A Study of Acetaminophen/Naproxen Sodium Fixed Combination Tablets in Adolescents 12 to <17 Years of Age With Pain

Inclusion Criteria:

• A parent or a legal guardian of the participant has signed and dated the informedconsent document and a written assent has been signed by the participant
• Has undergone an orthodontic procedure within 72 hours prior to dosing
• Is otherwise a healthy adolescent between the ages of 12 to less than (<) 17 years atbaseline (dosing). Health is defined as the absence of clinically relevantabnormalities as judged by the principle investigator (PI) on the basis of a detailedmedical history, physical examination, blood pressure, respiratory rate and pulse ratemeasurements, and clinical laboratory tests. The responsible PI may request additionalinvestigations or analyses if necessary
• Has a minimum weight of 72 pounds and has a Body Mass Index (BMI) between the 5th and 95th percentile for their age at dosing
• Has been fasted for at least 10 hours prior to dose administration of theinvestigational product
• Is a non-tobacco user or previous user who completely stopped smoking or using anyform of tobacco or nicotine-containing product [including e-cigarettes, cigarettes,non-combusted cigarettes, cigars, smokeless tobacco (such as dip, snuff, snus, andchewing tobacco)] for at least 12 months before screening visit of this study
• If female, have a negative test for pregnancy at screening and baseline (dosing)
• Females of childbearing potential and males agree to the contraceptive requirements
• Is able to comprehend the requirements of the study (based upon clinical sitepersonnel's assessment) and is willing and able to comply with scheduled visits,treatment plan, laboratory tests, and other study procedures specified within theprotocol
• Are willing for investigational product of this study to be the only analgesic productused during the study

Exclusion Criteria:

• Use of prescription or non-prescription medications within a period less than 5half-lives before the first investigational product (IP) administration unless theseare contraceptives or occasional use of other medications approved by the Investigator
• Use of Ibuprofen within 6 hours prior to the dose administration of theinvestigational product
• Use of any vitamins, dietary and herbal supplements within seven days before firstdose of study drug
• Has hypersensitivity to acetaminophen, naproxen, other non-steroidal anti-inflammatorydrug (NSAIDs), including acetylsalicylic acid, or to any of the ingredients
• If female, has a positive pregnancy test or is breast-feeding or currently trying tobecome pregnant
• Has a positive test for human immunodeficiency virus (HIV) 1 and 2 antibodies,hepatitis B surface antigen (HBsAg), or hepatitis C antibodies (anti-HCV)
• Has a positive test for drugs of abuse at screening or baseline (dosing)
• Has difficult venipuncture access and/or refuses to undergo venipuncture
• Has clinically significant renal or hepatic impairment according to the medicallyqualified Investigator discretion, or presence of a disease, which in the opinion ofthe Investigator, would preclude the use of IP
• Has a history of peptic ulcers, gastrointestinal bleeding of any etiology, bleedingdisorders, gastrointestinal disease (including chronic heartburn or gastroesophagealreflux disease, or any other active inflammatory disease of the gastrointestinal tractsuch as ulcerative colitis or crohn's disease), or has a history of gastrointestinalsurgery (including cholecystectomy) that would affect the pharmacokinetic (PK)assessment of the drug or the safety of the participant
• Has history of substance abuse, as judged by the PI, within 12 months preceding thisstudy
• Has used alcohol within 24 hours of baseline visit and/or has positive alcohol test inexpired air at screening or baseline visit
• Has used food or beverages containing xanthines (that is, tea, coffee, cola drinks,energy drinks or chocolate) for 48 hours prior to the dosing and during the studyperiod
• Has used grapefruit and savoy oranges for 48 hours prior to the dosing and during thestudy period
• Participating in a clinical trial and/or treated with any investigational productwithin 3 months preceding the dose of study drug
• Has preplanned surgery, procedures, or personal commitments that would interfere withthe conduct of the study
• Had an acute blood loss of 50 milliliter (mL) to 249 mL within the 30 days, or 250 mLto 449 mL within the 45 days, or greater than or equal to (>=) 450 mL within the 60days before first dose administration
• Has any acute or chronic medical or psychiatric condition(s) that may increase therisk associated with study participation or IP administration or may interfere withthe interpretation of study results and, in the judgment of the medically qualifiedInvestigator, would make the participant inappropriate for entry into this study
• Has any clinically important abnormal value for serum chemistry, hematology, orurinalysis at screening. Laboratory values will generally be within the normal ranges,although minor deviations in tests (except those explicitly specified in the inclusioncriteria) that are not considered clinically important by the Investigator areacceptable
• Is related to persons involved directly or indirectly with the conduct of the study (that is, principal investigator, sub-investigators, study coordinators, other studypersonnel, employees or contractors of the Sponsor or Johnson & Johnson (J&J)subsidiaries, and the family of each)