Guidance document: Non-prescription Oral Stool Softener Laxatives Labelling Standard

Date Adopted: 2015/07/09
Effective Date: 2015/07/31

Notice

Our file number: 15-103676-125

Regulatory Cooperation Initiative (RCI) Over-the-Counter (OTC) Products
Proposed Draft Monographs for Comment

Health Canada and the Australian Therapeutic Goods Administration (TGA) continue to work under the Regulatory Cooperation Initiative (RCI) project to explore various ways of work sharing between the two regulatory agencies. Two labelling standards have been developed (Non-prescription Oral Adult Antitussive Cough and Cold and Non-prescription Oral Stool Softener Laxatives) because they meet the goals of aligning the ongoing work of both regulators and reducing unnecessary differences.

The proposed Non-prescription Oral Stool Softener Laxatives Labelling Standard describes the requirements necessary to receive marketing authorization for non-prescription oral stool softener laxative products containing docusate sodium or docusate calcium as a single ingredient for use in adults and children 6 years of age and older for use as a stool softening laxative to relieve occasional constipation.

The proposed Non-prescription Oral Adult Antitussive Cough and Cold Labelling Standard describes the requirements necessary to receive marketing authorization for oral antitussive non-prescription products containing dextromethorphan or dextromethorphan hydrobromide as a single ingredient for use in adults to relieve dry cough due to cold.

This initiative is one step in the ongoing collaboration between Health Canada and the TGA to work toward greater regulatory convergence and harmonization where feasible. Both regulators will continue to explore if there may be additional opportunities for future OTC monograph initiatives.

Foreword

Guidance documents are meant to provide assistance to industry and health care professionals on how to comply with governing statutes and regulations. Guidance documents also provide assistance to staff on how Health Canada mandates and objectives should be implemented in a manner that is fair, consistent and effective.

Guidance documents are administrative instruments not having force of law and, as such, allow for flexibility in approach. Alternate approaches to the principles and practices described in this document may be acceptable provided they are supported by adequate justification. Such approaches should be discussed in advance with the relevant program area to avoid the possible finding that applicable statutory or regulatory requirements have not been met.

As a corollary to the above, it is equally important to note that Health Canada reserves the right to request information or material, or define conditions not specifically described in this document, in order to allow the Department to adequately assess the safety, efficacy or quality of a therapeutic product. Health Canada is committed to ensuring that such requests are justifiable and that decisions are clearly documented.

This document should be read in conjunction with the accompanying notice and the relevant sections of other applicable guidance documents.

Table of Contents

1. Introduction

This labelling standard describes the requirements necessary to receive market authorization (a Drug Identification Number (DIN)) for oral stool softener laxative non-prescription products containing docusate sodium or docusate calcium as a single ingredient for use in adults and children 6 years of age and older to relieve occasional constipation. This labelling standard does not apply to products for use by children under 6 years of age.

2. Medicinal ingredient

Table 1: Drug medicinal ingredient
Therapeutic Class Medicinal Ingredient
Preferred Name
Laxative Docusate Sodium
Docusate Calcium

3. Pharmaceutical forms

3.1 Acceptable:

3.2 Unacceptable:

4. Uses

4.1 Acceptable Indications

Laxative / stool softener

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:

5. Dosage directions

5.1 Dosage for Adults and children 12 years of age and older

Table 2
Therapeutic Class Medicinal ingredient
preferred name
Recommended Single Dose Dose Interval Maximum Daily Dose
Laxative Docusate Sodium 50-240 mg 1 or 2 per day 480 mg
Docusate Calcium 50-240 mg 1 or 2 per day 480 mg

5.2 Dosage for Children 6 to 11 years of age

Table 3
Therapeutic Class Medicinal ingredient
preferred name
Recommended Single Dose Dose Interval Maximum Daily Dose
Laxative Docusate Sodium 50-150 mg 1 or 2 per day 150 mg

5.3 Dosing Considerations

  1. Drink increased fluids (one full glass or more).
  2. This product generally produces bowel movement in one (1) to three (3) days.
  3. The quantitative declaration of the medicinal ingredients on any panel of the inner and outer labels should be prominently displayed and should be further identified by the therapeutic class or indication listed under Section 4.1, e.g.: "Active Ingredient: Docusate Sodium (laxative) 100 mg"; "Active Ingredient: Docusate Sodium (relief of occasional constipation) 100 mg".
  4. The labels should declare the recommended single and maximum daily dose, as well as the dosing interval for the product. Maximum daily dose may be expressed in terms of dosage units (e.g. do not take more than X tablets per day).
  5. For liquid formulations, the following statement should be included with the directions for use: "Use only the measuring device provided."

5.4 Combinations

Applicants should apply outside of the labelling standard if they wish to combine docusate sodium with other medicinal ingredients.

6. Warnings

For outer and inner labels

Ask a doctor or pharmacist before use if:

Stop use and ask a doctor if:

If pregnant or breast-feeding, ask a healthcare professional before use.

7. Product facts table: recommended (not mandatory)Product facts table footnote 1

Product Facts

Active ingredient (in each dosage unit)
Docusate Sodium XX mg.

Purpose
Laxative / stool softener

Uses

Warnings

Do not use

Ask a doctor or pharmacist before use if you are allergic to docusate sodium/calcium or any other ingredient in this product.

Stop use and ask a doctor if

If any of the above noted symptoms occur, stop use and seek medical help right away.

If pregnant or breast-feeding, ask a healthcare professional before use.
Overdose warning: In case of overdose, call a Poison Control Centre or a healthcare professional immediately even if you do not notice any signs or symptoms.

Directions Do not take more than directed
Adults and children 12 years and over

Other information

Inactive ingredients <List all NMIs>

Questions? Concerns? Call 1-877-XXX-XXXX

8. Other labelling requirements

For all products:

Legibility:

Although no specific type size is mentioned in the Food and Drug Regulations, Section A.01.016 specifies that all information required to appear on a label must be:

A person with normal vision, or those with corrective glasses that restore normal vision, should be able to read the information without straining. The colour, contrast, position, and spacing of the information are all to be taken into consideration in complying with these requirements.

9. Specifications

This labelling standard describes those requirements that are specific to this class of drug.

10. Non-medicinal ingredients

Non-medicinal ingredients must be chosen from the current Natural Health Products Ingredients Database (NHPID) and must meet the limitations outlined in that database, the Food and Drug Regulations (FDR), and/or the Herbs Used as Non-medicinal Ingredients in Nonprescription Drugs for Human Use, when relevant.

11. References

  1. Guidance Document: Labelling of Pharmaceutical Drugs for Human Use. Health Canada, January 10, 2014.
  2. Guidance for Industry: Impurities in Existing Drug Substances and Products. Health Canada, September 2005.
  3. Guidance to Industry: Product Monograph. Health Canada, October 2004.
  4. Herbs Used as Non-Medicinal Ingredients in Nonprescription Drugs for Human Use. Health Canada, September 1995.
  5. United States Food and Drug Administration: Laxative Drug Products For Over-The-Counter Human Use; Code of Federal Regulations Part 334, Volume 58, No. 169, Thursday, September 2, 1993.
    http://www.fda.gov/Drugs/DevelopmentApprovalProcess/DevelopmentResources/Over-the-CounterOTCDrugs/StatusofOTCRulemakings/ucm071835.htm

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