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This monograph is intended to serve as a guide to industry for the preparation of Product Licence Applications (PLAs) and labels for natural health product market authorization. It is not intended to be a comprehensive review of the medicinal ingredient.



September 25,2018

Proper name(s), Common name(s), Source material(s)

Table 1. Proper name(s), Common name(s), Source material(s)
Proper name(s) Common name(s) Source material(s)
Proper name(s) Part(s) Preparation
  • Serenoa repens
  • Saw palmetto liposterolic extract

Serenoa repens



References: Proper name: USDA 2018; Common name: USDA 2018, McGuffin et al. 2000; Source material: USP 32 2009, Blumenthal et al. 2000, Mills and Bone 2000.

Route of Administration


Dosage Form(s)

This monograph excludes foods or food-like dosage forms as indicated in the Compendium of Monographs Guidance Document.

Acceptable dosage forms for any age category listed in this monograph for the specified route of administration are listed in the Compendium of Monographs Guidance Document.

Use(s) or Purpose(s)

Used in Herbal Medicine to help relieve the urologic symptoms (e.g. weak urine flow/incomplete voiding/frequent daytime/night time urination) associated with mild to moderate benign prostatic hyperplasia (BPH) (Croom and Chan 2010; USP 32 2009; Bradley 2006; Wilt et al. 2002; Blumenthal et al. 2000).



Adult males 18 years and older


Methods of preparation: Standardized extracts (Dry extract, Tincture, Fluid extract, Decoction, Infusion)
100 - 400 milligrams of liposterolic extract of dried fruit standardized to 70 - 95 % fatty acids, per day (Croom and Chan 2010; derMarderosian and Beutler 2009; USP 32 2009).

Direction(s) for use

Take with food to minimize gastric disturbance (derMarderosian and Beutler 2009; USP 32 2009).

Duration(s) of Use

No statement required.

Risk Information

Caution(s) and warning(s)


No statement required.

Known adverse reaction(s)

No statement required.

Non-medicinal ingredients

Must be chosen from the current Natural Health Products Ingredients Database (NHPID) and must meet the limitations outlined in the database.

Storage conditions

Store in a tightly closed, light-resistant container in a cool, dry place (USP 32 2009; WHO 2002).


References Cited

References Reviewed