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Zyrtec-D labeling amendment

Executive Summary

Amended labeling for Pfizer's Zyrtec-D combination cetirizine/pseudoephedrine allergy therapy lists insomnia as most frequent adverse event reported in two trials. Insomnia occurred in 4% of Zyrtec-D users, compared to .6% of the placebo group. Labeling amendment approved April 14 reflects data from two trials comparing Zyrtec-D to unidentified active control and placebo for two weeks in 2,094 patients ages 12 and older with seasonal allergic rhinitis. Labeling continues to list somnolence as most frequent AE in trials on cetirizine alone...

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