Menopause Relief

Amyl Nitrosum, Calcarea Carbonica, Caulophyllum Thalictroides, Cimicifuga Racemosa, Ferrum Metallicum, Gelsemium Sempervirens, Lachesis Mutus, Pulsatilla, Sanguinaria Canadensis, Sepia, Sulphur, Sulphuricum Acidum.


King Bio Inc.
Human Otc Drug
NDC 57955-7006
Menopause Relief also known as Amyl Nitrosum, Calcarea Carbonica, Caulophyllum Thalictroides, Cimicifuga Racemosa, Ferrum Metallicum, Gelsemium Sempervirens, Lachesis Mutus, Pulsatilla, Sanguinaria Canadensis, Sepia, Sulphur, Sulphuricum Acidum. is a human otc drug labeled by 'King Bio Inc.'. National Drug Code (NDC) number for Menopause Relief is 57955-7006. This drug is available in dosage form of Liquid. The names of the active, medicinal ingredients in Menopause Relief drug includes Amyl Nitrite - 10 [hp_X]/59mL Black Cohosh - 10 [hp_X]/59mL Caulophyllum Thalictroides Root - 10 [hp_X]/59mL Gelsemium Sempervirens Root - 10 [hp_X]/59mL Iron - 10 [hp_X]/59mL Lachesis Muta Venom - 10 [hp_X]/59mL Oyster Shell Calcium Carbonate, Crude - 10 [hp_X]/59mL Pulsatilla Vulgaris Whole - 10 [hp_X]/59mL Sanguinaria Canadensis Root - 10 [hp_X]/59mL Sepia Officinalis Juice - 10 [hp_X]/59mL and more. The currest status of Menopause Relief drug is Active.

Drug Information:

Drug NDC: 57955-7006
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: Menopause 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: Amyl Nitrosum, Calcarea Carbonica, Caulophyllum Thalictroides, Cimicifuga Racemosa, Ferrum Metallicum, Gelsemium Sempervirens, Lachesis Mutus, Pulsatilla, Sanguinaria Canadensis, Sepia, Sulphur, Sulphuricum Acidum.
Also known as the generic name, this is usually the active ingredient(s) of the product.
Labeler Name: King Bio 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:AMYL NITRITE - 10 [hp_X]/59mL
BLACK COHOSH - 10 [hp_X]/59mL
CAULOPHYLLUM THALICTROIDES ROOT - 10 [hp_X]/59mL
GELSEMIUM SEMPERVIRENS ROOT - 10 [hp_X]/59mL
IRON - 10 [hp_X]/59mL
LACHESIS MUTA VENOM - 10 [hp_X]/59mL
OYSTER SHELL CALCIUM CARBONATE, CRUDE - 10 [hp_X]/59mL
PULSATILLA VULGARIS WHOLE - 10 [hp_X]/59mL
SANGUINARIA CANADENSIS ROOT - 10 [hp_X]/59mL
SEPIA OFFICINALIS JUICE - 10 [hp_X]/59mL
SULFUR - 10 [hp_X]/59mL
SULFURIC ACID - 10 [hp_X]/59mL
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: 12 Jun, 2022
This is the date that the labeler indicates was the start of its marketing of the drug product.
Marketing End Date: 24 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:King Bio 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.
UNII:22T8Z09XAK
K73E24S6X9
JTJ6HH6YEH
639KR60Q1Q
E1UOL152H7
VSW71SS07I
2E32821G6I
I76KB35JEV
N9288CD508
QDL83WN8C2
70FD1KFU70
O40UQP6WCF
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
57955-7006-21 BOTTLE, SPRAY in 1 CARTON (57955-7006-2) / 59 mL in 1 BOTTLE, SPRAY12 Jun, 2022N/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:

Equal volumes of each hpus ingredient in 10x, 30x, and 1lm potencies. amyl nitrosum................................hot flashes, profuse sweating calcarea carbonica ....................headaches, night sweats, chills caulophyllum thalictroides .........................irritability, exhaustion cimicifuga racemosa........................................... uterine cramps ferrum metallicum ........................................................irritability gelsemium sempervirens ....................... inability to concentrate lachesis mutus ............................prefers to be alone, sensitivity pulsatilla.................................................... mood swings, fatigue sanguinaria canadensis...........................headache, hot flashes sepia ..........................................................hot flashes, sweating sulphur..................................................confusion, poor memory sulphuricum acidum..................neck and back pain, impatience reference image: menopause.jpg

Product Elements:

Menopause relief amyl nitrosum, calcarea carbonica, caulophyllum thalictroides, cimicifuga racemosa, ferrum metallicum, gelsemium sempervirens, lachesis mutus, pulsatilla, sanguinaria canadensis, sepia, sulphur, sulphuricum acidum. amyl nitrite amyl nitrite oyster shell calcium carbonate, crude oyster shell calcium carbonate, crude caulophyllum thalictroides root caulophyllum thalictroides root black cohosh black cohosh iron iron gelsemium sempervirens root gelsemium sempervirens root lachesis muta venom lachesis muta venom pulsatilla vulgaris whole anemone pulsatilla sanguinaria canadensis root sanguinaria canadensis root sepia officinalis juice sepia officinalis juice sulfur sulfur sulfuric acid sulfuric acid ascorbic acid citric acid monohydrate citrus aurantium fruit oil orange peel citrus reticulata fruit oil water glycerin lactic acid, unspecified form lonicera japonica flower benzylpenicilloyl polylysine carya ovata bark steviol

Indications and Usage:

Uses for temporary relief of of discomforts associated with menopause: hot flashes night sweats chills headaches uterine cramps mood swings sensitivity irritability fatigue poor memory as per various homeopathic materia medicas. claims based on traditional homeopathic practice, not accepted medical evidence. these uses have not been evaluated by the fda, and product has not been clinically tested. reference image: menopause.jpg

Warnings:

Warnings stop use and consult a physician if symptoms worsen or persist for more than 7 days. if pregnant or breast-feeding , ask a healthcare professional before use. keep out of reach of children. in case of overdose, get medical help or contact a poison control center immediately. reference image: menopause.jpg

Dosage and Administration:

Directions initially, depress pump until primed. spray one dose directly into mouth. adults: 3 sprays 3 times per day. children ages 6-12: 2 sprays 3 times per day. consult a physician for use in children under 6 years of age. use additionally as needed, up to 6 times per day. reference image: menopause.jpg

Package Label Principal Display Panel:

Image description menopause.jpg


Comments/ Reviews:

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