mesalamine mesalamine film coated tablet delayed release
1 INDICATIONS AND USAGE Mesalamine delayed-release tablets are indicated for the: • induction and maintenance of remission in adult patients with mildly to moderately active ulcerative colitis. Pediatric use information is approved for Takeda Pharmaceuticals U.S.A., Inc.’s LIALDA (mesalamine) delayed-release tablets. However, due to Takeda Pharmaceuticals U.S.A., Inc.’s marketing exclusivity rights, this drug product is not labeled with that information. Mesalamine delayed-release tablets are an aminosalicylate indicated for the: • induction and maintenance of remission in adult patients with mildly to moderately active ulcerative colitis. ( 1 )
mylan pharmaceuticals inc.
OVAL BROWN M1200
M1200 OVAL BROWN
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16 HOW SUPPLIED/STORAGE AND HANDLING Mesalamine Delayed-Release Tablets, USP are available containing 1.2 g of mesalamine, USP. The 1.2 g tablets are tan, film-coated, ellipsoidal, unscored tablets imprinted with M1200 in black ink on one side of the tablet and plain on the other side. They are available as follows: NDC 0378-7401-78 bottles of 120 tablets Store at room temperature 20° to 25° C (68° to 77° F). [See USP Controlled Room Temperature.] Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.
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