{"database": "openregs", "table": "documents", "is_view": false, "human_description_en": "where docket_id = \"FDA-1982-N-0005\" and posted_year = 2016 sorted by posted_date descending", "rows": [["FDA-1982-N-0005-0022", "FDA", "FDA-1982-N-0005", "Tab II: Characteristics of the Solution Distinguishing Alka-Seltzer From Other Forms of Aspirin re Comment from Miles Laboratories, Inc.", "Supporting & Related Material", "Background Material", "2016-10-13T04:00:00Z", 2016, 10, null, null, "2016-10-13T18:28:40Z", null, 0, 0, "090000648050d5ed"], ["FDA-1982-N-0005-0026", "FDA", "FDA-1982-N-0005", "Tab VI: Evidence For Aspirin-Insensitive Mechanisms Capable of Effecting Normal Platelet Function", "Supporting & Related Material", "Background Material", "2016-10-13T04:00:00Z", 2016, 10, null, null, "2016-10-13T18:29:21Z", null, 0, 0, "090000648050d5f5"], ["FDA-1982-N-0005-0038", "FDA", "FDA-1982-N-0005", "Attachment 1: Introduction & Background re Comment from Adria Laboratories", "Supporting & Related Material", "Background Material", "2016-10-13T04:00:00Z", 2016, 10, null, null, "2016-10-13T20:11:01Z", null, 0, 0, "090000648050d69b"], ["FDA-1982-N-0005-0050", "FDA", "FDA-1982-N-0005", "Reference 11: Lukacovic M.F., Walters K.J., Dog bioavailability study with Pentagastrin - Pepto-Bismol with simethicone. PBDB # 14. Procter & Gamble. (1992)", "Supporting & Related Material", "Background Material", "2016-10-13T04:00:00Z", 2016, 10, null, null, "2016-10-13T20:19:01Z", null, 0, 0, "090000648050d6f2"], ["FDA-1982-N-0005-0064", "FDA", "FDA-1982-N-0005", "Appendix F re Supplement from Adria Laboratories", "Supporting & Related Material", "Background Material", "2016-10-13T04:00:00Z", 2016, 10, null, null, "2016-10-13T20:21:37Z", null, 0, 0, "090000648050d714"], ["FDA-1982-N-0005-0053", "FDA", "FDA-1982-N-0005", "Supplement from Procter and Gamble Company", "Other", "Supplement (SUP)", "2016-10-13T04:00:00Z", 2016, 10, "2016-10-13T04:00:00Z", null, "2016-10-13T20:20:21Z", null, 0, 0, "090000648050d6f8"], ["FDA-1982-N-0005-0077", "FDA", "FDA-1982-N-0005", "Attachment 4. \"Evaluation of Various Effervescent and Non-Effervescent Aspirin Formulations in Post Surgical Dental Pain\" (List of Table of Contents) re Request for Hearing from Miles, Inc.", "Supporting & Related Material", "Background Material", "2016-10-13T04:00:00Z", 2016, 10, null, null, "2016-10-13T20:32:47Z", null, 0, 0, "090000648050d725"], ["FDA-1982-N-0005-0085", "FDA", "FDA-1982-N-0005", "\"A Double-Blind, Single Dose Evaluation of the Relative Analgesic Efficacy and Adverse Effect Liability of Effervescent Aspirin, Non-Effervescent Aspirin and Placebo in the Treatment of Postoperative Pain Following Oral Surgery.\" (III. Protocol) re Request for Hearing from Miles, Inc.", "Supporting & Related Material", "Background Material", "2016-10-13T04:00:00Z", 2016, 10, null, null, "2016-10-13T20:33:42Z", null, 0, 0, "090000648050d741"], ["FDA-1982-N-0005-0106", "FDA", "FDA-1982-N-0005", "Attachment 1: Yip et al ., Chemical Equilibrium of Alka-Seltzer Solution and the Gas Formation Rate when Mixed with a Simulated Gastric Fluid", "Supporting & Related Material", "Background Material", "2016-10-13T04:00:00Z", 2016, 10, null, null, "2016-10-13T20:41:28Z", null, 0, 0, "090000648050d78c"], ["FDA-1982-N-0005-0027", "FDA", "FDA-1982-N-0005", "Tab VII: Evidence Against Assessing Any Role For Aspirin-Induced Platelet Dysfunction in Gastrointestinal Bleeding", "Supporting & Related Material", "Background Material", "2016-10-13T04:00:00Z", 2016, 10, null, null, "2016-10-13T18:29:31Z", null, 0, 