CHPA responds to Food and Drug Administration’s APAP recommendation

WASHINGTON — The Consumer Healthcare Products Association on Thursday responded to the Food and Drug Administration’s recommendation to discontinue prescribing and dispensing prescription combination medicines that contain more than 325 mg of acetaminophen per dosage unit, suggesting it would not impact use of over-the-counter formulations containing acetaminophen.

“By limiting prescription products to no more than 325 mg acetaminophen, the FDA is addressing the biggest cause of unintentional acetaminophen overdose," the association stated. "More than half (63%) of reported overdose cases involve the use of prescription opioid-acetaminophen combination medicines, such as Vicodin and Percocet. Lowering the amount in prescription products will help reduce the risk of consumers accidentally exceeding the maximum daily dose of 4,000 mg."

The industry has taken several proactive steps to educate consumers about acetaminophen safe-use and increase the visibility of acetaminophen on OTC product labels to help consumers better understand how to avoid accidental overdose. This has included enhanced labeling on both the front package panel and the Drug Facts label to call out the word “acetaminophen” on all OTC medicines that contain the ingredient. It is now prominently listed on the principal display panel (front of package) and bolded or highlighted in the ingredients section of the Drug Facts label. 

These initiatives are in tandem with FDA’s and others’ efforts on the prescription side to drive and improve acetaminophen safe use. 

In addition, the CHPA Educational Foundation co-founded and actively participates on the Acetaminophen Awareness Coalition and its Know Your Dose campaign, which educates consumers to read and follow the medicine label, know if acetaminophen is an ingredient in your medicines, and never take two medicines with acetaminophen at the same time. Advisors to those initiatives include the FDA’s Safe Use Initiative and the Centers for Disease Control and Prevention.