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Natural Product Number (NPN):

80053836

Market status:

Not Marketed

Licence Status:

Active

Brand name(s):

PMS Relief

Licence holder:

New Roots Herbal Inc.

Dosage Form:

Capsule

Recommended route of administration:

Oral

Recommended use or purpose:

Black Cohosh used in Herbal Medicine to help relive premenstrual symptoms; used in Herbal Medicine to relieve the pain associated with menstruation. Chasteberry is used in Herbal Medicine to help relieve premenstrual symptoms and is used in Herbal Medicine as a hormone normaliser to help stabilise menstrual cycle irregularities. Dandelion is traditionally used in Herbal Medicine as an alternative to help relieve dermatological conditions.

Risk Information:

Cautions and Warnings 

Consult a health care practitioner prior to use if you have any type of acute infection or are taking prescription medication. Consult a health care practitioner if symptoms persist or worsen. Consult a health care practitioner prior to use if you are taking hormone-containing medications such as progesterone preparations, oral contraceptives or hormone replacement therapy.

Contra-Indications 

Do not use if you are pregnant or breastfeeding or if you have a fever or diarrhea. Do not use if you have liver or gall bladder disorders, and/or bowel obstruction or if you have high blood pressure. Discontinue use if you develop symptoms of liver trouble. Do not use if you are attempting to conceive unless you have consulted with a health care practitioner.

Known Adverse Reactions 

May cause allergy. Discontinue use if signs of sensitivity (ie. allergy), nausea, diarrhea or other gastrointestinal symptoms occur.

List of medicinal ingredients:

Medicinal ingredients	Quantity (Qty)	Extract	Potency
Actaea racemosa	20.0 mg	12 : 1 DHE: 240 mg	2.5   % triterpene glycosides
Angelica sinensis	125.0 mg	20 : 1 DHE: 2500 mg	1.0   % Z-ligustilide
Eleutherococcus senticosus	5.0 mg	50 : 1 DHE: 250 mg	0.8   % Eleutherosides
Taraxacum officinale	150.0 mg	10 : 1 DHE: 1500 mg	3.0   % Flavonoids
Trifolium pratense	5.04 mg AIE 35.0 mg		8.0   % Isoflavone
Viburnum opulus	50.0 mg	4 : 1 DHE: 200 mg
Vitex agnus-castus	125.0 mg	3.333 : 1 DHE: 416.625 mg	0.5   % Agnuside
Zea mays	50.0 mg	4 : 1 DHE: 200 mg

List of non-medicinal ingredients:

• Hypromellose
• Magnesium Stearate
• Purified water

Date of licensing:

2014-09-12

Revised date of licence:

2024-06-03