0, "090000648050d5f7"], ["FDA-1982-N-0005-0035", "FDA", "FDA-1982-N-0005", "Background Material re Public Administrative File for the OTC Orally\nAdministered Products for Relief of Symptoms Associated\nwith Overindulgence in Food and Drink Rulemaking; Docket\nNo. 82N-0166", "Supporting & Related Material", "Background Material", "2016-10-13T04:00:00Z", 2016, 10, null, null, "2016-10-13T18:40:45Z", null, 0, 0, "090000648050d681"], ["FDA-1982-N-0005-0048", "FDA", "FDA-1982-N-0005", "Attachment 4: Aspirin, Paracetamol, and Haematemesis and Melaena by D. Coggon, M.J.S. Langman, and D. Spiegelhalter re Comment from Miles Laboratories, Inc.", "Supporting & Related Material", "Background Material", "2016-10-13T04:00:00Z", 2016, 10, null, null, "2016-10-13T20:14:53Z", null, 0, 0, "090000648050d6d8"], ["FDA-1982-N-0005-0060", "FDA", "FDA-1982-N-0005", "Table of Contents for Appendices re Supplement from Adria Laboratories", "Supporting & Related Material", "Background Material", "2016-10-13T04:00:00Z", 2016, 10, null, null, "2016-10-13T20:21:20Z", null, 0, 0, "090000648050d70d"], ["FDA-1982-N-0005-0065", "FDA", "FDA-1982-N-0005", "Appendix G re Supplement from Adria Laboratories", "Supporting & Related Material", "Background Material", "2016-10-13T04:00:00Z", 2016, 10, null, null, "2016-10-13T20:21:42Z", null, 0, 0, "090000648050d716"], ["FDA-1982-N-0005-0072", "FDA", "FDA-1982-N-0005", "Attachment 3. Effectiveness Data on the Solution (III) re Request for Hearing from Miles, Inc.", "Supporting & Related Material", "Background Material", "2016-10-13T04:00:00Z", 2016, 10, null, null, "2016-10-13T20:25:23Z", null, 0, 0, "090000648050d720"], ["FDA-1982-N-0005-0017", "FDA", "FDA-1982-N-0005", "\"Alcohol Involvement in Traffic Accidents: Recent Estimates from the National Center for Statistics and Analysis\" ( NHTSA Technical Report, DOT HS-806-269, May 1982) re Memorandum from FDA (HFN 510) to Dockets Management Branch (HFA-305)", "Supporting & Related Material", "Background Material", "2016-10-13T04:00:00Z", 2016, 10, null, null, "2016-10-13T18:22:56Z", null, 0, 0, "090000648206f0eb"], ["FDA-1982-N-0005-0088", "FDA", "FDA-1982-N-0005", "Clinical Protocol : Comparison of Emetrol Versus Placebo in Treating Upset Stomach in Children - 105008-999 -  re Protocol Review from Adria Laboratories", "Supporting & Related Material", "Background Material", "2016-10-13T04:00:00Z", 2016, 10, null, null, "2016-10-13T20:34:26Z", null, 0, 0, "090000648050d749"], ["FDA-1982-N-0005-0089", "FDA", "FDA-1982-N-0005", "Final Report: Comparison of Emetrol Versus Placebo In Treating Upset Stomach In Children re Protocol Review from Adria Laboratories", "Supporting & Related Material", "Background Material", "2016-10-13T04:00:00Z", 2016, 10, null, null, "2016-10-13T20:34:30Z", null, 0, 0, "090000648050d74a"], ["FDA-1982-N-0005-0094", "FDA", "FDA-1982-N-0005", "Tab E: Introduction to the Report By Reye\u2019s Syndrome Working Group to the FDA. 1982", "Supporting & Related Material", "Background Material", "2016-10-13T04:00:00Z", 2016, 10, null, null, "2016-10-13T20:36:06Z", null, 0, 0, "090000648050d767"], ["FDA-1982-N-0005-0118", "FDA", "FDA-1982-N-0005", "Reference 3: Lukacovic, M.F. and K.J. Watters, \"Dog Bioavailability Study with Pentagastrin - Pepto-Bismol with Simethicone, PBDB#14,\" The Procter & Gamble Co., in C12, 1992.", "Supporting & Related Material", "Background Material", "2016-10-13T04:00:00Z", 2016, 10, null, null, "2016-10-13T20:44:48Z", null, 0, 0, "090000648050d7c9"], ["FDA-1982-N-0005-0114", "FDA", "FDA-1982-N-0005", "Letter from Procter and Gamble Company