CINCINNATI (AP) -- The Food and Drug Administration has told Procter and Gamble Co. to provide a clearer label for Prilosec before the consumer products concern can sell the heartburn drug in stores.

The agency also told P and G in a letter earlier this month that the company would have to conduct a study to prove that patients can understand the label for an over-the-counter version of Prilosec.

The letter is standard procedure and usually indicates the agency expects to approve a drug once any remaining issues are resolved.

Cincinnati-based P and G had hoped to have the over-the-counter Prilosec on the market by early next year, but that was before the company had received the specific FDA requirements, Greg Allgood, associate director of P and G Health Sciences Institute, said Thursday.

"We always expected to do a label study and included that in our timeline projections, but we couldn't proceed until we got the specifics from the FDA," he said. "Now that we have those, we hope to have the drug on the market in the first half of 2003, pending FDA approval."

Allgood said P and G expects to keep the Prilosec name for its over-the-counter heartburn drug. The prescription version of Prilosec, which is used to treat a variety of acid-related diseases, is expected to remain on the market, he said.

Allgood said the requirements stated in the FDA letter were not any different from what an FDA advisory committee told P and G in June.

He said the company has no concerns that generic over-the-counter versions of Prilosec will make it to the market before P and G's over-the-counter drug.

"Once you get FDA approval, which is still pending, you normally have about three years of exclusivity before any generic over-the-counter drugs could get on the market," he said.

In afternoon trading on the New York Stock Exchange, P and G shares were down 55 cents at $90.34.

Copyright 2002 The Associated Press. All rights reserved.