FDA label
What is Motofen used for?
Motofen contains difenoxin and atropine. The FDA-approved uses below are quoted from the Indications and Usage section of its DailyMed label.
Source: DailyMed SPL label file dated 2026-10-23. Publisher page
The FDA label says: “MOTOFEN ®is indicated as adjunctive therapy in the management of acute nonspecific diarrhea and acute exacerbations of chronic functional diarrhea.”
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Motofen, tablet
Indications and Usage, quoted from the label by Legacy Pharma USA Inc. (NDA017744). Cross-references to other label sections are left out.
MOTOFEN ®is indicated as adjunctive therapy in the management of acute nonspecific diarrhea and acute exacerbations of chronic functional diarrhea.
Source: DailyMed label, set id 1fa11c67-5492-469c-9475-6bfa0e5e9ff8, version 2, effective March 23, 2026. NDC 83107-011, one of 2 listings for this product.
Questions
What is Motofen used for?
The FDA label says: “MOTOFEN ®is indicated as adjunctive therapy in the management of acute nonspecific diarrhea and acute exacerbations of chronic functional diarrhea.”
What drug class is Motofen?
FDA lists difenoxin and atropine in the Anticholinergic and Antidiarrheal and Cholinergic Muscarinic Antagonist established pharmacologic class.
Does this page cover off-label uses or dosing?
No. This page shows only the Indications and Usage section of the FDA label. Ask a pharmacist or prescriber about dosing.
More on Motofen
- Is Motofen a controlled substance?Schedule IV
- Generic for MotofenFDA Orange Book
- Is Difenoxin and Atropine a controlled substance?Schedule IV
- Anticholinergics listFDA drug class
- Antidiarrheals listFDA drug class
- Cholinergic Muscarinic Antagonists listFDA drug class
- NDC 54766-200Motofen NDC record
- NDC 83107-011Motofen NDC record
- Schedule IV drugs listDEA schedule