A Study to Learn How Well a Single Dose of the Study Treatment Naproxen Sodium and Caffeine Combined in One Tablet (Fixed-dose Combination) Works to Relieve Pain After Dental Surgeries Compared to the Single Ingredients and to Placebo

Inclusion Criteria:

• Healthy, ambulatory, male or female volunteers 16 years of age or older;

• Body mass index (BMI) 18.5 to 35.0 kg/m^2 inclusive as measured by the NationalInstitutes of Health (NIH) BMI Calculator;

• Participants will undergo surgical extraction of three or four third molars, two ofwhich must be mandibular molars. Maxillary third molars may be removed regardless ofimpaction level. The mandibular extractions must have a trauma rating of mild ormoderate and meet one of the following scenarios: two full bony impactions; twopartial bony impactions; one full bony impaction in combination with one partialbony impaction. Supernumerary teeth present may also be removed at the discretion ofthe oral surgeon;

• Have not taken any form of medication, nutritional supplements with analgesicproperties (e.g. gamma-Aminobutyric acid [GABA], turmeric) or herbal supplements (i.e., St. John's Wort) within 5 days of admission (except for oral contraceptives,prophylactic antibiotics, multivitamin supplements, or other routine medications totreat benign conditions (such as antibiotics to treat acne), and agree not to takeany medication (other than that provided to them) throughout the study;

• Use of only short-acting local anesthetic (e.g., mepivacaine or lidocaine)preoperatively, with or without a vasoconstrictor and nitrous oxide at thediscretion of the Investigator;

• Have moderate to severe postoperative pain on the Categorical Pain Intensity Scale (a score of at least 2 on a 4 point scale) and a score of ≥ 5 on the 0-10 painintensity Numerical Rating Scale (NRS) within 4.5 hours post-surgery.

Exclusion Criteria:

• History of hypersensitivity to naproxen sodium, caffeine, ibuprofen, nonsteroidalanti-inflammatory drug (NSAIDS), aspirin, similar pharmacological agents, localanesthetics, rescue medication or components of the investigational products;

• Evidence or history of clinically significant (in the judgment of the investigator)hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular (including hypertension and cardiac arrhythmia), hepatic, psychiatric, neurologicdiseases, or malignancies within the last 5 years;

• Participants with the following medical conditions may be eligible at the discretionof the investigator: attention deficit hyperactivity disorder (ADHD) on a stabledose regimen of methylphenidate/(dextro) amphetamine for at least 6 months;participants with hypothyroidism on a stable dose of synthetic thyroid hormone forat least 6 months;

• Have received any form of treatment in the form of medication for depression in thepast 6 months or any form of psychotropic agent (including selective serotoninuptake inhibitors [SSRI] but excluding ADHD medications described above) within thelast 6 months;

• Relevant concomitant disease such as asthma (exercise induced asthma is permitted);

• Current or past history of gastrointestinal ulceration, gastrointestinal bleeding orother bleeding disorder(s);

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

• Use of any over-the-counter (OTC) or prescription medications with which theadministration of naproxen, acetaminophen, ibuprofen, any other NSAID, (e.g.,tramadol) or if a medication is contraindicated;

• Use of any medications within 5 days of surgery until discharge from the study site (except oral contraceptives, prophylactic antibiotics, synthetic thyroid hormones,methylphenidate or medications to treat benign conditions such as antibiotics totreat acne);

• Use of caffeine within 2 days prior to the study;

• Habits of high consumption of caffeine (>400 mg/day equivalent to about 3-4 cups ofcoffee per day);

• Habituation to analgesic drugs including opioids (i.e., routine use of oralanalgesics 5 or more times per week for greater than 3 weeks within the past 2years);

• Surgeon's trauma rating of severe following surgery.