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"0187-0063-01", "0187-0063-50", "0187-0063-10", "0187-0064-01", "0187-0064-50", "0187-0064-10", "0187-0065-01", "0187-0065-50", "0187-0065-10", "0093-3425-01", "0093-3425-05", "0093-3425-10", "0093-3426-01", "0093-3426-05", "0093-3426-10", "0093-3427-01", "0093-3427-05", "0093-3427-10", "62135-549-43", "62135-861-01", "62135-862-01", "62135-863-01", "62559-195-01", "62559-195-05", "62559-195-10", "62559-196-01", "62559-196-05", "62559-196-10", "62559-197-01", "62559-197-05", "62559-197-10", "0641-6044-01", "0641-6044-25", "0641-6046-01", "0641-6046-10", "0641-6045-01", "0641-6045-25", "0641-6047-01", "0641-6047-10", "72572-380-01", "72572-380-25", "69315-904-01", "69315-904-05", "69315-904-10", "69315-905-01", "69315-905-05", "69315-905-10", "69315-906-01", "69315-906-05", "69315-906-10", "0409-1539-03", "0409-1539-31", "0409-1985-03", "0409-1985-30", "63304-772-90", "63304-772-01", "63304-772-05", "63304-772-10", "63304-773-90", "63304-773-01", "63304-773-05", "63304-773-10", "63304-774-90", "63304-774-01", "63304-774-05", "63304-774-10", "0641-6003-01", "0641-6003-25", "0641-6002-01", "0641-6002-10", "0641-6001-01", "0641-6001-25", "0641-6000-01", "0641-6000-10" ], "nui": [ "N0000175694", "M0002356" ], "pharm_class_epc": [ "Benzodiazepine [EPC]" ], "pharm_class_cs": [ "Benzodiazepines [CS]" ], "unii": [ "O26FZP769L" ] } }, { "drugcharacterization": "2", "medicinalproduct": "TYLENOL PM", "drugadministrationroute": "065", "drugindication": "PRODUCT USED FOR UNKNOWN INDICATION", "activesubstance": { "activesubstancename": "ACETAMINOPHEN\\DIPHENHYDRAMINE" }, "openfda": { "application_number": [ "M013" ], "brand_name": [ "TYLENOL PM EXTRA STRENGTH" ], "generic_name": [ "ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE", "ACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDE" ], "manufacturer_name": [ "Jones Healthcare Group - Packaging Services, Inc", "Kenvue Brands LLC" ], "product_ndc": [ "67414-608", "50580-608" ], "product_type": [ "HUMAN OTC DRUG" ], "route": [ "ORAL" ], "substance_name": [ "ACETAMINOPHEN", "DIPHENHYDRAMINE HYDROCHLORIDE" ], "rxcui": [ "1092189", "1092378" ], "spl_id": [ "20aec2bd-9934-370f-e063-6294a90a2bae", "57301337-05f3-6afe-e063-6394a90aa4dd" ], "spl_set_id": [ "639f4e01-9723-a619-e053-2991aa0a549a", "ce58105b-f010-47af-8f31-6dd4ce4e9cba" ], "package_ndc": [ "67414-608-06", "67414-608-00", "50580-608-01", "50580-608-02", "50580-608-03", "50580-608-04", "50580-608-05", "50580-608-06", "50580-608-07", "50580-608-08" ], "unii": [ "362O9ITL9D", "TC2D6JAD40" ] } }, { "drugcharacterization": "2", "medicinalproduct": "PRILOSEC", "drugadministrationroute": "065", "drugindication": "PRODUCT USED FOR UNKNOWN INDICATION", "activesubstance": { "activesubstancename": "OMEPRAZOLE MAGNESIUM" }, "openfda": { "application_number": [ "NDA022056" ], "brand_name": [ "PRILOSEC" ], "generic_name": [ "OMEPRAZOLE MAGNESIUM" ], "manufacturer_name": [ "Covis Pharma US, Inc" ], "product_ndc": [ "70515-610", "70515-625" ], "product_type": [ "HUMAN PRESCRIPTION DRUG" ], "route": [ "ORAL" ], "substance_name": [ "OMEPRAZOLE MAGNESIUM" ], "rxcui": [ "797058", "797061", "797063", "797065" ], "spl_id": [ "296db0e8-af6e-4053-874d-2a7c8f7aba50" ], "spl_set_id": [ "b6761f84-53ac-4745-a8c8-1e5427d7e179" ], "package_ndc": [ "70515-625-01", "70515-610-01" ], "unii": [ "426QFE7XLK" ] } }, { "drugcharacterization": "2", "medicinalproduct": "AMLODIPINE", "drugadministrationroute": "065", "drugindication": "PRODUCT USED FOR UNKNOWN INDICATION", "activesubstance": { "activesubstancename": "AMLODIPINE BESYLATE" }, "openfda": { "application_number": [ "NDA219531", "NDA214439", "NDA211340" ], "brand_name": [ "SDAMLO", "NORLIQVA", "KATERZIA" ], "generic_name": [ "AMLODIPINE" ], "manufacturer_name": [ "Pangea Pharmaceuticals, LLC", "CMP Pharma, Inc.", "Azurity Pharmaceuticals, Inc." ], "product_ndc": [ "81279-133", "81279-134", "81279-135", "46287-035", "46287-037", "52652-5001" ], "product_type": [ "HUMAN PRESCRIPTION DRUG" ], "route": [ "ORAL" ], "substance_name": [ "AMLODIPINE BESYLATE", "AMLODIPINE", "AMLODIPINE BENZOATE" ], "rxcui": [ "2726058", "2726064", "2726065", "2726067", "2726068", "2726070", "2599173", "2599179", "2184120", "2184126" ], "spl_id": [ "4b0523be-cded-6306-e063-6394a90a8a12", "63a6bb49-fb68-4351-be5f-a6b6e8f6b540", "4fee8eba-2fa2-4a9c-884a-ccec171e1977", "461e8d10-1805-e107-e063-6294a90aa288" ], "spl_set_id": [ "886a7f97-60a4-4206-a6c7-5206069ed487", "c1730a51-4383-4c61-a9a1-7e1326bd0abe", "614d974f-51c7-4b18-8171-39eb6e8d4c03", "df673a4d-acb8-444c-a472-c87ab8cbd366" ], "package_ndc": [ "81279-133-10", "81279-134-10", "81279-135-10", "46287-035-15", "46287-037-01", "52652-5001-1" ], "unii": [ "864V2Q084H", "1J444QC288", "XD75TQ8A2P" ], "nui": [ "N0000000069", "N0000175421", "N0000175566", "M0006414", "N0000190114" ], "pharm_class_moa": [ "Calcium Channel Antagonists [MoA]", "Cytochrome P450 3A Inhibitors [MoA]" ], "pharm_class_epc": [ "Dihydropyridine Calcium Channel Blocker [EPC]", "Calcium Channel Blocker [EPC]" ], "pharm_class_cs": [ "Dihydropyridines [CS]" ] } }, { "drugcharacterization": "2", "medicinalproduct": "SYMBICORT", "drugdosageform": "INHALER", "drugadministrationroute": "065", "drugindication": "PRODUCT USED FOR UNKNOWN INDICATION", "activesubstance": { "activesubstancename": "BUDESONIDE\\FORMOTEROL FUMARATE DIHYDRATE" }, "openfda": { "application_number": [ "NDA021929" ], "brand_name": [ "SYMBICORT" ], "generic_name": [ "BUDESONIDE AND FORMOTEROL FUMARATE DIHYDRATE" ], "manufacturer_name": [ "AstraZeneca Pharmaceuticals LP" ], "product_ndc": [ "0186-0370", "0186-0372" ], "product_type": [ "HUMAN PRESCRIPTION DRUG" ], "route": [ "RESPIRATORY (INHALATION)" ], "substance_name": [ "BUDESONIDE", "FORMOTEROL FUMARATE" ], "rxcui": [ "1246288", "1246290", "1246304", "1246306", "1246314", "1246315", "1246316", "1246317" ], "spl_id": [ "1f05ded1-7d31-4cfc-8537-0e75f99ad452" ], "spl_set_id": [ "fafa4cf1-99c2-43d5-73ad-51f256de3be0" ], "package_ndc": [ "0186-0370-20", "0186-0370-28", "0186-0370-60", "0186-0372-20", "0186-0372-28", "0186-0372-60" ], "nui": [ "N0000175576", "N0000175450" ], "pharm_class_epc": [ "Corticosteroid [EPC]" ], "pharm_class_moa": [ "Corticosteroid Hormone Receptor Agonists [MoA]" ], "unii": [ "W34SHF8J2K", "Q3OKS62Q6X" ] } } ], "summary": { "narrativeincludeclinical": "CASE EVENT DATE: 2013" } } }, { "safetyreportversion": "3", "safetyreportid": "10004060", "primarysourcecountry": "US", "occurcountry": "US", "transmissiondateformat": "102", "transmissiondate": "20150720", "reporttype": "1", "serious": "1", "seriousnesshospitalization": "1", "receivedateformat": "102", "receivedate": "20140312", "receiptdateformat": "102", "receiptdate": "20150327", "fulfillexpeditecriteria": "2", "companynumb": "US-BAYER-2014-036236", "duplicate": "1", "reportduplicate": { "duplicatesource": "BAYER", "duplicatenumb": "US-BAYER-2014-036236" }, "primarysource": { "reportercountry": "US", "qualification": "4" }, "sender": { "sendertype": "2", "senderorganization": "FDA-Public Use" }, "receiver": { "receivertype": "6", "receiverorganization": "FDA" }, "patient": { "patientonsetage": "33", "patientonsetageunit": "801", "patientagegroup": "5", "patientweight": "68.27", "patientsex": "2", "reaction": [ { "reactionmeddraversionpt": "18.0", "reactionmeddrapt": "Pulmonary embolism", "reactionoutcome": "2" }, { "reactionmeddraversionpt": "18.0", "reactionmeddrapt": "General physical health