Acamprosate calcium 333 MG Delayed Release Oral Tablet
1 INDICATIONS AND USAGE Acamprosate calcium delayed-release tablets are indicated for the maintenance of abstinence from alcohol in patients with alcohol dependence who are abstinent at treatment initiation ( 1 , 14 ). Treatment with acamprosate calcium delayed-release tablets should be part of a comprehensive management program that includes psychosocial support ( 1 ). Acamprosate calcium delayed-release tablets are indicated for the maintenance of abstinence from alcohol in patients with alcohol dependence who are abstinent at treatment initiation. Treatment with acamprosate calcium delayed-release tablets should be part of a comprehensive management program that includes psychosocial support. The efficacy of acamprosate calcium delayed-release tablets in promoting abstinence has not been demonstrated in subjects who have not undergone detoxification and not achieved alcohol abstinence prior to beginning acamprosate calcium delayed-release tablets treatment. The efficacy of acamprosate calcium delayed-release tablets in promoting abstinence from alcohol in polysubstance abusers has not been adequately assessed.
Zydus Pharmaceuticals (USA) Inc.
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16 HOW SUPPLIED/STORAGE AND HANDLING
ACAMPROSATE CALCIUM Delayed-release Tablets, 333 mg are white to off-white, round, biconvex, beveled edge, enteric coated tablets, debossed with '569' on one side and plain on the other side and are supplied as follows: NDC 68382-569-06 in bottles of 30 tablets with child-resistant closure NDC 68382-569-16 in bottles of 90 tablets with child-resistant closure NDC 68382-569-01 in bottles of 100 tablets with child-resistant closure NDC 68382-569-28 in bottles of 180 tablets with child-resistant closure NDC 68382-569-05 in bottles of 500 tablets NDC 68382-569-10 in bottles of 1000 tablets Storage and Handling Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Dispense in a tight container (USP).
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