Industry requirements for non-prescription drug labels
Companies producing and selling non-prescription drugs are responsible for ensuring that the labels on their products help Canadians make informed decisions.
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About the Canadian Drug Facts Table
A health product's label and package is where consumers find key information about the safe and proper use of the product. The ability to identify, select and administer a product safely is dependent on consumers being able to read and understand the information on the label.
Canada has updated its regulations and requirements for non-prescription drug labels to make them easy-to-read and understand, and to standardize the information. Companies producing and selling these products must make sure the labels of products available on store shelves meet the Plain Language Labelling (PLL) Requirements for non-prescription drugs by June 30, 2021.
The requirements include a standardized Canadian Drug Facts Table (CDFT). The CDFT must show specific information on the labels so the consumer can see and use it when they buy the product. This information helps to ensure Canadians select the best medications for their needs.
To establish a standard and predictable table for all non-prescription drugs, the CDFT requires specific formatting. It must:
- have common headings
- follow defined fonts and font sizes
- use active voice and direct action words such as “ask,” “stop,” keep”
These changes aim to:
- help Canadians find information quickly and easily
- increase legibility of the information; and
- help reduce confusion
The Canadian Drug Facts Table
Figure 1.
Figure 1 - Text Description
A unilingual sample of a Canadian drug facts table that shows formatting specifications.
There are 2 panels, one with the title Drug Facts and one with the title Drug Facts (continued).
The headings in the table are, in order: Active ingredient (in each tablet), Purpose, Uses, Warnings, Directions, Other information, Inactive ingredients, and Questions with a question mark. All headings are bolded and start with a capital letter.
Under the heading Warnings, there are subheadings: Allergy alert, Do not use, Ask a doctor or pharmacist before use if you, When using this product, Stop use and ask a doctor if, and Keep out of the reach of children. Headings are separated from each other by a horizontal heavy line, and subheadings in the warnings section are separated by horizontal hairlines. Each heading or subheading starts on a new line.
There is mock text after each heading and subheading, in short sentences or bullet points, except in the directions section which is presented in the form of an embedded table.
Dotted lines are used to point out important design elements in the table.
Canadian Drug Facts Table flexibilities
Centralizing all of the important product information in the CDFT may be challenging, given the various sizes and formats existing for non-prescription drugs. For this reason, Health Canada has consulted extensively with a wide variety of stakeholders to establish a set of graduated flexibilities to ensure compliance with these provisions. These flexibilities allow companies to make changes to the CDFT to reduce the space needed to display the information clearly and accurately, while respecting the objectives of PLL.
Flexibilities are applied in a consecutive basis. The requirements of each level must be met before moving on to the next level.
Standard Canadian Drug Facts Table
Figure 2.
Figure 2 - Text Description
A bilingual sample of a Canadian Drug Facts Table (CDFT) for the active ingredient Dimenhydrinate is shown, with no formatting flexibilities used (i.e. the standard format is shown).
Level 1
Level 1 Allows the formatting specifications of the CDFT to be altered or certain information to be moved from the CDFT to the main display panel of the product.
Figure 3.
Figure 3 - Text Description
A bilingual sample of a Canadian Drug Facts Table (CDFT) that shows the application of formatting flexibilities.
This CDFT shows the application of Level 1 flexibilities: the Uses section of the CDFT has been moved to a Principal Display Panel; hairlines from Warnings section have been removed; the weight of rules has been reduced to 1.0 point; the text in the Warnings section begins immediately following Warnings heading.
The header identifies other Level 1 flexibilities not shown in the figure, including: removal pf the Drug Facts (continued) heading; and use of a continuous box frame.
Level 2
Level 2 Allows an approved alternative condensed font on the CDFT
Figure 4.
Figure 4 - Text Description
A bilingual sample of a Canadian Drug Facts Table (CDFT) that shows the application of formatting flexibilities. This CDFT shows the application of Level 2 flexibilities: application of a condensed font, and horizontal scaling of text to 90% of the original width.
Level 3
Level 3 Allows information related to the proper storage of the product to be moved outside of the CDFT and elsewhere on the label. Non-medicinal ingredients may also be moved elsewhere on the label.
Figure 5.
Figure 5 - Text Description
A bilingual sample of a Canadian Drug Facts Table (CDFT) that shows the application of formatting flexibilities. This CDFT shows the application of Level 3 flexibilities: the storage information is moved from the CDFT to elsewhere on the outer label; and the list of inactive ingredients is moved from the CDFT to elsewhere on the outer label.
Level 4
Level 4 Allows select warning statements to be moved to a package insert or leaflet included with the product. In this case, warnings that are more important are moved from the label onto a package insert or leaftlet.
Figure 6.
Figure 6 - Text Description
A bilingual sample of a Canadian Drug Facts Table (CDFT) that shows the application of formatting flexibilities. This CDFT shows the application of Level 4 flexibilities: select point-of-use warning information is moved from the CDFT to a package insert.
To understand how and when to use these flexibilities, refer to the comprehensive Guidance Document: Labelling Requirements for Non-prescription Drugs.
Category IV Products
More flexibilities are available for products which pose lower health risks to Canadians. These include Category IV Products, mouthwashes and toothpastes. For these particular products, formatting flexibilities described in Level 1 and 2 apply, along with the option to move some information to a package insert or a URL. The CDFT will look similar to the following:
Figure 7.
Figure 7 - Text Description
A bilingual sample of a Canadian Drug Facts Table (CDFT) that shows the application of formatting flexibilities specific to products attesting to a Category IV monograph, toothpastes, and mouthwashes. The CDFT title, Drug Facts / Info-médicament, is listed at the top of the CDFT. Directly underneath the title, a prompt to consumers is included which provides a web address where consumers can find additional information (i.e. a complete CDF without the use of flexibilities).
The sample CDFT shows the application of tailored flexibilities for Category IV products, toothpastes, and mouthwashes, including: the Uses section of the CDFT has been moved to a Principal Display Panel; hairlines from Warnings section have been removed; the weight of rules has been reduced to 1.0 point; the text in the Warnings section begins immediately following Warnings heading: application of a condensed font; the list of inactive ingredients is moved from the CDFT to the bottom panel of the carton; and select point-of-use warning information is moved from the CDFT to a website. The fold line separates one panel of the carton from the other.
Self-Care Framework
We are moving toward a new regulatory framework for self-care products. Under the Self-Care Framework, sponsors will be able to label lowest risk health products without the use of a table format. For products that fall under Category I of the Self-Care Framework, sponsors will be able to adopt a format that resembles the following:
Figure 8.
Figure 8 - Text Description
A bilingual sample of a Canadian Drug Facts Table (CDFT) that shows the application of formatting flexibilities specific to low-risk products that fall in Category I of the Self-Care Framework. The sample CDFT shows the application of flexibilities for Category I products in the Self-Care Framework, including:
The CDFT title, Drug Facts / Info-médicament, is removed; the rules, hairlines, and box frame are removed; the purpose of the active ingredients is removed; the Uses section of the CDFT is moved to the Principal Display Panel; the text begins immediately following the CDFT headings; the sequence of information is altered when compared to the standard CDFT format; the list of inactive ingredients is moved from the CDFT to a website with a prompt for consumers on where to find the inactive ingredients list; and select point-of-use warning information is moved from the CDFT to a website. The fold line separates one panel of the carton from the other.
These flexibilities will be available as of December 1st, 2018, as outlined in the Guidance Document: Labelling Requirements for Non-prescription Drugs.
More Information
Detailed information on labelling non-prescription drugs can be found in the Guidance Document: Labelling Requirements for Non-prescription Drugs.
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