- Males and females 16 to 40 years of age
- Subjects who undergo surgical removal of at least two third molars
- One of which must be a partial or full bony mandibular impaction
- Subjects must have at least moderate baseline pain (a score of 2 on the categorical
pain severity rating scale) confirmed by a score of at least 50 mm on the 100-mm
visual analog scale-pain severity rating scale (VAS-PSR)
- Acute localized dental infection at the time of surgery that could confound the
post-surgical evaluation
- Presence or history of any significant organ disease
- Use of prescription or OTC first generation antihistamines
- Females who are pregnant, lactating or of childbearing potential and not using a
medically approved method to prevent pregnancy