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Natural Product Number (NPN):

80015830

Market status:

Marketed

Licence Status:

Active

Brand name(s):

Melatonin

Licence holder:

WN Pharmaceuticals Ltd

Dosage Form:

Tablet

Recommended route of administration:

Sublingual

Recommended use or purpose:

Helps increase 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 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 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 over two or more time zones).

Risk Information:

Cautions and Warnings 

All uses except jet lag: Consult a physician if sleeplessness persists for more than 4 weeks (chronic insomnia). All uses: Avoid taking with alcohol or products that increase drowsiness. Consult a physician prior to use if you have cardiovascular, immune, liver, or chronic kidney disease, hormonal or seizure disorders, asthma, depression, diabetes, low blood sugar, or migraine. Consult a physician prior to use if you are taking medication for seizure, blood pressure to suppress the immune system (immunosuppressive medications), to affect mental state or increase sedation, steroids or blood thinners.

Contra-Indications 

All uses: Do not use this product if pregnant or breastfeeding.

Known Adverse Reactions 

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

List of medicinal ingredients:

Medicinal ingredients	Quantity (Qty)	Extract	Potency
Melatonin	10.0 mg

List of non-medicinal ingredients:

• Cellulose
• Lactose Monohydrate
• Magnesium stearate
• Peppermint Flavour
• cross-linked carboxymethyl cellulose

Date of licensing:

2010-02-10

Revised date of licence:

2020-09-04