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Natural Product Number (NPN):

80032690

Market status:

Marketed

Licence Status:

Active

Brand name(s):

Psyllium Husks Fiber Ultra Rich

Licence holder:

New Roots Herbal Inc.

Dosage Form:

Capsule

Recommended route of administration:

Oral

Recommended use or purpose:

Psyllium is used 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. Lowers cholesterol. Promotes heart health. Helps to maintain a healthy cardiovascular system by promotinghealthy cholesterol levels.

Risk Information:

Cautions and Warnings 

Consult a health care practitioner if symptoms worsen of if laxative effect does not occur within 7 days. Consulta health care practitioner if you experience chest pain, vomiting, or difficulty in swallowing or breathing aftertaking this product. Consult a health care practitioner prior to use if you are taking medications which inhibitperistaltic 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, diseases of theesophagus and/or the superior opening of the stomach (cardia), potential or existing intestinal blockageparalysis of the intestine, megacolon, faecal impaction, inflamed bowel or appendicitis). Do not exceed therecommended dosage. Consult a health care practitioner if sore throat or cough persists for more than 3 daysor 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 undersupervision of a qualified health care practitioner. Contraindicated for diabetes and in hypertension, liverdisorders severe kidney insufficiency and hypokalemia.

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. Do not use if you are taking thiazide diuretics, cardiac glycosides, corticosteroids, stimulant laxatives or othermedications which may aggravate electrolyte imbalance.

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	10.12 mg
Hibiscus sabdariffa	80.98 mg
Inulin	42.92 mg
Plantago ovata	405.36 mg
Syzygium aromaticum	10.12 mg

List of non-medicinal ingredients:

• Hypromellose
• Magnesium Stearate
• Purified water
• Stevia rebaudiana leaf

Date of licensing:

2012-06-11

Revised date of licence:

2024-05-17