deterioration", "reactionoutcome": "2" }, { "reactionmeddraversionpt": "18.0", "reactionmeddrapt": "Pain", "reactionoutcome": "2" }, { "reactionmeddraversionpt": "18.0", "reactionmeddrapt": "Injury", "reactionoutcome": "2" }, { "reactionmeddraversionpt": "18.0", "reactionmeddrapt": "Abdominal pain" } ], "drug": [ { "drugcharacterization": "1", "medicinalproduct": "YAZ", "drugauthorizationnumb": "021676", "drugdosagetext": "UNK", "drugdosageform": "FILM-COATED TABLET", "drugstartdateformat": "610", "drugstartdate": "200712", "activesubstance": { "activesubstancename": "DROSPIRENONE\\ETHINYL ESTRADIOL" }, "openfda": { "application_number": [ "NDA021676" ], "brand_name": [ "YAZ" ], "generic_name": [ "DROSPIRENONE AND ETHINYL ESTRADIOL" ], "manufacturer_name": [ "Bayer HealthCare Pharmaceuticals Inc." ], "product_ndc": [ "50419-405" ], "product_type": [ "HUMAN PRESCRIPTION DRUG" ], "rxcui": [ "630734", "748797", "748798", "748856" ], "spl_id": [ "4f14f9c9-411b-48b0-a3d3-cac639cdfb8b" ], "spl_set_id": [ "065f33e4-b587-4e66-b896-ca9ab7b7c876" ], "package_ndc": [ "50419-405-03" ] } }, { "drugcharacterization": "2", "medicinalproduct": "NICOTINE.", "activesubstance": { "activesubstancename": "NICOTINE" }, "openfda": { "application_number": [ "ANDA074507", "ANDA074707", "ANDA090711", "ANDA078699", "ANDA078697", "ANDA077007", "ANDA079038", "ANDA203690", "ANDA074612", "NDA020076", "ANDA206393", "ANDA209206", "NDA020385", "ANDA079219", "ANDA090821", "M017", "ANDA206394", "ANDA076775", "ANDA207868", "ANDA210711", "ANDA078546", "ANDA079044", "505G(a)(3)", "NDA020165", "ANDA076779", "ANDA076777", "ANDA212056", "ANDA215357", "ANDA076789", "ANDA076569", "ANDA210712", "ANDA213266", "NDA020066", "ANDA079216", "ANDA074611", "ANDA074645" ], "brand_name": [ "NICOTINE", "KIRKLAND SIGNATURE NICOTINE", "NICOTINE TRANSDERMAL SYSTEM", "NICOTINE SUGAR FREE", "NICOTROL", "QUIT SMOKING PROVEN PATCHES", "NICOTINUM", "SIELKIN QUIT SMOKING NICOTINE PATCHES", "NICOTINE MINI", "NICOTINE PATCH", "RBUGR QUIT SMOKING NICOTINE PATCHES", "STPSMK QUIT SMOKING NICOTINE PATCHES", "QUIT SMOKING PATCHES", "NICOTINE TRANSDERMAL SYSTEM STEP 3", "NICOTINE TRANSDERMAL SYSTEM STEP 2", "NICOTINE TRANSDERMAL SYSTEM STEP 1", "NICOTINE STOP SMOKING AID", "GUHIO NICOTINE PATCH", "NICODERM CQ", "SIELKIN QUIT SMOKING NICOTINE PATCHES 21MG", "NWRB NICOTINE TRANSDERMAL PATCH", "NICOTINE POLACRILEX", "SIELKIN QUIT SMOKING NICOTINE PATCHES 14MG", "NICORETTE FRUIT CHILL NICOTINE POLACRILEX", "NICORETTE WHITE MINT NICOTINE POLACRILEX", "MEDLINE", "SEFUDUN QUIT SMOKING NICOTINE PATCHES" ], "generic_name": [ "NICOTINE POLACRILEX", "NICOTINE", "NICOTINE POLACRILEX MINI", "NICOTINE POLARILEX" ], "manufacturer_name": [ "Rugby Laboratories", "Costco Wholesale Company", "Walgreen Company", "Meijer, Inc.", "P & L Development, LLC", "CVS Pharmacy", "Publix Super Markets Inc", "Dr. Reddys Laboratories Inc.", "CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED", "Pharmacia & Upjohn Company LLC", "Lucy Goods, Inc.", "H E B", "Rite Aid Corporation", "Jiashen International Trade Limited", "Boiron", "McKesson Corporation dba SKY Packaging", "YITONGBADA (SHENZHEN) INTERNATIONAL TRADE CO., LTD", "Meijer Distribution Inc", "AmerisourceBergen (Good Neighbor Pharmacy) 46122", "Walgreens", "EXELAN PHARMACEUTICALS, INC.", "Rugby Laboratories, Inc.", "Guangzhou Yunzhen Trading Co., Ltd.", "Sam's West Inc", "Kroger Company", "HyVee Inc", "Nanjing Ludejin Corporation Management Co., Ltd", "Guangzhou Ouruisi Biotechnology Co., Ltd", "Padagis Israel Pharmaceuticals 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"41250-510-78", "41250-510-06", "37808-900-01", "37808-900-03", "37808-739-06", "56062-812-71", "30142-671-11" ], "nui": [ "N0000175706", "M0014836" ], "pharm_class_epc": [ "Cholinergic Nicotinic Agonist [EPC]" ], "pharm_class_cs": [ "Nicotine [CS]" ], "unii": [ "6M3C89ZY6R", "L7T10EIP3A" ], "rxcui": [ "359817", "314119", "311975", "359818", "198029", "198030", "198031", "892244", "1797886", "1797888", "2707585", "351427", "351429", "351433", "105071" ] } }, { "drugcharacterization": "2", "medicinalproduct": "LIPITOR", "drugstructuredosagenumb": "10", "drugstructuredosageunit": "003", "drugseparatedosagenumb": "1", "drugintervaldosageunitnumb": "1", "drugintervaldosagedefinition": "804", "drugdosagetext": "10 MG, UNK", "drugadministrationroute": "048", "activesubstance": { "activesubstancename": "ATORVASTATIN CALCIUM" }, "openfda": { "application_number": [ "NDA020702" ], "brand_name": [ "LIPITOR" ], "generic_name": [ "ATORVASTATIN CALCIUM" ], "manufacturer_name": [ "Viatris Specialty LLC" ], "product_ndc": [ "58151-155", "58151-156", "58151-157", "58151-158" ], "product_type": [ "HUMAN PRESCRIPTION DRUG" ], "route": [ "ORAL" ], "substance_name": [ "ATORVASTATIN CALCIUM TRIHYDRATE" ], "rxcui": [ "259255", "262095", "617310", "617311", "617312", "617314", "617318", "617320" ], "spl_id": [ "dd011a82-7356-4b83-86c4-b21cd9138fc6" ], "spl_set_id": [ "a60cc18b-0631-4cf0-b021-9f52224ece65" ], "package_ndc": [ "58151-155-77", "58151-156-77", "58151-157-77", "58151-158-77" ], "unii": [ "48A5M73Z4Q" ] } }, { "drugcharacterization": "1", "medicinalproduct": "YASMIN", "drugdosagetext": "UNK", "drugdosageform": "FILM-COATED TABLET", "drugstartdateformat": "602", "drugstartdate": "2004", "drugenddateformat": "602", "drugenddate": "2005", "activesubstance": { "activesubstancename": "DROSPIRENONE\\ETHINYL ESTRADIOL" }, "openfda": { "application_number": [ "NDA021098" ], "brand_name": [ "YASMIN" ], "generic_name": [ "DROSPIRENONE AND ETHINYL ESTRADIOL" ], "manufacturer_name": [ "Bayer HealthCare Pharmaceuticals Inc." ], "product_ndc": [ "50419-402" ], "product_type": [ "HUMAN PRESCRIPTION DRUG" ], "rxcui": [ "284207", "748797", "748800", "748857" ], "spl_id": [ "84c4a6e5-8157-4f6d-a51f-3665e8568a3c" ], "spl_set_id": [ "d7ea6a60-5a56-4f81-b206-9b27b7e58875" ], "package_ndc": [ "50419-402-03" ] } }, { "drugcharacterization": "2", "medicinalproduct": "LEXAPRO", "drugstructuredosagenumb": "20", "drugstructuredosageunit": "003", "drugseparatedosagenumb": "1", "drugintervaldosageunitnumb": "1", "drugintervaldosagedefinition": "804", "drugdosagetext": "20 MG, QD", "drugadministrationroute": "048", "activesubstance": { "activesubstancename": "ESCITALOPRAM OXALATE" }, "openfda": { "application_number": [ "NDA021323" ], "brand_name": [ "LEXAPRO" ], "generic_name": [ "ESCITALOPRAM" ], "manufacturer_name": [ "Allergan, Inc." ], "product_ndc": [ "0456-2005", "0456-2010", "0456-2020", "0456-2101" ], "product_type": [ "HUMAN PRESCRIPTION DRUG" ], "route": [ "ORAL" ], "substance_name": [ "ESCITALOPRAM OXALATE" ], "rxcui": [ "349332", "351249", "351250", "351285", "352272", "352273", "404408", "404420" ], "spl_id": [ "9ff46a66-0f97-4a78-9d18-ec576f63bae7" ], "spl_set_id": [ "13bb8267-1cab-43e5-acae-55a4d957630a" ], "package_ndc": [ "0456-2005-01", "0456-2010-01", "0456-2010-11", "0456-2010-63", "0456-2020-01", "0456-2020-11", "0456-2020-63", "0456-2101-08" ], "unii": [ "5U85DBW7LO" ] } } ], "summary": { "narrativeincludeclinical": "CASE EVENT DATE: 200801" } } }, { "safetyreportversion": "1", "safetyreportid": "10004259", "primarysourcecountry": "US", "occurcountry": "US", "transmissiondateformat": "102", "transmissiondate": "20141002", "reporttype": "1", "serious": "2", "receivedateformat": "102", "receivedate": "20140312", "receiptdateformat": "102", "receiptdate": "20140312", "fulfillexpeditecriteria": "2", "companynumb": "US-INCYTE CORPORATION-2013IN002960", "duplicate": "1", "reportduplicate": { "duplicatesource": "INCYTE", "duplicatenumb": 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"FDA" }, "patient": { "patientweight": "61.22", "patientsex": "2", "reaction": [ { "reactionmeddraversionpt": "17.0", "reactionmeddrapt": "Off label use", "reactionoutcome": "6" }, { "reactionmeddraversionpt": "17.0", "reactionmeddrapt": "Drug ineffective", "reactionoutcome": "6" } ], "drug": [ { "drugcharacterization": "1", "medicinalproduct": "OXYTROL FOR WOMEN", "drugbatchnumb": "3E04WS", "drugauthorizationnumb": "202211", "drugdosagetext": "UNK, UNKNOWN", "drugdosageform": "TRANSDERMAL PATCH", "drugadministrationroute": "062", "drugindication": "URINARY INCONTINENCE", "drugstartdateformat": "102", "drugstartdate": "20140124", "drugenddateformat": "102", "drugenddate": "20140209", "openfda": { "application_number": [ "NDA202211" ], "brand_name": [ "OXYTROL FOR WOMEN" ], "generic_name": [ "OXYBUTYNIN" ], "manufacturer_name": [ "Allergan, Inc." ], "product_ndc": [ "0023-9637" ], "product_type": [ "HUMAN OTC DRUG" ], "route": [ "TRANSDERMAL" ], "substance_name": [ "OXYBUTYNIN" ], 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Smith Co., Inc.", "Alternacare Home Health Services", "Ozark Physical Medicine Center for Operations Ozark Plaza and Medical Services DBA Ozark Home Medical Equipment", "AGP LLC", "Johns Hopkins Pharmaquip", "Reliance Bottle Gas Company Inc. dba Reliance Oxygen & Equipment Co.", "T.W. Smith Corp.", "Mountain West Medical Supply LLC", "Laurel Medical Supplies, Inc. dba Laurel Medical Solutions", "The Medical Store, Inc.", "AMO Medical Oxygen, Inc.", "Southern Tier Home Medical Supplies Inc", "United Respiratory Services, LLC", "Strate Welding Supply Co, Inc.", "Rogers Pharmacy", "AMERICAN MEDICAL GAS RESOURCES LLC", "Wesco Gas & Welding Supply, Inc.", "Leading Respiratory Service Inc.", "Depke Welding Supplies, Inc.", "Respiratory Medical Services", "Mercy Home Medical Equipment Inc dba MercyOne Clinton Home Medical Equipment", "InHome Oxygen & Medical Supplies, Inc.", "East Coast Oxygen", "Buckeye Home Health Center, Inc.", "AdaptHealth West, LLC", "Arcet Equipment Company dba Arc3 Gases North", "Advocate Home Care Products", "Intermountain Home Care", "Garrett County Memorial Hospital", "Surgimed Corporation", "Olympic Ambulance Inc. DBA Olympic Oxygen Service", "Med-Caire Inc.", "Atlas Welding Supply Company, Inc.", "Timberlake Respiratory Care and Home Medical", "MasVida Health Care Solutions, LLC", "JW Welding Supplies & Tools", "WEST PENN LACO, INC.", "IWS Gas and Supply of Texas, LTD", "Alpha Oxy-Med LLC", "Whole Gas Technologies LLC", "BayCare Home Care, Inc.", "Air Liquide Canada Inc", "B & J Welding Supply, LTD. dba B & J Welding Supply", "Express Medical Inc", "Mountain Aire Medical Supply, Inc", "Integrated HomeCare Services, Inc.", "Texoma Medical Services, Inc. dba Western Medical Equipment", "Florida Oxygen & Transfilling Inc.", "Bradshaw's Industrial Supply, Inc. dba Interstate Welding Supply", "Crumpton Welding Supply & Equipment, Inc.", "Elixair Medical Inc", "SAKRX, LLC dba Kohll's RX", "NexAir, LLC", "Ineos Pigments ASU LLC", "Fitzsimmons Surgical Supply, Inc", "Oxygen Support Systems Inc", "Noble Gas Solutions, Inc.", "Johnson Drug Company, Inc", "Roadrunner Oxygen Service, Inc.", "Memorial Health System of East Texas dba Memorial Medical Center East Texas", "West Healthcare Solutions, Inc dba Mercy Plaza Respiratory & Medical Supply", "Therap-ease Inc.", "Accurate Healthcare, Inc.", "UnityPoint at Home", "Professional Medical Supply", "Medi-Fair, Inc", "Elliot Hospital of the City of Manchester DBA: Home Medical Equipment and Infusion Services of Manchester & Southern N.H.", "Victor Welding Supply Company", "SG Homecare, Inc.", "Red Ball Oxygen Co., Inc.", "Medical Equipment and Supplies of America, LLC", "General Distributing Co.", "WELDERS SUPPLY COMPANY OF LOUISVILLE, INC.", "Inmon Respiratory Services Inc.", "West Plains Health Service, Inc. dba Ozarks Healthcare Medical