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The over-the-counter warning question is still open, eleven years after the FDA raised it

Vetted by Stefan Rest 3 min read

In August 2013 the FDA announced that acetaminophen had been associated with rare but serious skin reactions, including Stevens-Johnson syndrome and toxic epidermal necrolysis. It required a warning to be added to the labeling of prescription medicines containing acetaminophen, and said it would work with the makers of over-the-counter products on the same information. Over-the-counter labeling is governed by a separate and slower process, and in June 2024 the agency published a proposed administrative order addressing labeling for certain non-prescription internal analgesic products. The comment period closed the following month. A proposed order is not a final one — and in the meantime, what an over-the-counter box says about serious skin reactions is a question that has already been put to a jury.

What the FDA said in 2013

The agency’s own questions and answers on the warning are still the clearest short account of it. Acetaminophen has been associated with three serious skin conditions — Stevens-Johnson syndrome, toxic epidermal necrolysis and acute generalized exanthematous pustulosis. The reactions are rare. They can be fatal. They can occur in people who have taken the medicine before without incident, which is the detail that surprises most patients.

The agency’s response split along the line that divides American drug labeling. For prescription products containing acetaminophen, it required the warning to be added. For over-the-counter products — the bottles in a bathroom cabinet — it said it would work with manufacturers, because those labels are set through the nonprescription monograph system rather than product by product.

The monograph process, eleven years on

On June 14, 2024 the FDA published a proposed administrative order on internal analgesic, antipyretic and antirheumatic drug products — the over-the-counter category that includes acetaminophen and the common NSAIDs. The comment period ran through late July 2024. As of this writing the agency has not issued a final order concluding that rulemaking.

We are deliberately not characterizing what the proposed order would require. A proposed order is a proposal, it can change between proposal and finality, and a page that describes a proposal as though it were a rule does its readers no favors. What is worth knowing is structural: the over-the-counter labeling question the FDA opened in 2013 has not been closed, and any claim about an over-the-counter medicine is measured against the label that was actually on the box on the day it was bought.

What a jury already did with one of these labels

In Reckis v. Johnson & Johnson, decided in 2015, the Supreme Judicial Court of Massachusetts affirmed a failure-to-warn verdict for a child who developed toxic epidermal necrolysis after being given children’s ibuprofen. The label warned that the medicine could cause hives, facial swelling, asthma and rash. It did not name the reactions the child suffered.

The court rejected the manufacturer’s argument that federal law preempted the claim, and it declined to hold that a warning listing those four symptoms was adequate as a matter of law. The case is a state-court decision and it binds no other state. It is nonetheless the most useful available answer to a question people ask constantly: can an over-the-counter medicine sold without a prescription support a claim at all? A Massachusetts jury and its highest court said yes on those facts.

Why the date matters more than the current label

A failure-to-warn claim is a claim about what a company knew and said at a particular moment. So the useful document is not the label on the shelf today. It is the label that shipped with the product the patient took — which is why we ask for the box, the receipt, the pharmacy record, the hospital medication administration record, anything that fixes the product and the date.

None of this is a reason to change how anyone takes an ordinary pain reliever, and nothing here is medical advice. The reactions are rare, and the regulator that warned about them did not withdraw the medicine. But if the rare thing happened to you or to your child, the record of which product and which month is the thing worth preserving. Our page on Stevens-Johnson syndrome lists the rest.

This article is general information about how these cases work. It is not legal advice, it does not create an attorney-client relationship, and no two claims are alike. If something here sounds like your situation, the useful next step is a conversation about the facts.

Sources and citations

Statutes, regulations, agency material and decisions referred to above.

  1. Questions and Answers: FDA warns of rare but serious skin reactions with the pain reliever/fever reducer acetaminophenU.S. Food and Drug AdministrationThe FDA’s August 1, 2013 explanation of the warning. Source for the three skin reactions named, for the rarity and potential fatality of the reactions, for the point that they can occur in people who previously tolerated the medicine, and for the prescription labeling requirement and the agency’s stated approach to over-the-counter products.
  2. Nonprescription Drug Products; Internal Analgesic, Antipyretic, and Antirheumatic Drug Products; Proposed Order (Order Identifier OTC000035)U.S. Food and Drug Administration · Federal Register, Document 2024-13228Source for the June 14, 2024 publication date of the proposed administrative order, the category of over-the-counter products it addresses, and the close of the comment period in July 2024.
  3. Reckis v. Johnson & Johnson, 471 Mass. 272 (2015)Supreme Judicial Court of Massachusetts · CourtListenerSource for the affirmance of the failure-to-warn verdict, for the content of the children’s ibuprofen label at issue, and for the court’s treatment of the preemption and adequacy arguments.

Vetted by

Stefan Rest, managing director of CBW Law

Stefan Rest

Managing Director, CBW Law

Stefan Rest has spent more than two decades advocating for consumers and helping people understand how the law may provide a path forward when they’ve been wronged. As Managing Director of CBW Law, he oversees client relations, the firm’s national law-firm network and new partnerships. He writes about developing litigation and consumer legal issues because the right information can help people recognize when their own story may matter.

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