FDA Approves First Combination Ibuprofen, Acetaminophen for OTC Use


This approval marks the first for combination ibuprofen and acetaminophen for OTC use.

The FDA has approved a combination ibuprofen 250mg and acetaminophen 500mg (Advil Dual Action with Acetaminophen) for over-the-counter (OTC) pain relief. This approval marks the first for combination ibuprofen and acetaminophen for OTC use.

The drug provides relief for multiple symptoms, including those of headaches, muscle aches, backaches, arthritis, and other joint pain. The combination enables pain relief in 2 ways: ibuprofen is a nonsteroidal anti-inflammatory drug that targets pain at the source, temporarily reducing the production of prostaglandins. Simultaneously, acetaminophen blocks the transmission of pain signals to the brain.

The approval was based on data from 7 clinical studies, 3 of which were pivotal efficacy and safety studies in pain relief. The studies’ findings support the indication for pain relief and demonstrate that the fixed-dose combination achieves superior efficacy compared to the individual monocomponents alone.

The approval was awarded to GlaxoSmithKline, who said the drug will be available OTC nationwide in 2020.


FDA approves GSK’s Advil Dual Action with Acetaminophen for over-the-counter use in the United States [news release]. Warren, NJ; February 28, 2020. PR Newswire. https://www.prnewswire.com/news-releases/fda-approves-gsks-advil-dual-action-with-acetaminophen-for-over-the-counter-use-in-the-united-states-301013675.html. Accessed March 2, 2020.

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