{ "meta": { "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. 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WINTERGREEN", "CVS MIXED BERRY ANTACID HBG 28CT", "BEST CHOICE EXTRA STRENGTH TROPICAL FRUIT", "HEB EXTRA STRENGTH SMOOTH ANTACID ASSORTED FRUITS", "TUMS", "ULTRA STRENGTH ASSORTED BERRY ANTACID", "GOODSENSE ULTRA STRENGTH ANTACID", "FEVIA ACID CONTROL", "REGULAR STRENGTH ANTACID ASSORTED FRUIT REGULAR STRENGTH ANTACID", "TOPCARE ANTACID CALCIUM ULTRA STRENGTH", "EXTRA STRENGTH", "TOPCARE ANTACID CALCIUM", "MEIJER EXTRA STRENGTH ASSORTED FRUIT", "KROGER CHERRY ANTACID SOFT CHEW", "CARDINALEXTRA STRENGTH ANTACID WINTERGREEN FLAVOR", "KIDS TUMMY RELIEF", "ULINE ANTACID", "EQUQLINE REGULAR STRENGTH ANTACID", "LEADER EXTRA STRENGTH ANTACID", "EQUALINE REGULAR STRENGTH ANTACID PEPPERMINT", "EXTRA STRENGTH ANTACID TROPICAL FRUIT", "MEIJER REGULAR STRENGTH PEPPERMINT FLAVOR", "TUMS CHEWY BITES TROPICAL FRUIT SMOOTHIE", "CARDINAL EXTRA STRENGTH SMOOTH ANTACID ASSORTED FRUITS", "BELMORA MELOX AGRURA", "DG HEALTH EXTRA STRENGTH ANTACID WINTERGREEN FLAVOR", "WHOLE FOODS MARKET REGULAR STRENGTH PEPPERMINT FLAVOR", "SOOTHE CHILDRENS", "GOODSENSE EXTRA STRENGTH ANTACID", "EXTRA STRENGTH SMOOTH PEPPERMINT ANTACID", "REGULAR STRENGTH ANTACID REGULAR STRENGTH ANTACID", "EXTRA STRENGTH SUGAR FREE ORANGE CREAM FLAVOR", "EXTRA STRENGTH SUGAR FREE ANTACID", "KOSHER MEDS ANTACID", "ANTACID EXTRA STRENGTH", "KIDS ANTACID", "PUBLIX EXTRA STRENGTH ASSORTED BERRY", "KROGER ULTRA STRENGTH ASSORTED FRUIT", "DG HEALTH EXTRA STRENGTH ASSORTED FRUITS ANTACID", "ANTACID EXTRA STRENGTH ASSORTED BERRY", "TUMS ULTRA", "MGC HEALTH CALCIUM CARBONATE ANTACID ASSORTED BERRIES", "XPECT ANTACID", "HYVEE ULTRA STRENGTH ANTACID SOFT CHEWS CHERRY", "ULTRA STRENGTH ANTACID ASSORTED FRUIT", "GUARDIAN EXTRA STRENGTH ANTACID", "CHILDRENS STOMACH RELIEF ANTACID", "CAREONE EXTRA STRENGTH ASSORTED FRUITS", "ULTRA STRENGTH ANTACID TROPICAL FRUIT FLAVOR", "TUMS CHEWY BITES PEPPERMINT", "ALKA-SELTZER COOL ACTION EXTRA STRENGTH RELIEFCHEWS MINT", "WALGREENS EXTRA STRENGTH SMOOTH ANTACID", "RUGBY EXTRA STRENGTH ANTACID", "BASIC CARE ANTACID FRUIT CHEWS", "RITE AID PHARMACY EXTRA STRENGTH ASSORTED BERRIES", "HEB EXTRA STRENGTH SUGAR FREE ANTACID 174", "BI-MART REGULAR STRENGTH ANTACID", "FOSTER AND THRIVE REGULAR STRENGTH ANTACID", "GOOD NEIGHBOR PHARMACY ANTACID REGULAR STRENGTH", "EXTRA STRENGTH ANTACID SMOOTH DISSOLVING - ASSORTED