Guidance document: Non-prescription Oral Adult Cough, Cold and Flu Labelling Standard

(PDF Version - 237 kb)

Published by authority of the Minister of Health

Date Adopted: February 4, 2025
Effective Date: April 1, 2025

Health Products and Food Branch

Our mission is to help the people of Canada maintain and improve their health.

The Health Products and Food Branch's mandate is to manage the health-related risks and benefits of health products and food by:

• minimizing health risk factors to Canadians while maximizing the safety provided by the regulatory system for health products and food; and,
• providing information to Canadians so that they can make healthy, informed decisions about their health.

Health Products and Food Branch

^©Minister of Public Works and Government Services Canada 2025

Également disponible en français sous le titre : Ligne directrice
Norme d'étiquetage des médicaments oraux en vente libre pour adultes contre la toux, le rhume et la grippe

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. 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.

Table of contents

• 1. Introduction
• 2. Medicinal ingredients
  • 2.1 Cough and cold medicinal ingredients
  • 2.2 Complementary ingredients
• 3. Combinations
  • 3.1 Acceptable combinations
  • 3.2 Unacceptable combinations
• 4. Dosage forms
• 5. Indications
  • 5.1 Acceptable indications
  • 5.2 Unacceptable indications
• 6. Dosage directions
  • 6.1 Dosage for adults and children 12 years and older
  • 6.2 Dosing considerations
• 7. Warnings
  • 7.1 For outer and inner labels of all products
  • 7.2 For products containing acetaminophen
  • 7.3 For products containing an antihistamine
  • 7.4 For products containing an antitussive
  • 7.5 For products containing a decongestant
  • 7.6 For products containing an expectorant
• 8. Other labelling requirements
• 9. Specifications
• 10. Non-medicinal ingredients
• 11. Special notes
• 12. References

1. Introduction

This labelling standard describes the requirements necessary to receive marketing authorization (a DIN) for single and multiple-ingredient orally administered nonprescription products for use in adults and children 12 years of age and older to provide relief of symptoms associated with the common cold and flu. This labelling standard does not apply to products for use by children under 12 years of age. Further, 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.

This document contains information based on research, evidence and market experience that may be dated. In some cases, the information presented herein have not been reviewed against more recent scientific developments and findings. Readers should consider this context when interpreting the information, recognizing that advancements in knowledge may have occurred since the supporting information for this document was produced.

2. Medicinal ingredients

2.1 Cough and Cold Medicinal Ingredients^{Footnote 1}

The medicinal ingredients of a product complying with this labelling standard consist of the following ingredients when used singly or in acceptable combinations^{Footnote 2} within the established limits specified below.

2.2 Complementary Ingredients

Cough and cold products authorized using this labelling standard may include acetaminophen in combination, provided the combination of medicinal ingredients is acceptable as per Section 3.1.

Any acetaminophen-containing product using this labelling standard for market authorization must meet all conditions and labelling requirements within the Revised Guidance Document: Acetaminophen Labelling Standard (September 15, 2016).

Note:
This labelling standard does not apply to single ingredient acetaminophen products. Therefore, sponsors who intend to market single ingredient acetaminophen products in Canada should refer to the Revised Guidance Document: Acetaminophen Labelling Standard (September 15, 2016).

3. Combinations

3.1 Acceptable Combinations^{Footnote 4}

Only one ingredient per therapeutic class may be used in any combination with the limitations specified below.

1. An antihistamine may be combined with a decongestant
2. An antihistamine, except for diphenhydramine hydrochloride or citrate, may be combined with an antitussive, except for diphenhydramine hydrochloride or citrate
3. An antihistamine, except for diphenhydramine hydrochloride or citrate, may be combined with an antitussive, except for diphenhydramine hydrochloride or citrate, and a decongestant
4. An antitussive may be combined with a decongestant
5. An expectorant may be combined with a decongestant
6. Any single ingredient from Table 1 or Table 2 may be combined with acetaminophen
7. Any acceptable combination identified in (a) through (e) of this section may be combined with acetaminophen

3.2 Unacceptable Combinations

• Any antihistamine active ingredient in combination with an expectorant active ingredient
• Any antitussive active ingredient in combination with an expectorant active ingredient
• A combination of diphenhydramine hydrochloride or citrate with another antihistamine or antitussive
• Combinations with:
  • two or more ingredients from the same therapeutic class
  • ingredients from different therapeutic classes if any ingredient is present at less than the minimum effective dose
  • an ingredient specifically intended to counteract a side effect of another ingredient in the product

4. Dosage forms

The acceptable dosage forms are as follows:

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

Unacceptable dosage forms are as follows:

• 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 the European Directorate for the Quality of Medicines (EDQM) Certificate of Suitability, or equivalent document, is not available.
• Novel dosage forms (e.g., chewable liquid filled gelatine capsule, powder dosage form intended for direct application to the mouth, multiple ingredient thin strips, lollipops, popsicles/freezer pops).

