Indication

Asacol^® HD (mesalamine) delayed-release tablets are available only by prescription for the treatment of moderately active ulcerative colitis (UC).

Important Safety Information

You should not take Asacol HD if you are allergic to any of the ingredients or to salicylates, such as aspirin. Tell your doctor if you have liver problems, kidney problems, or a history of kidney disease. It is recommended that all patients have their kidney function tested prior to starting and periodically while on Asacol HD therapy. Worsening of UC symptoms can also occur. Serious side effects may occur. Asacol HD has not been studied in pregnant women. Talk to your doctor if you are pregnant, planning to become pregnant, or are breastfeeding because Asacol HD may not be right for you. If you have questions, please talk to your doctor.

Asacol HD is generally well tolerated. In clinical studies, some patients reported headache, upset stomach, sore throat, stomach pain, and worsening of UC symptoms.

You should not substitute one Asacol HD 800 mg tablet for two Asacol (mesalamine) delayed-release 400 mg tablets unless directed by your doctor.

For further safety and other information, please see the Asacol HD Prescribing Information.

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 a registered trademark of Medeva Pharma Suisse AG, used under license by Warner Chilcott Company, LLC.