Acetaminophen and phenyltoloxamine

Name: Acetaminophen and phenyltoloxamine

Acetaminophen and phenyltoloxamine side effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

In rare cases, acetaminophen may cause a severe skin reaction that can be fatal. This could occur even if you have taken acetaminophen in the past and had no reaction. Stop taking this medicine and call your doctor right away if you have skin redness or a rash that spreads and causes blistering and peeling. If you have this type of reaction, you should never again take any medicine that contains acetaminophen.

Stop using this medication and call your doctor at once if you have:

  • confusion, hallucinations, unusual thoughts or behavior;

  • little or no urinating; or

  • nausea, upper stomach pain, itching, tired feeling, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).

Common side effects may include:

  • dizziness, drowsiness;

  • feeling restless or excited (especially in children);

  • constipation;

  • blurred vision; or

  • dry mouth, nose, or throat.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect acetaminophen and phenyltoloxamine?

Ask a doctor or pharmacist before using this medicine if you are also using any other drugs, including prescription and over-the-counter medicines, vitamins, and herbal products. Some medicines can cause unwanted or dangerous effects when used together. Not all possible interactions are listed in this medication guide.

Taking this medicine with other drugs that make you sleepy or slow your breathing can worsen these effects. Ask your doctor before taking acetaminophen and phenyltoloxamine with a sleeping pill, narcotic pain medicine, muscle relaxer, or medicine for anxiety, depression, or seizures.

What are some side effects that I need to call my doctor about right away?

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

  • Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
  • Signs of liver problems like dark urine, feeling tired, not hungry, upset stomach or stomach pain, light-colored stools, throwing up, or yellow skin or eyes.
  • Feeling confused.
  • Not able to pass urine or change in how much urine is passed.
  • Very bad dizziness or passing out.
  • Feeling very tired or weak.
  • A very bad skin reaction (Stevens-Johnson syndrome/toxic epidermal necrolysis) may happen. It can cause very bad health problems that may not go away, and sometimes death. Get medical help right away if you have signs like red, swollen, blistered, or peeling skin (with or without fever); red or irritated eyes; or sores in your mouth, throat, nose, or eyes.

Usual Pediatric Dose for Pain

Acetaminophen-phenyltoloxamine 325 mg-30 mg oral tablet:
12 years or older: 1 or 2 tablets orally every 4 hours not to exceed 8 tablets daily.

Acetaminophen-phenyltoloxamine 500 mg-50 mg oral tablet:
6 to 11 years: 1/2 tablet orally every 4 hours not to exceed 2.5 tablets daily.
12 years or older: 1/2 to 1 tablet orally every 4 hours not to exceed 5 tablets daily.

Acetaminophen-phenyltoloxamine 500 mg-55 mg oral tablet:
6 to 11 years: 1/2 to 1 tablet orally every 4 hours not to exceed 4 tablets daily.
12 years or older: 1 or 2 tablets orally every 4 hours not to exceed 8 tablets daily.

Acetaminophen-phenyltoloxamine 600 mg-66 mg oral tablet, extended release:
6 to 11 years: 1/2 to 1 tablet orally every 12 hours not to exceed 2 tablets daily.
12 years or older: 1 to 2 tablets orally every 8 to 12 hours not to exceed 6 tablets daily.

Acetaminophen-phenyltoloxamine 635 mg-55 mg oral tablet and Acetaminophen-phenyltoloxamine 650 mg-60 mg oral tablet:
6 to 11 years: 1/2 tablet orally every 6 hours not to exceed 2 tablets daily. Not to exceed 5 days use.
12 years or older: 1/2 to 1 tablet orally every 6 hours not to exceed 4 tablets daily. Not to exceed 10 days use.

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