellus, Arnica Montana, Belladonna, Eupatorium Perfoliatum, Gelsemium Sempervirens, Mercurius Solubilis, Rhus Toxicodendron
Also known as the generic name, this is usually the active ingredient(s) of the product.
Labeler Name: Seroyal Usa
Name of Company corresponding to the labeler code segment of the ProductNDC.
Dosage Form: Tablet
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 - 6 [hp_X]/1
ARNICA MONTANA ROOT - 8 [hp_X]/1
ATROPA BELLADONNA - 8 [hp_X]/1
EUPATORIUM PERFOLIATUM FLOWERING TOP - 10 [hp_X]/1
GELSEMIUM SEMPERVIRENS ROOT - 12 [hp_X]/1
MERCURIUS SOLUBILIS - 10 [hp_X]/1
TOXICODENDRON PUBESCENS SHOOT - 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
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: 26 Jun, 2017
This is the date that the labeler indicates was the start of its marketing of the drug product.
Marketing End Date: 21 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:Seroyal USA
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
MUE8Y11327
WQZ3G9PF0H
1W0775VX6E
639KR60Q1Q
324Y4038G2
46PYZ1F82M
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
62106-9911-31 BLISTER PACK in 1 BOX (62106-9911-3) / 30 TABLET in 1 BLISTER PACK26 Jun, 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 flu-like symptoms accompanied by mild fever and fatigue.

Product Elements:

Febriplex aconitum napellus, arnica montana, belladonna, eupatorium perfoliatum, gelsemium sempervirens, mercurius solubilis, rhus toxicodendron aconitum napellus aconitum napellus arnica montana root arnica montana root atropa belladonna atropa belladonna eupatorium perfoliatum flowering top eupatorium perfoliatum flowering top gelsemium sempervirens root gelsemium sempervirens root mercurius solubilis mercurius solubilis toxicodendron pubescens shoot toxicodendron pubescens shoot lactose monohydrate magnesium stearate carboxymethylcellulose sodium xylitol

Indications and Usage:

Uses for the temporary relief of flu-like symptoms accompanied by mild fever and fatigue directions adults and adolescents (12 years and older): at the first sign of symptoms, take one tablet allowing it to dissolve under the tongue. continue every half hour to one hour. when symptoms subside, decrease frequency to every four hours. once the symptoms are gone, continue taking one tablet daily for three more days. children (under 12 years): take under the direction of your healthcare practitioner.

Warnings:

Warnings stop use and ask a doctor if symptoms continue to persist after three days of use or are accompanied by a fever. do not use if you have ever had an allergic reaction to this product or any of its ingredients. if pregnant or breastfeeding, ask a health professional before use. keep out of reach of children. in case of overdose, get medical help or contact a poison control center right away.

Dosage and Administration:

Directions adults and adolescents (12 years and older): at the first sign of symptoms, take one tablet allowing it to dissolve under the tongue. continue every half hour to one hour. when symptoms subside, decrease frequency to every four hours. once the symptoms are gone, continue taking one tablet daily for three more days. children (under 12 years): take under the direction of your healthcare practitioner.

Package Label Principal Display Panel:

Ndc 62106-9911-3 unda plex febriplex(tm) homeopathic preparation for the temporary relief of flu-like symptoms. 30 tablets 62106-9911-3


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.