<p><strong>Pregnancy</strong>&nbsp;category B. No adverse fetal effects were observed during teratological studies on animals, but there are no adequate and well-controlled studies in pregnant women. So this drug should be used during pregnancy only if clearly needed.<br />
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<strong>Lactation</strong>: Amlexanox was found in the milk of lactating rats; therefore, caution should be exercised when administering Amlexanox oral paste to a nursing woman.</p>