A Study of an Acetaminophen/Naproxen Sodium Fixed Combination, Acetaminophen and Naproxen Sodium in Postoperative Dental Pain

The purpose of this study is to evaluate how well a fixed combination of acetaminophen/naproxen sodium relieves postoperative dental pain compared with acetaminophen, naproxen sodium and placebo.

Inclusion Criteria:Weigh 100 pounds or greater and have a body mass index (BMI) of 17.5 to 30.4 (inclusive) at screeningSurgical removal of three or four third molars, of which, two must be mandibular impactionsMeets requirements for post-surgical pain levelFemales of childbearing potential and males agree to contraceptive requirements of studyHave a negative urine drug screen at screening, and on day of surgical procedureExclusion Criteria:Pregnant female, breastfeeding, trying to become pregnant or male with pregnant partner or partner currently trying to become pregnantHave a known allergy or hypersensitivity to naproxen (or other NSAIDs including aspirin) or to acetaminophen, oxycodone or other opioidsNot able to swallow whole large tablets or capsulesHistory of any condition(s) in investigator's opinion, may jeopardize subject safety, well-being and integrity of studyUse analgesics 5 or more times per weekHistory of chronic tranquilizer use, heavy drinking, or substance abuse, as judged by the investigator site staff, in the last 5 yearsUse any immunosuppressive drugs within 2 weeks of surgical procedureHistory of endoscopically documented peptic ulcer disease or bleeding disorder in the last 2 years