Evaluate Analgesic / Sedative Efficacy of Naproxen Sodium and Diphenhydramine in Patients With Postsurgical Dental Pain

Inclusion Criteria:

• Healthy, ambulatory, male and female volunteers ages 12 and older

• Scheduled to undergo surgical removal of a minimum of two third molars of which atleast one has to be a mandibular third molar. The mandibular extraction(s) required byeach subject must meet one of the following scenarios:

• one full bony impaction

• two partial bony impactions

• one full bony impaction and one partial bony impaction

• one full bony impaction and one soft tissue impaction

• one full bony impaction and one erupted third molar. Two full bony mandibularimpactions are not allowed. Maxillary third molars may be removed regardless ofimpaction level.

• Have moderate to severe postoperative pain on the Categorical Pain Rating Scale and ascore of >/= 50 mm on the 100-mm visual analog Pain Severity Rating Scale between 1600hour and 1830 hour on the day of surgery

• Female subjects of childbearing potential must be using a medically acceptable form ofbirth control for at least 1 month prior to screening (3 months on oralcontraceptives), e.g., oral or patch contraceptives, intrauterine device,Depo-Provera, or double-barrier and have a negative pregnancy test at Screening andprior to surgery. Female subjects of non-childbearing potential must be amenorrheicfor at least 2 years or had a hysterectomy and/or bilateral oophorectomy.

Exclusion Criteria:

• History of hypersensitivity to naproxen, diphenhydramine, nonsteroidalanti-inflammatory drug (NSAIDS), tramadol, aspirin or any other antihistamine andsimilar pharmacological agents or components of the products

• Evidence or history of clinically significant (in the judgment of the investigator)hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic,psychiatric, neurologic diseases, or malignancies within the last 5 years

• Relevant concomitant disease such as asthma (exercise induced asthma is permitted),chronic sinusitis or nasal structural abnormalities causing greater than 50 percentobstruction (polyposis nasi, marked septal deviation) that can interfere with theconduct of the study in the judgment of the investigator

• Current or past history of bleeding disorder(s)

• Acute illness or local infection prior to surgery that can interfere with the conductof the study in the judgment of the investigator

• Chronic use of antihistamines defined as using 5 or more times a week for 2 or moreconsecutive weeks during the past 3 months

• Positive alcohol breathalyzer test and positive urine drug test prior to surgery

• Females who are pregnant or lactating

• Chronic or severe sleep problems that do not respond to Over the Counter (OTC)medication and requires a prescription hypnotic or sedative

• Habitually spends less than 6.5 hours in bed