Diphenoxylate hydrochloride and atropine sulfate is contraindicated in:
- Pediatric patients less than 6 years of age due to the risks of respiratory and central nervous system (CNS) depression (see WARNINGS).
- Patients with diarrhea associated with pseudomembranous enterocolitis (Clostridium difficile) or other enterotoxin-producing bacteria due to the risk of gastrointestinal (GI) complications, including sepsis (see WARNINGS).
- Patients with known hypersensitivity to diphenoxylate or atropine.
- Patients with obstructive jaundice.