Equipment", "Dona Ana Medical Supply", "Smith's Drugs fo Forest City, Inc. dba Smith Drugs", "Medex LLC dba Medical Express", "Medical Equipment Solutions Inc dba Pur Air Products", "McKinley Medical Supply, Inc.", "Southern Gas and Supply LLC", "Frances Mahon Deaconess Hospital Home Oxygen", "Thompson Brothers Supplies Inc", "Super Gas, Inc.", "Greene Respiratory Services, Inc", "Machine & Welding Supply Company dba Arc3 Gases South", "Welders Supply Company", "Sanford HealthCare Accessories, LLC", "Biomedics Systems, Inc.", "Millennium Medical Supply", "California Tool and Welding Supply, LLC", "AxisCare Health Logistics, Inc.", "Isla Home Infusion", "Dusara Corporation dba UniversalMed Supply", "One Home Medical Equipment, LLC", "American Oxygen Company, Inc", "Lampton Welding Supply Company, Inc", "Comanche County Hospital Authority DBA Memorial Medi-Equip", "A & E Mill & Welding Supply Company", "Rocky Mountain Medical Equipment LLC", "Fresno Oxygen & Welding Suppliers Inc", "Parkmor Drug Inc. dba Goshen Home Medical", "All Saints Healthcare", "Larry's Home Oxygen, Inc.", "H & H Drug Stores Inc., DBA Western Drug Medical Supply", "Mountaineer Home Medical LLC", "Family Enterprises LLC dba Preferred Cylinder Services", "Geer Gas Corporation", "Premier Oxygen LLC", "Pulmonaire Service, Inc.", "Jackson Welding Supply Co Inc.", "Metro Welding Supply Corporation", "Service Drug dba Petersen Drug", "Institutional Care Pharmacy", "E-Z Oxygen LLC, dba AO2", "ProCaire, LLC", "Specialty Medical Products, Inc.", "Eastern Welding Supply, Inc.", "Spectrum Gas Products, Inc", "Penn Highlands Home Medical Equipment, LLC", "Loving Care and More Home Medical", "ALLIED MEDCOR SERVICES, INC.", "Atlas Welding Supply Co Inc", "Tennessee Medical Equipment, Inc.", "B&K Prescription Shop", "Beachwood Medical Supply, Inc.", "Young Welding Supply, Inc", "OxyPros Plus", "Velacorp, Inc. dba Lee's Pharmacy & Medical Equipment", "Lubbock Oxygen & Medical Gases, Inc.", "Superior Medical Equipment Company, LLC", "Clinical Medical Services, Inc.", "O2 Depot, LLC", "Diamond Respiratory Care, Inc.", "Dennis Welding Supply, Inc.", "C&C Oxygen Company", "Advantage Respiratory Services", "Enos Home Oxygen Therapy, Inc.", "RXO2 Oxygen & Medical Equipment Supply Co. Inc.", "Norco, Inc.", "Dillon Medical Supply", "DJB Gas Services, Inc", "Max's Breathe Easy Gases & Supplies, Inc.", "O.E. Meyer Company", "Eureka Oxygen Company", "Messer LLC", "Sentry Welding Supply LLC", "Medox Corporation", "Uintah Basin Medical Center dba Home Health Equipment and Supply", "Aspen Air U.S., LLC", "Allegheny Health Network Home Medical Equipment LLC", "KTL&C LLC dba RX Positive Medical Supply", "ANALGESIC SERVICES, INC.", "FULLERTON WELDING SUPPLY", "Volunteer Welding Supply Inc", "Maag Prescription Center, LLC", "Liquid O2 Transfills, Inc.", "Home Healthworks Inc.", "Craig's Drug Store, Inc.", "Hawaii Home Infusion Associates, Ltd.", "Central-McGowan, Inc.", "Linde Gas & Equipment Inc.", "Gemstone Gas, LLC", "CRYOGENIC SOLUTIONS LLC", "Heckman Healthcare Service & Supplies Inc. dba Quipt Home Medical", "Del Rio Welders Equipment, Inc.", "Service Drug", "Bickett Machine and Supply, Inc", "Southern Gas and Supply of Mississippi, Inc.", "Cook Children's Home Health", "United States Welding, Inc.", "General Air Service & Supply Co", "Baker's Gas & Welding Supplies Inc.", "O2 Plus, Inc", "Lubbock Welding Supply", "AIRSERVE, LLC", "Arkansas Welding Supply, Inc.", "Youngstown Oxygen & Welding Supply, Inc.", "T & C Flynn's Pharmacy Inc", "Gulf Coast Gas & Equipment, LLC", "Mississippi Welders Supply Company, Inc.", "MITCHELL WELDING SUPPLY DBA Meritus Texas", "Oz Arc/gas Equipment & Supply, Inc.", "Tri State Medical Supply", "KENRIC INC dba Trinity Medical Supplies", "Seaboard Welding Supply, Inc.", "Haun Specialty Gases, Inc.", "At Home Health Equipment", "Doyle's Medical Supply LLC", "SYOXSA, Inc.", "Oxygen Service Company, Inc", "Sandcreek Medical Sales and Rentals Inc", "Carepro Health Risk Management", "Williams Bros Health Care Pharmacy, Inc.", "Medical Comfort Systems Inc", "MID-SOUTH WELDING SUPPLY, INC.", "Butler Gas Products Company", "Aero All Gas Company", "Triweld Industries, Inc.", "TIMS SOUTH TEXAS LLC", "StateServ Medical, LLC", "Cammack's Pharmacies, Inc. dba Jim's Pharmacy", "GIBBS WELDING SUPPLY, INC.", "Greenville Truck and Welding Supplies LLC", "Air Liquide Large Industries U.S. LP", "Stillwater Medical Authority DBA Cimarron Medical Services", "CORNERSTONE HEALTH SYSTEMS, L.L.C.", "North Central Respiratory, Inc", "ROBINSON`S INDUSTRIAL GAS & EQUIPMENT CORP.", "Jones County Medical Supplies, Inc. dba Jones County Medical Supply, Inc.", "Walnut Medical Services", "Fairmeadows Home Health Center", "Professional Medical Services & Products, Inc.", "Linde Canada Inc.", "Island Equipment Company", "Bill Munn Supply, Inc.", "A&B Welding Supply, LLC", "Advanced Oxy-Med Services Inc", "General Welding Supply Corp.", "Life DME, LLC", "Genesis Respiratory Services", "Oxarc, LLC", "Quality Air Products Inc", "Westmoreland Medical Equipment, Inc.", "HOWARDS MEDICAL LLC", "Terry Supply Company Inc", "Linde Inc.", "Billings Clinic Home Oxygen & Medical Equipment Inc", "Lakeshore Respiratory Therapy Care Services, SC dba Lakeshore Respiratory Therapy Services, Inc.", "Haun Welding Supply, Inc.", "SOUTHERN GAS AND SUPPLY, INC. dba Gas and Supply", "Memorial Home Services of Central Illinois, Inc.", "Commonwealth Home Health Care, Inc.", "Adventist Health Sonora dba Adventist Health Oxygen & Medical Supply", "Humphries, Inc.", "CEE-KAY SUPPLY, INC.", "Peninsula Home Health Care", "A PLUS HOME MEDICAL, INC.", "MAVERICK OXYGEN & RESPIRATORY EQUIPMENT, LLC", "Kaup Pharmacy, Inc.", "Airtec Gases, LLC", "Messer Gas Puerto Rico, Inc", "Thumb Welding Supplies Inc", "American Welding & Gas, Inc.", "DuPuy Oxygen & Supply Company, Inc.", "Bandy's Pharmacy", "B & J WELDING SUPPLY, LTD. dba B & J Welding Supply", "Ali-Rob, Inc. dba Southern Oxygen & Welding Supply", "American Medical Inc", "Carolina Home Medical, Inc.", "Wilson Products Compressed Gas Co.", "Earlbeck Welding Supplies", "Matheson Tri-Gas, Inc.", "ALLIED GASES AND WELDING SUPPLIES, INC.", "Huber Supply Co. Inc.", "Boone Drugs, Inc", "Home Health Medical Equipment, Inc.", "Trico Oxygen", "Jayco Industrial Supply Inc", "TULSA GAS & GEAR, LLC", "Cornerstone Medical Services - Midwest, LLC", "Respiratory Care Partners, Inc", "Corrigan Propane LLC dba Blue Water Industrial Products", "Helget Gas Products", "Mount Vernon Community Pharmacy, Inc. dba TMS Mobility and Rehab", "AlpinAire Healthcare", "Super Care, LLC", "Minneapolis Oxygen Company", "Verio Healthcare, Inc.", "Smith's Home Medical Equipment, Inc.", "Liberty Oxygen and Homecare, Inc. dba Liberty Oxygen and Home Care, Inc.", "Alick's Home Medical Equipment, Inc.", "Augusta Health dba Care Home Medical", "Superior Welding Supply Co", "Clinical 1 Home Medical, Inc.", "Keen Compressed Gas Co. Inc.", "Coastal Med-Tech Corp.", "Calmar dba A&R Medical Supply", "Medassure Inc", "Gage Lucky 13 LLC dba Tecumseh Oxygen & Medical Supply", "Advanced Medical Equipment, LLC", "Central Welding Supply Company", "Central Drug Dorado Corp.", "James Oxygen and Supply Company", "ILMO Products Company", "- INDUSTRIAL WELDING SUPPLY CO. OF HARVEY, INC.", "Modern Supply Company, Inc.", "Boggs Gases div. Boggs Fire Equipment", "Airweld, Inc.", "All Oxygen Refills, Inc.", "Airgas USA, LLC", "CareLinc Medical Equipment", "Quick-Fill Mobile Oxygen LLC", "In Home Medical & Respiratory Services, Inc", "Bay State Medical, Inc.", "Denman Services, Inc.", "First Community Care", "BAY STREET PHARMACY, INC", "Rotech Healthcare Inc", "Ross Medical Supply Co. 