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U.S. Department of Health and Human Services

Regulatory Information

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OTC Panel Submissions (Indices Only): 09 - Laxatives

Laxative, Antidiarrheal, Emetic, Antiemetic Over the Counter Drugs Submitted for Review
090001 Lewis-Howe Company Concentrated Milk of Magnesia Milk of Magnesia As a Laxative
090002 Combe Inc. Espotabs Yellow Phenolphthalein As a laxative
090003 Lewis-Howe Co.

Nature’s Remedy Regular;

Nature Remedy Candy Coated; Nature’s Remedy Juniors

Aloe, Cascara Sagrada A dependable, all vegetable, family laxative for the relief of occasional constipation
090004 Riker labs.



Dorbantyl Forte

Danthron Promotes colonic peristalsis and is a superior laxative in the management and treatment of constipation.
090005 Merrick Medicine Company Percy Medicine

Bismuth Subnitrate

Rhubarb Fluidextract

Potassium Carbonate

Calcium Hydroxide

As antacid-Astrigent for simple diarrhea and temporary relief of gastric discomfort due to overeating or other dietary indiscretions.
090006 ICI America Inc.


Dialose Plus

Effersyllium Instant Mix

Dioctyl Sodium


Sodium Carboxymethylcell-ulose


For treating constipation due to hardness or lack of moisture in the intestinal contents, an effective fecal softener whose action will help to restore normal bowel function gradually, without griping or acute discomfort.
090007 Burton, Persons & Company L.A. Formula Psyllium Hydrophilic Mucilloid  
090008 Burton, Parsons & Company

Psyllium Hydrophilic

Mucilloid with Dextrose

Psyllium Hydrophilic

Mucilloid with Dextrose

090009 Burton, Parsons & Company Konsyl

Psyllium Hydrophilic


Provides a bland non-irritation bulk and lubricating effect to promote normal elimination.
090010 C.B. Fleet Company, Inc.

Fleet Enema

Fleet Enema Pediatric

Sodium Biphosphate

Sodium Phosphate

Monosodium Phosphate

Disodium Phosphate

090011 C.B. Fleet Company, Inc.

Fleet Buffered Laxative

Fleet Buffered Laxative, Flavored

Sodium Biphosphate

Monosodium Phosphate

Sodium Phosphate

Disodium Phosphate

Gentle regulated and predictable elimination.
090012 National Magnesia Co., Inc. National Solution of Citrate of Magnesia Anhydrous Tribasic Magnesium Citrate, Anhydrous Citric Acid, Anhydrous Tribasic Sodium Citrate Alkalizing laxative.
090013 Wyeth Laboratories, Inc.

Petrogalar Plain




Phenolphthalein Petrogalar




Cascara Petrogalar





Glycerine Suppositories Adult



Suppositories Children

Aqueous Suspension of Mineral Oil


Phenolphthalein in Aqueous Suspension Mineral Oil


Cascara Sagrada in an Aqueous Suspension of Mineral Oil


Glycerine Suppositories


Glycerine Suppositories















Use of Glycerin Suppositories will be found more convenient than enemas and more rapid in action than purgatives given by mouth.

090014 Wyeth Laboratories, Inc.




Polymagma plain


Polymagma Plain Tablets

Kaolin in Alumina Gel

Kaolin in Alumina Gel with Pectin

Activated Attapulgite, Pectin

Activated Attapulgite, Pectin Hydrated Alumina Powder

For the control of Diarrhea an activated fluid adscrbent




Control of diarrhea

090015 U.S.V. Pharmaceutical Corporation Neo-Cultol Mineral Oil Jelly For intestinal lubrication as a gentle corrective in constipation.
090016 U.S.V. Pharmaceutical Corporation Bacid

Lactobacillus Acidophilus

Sodium Carboxymethyl Cellulose

Relief of diarrhea and associated renal discomfort.
090017 Dorsey Laboratories Vacuetts Suppositories

Sodium Biphosphate Anhydrous

Sodium Acid Pyrophosphate

Sodium Bicarbonate

For bowel evacuation of the lower bowel in most common types of constipation.

Vacuetts are non-irritating to rectal mucosa and non-habit forming.

090018 Abbott Laboratories

Maltsupex Filmtab


Malt Soup Extract

Malt Soup Extract Solids

A natural corrective for chronic constipation, laxative dependence and rectal itching.  Effective, non-habit forming, it promotes soft, easily passed stools.
090019 Abbott Laboratories Syllamalt Powder

Malt Soup Extract

Blond Psyllium Seed Husks

Natural barley extract and psyllium seed husks are combined to promote bowel regulatory. Effective, non-habit forming.
090020 Abbott Laboratories Syllamalt Effervescent

Malt Soup Extract Powder

Blond Psyllium Seed Husks

Promotes bowel regularity.  Soften stools and serves to provide bulk.
090021 Pharmaseal Laboratories, Inc. Sigmol Enema

Sorbitol USP

Dioctyl Potassium Sulfosuccinate



090022-090023 Warren-Teed Pharmaceuticals Inc.


Modane, Mild


d-Calcium Pantothenate

090024 Lacto Products Company Acidophilus Concentrate Lactobacillus Acidophilus Used to change the bacterial flow of the intestinal tract.
090025 Denver  chemical Mfg., Co. Rectalad Enema


Diotyl Potassium Sulfosuccinate

To relieve occassional or temporary constipation.
090026 Whitehall Laboratories Inc. Preparation H (Non-Laxative Regulator) Dioctyl Sodium Sulfosuccinate Softens dry hard stools for easier, more comfortable passage.
090027 Warner-Lambert Company Veracolate

Bile Salts


Ext. Cascara Sagrada

Oleoresin Capsicum

Temporary relief of constipation.
090028 Warner-Lambert Company Veracolate

Bile Salts


Ext. Cascara Sagrada

Oleoresin Capsicum

Temporary relief of constipation.
090029 Chattem Drug and Chemical Company

Black-Draught Granulated

Black-Draught Senna-Lax Tablet

Black-Draught Powder

Black-Draught Syrup of

















Vol. I

J.B. Williams Co., Inc. Serutan Concentrated Powder Plantago Ovata Husk Methyl Cellulose Aid to regularity


Vol. II

J.B. Williams Co., Inc. Serutan Concentrated Fruit Flavored Plantago Ovata Husk Methyl Cellulose Aid to regularity
090032 J.B. Williams Co., Inc. Serutan Toasted Granules Plantago Ovata Husk Methyl Cellulose Aid to regularity


Vol. I


Vol. II

Ex-Lax, Inc.

Ex-Lax Chocolated


Ex-Lax Unflavored


Ex-Lax Instant Mix

Yellow Phenolphtalein

Yellow Phenolphtalein

Yellow Phenolphtalein

Relief of Constipation.  Laxative.
090035 The Upjohn Company

Imbicoll with Cascara


Imbicoll with Vitamin B1

Vegetable Gum, Cascara Sagrada


Vegetable Gum, Thiamine Hydrochloride

Laxative Bulk-producing aid.
090036 The Upjohn Company Phenolax Wafers Phenolphthalein Relief of constipation.
090037 The Upjohn Company



Kaolin, Pectin

Kaolin, Pectin

Treatment of diarrhea.
090038 International Pharmaceutical Corporation Dia-Quel Liquid Tincture of Opium, Homatropine Methlbromide, Pectin Rapid control of diarrhea, relief of cramping, colickky pain and nausea, soothes and protects intestinal tract.
090039 Searle Laboratories

Metamucil powder

Metamucil instant Mix

Psyllium Hydrophyllic Mucilloid Treatment of constipation, promotes natural elimination.


Vol. I

Searle Laboratories Dramamine Dimenhydrinate Prevent travel sickness.


Vol. II

Searle Laboratories Dramamine Liquid Dimenhydrinate Prevent travel sickness.


Vol. I








Vol. II


Hoechst Pharmaceuticals, Inc.












Doxinate Solution





Danthron, Dioctyl Sodium Sulfosuccinate


Danthron, Dioctyl Calcium Sulfosuccinate


Dioctyl Sodium Sulfosuccinate


Dioctyl Sodium Sulfosuccinate


Dioctyl Calcium Sulfosuccinate

Laxative with stool softener an aid in the treatment of temporary constipation.
090044 Beecham, Inc. ENO Sodium Bicarbonate, Sodium Carbonate, Tartaric Acid Mild Laxative.


Vol. I






Vol. II

A.H. Robins Company









Kaolin, Pectin, Hyoscyamine Sulfate, Atropine Sulfate, Hyoscine Hydrobromide


Kaolin, Pectin, Hyoscyamine Sulfate, Atropine Sulfate, Hyosine Hydrobromide, Powdered Opium, USP







Mild Laxative.

090047 Plough, Inc. Correctol Dioctyl Sodium Sulfosuccinate Yellow Phenolphthallein Women’s gentle laxative.
090048 Plough, Inc. Saraka Frangula, Sterculia All vetable laxative for planned regularity.


Vol. I


Vol. II

Plough, Inc.


Gum and Mints

Yellow Phenolphthalein  
090051 William H. Rorer, Inc. Emetrol Levulose, Dextrose, Ortho-phosphoric Acid For nausea and vomiting.  Relief of upset stomach and nausea associated with Colds, Food indiscetions, emotional upsets and travel discomfort.


Vol. I



Vol. II

Norwich Pharmacal Company Pepto-Bismol

Bismuth Subsalicylate


Zinc Phenolsulfonate

Upset stomach, indigestion, nausea and controls diarrhea.


Vol. I


Vol. II


Vol. III

Norwich Pharmacal Company



Chewable Tablets

Bismuth Subsalicylate

Precipitated Calcium Carbonate, USP Glycocoll

Relief for upset stomach, ingestion, nausea, common diarrhea.
090057 Whitehall Laboratories, Inc.

Petro-Syllium plain








Petro-Syllium with Phenolphthalein

Psyllium Seed, NF Mineral Oil, Protol, USP







Relief for constipation, softens hard stool and helps to move it through the intestinal tract comfortably.


Relief of constipation, nonfattening liquid emulsion of mineral oil.  Passes through stomach and upper intestine without upset or dyhydrationg effect.

090058 Sandoz Pharmaceuticals Glysennid Tablets Sennosides A and B Laxative.
090059 Cooper Laboratories, Inc.

Kondremul Plain




Kondremul with Cascara





Kondremul with Phenolphthalein



Mineral Oil, USP




Mineral Oil, USP Cascara Ext.





Mineral Oil, USP Phenolphthalein


Mineral Oil, USP Casathranol

Laxative, temporary relief of constipation.


Relief of constipation.  Promotes normal bowel movement, assures soft stool.


Same as Kondremul with Cascara.


Temporary relief of constipation, when severe symtoms of constipation have subsided, satisfactory action will usually be obtained by changing to Kondremul plain.



090060 Sterling Drug Inc.

Mucilose Flakes

Mucilose Granules

Mucilose Powder

Hemicellulose of Psillium Special formula to afford intestinal bulk and lubrication.
090061 Sterling Drug Inc.

Haley’s M-O





Milk of Magnesia, USP

Mineral Oil


Milk of Magnesia, USP

Mineral Oil

Gentle laxative antacid lubricant.



Same as Haley’s M-O but in Spanish

090062 Sterling Drug, Inc.

Sal Andrews

Andrews Salts

Tartaric Acid

Sodium Bicarbonate

Magnesium Sulfate Dihydrate

090063 Sterling Drug, Inc.

Phillip’s Milk of Magnesia

Phillip’s Milk of Magnesia Tablets

Milk of Magnesia


Magnesium Hydroxide



Gives more complete relief than single-purpose laxatives.  Is an effective antacid as well as laxative.

090064 Sterling Drug, Inc. Fletcher’s Castoria Extract Senna Leading laxative specially formulated for babies and growing children.
090065 Sterling Drug, Inc. Caroid and Bile Salts

Extract Cascara Sagrada


Desiccated Whole Bile



When Constipation occurs, caroid and bile salts help to restore a normal pattern of elimination.  They have been found so safe and gentle that doctors have recommended their use for the relief of constipation associated with pregnancy and in heart patients where straining at the stool may cause a dangerous rise in blood pressure.
090066 Pfizer Pharmaceuticals Bonine Meclizine Hydrochloride Prevent nausea and vomiting of travel sickness.
090067 Parke, Davis & Company

Alophen Pills





Casacara Sagrada Fluidextract-Aromatic


Cascara Sagrada Aromatic





Kapseals Desicol



D-S-S Capsules



D-S-S Plus
















Geriplex FS Liquid








Glycerin Suppositories




Milk of Magnesia

Aloin, Extract Belladona, Powdered Ipecac Phenolphthalein


Cascara Sagrada, USP Ground



Cascara Sagrada, USP Ground


Cascara Sagrada, USP


Desiccated Whole Fresh Bile


Diotyl Sodium Sulfosuccinate


Diotyl Sodium Sulfosuccinate, Casanthranol


Vit. A Acetate, Vit. C, Thiamine Mononitrate, USP riboflavin, USP Cyanocobalamin, Choline Dihydrogen Citrate NF Niacinamide, USP Vit. E, Dioctyl Sodium Sulfosuccinate


Thiamine Hydrochloride Vit. B2, Pyridoxine Hydrochloride, Cyanocobalamin Niacinamide, Iron, Pluronic F-68







Magnesium Hydroxide

Temporary relief of occasional constipation.
















Stool softener.



Laxative and stool softener.



Vit./ formula with fecal softener.











Geriatic Vit. Tonic with iron and a fecal softener.






Laxative, afford a quick method of emptying the lower bowel.
















Siblin Tablets

Kaolin, Pectin




Psyllium Seed Husks

Thiamine Hydrochloride, USP


Psyllium Seed Husk, Powdered


Pectin, NF

Agar, USP

Thiamine Hydrochloride, USP

Antidiarrheal for treatment of diarrhea.


Laxative, for the relief of functional constipation.




Laxative.  A preparation for the relief of functional constipation.

090068 Carter-Wallace, Inc. Carters Little Pills

Aloe, USP

Podophyllum Resin, USP

Reduce the following symtoms when due only to constipation: sluggishness, bloated feeling, headache, nervous-ness.
090069 William H. Rorer, Inc. Parepectolin Paregoric, Pectin Kaolin Anti-diarrheal.

received (May 8, 1973)

The Upjohn Company

Hydrolose Syrup Methylcellulose Aid to bowel regularity
090071 The Upjohn Company Bile Salts Phenol-phthalein Compound Bile Salts, Phenolphthalein, Papain, Ext. Cascara Sagrada, Ginger Temporary relief of constipation
090072 The Upjohn Company Casakol Capsules Poloxalkol, Casanthranol Temporary relief of occasional constipation
090073 The Upjohn Company Casyllium Cascara, Psyllium Husk Powder, Prune Powder Bulk-Producing preparation with added laxatives
090074 The Upjohn Company Polykol Poloxalkol Temporary relief of hard stools
090075 Scott Laboratories, Inc.

Caster Oil






Citrate of Magnesia

Caster Oil






Citrate of Magnesia




Used as an emollient


As an active purgative

090076 Merit Remedy Company

Gall - Solve









Merit Cathartics

Oxgall, Sodium Oleate








Cascara, Aloin, Podophyllin Oleoresin, Ginger

A cholagogue mild laxative to stimulate the flow of bile, recommended for constipation, headaches or biliousness due to constipation


Temporary relief of occasional constipation

090077 The Purdue Frederick Company Senokot Granules Senna Concentrate Gentle bowel stimulation aiding laxation relieves constipation
090078 The Purdue Frederick Company Senokot Tablets Senna Concentrate Relieves constipation
090079 Miles Laboratories, Inc. Decholin Dehydrocholic Acid Digestive Aid, Laxative.  Indigestion-after meal discomfort & fullness (particularly after fatty meals) - excessive belching-constipation
090080 Gray Pharmacal Co. X-Prep Powder Senna Concentrate For routine preradiologic bowel evacuation
090081 The Purdue Frederick Co. Senokot Suppositories Senna Concentrate Rectal laxative
090082 Gray Pharmaceutical Co. X-Prep Liquid Senna fruit extract Preradiographic bowel evacuant
090083 The Purdue Frederick Co. Gentlax S

Senna Concentrate

Dioctyl sodium sulfosuccinate

For gentle, reliable relief of constipation
090084 The Purdue Frederick Co. Gentlax Tablet Senna Concentrate Guar gum A gentle laxative, for relief of simple constipation
090085 The Purdue Frederick Co. Gentlax Granules

Senna concentrate

Guar gum

A gentle laxative with bulk for relief of simple constipation
090086 The Purdue Frederick Co. Senokap DSS Capsules

Senna concentrate

Dioctyl sodium sulfosuccinate

Relieves constipation, softens stool
090087 The Purdue Frederick Co. Senokot Syrup Extract senna fruit Natural vegetable laxative, relieves constipation
090088 The Purdue Frederick Co. Senokot with Psyllium Powder

Senna concentrate


Laxative with bulking agent for simple constipation
090089 Marcen Laboratories, Inc. Acelax Tablets


Chondrus crispus

Dioctyl sodium sulfosuccinate

Prune concentrate dehydrated



Vol. 1

Hynson, Wesrcott & Dunning, Inc. Lactinex Granules

Lactobacillus acidophilus

Lactobacillus bulgaricus

Assist in restoration & maintenance of normal intestinal flora, & to help relieve the discomforts of diarrhea & fever blisters.


