Genexa Kids Sleepology

Alfalfa, Calcarea Phosphorica, Chamomilla, Eschscholtzia Californica, Melissa Officinalis, Passiflora Incarnata, Pulsatilla, Scutellaria Lateriflora, Valeriana Officinalis

Genexa Inc.
Human Otc Drug
NDC 69676-0053

Genexa Kids Sleepology also known as Alfalfa, Calcarea Phosphorica, Chamomilla, Eschscholtzia Californica, Melissa Officinalis, Passiflora Incarnata, Pulsatilla, Scutellaria Lateriflora, Valeriana Officinalis is a human otc drug labeled by 'Genexa Inc.'. National Drug Code (NDC) number for Genexa Kids Sleepology is 69676-0053. This drug is available in dosage form of Tablet, Chewable. The names of the active, medicinal ingredients in Genexa Kids Sleepology drug includes Alfalfa - 6 [hp_X]/1 Eschscholzia Californica - 6 [hp_X]/1 Matricaria Chamomilla Whole - 6 [hp_X]/1 Melissa Officinalis Leaf - 3 [hp_X]/1 Passiflora Incarnata Flowering Top - 6 [hp_X]/1 Pulsatilla Vulgaris - 12 [hp_X]/1 Scutellaria Lateriflora Top - 3 [hp_X]/1 Tribasic Calcium Phosphate - 8 [hp_X]/1 Valerian - 6 [hp_X]/1 . The currest status of Genexa Kids Sleepology drug is Active.

Drug Information:

Drug NDC:	69676-0053
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 Kids Sleepology
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:	Alfalfa, Calcarea Phosphorica, Chamomilla, Eschscholtzia Californica, Melissa Officinalis, Passiflora Incarnata, Pulsatilla, Scutellaria Lateriflora, Valeriana Officinalis
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:	ALFALFA - 6 [hp_X]/1 ESCHSCHOLZIA CALIFORNICA - 6 [hp_X]/1 MATRICARIA CHAMOMILLA WHOLE - 6 [hp_X]/1 MELISSA OFFICINALIS LEAF - 3 [hp_X]/1 PASSIFLORA INCARNATA FLOWERING TOP - 6 [hp_X]/1 PULSATILLA VULGARIS - 12 [hp_X]/1 SCUTELLARIA LATERIFLORA TOP - 3 [hp_X]/1 TRIBASIC CALCIUM PHOSPHATE - 8 [hp_X]/1 VALERIAN - 6 [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:	28 Jan, 2021
This is the date that the labeler indicates was the start of its marketing of the drug product.
Marketing End Date:	10 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.
UNII:	DJO934BRBD 9315HN272X G0R4UBI2ZZ 50D2ZE9219 CLF5YFS11O I76KB35JEV C6CNB75R61 91D9GV0Z28 JWF5YAW3QW
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 NDC	Description	Marketing Start Date	Marketing End Date	Sample Available
69676-0053-1	1 BOTTLE, PLASTIC in 1 CARTON (69676-0053-1) / 60 TABLET, CHEWABLE in 1 BOTTLE, PLASTIC	28 Jan, 2021	N/A	No
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.

Other medicines with the same generic name

Sleepology For Children

Alfalfa & more..

Tablet, Chewable
Genexa Inc.
NDC: 69676-0018

Genexa Kids Sleepology

Alfalfa & more..

Tablet, Chewable
Genexa Inc.
NDC: 69676-0053

Purpose:

Purpose restless sleep frequent waking inability to fall asleep sleeplessness restless sleep sleeplessness from restlessness, worries and exhaustion frequent waking sleeplessness from nervousness and excitability restless sleep

Product Elements:

Genexa kids sleepology alfalfa, calcarea phosphorica, chamomilla, eschscholtzia californica, melissa officinalis, passiflora incarnata, pulsatilla, scutellaria lateriflora, valeriana officinalis eschscholzia californica eschscholzia californica carnauba wax maltodextrin rice bran passiflora incarnata flowering top passiflora incarnata flowering top valerian valerian matricaria chamomilla whole matricaria chamomilla whole tribasic calcium phosphate phosphate ion scutellaria lateriflora top scutellaria lateriflora top melissa officinalis leaf melissa officinalis leaf pulsatilla vulgaris pulsatilla vulgaris alfalfa alfalfa dextrose off-white g vanilla lavender

Indications and Usage:

Uses* addresses sleeplessness and/or restless sleep.

Warnings:

Warnings stop use and ask a doctor if symptoms persist for more than 3 days or worsen. keep out of reach of children.

Dosage and Administration:

Directions children 3-11 years of age chew 2 tablets at bedtime do not swallow whole 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 homeopathic kids' sleepology deep and restful sleep* relax and sweet dreams* wake up refreshed* organic nighttime sleep aid* non-habit forming and melatonin-free made with vanilla lavender flavor no common allergens, artificial dyes or parabens 60 chewable tablets ages 3-11 kids' sleepology

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.