FDA Label for Sleepology
View Indications, Usage & Precautions
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 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 seal is disturbed or missing.
Distributed by: Genexa Inc.
Los Angeles, CA 90034
genexa.com
Certified Organic by SCS Global Services
Made in the USA with globally sourced ingredients
R-20200804
NDC 69676-0012-1
Otc - Active Ingredient
Active ingredients ‡**
Alfalfa 6X HPUS
Avena sativa 6X HPUS
Chamomilla 6X HPUS
Eschscholtzia californica 6X HPUS
Gelsemium sempervirens 12X HPUS
Nux moschata 9X HPUS
Passiflora incarnata 6X HPUS
Piper methysticum 6X 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
sleeplessness from nervousness and exhaustion
inability to fall asleep
sleeplessness from stress
sleeplessness from pain, irritability and excitability
frequent waking
sleeplessness from worries and restlessness
inability to fall asleep
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 - Pregnancy Or Breast Feeding
If pregnant or breast-feeding, ask a health professional before use.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children.
Dosage & Administration
Directions
adults and children 12 years of age and older |
|
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 maltodextrin, organic rice bran extract, organic tapioca dextrose
Otc - Questions
Questions?
1-855-436-3921
Mon. - Fri. 7am - 6pm PST
Package Label.Principal Display Panel
Genexa
REAL REMEDIES MADE CLEAN
Homeopathic
Sleepology
Deep and Restful Sleep*
Relax and Sweet Dreams*
Wake Up Refreshed*
Organic Nighttime Sleep Aid*
Non-Habit Forming & Melatonin-Free
Flavored with Organic Vanilla & Lavender
No allergens, dyes or parabens
60 Chewable Tablets
* Please review the disclaimer below.