Tylenol (acetaminophen) dosing, indications, interactions, adverse effects, and more (original) (raw)

Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

tablet

caplet

capsule

caplet, extended-release

tablet, oral-disintegrating

tablet chewable

solution or suspension, oral

liquid oral

syrup oral

Analgesia & Fever

immediate-release

extended-release

maximum dose

Dosing Considerations

When calculating the maximum daily dose, consider all sources of acetaminophen, including OTC, and routes of administration not to exceed the maximum recommended daily dosing

Renal Impairment

GFR≥50 mL/min: No dosage adjustment necessary

GFR 10-50 mL/min: Administer q6hr

GFR<10mL/min: Administer q8hr

Continuous renal replacement therapy: Administer q6hr

Hepatic Impairment

Use extreme caution; avoid use as much as possible; limit therapy to short-term use at doses not to exceed 2 g/day

Dosage Forms & Strengths

tablet

caplet

capsule

caplet, extended-release

tablet, oral-disintegrating

tablet chewable

solution or suspension, oral

liquid oral

syrup oral

Pain & Fever Relief

Weight-based dosing

Fixed dosing

Dosing Considerations

When calculating the maximum daily dose, consider all sources of acetaminophen, including OTC, and routes of administration not to exceed the maximum recommended daily dosing

Interactions

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Serious (3)

Monitor Closely (26)

Minor (49)

Adverse Effects

Frequency Not Defined

Angioedema

Disorientation

Dizziness

Pruritic maculopapular rash

Rash

Hyperammonemia

Stevens-Johnson syndrome

Toxic epidermal necrolysis

Urticaria

Gastrointestinal hemorrhage

Laryngeal edema

Agranulocytosis

Leukopenia

Neutropenia

Pancytopenia

Thrombocytopenia

Thrombocytopenic purpura

Hepatotoxicity

Liver failure

Nephrotoxicity

Pneumonitis

Anaphylactoid

Warnings

Contraindications

Hypersensitivity

Severe active liver disease

Cautions

Hypersensitivity and anaphylactic reactions reported; discontinue immediately if symptoms of allergic or hypersensitivity reactions occur

Acetaminophen is available in many dosage forms and products, check label carefully to avoid overdose

Use caution in patients with hepatic impairment or active liver disease

Risk of hepatotoxicity is higher in patients taking chronic high dose, or use of more than one acetaminophen-containing product

Use caution in patients with severe renal impairment; consider dosage adjustments

Consumption of 3 or more alcoholic drinks/day may increase risk of liver damage

Use with caution in patients with G6PD deficiency

Use caution in patients with chronic malnutrition

Risk for rare, but serious skin reactions that can be fatal; these reactions include Stevens-Johnson Syndrome (SJS), toxic epidermal necrolysis (TEN), and acute generalized exanthematous pustulosis (AGEP); symptoms may include skin redness, blisters and rash

Limit acetaminophen dose from all sources and routes to <4 g/day in adults

Pregnancy & Lactation

Pregnancy

Drug crosses placenta and can be detected in cord blood, newborn serum, and urine immediately after delivery

Increased risk of teratogenic effects not reported following maternal use of drug during pregnancy

Use of normal doses during pregnancy not associated with increased risk of miscarriage or still birth; however, increase in fetal death or spontaneous abortion may be seen with maternal overdose if treatment delayed

Wheezing and asthma in early childhood associated with frequent maternal use of drug during pregnancy

Lactation

Drug is excreted in milk; in general, breastfeeding is generally acceptable if relative infant dose (RID) is <10%; avoid breastfeeding when RID>25%

Pregnancy Categories

A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

NA: Information not available.

Pharmacology

Mechanism of Action

Acts on hypothalamus to produce antipyresis

May work peripherally to block pain impulse generation; may also inhibit prostaglandin synthesis in CNS

Pharmacokinetics

Peak Plasma Time: 10-60 min (PO immediate-release); 60-120 min (PO extended-release); 6 hr (PO 500 mg, conventional tablet); 8 hr (PO 650 mg, extended-release tablet)

Peak Plasma Concentration: 2.1 mcg/mL (PO 500 mg, conventional tablet); 1.8 mcg/mL (PO 650 mg, extended-release tablet)

Onset: 1 hr

Distribution: 1 L/kg

Protein Bound: 10 to 25%

Metabolism: Liver (microsomal enzyme systems); conjugation (glucuronic/sulfuric acid)

Metabolites: N-acetyl-p-benzoquinoneimine, N-acetylimidoquinone, NAPQI; further metabolized via conjugation with glutathione

