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The safety of fexofenadine hydrochloride for the treatment of chronic idiopathic urticaria in subjects 6 months to 11 years of age is based on cross-study comparison of the pharmacokinetics of allegra in adult and pediatric subjects and on the safety profile of fexofenadine in both adult and pediatric subjects at doses equal to or higher than the recommended dose.
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Composite cardiac failure was also examined in a separate 4-year placebo-controlled trial evaluating dutas in men at risk for development of prostate cancer.
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