Guidance Document: Non-prescription Oral Adult Antitussive Cough and Cold Labelling Standard
Our file number: 15- 103675-578
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 two draft labelling standards will be posted for a 60-day external comment period closing June 1, 2015.
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.
Health Products and Food Branch
Published by authority of the Minister of Health
- Effective Date: 2015/XX/XX
Guidance documents are meant to provide assistance to industry and health care professionals on how to comply with governing statutes and regulations. They 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. These alternate approaches to the principles and practices described in this document may be acceptable provided they are supported by adequate justification. Alternate 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 and regulations.
Table of Contents
- Medicinal Ingredient
- Pharmaceutical Forms
- Dosage Directions
- Drug Facts Table: Recommended (not Mandatory)
- Other Labelling Requirements
- Non-medicinal Ingredients
This labelling standard describes the requirements necessary to receive marketing authorization (a Drug Identification Number (DIN)) for oral antitussive non-prescription products containing dextromethorphan or dextromethorphan hydrobromide as a single ingredient for use in adults and children 12 years of age and older to relieve symptoms of common cold. This labelling standard does not apply to products for use by children under 12 years of age.
2. Medicinal Ingredient
|Therapeutic Class||Medicinal Ingredient
3. Pharmaceutical Forms
- Immediate release solid oral dosage forms such as tablets, caplets, capsules, chewable tablets, effervescent tablets, powders, lozenges.
- Oral liquid formulations such as suspension, syrup, elixir.
- 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., liquid filled capsule, powder dosage form intended for direct application to the mouth, thin strips, lollipops, popsicles/freezer pops etc.
4.1 Acceptable Uses
Antitussive / cough suppressant
Temporary relief of dry cough due to:
- minor bronchial irritation occurring with a cold / common cold / inhaled irritants
- minor throat and bronchial irritation occurring with a cold / common cold / inhaled irritants
- cold / common cold / inhaled irritants.
4.2 Unacceptable Uses
The following indications for antitussive products are excluded and would require a review outside of this labelling standard. These include but are not limited to:
- treat lower respiratory tract conditions (including infections and asthma)
- persistent or chronic cough due to smoking, emphysema or asthma
- coughs due to allergies
- allergy/hay fever symptoms
- relief of wet cough
5. Dosage Directions
5.1 Dosage for Adults and children 12 years of age and olderFootnote 5.1
|Therapeutic Class||Medicinal ingredient preferred name||Recommended Single DoseFootnote 5.2||Dose Interval||Maximum Daily Dose|
|Antitussive||Dextromethorphan OR Dextromethorphan hydrobromide||10-20 mg||every 4 hours||120 mg|
|30 mg||every 6-8 hours|
Do not take more than 120 mg of dextromethorphan in 24 hours.
5.2 Dosing Considerations
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.: "Medicinal Ingredient: Dextromethorphan (antitussive) 10mg"; "Medicinal Ingredient: Dextromethorphan (relief of dry cough) 10mg".
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 exceed X tablets per day).
For liquid formulations, the following statement should be included with the directions for use: "Use only the measuring device provided."
Applicants should apply outside of the labelling standard if they wish to combine dextromethorphan or dextromethorphan hydrobromide with other medicinal ingredients.
For outer and inner label
- Do not use with a monoamine oxidase inhibitor (MAOI) (drugs for depression or Parkinson's disease) or for 2 weeks after stopping the MAOI drug.
Ask a doctor before use if you have:
- persistent cough such as occurs with smoking, asthma or emphysema
- cough with excessive phlegm (mucus)
- difficulty breathing or other chronic lung conditions
These could be signs of serious condition.
Ask a doctor or pharmacist before use if you:
- are allergic to dextromethorphan or any other ingredient in this product
Stop use and ask a doctor if:
- symptoms worsen, last for more than 1 week
- fever, rash, or persistent headache develops
- In Case of Overdose: Call a Poison Control Centre or doctor immediately, even if you do not notice any signs or symptoms.
7. Product Facts Table: Recommended (not Mandatory)Footnote 7.3
Medicinal ingredient (in each dosage unit)
Dextromethorphan XX mg
Antitussive / cough suppressant
Uses temporary relief of dry cough due to:
Ask a doctor before use if you have:
Ask a doctor or pharmacist before use if you are allergic to dextromethorphan or any other ingredient in this product
Stop use and ask a doctor if
Overdose warning: In case of overdose, get medical help or call a Poison Control Centre immediately
Non-medicinal ingredients:< List all NMIs>
8. Other Labelling Requirements
Declaration of ingredients for all products:
Section C.01.004 of the Food and Drug Regulations indicates that for single ingredient products and/or products for which a compendial standard exists, the following must be shown on the inner and outer labels:
- the proper name on the principal display panel immediately preceding or following the brand name in a font size not less than 1/2 the size of the brand name
- a quantitative list of the medicinal ingredients by their proper names, or common names if they have no proper names
- a qualitative list of non-medicinal ingredients clearly distinguished from the medicinal ingredients.
Health Canada’s Guidance Document: Labelling of Pharmaceutical Drugs for Human Use should be consulted for applicable labelling requirements
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, the position, and the spacing of the information are all to be taken into consideration in complying with these requirements.
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 of the Food and Drugs Act, or equivalent standards.
Where no Schedule B monograph exists for the finished product’s dosage form, specifications should be similar to those of a comparable compendial dosage form demonstrating 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, 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 and must meet the limitations outlined in that database.
Non-medicinal ingredients must be restricted to those substances, necessary for the formulation of the dosage form. Their concentration must not exceed the minimum required to provide their intended effect. They must be harmless in the amounts used, their presence must not affect the therapeutic efficacy or safety of the medicinal ingredients and they must not interfere with assays and tests for the medicinal ingredients and, if present, antimicrobial preservatives. Sponsors should be aware that ingredients of botanical origin added as non-medicinal ingredients must comply with the Health Canada Policy entitled Herbs Used as Non-Medicinal Ingredients in Non-prescription Drugs for Human Use (1995).
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