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:

  • Immediate release solid oral dosage forms such as tablets, caplets, capsules, or chewable tablets.
  • Oral liquid formulations, such as solution, suspension, or syrup.

3.2 Unacceptable:

  • Modified dose release (e.g. liquid extended release, solid oral sustained release, bi-layer formulations or enteric coated products).
  • Products that require evaluation of animal sourced ingredients (e.g. animal tissue based gelatin capsules, where a valid European Directorate for the Quality of Medicines (EDQM) Certificate of Suitability or equivalent is not provided).
  • Other dosage forms (e.g. chewable liquid filled capsule, powder dosage form intended for direct application to the mouth, thin strips, lollipops, popsicles/freezer pops, etc.)

4. Uses

4.1 Acceptable Indications

Laxative / stool softener

  • Laxative
  • Relief of occasional constipation
  • Stool softener, 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

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

  • Do not use in the presence of abdominal pain, nausea, fever or vomiting.
  • Do not use with other medicines or if you are presently taking mineral oil.
  • Do not use if you are on a low salt diet (for products containing more than 115 mg sodium in the maximum recommended daily dose).
  • Do not use longer than seven (7) days.
  • Frequent or prolonged use may result in dependence on laxatives.

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:

  • rectal bleeding occurs;
  • symptoms persist or last for more than one (1) week; or you notice a sudden change in bowel habits that persists over a period of two (2) weeks.

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

  • In Case of Overdose: Call a Poison Control Centre or a healthcare professional immediately, even if you do not notice any signs or symptoms.

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

  • Laxative
  • Relief of occasional constipation
  • Stool softener, softens the stools or stool softening laxative

Warnings

  • Frequent or prolonged use may result in dependence on laxatives

Do not use

  • in the presence of abdominal pain, nausea, fever or vomiting
  • with other medicines or if you are presently taking mineral oil
  • if you are on a low salt diet
  • longer than 7 days

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

  • rectal bleeding occur
  • symptoms persist, last for more than 1 week
  • you have noticed a sudden change in bowel habits that persists over a period of 2 weeks.

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

  • Take 1 (tablet/caplet/..) 1 or 2 times a day
  • Do not take more than X tablets per day
  • Drink lots of fluids (one full glass or more)

Other information

  • May take up to 3 days for you to have a bowel movement

Inactive ingredients <List all NMIs>

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

8. Other labelling requirements

For all products:

  • Declaration of ingredients:
    Single ingredient products and/or ones for which a compendial standard exists must:
    • declare the proper name of the finished product on the front panel of all labels, immediately preceding or following the brand name, in a font size not less than ½ the size of the brand name. (C.01.004)
    • All products must declare the active ingredients on the inner and outer labels, and clearly label these as "active" or "medicinal" ingredients. (C.01.004)
    • Non-prescription products must provide a qualitative listing of “non-medicinal” ingredients on the outer label. (C.01.004)
  • Guidance Document - Labelling of Pharmaceutical Drugs for Human Use: This document should be consulted for guidance on how to comply with the applicable labelling requirements.

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:

  • Clearly and prominently displayed; and
  • Readily discernible to the purchaser or consumer under the customary conditions of purchase and use.

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.

  • Products must comply with the requirements in the Food and Drugs Act and associated Regulations. It is also noted that all products are subject to Part C, Division 2 of the Food and Drug Regulations.

    All ingredient (medicinal and non-medicinal) and finished product specifications must meet or exceed the standards described in the publications referred to in Schedule B to the Food and Drugs Act, or equivalent standards.

  • Where no Schedule B monograph exists for the dosage form, specifications should be similar to those of a comparable compendial dosage form. In the absence of a Schedule B standard for any dosage form, testing must be adequate to demonstrate the product's identity, potency, purity and quality.

  • Finished product specifications should include tests for identification and an assay with suitable limits for the medicinal ingredient(s). The specifications for all dosage forms should include a description of the dosage form, including organoleptic properties as well as physico-chemical testing e.g. pH, specific gravity, and viscosity, appropriate to the dosage form. Where antimicrobial preservatives are added, an assay with suitable limits should be included. Antimicrobial preservative effectiveness should be determined in order to establish that the product is capable of resisting microbial contamination.

  • Any change to the manufacturing process that impacts the safety and efficacy of the ingredients, such as the use of novel technology (e.g. nanotechnology), requires supporting data and will be reviewed outside the labelling standard.

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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