Safety Trial of Naproxen Sodium/ Diphenhydramine

Exclusion Criteria

• •History of hypersensitivity to naproxen sodium, acetaminophen, or any NSAIDs (Nonsteroidal Antiinflammatory Drugs), diphenhydramine or any other antihistamines, and similar pharmacological agents or components of the product
• •Evidence or history of clinically significant (in the judgment of the investigator) hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic diseases, or malignancies with the last 5 years
• •A history of a chronic or severe sleep problem which does not respond to OTC (Over-the-counter) medication and/or requires a prescription hypnotic or sedative
• •Currently experiencing chronic pain or on chronic NSAID therapy (defined as taking a daily \[5 to 7 days per week\] regimen of prescription or OTC NSAIDs)
• •Current or past history of gastrointestinal ulcers or bleeding or other bleeding disorders
• •Use of any OTC or prescription medications with which the administration of naproxen, acetaminophen, or any NSAIDs, diphenhydramine or any other antihistamines or sedatives, is contraindicated
• •Chronic use of other products containing diphenhydramine, including topical products
• •Use of steroids or blood thinning (anticoagulant) drugs (aspirin 81 mg is permitted if the dose has been taken for at least one month prior to screening)