FRUIT", "TUMS CHEWY BITES", "MGC HEALTH CALCIUM CARBONATE ANTACID TROPICAL FRUIT", "ORANGE ANTACID SOFT CHEW", "ALKA-SELTZER ULTRA STRENGTH HEARTBURN RELIEFCHEWS STRAWBERRY AND ORANGE", "TUMS CHEWY BITES MIXED FRUIT", "CVS MIXED BERRY ANTACID HBG 54CT", "CHILDRENS STOMACH RELIEF", "FAMILY WELLNESS REGULAR STRENGTH ANTACID 126 REGULAR STRENGTH ANTACID", "WALGREENS WILD BERRY ANTACID CHEWS", "PUBLIX EXTRA STRENGTH TROPICAL FRUIT", "RITE AID PHARMACY ULTRA STRENGTH ASSORTED FRUITS", "BESTMADE NATURAL PRODUCTS CALCIUM CARBONATE (CALC CARB)", "WINCO FOODS ANTACID REGULAR STRENGTH", "D-CAL", "CVS EXTRA STRENGTH SMOOTH", "ULTRA STRENGTH ASSORTED BERRIES", "HEB EXTRA STRENGTH SMOOTH ANTACID PEPPERMINT", "MEIJER WILD BERRY ANTACID CHEWS", "MGC HEALTH CALCIUM CARBONATE ANTACID ASSORTED FRUITS", "HEARTBURN AND GAS FRUIT CHEWS", "ALKA-SELTZER EXTRA STRENGTH HEARTBURN RELIEFCHEWS", "CALCIUM ANTACID", "ALKA-SELTZER HEARTBURN RELIEFCHEWS STRAWBERRY AND ORANGE", "MCKESSON ANTACID CALCIUM CARBONATE", "CALCIUM CARBONATE ANTACID ASSORTED BERRIES", "MIXED BERRY ANTACID AND ANTI-GAS CHEWS", "EXCHANGE SELECT ULTRA STRENGTH ANTACID ASSORTED FRUIT", "ALKA-SELTZER COOL ACTION HEARTBURN RELIEF MINT", "RITE AID EXTRA STRENGTH ASSORTED FRUIT", "TUMEEZ ORGANIC APPLE", "TUMEEZ ORGANIC GRAPE", "TUMEEZ VARIETY PACK", "TOPCARE ULTRA STRENGTH ANTACID PEPPERMINT", "ANTACID CHILDRENS", "AMAZON ULTRA STRENGTH ANTACID", "ASSORTED FRUIT ANTACID CHEWS", "RITE AID EXTRA STRENGTH ASSORTED FRUITS", "HEB ANTACID CALCIUM ASSORTED BERRY", "EXTRA STRENGTH NATURAL ANTACID", "UNISHIELD ANTACID", "CHILDRENS TUMMY RELIEF", "GUARDIAN ULTRA STRENGTH ANTACID ASSORTED FRUIT", "BI-MART EXTRA STRENGTH ANTACID ASSORTED BERRY", "PHYSICIANSCARE ANTACID", "CVS NATURALS", "DG HEALTH ULTRA STRENGTH ASSORTED BERRY ANTACID", "PUBLIX ULTRA STRENGTH ASSORTED FRUIT", "GUARDIAN REGULAR STRENGTH ALKUMS", "ANTACID RELIEF", "EXTRA STRENGTH ANTACID SMOOTH DISSOLVE ASSORTED FRUIT", "EXTRA STRENGTH SMOOTH", "DG HEALTH REGULAR STRENGTH ANTACID", "EQU ULTRA STRENGTH ANTACID ASSORTED FRUIT 171AF", "REGULAR STRENGTH ANTACID ASSORTED FRUIT", "RITE AID EXTRA STRENGTH TROPICAL FRUIT", "TOPCARE EXTRA STRENGTH ANTACID ASSORTED FRUIT", "ASSORTED FRUIT ANTACID FLAVOR CHEWS", "TOPCARE CHERRY ANTACID SOFT CHEWS", "FW EXTRA STRENGTH AF SMOOTH ANTACID", "LEADER ULTRA STRENGTH ANTACID", "REGULAR STRENGTH ASSORTED FRUIT", "MGC HEALTH ANTACID SOFT CHEWS CHERRY FLAVOR", "ANTACID FLAVOR CHEW", "NOVA ANTACID", "BI-MART ULTRA STRENGTH ANTACID ASSORTED FRUIT", "ALKUMS ANTACID", "EXTRA STRENGTH SMOOTH ANTACID ASSORTED BERRIES", "CVS PHARMACY ASSORTED FRUIT ANTACID", "MEIJER EXTRA STRENGTH SMOOTH ANTACID ASSORTED FRUITS", "WONDERBELLY MAXIMUM STRENGTH ANTACID - SWEET MINT", "GDC EXTRA STRENGTH ALKUMS ANTACID 127AF", "CHILDRENS ANTACID EXTRA STRENGTH", "BI-MART EXTRA STRENGTH ANTACID ASSORTED FRUIT", "GOODSENSE ULTRA STRENGTH ANTACID PEPPERMINT", "EQUATE WILD BERRY ANTACID CHEWS", "TOPCARE EXTRA STRENGTH ANTACID EXTRA STRENGTH ANTACID ASSORTED BERRY", "GOODSENSE EXTRA STRENGTH ANTACID ASSORTED FRUIT", "TUMS NATURALS", "WINCO FOODS ANTACID EXTRA STRENGTH", "EXTRA STRENGTH ASSORTED FRUIT ANTACID", "PEPTO KIDS", "TUMS CHEWY BITES BERRY SHAKE", "EXTRA STRENGTH ASSORTED BERRY", "BASIC CARE BERRY ANTACID HBG", "EQUATE ULTRA STREGTH ANTACID", "GUARDIAN EXTRA STRENGTH ASSORTED BERRY ANTACID EXTRA STRENGTH ASSORTED BERRY ANTACID", "KIRKLAND ULTRA STREGTH ANTACID 171AB", "CVS ORANGE CREAM ANTACID CHEWS", "EXTRA STRENGTH SMOOTH ANTACID ASSORTED FRUIT", "QUALITY CHOICE ULTRA STRENGTH ASSORTED FRUIT", "QUALITY CHOICE EXTRA STRENGTH ASSORTED FRUIT", "GOODSENSE ULTRA STRENGTH ANTACID ASSORTED FRUIT", "ALKA-SELTZER HEARTBURN RELIEFCHEWS", "RITE AID WILD BERRY ANTACID CHEWS", "FAMILY WELLNESS ANTACID RELIEF CHEWS", "TUMS CHEWY BITES ORANGE AND CREAM ES", "WALGREENS CHERRY BERRY LIME ANTACID HBG 54CT", "EXCHANGE SELECT EXTRA STRENGTH ANTACID ASSORTED BERRIES", "TUMS EXTRA STRENGTH SUGAR-FREE", "EQUALINE ULTRA STRENGTH ANTACID ASSORTED BERRY ULTRA STRENGTH ASSORTED FRUIT ANTACID", "EXTRA STRENGTH ASSORTED BERRY ANTACID", "ANTACID FLAVOR CHEWS", "KROGER EXTRA STRENGTH ASSORTED FRUIT", "CITRUS FLAVORED ANTACID", "TARGET ANTACID - ANTI-GAS RELIEF CHEWS", "FAMILY WELLNESS EXTRA STRENGTH ANTACID EXTRA STRENGTH ASSORTED FRUIT ANTACID", "CALCIUM ANTACIDEXTRA STRENGTH EXTRA STRENGTH", "HEB ULTRA STRENGTH ASSORTED FRUITS", "EQUQLINE EXTRA STRENGTH ANTACID ASSORTED FRUIT", "TOPCARE CHERRY BERRY LIME ANTACID HBG", "ULTRA STRENGTH ASSORTED FRUIT ANTACID", "AMAZON BASICS CHERRY ANTACID SC", "ALKA-SELTZER ULTRA STRENGTH HEARTBURN RELIEFCHEWS", "CVS PHARMACY ASSORTED BERRY ANTACID", "ALKA-SELTZER HEARTBURN RELIEF PEPPERMINT", "MARC GLASSMAN EXTRA STRENGTH", "PUBLIX REGULAR STRENGTH PEPPERMINT FLAVOR", "QUALITY CHOICE ASSORTED BERRIES EXTRA STRENGTH", "HEB WILD BERRY ANTACID CHEWS", "TARGET WILD BERRY ANTACID CHEWS 60CT", "MINT