Half-life elimination: 1.25-3 hr (adolescents); 2-5 hr (children); 4 hr (infants); 7 hr (neonates); 2-3 hr (adults)

Excretion: urine (principally as acetaminophen glucuronide with acetaminophen sulfate/mercaptate)

Images

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BRAND FORM. UNIT PRICE PILL IMAGE
Tylenol 8 Hour oral- 650 mg tablet
Pharbetol oral- 500 mg tablet
Pharbetol oral- 325 mg tablet
Pain Relief (acetaminophen) oral- 325 mg tablet
Pain Relief (acetaminophen) oral- 650 mg tablet
Pain Relief (acetaminophen) oral- 500 mg tablet
Pain Relief (acetaminophen) oral- 650 mg tablet
Pain Relief (acetaminophen) oral- 325 mg tablet
Pain Relief (acetaminophen) oral- 500 mg tablet
Pain Relief (acetaminophen) oral- 160 mg/5 mL liquid
Pain Relief (acetaminophen) oral- 650 mg tablet
Pain Relief (acetaminophen) oral- 160 mg/5 mL liquid
Pain Relief (acetaminophen) oral- 500 mg tablet
Pain Relief (acetaminophen) oral- 500 mg tablet
Non-Aspirin oral- 325 mg tablet
Non-Aspirin oral- 325 mg tablet
Non-Aspirin oral- 325 mg tablet
Non-Aspirin oral- 325 mg tablet
acetaminophen oral- 500 mg tablet
acetaminophen oral- 500 mg tablet
acetaminophen oral- 325 mg tablet
acetaminophen oral- 500 mg tablet
acetaminophen oral- 500 mg tablet
acetaminophen oral- 325 mg tablet
acetaminophen oral- 325 mg tablet
acetaminophen oral- 500 mg tablet
acetaminophen oral- 325 mg tablet
acetaminophen oral- 500 mg tablet
acetaminophen oral- 650 mg/20.3 mL suspension
acetaminophen oral- 500 mg tablet
acetaminophen oral- 325 mg tablet
acetaminophen oral- 160 mg/5 mL liquid
acetaminophen oral- 650 mg tablet
acetaminophen oral- 500 mg tablet
acetaminophen oral- 500 mg tablet
acetaminophen oral- 325 mg tablet
acetaminophen oral- 500 mg tablet
acetaminophen oral- 650 mg tablet
acetaminophen oral- 500 mg tablet
acetaminophen oral- 500 mg tablet
acetaminophen oral- 500 mg tablet
acetaminophen oral- 160 mg/5 mL liquid
acetaminophen oral- 650 mg tablet
acetaminophen oral- 325 mg tablet
acetaminophen oral- 500 mg tablet
acetaminophen oral- 500 mg tablet
acetaminophen oral- 80 mg tablet
acetaminophen oral- 500 mg tablet
acetaminophen oral- 325 mg tablet
acetaminophen oral- 325 mg tablet
acetaminophen oral- 500 mg tablet
acetaminophen oral- 325 mg tablet
acetaminophen oral- 325 mg tablet
acetaminophen oral- 500 mg tablet
acetaminophen oral- 500 mg tablet
acetaminophen oral- 650 mg tablet
acetaminophen oral- 325 mg/10.15 mL suspension
acetaminophen oral- 325 mg tablet
acetaminophen oral- 325 mg tablet
acetaminophen oral- 325 mg tablet
acetaminophen oral- 160 mg/5 mL (5 mL) solution
Pain Reliever (acetaminophen) oral- 325 mg tablet
Pain Reliever (acetaminophen) oral- 500 mg tablet
Pain Reliever (acetaminophen) oral- 325 mg tablet
Pain Reliever (acetaminophen) oral- 325 mg tablet
Tylenol oral- 325 mg tablet
Tylenol oral- 325 mg tablet
Non-Aspirin Extra Strength oral- 500 mg tablet
Non-Aspirin Extra Strength oral- 500 mg tablet
Non-Aspirin Extra Strength oral- 500 mg tablet
Mapap (acetaminophen) oral- 325 mg tablet
Mapap (acetaminophen) oral- 500 mg capsule
MAXrelief junior oral- 160 mg/5 mL suspension
MAXrelief junior oral- 160 mg/5 mL suspension
MAXrelief junior oral- 160 mg/5 mL liquid
Pain Reliever Extra Strength (acetaminophen) oral- 500 mg tablet
Pain Reliever Extra Strength (acetaminophen) oral- 500 mg tablet
