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Acetaminophen Oral solution

It is used to treat mild pain and fever

Generic Name: acetaminophen  |  Brand Name: DAFALGAN

There is an FDA Alert for this drug. Click here to view it.

Special Alerts:

[Posted 01/13/2011] ISSUE: FDA notified healthcare professionals that it has asked drug manufacturers to limit the strength of acetaminophen in prescription drug products, predominantly combinations of acetaminophen and opioids, to 325 mg per tablet, capsule, or other dosage unit, making these products safer for patients. This action will help to reduce the risk of severe liver injury and allergic reactions associated with acetaminophen. A Boxed Warning highlighting the potential for severe liver injury and a Warning highlighting the potential for allergic reactions (swelling of the face, mouth, and throat, difficulty breathing, itching, or rash) will be added to the label of all prescription drug products that contain acetaminophen.

BACKGROUND: Acetaminophen, one of the most commonly used drugs in the United States, is widely and effectively used in both prescription and over-the-counter (OTC) products to reduce pain and fever. Examples of prescription products that contain acetaminophen include hydrocodone with acetaminophen (Vicodin, Lortab), and oxycodone with acetaminophen (Tylox, Percocet). OTC products containing acetaminophen (e.g., Tylenol) are not affected by this action. Information about the potential for liver injury is already required on the label for OTC products containing acetaminophen. FDA is continuing to evaluate ways to reduce the risk of acetaminophen related liver injury from OTC products. No drug shortages are expected, because the 3-year implementation period should permit adequate time for necessary reformulations.

RECOMMENDATION: Healthcare professionals were reminded to advise patients not to exceed the acetaminophen maximum total daily dose (4 grams/day), and not to drink alcohol while taking acetaminophen-containing medications.

Healthcare professionals were encouraged to inform patients that there is no immediate danger to patients who take these combination pain medications, and patients should continue to take them as directed by their health care provider. The Drug Safety Communication provides additional information for healthcare professionals, information for patients, a data summary and a list of all affected products. For more information visit the FDA website at: [Web] and [Web].

What is this medicine?

ACETAMINOPHEN (a set a MEE noe fen) is a pain reliever. It is used to treat mild pain and fever.

What should I tell my health care provider before I take this medicine?

They need to know if you have any of these conditions:
  • if you frequently drink alcohol containing drinks
  • liver disease
  • phenylketonuria
  • an unusual or allergic reaction to acetaminophen, other medicines, foods, dyes or preservatives
  • pregnant or trying to get pregnant
  • breast-feeding

How should I use this medicine?

Take this medicine by mouth. This medicine comes in more than one concentration. Check the concentration on the label before every dose to make sure you are giving the right dose. Follow the directions on the package or prescription label. Use a specially marked spoon or dropper to measure each dose. Ask your pharmacist if you do not have one. Household spoons are not accurate. Do not take your medicine more often than directed.

Talk to your pediatrician regarding the use of this medicine in children. While this drug may be prescribed for children as young as 2 years old for selected conditions, precautions do apply.

What if I miss a dose?

If you miss a dose, take it as soon as you can. If it is almost time for your next dose, take only that dose. Do not take double or extra doses.

What may interact with this medicine?

  • alcohol
  • imatinib
  • isoniazid
  • other medicines that contain acetaminophen

What should I watch for while using this medicine?

Tell your doctor or health care professional if the pain lasts more than 10 days (5 days for children), if it gets worse, or if there is a new or different kind of pain. Also, check with your doctor if a fever lasts for more than 3 days.

Do not take acetaminophen (Tylenol) or other medicines that contain acetaminophen with this medicine. Too much acetaminophen can be very dangerous and cause an overdose. Always read labels carefully.

Report any possible overdose to your doctor right away, even if there are no symptoms. The effects of extra doses may not be seen for many days.

What side effects may I notice from receiving this medicine?

Side effects that you should report to your doctor or health care professional as soon as possible:
  • allergic reactions like skin rash, itching or hives, swelling of the face, lips, or tongue
  • breathing problems
  • redness, blistering, peeling or loosening of the skin, including inside the mouth
  • sore throat with fever, headache, rash, nausea, or vomiting
  • trouble passing urine or change in the amount of urine
  • unusual bleeding or bruising
  • unusually weak or tired
  • yellowing of the eyes, skin

Side effects that usually do not require medical attention (report to your doctor or health care professional if they continue or are bothersome):

  • headache
  • nausea, stomach upset

Where should I keep my medicine?

Keep out of reach of children.

Store at room temperature between 20 and 25 degrees C (68 and 77 degrees F). Protect from moisture and heat. Throw away any unused medicine after the expiration date.

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.


Last Updated: August 02, 2013
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