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Natural Product Number (NPN):

80016397

Market status:

Not Marketed

Licence Status:

Active

Brand name(s):

Tranquil Sleep ;
Somno Pro

Licence holder:

Natural Factors Nutritional Products Limited

Dosage Form:

Tablet

Recommended route of administration:

Oral

Recommended use or purpose:

Helps relieve the daytime fatigue associated with jet lag. Helps to reduce the time it takes to fall asleep (sleep onset latency aspect of sleep quality) in people with delayed sleep phase syndrome. Helps re-set the body's sleep-wake cycle (aspect of circadian rhythm). 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 temporarily promote relaxation.

Risk Information:

Cautions and Warnings 

Consult a health care practitioner prior to use if you have a hormonal disorder, diabetes, liver or kidney disease, cerebral palsy, seizure disorders, migraine, depression and/or hypertension. Consult a health care practitioner prior to use if you are taking carbidopa or drugs/supplements with serotonergic activity. These may include, but are not limited to L-tryptophan, S-adenosylmethionine (SAMe), St. John's wort, antidepressants, pain killers, over the counter cough and cold medication containing dextromethorphan, anti-nausea medication and anti-migraine medication. If symptoms worsen or persist for more than 3 weeks (chronic insomnia), consult your health care practitioner. Some people may experience diarrhea, nausea, vomiting and abdominal pain. Discontinue use if you show signs of weakness, oral ulcers, or abdominal pain accompanied by severe muscle pain, or if you experience skin changes.

Contra-Indications 

Do not use if you are taking blood pressure, immunosuppressive, sedative/hypnotic medication, or if you are pregnant or breastfeeding or have scleroderma. Do not drive, use machinery, or engage in activities requiring mental alertness for 5 hours after taking melatonin. Keep out of reach of children.

List of medicinal ingredients:

Medicinal ingredients	Quantity (Qty)	Extract	Potency
L-5-Hydroxytryptophan	15.0 mg
L-Theanine	100.0 mg
Melatonin	1.5 mg

List of non-medicinal ingredients:

• Citric acid
• Magnesium Stearate
• Natural Pineapple Flavour
• Natural Pomegranate flavour
• Natural banana flavour
• Natural mango flavour
• Natural passion fruit
• Natural peach flavour
• Silicon dioxide
• Stearic Acid
• Sugarcane juice
• Xylitol

Date of licensing:

2010-03-08

Revised date of licence: