Kenvue, the American company that makes Tylenol, says the U.S. Food and Drug Administration should not make proposed changes to the product’s safety label to reflect research about a possible connection between its use in pregnancy and diagnoses of autism or ADHD in children.

Kenvue says that acetaminophen, the generic name for the painkiller and fever reducer also known as paracetamol, is “one of the most studied medicines in history” and that “adoption of the proposed labeling revisions would be arbitrary, capricious, and contrary to law.”

Tylenol generates $1 billion annually for the company and is considered the company’s biggest-selling brand, according to the brokerage Morningstar.

The current label instructs people who are pregnant or breastfeeding to “ask a health professi

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