Genexa Motion Sickness Relief

Bryonia Alba, Cinnamonum, Cocculus Indica, Colchicum Autumnale, Iris Versicolor, Kali Carbonicum, Nux Moschata, Staphysagria, Tabacum, Zingiber Officinale


Genexa Inc.
Human Otc Drug
NDC 69676-0028
Genexa Motion Sickness Relief also known as Bryonia Alba, Cinnamonum, Cocculus Indica, Colchicum Autumnale, Iris Versicolor, Kali Carbonicum, Nux Moschata, Staphysagria, Tabacum, Zingiber Officinale is a human otc drug labeled by 'Genexa Inc.'. National Drug Code (NDC) number for Genexa Motion Sickness Relief is 69676-0028. This drug is available in dosage form of Tablet, Chewable. The names of the active, medicinal ingredients in Genexa Motion Sickness Relief drug includes Anamirta Cocculus Seed - 30 [hp_X]/1 Bryonia Alba Whole - 6 [hp_X]/1 Cinnamon - 6 [hp_X]/1 Colchicum Autumnale Bulb - 12 [hp_X]/1 Delphinium Staphisagria Seed - 6 [hp_X]/1 Ginger - 6 [hp_X]/1 Iris Versicolor Root - 12 [hp_X]/1 Nutmeg - 6 [hp_X]/1 Potassium Carbonate - 6 [hp_X]/1 Tobacco Leaf - 30 [hp_X]/1 . The currest status of Genexa Motion Sickness Relief drug is Active.

Drug Information:

Drug NDC: 69676-0028
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: Genexa Motion Sickness 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: Bryonia Alba, Cinnamonum, Cocculus Indica, Colchicum Autumnale, Iris Versicolor, Kali Carbonicum, Nux Moschata, Staphysagria, Tabacum, Zingiber Officinale
Also known as the generic name, this is usually the active ingredient(s) of the product.
Labeler Name: Genexa Inc.
Name of Company corresponding to the labeler code segment of the ProductNDC.
Dosage Form: Tablet, Chewable
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:ANAMIRTA COCCULUS SEED - 30 [hp_X]/1
BRYONIA ALBA WHOLE - 6 [hp_X]/1
CINNAMON - 6 [hp_X]/1
COLCHICUM AUTUMNALE BULB - 12 [hp_X]/1
DELPHINIUM STAPHISAGRIA SEED - 6 [hp_X]/1
GINGER - 6 [hp_X]/1
IRIS VERSICOLOR ROOT - 12 [hp_X]/1
NUTMEG - 6 [hp_X]/1
POTASSIUM CARBONATE - 6 [hp_X]/1
TOBACCO LEAF - 30 [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: 21 Jan, 2020
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, 2024
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:Genexa 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:0857630006779
UPC stands for Universal Product Code.
NUI:N0000185371
N0000175629
N0000184306
M0006342
M0008672
M0000728
N0000185375
M0016962
M0516536
N0000185001
Unique identifier applied to a drug concept within the National Drug File Reference Terminology (NDF-RT).
UNII:810258W28U
56K0VVT47P
5S29HWU6QB
993QHL78E6
00543AP1JV
C5529G5JPQ
X43D4L3DQC
AEE24M3MQ9
BQN1B9B9HA
6YR2608RSU
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:Non-Standardized Food Allergenic Extract [EPC]
Non-Standardized Plant Allergenic Extract [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:Increased Histamine Release [PE]
Cell-mediated Immunity [PE]
Increased IgG Production [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:Dietary Proteins [CS]
Food Additives [CS]
Allergens [CS]
Plant Proteins [CS]
Seed Storage Proteins [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:Allergens [CS]
Cell-mediated Immunity [PE]
Dietary Proteins [CS]
Food Additives [CS]
Increased Histamine Release [PE]
Increased IgG Production [PE]
Non-Standardized Food Allergenic Extract [EPC]
Non-Standardized Plant Allergenic Extract [EPC]
Plant Proteins [CS]
Seed Storage Proteins [CS]
These are the reported pharmacological class categories corresponding to the SubstanceNames listed above.

Packaging Information:

Package NDCDescriptionMarketing Start DateMarketing End DateSample Available
69676-0028-11 BOTTLE, PLASTIC in 1 CARTON (69676-0028-1) / 60 TABLET, CHEWABLE in 1 BOTTLE, PLASTIC21 Jan, 2020N/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:

Purpose headache, loss of appetite and vomiting nausea and vomiting headache, nausea and vomiting salivation and dizziness vomiting and dizziness loss of appetite drowsiness and fatigue headache and fatigue nausea, vomiting and cold perspiration loss of appetite and nausea

Product Elements:

Genexa motion sickness relief bryonia alba, cinnamonum, cocculus indica, colchicum autumnale, iris versicolor, kali carbonicum, nux moschata, staphysagria, tabacum, zingiber officinale bryonia alba whole bryonia alba whole cinnamon cinnamon anamirta cocculus seed anamirta cocculus seed colchicum autumnale bulb colchicum autumnale bulb iris versicolor root iris versicolor root potassium carbonate carbonate ion nutmeg nutmeg delphinium staphisagria seed delphinium staphisagria seed tobacco leaf tobacco leaf maltodextrin rice bran dextrose ginger ginger carnauba wax g white to off-white with specks

Indications and Usage:

Uses* addresses the following symptoms associated with motion sickness: nausea vomiting dizziness

Warnings:

Warnings stop use and ask a doctor if symptoms persist for more than 3 days or worsen. if pregnant or breastfeeding, ask a health professional before use. keep out of reach of children.

Dosage and Administration:

Directions adults and children 12 years of age and older chew 2 tablets at the onset of symptoms do not swallow whole repeat every 4-6 hours as needed children 3-11 years of age chew 1 tablet at the onset of symptoms do not swallow whole repeat every 4-6 hours as needed children under 3 years of age ask a doctor before use

Stop Use:

Stop use and ask a doctor if symptoms persist for more than 3 days or worsen.

Package Label Principal Display Panel:

Genexa motion sickness relief organic motion sickness relief formula*nausea* nausea* dizziness* vomiting* know you ingredients made with organic acai berry flavor made without: common allergens, artificial dyes, or parabens homeopathic 60 chewable tablets unit carton

Further Questions:

Questions? 1-855-436-3921


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.