FDA Label for Genexa Kids Sleepology
View Indications, Usage & Precautions
Genexa Kids Sleepology 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.
** 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-20201106
NDC 69676-0053-1
Otc - Active Ingredient
Active ingredients**
Alfalfa † 6X HPUS
Calcarea phosphorica 8X HPUS
Chamomilla † 6X HPUS
Eschscholtzia californica † 6X HPUS
Melissa officinalis † 3X HPUS
Passiflora incarnata † 6X HPUS
Pulsatilla † 12X HPUS
Scutellaria latiflora † 3X HPUS
Valeriana officinalis † 6X HPUS
† Certified Organic
"HPUS" indicates that this ingredient is officially included in the Homoeopathic Pharmacopoeia of the United States.
Otc - 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
Indications & Usage
Uses*
addresses sleeplessness and/or restless sleep.
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 20°-25°C (68°-77°F) in a dry place out of direct sunlight
Inactive Ingredient
Inactive ingredients
organic carnuaba 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' Sleepology
Deep and restful sleep*
Relax and Sweet Dreams*
Wake Up Refreshed*
Organic Nighttime Sleep Aid*
Non-Habit Forming and Melatonin-Free
Flavored with Organic Vanilla & Lavender
No allergens, dyes or parabens
60 Chewable Tablets
Ages 3*
* Please review the disclaimer below.