This is a randomized, double blind, placebo-controlled, parallel group, single-center study
in approximately 560 subjects to determine the overall analgesic efficacy and safety of a
fixed-dose ibuprofen 250 mg / acetaminophen 500 mg formulation compared to ibuprofen 250 mg
alone, acetaminophen 650 mg alone, and to placebo. Subjects will be healthy males and females
aged 18-40 years, inclusive, who are experiencing post-operative pain following surgical
extraction of 3 or more third molar teeth. Following extraction, subjects must experience,
within 5 hours, post-surgical pain of at least moderate severity (on a 4-point categorical
scale), confirmed by a Visual Analog Pain Severity Rating Scale (VAS PSR) of at least 50 mm
on a 100 mm VAS PSR scale. Eligible subjects will be randomized to receive a single oral dose
of study medication under double-blind conditions and then evaluated on site for 12 hours
following administration of study medication. Subjects will provide self-ratings of pain
severity and pain relief at various time points using categorical and numerical scales.
Additionally, subjects will also evaluate the time to first perceptible relief and time to
meaningful relief using a double stopwatch method. Finally, at 12 hours, subjects will
complete a categorical Global Evaluation of the study medication. A review of any reported
adverse events will also be completed.