to FDA/CDER", "Other", "Letter(s)", "2016-10-13T04:00:00Z", 2016, 10, "2016-10-13T04:00:00Z", null, "2016-10-13T20:43:58Z", null, 0, 0, "090000648050d7c2"], ["FDA-1982-N-0005-0081", "FDA", "FDA-1982-N-0005", "\"Evaluation of Various Effervescent and Non-Effervescent Aspirin Formulations in Post Surgical Dental Pain\" (IV. Protocol) re Request for Hearing from Miles, Inc.", "Supporting & Related Material", "Background Material", "2016-10-13T04:00:00Z", 2016, 10, null, null, "2016-10-13T20:33:11Z", null, 0, 0, "090000648050d729"], ["FDA-1982-N-0005-0083", "FDA", "FDA-1982-N-0005", "\"A Double-Blind, Single Dose Evaluation of the Relative Analgesic Efficacy and Adverse Effect Liability of Effervescent Aspirin, Non-Effervescent Aspirin and Placebo in the Treatment of Postoperative Pain Following Oral Surgery.\" (I. Study Synopsis) re Request for Hearing from Miles, Inc.", "Supporting & Related Material", "Background Material", "2016-10-13T04:00:00Z", 2016, 10, null, null, "2016-10-13T20:33:26Z", null, 0, 0, "090000648050d73c"], ["FDA-1982-N-0005-0020", "FDA", "FDA-1982-N-0005", "Appendix A: Safety of Alka-Seltzer From Gastric Damage or From Gastrointestinal or Other Bleeding re Comment from Miles Laboratories, Inc.", "Supporting & Related Material", "Background Material", "2016-10-13T04:00:00Z", 2016, 10, null, null, "2016-10-13T18:28:20Z", null, 0, 0, "090000648050d5e9"], ["FDA-1982-N-0005-0029", "FDA", "FDA-1982-N-0005", "References re Comment from Miles Laboratories, Inc.", "Supporting & Related Material", "Background Material", "2016-10-13T04:00:00Z", 2016, 10, null, null, "2016-10-13T18:29:53Z", null, 0, 0, "090000648050d5fb"], ["FDA-1982-N-0005-0058", "FDA", "FDA-1982-N-0005", "Appendix A re Supplement from Adria Laboratories", "Supporting & Related Material", "Background Material", "2016-10-13T04:00:00Z", 2016, 10, null, null, "2016-10-13T20:21:09Z", null, 0, 0, "090000648050d705"], ["FDA-1982-N-0005-0070", "FDA", "FDA-1982-N-0005", "Attachment 1:  Ingredients and Their Characteristics (II) re Request for Hearing from Miles, Inc.", "Supporting & Related Material", "Background Material", "2016-10-13T04:00:00Z", 2016, 10, null, null, "2016-10-13T20:25:10Z", null, 0, 0, "090000648050d71e"], ["FDA-1982-N-0005-0078", "FDA", "FDA-1982-N-0005", "\"Evaluation of Various Effervescent and Non-Effervescent Aspirin Formulations in Post Surgical Dental Pain\" (I. Study Synopsis) re Request for Hearing form Miles, Inc.", "Supporting & Related Material", "Background Material", "2016-10-13T04:00:00Z", 2016, 10, null, null, "2016-10-13T20:32:54Z", null, 0, 0, "090000648050d726"], ["FDA-1982-N-0005-0115", "FDA", "FDA-1982-N-0005", "List of References 1-11", "Supporting & Related Material", "Background Material", "2016-10-13T04:00:00Z", 2016, 10, null, null, "2016-10-13T20:44:26Z", null, 0, 0, "090000648050d7c6"], ["FDA-1982-N-0005-0016", "FDA", "FDA-1982-N-0005", "Memorandum from FDA/HFN-510 to Dockets Management Branch (HFA-305) re Public Administrative File for Decision on Ingredients Intended to Minimize or Prevent Inebriation; Docket No. 82N-0166", "Other", "Memorandum", "2016-10-13T04:00:00Z", 2016, 10, "2016-10-13T04:00:00Z", null, "2016-10-13T18:22:48Z", null, 0, 0, "090000648050d5d7"], ["FDA-1982-N-0005-0032", "FDA", "FDA-1982-N-0005", "Appendix A References Vol. 2 178A: Clinical Experts Reports on The Antacid Properties of Alka-Seltzer from Miles Laboratories, Inc.", "Supporting & Related Material", "Background Material", "2016-10-13T04:00:00Z", 2016, 10, null, null, "2016-10-13T18:37:46Z", null, 0, 0, "090000648050d654"], ["FDA-1982-N-0005-0052", "FDA", "FDA-1982-N-0005", "List of References re Comment from Procter & Gamble Company", "Supporting & Related Material", "Background Material", "2016-10-13T04:00:00Z", 2016, 10, null, null, "2016-10-13T20:20:01Z", null, 0, 0, "09000064822e9e4c"], ["FDA-1982-N-0005-0121", "FDA", "FDA-1982-N-0005", "Legacy Docket Log 1982N-0166", "Other", "List (LST)", "2016-10-13T04:00:00Z", 2016, 10, "2016-10-13T04:00:00Z", null, "2016-10-13T20:47:22Z", null, 0, 0, "0900006481ced331"], ["FDA-1982-N-0005-0025", "FDA", "FDA-1982-N-0005", "Tab V: Order of Risk of Major Gastrointestinal Bleeding Low With Aspirin and Absent With Alka-Seltzer", "Supporting & Related Material", "Background Material", "2016-10-13T04:00:00Z", 2016, 10, null, null, "2016-10-13T18:29:12Z", null, 0, 0, "090000648050d5f3"], ["FDA-1982-N-0005-0046", "FDA", "FDA-1982-N-0005", "Attachment 2: Safety of Alka-Seltzer from Gastric Damage or From Gastrointestinal or Other Bleeding re Comment from Miles Laboratories, Inc.", "Supporting & Related Material", "Background Material", "2016-10-13T04:00:00Z", 2016, 10, null, null, "2016-10-13T20:14:42Z", null, 0, 0, "090000648050d6d4"], ["FDA-1982-N-0005-0079", "FDA", "FDA-1982-N-0005", "\"Evaluation of Various Effervescent and Non-Effervescent Aspirin Formulations in Post Surgical Dental Pain\" (II. Statistical Report) re Request for Hearing form Miles, Inc.", "Supporting & Related Material", "Background Material", "2016-10-13T04:00:00Z", 2016, 10, null, null, "2016-10-13T20:33:00Z", null, 0, 0, "090000648050d727"], ["FDA-1982-N-0005-0084", "FDA", "FDA-1982-N-0005", "Analgesic Effect of Effervescent Aspirin and Noneffervescent Aspirin in Postoperative Oral Surgery Pain re Request for Hearing form Miles, Inc.", "Supporting & Related Material", "Background Material", "2016-10-13T04:00:00Z", 2016, 10, null, null, "2016-10-13T20:33:35Z", null, 0, 0, "090000648050d73e"], ["FDA-1982-N-0005-0092", "FDA", "FDA-1982-N-0005", "Table of Contents re Comment from Procter & Gamble", "Supporting & Related Material", "Background Material", "2016-10-13T04:00:00Z", 2016, 10, null, null, "2016-10-13T20:35:24Z", null, 0, 0, "090000648050d761"], ["FDA-1982-N-0005-0041", "FDA", "FDA-1982-N-0005", "The Effect of Caffeine on Gastric Acid Production at Doses Recommended in the Treatment of Hangovers from Xavier University College of Louisiana", "Supporting & Related Material", "Background Material", "2016-10-13T04:00:00Z", 2016, 10, null, null, "2016-10-13T20:14:02Z", null, 0, 0, "090000648050d6c6"], ["FDA-1982-N-0005-0047", "FDA", "FDA-1982-N-0005", "Attachment 3: Symptom Category re Comment from Miles Laboratories, Inc.", "Supporting & Related Material", "Background Material", "2016-10-13T04:00:00Z", 2016, 10, null, null, "2016-10-13T20:14:47Z", null, 0, 0, "090000648050d6d5"], ["FDA-1982-N-0005-0082", "FDA", "FDA-1982-N-0005", "Attachment 5. \"A Double-Blind, Single Dose Evaluation of the Relative Analgesic Efficacy and Adverse Effect Liability of Effervescent Aspirin, Non-Effervescent Aspirin and Placebo in the Treatment of Postoperative Pain Following Oral Surgery.