Meeting requirements for over-the-counter (OTC) medicines containing ranitidine hydrocholride

This monograph only applies to medicines containing ranitidine hydrochloride (CAS no. 66357-59-3) and excludes preparations containing any other salts and derivatives of ranitidine.

Acceptable dosage forms and strengths are shown in the table below.

* Ranitidine content, equivalent to 167.4 mg, 334.8 mg or 16.74 mg/mL ranitidine hydrochloride, respectively.

Required therapeutic indications for inclusion in the Australian Register of Therapeutic Goods

Relief of symptoms of gastro-oesophageal reflux.

Label indications

• Symptomatic relief of heartburn
• Reference should also be made, at least once, to relief of 'symptoms of gastro-oesophageal reflux' or 'heartburn due to gastro-oesophageal reflux' or similar.

The following label indications/claims are also acceptable:

• Symptomatic relief of acid indigestion and/or dyspepsia
• 'Works by decreasing the amount of acid made by the stomach', or similar
• 'Long lasting'
• For 150 mg tablet and oral liquid: 'Up to 12 hours relief' and/or '12 hour action'
• For 300 mg tablet: A prominent statement is required on the main panel of the carton label indicating that the medicine is intended for use by patients who routinely require two 150 mg ranitidine tablets for relief of their symptoms. The statement should be presented in such a way that it clearly stands out to prospective purchasers.

Directions are to be as shown in the table below.

For effervescent tablets, refer to placing the tablet in water and waiting till dissolved.

Directions for coated tablets may refer to taking with a glass of water.

Requirements in relation to measuring devices provided with oral liquid products are included under the Container/measuring device section of this guidance.

Labelling must comply with all relevant Australian regulatory requirements, as detailed in the document Requirements for OTC new medicine N2 applications, including all required warning statements.

In addition to statements required by RASML, the following statement is required:

If you are pregnant or intend to become pregnant, or are breastfeeding, check with your doctor or pharmacist before using this product.¹

Where 150 and 300 mg strengths of the same brand name are to be marketed, there must be sufficient differentiation between the product name and labelling of the two different strengths (e.g. inclusion of 'Extra strength' in the product name of the 300 mg product and colour differentiation between labelling).

In addition to the quality requirements outlined in the document Requirements for OTC new medicine N2 applications, the following specific requirements apply to ranitidine hydrochloride monograph medicine:

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 TGO78 requirements. Further reference to these is not required. References to pharmacopoeial monographs below refer to the current monograph at time of application.

Coated tablets

The tests and limits in the BP monograph Ranitidine Tablets with the addition of:

• tablet appearance
• dissolution (900 mL water, paddle at 50 rpm, 80% (Q) after 45 minutes)²
• uniformity of dosage units (BP)
• microbiological quality, in compliance with TGO 77

Effervescent tablets

The tests and limits in the BP monograph Ranitidine Tablets with the addition of:

• tablet appearance
• disintegration (BP)
• uniformity of dosage units (BP)
• microbiological quality, in compliance with TGO 77

Oral liquid

The tests and limits in the BP or USP monograph Ranitidine Oral Solution with the addition of:

• solution appearance
• content of any preservatives included in the formulation
• microbiological quality, in compliance with TGO 77

Container/measuring device

• If a measuring device is to be supplied with the product, 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.

1. This statement will be revised pending a final outcome on a RASML consultation on a pregnancy and breastfeeding warning statement for ranitidine.
2. From Ranitidine Tablets USP