Vol. 2

Hynson, Westcott & Dunning, Inc. Lactinex Tablets

Lactobacillus acidophilus

Lactobacillus bulgaricus

Assist in restoration & maintenance of normal intestinal flora, & to help relieve the discomforts of diarrhea & fever blisters.
090092 E.R.Squibb & Sons, Inc.

C.T. Milk of Magnesia  





Milk of Magnesia



Glycerine Suppositories


Mineral Oil, U.S.P.

Magnesium hydroxide


Magnesium hydroxide


Magnesium hydroxide





Mineral oil

Laxative, antacid



Antacid, laxative



Antacid, laxative






Intestinal libricant

090093 Hoechst Pharmaceuticals Inc. Supplemental submission Vol. 1 Doxan tablets Addendum to Volume 090042  
090094 Hoechst Pharmaceuticals, Inc. Same as above, Volume II      
090095 Eneglotaria Medicine Co., Inc. Of Puerto Rico Kao Gest Colloidal kaolin, pectin For the treatment of common diarrhea
090096 The Purdue Frederick Co. Parelixir Liquid Tincture opium, pectin alcohol Nonspecific diarrhea
090097 Miles Laboratories, Inc. Decholin Addendum to Volume 090079  
090098 C.B. Fleet Co., Inc. Fleet Enema Addendum to Volume 090010  
090099 Norwich Pharmacal Co. Pepto Bismol Addendum to Volume 090052  
090100 Bristol  Myers Products Bran Bran  
090101 Bristol Myers Products Bran Pharmacology reports  
090102 Bristol Myers Products Bran Reprints  
090103 Bristol Myers Products Bran Reprints  
090104 Lewis Howe Company Nature’s Remedy Supplemental submission on aloe  
090105 Lewis Howe Company Nature’s Remedy Supplemental submission on aloe  
090106 Lewis Howe Company Nature’s Remedy Supplemental submission on aloe  
090107 Lewis Howe Company Nature’s Remedy Supplemental submission on aloe  
090108 American Cyanamid Co. Dioctyl Sodium Sulfosucinate (no trade name)  
090109 In House report for OTC Antiemetics      
090110 In House report for Bisacodyl      
090111 In House report for Guar Gum      
090112 E.R. Squibb & Sons, Inc. Caster Oil Supplemental labeling submission  
090113 Carter Wallace, Inc. Carter’s Little Pills Supplement to Volume 090068  
090114 Boehringer Ingelheim Ltd.

Dulcolax Tablets

Dulcolax Suppositories

Bisacodyl Laxative

Boehringer Ingelheim Ltd.

(Volume 2)


Boehringer Ingelheim Ltd.

(Volume 3)

090117 Forest  Laboratories Mel-O-Lax Magnesium hydroxide  
090118 Bristol-Myers Co. Sol Hepatica

Sodium bicarbonate

Citric acid

Monosodium phosphate



Volume 1

Norwich Pharmaceutical Co. Pepto Bismol Supplement to Volume 090052  
090120 Norwich Pharmaceutical Co. Pepto Bismol Supplement to Volume 090052  
090121 The Upjohn Company Kaolin - pectin Supplement to Volume 090037  
090122 Parke Davis Co. Alophen Pills

Supplement to

Vol. 090067

090123 Norwich Pharmaceutical Co. Pepto-Bismol

Supplement to

Vol. 090052

090124 Merrick Medicine Co. Rhubarb Fluidextract Rhubarb  
090125 Upjohn Company Kaolin-pectin

Supplement to

Vol. 090037



(Vol. 1)

Merrell National Laboratories Cephulac

Lactulose syrup

(galactose and lactose)



(Vol. 2)

Merrell national Laboratories Cephulac

lactulose syrup

(galactose and lactose)

090128 Bristol-Myers Products Bran tablets    
090129 Bristol-Myers Products Bran tablets    
090130 Bristol-Myers Products Bran tablets    
090131 Bristol-Myers Products Bran tablets    
090132 Norwich Pharmacal Co. Pepto-Bismol

Supplement to

Vol. 090052

090133 Pfizer   Data submission to Panel  
090134 Published references cited in Panel Report      
090135 Communication from Dr. Picchioni and copy of microfilm “Reference No. 8" cited in Panel Report      
090136 Pfizer Bovine tablets    
090137 Pfizer Scopolamine hydrobromide    
090138 Upjohn supplement to 090037    
090139 Upjohn Supplement to 090037    
090140 Hynson, Westcott & Dunning, Inc. Lactinex Supplement to 090090  
090141 Sterling Drug Haley’s M-O Supplement to 090061  
090142 Assorted Correspondence      
090143 Panel Administrator’s File