The FDA has approved Advil Dual Action with Acetaminophen (GlaxoSmithKline), the first over-the-counter (OTC) fixed-dose combination therapy containing ibuprofen and acetaminophen for the temporary relief of minor aches and pains due to headache, backache, muscular aches, toothache, menstrual cramps, and minor pain of arthritis.
Each caplet contains 125mg of Ibuprofen, a nonsteroidal anti-inflammatory drug (NSAID) and 250mg of acetaminophen and is indicated for adults and children 12 years of age and older. The approval was based on study data that showed use of the fixed-dose combination therapy was associated with superior pain relief compared with the individual components taken alone.
Advil Dual Action with Acetaminophen is expected to be available nationwide sometime during 2020.
GlaxoSmithKline recently received FDA approval for another OTC pain reliever, Voltaren Arthritis Pain (diclofenac topical gel), for the temporary relief of arthritis pain in the hand, wrist, elbow, foot, ankle or knee in adults ≥18 years old. The OTC formulation is the same as the prescription strength (10mg of diclofenac sodium per gram or 1%). It is expected to be available in spring 2020.
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