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SCARs Label Warning For OTC PPIs In US Starts With Perrigo’s 131 Omeprazole Product Options

 
• By Malcolm Spicer

FDA approves warning for severe cutaneous adverse reactions on labeling for Perrigo's 131 20-mg omeprazole delayed-release tablet products across unflavored and cool mint or wild berry-mint options and 14-, 28- and 42-count packages. 

• Source: Shutterstock

Manufacturing the most OTC drug products marketed in the US puts Perrigo Company PLC first in line for adding a label warning to an omeprazole proton pump inhibitor about a potential risk of rare skin reaction.

The Food and Drug Administration has approved adding a warning for severe cutaneous adverse reactions (SCARs) to labeling for 131 separate 20-mg omeprazole delayed-release tablet products in unflavored and cool mint or wild berry-mint options and in 14-, 28- and 42-count packages

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