🇺🇸 acetaminophen Caplet in United States

1 US adverse-event reports

Marketing authorisation

FDA

Status: approved

Safety signals — FAERS

Adverse reaction reports describe suspected side effects. A report does not mean the drug caused the event — co-medications, underlying disease and coincidence all contribute.

Window: 20 April 2025 – 20 April 2026
Total reports: 1

Most-reported reactions

Oesophagitis — 1 report (100%)

Source database →

acetaminophen Caplet in other countries

Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.

🇨🇦 Canada

Frequently asked questions

Is acetaminophen Caplet approved in United States?

Yes. FDA has authorised it.

Who is the marketing authorisation holder for acetaminophen Caplet in United States?

Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division is the originator. The local marketing authorisation holder may differ — check the official source linked above.