{"@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": "Claritin-D 12 Hour is an over-the-counter extended-release tablet containing loratadine (5 mg) and pseudoephedrine sulfate (120 mg). It relieves allergy symptoms like runny nose, sneezing, and itchy throat, plus nasal congestion. Take orally as directed. Manufactured by Bayer HealthCare 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 Loratadine and pseudoephedrine sulfate \u2014 ANDA 076050 submitted by Mylan Institutional LLC\n    ", "downloadURL": "https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=076050", "mediaType": "text/html", "title": "Loratadine and pseudoephedrine sulfate"}], "identifier": "ANDA076050", "issued": "2016-09-16", "keyword": ["drug-safety", "medications", "pharmaceuticals", "drug-manufacturers", "health-care"], "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": "Loratadine and pseudoephedrine sulfate"}