ASACOL HD (Mesalamine) TABLET, DELAYED RELEASEContaining 400 and 800 mg Mesalamine

SECTION 2: Hazards identification

Product definition

This product is supplied as yellow-brown capsule-shaped tablets

Health hazards

In the workplace, exposure via inhalation or eye contact may cause irritation. No information is available on possible effects from skin exposure. Accidental ingestion may be harmful. In therapeutic use, the most common adverse effects reported include headache, nausea, nasopharyngitis, abdominal pain, and worsening of ulcerative colitis.

Other hazards

reported have included renal damage and hypersensitivity reactions, including cardiac hypersensitivity reactions. May cause fetal harm, based on animal data for Dibutyl Phthalate (inactive ingredient in Asacol HD enteric coating). Other adverse effects seen from therapeutic use are described in Section 11 (Toxicological information). Flammability Hazards: If heated to high temperatures for a prolonged period, the product may ignite. When involved in a fire, this material may decompose and produce irritating vapors and toxic compounds (including carbon, iron, sodium. magnesium, and nitrogen oxides). Reactivity Hazards: This product is not reactive.

Environmental hazards

The Dibutyl Phthalate ingredient is acutely toxic to aquatic organisms. Large quantities of this product released to the aquatic and terrestrial environment may have an adverse effect. Emergency Considerations: Emergency responders should wear appropriate protection for the situation to which they respond.