b) OTC Pantoprazole

Pantoprazole 20 mg tablet labeled for the relief of heartburn symptoms associated with acid reflux in patients of 18 years old or above, with a maximum daily dose of 20 mg, and in packs with max supply of 7 days.


In the PPR pantoprazole is listed under Schedule 1 and 3 as:

"Pantoprazole; its salts; except when contained in oral preparations with 20 mg or less per solid dosage unit, indicated with the maximum daily dose of 20 mg for relief of heartburn symptoms associated with acid refux in patients of 18 years old or above , and in packs with the maximum supply of 7 days"


...and under Schedule 10 Part 1 as:

"Pantoprazole; its salts"


This means the version of pantoprazole which is marketed in small packets of 7 for OTC treatment of heartburn and contains dose unit of no more than 20 mg, with the above mentioned labelling is a P1 drug only.

Pantoprazole 40 mg, or 20 mg in packets containing more than 7, or without the labelling requirement would be a P1S1S3 drug.


Answer: P1