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Frequently Asked Questions

Below are answers to some frequently asked questions about Vicodin and acetaminophen

Risks Associated With Acetaminophen

Why did the U.S. Food and Drug Administration (FDA) limit acetaminophen?

There is the potential that taking too much acetaminophen can seriously harm your liver.

If you want more information on how the FDA has advised drug companies about acetaminophen, go to the FDA website at http://www.fda.gov/Drugs/​DrugSafety/ucm239821.htm.2

What is acetaminophen?

Acetaminophen (an ingredient found in Tylenol®) is a common pain reliever that can be found in many different products you can buy without a prescription. It is also found in prescription medicines, including Vicodin. The recommended maximum daily dose of acetaminophen is 4000 mg.2,3

Tylenol is a registered trademark of McNeil Consumer Healthcare.

What are the risks of taking too much acetaminophen?

Taking too much acetaminophen may seriously harm your liver. The FDA believes that limiting the amount of acetaminophen in prescription drugs may help reduce chances of harm to the liver.2 Information about the risks of taking too much acetaminophen can be found on the FDA website at http://www.fda.gov/ForConsumers/
ConsumerUpdates/ucm168830.htm
.3

Product Information

What does AbbVie's Vicodin look like?

The formulations of AbbVie's Vicodin look like this1:

Not Actual Size
Not Actual Size
Not Actual Size
What are the most important things I should know about taking Vicodin?
  • Only use Vicodin the way your doctor tells you to.
  • Only use Vicodin for the condition for which it was prescribed.
  • Make sure that you don't take more than 4000 mg of acetaminophen per day (acetaminophen is a part of Vicodin).
  • Don't share your medication with anyone else, even if they have the same symptoms or condition. Sharing is illegal and may cause severe health problems in another person, even death.
  • Keep your medication in a safe place to which children do not have access.
Can I get information on the risks associated with the opioid in Vicodin?1
  • VICODIN, VICODIN ES, and VICODIN HP should not be used if you are allergic to hydrocodone or acetaminophen. Tell your healthcare provider if you are allergic to any other opioid pain medicine before taking this drug, as you may exhibit cross-sensitivity to hydrocodone.
  • Rarely, one ingredient in VICODIN, VICODIN ES, and VICODIN HP, acetaminophen, can cause serious skin reactions, such as acute generalized exanthematous pustulosis, Stevens-Johnson syndrome, and toxic epidermal necrolysis. These reactions may develop at any point after use, whether after one time or long-term use, and can be fatal. If you get serious skin reactions or a skin rash, especially with blisters and a fever, immediately contact your healthcare provider. VICODIN, VICODIN ES, and VICODIN HP should be discontinued at the first appearance of skin rash or any other sign of hypersensitivity.
  • VICODIN, VICODIN ES, and VICODIN HP should not be used if you have breathing problems or a blocked bowel. These drugs can cause breathing problems at high doses or in sensitive patients. Talk with your healthcare provider if you have had a recent head injury, if your breathing slows down, or if you feel faint, dizzy, or confused. If you have trouble breathing, or your face or throat swells, immediately contact your healthcare provider.
  • One ingredient in VICODIN, VICODIN ES, and VICODIN HP is hydrocodone, a controlled substance that can be habit-forming and/or abused. You should take this drug only for the condition for which it is prescribed, for as long as it is prescribed, in the amount prescribed, and no more frequently than prescribed. Do not give this drug to others, even if they have similar symptoms. Unused tablets should be thrown away with household waste.
  • Taking VICODIN, VICODIN ES, and VICODIN HP can make you drowsy and impair your ability to drive a car, operate machinery, or perform other potentially dangerous activities. Do not drive or operate heavy machinery until you know how you react to this medicine.
  • VICODIN, VICODIN ES, and VICODIN HP should be used with caution if you are elderly or disabled, or if you have any of the following medical conditions: heart, liver, or kidney problems; adrenal or thyroid gland problems; enlarged prostate or difficulty urinating; lung disease; difficulty swallowing; stomach problems; or current or past problems with alcohol and drug abuse.
  • Avoid taking VICODIN, VICODIN ES, and VICODIN HP with alcohol or other depressants. To avoid possible serious drug interactions, be sure to tell your healthcare provider about all prescription and non-prescription medicines, vitamins, and herbal supplements you take. Also tell your healthcare provider if you are already using medicines to treat depression or allergic reactions, other pain medicines, or medicines that make you sleepy, including those to treat anxiety or seizures, or for muscle relaxation.
  • VICODIN, VICODIN ES, and VICODIN HP contain acetaminophen, an ingredient in many other prescription and non-prescription medicines. Do not take other medicines containing acetaminophen unless your healthcare provider recommends it. Taking too much acetaminophen can be harmful to your liver.
  • Do not take VICODIN, VICODIN ES, or VICODIN HP if you are pregnant or plan to become pregnant, unless you are directed to do so by your healthcare provider. Drug dependence and breathing problems have occurred in newborns when the mother has taken this drug before delivery.
  • If you are breast-feeding (nursing), you should be aware that the medicines in VICODIN, VICODIN ES, and VICODIN HP might pass into your breast milk. Ask your healthcare provider for advice before taking any medicine while breast-feeding.
  • If you stop taking VICODIN, VICODIN ES, or VICODIN HP suddenly after taking it for a few days to weeks, you may experience signs of withdrawal, such as irritability, sweating, racing heart, and faster breathing. Contact your healthcare provider if you experience these withdrawal signs to learn how to safely stop taking this medication.
  • Keep VICODIN, VICODIN ES, and VICODIN HP out of the reach of children and keep your tablets in a secure place where they will not be stolen.
  • If you take too much VICODIN, VICODIN ES, or VICODIN HP or overdose, call your local emergency or poison control center right away.
  • The most common side effects of VICODIN, VICODIN ES, and VICODIN HP are lightheadedness, dizziness, drowsiness, nausea, vomiting, and constipation.

