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Acetaminophen

Generic Name: acetaminophen (oral) (a SEET a MIN oh fen)
Brand Names: Actamin, Anacin AF, Apra, Bromo Seltzer, Children's Tylenol, Elixsure Fever/Pain, Little Fevers, Mapap, Medi-Tabs, Q-Pap, Silapap Childrens, Tactinal, Tempra Quicklets, Tycolene, Tylenol, Vitapap

What is acetaminophen?

Acetaminophen is a pain reliever and a fever reducer.

Acetaminophen is used to treat many conditions such as headache, muscle aches, arthritis, backache, toothaches, colds, and fevers.

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

Important information
You should not use acetaminophen if you have severe liver disease.

There are many brands and forms of acetaminophen available and not all brands are listed on this leaflet.

Do not take more of this medication than is recommended. An 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).
Do not take this medication without a doctor's advice if you have ever had alcoholic liver disease (cirrhosis) or if you drink more than 3 alcoholic beverages per day. You may not be able to take this medicine. Avoid drinking alcohol. It may increase your risk of liver damage while taking acetaminophen.

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Ask a doctor or pharmacist before using any other cold, allergy, pain, or sleep medication. Acetaminophen (sometimes abbreviated as APAP) is contained in many combination medicines. Taking certain products together can cause you to get too much acetaminophen which can lead to a fatal overdose. Check the label to see if a medicine contains acetaminophen or APAP.

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.

Before taking this medicine
You should not take acetaminophen if you are allergic to it, or if you have severe liver disease.

Do not take this medicine without a doctor's advice if you have ever had alcoholic liver disease (cirrhosis) or if you drink more than 3 alcoholic beverages per day. You may not be able to take acetaminophen.

Your doctor will determine whether acetaminophen is safe for you to use during pregnancy. Do not use this medicine without the advice of your doctor if you are pregnant.

Acetaminophen can pass into breast milk and may harm a nursing baby. Tell your doctor if you are breast-feeding a baby.

Do not give this medicine to a child younger than 2 years old without the advice of a doctor.


How should I take acetaminophen?
Use acetaminophen exactly as directed on the label, or as prescribed by your doctor. Do not use in larger or smaller amounts or for longer than recommended.

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

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.

If you are treating a child, use a pediatric form of acetaminophen. Use only the special dose-measuring dropper or oral syringe that comes with the specific pediatric form you are using. Carefully follow the dosing directions on the medicine label.

Acetaminophen made for infants is available in two different dose concentrations, and each concentration comes with its own medicine dropper or oral syringe. These dosing devices are not equal between the different concentrations. Using the wrong device may cause you to give your child an overdose of acetaminophen. Never mix and match dosing devices between infant formulations of acetaminophen.

You may need to shake the liquid before each use. Follow the directions on the medicine label.

The chewable tablet must be chewed thoroughly before you swallow it.

Make sure your hands are dry when handling the acetaminophen disintegrating tablet. Place the tablet on your tongue. It will begin to dissolve right away. Do not swallow the tablet whole. Allow it to dissolve in your mouth without chewing.

To use the acetaminophen effervescent granules, dissolve one packet of the granules in at least 4 ounces of water. Stir this mixture and drink all of it right away. To make sure you get the entire dose, add a little more water to the same glass, swirl gently and drink right away.

Stop taking acetaminophen and call your doctor if:

you still have a fever after 3 days of use;
you still have pain after 7 days of use (or 5 days if treating a child);
you have a skin rash, ongoing headache, or any redness or swelling; or
if your symptoms get worse, or if you have any new symptoms.
This medication can cause unusual results with certain lab tests for glucose (sugar) in the urine. Tell any doctor who treats you that you are using acetaminophen.

Store at room temperature away from heat and moisture.

See also: Dosage Information (in more detail)

What happens if I miss a dose?
Since acetaminophen is taken as needed, you may not be on a dosing schedule. If you are taking the medication regularly, take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

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.

What should I avoid while taking acetaminophen?
Ask a doctor or pharmacist before using any other cold, allergy, pain, or sleep medication. Acetaminophen (sometimes abbreviated as APAP) is contained in many combination medicines. Taking certain products together can cause you to get too much acetaminophen which can lead to a fatal overdose. Check the label to see if a medicine contains acetaminophen or APAP.

Avoid drinking alcohol. It may increase your risk of liver damage while taking acetaminophen.


