Somease
FDA Label NDC 71902-100
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Biotico Health Canada Limited for the product Somease (NDC 71902-100). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding drug facts, active ingredients:, otc - purpose, indications & usage, warnings:, otc - keep out of reach of children, usage instructions:, inactive ingredients:, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Active Ingredients:
Melatonin 1 mg per spray
Otc - Purpose
Relieve symptoms associated with sleeplessness
Indications & Usage
Solution for difficult sleeping.
For people with sleeplessness due to stress or for people with insomnia.
Warnings:
If you are pregnant, nursing, taking any medications, planning any medical or surgical procedure, or have any medical condition, consult your physician before use. Do not exceed the recommended daily dose.
Otc - Keep Out Of Reach Of Children
Keep out of the reach of children.
Usage Instructions:
Take 3 to 5 sprays before going to bed, preferably under the tongue.
Doses per bottle: 250 Sprays
Inactive Ingredients:
Water, Polyoxyethylene sorbitan monooleate, Glycerol, Medium-chain triglycerides, L–ascorbyl palmitate, Flavouring, Potassium sorbate, Citric acid, Sucralose.
Storage Instructions:
Store in a cool dry place, at a temperature not exceeding 25° C, away from light and direct heat.
Other
Melatonin Oral Spray
For Busy People
For people with insomnia
For people with sleeplessness due to stress
Sleep faster, sleep better. 4 times stronger and 3 times faster than other sleep products.*
Developed in Italy, Somease is the natural solution for difficult sleeping. Somease is a sublingual food spray containing melatonin that reduces the time it takes to fall asleep and helps you wake up without morning sleepiness and discomfort. Somease’s patented nano emulsion allows for rapid absorption (5 minutes) by the body.
*compared to sleep products in capsule form containing melatonin.
Non-GMO
Gluten Free
Nut Free
Somease,Toronto, Ontario, Canada
www.somease.com
Made in Italy
Biotico Health Canada Limited Toronto, Ontario M9W 6V6 CANADA
Email us at: [email protected]
Packaging
Image Description (Label)
* Please review the disclaimer below.
