Acetaminophen and phenyltoloxamine

Name: Acetaminophen and phenyltoloxamine

What is acetaminophen and phenyltoloxamine?

Acetaminophen is a pain reliever and a fever reducer.

Phenyltoloxamine is an antihistamine that reduces the effects of natural chemical histamine in the body. Histamine can produce symptoms of sneezing, itching, watery eyes, and runny nose.

Acetaminophen and phenyltoloxamine is a combination medicine used to treat fever, headache, menstrual pain, and other minor aches and pains. This medicine also treats itchy or watery eyes, and pain or fever caused by the common cold or seasonal allergies.

Acetaminophen and phenyltoloxamine may also be used for purposes not listed in this medication guide.

What is the most important information I should know about acetaminophen and phenyltoloxamine?

Do not take more than your recommended dose. An acetaminophen overdose can damage your liver or cause death. Call your doctor at once if you have nausea, pain in your upper stomach, itching, loss of appetite, dark urine, clay-colored stools, or jaundice (yellowing of your skin or eyes).

In rare cases, acetaminophen may cause a severe skin 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.

How should I take acetaminophen and phenyltoloxamine?

Do not take more of this medicine than is recommended. An overdose of acetaminophen can damage your liver or cause death.

Use exactly as directed on the label, or as prescribed by your doctor. This medicine is usually taken only for a short time until your symptoms clear up.

Always ask a doctor before giving a cough or cold medicine to a child. Death can occur from the misuse of cough and cold medicines in very young children.

Measure liquid medicine with the dosing syringe provided, or with a special dose-measuring spoon or medicine cup. If you do not have a dose-measuring device, ask your pharmacist for one.

Do not take for longer than recommended. Stop taking the medicine and call your doctor if:

  • you still have a fever after 3 days of use;

  • you still have pain after 10 days;

  • your symptoms get worse; or

  • you have any redness or swelling.

If you need surgery or medical tests, tell the surgeon or doctor ahead of time if you have taken this medicine within the past few days.

Store at room temperature away from moisture and heat. Do not allow liquid medicine to freeze.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. An overdose of acetaminophen can be fatal.

The first signs of an acetaminophen overdose include loss of appetite, nausea, vomiting, stomach pain, sweating, and confusion or weakness. Later symptoms may include pain in your upper stomach, dark urine, and yellowing of your skin or the whites of your eyes.

Usual Pediatric Dose for Cold Symptoms

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.

Usual Pediatric Dose for Headache

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.

Liver Dose Adjustments

Use with caution in patients with liver disease. Chronic use of acetaminophen is not recommended in patients with liver disease.

Dialysis

Data not available

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