Acetaminophen side effects
Get emergency medical help if you have signs of an allergic reaction to acetaminophen: 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 this medicine 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 taking acetaminophen and call your doctor at once if you have:

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

See also: Side effects (in more detail)

Acetaminophen dosing information
Usual Adult Dose for Fever:

Parenteral:
Weight 50 kg or greater: 1000 mg IV every 6 hours OR 650 mg IV every 4 hours
Maximum Single Dose: 1000 mg
Minimum Dosing Interval: every 4 hours
Maximum Dose: 4000 mg per 24 hours

Weight less than 50 kg: 15 mg/kg IV every 6 hours OR 12.5 mg/kg IV every 4 hours
Maximum Single Dose: 15 mg/kg
Minimum Dosing Interval: every 4 hours
Maximum Dose: 75 mg/kg per 24 hours

Oral:
Immediate-release: 325 mg to 1 g orally every 4 to 6 hours
Minimum Dosing Interval: every 4 hours
Maximum Single Dose: 1000 mg
Maximum Dose: 4 g per 24 hours

Extended-Release: 1300 mg orally every 8 hours
Maximum dose: 3900 mg per 24 hours

Rectal:
650 mg rectally every 4 to 6 hours
Maximum dose: 3900 mg per 24 hours

Comments:
-Maximum daily dose is based on all routes of administration and all products containing acetaminophen.
-Maximum daily dose and dosing recommendations may differ by product; some manufacturers have decreased the maximum daily dose to protect consumers from inadvertent overdoses.
-For IV administration, verify the dose in mg and mL to ensure the dose is correct; verify that infusion pumps are properly programmed

Uses:
-For the management of mild to moderate pain and the management of moderate to severe pain with adjunctive opioid analgesics.
-For the reduction of fever.

Usual Adult Dose for Pain:

Parenteral:
Weight 50 kg or greater: 1000 mg IV every 6 hours OR 650 mg IV every 4 hours
Maximum Single Dose: 1000 mg
Minimum Dosing Interval: every 4 hours
Maximum Dose: 4000 mg per 24 hours

Weight less than 50 kg: 15 mg/kg IV every 6 hours OR 12.5 mg/kg IV every 4 hours
Maximum Single Dose: 15 mg/kg
Minimum Dosing Interval: every 4 hours
Maximum Dose: 75 mg/kg per 24 hours

Oral:
Immediate-release: 325 mg to 1 g orally every 4 to 6 hours
Minimum Dosing Interval: every 4 hours
Maximum Single Dose: 1000 mg
Maximum Dose: 4 g per 24 hours

Extended-Release: 1300 mg orally every 8 hours
Maximum dose: 3900 mg per 24 hours

Rectal:
650 mg rectally every 4 to 6 hours
Maximum dose: 3900 mg per 24 hours

Comments:
-Maximum daily dose is based on all routes of administration and all products containing acetaminophen.
-Maximum daily dose and dosing recommendations may differ by product; some manufacturers have decreased the maximum daily dose to protect consumers from inadvertent overdoses.
-For IV administration, verify the dose in mg and mL to ensure the dose is correct; verify that infusion pumps are properly programmed

Uses:
-For the management of mild to moderate pain and the management of moderate to severe pain with adjunctive opioid analgesics.
-For the reduction of fever.

Usual Pediatric Dose for Fever:

PARENTERAL:
2 to 12 years: 15 mg/kg IV or 12.5 mg/kg IV every 4 hours
Maximum Single Dose: 15 mg/kg; not to exceed 750 mg
Minimum Dosing Interval: every 4 hours
Maximum Daily Dose: 75 mg/kg in 24 hours; not to exceed 3750 mg

13 years or older; weight less than 50 kg: 15 mg/kg IV every 6 hours OR 12.5 mg/kg IV every 4 hours
Maximum Single Dose: 15 mg/kg
Minimum Dosing Interval: every 4 hours
Maximum Daily Dose: 75 mg/kg in 24 hours

13 years or older; weight 50 kg or greater: 1000 mg IV every 6 hours OR 650 mg IV every 4 hours
Maximum Single Dose: 1000 mg
Minimum Dosing Interval: every 4 hours
Maximum Daily Dose: 4000 mg in 24 hours

ORAL:
10 to 15 mg/kg orally every 4 to 6 hours as needed not to exceed 5 doses in 24 hours
-Alternatively, use weight first, then age:
2.7 to 5.3 kg (0 to 3 months): 40 mg orally every 4 hours as needed not to exceed 5 doses in 24 hours
5.4 to 8.1 kg (4 to 11 months): 80 mg orally every 4 hours as needed not to exceed 5 doses in 24 hours
8.2 to 10.8 kg (12 to 23 months): 120 mg orally every 4 hours as needed not to exceed 5 doses in 24 hours
10.9 to 16.3 kg (2 to 3 years): 160 mg orally every 4 hours as needed not to exceed 5 doses in 24 hours
16.4 to 21.7 kg (4 to 5 years): 240 mg orally every 4 hours as needed not to exceed 5 doses in 24 hours
21.8 to 27.2 kg (6 to 8 years): 320 mg orally every 4 hours as needed not to exceed 5 doses in 24 hours
27.3 to 32.6 kg (9 to 10 years): 400 mg orally every 4 hours as needed not to exceed 5 doses in 24 hours
32.7 to 43.2 kg (11 to 12 years): 480 mg orally every 4 hours as needed not to exceed 5 doses in 24 hours

12 years or older:
Immediate-release: 325 mg to 1 g orally every 4 to 6 hours
Minimum Dosing Interval: every 4 hours
Maximum Single Dose: 1000 mg
Maximum Dose: 4 g per 24 hours

