- Outpatients who have undergone surgical extraction of 3 or more third molars, of which
at least 2 must be a partial or complete bony mandibular impaction.
- Subject must have at least moderate pain on the 4-point categorical scale, confirmed
by at least 50 mm on the 100 mm VAS PSR scale within approximately 5 hours (i.e., less
than or equal to 5 hours, 15 minutes) after surgery is completed.
- Female subjects are not pregnant or breast feeding.
- Informed consent.
- Presence or history of any significant hepatic, renal, endocrine, cardiovascular,
neurological, psychiatric, gastrointestinal, pulmonary, hematologic, or metabolic
disorder determined by the Investigator to place the subject at increased risk,
including the presence or history within 2 years of screening.
- Acute localized dental alveolar infection at the time of surgery that could confound
the post-surgical evaluation.
- Hypersensitivity to ibuprofen, naproxen, aspirin, or any other NSAID; or to APAP,
tramadol, other opioids, or to their combinations.