Prescription Acetaminophen Dose Changes: What You Need to Know

Roni Shye
Roni Shye, PharmD BCGP BCACP, is a licensed pharmacist in the states of Florida, Ohio, and Pennsylvania.
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General Overview

What has been discontinued?

All prescription drug products with more than 325 mg of acetaminophen (also known as APAP or paracetamol, and the active ingredient in Tylenol). The FDA has asked that manufacturers limit the amount of acetaminophen in these products to 325 mg to prevent liver injury from overdose.

Some examples of these drugs include Vicodin (hydrocodone/acetaminophen), Percocet (oxycodone/acetaminophen), Fioricet (butalbital/acetaminophen/caffeine), and Fioricet with codeine (butalbital/acetaminophen/caffeine/codeine).
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Why the limit of 325 mg?

The MAXIMUM daily dose of acetaminophen is 4000 mg. Some prescription products had as much as 750 mg of acetaminophen in one pill, making it too easy to accidentally overdose.

Does this affect regular Tylenol and other over-the-counter products?

No, not at this time, but the FDA is considering other rules and safety measures for over-the-counter acetaminophen products.

Where can I find more information, and a complete list of the changed or discontinued drugs?

Check out the article from the FDA regarding prescription acetaminophen products limiting their dosage to 325 mg per dose. You can also see a complete list of affected medications here.

There are also some brand-name drugs that haven’t been discontinued, but have just lowered the amount of acetaminophen. See below for a quick guide on the changes to Fioricet and Vicodin.

Medication Review: Fioricet

What are the OLD Fioricet strengths?

Fioricet: 50 mg/325 mg/40 mg

Fioricet with codeine: 50 mg/325 mg/40 mg/30 mg

What are the NEW Fioricet strengths?

Fioricet: 50 mg/300 mg/40 mg

Fioricet with codeine: 50 mg/300 mg/40 mg/30 mg

Why was the change made for Fioricet since it only contained 325 mg of acetaminophen?

It was still a change in response to the same FDA guideline recommending the limit on acetaminophen doses in prescription medications. The manufacturers of Fioricet decided to limit the dose further than the guidelines required.

What are Fioricet and Fioricet with codeine used for?

They are indicated for the relief of tension (or muscle contraction) headaches.

Important information to know:

• The FDA has determined that Fioricet and Fioricet with Codeine with 300 mg of acetaminophen have the same therapeutic effect as the discontinued products, which contained 325 mg of acetaminophen.

• Generic butalbital/acetaminophen/caffeine and butalbital/acetaminophen/caffeine/codeine are also available in the new 300 mg strengths.

Fioricet (butalbital/acetaminophen/caffeine) has received exempted prescription drug status from the DEA and is no longer regulated as a Schedule III product!

Medication Review: Vicodin

What are the OLD Vicodin strengths?

Vicodin: 5 mg/500 mg (max dose 8 per day)

Vicodin ES: 7.5 mg/750 mg (max dose 5 per day)

Vicodin HP: 10  mg/660 mg (max dose 6 per day)

What are the NEW Vicodin strengths?

Vicodin: 5 mg/300 mg (max dose 8 per day)

Vicodin ES: 7.5 mg/300 mg (max dose 6 per day)

Vicodin HP: 10 mg/300 mg (max dose 6 per day)

Important information to know:

• The maximum dose of hydrocodone is 60 mg per day, which also limits the maximum dose of Vicodin.

• Generic hydrocodone/acetaminophen is also available in the new 300 mg strengths.

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