Good Label and Package Practices Guide for Non-prescription Drugs and Natural Health Products

From [Marketed Health Products Directorate, Health Products and Foods Branch and Institute for Safe Medication Practices Canada]

Overview

This best practices guide provides direction to industry on the design of safe and clear health product labels. It applies to the following products:

• Non-prescription drugs
• Natural health products

In this guide

• 1 Overview of the Guide
  • 1.1 Objective
  • 1.2 Introduction
  • 1.3 Scope
  • 1.4 Content contributing to guide development
• 2 Designing Labels and Packages for Safety
  • 2.1 Introduction
  • 2.2 Planning the design of labels and packages
  • 2.3 Design and layout
    • 2.3.1 Type style and size
    • 2.3.2 Proximity and compatibility of information on the principal display panel
    • 2.3.3 White space
    • 2.3.4 Colour and contrast
    • 2.3.5 Use of abbreviations, symbols, and dose designations
    • 2.3.6 Bilingual labelling
    • 2.3.7 Logo, branding, and trade dress
    • 2.3.8 Permanence
  • 2.4 Label information
    • 2.4.1 Key elements on the principal display panel
    • 2.4.2 Expression of strength
    • 2.4.3 Warnings
    • 2.4.4 Expiry date
    • 2.4.5 Lot or batch number
    • 2.4.6 Automated identification (e.g., bar coding)
  • 2.5 Packaging
    • 2.5.1 General packaging considerations
    • 2.5.2 Small containers and small-volume containers
    • 2.5.3 Pediatric products
    • 2.5.4 Blister packaging
    • 2.5.5 Transdermal patches
• 3 Drug Facts Table for Non-prescription Drugs and Product Facts Table for Natural Health Products
• Appendix 1 - Glossary
• Appendix 2 - Human Factors Principles and Assessment Methods Relevant to Labelling and Packaging
• Appendix 3 - Product-Use Process Maps
• Appendix 4 - Acknowledgements
• References

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Details and history

Published: June 30, 2016

Updated: September 28, 2018

Consulted: March 2015

Part of topic(s): Plain language labelling regulations, Labelling of nonprescription drugs and natural health products for human use