Monograph: Saw Palmetto

Help on accessing alternative formats, such as Portable document format (PDF), Microsoft word and PowerPoint (PPT) files, can be obtained in the alternate format help section.

This monograph is intended to serve as a guide to industry for the preparation of Product Licence Applications (PLA) and label for natural health product market authorization. It is not intended to be a comprehensive review of the medicinal ingredient. It is a referenced document to be used as a labelling standard. Note: Text in parentheses is additional optional information which can be included on the PLA and product labels at the applicant's discretion. The solidus (/) indicates that the terms are synonyms or that the statements are synonymous. Either term or statement may be selected by the applicant.
Date: 2018-09-25

NHPID name

Serenoa repens ( Germplasm Resources Information Network Taxonomy )

Proper name(s)

Serenoa repens ( USDA 1997 )

Common name(s)

Source material

Fruit ( Blumenthal et al. 2000 , Mills and Bone 2000 , USP 32 )

Route Of administration


Dosage form(s)

Those suited to the allowable route(s) of administration. This monograph is not intended to include food-like dosage forms such as bars, chewing gums or beverages.

Use(s) or purpose(s)

Statement(s) to the effect of:

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).




1 Day per day

Directions for use: Take with food to minimize gastric disturbance.

See Appendix 1 for examples of appropriate dosage preparations and frequencies of use, according to cited references. The purpose of Appendix 1 is to provide guidance to industry.

Duration of use

No statement is required

Risk information

Statement(s) to the effect of:

Caution(s) and Warning(s): Contraindication(s): No statement is required Known Adverse Reaction(s): No statement is required

Non-medicinal ingredients

Must be chosen from the current Natural health products ingredients database 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, WHO 2002).


References cited

References reviewed

Appendix 1: Examples of dosage preparations and frequencies of use taken verbatim from the cited references

Dried berry:


Fluid extract: