Pain Management Health Center

Acetaminophen Safety: FAQ

What did the FDA advisory committees recommend?

Here are the measures that advisory committees voted to recommend to the FDA:

• Lower the maximum total daily dose in over-the-counter products: 21 yes votes, 16 no votes. The yes votes include 11 committee members who said this should be a high priority.
• Limit the maximum single dose for adults taking over-the-counter products: 24 yes votes, 13 no votes. The yes votes include 12 committee members who said this should be a high priority.
• Switch the current maximum dose of acetaminophen to prescription status: 26 yes votes, 11 no votes. The yes votes include eight committee members who said this should be a high priority.
• Make only one concentration of nonprescription liquid acetaminophen available: 36 yes votes, 1 no vote. The yes votes include 19 committee members who said this should be a high priority.
• Eliminate prescription drugs that combine acetaminophen with other drugs: 20 yes votes, 17 no votes. The yes votes include 10 committee members who said this should be a high priority.
• Require certain packaging changes for prescription drugs that combine acetaminophen with other drugs: 27 yes votes, 10 no votes. The yes votes include five committee members who said this should be a high priority.
• Require a "black box" warning (the FDA's sternest warning) for prescription medicines that combine acetaminophen with other drugs: 36 yes votes, 1 no vote. The yes votes include 25 committee members who said this should be a high priority.

Here are the measures that the FDA advisory committees did not recommend:

• Limit pack sizes for over-the-counter acetaminophen products: 17 yes votes, 20 no votes. The yes votes include two committee members who said this should be a high priority.
• Eliminate over-the-counter products that combine acetaminophen with other drugs: 13 yes votes, 24 no votes. The yes votes include two committee members who said this should be a high priority.

For more on the FDA advisory committee vote, and reactions from the drug industry, read WebMD's news story, filed on the day of the committee vote.

Are those recommendations now in effect?

No. FDA advisory committees make recommendations, but they don't set policy. That's the FDA's job.

The FDA has the final word on how to handle acetaminophen. The FDA often follows the advice of its advisory committees, but it's not required to do so. It could accept some, all, or none of the recommendations.

When will the FDA make its decision on acetaminophen?

There is no set deadline for the FDA to do that. It could take months. When the FDA acts on acetaminophen, WebMD will cover that news.

How can I take drugs containing acetaminophen safely?

The key with acetaminophen -- or any other drug -- is to take it exactly as instructed by your doctor or the drug label. Taking too much, even a little too much, is risky, even if you didn't need a prescription to get it.