<p><strong>Pregnancy</strong>&nbsp;Category B. Reproduction studies performed in mice, rats, and rabbits using a subcutaneous dose of 100 mg/kg/day (approximately 30 times, 60 times, and 116 times, respectively, the maximum recommended human daily inhalation dose on a mg/m2&nbsp;basis) revealed no evidence of teratogenicity or harm to the&nbsp;fetus&nbsp;due to nedocromil sodium. There are, however, no adequate and well-controlled studies in&nbsp;pregnant&nbsp;women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed.<br />
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<strong>Nursing Mothers</strong>:&nbsp;It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Nedocromil inhalation aerosol is administered to a nursing woman.</p>