{"id":"naproxen-sodium-pseudoephedrine-hcl","safety":{"commonSideEffects":[{"rate":null,"effect":"Gastrointestinal upset (nausea, dyspepsia, abdominal pain)"},{"rate":null,"effect":"Headache"},{"rate":null,"effect":"Dizziness"},{"rate":null,"effect":"Nervousness or insomnia"},{"rate":null,"effect":"Tachycardia"}]},"_chembl":null,"_dailymed":{"setId":"83f7cfbb-ab84-4594-ae7a-4a657385c8a7","title":"LEADER ALL DAY SINUS AND COLD D (NAPROXEN SODIUM, PSEUDOEPHEDRINE HCL) TABLET, FILM COATED, EXTENDED RELEASE [CARDINAL HEALTH 110, LLC. DBA LEADER]"},"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"Naproxen sodium is a nonsteroidal anti-inflammatory drug (NSAID) that inhibits cyclooxygenase (COX) enzymes, reducing prostaglandin synthesis and thereby decreasing pain, fever, and inflammation. Pseudoephedrine HCl is a sympathomimetic amine that acts as an alpha-adrenergic agonist on nasal blood vessels, causing vasoconstriction to relieve nasal and sinus congestion. This combination addresses both pain/inflammation and congestion symptoms commonly associated with cold and sinus conditions.","oneSentence":"Naproxen sodium reduces pain and inflammation via COX inhibition, while pseudoephedrine HCl constricts nasal blood vessels to relieve congestion.","_ai_confidence":"high"},"_scrapedAt":"2026-03-28T05:17:10.722Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Temporary relief of minor aches and pains due to the common cold, headache, muscular aches, backache, minor pain of arthritis, menstrual cramps, and toothache with nasal congestion"}]},"trialDetails":[{"nctId":"NCT01131767","phase":"PHASE1","title":"Bioequivalence Study of Naproxen Sodium 220 mg & Pseudoephedrine HCl 120 mg ER Tablets of Dr. Reddy's Under Fed Conditions","status":"COMPLETED","sponsor":"Dr. Reddy's Laboratories Limited","startDate":"2004-07","conditions":"Healthy","enrollment":26},{"nctId":"NCT01131728","phase":"PHASE1","title":"Bioequivalence Study of Naproxen Sodium 220 mg & Pseudoephedrine HCl 120 mg ER Tablets of Dr. Reddy's Under Fasting Conditions","status":"COMPLETED","sponsor":"Dr. Reddy's Laboratories Limited","startDate":"2004-07","conditions":"Healthy","enrollment":26}],"_emaApprovals":[],"_faersSignals":[],"_approvalHistory":[],"publicationCount":0,"rwe":[],"genericFilers":[],"relatedDrugs":[],"labelChanges":[],"biosimilarFilings":[],"pricing":[],"formularyStatus":[],"manufacturing":[],"companionDiagnostics":[],"competitors":[],"timeline":[],"patents":[],"ownershipHistory":[],"trials":[],"biosimilars":[],"latestUpdates":[],"references":[],"tags":[],"ecosystem":[],"genericManufacturerList":[],"offLabel":[],"developmentCodes":[],"aliases":["Aleve Cold and Sinus"],"phase":"marketed","status":"active","brandName":"Naproxen Sodium & Pseudoephedrine HCl","genericName":"Naproxen Sodium & Pseudoephedrine HCl","companyName":"Dr. Reddy's Laboratories Limited","companyId":"dr-reddy-s-laboratories-limited","modality":"Small molecule","firstApprovalDate":"","aiSummary":"Naproxen sodium reduces pain and inflammation via COX inhibition, while pseudoephedrine HCl constricts nasal blood vessels to relieve congestion. Used for Pain and inflammation associated with cold, flu, or sinus congestion, Nasal and sinus congestion relief.","enrichmentLevel":3,"visitCount":1,"trialStats":{"total":0,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}