A Study to Evaluate a Fixed Combination of Acetaminophen/Naproxen Sodium in Acute Postoperative Pain Following Bunionectomy

Inclusion Criteria:

• Females have a negative urine pregnancy at screening and on the morning of surgery

• Weight of 100 pounds or greater and have a body mass index (BMI) of 17.5 to 38.0 (inclusive) at screening

• Scheduled to undergo primary, unilateral, distal, first metatarsal bunionectomy (osteotomy and internal fixation) with no additional collateral procedures.Participants who have previously undergone bunionectomy on the contralateral footwill not be prohibited from enrolling in this study if performed greater than orequal to (>=) 6 months

• Are able to comprehend and follow the requirements of the study (includingpre-surgical instructions provided by the site and availability on scheduled visitdates) based upon research site personnel's assessment

• Provide written informed consent (for participants who are below the age of legalconsent, parent or legally authorized representative provides written informedconsent and the participant provides written assent)

• Participant agrees to the contraceptive requirements

• Are willing for this to be the only investigational product used during the study

• Have a negative urine drug screen at screening, and on day of surgical procedure. a)a positive drug screen for a known prescribed concomitant medication that is nototherwise exclusionary will not disqualify a participant; b) drug and alcohol screenresults must be negative for a participant to receive study medication, a positiveTetrahydrocannabinol (THC) screen will only be exclusionary on day of surgery (Day

Postoperative Inclusion Criteria

• Participant reports both of the following after discontinuation of the poplitealblock and before 2:00 PM on Day 1. a) moderate or severe pain on a 4-pointcategorical pain rating scale (with categories of none, mild, moderate, or severe;b) a score >= 5 on 11-point pain intensity-numerical pain rating scale (PI-NRS)

• Participant is able to answer questions and follow commands, and appropriatelyparticipate in requisite pain evaluation assessments dictated in the protocol

• The surgical procedure from incision to closure was not longer than 2 hours

• The participant has had no evidence of respiratory insufficiency, clinicallysignificant hypotension, brady cardia, or any other abnormality, during or followingsurgery that, in the Investigator's opinion, significantly increases the risks ofstudy drug administration

• There were no significant deviations from the surgical protocol, anestheticprotocol, or specified analgesic regimen, that would, in the opinion of theInvestigator, put the participant at risk of participation in the trial, confoundthe analgesic endpoints of the trial or cause concern regarding the participantsability to participate in the trial

Exclusion Criteria:

• Are female and are pregnant, breastfeeding, or currently trying to become pregnant

• Are male with a pregnant partner or a partner who is currently trying to becomepregnant

• Have a known allergy or hypersensitivity to: a) naproxen or other nonsteroidalanti-inflammatory drugs, including aspirin; b) oxycodone or other opioids; c)acetaminophen; d) any other drug listed in the surgical and anesthetic protocol orpostoperative pain management of the study protocol

• Have presence or a history of major medical condition that in the investigator'sopinion may jeopardize the participant's safety or well-being, or the integrity ofthe study, example; a) hepatic, renal, pancreatic, gastrointestinal, cardiovascular,cerebrovascular, or thyroid diseases; b) history of head injury or seizures; c)history of respiratory depression or lung problems such as but not limited to asthmaor chronic obstructive pulmonary disease; d) psychiatric disorders (althoughparticipants with well-controlled depression or anxiety, who are on a stable dose ofmedication may be allowed); e) problems urinating; f) history of blockage ornarrowing of the stomach or intestines; g) uncontrolled hypertension indicated assystolic blood pressure >=160 millimetres of mercury (mmHg) or diastolic bloodpressure >=100 mmHg. Blood pressure may be repeated after the participant hasremained in a rested state for at least 10 minutes. The final blood pressure valuewill be used for eligibility; h) uncontrolled diabetes, as determined by theinvestigator, in the last six months; i) medical conditions that would interferewith normal pain perception (example diabetic neuropathy) in the opinion of theInvestigator

• Have a history of endoscopically documented peptic ulcer disease or bleedingdisorder in the last two years

• Are not able to swallow whole large tablets or capsules

• Participants will be excluded from the study for any of the following:a) routine useof oral analgesics >=3 times per week for a medical condition unrelated to bunionpain in the 2 months prior to surgery; b) opioid tolerant, that is, the participantis currently taking or has taken a chronic opioid for pain at a dose greater than orequal to 10 milligrams (mg) hydrocodone per day, more than 1 out of 7 days per week,in the 2 months prior to surgery; c. History of chronic tranquilizer use, heavydrinking, opioid abuse, or other substance abuse, as judged by the Investigator, inthe last five years. Heavy drinking is defined as the use of more than four standarddrinks daily or more than 14 drinks a week for men, and more than three standarddrinks daily or more than seven standard drinks in a week for women. Standard drinkrefers to 14 grams (g) (0.6 ounce [oz.]) of pure alcohol, which is approximately 12oz. of beer, 8 oz. of malt liquor, 5 oz. of wine, 1.5 oz. or "shot" of 80 proofdistilled spirits or liquor (example., gin, rum, vodka, or whiskey); d) use of anyimmunosuppressive drugs, corticosteroids (except for topical corticosteroids), orinjectable or oral anticoagulants (example., heparin, Lovenox, Xarelto, Eliquis,Pradaxa, Coumadin, Miradon) within 2 weeks prior to surgery; e) use of monoamineoxidase inhibitors within 2 weeks prior to surgery; f) use of alcohol within 24hours prior to surgery; g) consumption of methylxanthine containing products (example, chocolate bars or chocolate beverages, coffee, tea, cola or caffeinatedenergy drinks), tobacco, or nicotine containing products (example, cigarettes,cigars, nicotine replacement therapies, vaping devices) less than (<) 12 hours priorto surgery; h) use of any other over-the-counter or prescription medications orsupplements that, in the Investigator's opinion, may cause participation in thestudy to jeopardize the participant's safety or well-being, or may jeopardize theintegrity of the study, within 5 days (or longer if the investigator deems a longerwashout is warranted) prior to surgery

• Have a positive test for human immunodeficiency virus (HIV) antibody, hepatitis Bsurface antigen (HBsAg), or hepatitis C virus antibody (anti-HCV)

• Have participated in any interventional clinical trials within 30 days beforescreening

• Are related to those persons involved directly or indirectly with the conduct ofthis study (that is., Principal Investigator, sub-investigators, study coordinators,other site personnel, employees of Johnson & Johnson [J&J] subsidiaries, contractorsof J&J, and the families of each)