Labelling Standard for Docusate Products

Health Canada’s Proposed Labelling Standard for Docusate Products

Health Canada has published a new label standard for docusate calcium and docusate sodium over-the-counter products. This label standard has been developed in association with the Australian authorities (TGA) in an effort to increase regulatory harmonization and alignment between the two regulators.

The proposed Non-prescription Oral Stool Softener Laxatives Labelling Standard describes the requirements necessary to receive approval in Canada for non-prescription oral stool softener laxative products containing docusate as a single ingredient for relief of occasional constipation.

In order to receive approval however, the statements in your label must remain within the allowable ones provided in Health Canada’s proposed labelling standard.

For example, your product use statements must be selected from the list in Section 4.1 below, and not Section 4.2, which lists Unacceptable Uses for the products.

4. Uses
4.1 Acceptable Indications

Relief of occasional constipation
Stool softener or softens the stools or stool softening laxative.

4.2 Unacceptable Indications

The following indications for oral stool softener laxative products are excluded and would require a review outside of the standard. These include but are not limited to:

Regular use
Treatment for obesity
Laxative is “natural” because of its source – this implies that the product or ingredient is a “natural way” to induce a bowel movement
Relieves indigestion, excessive belching, after-meal discomfort, headaches or biliousness

Coming Soon

Look out for more label standard postings in the near future as additional categories of over-the-counter products are planned for review by Health Canada and the Australian authorities.