Managing Vicodin Treatment

Does AbbVie provide co-pay assistance for patients who take Vicodin?

AbbVie does not offer co-pay assistance for patients taking Vicodin. Vicodin is a generic product. This means patients will pay a generic co-pay at the pharmacy.

How do I properly dispose of my medications?

Follow these steps to properly dispose of your medications4:

  1. Start by taking inventory of the prescription drugs in your home.
  2. Discard expired or unused prescription drugs when children or teens are not at home.
  3. The best disposal method is to mix medications with undesirable substances like coffee grounds or kitty litter.
  4. Do not flush medication down the toilet.

For more information, please visit http://www.fda.gov/ForConsumers/​ConsumerUpdates/ucm101653.htm.

How can I report negative side effects of Vicodin?

You can assist us with monitoring the safety of Vicodin by reporting negative side effects to AbbVie at 1-800-633-9110. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

USE AND IMPORTANT SAFETY INFORMATION1

USE1

VICODIN® 5 mg/300 mg, VICODIN ES® 7.5 mg/300 mg, and VICODIN HP® 10 mg/300 mg (hydrocodone bitartrate and acetaminophen) tablets, USP are used for the relief of moderate to moderately severe pain. VICODIN, VICODIN ES, and VICODIN HP contain two different ingredients: hydrocodone (an opioid pain medicine) and acetaminophen (a non-aspirin pain medicine).

IMPORTANT SAFETY INFORMATION1

Warning for liver damage: One ingredient in this product is acetaminophen. Acetaminophen has been associated with cases of acute liver failure, at times resulting in liver transplant and death. Most of the cases of liver injury are associated with the use of acetaminophen at doses that exceed 4000 milligrams per day, and often involve more than one acetaminophen-containing product.

Please see Full Prescribing Information, including Important WARNING, for Vicodin formulations and discuss with your doctor.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088 (1-800-332-1088).

If you cannot afford your medication, visit www.pparx.org for assistance.

References: 1. VICODIN, VICODIN ES, VICODIN HP 5, 7.5, 10 mg (hydrocodone)/300 mg (acetaminophen) [package insert]. 2. US Department of Health and Human Services. FDA drug safety communication. US Food and Drug Administration website. http://www.fda.gov/Drugs/DrugSafety/
ucm239821.htm
. Accessed January 21, 2016. 3. US Department of Health and Human Services. Acetaminophen and liver injury: Q & A for consumers. US Food and Drug Administration website. http://www.fda.gov/ForConsumers/
ConsumerUpdates/ucm168830.htm
. Accessed January 21, 2016. 4. US Department of Health and Human Services. How to dispose of unused medicines. US Food and Drug Administration website. http://www.fda.gov/ForConsumers/
ConsumerUpdates/ucm101653.htm
. Accessed January 21, 2016.