NDC 69676-0054 Genexa Kids Calm Keeper

Aconitum Napellus, Calcarea Phosphorica, Chamomilla, Gelsemium Sepervirens, Ignatia Amara, Kali Carbonicum, Passiflora Incarnata, Valeriana Officinalis

NDC Product Code 69676-0054

NDC CODE: 69676-0054

Proprietary Name: Genexa Kids Calm Keeper What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.

Non-Proprietary Name: Aconitum Napellus, Calcarea Phosphorica, Chamomilla, Gelsemium Sepervirens, Ignatia Amara, Kali Carbonicum, Passiflora Incarnata, Valeriana Officinalis What is the Non-Proprietary Name?
The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.

Product Characteristics

Color(s):
WHITE (C48325 - OFF-WHITE)
Shape: ROUND (C48348)
Size(s):
10 MM
Imprint(s):
G
Score: 1
Flavor(s):
VANILLA (C73421 - LAVENDER)

NDC Code Structure

  • 69676 - Genexa Inc.

NDC 69676-0054-1

Package Description: 1 BOTTLE, PLASTIC in 1 CARTON > 60 TABLET, CHEWABLE in 1 BOTTLE, PLASTIC

NDC Product Information

Genexa Kids Calm Keeper with NDC 69676-0054 is a a human over the counter drug product labeled by Genexa Inc.. The generic name of Genexa Kids Calm Keeper is aconitum napellus, calcarea phosphorica, chamomilla, gelsemium sepervirens, ignatia amara, kali carbonicum, passiflora incarnata, valeriana officinalis. The product's dosage form is tablet, chewable and is administered via oral form.

Labeler Name: Genexa Inc.

Dosage Form: Tablet, Chewable - A solid dosage form containing medicinal substances with or without suitable diluents that is intended to be chewed, producing a pleasant tasting residue in the oral cavity that is easily swallowed and does not leave a bitter or unpleasant after-taste.

Product Type: Human Otc Drug What kind of product is this?
Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.

Genexa Kids Calm Keeper Active Ingredient(s)

What is the Active Ingredient(s) List?
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.

  • TRIBASIC CALCIUM PHOSPHATE 8 [hp_X]/1
  • MATRICARIA CHAMOMILLA WHOLE 6 [hp_X]/1
  • GELSEMIUM SEMPERVIRENS ROOT 12 [hp_X]/1
  • STRYCHNOS IGNATII SEED 12 [hp_X]/1
  • POTASSIUM CARBONATE 8 [hp_X]/1
  • VALERIAN 3 [hp_X]/1
  • PASSIFLORA INCARNATA FLOWERING TOP 3 [hp_X]/1
  • ACONITUM NAPELLUS 12 [hp_X]/1

Inactive Ingredient(s)

About the Inactive Ingredient(s)
The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product.

  • CARNAUBA WAX (UNII: R12CBM0EIZ)
  • MALTODEXTRIN (UNII: 7CVR7L4A2D)
  • RICE BRAN (UNII: R60QEP13IC)
  • DEXTROSE (UNII: IY9XDZ35W2)

Administration Route(s)

What are the Administration Route(s)?
The translation of the route code submitted by the firm, indicating route of administration.

  • Oral - Administration to or by way of the mouth.

Product Labeler Information

What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Genexa Inc.
Labeler Code: 69676
Marketing Category: UNAPPROVED HOMEOPATHIC - What is the Marketing Category?
Product types are broken down into several potential Marketing Categories, such as NDA/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.

Start Marketing Date: 02-01-2021 What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.

Listing Expiration Date: 12-31-2022 What is the Listing Expiration Date?
This is the date when the listing record will expire if not updated or certified by the product labeler.

Exclude Flag: N What is the NDC Exclude Flag?
This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA’s requests for correction to deficient or non-compliant submissions. Values = ‘Y’ or ‘N’.

* Please review the disclaimer below.

Genexa Kids Calm Keeper Product Label Images

Genexa Kids Calm Keeper Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Labeling Index

Other

Keep outer package for complete product informationDrug Facts

* CLAIMS BASED ON TRADITIONAL HOMEOPATHIC PRACTICE, NOT ACCEPTED MEDICAL EVIDENCE. NOT EVALUATED BY THE FOOD AND DRUG ADMINISTRATION.NOTE: THIS PRODUCT IS NOT INTENDED TO TREAT ADHD, AUTISM, OR ANXIETY DISORDERS
** X is a homeopathic dilution: see genexa.com for more information.

Bottle is safety sealed. DO NOT use if bottle seal is disturbed or missing.Patent Pending | Distributed by:Genexa Inc. Atlanta, GA 30318genexa.comCertified Organic by SCS Global Services

Made in the USA with globally sourced ingredientsR-20201204-1NDC 69676-0054-1

Otc - Active Ingredient

Active ingredients** Aconitum napellus
‡ 12X HPUS
Calcarea phosphorica 8X HPUSChamomilla
‡ 6X HPUS
Gelsemium sempervirens
‡ 12X HPUS
Ignatia amara
‡ 12X HPUS
Kali carbonicum 8X HPUSPassiflora incarnata
‡ 3X HPUS
Valeriana officinalis
‡ 3X HPUS
‡ Certified Organic"HPUS" indicates that this ingredient is officially included in the Homeopathic Pharmacopoeia of the United States.

Otc - Purpose

Purposestress and tensionworry, stress and sleeplessnessirritability and restlessnessfatigue and restlessnesstension and inability to think clearlyoversensitivity and irritabilityrestless sleep and worryfatigue and stress

Indications & Usage

  • Uses*addresses the following symptoms associated with stress:irritabilitysleeplessnessrestlessnessnervousnessoversensitivity

Warnings

Warnings

Otc - Stop Use

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

Otc - Keep Out Of Reach Of Children

Keep out of reach of children.

Dosage & Administration

  • Directionschildren 3-11 years of agechew 2 tablets at the onset of symptomsdo not swallow wholerepeat every 6 hours as neededchildren under 3 years of ageask a doctor before use

Storage And Handling

Other informationstore between 29-25° C (68-77° F) in a dry place out of direct sunlight

Inactive Ingredient

Inactive ingredientsorganic carnauba wax, organic compliant vanilla lavender flavor, organic dextrose, organic maltodextrin, organic rice bran extract

Otc - Questions

Questions?1-855-436-3921

* Please review the disclaimer below.