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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.



November 25, 2022

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

Table 1. Proper name(s), Common name(s), Source information
Proper name(s) Common name(s)
Source information
Source material(s) Part(s)

Stem bromelain

  • Bromelain
  • Pinneapple stem bromelain
  • Stem bromelain
  • Ananas comosus var. bracteatus
  • Ananas comosus var. comosus


References: Proper name: IUBMB 1992; Common names: IUBMB 1992; Source information: USDA 2011.

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 oral use are indicated in the dosage form drop-down list of the web-based Product Licence Application form for Compendial applications.

Use(s) or Purpose(s)



Adults 18 years and older


Minor pain, swelling and inflammation relief

Digestive enzyme


Direction(s) for use

Digestive enzyme (optional for minor pain, swelling and inflammation relief)

Take with food/meal.

Duration(s) of Use

Products providing up to 20,000,000 FCC PU of enzymatic activity per day

Consult a health care practitioner/health care provider/health care professional/doctor/physician for prolonged use.

Products providing more than 20,000,000 FCC PU of enzymatic activity per day

For occasional use only.

Risk Information

Caution(s) and warning(s)


No statement required.

Known adverse reaction(s)

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

Must be established in accordance with the requirements described in the Natural Health Products Regulations (NHPR).


References Cited

References Reviewed