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FDA Adds New Label Warnings to Over-the-Counter Painkillers
Date:4/28/2009

include a stomach bleeding warning," Holman said.

The warning will highlight risk factors for severe stomach bleeding associated with the product. These include being 60 or older, having stomach ulcers or bleeding problems, taking a blood thinner or steroid, or taking other prescription or nonprescription NSAIDs, Holman said.

Consumers are also warned to ask their doctor about their risk of taking NSAIDs and to stop taking the drug and consult their doctor if there are any signs of stomach bleeding.

These signs include stomach pain that doesn't go away, vomiting blood or blood in the stool, Holman said.

More information

For more on the dangers of NSAIDs and acetaminophen, visit the U.S. Food and Drug Administration.



SOURCE: April 28, 2009, teleconference with: Matthew Holman, Ph.D., deputy director, Division of Nonprescription Regulation Development, Office of Nonprescription Products, Office of New Drugs, Center for Drug Evaluation and Research, U.S. Food and Drug Administration


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