ApprovalTrail

Natural health product · NPN 80100971

Mela

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 May 28, 2020.
Natural Product Number (NPN)
80100971
Dosage form
Tablet, multilayer
Route
Oral
Licensing route
CompendialThe company attested that the product meets a Health Canada monograph.
First licensed
May 28, 2020

Medicinal ingredients

Per dosage unit, as licensed.

IngredientAmount
N-[2-(5-Methoxy-1H-indol-3-yl)ethyl]acetamideMelatonin10 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 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

Hydroxypropylmethylcellulose; Croscarmellose sodium; Calcium phosphate, dibasic, dihydrate; Polyethylene glycol; Silicified Microcrystalline Cellulose; Sodium copper chlorophyllin; Silicon dioxide; Magnesium stearate

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