MONDAY, June 23, 2003 (HealthDayNews) -- The anti-heartburn drug Prilosec (omeprazole), one of the world's best-selling medications, has been approved for sale without a prescription by the U.S. Food and Drug Administration.
The proton pump inhibitor, which works to limit production of stomach acid, is newly approved to treat frequent heartburn, occurring two or more days a week. The condition affects some 50 million Americans, according to Prilosec OTC's manufacturer, Procter & Gamble (P&G).
The just-approved 20-milligram dose is to be taken once daily for 14 days. It is not meant for instant relief of heartburn symptoms, as it may take one to four days to feel the full effects, the FDA says. It is also not meant for people who experience heartburn symptoms less than twice weekly.
Higher doses of prescription-strength Prilosec, first approved by the FDA in 1989, will remain available to treat related conditions that require a doctor's supervision, including gastroesophageal reflux disease, inflammation of the esophagus, and ulcers.
Referred to in TV ads as "the purple pill," the OTC version actually has a more pinkish hue. The nonprescription version is expected to sell for under $1 a day, less than one-third the price of the prescription version, P&G says.