5. Indications

5.1 Acceptable Indications

Note:

The solidus (/) indicates that the terms and/or the statements are synonymous. Either term or statement may be selected by the applicant. Text in parentheses is additional optional information which can be included on the REP - Product Information Template and label at the applicant's discretion.

At least one of the following claims must appear for products containing an antihistamine:

• Temporarily relieves cold /(and) flu symptoms:
  • runny nose / sniffles
  • sneezing

At least one of the following claims must appear for products containing an antitussive:

• Temporarily relieves cold /(and) flu symptoms:
  • dry cough (due to minor bronchial irritation)
  • minor throat and bronchial irritation

At least one of the following claims must appear for products containing a decongestant:

• Temporarily relieves cold /(and) flu symptoms:
  • nasal congestion
  • stuffy nose / stuffiness

At least one of the following claims must appear for products containing an expectorant

• Temporarily relieves cold /(and) flu symptoms:
  • wet cough / wet chest cough
  • chest congestion
• Helps loosen phlegm/mucus (and) (thin lung secretions) (make coughs more productive)
• Helps thin mucus/bronchial secretions

At least one of the following claims must appear for products containing acetaminophen:

• Temporarily relieves cold /(and) flu symptoms:
  • (reduces) fever
  • chills
  • headache
  • (minor [to moderate]) aches and pains
  • sore throat pain

For all products, a statement indicating the therapeutic class of each ingredient, as described in Tables 1, 2 and 3, may be made.

5.2 Unacceptable Indications

The following indications are excluded and would require a review outside of this labelling standard. These include but are not limited to:

• Relief of nasal symptoms other than runny nose and sneezing (for antihistamine)
• Alleviates nasal congestion (for antihistamine)
• Treats lower respiratory tract conditions (including infections and asthma)
• Persistent or chronic cough due to smoking, emphysema or asthma
• Allergy/hay fever symptoms (for antitussives and expectorants)
• Bronchitis
• Sinusitis
• Promotes sinus drainage
• Coughs due to allergies or inhaled irritants (for antitussives and expectorants)
• Chest coughs not associated with common cold and flu (for antitussives and expectorants)
• Relief of wet cough (for antitussives)

6. Dosage directions

Products authorized using this labelling standard shall provide dosing for Adults and children 12 years and older, as follows:

6.1 Dosage for Adults and children 12 years and older^{Footnote 5}

When acetaminophen is included in combination, dosing shall be provided for Adults and children 12 years and older, as follows:

Note:
This labelling standard does not apply to products that recommend dosages in excess of 650 mg acetaminophen per single dose.

6.2 Dosing Considerations

1. The intended subpopulation in the directions for use shall be Adults and children 12 years and older.

2. The quantitative declaration of the medicinal ingredients on any panel of the inner label and Canadian Drug Facts Table (CDFT) of the outer label should be prominently displayed and should be further identified by the therapeutic class,

   e.g.:

   Active ingredient (in each 30 mL/tablet/etc.)	Purpose
   Guaifenesin 200 mg	Expectorant

3. 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/ X mL in 24 hours).
4. For liquid formulations, it is strongly recommended that a dosing device be provided, and the following statement should be included with the directions for use if a device is included: Use only the measuring device provided. Accurate dosing is a critical component in achieving optimal therapeutic outcomes and minimizing the risk of adverse effects. To this end, Health Canada strongly encourages all drug manufacturers to include a dosing device with their products. The inclusion of dosing devices, such as measuring cups, offers several significant benefits, including accurate and consistent doses, ease of use, and enhanced patient safety. It further aligns with best practices and regulatory recommendations, demonstrating a commitment to patient safety.

7. Warnings

7.1 For outer and inner labels of all products

Do not use

• if you are allergic to any of the ingredients

Ask a doctor of pharmacist before use if you

• are pregnant or breastfeeding
• take any other cough and cold medications or prescription drugs

Stop use and ask a doctor if

• new symptoms appear or existing symptoms worsen
• symptoms last for more than a week
• symptoms are accompanied by a high fever that lasts longer than 3 days, the production of thick yellow/green phlegm, rash or a persistent headache
• sore throat pain lasts more than 2 days [required if sore throat pain claim is made]

Keep out of reach of children. In case of overdose, call a Poison Control Centre or get medical help right away.

7.2 For products containing acetaminophen

The warnings shall follow the Revised Guidance Document: Acetaminophen Labelling Standard (September 15, 2016).

