SPL Set ID: 976be6e3-a9db-49c6-9b02-1ab168cf17b1

Clozapine, an atypical antipsychotic drug, is a tricyclic dibenzodiazepine derivative, 8-chloro-11-(4-methyl-1-piperazinyl)-5 H -dibenzo [ b,e ] [1,4] diazepine. The structural formula is: Clozapine orally disintegrating tablets are available as peach, orally disintegrating tablets of 25 mg, 100 mg, 150 mg or 200 mg for oral administration without water. Clozapine orally disintegrating tablets may be chewed. Each orally disintegrating tablet contains clozapine equivalent to 25 mg, 100 mg, 150 mg or 200 mg. The active component of clozapine orally disintegrating tablets is clozapine. The remaining components are aspartame, crospovidone, FD&C Yellow No. 6 Aluminum Lake, magnesium stearate, mannitol, microcrystalline cellulose, peppermint flavor, silicon dioxide and sodium stearyl fumarate. THIS PRODUCT CONTAINS ASPARTAME AND IS NOT INTENDED FOR USE BY INFANTS. PHENYLKETONURICS: CONTAINS PHENYLALANINE [see Warnings and Precautions (5.19) ] . Phenylalanine is a component of aspartame. Each 25 mg, orally disintegrating tablet contains 3.38 mg aspartame, thus, 1.90 mg phenylalanine. Each 100 mg, orally disintegrating tablet contains 13.52 mg aspartame, thus, 7.59 mg phenylalanine. Each 150 mg, orally disintegrating tablet contains 20.28 mg aspartame, thus, 11.38 mg phenylalanine. Each 200 mg, orally disintegrating tablet contains 27.04 mg aspartame, thus, 15.18 mg phenylalanine. The allowable daily intake of aspartame is 50 mg per kilogram of body weight per day. Clozapine Structural Formula