FDA Label for Genexa Kids Calm Keeper
View Indications, Usage & Precautions
Genexa Kids Calm Keeper Product Label
The following document was submitted to the FDA by the labeler of this product Genexa Inc.. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Other
Keep outer package for complete product information
Drug 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 30318
genexa.com
Certified Organic by SCS Global Services
Made in the USA with globally sourced ingredients
R-20201204-1
NDC 69676-0054-1
Otc - Active Ingredient
Active ingredients**
Aconitum napellus ‡ 12X HPUS
Calcarea phosphorica 8X HPUS
Chamomilla ‡ 6X HPUS
Gelsemium sempervirens ‡ 12X HPUS
Ignatia amara ‡ 12X HPUS
Kali carbonicum 8X HPUS
Passiflora 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
Purpose
stress and tension
worry, stress and sleeplessness
irritability and restlessness
fatigue and restlessness
tension and inability to think clearly
oversensitivity and irritability
restless sleep and worry
fatigue and stress
Indications & Usage
Uses*
addresses the following symptoms associated with stress:
- irritability
- sleeplessness
- restlessness
- nervousness
- oversensitivity
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
Directions
children 3-11 years of age |
|
children under 3 years of age | ask a doctor before use |
Storage And Handling
Other information
store between 29-25° C (68-77° F) in a dry place out of direct sunlight
Inactive Ingredient
Inactive ingredients
organic carnauba wax, organic compliant vanilla lavender flavor, organic dextrose, organic maltodextrin, organic rice bran extract
Otc - Questions
Questions?
1-855-436-3921
Package Label.Principal Display Panel
Genexa
REAL REMEDIES MADE CLEAN
Homeopathic
Kids' Calm Keeper
Eases Worries & Tension*
Reduces Fatigue*
Lessens Irritability*
Organic Calming and Relaxation Formula*
Non-Habit Forming
Flavored with Organic Vanilla & Lavender
No allergens, dyes or parabens
60 Chewable Tablets
Ages 3+
* Please review the disclaimer below.