The agency also is considering whether additional words such as "This is temporary and not serious" would be beneficial. FDA said it has received a number of complaints about dilated pupils and hoped the warning would reduce the number of adverse incidents. FDA is also proposing that product labeling requirements for these products be amended to read, "If you have narrow-angle glaucoma, do not use this product except under the advice and supervision of a doctor." Currently, the warning applies to those having glaucoma of any type.
Eye drug warnings
Labels of popular OTC eye allergy relief drugs such as Pfizer's Visine, Ross Labs' Murine Tears Plus and Clear Eyes ACR, Bausch & Lomb's Sensitive Eyes, and other vasoconstrictor drugs containing ephedrine, naphazoline, phenylephrine, and tetrahydrozaline should include the warning "Pupils may become dilated (enlarged)," according to an FDA proposal.
Mar 31, 1998
Recommended
Machinery Basics
Co-packers: the competitive gap is widening
Brands want more than low bids. See what automation, services, and sustainability mean for CM/CPs in 2026.
Read More
Discover How to Stay Ahead of the Competition at PACK EXPO International
See new solutions from 2,600 exhibitors. Gain insights from 150+ free educational sessions. From automation & robotics to real-time data insights, find the tech for your company’s future at North America’s largest packaging & processing event.
REGISTER NOW & SAVE
Downloads
