ApprovalTrail

Natural health product · NPN 80103308

Melatonin

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 August 5, 2020.
Natural Product Number (NPN)
80103308
Licence holder
Zacomi Corp
Dosage form
Film strip
Route
Oral
Licensing route
Compendial
First licensed
August 5, 2020

Medicinal ingredients

Per dosage unit, as licensed.

IngredientAmount
N-[2-(5-Methoxy-1H-indol-3-yl)ethyl]acetamide7 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

Mannitol; Maltodextrin; Acesulfame potassium; Sucralose; Hydroxymethyl cellulose; Glycerine; FD&C Green No. 3; Peppermint flavour; Pullulan; Sodium saccharin; Sodium hydroxide; Povidone; Lemon flavour; Polysorbate 80; Purified water; Potassium sorbate