\" re Request for Hearing from Miles, Inc.", "Supporting & Related Material", "Background Material", "2016-10-13T04:00:00Z", 2016, 10, null, null, "2016-10-13T20:33:18Z", null, 0, 0, "090000648050d72a"], ["FDA-1982-N-0005-0107", "FDA", "FDA-1982-N-0005", "Attachment 3: Analysis of the History of the Regulation of Alka-Seltzer in the OTC Drug Review", "Supporting & Related Material", "Background Material", "2016-10-13T04:00:00Z", 2016, 10, null, null, "2016-10-13T20:41:37Z", null, 0, 0, "090000648050d790"], ["FDA-1982-N-0005-0013", "FDA", "FDA-1982-N-0005", "Supporting material re Comment from Norwich Eaton Pharmacal Company Division Morton -Norwich Products, Inc. - Final Report", "Supporting & Related Material", "Background Material", "2016-10-13T04:00:00Z", 2016, 10, null, null, "2016-10-13T18:19:57Z", null, 0, 0, "09000064822ea628"], ["FDA-1982-N-0005-0044", "FDA", "FDA-1982-N-0005", "Comments on the Tentative Final Monograph for Orally Administered Drug Products for Relief of Symptoms Associated with Overindulgence in Food and Drink, and on the Proposed Amendment to the Tentative Final Monograph on Internal Analgesic, Antipyretic, and Antirheumatic Drug Products - Docket Nos. 82N-0166, 77N-0094", "Supporting & Related Material", "Background Material", "2016-10-13T04:00:00Z", 2016, 10, null, null, "2016-10-13T20:14:33Z", null, 0, 0, "090000648050d6cf"], ["FDA-1982-N-0005-0074", "FDA", "FDA-1982-N-0005", "Attachment 5. \"Double-Blind, Single Dose Evaluation of the Relavite analgesic Efficacy and Adverse Effect Liability of Effervescent Aspirin, Non-Effervescent Aspirin and Placebo in the Treatment of Postoperative Pain Following Oral Surgery.\" re Request for Hearing form Miles, Inc.", "Supporting & Related Material", "Background Material", "2016-10-13T04:00:00Z", 2016, 10, null, null, "2016-10-13T20:25:33Z", null, 0, 0, "090000648050d722"], ["FDA-1982-N-0005-0098", "FDA", "FDA-1982-N-0005", "Tab J: Final Rule Making on Labeling for Oral and Rectal Over-the-\nCounter Aspirin and Aspirin-Containing Drug Products. Federal Register June 9, 1988; 52 FR 11 I;21 633-21637.", "Supporting & Related Material", "Background Material", "2016-10-13T04:00:00Z", 2016, 10, null, null, "2016-10-13T20:36:39Z", null, 0, 0, "090000648050d76d"], ["FDA-1982-N-0005-0105", "FDA", "FDA-1982-N-0005", "Statement re Comment from Miles, Inc.", "Supporting & Related Material", "Background Material", "2016-10-13T04:00:00Z", 2016, 10, null, null, "2016-10-13T20:41:23Z", null, 0, 0, "090000648050d78a"], ["FDA-1982-N-0005-0117", "FDA", "FDA-1982-N-0005", "Reference 2: The Procter & Gamble co., \" In-vitro Foam Reducing Capacity Test: Pepto-Bismol With Simethicone,\" in C12.", "Supporting & Related Material", "Background Material", "2016-10-13T04:00:00Z", 2016, 10, null, null, "2016-10-13T20:44:41Z", null, 0, 0, "090000648050d7c8"], ["FDA-1982-N-0005-0103", "FDA", "FDA-1982-N-0005", "Letter from FDA/CDER to Nonprescription Drug Manufacturers Association", "Other", "Letter(s)", "2016-10-13T04:00:00Z", 2016, 10, "2016-10-13T04:00:00Z", null, "2016-10-13T20:41:02Z", null, 0, 0, "090000648050d787"], ["FDA-1982-N-0005-0024", "FDA", "FDA-1982-N-0005", "Tab IV: Evidence For the Acid-Mediated Mechanism As the Cause of Aspirin-Induced Gastric Damage", "Supporting & Related Material", "Background Material", "2016-10-13T04:00:00Z", 2016, 10, null, null, "2016-10-13T18:29:05Z", null, 0, 0, "090000648050d5f1"], ["FDA-1982-N-0005-0039", "FDA", "FDA-1982-N-0005", "Attachment 2: Emetrol (Phosphorated Carbohydrate Solution)", "Supporting & Related Material", "Background Material", "2016-10-13T04:00:00Z", 2016, 10, null, null, "2016-10-13T20:13:03Z", null, 0, 0, "090000648050d69c"], ["FDA-1982-N-0005-0057", "FDA", "FDA-1982-N-0005", "Table of Contents for Appendices re Supplement from Adria Laboratories", "Supporting & Related Material", "Background Material", "2016-10-13T04:00:00Z", 2016, 10, null, null, "2016-10-13T20:21:05Z", null, 0, 0, "090000648050d703"], ["FDA-1982-N-0005-0059", "FDA", "FDA-1982-N-0005", "Appendix B re Supplement from Adria Laboratories", "Supporting & Related Material", "Background Material", "2016-10-13T04:00:00Z", 2016, 10, null, null, "2016-10-13T20:21:14Z", null, 0, 0, "090000648050d707"], ["FDA-1982-N-0005-0014", "FDA", "FDA-1982-N-0005", "Request for Extension from Miles Laboratories, Inc.", "Other", "Request for Extension", "2016-10-13T04:00:00Z", 2016, 10, "2016-10-13T04:00:00Z", null, "2016-10-13T18:20:34Z", null, 0, 0, "090000648050d5d2"], ["FDA-1982-N-0005-0055", "FDA", "FDA-1982-N-0005", "Study Summary re Supplement from Adria Laboratories", "Supporting & Related Material", "Background Material", "2016-10-13T04:00:00Z", 2016, 10, null, null, "2016-10-13T20:20:55Z", null, 0, 0, "090000648050d6fe"], ["FDA-1982-N-0005-0062", "FDA", "FDA-1982-N-0005", "Appendix D re Supplement from Adria Laboratories", "Supporting & Related Material", "Background Material", "2016-10-13T04:00:00Z", 2016, 10, null, null, "2016-10-13T20:21:28Z", null, 0, 0, "090000648050d710"], ["FDA-1982-N-0005-0069", "FDA", "FDA-1982-N-0005", "Introduction re Request for Hearing from Miles, Inc.", "Supporting & Related Material", "Background Material", "2016-10-13T04:00:00Z", 2016, 10, null, null, "2016-10-13T20:24:59Z", null, 0, 0, "090000648050d71d"], ["FDA-1982-N-0005-0023", "FDA", "FDA-1982-N-0005", "Tab III: Evidence Demonstrating Absence of Gastric Damage With Alka-Seltzer", "Supporting & Related Material", "Background Material", "2016-10-13T04:00:00Z", 2016, 10, null, null, "2016-10-13T18:28:50Z", null, 0, 0, "090000648050d5ef"], ["FDA-1982-N-0005-0033", "FDA", "FDA-1982-N-0005", "Federal Register, FDA, Department of Health and Human Services, Re:  External Analgesic Drug Products for Over-the-Counter Human Use; Tentative Final Monograph", "Supporting & Related Material", "Background Material", "2016-10-13T04:00:00Z", 2016, 10, null, null, "2016-10-13T18:37:53Z", null, 0, 0, "090000648050d656"], ["FDA-1982-N-0005-0051", "FDA", "FDA-1982-N-0005", "Reference 12: Lukacovic, M.F., Watters, K.J., Rat gastric lesion study - Pepto-Bismol with simethicone. EtOH Study - ANTR # 53, Procter & Gamble. (1991)", "Supporting & Related Material", "Background Material", "2016-10-13T04:00:00Z", 2016, 10, null, null, "2016-10-13T20:19:06Z", null, 0, 0, "090000648050d6f4"], ["FDA-1982-N-0005-0056", "FDA", "FDA-1982-N-0005", "Final Report CS# 105005-000 re Supplement from Adria Laboratories", "Supporting & Related Material", "Background Material", "2016-10-13T04:00:00Z", 2016, 10, null, null, "2016-10-13T20:21:01Z", null, 0, 0, "090000648050d701"], ["FDA-1982-N-0005-0113", "FDA", "FDA-1982-N-0005", "List of References re Supplement from The Procter and Gamble Company", "Supporting & Related Material", "Background Material", "2016-10-13T04:00:00Z", 2016, 10, null, null, "2016-10-13T20:43:41Z", null, 0, 0, "090000648229b419"], ["FDA-1982-N-0005-0095", "FDA", "FDA-1982-N-0005", "Tab G: Review of the PHS Report of the Pilot Study by the Committee on the Reye Syndrome and Medications. National Academy of Sciences Institute of Medicine Report No. 5. December 1985.", "Supporting & Related Material", "Background Material", "2016-10-13T04:00:00Z", 2016, 10, null, null, "2016-10-13T20:36:22Z", null, 0, 0, "090000648050d76a"], ["FDA-1982-N-0005-0086", "FDA", "FDA-1982-N-0005", "Protocol Review from Adria Laboratories re OTC Drug Products for Relief of Symptoms Associated with Overindulgence in Food and Drink, Tentative Final Monograph, 56 Fed. Reg. 66742 (December 24, 1991)", "Other", "Protocol Review", "2016-10-13T04:00:00Z", 2016, 10, "2016-10-13T04:00:00Z", null, "2016-10-13T20:34:06Z", null, 0, 