FDA OKs OTC Ibuprofen, Acetaminophen Combination Product

Drug Topics JournalDrug Topics April 2020
Volume 164
Issue 4

Advil Dual Action, an ibuprofen and acetaminophen fixed-dose combination, has been approved as an OTC product for pain relief.

FDA approved

Officials with the FDA have approved GlaxoSmithKline’s (GSK) Advil Dual Action, the first OTC formulation combining ibuprofen and acetaminophen, for pain relief, according to a press release.1

Advil Dual Action’s formulation gives it the ability to fight pain in 2 ways. Ibuprofen, which is a non-steroidal anti-inflammatory, targets pain at the source, whereas acetaminophen is a pain relief that blocks the transmission of pain signals to the brain.

Each tablets contains 125 mg of ibuprofen and 250 mg of acetaminophen and is indicated for adults and children 12 years of age and older.

The approval is based on data from 7 clinical studies, 3 of which were pivotal efficacy and safety studies in pain relief. The findings demonstrated that the combination product achieved superior efficacy compared with the individual monocomponents of ibuprofen and acetaminophen alone, as evidenced by appreciable improvements in acute pain symptoms across multiple pre-specified endpoints.

“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,” Now Advil, the No. 1 selling OTC pain reliever, will offer US consumers the first-ever alternative option–a single, fixed-dose combination pain relief.”

The product will be available over-the-counter sometime this year, according to GSK.

GSK also recently received FDA approval for its arthritis pain relief product for OTC use in adults aged 18 years and older with arthritis. Diclofenac sodium topical gel, 1% (Voltaren Arthritis Pain), which will now be available over-the-counter, is indicated for the temporary relief of arthritis pain in the hand, wrist, elbow, foot, ankle, or knee.2


1. FDA Approves GSK’s Advil Dual Action with Acetaminophen for over-the-counter use in the United States [news release]. GlaxoSmithKline’s website. https://www.gsk.com/en-gb/media/press-releases/fda-approves-gsk-s-advil-dual-action-with-acetaminophen-for-over-the-counter-use-in-the-united-states/. Accessed March 5, 2020.

2. FDA approves GSK’s Voltaren Arthritis Pain for over-the-counter use in the United States [news release]. GlaxoSmithKline’s website. https://www.gsk.com/en-gb/media/press-releases/fda-approves-gsk-s-voltaren-arthritis-pain-for-over-the-counter-use-in-the-united-states/. Accessed March 5, 2020.

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