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Pregnant Women: There are no adequate or well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, pms-URSODIOL C should not be used in women who are or may become pregnant. If this drug is used during pregnancy or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential hazard to the fetus (see also Pharmacology: Toxicology: Non-Clinical Toxicology: General Toxicology: Reproductive and Developmental Toxicology under Actions).
Breast-feeding: It is not known whether ursodiol is excreted in human milk.
Since many drugs are excreted in human milk, caution should be exercised when pms-URSODIOL C is administered to a nursing mother.
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