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Campral (acamprosate calcium) delayed-release tablets
Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) – December 2010
Carcinogenicity, Mutagenicity and Impairment of Fertility
- In mice, acamprosate calcium administered orally for 60 days prior to mating and throughout gestation in females at doses up to 2400 mg/kg/day (approximately 5 times the maximum recommended human daily oral dose on a mg/m2 basis) had no effect on fertility.