The FDA has approved an updated labeling of Cumberland Pharmaceutical’s Acetadote (acetylcysteine) injection to include new information from a post-marketing safety study reporting a lower incidence of side effects compared to previously reported data. This post-marketing study of 4,709 adults and 1,905 children found the observed overall rate of reactions commonly associated with Acetadote to be 8.4 percent, or approximately one-half of the 17 percent rate reported in a previous study.

Acetadote is indicated to minimize hepatic injury after acetaminophen overdose.

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