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Natural Product Number (NPN):

80068400

Market status:

Marketed

Licence Status:

Active

Brand name(s):

Melatonin 10 mg

Licence holder:

New Roots Herbal Inc.

Dosage Form:

Tablet

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/minimize jet lag (e.g. daytime fatigue, sleep disturbance) (for people travelling by plane easterly across two or more time zones/if flying east over two or more time zones). Helps to speed up/ reduce the time it takes to fall asleep (sleep onset latency aspect of sleep quality) in people who fall asleep slowly/with delayed sleep phase disorder. Helps to re-set the body's sleep-wake cycle (aspect of the circadian rhythm).

Risk Information:

Cautions and Warnings 

Ask a health care practitioner before use if you are taking medications for seizure, blood pressure, to suppress the immune system, to affect mental state or increase sedation, steroids or blood thinners. Ask a health care practitioner before use if you have cardiovascular, immune, liver or kidney disease, seizure disorder, asthma or diabetes. When using this product avoid taking with alcohol or products that cause drowsiness. When using this product avoid driving or using machinery for 5 hours. Ask a health care practitioner if sleeplessness persists for more than 4 weeks (chronic insomnia).

Contra-Indications 

Do not use if you are pregnant or breastfeeding.

Known Adverse Reactions 

Stop use if allergy occurs or if you experience headache, confusion, or nausea.

List of medicinal ingredients:

Medicinal ingredients	Quantity (Qty)	Extract	Potency
N-Acetyl-5-methoxytryptamine	10.0 milligrams

List of non-medicinal ingredients:

• Croscarmellose Sodium
• Dicalcium Phosphate
• Magnesium Stearate
• Microcrystalline cellulose
• Silicon dioxide
• Stearic Acid

Date of licensing:

2016-04-11

Revised date of licence:

2024-06-10