Cimicifuga Plex

Caulophyllum Thalictroides, Cimicifuga Racemosa, Cuprum Metallicum, Folliculinum, Gossypium Herbaceum, Histaminum Hydrochloricum, Hypothalamus, Hypophysis Cerebri, Magnesia Phosphorica, Platinum Metallicum, Sepia, Thyroidinum


Seroyal Usa
Human Otc Drug
NDC 62106-0902
Cimicifuga Plex also known as Caulophyllum Thalictroides, Cimicifuga Racemosa, Cuprum Metallicum, Folliculinum, Gossypium Herbaceum, Histaminum Hydrochloricum, Hypothalamus, Hypophysis Cerebri, Magnesia Phosphorica, Platinum Metallicum, Sepia, Thyroidinum is a human otc drug labeled by 'Seroyal Usa'. National Drug Code (NDC) number for Cimicifuga Plex is 62106-0902. This drug is available in dosage form of Liquid. The names of the active, medicinal ingredients in Cimicifuga Plex drug includes Black Cohosh - 10 [hp_X]/30mL Caulophyllum Thalictroides Root - 10 [hp_X]/30mL Copper - 10 [hp_X]/30mL Estrone - 15 [hp_X]/30mL Gossypium Herbaceum Root Bark - 10 [hp_X]/30mL Histamine Dihydrochloride - 15 [hp_X]/30mL Magnesium Phosphate, Dibasic Trihydrate - 10 [hp_X]/30mL Oryctolagus Cuniculus Hypothalamus - 14 [hp_X]/30mL Oryctolagus Cuniculus Pituitary Gland - 14 [hp_X]/30mL Oryctolagus Cuniculus Thyroid - 14 [hp_X]/30mL and more. The currest status of Cimicifuga Plex drug is Active.

Drug Information:

Drug NDC: 62106-0902
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: Cimicifuga Plex
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: Caulophyllum Thalictroides, Cimicifuga Racemosa, Cuprum Metallicum, Folliculinum, Gossypium Herbaceum, Histaminum Hydrochloricum, Hypothalamus, Hypophysis Cerebri, Magnesia Phosphorica, Platinum Metallicum, Sepia, Thyroidinum
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: 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:BLACK COHOSH - 10 [hp_X]/30mL
CAULOPHYLLUM THALICTROIDES ROOT - 10 [hp_X]/30mL
COPPER - 10 [hp_X]/30mL
ESTRONE - 15 [hp_X]/30mL
GOSSYPIUM HERBACEUM ROOT BARK - 10 [hp_X]/30mL
HISTAMINE DIHYDROCHLORIDE - 15 [hp_X]/30mL
MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE - 10 [hp_X]/30mL
ORYCTOLAGUS CUNICULUS HYPOTHALAMUS - 14 [hp_X]/30mL
ORYCTOLAGUS CUNICULUS PITUITARY GLAND - 14 [hp_X]/30mL
ORYCTOLAGUS CUNICULUS THYROID - 14 [hp_X]/30mL
PLATINUM - 12 [hp_X]/30mL
SEPIA OFFICINALIS JUICE - 10 [hp_X]/30mL
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: 14 Aug, 2017
This is the date that the labeler indicates was the start of its marketing of the drug product.
Marketing End Date: 16 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.
NUI:M0005152
N0000175831
N0000008595
N0000008924
N0000175830
Unique identifier applied to a drug concept within the National Drug File Reference Terminology (NDF-RT).
UNII:K73E24S6X9
JTJ6HH6YEH
789U1901C5
2DI9HA706A
VQN1631P4C
3POA0Q644U
HF539G9L3Q
QMH532G890
T9F9ZW799A
97K9E28344
49DFR088MY
QDL83WN8C2
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.
Pharmacologic Class EPC:Copper-containing Intrauterine Device [EPC]
Established pharmacologic class associated with an approved indication of an active moiety (generic drug) that the FDA has determined to be scientifically valid and clinically meaningful. Takes the form of the pharmacologic class, followed by `[EPC]` (such as `Thiazide Diuretic [EPC]` or `Tumor Necrosis Factor Blocker [EPC]`.
Pharmacologic Class PE:Decreased Embryonic Implantation [PE]
Decreased Sperm Motility [PE]
Inhibit Ovum Fertilization [PE]
Physiologic effect or pharmacodynamic effect—tissue, organ, or organ system level functional activity—of the drug’s established pharmacologic class. Takes the form of the effect, followed by `[PE]` (such as `Increased Diuresis [PE]` or `Decreased Cytokine Activity [PE]`.
Pharmacologic Class CS:Copper [CS]
Chemical structure classification of the drug product’s pharmacologic class. Takes the form of the classification, followed by `[Chemical/Ingredient]` (such as `Thiazides [Chemical/Ingredient]` or `Antibodies, Monoclonal [Chemical/Ingredient].
Pharmacologic Class:Calculi Dissolution Agent [EPC]
Copper [CS]
Copper-containing Intrauterine Device [EPC]
Decreased Embryonic Implantation [PE]
Decreased Sperm Motility [PE]
Increased Large Intestinal Motility [PE]
Inhibit Ovum Fertilization [PE]
Inhibition Large Intestine Fluid/Electrolyte Absorption [PE]
Inhibition Small Intestine Fluid/Electrolyte Absorption [PE]
Magnesium Ion Exchange Activity [MoA]
Osmotic Activity [MoA]
Osmotic Laxative [EPC]
Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]
These are the reported pharmacological class categories corresponding to the SubstanceNames listed above.

Packaging Information:

Package NDCDescriptionMarketing Start DateMarketing End DateSample Available
62106-0902-01 BOTTLE, GLASS in 1 CARTON (62106-0902-0) / 30 mL in 1 BOTTLE, GLASS14 Aug, 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 helps promote and maintain female health. for the temporary relief of mild symptoms associated with premenstrual syndrome.

Product Elements:

Cimicifuga plex caulophyllum thalictroides, cimicifuga racemosa, cuprum metallicum, folliculinum, gossypium herbaceum, histaminum hydrochloricum, hypothalamus, hypophysis cerebri, magnesia phosphorica, platinum metallicum, sepia, thyroidinum platinum platinum oryctolagus cuniculus thyroid oryctolagus cuniculus thyroid sepia officinalis juice sepia officinalis juice water alcohol caulophyllum thalictroides root caulophyllum thalictroides root black cohosh black cohosh copper copper estrone estrone gossypium herbaceum root bark gossypium herbaceum root bark magnesium phosphate, dibasic trihydrate magnesium cation histamine dihydrochloride histamine oryctolagus cuniculus hypothalamus oryctolagus cuniculus hypothalamus oryctolagus cuniculus pituitary gland oryctolagus cuniculus pituitary gland

Indications and Usage:

Uses helps promote and maintain female health. for the temporary relief of mild symptoms associated with premenstrual syndrome. directions to be taken ten minutes away from food. invert bottle and shake lightly allowing drops to fall directly under the tongue or into ¼ oz of water. hold contents for about 20 seconds and swallow. to promote drop flow, invert bottle and shake before each use. adults and adolescents (12 years and older) take 10 to 15 drops daily 15 days prior to menstruation or as recommended by your healthcare practitioner.

Warnings:

Warnings stop use and ask a doctor if symptoms persist or worsen. 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 to be taken ten minutes away from food. invert bottle and shake lightly allowing drops to fall directly under the tongue or into ¼ oz of water. hold contents for about 20 seconds and swallow. to promote drop flow, invert bottle and shake before each use. adults and adolescents (12 years and older) take 10 to 15 drops daily 15 days prior to menstruation or as recommended by your healthcare practitioner.

Package Label Principal Display Panel:

Ndc 62106-0902-0 unda plex cimicifuga plex homeopathic preparation for the temporary relief of mild symptoms associated with premenstrual syndrome. contains 25% alcohol 1 fl oz (30 ml) 62106-0902-0


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.