- Males and females 16 years to 40 years of age (inclusive).
- Subjects who have undergone outpatient surgical extraction of 3 or more third molars,
of which at least 2 must be a partial or complete bony mandibular impaction within 30
days of Screening and have met baseline pain criteria as described in this protocol
- Examined by the attending dentist or physician and medically cleared to participate in
the study.
- Evidence or history of clinically significant hematological, renal, endocrine,
pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic,
metabolic or allergic disease (including drug allergies, but excluding untreated,
asymptomatic, seasonal allergies at the time of dosing) determined by the Investigator
to place the subject at increased risk including the presence or history within 2
years of screening of the following medical conditions/disorders:
- Bleeding disorder;
- Gastrointestinal ulcer or gastrointestinal bleeding;
- Paralytic ileus or other gastrointestinal obstructive disorders.
- Pregnant female subjects; breastfeeding female subjects; fertile male subjects and
female subjects of childbearing potential who are unwilling or unable to use a highly
effective method of contraception
- Hypersensitivity to ibuprofen, naproxen, aspirin, or any other NSAID, caffeine, or
other component of the product.