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Natural Product Number (NPN):

80100520

Market status:

Marketed

Licence Status:

Active

Brand name(s):

Prolax

Licence holder:

New Roots Herbal Inc.

Dosage Form:

Capsule

Recommended route of administration:

Oral

Recommended use or purpose:

(Used in Herbal Medicine as a) stimulant laxative to promote bowel movement and short-term relief of occasional constipation. (Used in Herbal Medicine to) promote(s) bowel movement (by direct action on the large intestine).

Risk Information:

Cautions and Warnings 

Consult a health care practitioner/health care provider/health care professional/doctor/ physician if symptoms persist or worsen. Consult a health care practitioner/health care provider/health care professional/doctor/ physician prior to use if you are taking cardiac medications such as cardiac glycosides or antiarrhythmic medications, thiazide diuretics, corticosteroids, licorice root or other medications or health products which may aggravate electrolyte imbalance. Consult a health care practitioner/health care provider/health care professional/doctor/ physician prior to use if you have a kidney disorder, faecal impaction or symptoms such as abdominal pain, nausea, vomiting or fever. Reduce dose or stop use if you experience abdominal pain, cramps, spasms and/or diarrhoea. Call a Poison Control Center immediately if overdose or accidental ingestion occurs. Keep out of the reach of children.

Contra-Indications 

Do not use this product if you are pregnant or breastfeeding. Do not use this product if you have abnormal constrictions of the gastrointestinal tract, potential or existing intestinal blockage, atonic bowel, appendicitis, inflammatory colon disease such as Crohn's disease or ulcerative colitis, abdominal pain of unknown origin, undiagnosed rectal bleeding, severe dehydration with depleted water or electrolytes or diarrhoea. Do not use if you have hypokalemia, high blood pressure, or a kidney or cardiovascular disorder. Do not use if you have arthritis. Contraindicated in those with a weak stomach and those who do not have constipation.

Known Adverse Reactions 

Stop use if hypersensitivity/allergy occurs. With chronic use or abuse, disturbances of electrolyte balance, especially potassium deficiency, albuminuria and hematuria may occur; Rectal bleeding or failure to have a bowel movement after the use of a laxative may indicate a serious condition. May cause cramp-like discomfort of the gastrointestinal tract, which may require a reduction of dosage. The astringent effect of rhubarb may exacerbate, rather than relieve symptoms of constipation.

List of medicinal ingredients:

Medicinal ingredients	Quantity (Qty)	Extract	Potency
Capsicum annuum	20.0 mg
Chondrus crispus	20.0 mg
Frangula purshiana	180.0 mg
Juglans cinerea	160.0 mg
Rheum officinale	110.0 mg
Zingiber officinale	20.0 mg

List of non-medicinal ingredients:

• Hypromellose
• Magnesium stearate
• Purified water

Date of licensing:

2020-05-21

Revised date of licence: