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(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    

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