Key takeaways:
Acetaminophen (Tylenol) is an ingredient in many over-the-counter (OTC) and prescription products. Prescription-strength Tylenol products combine acetaminophen and other medication(s), such as opioids, caffeine, and/or butalbital.
The FDA limits the amount of Tylenol in prescription products to 325 mg per dose. But OTC products can contain more acetaminophen. For example, Tylenol Extra Strength contains 500 mg of acetaminophen.
For most people, the maximum Tylenol dosage is 4,000 mg daily. Exceeding that dose raises your risk of an accidental overdose and liver failure. Make sure to calculate how much Tylenol you take per day, or ask your pharmacist to help you.
In any given week, over 60 million people in the U.S. take acetaminophen (Tylenol). You may hear it referred to by many names, including acetaminophen, APAP, and paracetamol. Tylenol is available over-the-counter (OTC) in tablet, liquid, and topical forms, among others. It’s also available as part of several OTC combination products, such as DayQuil (acetaminophen / dextromethorphan / phenylephrine). Tylenol is also combined with other medications — such as opioids — in prescription-only pills.
Many people aren’t aware that the active ingredient in Tylenol is in so many products. And taking too much Tylenol is dangerous because it can lead to liver damage and overdose. In fact, Tylenol is the leading cause of acute liver failure. And it’s estimated that over 80,000 ER visits in the U.S. are related to Tylenol overdose.
In this article, we’ll cover everything you need to know about prescription-strength Tylenol and how to avoid taking too much of it.
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"Prescription-strength Tylenol” refers to an acetaminophen-based product that requires a prescription from a healthcare professional. And it can only be dispensed by a pharmacy. All prescription-strength Tylenol products have at least one additional medication.
A few examples include:
Hydrocodone / acetaminophen (previously Norco, Lortab, Vicodin)
Oxycodone / acetaminophen (Percocet / Oxycet)
Acetaminophen / tramadol (previously Ultracet)
Acetaminophen / codeine (previously Tylenol #3)
Butalbital / acetaminophen / caffeine (previously Fioricet)
Fioricet with codeine (butalbital / acetaminophen / caffeine / codeine)
Acetaminophen / butalbital (Allzital, Bupap)
The maximum amount of acetaminophen in prescription-strength Tylenol is 325 mg. But this hasn’t always been the case.
Previously, prescription-strength Tylenol products could have up to 750 mg of acetaminophen. In 2011, the FDA took action to make prescription Tylenol products safer. They recommended that prescription Tylenol products contain no more than 325 mg acetaminophen per pill. The goal was to lower the risk of liver damage and allergic reactions from Tylenol.
In 2014, all prescription products with more than 325 mg of acetaminophen were officially discontinued. But OTC products weren't affected by this FDA regulation. So OTC Tylenol products can still contain more than 325 mg of acetaminophen.
Below, we’ll cover a few prescription-strength Tylenol products and how much acetaminophen they contain.
Vicodin is prescribed to relieve moderate to severe pain when non-opioid pain relievers haven’t worked. It’s a combination of acetaminophen and hydrocodone, an opioid.
Brand-name Vicodin is no longer available. Generic hydrocodone / acetaminophen combination tablets come in a few strengths, but they all contain 300 mg or 325 mg of acetaminophen. It’s also available as an oral liquid that contains 300 mg or 325 mg of acetaminophen per 15 mL.
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Potential side effects: Liver damage and overdose are two of Tylenol’s most serious risks. Read more about Tylenol side effects here.
What are some non-medication treatment options for pain? When it comes to pain, there are ways to find relief that don’t involve medications.
Vicodin, like all opioids, is a controlled substance. Controlled substances can be habit-forming and can lead to misuse. These medications should be used with caution because they have a higher chance of causing substance use disorder.
There are also special restrictions for filling and refilling controlled substances. With Vicodin, refills are not allowed. This means you need a new prescription every time you need to pick up Vicodin.
Percocet is typically used to relieve pain that isn’t relieved by non-opioids. It’s a combination of acetaminophen and oxycodone, which is another opioid.
Percocet and Oxycet come as tablets that contain 325 mg of acetaminophen. Generic oxycodone / acetaminophen comes as a tablet and oral solution. The oral solution contains either 300 mg or 325 mg of acetaminophen per 5 mL.
Like Vicodin, Percocet is a controlled substance and refills aren’t allowed.
Ultracet is a medication that treats short-term pain. It’s a combination of acetaminophen and tramadol, which is an opioid.
Brand-name Ultracet is no longer available. Generic tramadol / acetaminophen comes as a tablet that contains 325 mg of acetaminophen.
Like Vicodin and Percocet, Ultracet is a controlled substance. Refills are allowed, but they’re limited to five refills in 6 months in most states.
Tylenol #3 contains acetaminophen and codeine (an opioid). It’s used for mild-to-moderate pain which isn’t relieved by non-opioid medications.
The generic version of Tylenol #3 comes as a tablet that contains 300 mg of acetaminophen. It’s also available as an oral solution that contains 120 mg of acetaminophen per 5 mL.
Like other opioids, Tylenol #3 is a controlled substance. Refills are allowed, but they’re limited to five refills in 6 months in most states.
Fioricet is a combination of butalbital, acetaminophen, and caffeine that treats tension headaches. These are a common type of headache that feels like pressure in your head.
Brand-name Fioricet is no longer available. Generic Fioricet contains:
300 mg or 325 mg of acetaminophen per capsule
300 mg of acetaminophen per tablet
325 mg of acetaminophen per 15 mL in the oral solution
Butalbital can lead to dependence and misuse. So, some states consider Fioricet a controlled substance. So there may be restrictions around how it’s prescribed and refilled.
Fioricet with codeine has the same ingredients as Fioricet, but codeine is also added. It’s prescribed to treat tension headaches. It’s available in generic and brand-name forms. They contain either 300 mg or 325 mg of acetaminophen per capsule.
Fioricet with codeine is a controlled substance. It’s limited to five refills in 6 months in most states.
Bupap (brand name no longer available) is a combination of butalbital and acetaminophen. It's prescribed to treat tension headaches. It’s also available under the brand-name Allzital. Bupap and Allzital contain 300 mg or 325 mg of acetaminophen.
Like Fioricet, some states consider butalbital and acetaminophen a controlled substance. So there may be restrictions around how it’s prescribed and refilled.
The typical dosage of prescription-strength Tylenol depends on what product you’re taking. For example, Percocet can be taken every 6 hours while Vicodin can be taken every 4 to 6 hours. Fioricet with codeine may be taken every 4 hours. Because different products have different dosage recommendations, pay attention to your prescriber’s instructions.
For most adults, the maximum daily dosage of Tylenol is 4,000 mg. For children, it's 75 mg per kg of body weight (but no more than 4,000 mg per day). This is the total daily dose from all products you take containing Tylenol. Since Tylenol is part of so many OTC and prescription products, make sure to check each of your medications for acetaminophen. To avoid an accidental overdose or liver damage, your total daily intake of Tylenol shouldn’t exceed 4,000 mg per day.
Keep in mind that certain groups of people should take less Tylenol. This includes people with liver damage or who use alcohol heavily. If you take Tylenol products regularly, check with your pharmacist or prescriber about what the appropriate maximum daily dose is.
The amount of Tylenol in prescription-strength Tylenol may be lower than what's in OTC Tylenol. As mentioned, prescription Tylenol products can have no more than 325 mg of acetaminophen per pill. But some OTC products with Tylenol contain more than this. For example, Extra Strength Tylenol contains 500 mg of acetaminophen per caplet. And Tylenol 8-Hour Arthritis Pain caplets each contain 650 mg of acetaminophen.
However, other ingredients in prescription-strength Tylenol products can make it “stronger” than OTC Tylenol. For example, opioids like hydrocodone, oxycodone, and tramadol are considered stronger than acetaminophen for treating pain in many cases. So prescription-strength Tylenol products that contain these opioids may be considered stronger than OTC Tylenol.
Remember that taking too much acetaminophen from any product is dangerous. So don’t be fooled into thinking that OTC Tylenol use doesn’t need your close attention. Make sure you’re not exceeding the maximum Tylenol dose of 4,000 mg per day. And talk to a healthcare professional about whether your individual maximum dosage should be less.
Tylenol (acetaminophen) is a medication that’s available over-the-counter (OTC) and by prescription. Prescription-strength Tylenol products combine acetaminophen with other medication(s). Examples include hydrocodone / acetaminophen (previously Lortab, Vicodin, Norco), oxycodone / acetaminophen (Percocet / Oxycet), and acetaminophen / codeine (previously Tylenol #3).
The FDA limits the amount of acetaminophen in prescription-strength Tylenol products to 325 mg per dosage form. But OTC Tylenol products can contain more than this. For example, Extra Strength Tylenol products contain 500 mg of acetaminophen.
The maximum daily dose of Tylenol is 4,000 mg. But it may be lower for some people, like those who drink a lot of alcohol or have liver damage. Talk to your healthcare professional about how much Tylenol is safe for you to take. Don’t take more than what's recommended for you, as this can lead to liver damage and overdose.
Agrawal, S., et al. (2023). Acetaminophen toxicity. StatPearls.
Rubin, J. B., et al. (2017). Acetaminophen-induced acute liver failure is more common and more severe in women. Clinical Gastroenterology and Hepatology.
U.S. Food and Drug Administration. (2014). All manufacturers of prescription combination drug products with more than 325 mg of acetaminophen have discontinued marketing.
U.S. Food and Drug Administration. (2018). FDA drug safety communication: Prescription acetaminophen products to be limited to 325mg per dosage unit; boxed warning will highlight potential for severe liver failure.
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