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OTC medicine monograph: Guaifenesin

Version 1.0, December 2014

16 December 2014

Introduction

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.

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 the document 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 the document 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.

  1. 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.
  2. 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.
  3. 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.
  4. 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

Reference

  1. USP Monographs: Guaifenesin
  2. USP Monographs: Guaifenesin Oral Solution

Copyright

© Commonwealth of Australia 2014
This work is copyright. You may download, display, print and reproduce the whole or part of this work in unaltered form for your own personal use or, if you are part of an organisation, for internal use within your organisation, but only if you or your organisation do not use the reproduction for any commercial purpose and retain this copyright notice and all disclaimer notices as part of that reproduction. Apart from rights to use as permitted under the Copyright Act 1968 or allowed by this copyright notice, all other rights are reserved and you are not allowed to reproduce the whole or any part of this work in any way (electronic or otherwise) without first being given specific written permission from the Commonwealth to do so. Requests and inquiries concerning reproduction and rights are to be sent to the TGA Copyright Officer, Therapeutic Goods Administration, PO Box 100, Woden ACT 2606 or emailed to <tga.copyright@tga.gov.au>.

Version Description of change Author Effective date
V1.0 Original publication OTC Medicines Evaluation/Office of Medicines Authorisation 15/12/2014