April 29, 2017
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How Supplied


MOTOFEN® is indicated as adjunctive therapy in the management of acute nonspecific diarrhea and acute exacerbations of chronic functional diarrhea.


The recommended starting dose of MOTOFEN® tablets in adults is 2 tablets then 1 tablet after each loose stool or 1 tablet every 3 to 4 hours as needed, but the total dosage during any 24-hour treatment period should not exceed 8 tablets. In the treatment of diarrhea, if clinical improvement is not observed in 48 hours, continued administration of this type of medication is not recommended. For acute diarrheas and acute exacerbations of functional diarrhea, treatment beyond 48 hours is usually not necessary.

Studies in children below the age of 12 have been inadequate to evaluate the safety and effectiveness of MOTOFEN® in this age group. MOTOFEN® is contraindicated in children under 2 years of age.


MOTOFEN® is available as a white, dye-free, five-sided, scored tablet with “0200” on the scored side and “M” on the other side. Each tablet contains 1 mg difenoxin and 0.025 mg atropine sulfate. Supplied in bottles of 100 tablets (NDC 54766-200-10). Store at 20°-25°C (68°-77°F) [See USP Controlled Room Temperature].

Distributed by: 645 Hembree Parkway, Suite I Roswell, GA 30076. Revised: Mar. 2017

This monograph has been modified to include the generic and brand name in many instances.

Last reviewed on RxList: 4/5/2017

How Supplied

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