acamprosate calcium tablet delayed release
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. Treatment with acamprosate calcium delayed-release tablets should be part of a comprehensive management program that includes psychosocial support. The efficacy of acamprosate calcium 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 in promoting abstinence from alcohol in polysubstance abusers has not been adequately assessed. 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 ).
teva pharmaceuticals usa, inc.
ROUND WHITE 77 1140
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16 HOW SUPPLIED/STORAGE AND HANDLING Acamprosate Calcium Delayed-release Tablets are available as: 333 mg: white to off-white, round, enteric-coated, biconvex, unscored tablet debossed with 77 on one side and 1140 on the other side. Available in bottles of 180 tablets (NDC 0093-5352-86). Store at 20º to 25ºC (68º to 77ºF) [See USP Controlled Room Temperature]. Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required). KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.
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