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Purpose
This OTC Medicine Monograph outlines the requirements for Australian market authorisation of a cough expectorant containing guaifenesin as a single active ingredient when applied for as an OTC new medicine N2 application. Proposed medicines must comply with all aspects of the monograph relevant to their strength and dosage form to qualify for evaluation as an N2 application.
This monograph should be read in conjunction with the document Requirements for OTC new medicine N2 applications.
Legislation
Therapeutic Goods Order No. 78 - Standard for Tablets and Capsules (29/10/2008)
Therapeutic Goods Order No. 77 - Microbiological Standards for Medicines (22/09/2008)
Therapeutic Goods Order No. 80 - Child-Resistant Packaging Requirements for Medicines (27/08/2008)
Active substances
This monograph only applies to medicines containing guaifenesin (CAS no. 93-14-1).
Dosage forms and strengths
Acceptable dosage forms and strengths are shown in the table below.
| Active substance | Dosage strengths | Dosage forms (Excludes modified release dosage forms) |
|---|---|---|
| Guaifenesin | 200 mg | Capsules Tablets, chewable tablets, effervescent tablets Powder for oral solution |
10 mg/mL, 13.33 mg/mL, and 20 mg/mL | Oral liquid |
Indications
Therapeutic indications for inclusion in the Australian Register of Therapeutic Goods (ARTG)
Expectorant. Provides symptomatic relief from congested chests and coughs due to the common cold.
Label indications
Required label indication is "Temporary relief of chesty cough due to common colds".
The following label indications are also acceptable:
- Expectorant.
- For wet/chesty cough due to common colds.
- Helps loosen phlegm (mucus) due to common colds.
- Temporary relief of chest congestion due to common colds.
- Makes coughs more productive.
- Helps thin bronchial secretions.
Directions for use
Dosages must be as shown in the following table.
| Dosage | Single dose | Dose interval | Maximum daily dose |
|---|---|---|---|
| Adults and children 12 years and over | 200 to 400 mg | Every 4 to 6 hours when necessary | 2400 mg (6 doses in 24 hours) |
| Children 6-11 years (only on the advice of a doctor, pharmacist or nurse practitioner) | 100 to 200 mg | Every 4 to 6 hours when necessary | 1200 mg (6 doses in 24 hours) |
| Do not use in children under 6 years of age. | |||
Additional instruction
The following instruction is also required:
If coughing persists, consult your doctor or pharmacist.
Labels
Labelling must comply with all relevant Australian requirements, as detailed in the document Requirements for OTC new medicine N2 applications, including all required warning statements.
Quality requirements
In addition to the quality requirements outlined in Requirements for OTC new medicine N2 applications, the following specific requirements apply to guaifenesin monograph medicines:
Finished product specifications
In addition to other requirements specified in Requirements for OTC new medicines N2 applications, the finished product specifications must comply, at a minimum, with the relevant set of requirements below.
The requirements below include all relevant BP general monograph/USP General Chapter requirements and TGO 78 requirements. Further references to these are not required.
Reference to the USP monograph below refer to the current monograph at the time of application.
- For capsules, the tests and limits in the USP monograph Guaifenesin Capsules with the addition of:
- Capsule appearance.
- Assay limits 92.5 - 107.5%.
- Guaifenesin β-isomer NMT 1.5%1, any other individual impurity NMT 1.0% and total impurities including guaifenesin β-isomer NMT 3.0%.
- Microbiological quality in compliance with TGO 77.
- For tablets (including chewable and effervescent tablets), the tests and limits in the USP monograph Guaifenesin Tablets with the addition of:
- Tablet appearance.
- Assay limits 92.5 - 107.5%.
- Guaifenesin β-isomer NMT 1.5%1, any other individual impurity NMT 1.0% and total impurities including guaifenesin β-isomer NMT 3.0%.
- Microbiological quality in compliance with TGO 77.
- For oral solutions, the tests and limits in the USP monograph Guaifenesin Oral Solution with the addition of:
- Solution appearance.
- Content of any preservatives included in the formulation.
- Guaifenesin β-isomer NMT 1.5%1, any other individual impurity NMT 1.0% and total impurities including guaifenesin β-isomer NMT 3.0%.
- Microbiological quality in compliance with TGO 77.
- For powders for oral solution, the following tests and limits:
- Powder appearance and/or solution appearance.
- Identification (as for USP tablets and capsules).
- pH of solution between 2.3 and 3.02
- Uniformity of dosage units if the medicine is packaged in single-unit containers.
- Assay limits 90.0 - 110.0% LC.
- Guaifenesin β-isomer NMT 1.5%1, any other individual impurity NMT 1.0% and total impurities including guaifenesin β-isomer NMT 3.0%.
- Microbiological quality in compliance with TGO 77.
Container/measuring device
- Guaifenesin medicines must be sold in containers that comply with Therapeutic Goods Order No 80, Child Resistant Packaging Requirements for Medicines.
- If a measuring device is to be supplied with the medicine, calibrations must be exclusively in metric units and must allow all the doses shown on the labels to be measured accurately. Details of the calibrations on the measuring device must be provided with the submission (a sample may also be requested). Further considerations and requirements regarding measuring devices are detailed in ARGOM Appendix 2: Guidelines on quality aspects of OTC applications, 8. Finished product container.
Footnotes
- USP Monographs: Guaifenesin
- USP Monographs: Guaifenesin Oral Solution
Page history
Original publication.
Original publication.