{"@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": "Guaifenesin and Pseudoephedrine HCl is an over-the-counter extended-release tablet that helps relieve chest congestion and nasal congestion. It combines guaifenesin, an expectorant that loosens mucus, with pseudoephedrine HCl, a decongestant that shrinks swollen blood vessels in the nasal passages. Available in strengths like 600mg guaifenesin and 60mg pseudoephedrine HCl per tablet, it's manufactured by Dr. Reddy's Laboratories Limited and marketed by Walgreens. 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 Guaifenesin and pseudoephedrine hcl \u2014 ANDA 216082 submitted by Mylan Institutional LLC\n    ", "downloadURL": "https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=216082", "mediaType": "text/html", "title": "Guaifenesin and pseudoephedrine hcl"}], "identifier": "ANDA216082", "issued": "2016-09-16", "keyword": ["drug-safety", "fda", "health-care", "medications", "prescription-drugs"], "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": "Guaifenesin and pseudoephedrine hcl"}