Cumberland Pharmaceuticals announced that the FDA has approved updated labeling for Acetadote (acetylcysteine) Injection that includes a revised indication and new dosing guidance for specific patient populations.

RELATED: Poisoning and Drug Dependence Resource Center

Acetadote’s new indication now states, “Acetadote is an antidote for acetaminophen overdose indicated to prevent or lessen hepatic injury after ingestion of a potentially hepatotoxic quantity of acetaminophen.”  The phrase “administered intravenously within 8 to 10 hours” from the previous indication has been removed due to potential confusion concerning efficacy when administration within that time period is not possible.

In addition, specific dosing guidance has been included for patients weighing >100kg. The new label also includes information on extending therapy for patients in certain clinical situations.

Used in the emergency department, Acetadote is an injectable product approved in the United States to treat overdose of acetaminophen, a common ingredient in many over-the-counter painkillers.

For more information call (866) 767-5077 or visit