{"@type": "dcat:Dataset", "accessLevel": "public", "accrualPeriodicity": "R/P1Y", "bureauCode": ["009:10"], "contactPoint": {"@type": "vcard:Contact", "fn": "Division of Drug Information", "hasEmail": "mailto:druginfo@fda.hhs.gov"}, "description": "Butalbital, Acetaminophen, and Caffeine is a prescription tablet used to relieve tension headaches. It combines butalbital (a sedative), acetaminophen (pain reliever), and caffeine (enhancer) in strengths of 50mg, 325mg, and 40mg respectively. It's a Schedule III controlled substance, available orally from Mikart, LLC. This information was generated using AI and is provided for informational and research purposes only.", "distribution": [{"@type": "dcat:Distribution", "description": "\n        Access the FDA dataset for Butalbital, acetaminophen and caffeine \u2014 ANDA 204733 submitted by Mylan Institutional LLC\n    ", "downloadURL": "https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=204733", "mediaType": "text/html", "title": "Butalbital, acetaminophen and caffeine"}], "identifier": "ANDA204733", "issued": "2016-09-16", "keyword": ["drug-safety", "pharmaceuticals", "fda", "health-care", "medications"], "landingPage": "https://www.fda.gov/drugs", "license": "https://open.fda.gov/license", "modified": "2025-03-17", "programCode": ["009:002"], "publisher": {"@type": "org:Organization", "name": "U.S. Food and Drug Administration"}, "theme": ["FDA"], "title": "Butalbital, acetaminophen and caffeine"}