Product information
From Health Canada
Note - The product information found within this database originates from organizations not subject to the Official Languages Act and is available in the language in which it was written and submitted to Health Canada.
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Product licence holders - if you wish to update a product's market status, you are invited to complete the Natural Health Products Market Notification Web Form. As with all other notifications, there is no current service standard. The NNHPD will process the market status update as soon as feasible, based on its available resources. As a reminder, market notification is voluntary; therefore, a licence holder is not required to wait for the LNHPD to be updated before a licensed product is sold in Canada. As such, products that are identified in the LNHPD as "not marketed" may still be sold in Canada.
- 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
Sub population (Sub Pop.) | Quantity (Qty) | Frequency (Freq.) | ||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|
Sub Pop. | Age | Min. | Max. | UoM Footnote1 Age | Qty | Min. | Max. | UoM Qty | Freq. | Min. | Max. | UoM Freq. |
Adults | 0.5 | 1.0 | tablet | 1 | daily | |||||||
- 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.
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
Application information
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