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OTC vasoconstrictor eyedrop pupil dilation warning proposed by FDA.

This article was originally published in The Tan Sheet

Executive Summary

OTC OPHTHALMIC VASOCONSTRICTORS PUPIL DILATION WARNING PROPOSED BY FDA in a notice published in the Feb. 23 Federal Register. The proposed rule would amend the 1988 FDA final monograph for OTC eye allergy relief drug products to include the statement, "Pupils may become dilated (enlarged)." The vasoconstrictor ingredients covered under the proposed rule would include ephedrine, naphazoline, phenylephrine and tetrahydrozoline.

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