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About Procter & Gamble (NYSE:PG)
Three billion times a day, P&G brands touch the lives of people around the world. The company has one of the strongest portfolios of trusted, quality, leadership brands, including Actonel ® , (risedronate sodium) tablets, Asacol ® (mesalamine) delayed-release tablets, Enablex ® (darifenacin) extended-release tablets, Prilosec OTC ® , Metamucil ® , Fibersure ® , Align ® , Pepto-Bismol ® , Vicks ® , PUR ® , Crest ® and Oral-B ® . The P&G community consists of over 135,000 employees working in over 80 countries worldwide. Please visit http://www.pg.com for the latest news and in-depth information about P&G and its brands.
About Asacol ® (mesalamine) Delayed-Release Tablets 400 mg
Asacol is indicated for the treatment of mildly to moderately active UC (the indicated dosage is two 400 mg tablets tid for 6 weeks) and for the maintenance of remission of UC (the indicated dosage is 1.6 g/day in divided doses).
Asacol was well-tolerated in clinical studies. Overall, the incidence of adverse events with Asacol was comparable to placebo. In pivotal clinical studies of mildly to moderately active UC, the most frequent adverse events reported for Asacol and placebo, respectively, were headache (35 percent vs. 36 percent), abdominal pain (18 percent vs. 14 percent), eructation (16 percent vs. 15 percent), pain (14 percent vs. eight percent) and nausea (13 percent vs. 15 percent); for the maintenance of remission of UC, the most frequent adverse events were headache (50 percent vs. 50 percent), rhinitis (42 percent vs. 36 percent), diarrhea (35 percent vs. 50 percent), abdominal pain (32 percent vs. 44 percent) and flatulence (24 percent vs. 30 percent). You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch , or call 1-800-FDA-1088.
Asacol is contraindicated in patients with hypersensitivity to salicylates. Caution should be exercised when using Asacol in patients with known renal dysfunction or history of renal disease. It is recommended that all patients have an evaluation of renal function prior to initiation of Asacol tablets and periodically while on Asacol therapy. Serious adverse events may occur with Asacol. Please visit http://www.asacol.com/pdf/us-asacol.pdf for full prescribing information.
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