Acetaminophen, Salicylamide, and Phenyltoloxamine

Name: Acetaminophen, Salicylamide, and Phenyltoloxamine

Uses of Acetaminophen, Salicylamide, and Phenyltoloxamine

  • It is used to ease pain and fever.

What do I need to tell my doctor BEFORE I take Acetaminophen, Salicylamide, and Phenyltoloxamine?

For all patients taking acetaminophen, salicylamide, and phenyltoloxamine:

  • If you have an allergy to acetaminophen, salicylamide, phenyltoloxamine or any other part of this medicine.
  • If you are allergic to any drugs like this one, any other drugs, foods, or other substances. Tell your doctor about the allergy and what signs you had, like rash; hives; itching; shortness of breath; wheezing; cough; swelling of face, lips, tongue, or throat; or any other signs.
  • If you have any of these health problems: Kidney disease or liver disease.
  • If you are taking a blood thinner.

Children:

  • If your child has or is getting better from flu signs, chickenpox, or other viral infections.

This is not a list of all drugs or health problems that interact with acetaminophen, salicylamide, and phenyltoloxamine.

Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take this medicine with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

What are some things I need to know or do while I take Acetaminophen, Salicylamide, and Phenyltoloxamine?

  • Tell all of your health care providers that you take acetaminophen, salicylamide, and phenyltoloxamine. This includes your doctors, nurses, pharmacists, and dentists.
  • Avoid driving and doing other tasks or actions that call for you to be alert or have clear eyesight until you see how this medicine affects you.
  • Do not take more than what your doctor told you to take. Taking more than you are told may raise your chance of very bad side effects.
  • Avoid other sources of acetaminophen. Check labels closely. Too much acetaminophen may cause problems.
  • This medicine has acetaminophen in it. Very bad and sometimes deadly liver problems like the need for a liver transplant have happened with acetaminophen use. Most of the time, liver problems have happened in people taking more than 4,000 milligrams of acetaminophen in a day. Also, people who had liver problems were often using more than 1 drug that had acetaminophen in it. Talk with your doctor.
  • Call your doctor right away if you take more than 4,000 mg (milligrams) of acetaminophen in a day, even if you feel well.
  • This medicine may affect certain lab tests. Tell all of your health care providers and lab workers that you take acetaminophen, salicylamide, and phenyltoloxamine.
  • Talk with your doctor before you drink alcohol or use other drugs and natural products that slow your actions.
  • You may bleed more easily. Be careful and avoid injury. Use a soft toothbrush and an electric razor.
  • Do not give to children and teenagers who have or are getting better from flu signs, chickenpox, or other viral infections due to the chance of Reye's syndrome. Reye's syndrome causes very bad problems to the brain and liver.
  • If you are 65 or older, use this medicine with care. You could have more side effects.
  • Tell your doctor if you are pregnant or plan on getting pregnant. You will need to talk about the benefits and risks of using acetaminophen, salicylamide, and phenyltoloxamine while you are pregnant.
  • Tell your doctor if you are breast-feeding. You will need to talk about any risks to your baby.

If OVERDOSE is suspected

If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

What are some other side effects of this drug?

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

  • Feeling sleepy.
  • Dry mouth.
  • Upset stomach.
  • Heartburn.
  • Not hungry.
  • Loose stools (diarrhea).

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

Acetaminophen / phenyltoloxamine / salicylamide Pregnancy Warnings

It is not known whether acetaminophen/phenyltoloxamine/salicylamide can cause fetal harm when administered to a pregnant women or can affect reproduction capability. Two cases of acetaminophen overdose in late pregnancy have been reported. In both cases neither the neonate nor the mother suffered hepatic toxicity. Investigations have revealed conflicting results with regards to the pharmacokinetic disposition of acetaminophen in pregnant women. One study has suggested that the oral clearance of acetaminophen is 58% higher and the elimination half-life is 28% longer in pregnant women compared to nonpregnant women. Another study has suggested that the elimination half-life is not different in patients who are pregnant. That study also suggested that the volume of distribution of acetaminophen may be higher in pregnant women. One study has suggested that acetaminophen in typical oral doses may result in a reduced production of prostacyclin in pregnant women. That study also suggested that acetaminophen does not affect thromboxane production.

The combination drug acetaminophen, phenyltoloxamine, and salicylamide has been assigned to pregnancy category C by the FDA. Animal studies have not been conducted on this combination product. There are no controlled data in human pregnancy. The combination drug acetaminophen, phenyltoloxamine, and salicylamide should only be given during pregnancy when benefits outweigh risks.

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