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Natural Product Number (NPN):

80120429

Market status:

Not Marketed

Licence Status:

Active

Brand name(s):

Melatonin 3 mg

Licence holder:

New Roots Herbal Inc.

Dosage Form:

Tablet, Delayed Release

Recommended route of administration:

Oral

Recommended use or purpose:

Helps increase the total sleep time (aspect of sleep quality) in people suffering from sleep restriction or altered sleep schedule, e.g. shift-work and jet lag. Helps to prevent and/or reduce the effects of jet lag (e.g. daytime fatigue, sleep disturbance) for people travelling by plane easterly across two or more time zones. Helps to reduce the time it takes to fall asleep (sleep onset latency aspect of sleep quality) in people with delayed sleep phase disorder. Helps re-set the body's sleep-wake cycle (aspect of the circadian rhythm).

Risk Information:

Cautions and Warnings 

Avoid taking with alcohol or products that increase drowsiness. Consult a health care practitioner/health care provider/health care professional/doctor/ physician prior to use if you are taking medications for seizure, blood pressure, to suppress the immune system (immunosuppressive medications), to affect mental state or increase sedation, steroids or blood thinners. Consult a health care practitioner/health care provider/health care professional/doctor/ physician prior to use if you have cardiovascular, immune, liver or chronic kidney disease, hormonal or seizure disorders, asthma, depression, diabetes, low blood sugar, or migraine. Consult your health care practitioner/health care provider/health care professional/doctor/ physician if sleeplessness persists for more than 4 weeks (chronic insomnia).

Contra-Indications 

Do not use this product if you are pregnant or breastfeeding.

Known Adverse Reactions 

May cause extended drowsiness. Stop use if allergy occurs or if you experience headache, confusion, or nausea.

List of medicinal ingredients:

Medicinal ingredients	Quantity (Qty)	Extract	Potency
N-[2-(5-Methoxy-1H-indol-3-yl)ethyl]acetamide	3.0 mg

List of non-medicinal ingredients:

• Calcium phosphate, dibasic
• Hyprolose
• Magnesium stearate
• Microcrystalline cellulose
• Silicon dioxide
• Stearic acid

Date of licensing:

2022-08-07

Revised date of licence: