Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed. It is not known whether ursodiol is excreted in human milk. The most severe manifestation of overdosage would likely consist of diarrhea which should be treated symptomatically. Symptoms of acute toxicity were salivation and vomiting in dogs, and ataxia, dyspnea, ptosis, agonal convulsions and coma in hamsters. Dispense in a tight container.
Federal law prohibits dispensing without a prescription.
Axcan Pharma U.S. Inc April 1998 Printed in Canada.