Pain Reliever Extra Strength (acetaminophen) oral- 500 mg tablet
Pain Reliever Extra Strength (acetaminophen) oral- 500 mg tablet
8HR Muscle Aches-Pain oral- 650 mg tablet
Acetaminophen Extra Strength oral- 500 mg tablet
Acetaminophen Extra Strength oral- 500 mg tablet
M-PAP oral- 160 mg/5 mL liquid
M-PAP oral- 160 mg/5 mL liquid
Children's Acetaminophen oral- 160 mg/5 mL (5 mL) suspension
Children's Acetaminophen oral- 32 mg/mL solution
Children's Acetaminophen oral- 160 mg/5 mL suspension
Children's Acetaminophen oral- 160 mg/5 mL suspension
Children's Acetaminophen oral- 160 mg/5 mL suspension
Children's Acetaminophen oral- 160 mg/5 mL suspension
Children's Acetaminophen oral- 160 mg/5 mL liquid
Tylenol Arthritis Pain oral- 650 mg tablet
Children's Pain and Fever Relief oral- 160 mg/5 mL suspension
Children's Pain and Fever Relief oral- 160 mg/5 mL suspension
Children's Pain and Fever Relief oral- 160 mg/5 mL suspension
Children's Pain and Fever Relief oral- 160 mg/5 mL suspension
Children's Pain and Fever Relief oral- 160 mg/5 mL suspension
Children's Pain and Fever Relief oral- 160 mg/5 mL suspension
Children's Pain and Fever Relief oral- 160 mg/5 mL suspension
Children's Pain and Fever Relief oral- 160 mg/5 mL suspension
Children's Pain and Fever Relief oral- 160 mg/5 mL suspension
Children's Pain and Fever Relief oral- 160 mg/5 mL suspension
Children's Pain and Fever Relief oral- 160 mg/5 mL suspension
Children's Pain and Fever Relief oral- 160 mg/5 mL suspension
Children's Pain and Fever Relief oral- 160 mg/5 mL suspension
Children's Non-Aspirin oral- 160 mg/5 mL suspension
Children's Non-Aspirin oral- 160 mg/5 mL suspension
Children's Non-Aspirin oral- 160 mg/5 mL suspension
Children's Tylenol oral- 160 mg chewable tablet
Children's Tylenol oral- 160 mg chewable tablet
Children's Pain Relief oral- 160 mg/5 mL suspension
Arthritis Pain Relief (acetaminophen) oral- 650 mg tablet
Arthritis Pain Relief (acetaminophen) oral- 650 mg tablet
Arthritis Pain Relief (acetaminophen) oral- 650 mg tablet
8 Hour Pain Reliever oral- 650 mg tablet
8 Hour Pain Reliever oral- 650 mg tablet
8 Hour Pain Reliever oral- 650 mg tablet
Tactinal oral- 325 mg tablet
Feverall rectal- 325 mg suppos
Feverall rectal- 120 mg suppos
Feverall rectal- 325 mg suppos
Feverall rectal- 120 mg suppos
Feverall rectal- 80 mg suppos
Feverall rectal- 80 mg suppos
Feverall rectal- 650 mg suppos
Infant's Tylenol oral- 160 mg/5 mL suspension
Arthritis Pain Reliever oral- 650 mg tablet
acetaminophen rectal- 120 mg suppos
acetaminophen rectal- 650 mg suppos
acetaminophen rectal- 120 mg suppos
acetaminophen rectal- 650 mg suppos
acetaminophen rectal- 650 mg suppos
Children's Mapap oral- 80 mg chewable tablet
acetaminophen intravenous- 1,000 mg/100 mL (10 mg/mL) vial
acetaminophen intravenous- 1,000 mg/100 mL (10 mg/mL) vial
acetaminophen intravenous- 1,000 mg/100 mL (10 mg/mL) vial
Tylenol Extra Strength oral- 500 mg tablet
Pain Relief Extra Strength (acetaminophen) oral- 500 mg tablet
Pain Relief Extra Strength (acetaminophen) oral- 500 mg tablet
Pain Relief Extra Strength (acetaminophen) oral- 500 mg tablet
Pain Relief Extra Strength (acetaminophen) oral- 500 mg tablet
Pain Relief Extra Strength (acetaminophen) oral- 500 mg tablet
Pain Relief Extra Strength (acetaminophen) oral- 500 mg tablet