ANTACID 100", "MINT ANTACID 250", "CHERRY ANTACID", "MEDIQUE ALCALAK", "MEDI-FIRST ANTACID", "MEDI-FIRST PLUS ANTACID", "QUALITY CHOICE", "FOSTER AND THRIVE EXTRA STRENGTH SUGAR FREE ANTACID ORANGE", "MEIJER ULTRA STRENGTH ANTACID ASSORTED FRUIT", "TOPCARE ULTRA STRENGTH ANTACID ASSORTED BERRY", "BI-MART ULTRA STRENGTH ANTACID PEPPERMINT", "CALCIUM CARBONATE CHEWABLE ANTACID", "GOODSENSE REGULAR STRENGTH ANTACID", "BEST CHOICE REGULAR STRENGTH", "TARGET BERRY LIME HBG CHEWS", "TUMS CHEWY BITES VANILLA AND MINT", "DG HEALTH EXTRA STRENGTH ANTACID", "TOPCARE EXTRA STRENGTH ANTACID ASSORTED FRUIT EXTRA STRENGTH ANTACID ASSORTED FRUIT", "CALCIUM CARBONATE 1250 MG", "MEIJER EXTRA STRENGTH WINTERGREEN FLAVOR", "FAMILY WELLNESS ULTRA STREGTH ANTACID 171AB", 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"product_type": [ "HUMAN OTC DRUG" ], "route": [ "ORAL", "TOPICAL" ], "substance_name": [ "CALCIUM CARBONATE", "DIMETHICONE" ], "rxcui": [ "308892", "308915", "313884", "1358869", "1492387", "308907", "1432465", "308906", "1538595", "1484737", "1044532", "317865", "308901", "1044524", "577040", "2281777", "2204565", "2667489", "204636", "210111", "701392", "308891", "282465", "210117", "1653049" ], "spl_id": [ "44f5a000-3118-a60e-e063-6394a90a0088", "6c4d31c9-192b-4390-92e4-948e8acb1452", "326e3775-d7fa-2fd9-e063-6294a90a059b", "1f253919-2335-4266-a415-c0aacfa2e1dc", "4d5db8d8-b7f8-7946-e063-6394a90a24f9", "3168c90f-a092-ca4d-e063-6394a90a1737", "3c3de8f2-3421-e135-e063-6294a90a7072", "4c1b0b8c-69c3-95a4-e063-6394a90afc61", "ee4aed8d-899e-4a27-9d95-b11151eec298", "456882f3-c8a2-3854-e063-6394a90a8c4b", "464108e4-9e83-2e1b-e063-6294a90a3aeb", "32057a64-7164-6dbc-e063-6394a90a2827", "43118047-20f2-d9c4-e063-6394a90afc25", "0688a639-0392-47a1-ba1f-ea2412dbebba", 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"71288-803-91", "71288-803-92", "72603-751-01" ], "unii": [ "9242ECW6R0", "UXH81S8ZVB" ] } }, { "drugcharacterization": "2", "medicinalproduct": "METICORTEN", "drugstructuredosagenumb": "60", "drugstructuredosageunit": "003", "drugseparatedosagenumb": "1", "drugintervaldosageunitnumb": "1", "drugintervaldosagedefinition": "804", "drugadministrationroute": "065", "drugindication": "IMMUNOSUPPRESSION", "activesubstance": { "activesubstancename": "PREDNISONE" } }, { "drugcharacterization": "2", "medicinalproduct": "METHYLDOPA.", "drugadministrationroute": "065", "drugstartdateformat": "102", "drugstartdate": "20140114", "activesubstance": { "activesubstancename": "METHYLDOPA" }, "openfda": { "application_number": [ "ANDA070076", "NDA018934" ], "brand_name": [ "METHYLDOPA" ], "generic_name": [ "METHYLDOPA" ], "manufacturer_name": [ "Rising Pharma Holdings, Inc.", "Chartwell RX, LLC" ], "product_ndc": [ "64980-571", "64980-572", "62135-321", "62135-322" ], "product_type": [ "HUMAN PRESCRIPTION DRUG" ], "route": [ "ORAL" ], "substance_name": [ "METHYLDOPA" ], "rxcui": [ "197956", "197958" ], "spl_id": [ "807ace4b-b2af-44b4-9371-884d73e21601", "31442b54-cca3-2834-e063-6294a90aaccc" ], "spl_set_id": [ "9e22e1d8-04ec-4b67-92ea-b09c706f2703", "e1114a58-9ab5-486e-85ed-360365b06396" ], "package_ndc": [ "64980-572-01", "64980-571-01", "62135-321-90", "62135-321-18", "62135-322-90", "62135-322-18" ], "unii": [ "56LH93261Y" ] } } ], "summary": { "narrativeincludeclinical": "CASE EVENT DATE: 20130528" } } }, { "safetyreportversion": "2", "safetyreportid": "10005995", "primarysourcecountry": "US", "occurcountry": "US", "transmissiondateformat": "102", "transmissiondate": "20141002", "reporttype": "1", "serious": "1", "seriousnesshospitalization": "1", "receivedateformat": "102", "receivedate": "20140313", "receiptdateformat": "102", "receiptdate": "20140313", "fulfillexpeditecriteria": "1", "companynumb": "US-BEH-2011028045", "duplicate": "1", "reportduplicate": { "duplicatesource": "CSL BEHRING", "duplicatenumb": "US-BEH-2011028045" }, "primarysource": { "reportercountry": "US", "qualification": "5" }, "sender": { "sendertype": "2", "senderorganization": "FDA-Public Use" }, "receiver": { "receivertype": "6", "receiverorganization": "FDA" }, "patient": { "patientonsetage": "44", "patientonsetageunit": "801", "patientweight": "67", "patientsex": "2", "reaction": [ { "reactionmeddraversionpt": "17.0", "reactionmeddrapt": "Gastroenteritis Escherichia coli", "reactionoutcome": "6" }, { "reactionmeddraversionpt": "17.0", "reactionmeddrapt": "Nausea", "reactionoutcome": "6" }, { "reactionmeddraversionpt": "17.0", "reactionmeddrapt": "Vomiting", "reactionoutcome": "6" }, { "reactionmeddraversionpt": "17.0", "reactionmeddrapt": "Diarrhoea", "reactionoutcome": "6" }, { "reactionmeddraversionpt": "17.0", "reactionmeddrapt": "Bronchitis", "reactionoutcome": "6" }, { "reactionmeddraversionpt": "17.0", "reactionmeddrapt": "Dyspnoea", "reactionoutcome": "6" 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