Regulatory Information
(OTC Panel Submissions (Indices Only): 03 - Internal Analgesic
Data and Information
| Volume | Submitted by | Trade Name | Ingredients Listed |
|---|---|---|---|
| 030001 |
Plough, Inc. Memphis, Tenn. |
St. Joseph Aspirin for Children | Aspirin |
| 030002 | Plough, Inc. | St. Joseph Aspirin | Aspirin |
| 030003 |
A.H. Robins Co. Richmond , VA |
Arthralgen Tablets |
Sallcylamide Acetaminophen |
| 030004 | A.H. Robins Co. | Pabalate Tablets | Sodium Sallcylate (PABA) Sodium Aminobenzoate |
|
030005 030006 030007 |
Warner Lambert Co. Morris Plains , N.Y. |
Bromo Seltzer |
Acetaminophen Phenacetin Potassium bromide Caffeine Sodium bicarbonate Citric acid |
|
030008 to 030015 |
Miles Laboratories Inc. Elkhart, Indiana |
Alka-Seltzer |
Aspirin Mono-calcium phosphate Sodium bicarbonate Citric acid |
|
030016 to 030029 |
McNeil Laboratories, Inc. Camp Hill Road Fort Washington , PA 19034 |
Tylenol Tablets | Acetaminophen |
|
030030 to 030032 |
McNeil | Tylenol Elixir | Acetaminophen |
|
030033 to 030035 |
McNeil | Tylenol Chewable Tablets | Acetaminophen |
| 030036 | McNeil | Tylenol Drops | Acetaminophen |
| 030037 |
Abbott Laboratories North Chicago , Ill 60064 |
Children’s Chewable Tab. | Aluminum Aspirin |
| 030038 |
Smith Kline & French Lab. 15000 Spring Carden St. Philadelphia, Pa 19101 |
Ecotrin, enteric coated | Aspirin |
| 030039 |
The Dow Chemical Co. Research Center P.O. Box 10 Zionsville , Indiana 46077 |
Tenlap Elixir | Acetaminophen |
| 030040 | The Dow Chemical Co. | Phensal Tablets |
Aspirin Phenacetin Caffeine |
| 030041 |
Plough, Inc. Memphis , Texas 38101 |
Aspergum | Aspirin |
| 030042 |
Warren-Teed Pharm. Inc. Columbus , Ohio 43215 |
Magan Tablets | Magnesium Salicylate |
| 030043 |
Whitehall Laboratories Inc. 685 Thrid Avenue New York, N.Y. 10017 |
Duplexin Tablets |
Dihydroxy Aluminum Sodium Carbonate Magnesium Carbonate Aspirin Phenacetin Caffeine |
| 030044 | Whitehall Labs Inc. | Arthritis Pain Formula |
Micronized Aspirin Dried Aluminum Hydroxide gel Magnesium Hydroxide |
| 030045 | Whitehall Labs | Anacin |
Aspirin Caffeine |
| 030046 | Whitehall Labs | Saloxium Tablet | Salicylsalicylic Acid (Salsalate) |
| 030047 |
VSV Pharmaceutical Corp. 1 Scarsdalle Road Tuckahoe, New York 10707 <> |
Liquiprin Suspension | Acetaminophen |
| 030048 | USV | Femicin Tablets |
Acetaminophen Saliylamide Caffeine Pyrilamine Maleate Homatropine Methylbromide |
| 030049 | USV | Comeback Tablets |
Acetaminophen Salicylamide Caffeine |
| 030050 |
Dorsey Laboratories Box 83288 Lincoln , Nebraska 68501 |
Calurin Tablets | Calcium Carbaspirin |
| 030051 | Dorsey | Cama Inlay Tabs |
Aspirin (10 grains) Magesium hydroxide Aluminum hydroxide dried gel |
| 030052 | Dorsey | Chexit Tablets |
Phenylpropanaolamine hydrochloride Pheniramine maleate Phrilamine maleate Dextromethorphan hydrobromide Terpin hydrate Acetaminophen |
| 030053 | Dorsey | Pabirin Tablets |
Aspirin Aminobenzomic acid dried aluminum hydroxide gel |
| 030054 | Dorsey | Triaminicin Tablets |
Phenylpropanolamine hydrochloride Pheniramine maleate Pyrilamine maleate Aspirin Acetaminophen Caffeine Ascorbic acid |
| 030055 | Dorsey | Tussagesic Tablets/Suspension |
Phenylpropanolamine hydrochloride Pheniramine maleate Pyrilamine maleate Dextromethorphan hydrobromide Terpin hydrate Acetaminophen |
| 030056 | Dorsey | Ursinus Inlay Tabs |
Calcium Carbaspirin Phenylpropanolamine hydrochloride Phyrilamine maleate |
| 030057 |
Mead Johnson Research Center Evansville, Indiana 47721 |
Tempra Drops,Syrup, Tablet |
Acetaminophen (Drops) (Syrup) (Tablets) |
| 030058 | Block Drug Company Inc. | BC Powder |
Aspirin Salicylamide Caffeine |
| BC Tablet |
Aspirin Salicylamide Caffeine |
||
| 030059 |
William H. Rorer Inc. Fort Washington , Pa 19034 |
Ascriptin Tablet |
Aspirin Magnesium Hydroxide Aluminum Hydroxide |
| 030060 |
Monsanto Industrial Chemicals Co. 800 N. Lindbergh Boulevard St. Louis , Missouri 63166 |
Salicylamide | (No dosage form) |
| 030061 | Monsanto | Aspirin | (No dosage form) |
| 030062 | Monsanto | Phenacetin | (No dosage form) |
| 030063 |
J. Maxwell Little, Ph.D. Professor & Chairman Dept. Of Pharmacology Bowman Gray School of Medicine |
Headache Powders |
Phenacetin Caffeine Citric acid Potassium chloride Lactose Aspirin |
| 030064 |
Sterling Drug Inc. 90 Park Avenue New York , N.Y. 10016 |
Bayer Aspirin tablets Bayer Children’s Aspirin Bayer Timed-Release Measurin Tablets Cortal para Ninos Fizrin |
Aspirin Aspirin Aspirin Aspirin Aspirin Aspirin Sodium Bicarbonate Sodium Carbonate Citric Acid |
| 030065 | Sterling |
Mejoral Cafenol Tablet Cafiaspirina Tablet |
Aspirin Caffeine Aspirin Caffeine Aspirin Caffeine |
| 030066 | Sterling | Midol |
Aspirin Cinnamedrin hydrochloride Caffeine |
| 030067 | Sterling | Vanquish |
Aspirin Acetaminophen Caffeine Dried Aluminum hydroxide gel Magnesium hydroxide |
| 030068 | Sterling | Cope |
Aspirin Caffeine Methapyrilene fumarate Magnesium hydroxide Dried Aluminum hydroxide gel |
|
030069 to 030072 |
Bristol-Myers Products New York , New York |
>Bufferin Arthritis Strength Bufferin Excedrin Excedrin P.M. |
Aspirin Magnesium Carbonate Dihydroxyaluminum aminoacetate Aspirin Magnesium carbonate Dithydroxyaluminum aminoacetate Aspirin Acetaminophen Caffeine Salicylamide Aspirin Salicylamide Acetaminophen Methapyrilene fumarate Aspirin Sodium bicarbonate Powdered citric acid Monocalcium phosphate |
| 030073 | Sandoz Pharmaceuticals | Fiogesic Tablets |
Calcium carbaspirin Phenylpropanolamine hydrochoride Pheniramine maleate Pyrilamine maleate |
| 030074 | E.R. Squibb & Sons Inc. |
Aspirin Tablets Trigesic Tablets Valadol Liquid Valadol Tablets Valadol Chewable Tablets |
Aspirin Acetaminophen Caffeine Acetylsalicylic acid Acetaminophen Acetaminophen Acetaminophen |
| 030075 |
Templetons Inc. Buffalo , New York |
Templeton’‘s T-R-C’s |
Aspirin Caffeine |
| 030076 | Fountain Labs, Inc. | PANO |
Aspirin Caffeine |
| 030077 | The Purdue Frederick Co. | Arthropan Liquid | Choline Salicylate |
| 030078 |
Federal Register Notice of April 20, 1972 and NAS/NRC Reports |
Surfacaine Suppositories Bufferin Tablets Trigesic Tablets Nebs Tablets Apamide Tablets Metalid Tablets Duplexin Tablets Nysacetol Tablets Tylenol Elixir Tempra Drops, Syrup Tralgon Elixir Tylenol Tablets Arthropan Liquid Actasal Pediatric Drops Defencin Tablets |
Cyclomethycaine Aspirin Aluminum Glycinate Magnesium Carbonate Acetaminophen Aspirin Caffeine Acetaminophen Acetaminophen Acetaminophen Dihydroxyaluminum Sodium Carbonate Magnesium Carbonate Aspirin Phenacetin Caffeine Acetaminophen Acetaminophen Acetaminophen Acetaminophen Acetaminophen Choline Salicylate Choline Salicylate Glycerylguaiacolate Aspirin Phenyltoloxamine Dihydrogen Citrate |
| 030079 | The Upjohn Company | Aspirin Tablets | Aspirin |
| 030080 | P-A-C Compound Tablets, Capsules |
Phenacetin Aspirin Caffeine |
|
| 030081 | Acetonyl Effervescent Salt | Aspirin | |
| 030082 | Salicionyl Effervescent Salt |
Sodium Salicylate Sodium Bicarbonate |
|
|
030083 to 030086 |
Warner-Chilcott Laboratories | Sinutab |
Acetaminophen Phenacetin Phenylpropanolamine HCl Phenylpropanolamine Citrate |
| Sinutab ll |
Acetaminophen Phenacetin Phenylpropanolamine HCl |
||
|
030087 030088 to 030090 |
Norwich Pharmacal Co. |
Aspirin Nebs Tablets Nebs Elixir |
Aspirin Acetaminophen Acetaminophen |
| 030091 (labels only) | Eneglotaria Medicine Co. of Pureto Rico | Pediascirin Syrup | Acetaminophen |
| L.W. Estes Co., Inc. | Estes Nu-Ral Tablets |
Aspirin Caffeine |
|
| The Rilox Co. | Baltar’s Medium |
Sodium Salicylate Potassium Iodide Cascara Sagrade |
|
|
R.L. Gaddy Pharmacist |
EZ-IT Tablets |
Aspirin Phenacetin Caffeine |
|
| 030092 | McMurray & Pendergast for Cooper Labs. Inc. | Persistin |
Salicylsalicylic acid Aspirin |
| 030093 (labels only) | Curtis Drug Co. |
Curtis A-R Pain Relief |
Sodium Sallcylate Sodium Para Aminobenzoate Vitamin C (Ascorbic Acid) Vitamin B (Thiamin Hydrochloride) Vitamin B (Riboflavin) |
| Berry & Withington Co. |
Sodium Salicylate Aspirin Buffered Aspirin Aspirin Compound No.2 |
Aspirin Glycline, Aluminum Hydroxide Magnesium Carbonate Aspirin Penacetin Caffeine |
|
|
030093 (cont.) |
Republic Drug Co. | A.P.C. Tablets |
Aspirin Phenacetin Caffeine |
|
A.P.C. with Codeline Aspirin Buffered Aspirin Superin Tapanol |
Aspirin Phenacetin Caffeine Codeine Phosphate Aspirin Aluminum Hydroxide Glycine Magnesium Carbonate N-Acetyl-p-aminophenol Salicylamide Aspirin Caffeine Acetaminophen |
||
| Boericke & Tafel | Boericke & Runyon Tablets No. 200 |
Acetanilid Caffeine Sodium Bicarbonate Calomel Iris Versicolor Nux Vomica |
|
| Boericke & Tafel | B & R Tablet No. 171A |
Henatyne (represents Acetylsalicylic 1/10 gr. And Magnesium Oxide 2/10 gr.) Acetylsalicylic Acid Macrotin Bryonin |
|
| Lewis’ Mfg. Co. | Dr. Lewis’ Preparation for Rheumatism | Sodium Salicylate | |
| 030094 |
Prepared bt Lee M. Quon, OTC Staff |
Comparative Toxicity of Phenacetin and Acetaminophen | |
| 030095 | Miles Laboratories |
Prepared by Allen R. Cooke, M.D. The Role of Acid in the Pathogenesis of Aspirin Induced Gastronintestinal Erosions and Hemorrhage |
|
| 030096 |
T.E. Watson Co. American Felsol Co. Division |
Felsol Powders Felsol Tablets |
Antipyrine Iodopyrine Citrated Caffeine |
| 030097 | Edgar Larsen | Hoover Powders |
Acetanilid Caffeine Sodium Bicarbonate |
| 030098 | T.E. Watson Co. | Antipyrine | |
| 030099 | T.E. Watson Co. | Antipyrine | |
| 030100 | T.E. Watson Co. | Antipyrine | |
| 030101 | T.E. Watson Co. | Antipyrine | |
| 030102 | Sterling Drug Inc. | Vanquish addition | Acetaminophen literature |
| 030103 | Bristol-Myers Co. | Remarks concerning the safety and effectiveness of Caffeine in combination with aspirin-order analgesic with special reference to Excedrin | |
| 030104 | Miles Laboratories Inc. | Alka Seltzer-Safety And Effectiveness of a Buffered Sodium Acetylsalicylate Solution | |
|
030105 to 030112 |
Miles Laboratories Inc. | References for Volume 030104 | |
| 030113 | Bristol-Myers Products | Presentation to the Panel on Bufferin and Excedrin | |
|
030114 and 030115 |
Bristol-Myers Products | Excedrin P.M. |
Aspirin Salicylamide Acetaminophen Methapyrilene Fumarate |
| 030116 | Plough, Inc. | Aspergum - Additional data | |
| 030117 | Bristol-Myers Products | Duration of Action Bufferin compared to standard aspirin | |
| 030118 | Plough, Inc. | Aspergum - additional data #2 | |
| 030119 | Smith Kling & French Laboratories | Ecotrin - additional data | |
| 030120 | T.E. Watson Co. | Felsol (Additional Data) | Antipyrine |
|
030121 to 030124 |
Miles Laboratories |
Alka-Seltzer (Additional Data) |
|
|
030125 to 030127 |
Whitehall Laboratories |
Anacin Arthritis Pain Formula (Additional Data Prepared by Clinical Resources, Inc.) |
|
| 030128 | McNeil Laboratories, Inc. | Acetaminophen | Acetaminophen (additional data) |
| 030129 | Whitehall Laboratories | Additional data | Micronized Aspirin |
| 030130 | Ciba-Geigy Corp. | General Comments on Buffered Analgesics | |
| 030131 | Endo Laboratories, Inc. |
Percogesic Dilone |
Acetaminophen Phenyltoloxamine citrate Acetaminophen Phenyltoloxamine citrate Caffeine |
| 030132 | Miles Labs., Inc. | References for Alka-Seltzer | |
| 030133 | Sterling Drug Inc. | Additional Information | |
| 030134 | Burroughs Wellcome Co. | Additional Information | |
| 030135 | Warner-Lambert Res. Inst. | Additional Information on Bromo-Seltzer |
Acetaminophen Sodium bicarbonate Citric Acid |
|
030136 to 030138 |
Bristol-Myers Products | Bufferin | Additional information |
| 030139 | Bristol-Myers Products | Bufferin | Additional Information |
| 030140 | Eli Lilly & Co. | Aspirin Suppositories | Aspirin |
| 030141 | Glenbrook Laboratories, Division of Sterling Drug, Inc. | Information on Acetaminophen | |
| 030142 | Plough, Inc. | Additional inforamtion on St. Joseph Aspirin for Children | |
|
030143 and 030144 |
American Home Products and Bristol-Myers Products |
Joint presentation to the 24th Panel meeting “arthritis in the label” | |
| 030145 | T.E. Watson Co. | Felsol Powder and Tablet | additional information |
| 030146 | S.B. Penick & Co. | Salicylamide bibliography | |
| 030147 | Miles Laboratories Inc. | Additional data on Alka-Seltzer | |
| 030148 | Bristol-Myers Products | Crystal size data on aspirin | |
| 030149 | Sterling Drug Inc. | Dr. Fallier’s presentation on 9/25/74 | |
| 030150 | OTC Division | General data collection | |
| 030151 | McNeil Laboratories | Abstract of Study by Drs. Cooper and Beaver | |
| 030152 | Reprints and bibliography on analgesic nephropathy | ||
| 030153 | Bristol-Myers | Excedrin | Additional data |
| 030154 | Endo | Percogesic | Acetaminophen |
| 030155 | phenyltoloxamine | ||
| 030156 | Whitehall Laboratories | Saloxium, | additional data |
| 030157 | Warner-Lambert Company | Bromo-Seltzer | additional data |
| 030158 | Glenbrook Laboratories Division of Sterling Drug, Inc. | Information, and reprints, on aspirin | |
| 030159 | Primer on the Rheumatic Diseases, Prepared by a Committee of the American Rheumatism Association Section of the Arthritis Foundation, 1973 | ||
| 030160 | Bristol-Myers | Neolin |
Aspirin Magnesium carbonate Calcium carbonate |
| 030161 | McNeil Laboratories, Inc. | Acetaminophen | Pediatric dose comments, data |
| 030162 | Miles Laboratories, Inc. | Alka-Seltzer | Additional information |
| 030163 | Endo Laboratories, Inc. | Percogesic | Additional information |
| 030164 |
Burroughs Wellcome Co. Block Drug Co., Inc. The Proprietary Assn. Plough, Inc. Vick Divisions Reseach/Vick Chemical Co. Bristol-Myers Products |
||
| 030165 | Endo Laboratories | Percogesic | additional information presented at the November 22, 1976 meeting. |
| 030166 | Glenbrook Laboratories, Division of Sterling Drug, Inc. | ||
| 030167 | Miles Laboratories, Inc. | ||
| 030168 | American Home Products Corp. | ||
| 030169 | Various memoranda of discussions and evaluations of Percogesic | ||
| 030170 | Miles Laboratories | Supplemental Data on Alka-Seltzer, dated October 30, 1974, Master List of References | |
| 030171 | |||
| 030172 | Negative responses to request for data--38 companies | ||
| 030173 | Summary minutes of Panel meetings #1-#28 | ||
| 030174 | Bibiography, 1972 compiled by FDA Medical Library | ||
| 030175 | FDA-OTC Literature Search | Abstract Bibiography | Aspirin, 1972 |
| 030176 | FDA-OTC Literature Search | Abstract Bibliography | Phenacetin, 1972 |
| 030177 | FDA-OTC Literature Search | Abstract Bibliography | Caffeine, 1972 |
| 030178 | FDA-OTC Literature Search | Abstract Bibliography | Internal Analgesics other than aspirin, phenacetin, caffeine, 1972 |
| 030179 | Federal Trade Commission | Comments on preliminary Draft #6 | |
| 030180 | The Propietary Association, position statement for discussion of labeling at the August 21-23, 1976 meeting | ||
| 030181 | Various Submissions, Memoranda, etc. regarding aspirin, phenacetin | ||
| 030182 | Various Submissions, Memoranda, etc. regarding acetaminophen, antipyrine, caffeine |