0, "090000648050d742"], ["FDA-1982-N-0005-0109", "FDA", "FDA-1982-N-0005", "Letter from Procter and Gamble Company", "Other", "Letter(s)", "2016-10-13T04:00:00Z", 2016, 10, "2016-10-13T04:00:00Z", null, "2016-10-13T20:42:02Z", null, 0, 0, "090000648050d794"], ["FDA-1982-N-0005-0031", "FDA", "FDA-1982-N-0005", "Supplement from Miles Laboratories, Inc.", "Other", "Supplement (SUP)", "2016-10-13T04:00:00Z", 2016, 10, "2016-10-13T04:00:00Z", null, "2016-10-13T18:37:33Z", null, 0, 0, "090000648050d652"], ["FDA-1982-N-0005-0075", "FDA", "FDA-1982-N-0005", "Attachment 6. Excerpt on Alka-Seltzer Submitted to the Advisory Review Panel on Over-The-Counter Miscellaneous Internal Drug Products(VI. The Analgesics Proceeding) re Request for Hearing form Miles, Inc.", "Supporting & Related Material", "Background Material", "2016-10-13T04:00:00Z", 2016, 10, null, null, "2016-10-13T20:25:40Z", null, 0, 0, "090000648050d723"], ["FDA-1982-N-0005-0076", "FDA", "FDA-1982-N-0005", "Attachment 7. Excerpt on Alka-Seltzer Submitted to the Advisory Review Panel on Over-The-Counter Miscellaneous Internal Drug Products(Appendix C Plus - List of References) re Request for Hearing form Miles, Inc.", "Supporting & Related Material", "Background Material", "2016-10-13T04:00:00Z", 2016, 10, null, null, "2016-10-13T20:25:45Z", null, 0, 0, "090000648050d724"], ["FDA-1982-N-0005-0111", "FDA", "FDA-1982-N-0005", "Supporting material re Comment from Procter & Gamble Company", "Supporting & Related Material", "Background Material", "2016-10-13T04:00:00Z", 2016, 10, null, null, "2016-10-13T20:42:24Z", null, 0, 0, "090000648050d79b"], ["FDA-1982-N-0005-0116", "FDA", "FDA-1982-N-0005", "Reference 1: FDA, \"General Guidelines for OTC Drug Combination Products, September 1978,\" Division of Dockets Management, Docket No. 1978D-0322", "Supporting & Related Material", "Background Material", "2016-10-13T04:00:00Z", 2016, 10, null, null, "2016-10-13T20:44:34Z", null, 0, 0, "090000648050d7c7"], ["FDA-1982-N-0005-0028", "FDA", "FDA-1982-N-0005", "Tab VIII: Safety of Alka-Seltzer in Self-Medication", "Supporting & Related Material", "Background Material", "2016-10-13T04:00:00Z", 2016, 10, null, null, "2016-10-13T18:29:43Z", null, 0, 0, "090000648050d5f9"], ["FDA-1982-N-0005-0066", "FDA", "FDA-1982-N-0005", "Appendix H re Supplement from Adria Laboratories", "Supporting & Related Material", "Background Material", "2016-10-13T04:00:00Z", 2016, 10, null, null, "2016-10-13T20:21:46Z", null, 0, 0, "090000648050d718"], ["FDA-1982-N-0005-0087", "FDA", "FDA-1982-N-0005", "Introduction/Background: Emetrol re Protocol Review from Adria Laboratories", "Supporting & Related Material", "Background Material", "2016-10-13T04:00:00Z", 2016, 10, null, null, "2016-10-13T20:34:13Z", null, 0, 0, "090000648050d745"], ["FDA-1982-N-0005-0093", "FDA", "FDA-1982-N-0005", "Tab D: Advanced Notice of Proposed Rule Making on Labeling for\nSalicylate-Containing Drug Products, Federal Register December 28, 1982; 47 FR 249, 57886-57901", "Supporting & Related Material", "Background Material", "2016-10-13T04:00:00Z", 2016, 10, null, null, "2016-10-13T20:36:00Z", null, 0, 0, "090000648050d766"], ["FDA-1982-N-0005-0096", "FDA", "FDA-1982-N-0005", "Tab H:  Review of the PHS Continuing Study by the Committee on the\nReye Syndrome and Medications. National Academy of Sciences Institute of Medicine Report NO. 6 February 1987", "Supporting & Related Material", "Background Material", "2016-10-13T04:00:00Z", 2016, 10, null, null, "2016-10-13T20:36:28Z", null, 0, 0, "090000648050d76b"], ["FDA-1982-N-0005-0099", "FDA", "FDA-1982-N-0005", "Tab