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U.S. Department of Health and Human Services

Safety

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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

Summary View

 

PRECAUTIONS

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.
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