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Natural Product Number (NPN):

80044396

Market status:

Marketed

Licence Status:

Active

Brand name(s):

ULTRA FIBRE PLANTAGO

Licence holder:

New Roots Herbal Inc.

Dosage Form:

Powder

Recommended route of administration:

Oral

Recommended use or purpose:

Psyllium is use in herbal medicine as a bulk-forming laxative and to promote bowel movements by increasing bulk volume and water content. Psyllium provides gentle relief of constipation and/or irregularity.

Risk Information:

Cautions and Warnings 

Consult a health care practitioner if symptoms worsen of if laxative effect does not occur within 7 days.Consult a health care practitioner if you experience chest pain, vomiting, or difficulty swallowing or breathing after taking the product. Consult a health care practitioner prior to use if you are taking medications which inhibit peristaltic movement (e.g. opoids, loperamide), or if you have symptoms such as abdominal pain, nausea, vomiting or fever (as these could be signs of abnormal constrictions of the gastrointestinal tract, disease of the esophagus and/or the superior opening of the stomach (cardia), potential or existing intestinal blockage, paralysis of the intestine, megacolon, faecal impaction, inflamed bowel or appendicitis). Do not exceed the recommended dosage. Consult a health care practitioner prior to use if sore throat or cough persists for more than 3 days or if you are taking any prescription medication. Consult a health care practitioner prior to use if liver function is impaired or if taking acetaminophen or anticoagulants. Not for prolonged use in high doses except under supervision of a qualified health care practitioner. Contraindicated for diabetes and in hypertension, liver disorders severe kidney insufficiency and hypokalemia. May potentiate potassium depletion of thiazide diuretics and stimulant laxatives as well as the action of cardiac glycosides and cortisol.

Contra-Indications 

Do not use if you are experiencing a sudden change in bowel habits that has persisted for more than 2 weeks, undiagnosed rectal bleeding, or failure to defaecate following the use of another laxative product. Do not use if you have diabetes mellitus in which blood sugars are difficult to regulate. Do not use if you have difficulty swallowing. Do not use if you are experiencing distention and fullness of the chest and abdomen; if you are vomiting from overabundant dampness; if you have edema, hypertension, hypokalemia, cholestatic disorders, cirrhosis of the liver, chronic renal insufficiency or congestive heart failure. Do not use if you are pregnant or breastfeeding or undergoing corticosteroid treatment. Do not use if you suffer from febril disorder.

Known Adverse Reactions 

Hypersensitivity, such as allergy, has been known to occur following inhaled and/or ingested psyllium, in which case discontinue use. May cause temporary gas and/or bloating. Consult a health care practitioner in the event of an allergic reaction, nausea, vomiting, or diarrhea.

List of medicinal ingredients:

Medicinal ingredients	Quantity (Qty)	Extract	Potency
Glycyrrhiza uralensis	53.0 mg
Hibiscus sabdariffa	126.0 mg
Inulin	100.0 mg
Plantago ovata	2128.0 mg
Syzygium aromaticum	53.0 mg

List of non-medicinal ingredients:

Stevia rebaudiana leaf

Date of licensing:

2013-08-26

Revised date of licence:

2013-10-24