May 17, 2023
Safe Use of Acetaminophen
CHPA supports the current acetaminophen monograph dosing.
Acetaminophen is the most common drug ingredient in the United States. It’s found in more than 600 different medicines, including prescription and over-the-counter (OTC) pain relievers, fever reducers, and sleep aids as well as cough, cold, and allergy medicines. Each week, approximately 23 percent of U.S. adults — or 52 million consumers — use an acetaminophen-containing medicine.
When used as directed, acetaminophen is safe and effective. But taking more than directed is an overdose and can lead to liver damage. The root cause of unintentional acetaminophen-related liver toxicity is consumer dosing behavior: people taking more than the recommended dose by not reading/following dosing directions, re-dosing too soon, or taking multiple products with acetaminophen at the same time.
Safe use of acetaminophen is a top priority for the manufacturers of these medicines. Over the last five years, manufacturers have worked closely with the U.S. Food and Drug Administration (FDA), healthcare provider groups, pharmacist groups, and consumer health advocates to drive safe and responsible use of acetaminophen. Significant efforts include:
- Raising the visibility of acetaminophen in OTC medicines via labeling improvements: All OTC medicines that contain acetaminophen now prominently display the word ‘acetaminophen’ on the front panel of packaging to make it easier for consumers to identify this ingredient. OTC medicines with acetaminophen also now highlight or bold ‘acetaminophen’ on the Drug Facts Label.
- Limiting acetaminophen in prescription products: FDA has limited the strength of acetaminophen in prescription combination products (Percocet and Vidocin and their generic equivalents, for example) to 325 mg/dose.
- Improving prescription labeling: FDA together with the National Council for Prescription Drug Programs (NCPDP) has worked with pharmacies nationwide to ensure that “acetaminophen” is written in full on pharmacy-printed prescription drug labels, and not abbreviated as “APAP” or “acetam” as had been done previously. Today, NCPDP estimates that more than 95 percent of U.S. pharmacies are now working to fully spell out “acetaminophen” on prescription labels.
- Standardizing pediatric dosing to reduce the potential for dosing errors: Manufacturers standardized the strength (concentration) of single-ingredient liquid acetaminophen medicines for infants and children, to make dosing easier for parents and reduce pediatric dosing errors. All single-ingredient liquid acetaminophen products for both infants and children are now the same strength. These medicines now also include age-appropriate dosing devices with standardized markings for infants and children.
- Demonstrating the benefits of acetaminophen strengths: Manufacturers have conducted studies1 to provide additional evidence demonstrating the pain relief benefits of a 1,000 mg (an “extra strength” dose) and 650 mg dose (“regular strength”). Studies have been submitted to FDA.
- Educating consumers to change dosing behavior: The CHPA Educational Foundation co-founded the Acetaminophen Awareness Coalition and its Know Your Dose campaign, which educates consumers on safe acetaminophen use. Since 2011, the ongoing campaign has reached more than 700 million consumers and healthcare providers through the distribution of more than 11 million free educational materials, outreach activities supported by the coalition’s 25+ members and partners, and targeted paid and earned media. Manufacturers are also conducting educational campaigns, such as Get Relief Responsibly, a consumer education initiative launched by McNeil Consumer Healthcare, the manufacturer of Tylenol®.
FDA convened an advisory committee in 2009 to discuss opportunities to drive acetaminophen safe use and promote education. The CHPA Educational Foundation continues to collaborate with FDA and its Safe Use Initiative on educational programs to promote awareness and drive acetaminophen safe use. Educational initiatives are having impact. CHPA's 2019 acetaminophen consumer awareness survey shows safe use knowledge and risk awareness among pain medicine users remain high.
1"A Randomized, Double-Blind, Placebo-Controlled Study of Acetaminophen 1000 mg Versus Acetaminophen 650 mg for the Treatment of Postsurgical Dental Pain" and "Post-operative Dental Pain Study Comparing Two Different Dosage of Analgesic Efficacy"