Acetaminophen and phenyltoloxamine

You should not take this medication if you are allergic to acetaminophen or phenyltoloxamine.

Ask a doctor or pharmacist if it is safe for you to take this medicine if you have other medical conditions, especially:

• asthma or COPD, emphysema, or other breathing problems;

• liver disease, alcoholism, or if you drink more than 3 alcoholic beverages per day;

• enlarged prostate or urination problems;

• glaucoma; or

• if you also take warfarin (Coumadin, Jantoven).

Acetaminophen and phenyltoloxamine should not be given to a child younger than 12 years old without medical advice.

It is not known whether this medicine will harm an unborn baby. Do not use this medicine without your doctor's advice if you are pregnant.

This medication may pass into breast milk and may harm a nursing baby. Antihistamines may also slow breast milk production. Do not use this medicine without your doctor's advice if you are breast-feeding a baby.

Artificially sweetened liquid medicine may contain phenylalanine. Check the medication label if you have phenylketonuria (PKU).

Usual Adult Dose for Cold Symptoms:

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

Acetaminophen-phenyltoloxamine 500 mg-50 mg oral tablet:
1/2 to 1 tablet orally every 4 hours not to exceed 5 tablets daily.

Acetaminophen-phenyltoloxamine 500 mg-55 mg oral tablet:
1 or 2 tablets orally every 4 hours not to exceed 8 tablets daily.

Acetaminophen-phenyltoloxamine 600 mg-66 mg oral tablet, extended release:
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:
1/2 to 1 tablet orally every 6 hours not to exceed 4 tablets daily. Not to exceed 10 days use.

Usual Adult Dose for Influenza:

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

Acetaminophen-phenyltoloxamine 500 mg-50 mg oral tablet:
1/2 to 1 tablet orally every 4 hours not to exceed 5 tablets daily.

Acetaminophen-phenyltoloxamine 500 mg-55 mg oral tablet:
1 or 2 tablets orally every 4 hours not to exceed 8 tablets daily.

Acetaminophen-phenyltoloxamine 600 mg-66 mg oral tablet, extended release:
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:
1/2 to 1 tablet orally every 6 hours not to exceed 4 tablets daily. Not to exceed 10 days use.

Usual Adult Dose for Pain:

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

Acetaminophen-phenyltoloxamine 500 mg-50 mg oral tablet:
1/2 to 1 tablet orally every 4 hours not to exceed 5 tablets daily.

Acetaminophen-phenyltoloxamine 500 mg-55 mg oral tablet:
1 or 2 tablets orally every 4 hours not to exceed 8 tablets daily.

Acetaminophen-phenyltoloxamine 600 mg-66 mg oral tablet, extended release:
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:
1/2 to 1 tablet orally every 6 hours not to exceed 4 tablets daily. Not to exceed 10 days use.

Usual Adult Dose for Headache:

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

Acetaminophen-phenyltoloxamine 500 mg-50 mg oral tablet:
1/2 to 1 tablet orally every 4 hours not to exceed 5 tablets daily.

Acetaminophen-phenyltoloxamine 500 mg-55 mg oral tablet:
1 or 2 tablets orally every 4 hours not to exceed 8 tablets daily.

Acetaminophen-phenyltoloxamine 600 mg-66 mg oral tablet, extended release:
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:
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 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 Influenza:

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 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.

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.

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.
• Dizziness.
• Feeling nervous and excitable.
• Dry mouth.
• Dry nose.
• Upset stomach.

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

Acetaminophen-phenyltoloxamine 500 mg-50 mg oral tablet:
1/2 to 1 tablet orally every 4 hours not to exceed 5 tablets daily.

Acetaminophen-phenyltoloxamine 500 mg-55 mg oral tablet:
1 or 2 tablets orally every 4 hours not to exceed 8 tablets daily.

Acetaminophen-phenyltoloxamine 600 mg-66 mg oral tablet, extended release:
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:
1/2 to 1 tablet orally every 6 hours not to exceed 4 tablets daily. Not to exceed 10 days use.

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

Acetaminophen-phenyltoloxamine 500 mg-50 mg oral tablet:
1/2 to 1 tablet orally every 4 hours not to exceed 5 tablets daily.

Acetaminophen-phenyltoloxamine 500 mg-55 mg oral tablet:
1 or 2 tablets orally every 4 hours not to exceed 8 tablets daily.

Acetaminophen-phenyltoloxamine 600 mg-66 mg oral tablet, extended release:
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:
1/2 to 1 tablet orally every 6 hours not to exceed 4 tablets daily. Not to exceed 10 days use.

Data not available

Patients who consume three or more alcohol containing drinks per day should be informed to consult with their physician for advice on when and how to take acetaminophen. Chronic, heavy alcohol users may be at increased risk of liver damage when taking more than recommended dosages.

Patients and adults taking care of children should be advised to consult with their doctor before continuing to use acetaminophen if symptoms of illness worsen. Although rare, there is the possibility of acetaminophen intoxication on chronic use of the drug, and the symptoms seen during the first phase of intoxication (nausea, vomiting, anorexia, malaise, and diaphoresis) may trigger the use of more doses.

Patients should be warned of the sedative effects of phenyltoloxamine, and advised not to take this drug with alcohol.

Phenyltoloxamine should be used with caution in patients with narrow-angle glaucoma, stenosing peptic ulcer, pyloroduodenal obstruction, prostatic hypertrophy, or bladder-neck obstructions, increased intraocular pressure, hyperthyroidism, cardiovascular disease, or hypertension.

Acetaminophen has not been formally assigned to a pregnancy category by the FDA. It is routinely used for short-term pain relief and fever in all stages of pregnancy. Acetaminophen is believed to be safe in pregnancy when used intermittently for short durations. Acetaminophen-phenyltoloxamine has not been formally assigned to a pregnancy category by the FDA. Animal studies not been reported. There are no controlled data in human pregnancy. Acetaminophen-phenyltoloxamine should only be given during pregnancy when need has been clearly established.

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.