prilosec1 20 mg tabletsrx to otc switch daiva shetty md division of over the counter drug products hfd 560 food and administration rx overview regulatory history proposed label target population actual use study 007 differences between original resubmission nda originalresubmitted dose10 mg20 12 years 18 anybody with hbhb 2 x week usesrelief prevention frequent hb duration10 days14 days intermittent continuous program three comprehension studies 02255 12179 17859 labeling safety update uses for symptoms heartburn 24 hours only those who suffer two or more a directions adults age older swallow 1 tablet glass water in morning take every day 14 do not continue beyond unless directed by your doctor if continues returns it could be sign serious condition warning