- Normal, healthy males and females 16 to 40 years of age
- Outpatients who have moderate to severe post-operative pain (confirmed by a Visual
Analog Scale-Pain Severity Rating [VAS-PSR] score of at least 50 mm on a 100 mm
VAS-PSR) following surgical extraction of two or more third molars, at least one of
which must be a partial or complete bony mandibular impaction
- Use of only the following pre-operative medication(s)/anesthetic(s): topical
benzocaine, a short acting parenteral (local) anesthetic (mepivacaine or lidocaine)
with or without vasoconstrictor and/or nitrous oxide
- Pregnancy or breast-feeding
- Alcohol or substance abuse
- Any serious medical or psychiatric disorder
- History of stomach ulcers, stomach bleed, or other bleeding disorders
- Use of a prescription or over-the-counter drug with which administration of ibuprofen
or any other non-steroidal anti-inflammatory drug, acetaminophen, or hydrocodone is
contraindicated (including: opioids, antipsychotics, antianxiety agents, or other
central nervous system depressants[including alcohol])