ApprovalTrail

Natural health product · NPN 80098109

Melatonin 10 mg

Yes: licensed in Canada

The product licence is active. Whether the product is actually on the market is a separate, voluntary notice; the official record shows it.

Licence status Active; licensed April 2, 2020.
Natural Product Number (NPN)
80098109
Licence holder
Wampole Group L.P.
Dosage form
Tablet
Route
Sublingual
Licensing route
CompendialThe company attested that the product meets a Health Canada monograph.
First licensed
April 2, 2020

Medicinal ingredients

Per dosage unit, as licensed.

IngredientAmount
N-[2-(5-Methoxy-1H-indol-3-yl)ethyl]acetamide10 mg

What it is licensed for

The licence’s own wording. Directions, doses, cautions and warnings are on the official record and the label.

  • 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 re-set the body's sleep-wake cycle (aspect of the circadian rhythm). Helps re-set the body's sleep-wake cycle (aspect of the circadian rhythm) and 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 re-set the body's sleep-wake cycle (aspect of the circadian rhythm) and 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 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.

Non-medicinal ingredients

Maltodextrin; Cellulose; Peppermint flavour; Lactose monohydrate; Magnesium stearate; Silica; Peppermint Extract