V: Center for Disease Control: Reye Syndrome Surveillance - United\nStates 1989. MMWR February 8, 1991", "Supporting & Related Material", "Background Material", "2016-10-13T04:00:00Z", 2016, 10, null, null, "2016-10-13T20:37:25Z", null, 0, 0, "090000648050d779"], ["FDA-1982-N-0005-0045", "FDA", "FDA-1982-N-0005", "Attachment 1: Comments on the Advance Notice of Proposed Rulemaking Regarding the Establishment of A Monograph for Orally Administered Drug Products for Relief of Symptoms Associated with Overindulgence in Alcohol and food for Over-the-Counter Human Use re Comment from Miles Laboratories, Inc.", "Supporting & Related Material", "Background Material", "2016-10-13T04:00:00Z", 2016, 10, null, null, "2016-10-13T20:14:38Z", null, 0, 0, "090000648050d6d0"], ["FDA-1982-N-0005-0063", "FDA", "FDA-1982-N-0005", "Appendix E re Supplement from Adria Laboratories", "Supporting & Related Material", "Background Material", "2016-10-13T04:00:00Z", 2016, 10, null, null, "2016-10-13T20:21:33Z", null, 0, 0, "090000648050d712"], ["FDA-1982-N-0005-0067", "FDA", "FDA-1982-N-0005", "Appendix I re Supplement from Adria Laboratories", "Supporting & Related Material", "Background Material", "2016-10-13T04:00:00Z", 2016, 10, null, null, "2016-10-13T20:21:51Z", null, 0, 0, "090000648050d719"], ["FDA-1982-N-0005-0071", "FDA", "FDA-1982-N-0005", "Attachment 2: Appendix B re Request for Hearing from Miles, Inc.", "Supporting & Related Material", "Background Material", "2016-10-13T04:00:00Z", 2016, 10, null, null, "2016-10-13T20:25:15Z", null, 0, 0, "090000648050d71f"], ["FDA-1982-N-0005-0073", "FDA", "FDA-1982-N-0005", "Attachment 4. \"Evaluation of Various Effervescent and Non-Effervescent Aspirin Formulations in Post-Surgical Dental Pain\" re Request for Hearing from Miles, Inc.", "Supporting & Related Material", "Background Material", "2016-10-13T04:00:00Z", 2016, 10, null, null, "2016-10-13T20:25:28Z", null, 0, 0, "090000648050d721"], ["FDA-1982-N-0005-0108", "FDA", "FDA-1982-N-0005", "Memorandum of Telephone Conversation Between FDA/CDER and The Procter & Gamble Company", "Other", "Memorandum", "2016-10-13T04:00:00Z", 2016, 10, "2016-10-13T04:00:00Z", null, "2016-10-13T20:41:51Z", null, 0, 0, "090000648050d792"], ["FDA-1982-N-0005-0011", "FDA", "FDA-1982-N-0005", "Memorandum from Chief, Gastrointestinal and Contraceptive Drug Monographs Branch (HFN - 514) To Dockets Management Branch (HFA - 305) re Comment to the Overindulgence Report", "Other", "Memorandum", "2016-10-13T04:00:00Z", 2016, 10, "2016-10-13T04:00:00Z", null, "2016-10-13T18:17:44Z", null, 0, 0, "090000648050d5ce"], ["FDA-1982-N-0005-0080", "FDA", "FDA-1982-N-0005", "Pharmacokinetic Data Analysis on Post Surgical Dental Pain (III. Pharmacokinetic Report) re Request for Hearing form Miles, Inc.", "Supporting & Related Material", "Background Material", "2016-10-13T04:00:00Z", 2016, 10, null, null, "2016-10-13T20:33:08Z", null, 0, 0, "090000648050d728"], ["FDA-1982-N-0005-0097", "FDA", "FDA-1982-N-0005", "Tab I: Analysis of Exposure to Non-Aspirin Salicylates Among Subjects\nfrom the Ohio Department of Health Survey and the Public Health Service Pilot Study on Reye Syndrome. Biometric Research Institute. June 13, 1986", "Supporting & Related Material", "Background Material", "2016-10-13T04:00:00Z", 2016, 10, null, null, "2016-10-13T20:36:33Z", null, 0, 0, "090000648050d76c"], ["FDA-1982-N-0005-0119", "FDA", "FDA-1982-N-0005", "Reference 4: Lukacovic, M. F. and K.J. Watters, \"Rat Gastric Lesion Study-Pepto Bismol With Simethicone. 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