Copyright © 2010 First DataBank, Inc.

Patient Handout

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ACETAMINOPHEN - ORAL

(a-SEET-a-MIN-oh-fen)

COMMON BRAND NAME(S): Panadol, Tylenol

WARNING: Taking too much acetaminophen may cause serious (possibly fatal) liver disease. Adults should not take more than 4000 milligrams (4 grams) of acetaminophen a day. People with liver problems and children should take less acetaminophen. Ask your doctor or pharmacist how much acetaminophen is safe to take.Do not use with any other drug containing acetaminophen without asking your doctor or pharmacist first. Acetaminophen is in many nonprescription and prescription medications (such as pain/fever drugs or cough-and-cold products). Check the labels on all your medicines to see if they contain acetaminophen, and ask your pharmacist if you are unsure.Get medical help right away if you take too much acetaminophen (overdose), even if you feel well. Overdose symptoms may include nausea, vomiting, loss of appetite, sweating, stomach/abdominal pain, extreme tiredness, yellowing eyes/skin, and dark urine.Daily alcohol use, especially when combined with acetaminophen, may damage your liver. Avoid alcohol.

USES: This drug is used to treat mild to moderate pain (from headaches, menstrual periods, toothaches, backaches, osteoarthritis, or cold/flu aches and pains) and to reduce fever.

HOW TO USE: Take this product by mouth as directed. Follow all directions on the product package. If you have any questions, ask your doctor or pharmacist.There are many brands and forms of acetaminophen available. Read the dosing instructions carefully for each product because the amount of acetaminophen may be different between products. Do not take more acetaminophen than recommended. (See also Warning section.)If you are giving acetaminophen to a child, be sure you use a product that is meant for children. Use your child's weight to find the right dose on the product package. If you don't know your child's weight, you can use their age.For suspensions, shake the medication well before each dose. Some liquids do not need to be shaken before use. Follow all directions on the product package. Measure the liquid medication with the provided dose-measuring spoon/dropper/syringe to make sure you have the correct dose. Do not use a household spoon.For rapidly-dissolving tablets, chew or allow to dissolve on the tongue, then swallow with or without water. For chewable tablets, chew thoroughly before swallowing.Do not crush or chew extended-release tablets. Doing so can release all of the drug at once, increasing the risk of side effects. Swallow the tablets whole.For effervescent tablets, dissolve the dose in the recommended amount of water, then drink.Pain medications work best if they are used as the first signs of pain occur. If you wait until the symptoms have worsened, the medication may not work as well.Do not take this medication for fever for more than 3 days unless directed by your doctor. For adults, do not take this product for pain for more than 10 days (5 days in children) unless directed by your doctor. If the child has a sore throat (especially with high fever, headache, or nausea/vomiting), consult the doctor promptly.Tell your doctor if your condition lasts or gets worse or if you develop new symptoms. If you think you may have a serious medical problem, get medical help right away.

SIDE EFFECTS: See also Warning section.This drug usually has no side effects. If you have any unusual effects, contact your doctor or pharmacist promptly.If your doctor has directed you to use this medication, remember that your doctor has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.In the US -Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

PRECAUTIONS: See also Warning section.Before taking acetaminophen, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.Before using this product, tell your doctor or pharmacist your medical history, especially of: liver disease, regular use/abuse of alcohol.Liquid products, chewable tablets, or dissolving/effervescent tablets and powders may contain sugar or aspartame. Caution is advised if you have diabetes, phenylketonuria (PKU), or any other condition that requires you to limit/avoid these substances in your diet. If you have any of these conditions, ask your doctor or pharmacist about using these products safely.Tell your doctor if you are pregnant before using this medication.Acetaminophen passes into breast milk. Consult your doctor before breastfeeding.

DRUG INTERACTIONS: See also Warning section.Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.Some products that may interact with this drug are: ketoconazole, levoketoconazole.This medication may interfere with certain lab tests, possibly causing false test results. Make sure lab personnel and all your doctors know you use this drug.

OVERDOSE: If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call 1-800-222-1222. Canada residents can call 1-844-764-7669. Symptoms of overdose may include: nausea, vomiting, loss of appetite, sweating, stomach/abdominal pain, extreme tiredness, yellowing eyes/skin, dark urine.

NOTES: Acetaminophen does not cause the stomach and intestinal ulcers that NSAIDs such as aspirin, ibuprofen, and naproxen may cause. However, acetaminophen does not reduce swelling (inflammation) like the NSAIDs do. Consult your doctor for more details and to see which medication might be right for you.

MISSED DOSE: If you are taking this medication on a regular schedule and miss a dose, take it as soon as you remember. If it is near the time of the next dose, skip the missed dose. Take your next dose at the regular time. Do not double the dose to catch up.

STORAGE: Store at room temperature away from light and moisture. Do not store in the bathroom. Keep all medications away from children and pets.Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.

Information last revised May 2024. Copyright(c) 2024 First Databank, Inc.

IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.

Medscape prescription drug monographs are based on FDA-approved labeling information, unless otherwise noted, combined with additional data derived from primary medical literature.