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Natural Product Number (NPN):

80069682

Market status:

Marketed

Licence Status:

Active

Brand name(s):

Joyful

Licence holder:

New Roots Herbal Inc.

Dosage Form:

Capsule

Recommended route of administration:

Oral

Recommended use or purpose:

Helps to promote healthy mood balance. Helps to temporarily promote relaxation.

Risk Information:

Cautions and Warnings 

Keep out of the reach of children. DO NOT USE MORE THEN THE RECOMMENDED DOSE: 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 and monoamine oxidase inhibitor (MAOI). Serotonin syndrome is a serious side effect and a consequence of excess serotonin on the CNS and/or peripheral nervous system. Discontinue use and consult a health care practitioner if you develop at least three of the following symptoms related to serotonin syndrome: Mental status changes (confusion, hypomania), agitation, myoclonus, hyperreflexia, diaphoresis, shivering, tremor, diarrhoea, incoordination, and fever. If symptoms persist or worsen, consult a health care practitioner. Discontinue use and consult a health care practitioner if you show signs of weakness, oral ulcers, or abdominal pain accompanied by severe muscle pain or if you experience skin changes. Consult a health care practitioner prior to use if you are taking medications for diabetes, high blood pressure, or seizures. If new symptoms develop, consult a health care practitioner. If you are taking any other prescription medications, consult a health care practitioner prior to use. If you are pregnant or breastfeeding, do not use this product. Ensure that you are up-to-date on gynaecological exams prior to use of this product and during continued prolonged use; consult a health care practitioner prior to use if you have a hormone sensitive condition.

Contra-Indications 

Do not use if you have scleroderma. Do not use with alcohol.

Known Adverse Reactions 

Some people may experience drowsiness. Exercise caution if operating heavy machinery, driving a motor vehicle or involved in activities requiring mental alertness. Some people may experience diarrhea, nausea, vomiting and abdominal pain. Hypersensitivity, such as an allergy, has been known to occur; in which case, discontinue use.

List of medicinal ingredients:

Medicinal ingredients	Quantity (Qty)	Extract	Potency
Folate	0.333 milligrams
Gamma-Aminobutyric Acid	200.0 milligrams
L-5-Hydroxytryptophan	50.0 milligrams
L-Theanine	83.33 milligrams
L-Tryptophan	73.333 milligrams
Magnolia officinalis	5.0 milligrams	50 : 1 DHE: 250 milligrams
Panax notoginseng	50.0 milligrams		10.0   % Saponins
Phellodendron amurense	10.0 milligrams	12 : 1	1.0   % Berberine
Vitamin B12	0.3667 milligrams
Vitamin B6	12.0 milligrams
Vitamin D	8.33 micrograms

List of non-medicinal ingredients:

• Hypromellose
• Magnesium Stearate
• Purified water
• Silicon dioxide

Date of licensing:

2016-05-25

Revised date of licence: