FDA clears GSK Consumer Healthcare’s Advil Dual Action as an OTC

David Salazar
Managing Editor
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GSK Consumer Healthcare could soon be bringing another OTC powerhouse to shelves with its latest approval from the Food and Drug Administration. The agency has given the company the green light to sell Advil Dual Action with acetaminophen as an OTC product for pain relief. This makes the product the first FDA-approved OTC combination of ibuprofen and acetaminophen in the United States. 

The company plans to launch the product nationwide this year. 

“For decades, many consumers have been using ibuprofen and acetaminophen to get the benefits of both active ingredients when safely treating their headaches, muscle aches, backaches, arthritis and other joint pain,” said Franck Riot, head of research and development at GSK Consumer Healthcare. “Now Advil, the No. 1-selling OTC pain reliever, will offer U.S. consumers the first-ever alternative option — a single, fixed-dose combination pain reliever. As the world-leader in pain relief, Advil Dual Action and our recently FDA-approved Voltaren Arthritis Pain gel, demonstrates GSK's commitment to providing new safe, effective and convenient pain relief options for consumers.”

As Riot noted, this is the second big OTC launch GSK Consumer Healthcare is overseeing this year. Last month, the Warren, N.J.-based company received FDA approval for an Rx-to-OTC switch of its Voltaren Gel, which will be sold OTC as Voltaren Arthritis Pain.