Monograph: Flaxseed

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This monograph is intended to serve as a guide to industry for the preparation of Product Licence Applications (PLA) and labels 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 label 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

Linum usitatissimum ( Germplasm Resources Information Network Taxonomy )

Proper name(s)

Linum usitatissimum ( USDA 2004 )

Common name(s)

Source material

Seed ( Blumenthal et al. 2000 )

Route Of administration


Dosage form(s)

Use(s) or purpose(s)

Statement(s) to the effect of:




1 Day per day

Directions for use:
  • Effects observed 12-24 hours after first dose, and may take 2-3 days.
  • For products providing doses that are ≥ 5 g per day, the following statement is required: For each dose, drink (or mix with) at least 150 ml of liquid. ( EMEA 2006 , ESCOP 2003 )
  • Minimum daily dose may be increased, up to the maximum daily dose, until desired effect is obtained.
  • For products providing doses that are ≥ 5 g per day, the following statement is required: Take 2 hours before or after taking other medications. ( Sweetman 2007 )
  • null;promote(s) bowel movement;constipation and/or irregularity: Take during the day (not immediately prior to bedtime). ( EMEA 2006 , ESCOP 2003 )

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):

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


References cited

References reviewed

Appendix 1: Examples of appropriate dosage preparations, frequencies of use and directions for use