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Posen", "Badger Welding Supplies, Inc.", "Respitek Inc", "Kent Welding Supply", "Pacific Island Medical, Inc.", "MEDICAL-TECHNICAL GASES, INC.", "Pieri Inc dba McKnight Medical Equipment", "James Supplies, L.L.c", "Gas and Supply Carolinas, LLC", "Wiggins Drugs, Limited", "Alpine Medical, LLC", "Vantage DME Partnership dba Vantage Home Medical Equipment and Services", "Med Resources, Inc.", "Professionals PRN LLC dba Genesis Oxygen & Sleep Therapy", "T J Nowak Supply Co Inc", "RTA Pediatric Care Inc.", "VirtAir Inc.", "Jernigan Healthcare, Inc.", "County Welding Supply Co.", "Bernens Convalescent Pharmacy, Inc", "Support Medical Systems, Inc.", "Northeast Home Medical Supplies Inc.", "Abilene Oxygen Inc.", "St. Luke Community Hospital and Nursing Home dba Saint Luke Community Oxygen & Medical Equipment", "Dade Medical, Inc. dba Integrated Home Care", "Eagle Home Medical Corp.", "T & S Home Oxygen Supply Co.", "Virginia Medical and Respiratory Equipment Inc", "Logan Health", "Messer 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"US", "occurcountry": "US", "transmissiondateformat": "102", "transmissiondate": "20141002", "reporttype": "1", "serious": "2", "receivedateformat": "102", "receivedate": "20140312", "receiptdateformat": "102", "receiptdate": "20140328", "fulfillexpeditecriteria": "1", "companynumb": "US-RB-064355-14", "duplicate": "1", "reportduplicate": { "duplicatesource": "RECKITT BENCKISER", "duplicatenumb": "US-RB-064355-14" }, "primarysource": { "reportercountry": "US", "qualification": "5" }, "sender": { "sendertype": "2", "senderorganization": "FDA-Public Use" }, "receiver": { "receivertype": "6", "receiverorganization": "FDA" }, "patient": { "patientonsetage": "55", "patientonsetageunit": "801", "patientsex": "2", "reaction": [ { "reactionmeddraversionpt": "17.0", "reactionmeddrapt": "Wrong technique in drug usage process", "reactionoutcome": "3" } ], "drug": [ { "drugcharacterization": "1", "medicinalproduct": "SUBOXONE FILM", "drugbatchnumb": "UNKNOWN", "drugauthorizationnumb": "022410", "drugdosagetext": "SUBOXONE FILM; TAKING 2.5 STRIPS DAILY", "drugadministrationroute": "060", "drugindication": "DRUG DEPENDENCE", "drugstartdateformat": "602", "drugstartdate": "2011", "actiondrug": "4" }, { "drugcharacterization": "1", "medicinalproduct": "SUBOXONE FILM", "drugbatchnumb": "UNKNOWN", "drugauthorizationnumb": "022410", "drugdosagetext": "SUBOXONE FILM; TAKING 2.5 STRIPS DAILY", "drugadministrationroute": "060", "drugindication": "DRUG DEPENDENCE", "drugstartdateformat": "602", "drugstartdate": "2011", "actiondrug": "4" }, { "drugcharacterization": "2", "medicinalproduct": "STOOL SOFTENER", "drugdosagetext": "1 TABLET OF UNSPECIFIED STRENGTH TAKEN AS NEEDED", "drugadministrationroute": "048", "drugindication": "CONSTIPATION", "drugstartdateformat": "602", "drugstartdate": "1999", "openfda": { "application_number": [ "M007", "505G(a)(3)" ], "brand_name": [ "STOOL SOFTENER", "STOOL SOFTENER STIMULANT LAXATIVE", "STOOL SOFTENER EXTRA STRENGTH", "STOOL SOFTENER PLUS STIMULANT LAXATIVE", "STOOL SOFTENER PLUS STIMULANT", "STOOL SOFTENER REGULAR STRENGTH", "STOOL SOFTENER WITH LAXATIVE" ], "generic_name": [ "DOCUSATE CALCIUM", "DOCUSATE SODIUM", "MARC GLASSMAN", "DOCUSATE SODIUM SENNOSIDES", "DOCUSATE SODIUM AND SENNOSIDES", "DOCUSATE SODIUM 100MG", "STOOL SOFTENER" ], "manufacturer_name": [ "Walgreens", "CVS Pharmacy", "Marc Glassman, Inc.", "QUALITY CHOICE (Chain Drug Marketing Association)", "HEB", "Bi-Mart", "Reliable 1 Laboratories LLC", "KROGER COMPANY", "P & L Development, LLC", "EQUATE (Wal-Mart Stores, Inc.) 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