17.4 Peripheral and Central Nervous System
In the presence of a high environmental temperature, heat prostration can occur with BENTYL use (fever and heat stroke due to decreased sweating). If symptoms occur, the drug should be discontinued and a physician contacted. BENTYL may produce drowsiness or blurred vision.  The patients should be warned not to engage in activities requiring mental alertness, such as operating a motor vehicle or other machinery or to perform hazardous work while taking BENTYL.  [see Warnings and Precautions (5.3)].

Manufactured for:

Axcan Pharma US, Inc.

22 Inverness Center Parkway

Suite 310
Birmingham, AL 35242 USA

www.axcan.com

BENTYL® is a registered trademark owned by Axcan Pharma Inc., an affiliated company of Axcan Pharma US, Inc.
Principal Display Panel
BENTYL Capsules:

BENTYL Injection, Ampule:

BENTYL Injection, Box:

BENTYL, Syrup:

BENTYL, Tablets:

BENTYL 
dicyclomine hydrochloride capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:58914-012
Route of Administration ORAL DEA Schedule      
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Dicyclomine hydrochloride (Dicyclomine)  Dicyclomine hydrochloride 10 mg
Inactive Ingredients
Ingredient Name Strength
Lactose monohydrate  
Calcium sulfate  
Starch, corn  
Magnesium stearate  
Product Characteristics
Color blue Score no score 
Shape CAPSULE Size 10mm
Flavor  Imprint Code BENTYL;10 
Contains     
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:58914-012-10 100 CAPSULE ( CAPSULE) in 1 BOTTLE, PLASTIC None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA007409 05/11/1950 
BENTYL 
dicyclomine hydrochloride tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:58914-013
Route of Administration ORAL DEA Schedule      
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Dicyclomine hydrochloride (Dicyclomine)  Dicyclomine hydrochloride 20.6 mg
Inactive Ingredients
Ingredient Name Strength
Acacia  
Dibasic calcium phosphate dihydrate  
Starch, corn  
Lactose monohydrate  
Magnesium stearate  
Sucrose  
Product Characteristics
Color blue (Light blue)  Score no score 
Shape ROUND (Compressed round)  Size 10mm
Flavor  Imprint Code BENTYL;20 
Contains     
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:58914-013-10 100 TABLET ( TABLET) in 1 BOTTLE, PLASTIC None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA007409 05/11/1950 
BENTYL 
di