7.3 For products containing an antihistamine

For products containing diphenhydramine hydrochloride or citrate:

Do not use

• with any other product containing diphenhydramine, even one used on skin

For all antihistamines:

Ask a doctor or pharmacist before use if you

• have
  • glaucoma
  • breathing problems or chronic lung disease
  • difficulty with urination
• take sedatives or tranquilizers

When using this product

• drowsiness may occur. Do not drive or engage in activities requiring alertness
• alcohol, sedatives and tranquilizers may increase drowsiness
• avoid alcoholic drinks
• excitability may occur

7.4 For products containing an antitussive

For products containing diphenhydramine hydrochloride or citrate:

All statements under section 7.3, as they are required for oral antihistamine

For all antitussives:

Do not use

• with a monoamine oxidase inhibitor (MAOI) (drugs for depression or Parkinson's disease) or for two (2) weeks after stopping the MAOI drug

Ask a doctor or pharmacist before use if you

• have a persistent cough, breathing problems or chronic lung disease, as these could be signs of a serious condition
• have a cough with excessive phlegm (mucus)

7.5 For products containing a decongestant

Do not use

• with a monoamine oxidase inhibitor (MAOI) (drugs for depression or Parkinson's disease) or for two (2) weeks after stopping the MAOI drug

Ask a doctor or pharmacist before use if you

• have
  • asthma, diabetes, glaucoma, heart disease, thyroid disease, kidney disease, seizure disorders
  • high blood pressure
  • difficulty urinating
  • any other serious medical condition
• are taking
  • medication for weight control
  • products which contain caffeine or ephedrine

Stop use and ask a doctor if you

• have
  • difficulty or pain when urinating
  • severe headache
  • confusion
  • visual changes / changes in vision
• are
  • nervous
  • dizzy
• can't sleep

7.6 For products containing an expectorant

Ask a doctor or pharmacist before use if you

• have
  • a persistent (or chronic) cough
  • breathing problems or chronic lung disease

8. Other labelling requirements

All acetaminophen containing products intended for use in Adults and children 12 years of age and older shall provide at least one package size in a child resistant container, and the outer label of all package sizes that are not child resistant shall carry a statement that the drug is also available in a child resistant package. (Section C.01.031(a)(ii),(b) of the Food and Drug Regulations)

All other labelling requirements for drugs, including the 2014 Regulations Amending the Food and Drug Regulations (Labelling, Packaging and Brand Names of Drugs for Human Use), commonly referred to as the Plain Language Labelling Regulations for Non-Prescription Drugs, must be met. Applicants are encouraged to consult the Guidance document: Labelling of Pharmaceutical Drugs for Human Use, Guidance document: Labelling Requirements for Non-prescription Drugs and Guidance document: Questions and Answers: Plain Language Labelling Regulations for Non-prescription Drugs.

9. Specifications

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

Products must comply with the requirements in the Food and Drugs Act and associated Regulations. It is also noted that all drug 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), as well as tests to ensure purity of medicinal ingredients and the drug product, that includes testing for elemental impurities, residual solvents and nitrosamines, as applicable. 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., tablet hardness, dissolution, disintegration and friability), 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.

10. Non-medicinal ingredients

Ingredients should be chosen from the current Natural Health Products Ingredients Database (NHPID) and should meet the limitations outlined in that database, the Food and Drug Regulations, and the current Cosmetic Ingredient Hotlist, when relevant.

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, Herbs Used as Non-Medicinal Ingredients in Nonprescription Drugs for Human Use (1995).

11. Special notes

Sponsors are requested to take note of the following combinations of cough and cold products since additional data could be required in support of the appropriate use of such a proposed product. Health Canada could also require that an application/submission outside of the labelling standard be submitted. When applicable, a review outside of the labelling standard would be appropriate as noted below. Please note that if the conditions of Section C.08.001 of the Food and Drug Regulations are met, a New Drug Submission will be required.

• Combinations of cough and cold products that include an analgesic/antipyretic other than acetaminophen.
• Combinations that contain codeine, codeine phosphate and codeine sulphate. Codeine should not be administered to children under 18 years of age except on the advice of a health care professional. Section 36 of the Narcotic Control Regulations should be consulted for the conditions of acceptability of codeine in non-prescription medications. For such a proposed product, an application / submission outside of the labelling standard may be submitted.
• Combinations with an active ingredient regulated as a natural health product other than pseudoephedrine (e.g. vitamins, echinacea, menthol, camphor, caffeine, eucalyptus). Should a sponsor have sufficient supporting data for the appropriate use of such a proposed product, an application / submission outside of the labelling standard may be submitted.
• Combinations of ingredients in a dosage form identified as unacceptable for submission under this labelling standard as per Section 4 (e.g. modified dose release and novel dosage forms). Should a sponsor have sufficient supporting data for the appropriate use of such a proposed product, an application / submission outside of the labelling standard may be submitted.

12. References

• Health Canada: Guidance Document - Non-prescription Oral Adult Antitussive Cough and Cold Labelling Standard 2015/07/31
• Health Canada: Revised Guidance Document: Acetaminophen Labelling Standard. September 15, 2016
• Health Canada: Guidance Document: Nonprescription Oral Paediatric Cough and Cold Labelling Standard. February 6, 2009
• Health Canada: Guidance Document - Nonprescription oral adult expectorant cough and cold labelling standard. 2014/05/30
• United States Food and Drug Administration: Proposes Ending Use of Oral Phenylephrine as OTC Monograph Nasal Decongestant Active Ingredient After Extensive. Review November 07, 2024
• U.S. Food and Drug Administration Final Administrative Order for Over-the-Counter Monograph M012: Cold, Cough, Allergy, Bronchodilator, and Antiasthmatic Drug Products for Over-the Counter Human Use (Posted October 14, 2022)