Extended-Release: 1300 mg orally every 8 hours
Maximum dose: 3900 mg per 24 hours

RECTAL:
6 to 11 months: 80 mg rectally every 6 hours up to a maximum of 4 doses in 24 hours
12 to 36 months: 80 mg rectally every 4 to 6 hours up to a maximum of 5 doses in 24 hours
3 to 6 years: 120 mg rectally every 4 to 6 hours up to a maximum of 5 doses in 24 hours
6 to 12 years: 325 mg rectally every 4 to 6 hours up to a maximum of 5 doses in 24 hours
12 years or older: 650 mg rectally every 4 to 6 hours up to a maximum of 6 doses in 24 hours

Comments:
-Maximum daily dose is based on all routes of administration and all products containing acetaminophen.
-Maximum daily dose and dosing recommendations may differ by product; some manufacturers have decreased the maximum daily dose to protect consumers from inadvertent overdoses.
-For IV administration, verify the dose in mg and mL to ensure the dose is correct; verify that infusion pumps are properly programmed

Uses:
-For the management of mild to moderate pain and the management of moderate to severe pain with adjunctive opioid analgesics.
-For the reduction of fever.

Usual Pediatric Dose for Pain:

PARENTERAL:
2 to 12 years: 15 mg/kg IV or 12.5 mg/kg IV every 4 hours
Maximum Single Dose: 15 mg/kg; not to exceed 750 mg
Minimum Dosing Interval: every 4 hours
Maximum Daily Dose: 75 mg/kg in 24 hours; not to exceed 3750 mg

13 years or older; weight less than 50 kg: 15 mg/kg IV every 6 hours OR 12.5 mg/kg IV every 4 hours
Maximum Single Dose: 15 mg/kg
Minimum Dosing Interval: every 4 hours
Maximum Daily Dose: 75 mg/kg in 24 hours

13 years or older; weight 50 kg or greater: 1000 mg IV every 6 hours OR 650 mg IV every 4 hours
Maximum Single Dose: 1000 mg
Minimum Dosing Interval: every 4 hours
Maximum Daily Dose: 4000 mg in 24 hours

ORAL:
10 to 15 mg/kg orally every 4 to 6 hours as needed not to exceed 5 doses in 24 hours
-Alternatively, use weight first, then age:
2.7 to 5.3 kg (0 to 3 months): 40 mg orally every 4 hours as needed not to exceed 5 doses in 24 hours
5.4 to 8.1 kg (4 to 11 months): 80 mg orally every 4 hours as needed not to exceed 5 doses in 24 hours
8.2 to 10.8 kg (12 to 23 months): 120 mg orally every 4 hours as needed not to exceed 5 doses in 24 hours
10.9 to 16.3 kg (2 to 3 years): 160 mg orally every 4 hours as needed not to exceed 5 doses in 24 hours
16.4 to 21.7 kg (4 to 5 years): 240 mg orally every 4 hours as needed not to exceed 5 doses in 24 hours
21.8 to 27.2 kg (6 to 8 years): 320 mg orally every 4 hours as needed not to exceed 5 doses in 24 hours
27.3 to 32.6 kg (9 to 10 years): 400 mg orally every 4 hours as needed not to exceed 5 doses in 24 hours
32.7 to 43.2 kg (11 to 12 years): 480 mg orally every 4 hours as needed not to exceed 5 doses in 24 hours

12 years or older:
Immediate-release: 325 mg to 1 g orally every 4 to 6 hours
Minimum Dosing Interval: every 4 hours
Maximum Single Dose: 1000 mg
Maximum Dose: 4 g per 24 hours

Extended-Release: 1300 mg orally every 8 hours
Maximum dose: 3900 mg per 24 hours

RECTAL:
6 to 11 months: 80 mg rectally every 6 hours up to a maximum of 4 doses in 24 hours
12 to 36 months: 80 mg rectally every 4 to 6 hours up to a maximum of 5 doses in 24 hours
3 to 6 years: 120 mg rectally every 4 to 6 hours up to a maximum of 5 doses in 24 hours
6 to 12 years: 325 mg rectally every 4 to 6 hours up to a maximum of 5 doses in 24 hours
12 years or older: 650 mg rectally every 4 to 6 hours up to a maximum of 6 doses in 24 hours

Comments:
-Maximum daily dose is based on all routes of administration and all products containing acetaminophen.
-Maximum daily dose and dosing recommendations may differ by product; some manufacturers have decreased the maximum daily dose to protect consumers from inadvertent overdoses.
-For IV administration, verify the dose in mg and mL to ensure the dose is correct; verify that infusion pumps are properly programmed

Uses:
-For the management of mild to moderate pain and the management of moderate to severe pain with adjunctive opioid analgesics.
-For the reduction of fever.

What other drugs will affect acetaminophen?
Other drugs may interact with acetaminophen, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell each of your health care providers about all medicines you use now and any medicine you start or stop using.
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