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Acetaminophen Drug Information Provided by Lexi-Comp

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Special Alerts

Acetaminophen: Change in Maximum Content of Prescription Products and Labeling Changes

January 2011

The Food and Drug Administration (FDA) is asking manufacturers to limit the strength of acetaminophen in prescription products to 325 mg per dosage unit. Drug manufacturers will have until January 14, 2014 to comply with the FDA's request. The dosing instructions of prescription acetaminophen products will not change. For example, the instructions of 1-2 tablets every 4-6 hours for a combination product of acetaminophen 500 mg with an opioid can still be used for a combination product of acetaminophen 325 mg with an opioid.

The FDA is also notifying healthcare professionals of labeling changes for all prescription products that contain acetaminophen. A Boxed Warning will be required on all prescription acetaminophen products to describe the potential risk of severe liver injury. Additionally, the FDA has asked manufacturers to add a Warning regarding the potential for allergic reactions, including anaphylaxis.

Healthcare professionals should advise patients:

- not to exceed 4 g/day of acetaminophen

- not to take multiple acetaminophen-containing products (including over-the-counter products)

- not to consume alcohol while taking acetaminophen-containing products

- that severe liver injury and cases of hypersensitivity reactions (including anaphylaxis) have occurred with the use of acetaminophen

- to report taking more acetaminophen than directed

- to report any adverse events that may have occurred with the use of acetaminophen

Further information may be found at: http://www.fda.gov/Drugs/DrugSafety/ucm239821.htm

Pronunciation

(a seet a MIN oh fen)

Generic Available (U.S.)

Yes: Excludes extended release products; injectable formulation

Index Terms

  • APAP
  • N-Acetyl-P-Aminophenol
  • Paracetamol

U.S. Brand Names

  • Acephen™ [OTC]
  • APAP 500 [OTC]
  • Aspirin Free Anacin® Extra Strength [OTC]
  • Cetafen® Extra [OTC]
  • Cetafen® [OTC]
  • Excedrin® Tension Headache [OTC]
  • Feverall® [OTC]
  • Infantaire [OTC]
  • Little Fevers™ [OTC]
  • Mapap® Arthritis Pain [OTC]
  • Mapap® Children's [OTC]
  • Mapap® Extra Strength [OTC]
  • Mapap® Infant's [OTC]
  • Mapap® Junior Rapid Tabs [OTC]
  • Mapap® [OTC]
  • Nortemp Children's [OTC]
  • Ofirmev™
  • Pain & Fever Children's [OTC]
  • Pain Eze [OTC]
  • Silapap Children's [OTC]
  • Silapap Infant's [OTC]
  • Triaminic™ Children's Fever Reducer Pain Reliever [OTC]
  • Tylenol® 8 Hour [OTC]
  • Tylenol® Arthritis Pain Extended Relief [OTC]
  • Tylenol® Children's Meltaways [OTC]
  • Tylenol® Children's [OTC]
  • Tylenol® Extra Strength [OTC]
  • Tylenol® Infant's Concentrated [OTC]
  • Tylenol® Jr. Meltaways [OTC]
  • Tylenol® [OTC]
  • Valorin Extra [OTC]
  • Valorin [OTC]

Canadian Brand Names

  • Abenol®
  • Apo-Acetaminophen®
  • Atasol®
  • Novo-Gesic
  • Pediatrix
  • Tempra®
  • Tylenol®

Pharmacologic Category

  • Analgesic, Miscellaneous

Use: Labeled Indications

Treatment of mild-to-moderate pain and fever (analgesic/antipyretic)

I.V.: Additional indication: Management of moderate-to-severe pain when combined with opioid analgesia

Use: Dental

Treatment of postoperative pain

Pregnancy Risk Factor

C (intravenous)

Pregnancy Considerations

Animal reproduction studies have not been conducted with intravenous acetaminophen, therefore, acetaminophen I.V. is classified as pregnancy category C. Acetaminophen crosses the placenta and can be detected in cord blood, newborn serum, and urine immediately after delivery. An increased risk of teratogenic effects has not been observed following maternal use of acetaminophen during pregnancy. Prenatal constriction of the ductus arteriosus has been noted in case reports following maternal use during the third trimester. The use of acetaminophen in normal doses during pregnancy is not associated with an increased risk of miscarriage or still birth; however, an increase in fetal death or spontaneous abortion may be seen following maternal overdose if treatment is delayed. Frequent maternal use of acetaminophen during pregnancy may be associated with wheezing and asthma in early childhood. The absorption may be delayed and the bioavailability of acetaminophen may be decreased in some women during pregnancy due to delayed gastric emptying.

Lactation

Enters breast milk/use caution (AAP rates “compatible”; AAP 2001 update pending)

Breast-Feeding Considerations

Low concentrations of acetaminophen are excreted into breast milk and can be detected in the urine of nursing infants. Adverse reactions have generally not been observed; however, a rash caused by acetaminophen exposure was reported in one breast-feeding infant.

Contraindications

Hypersensitivity to acetaminophen or any component of the formulation; severe hepatic impairment or severe active liver disease (Ofirmev™)

Warnings/Precautions

Concerns related to adverse effects:

• Hepatotoxicity: May cause severe hepatotoxicity on acute overdose; in addition, chronic daily dosing in adults has resulted in liver damage in some patients. Use with caution in patients with chronic malnutrition.

• Hypersensitivity/anaphylactic reactions: Hypersensitivity and anaphylactic reactions have been reported; discontinue immediately if symptoms of allergic or hypersensitivity reactions occur.

Disease-related concerns:

• Ethanol use: Use with caution in patients with alcoholic liver disease; consuming ≥3 alcoholic drinks/day may increase the risk of liver damage.

• G6PD deficiency: Use with caution in patients with known G6PD deficiency; rare reports of hemolysis have occurred.

• Hepatic impairment: Use with caution in patients with hepatic impairment or active liver disease; use of the intravenous formulation is contraindicated in patients with severe hepatic impairment or severe active liver disease.

• Hypovolemia: Use the intravenous formulation with caution in patients with severe hypovolemia (eg, due to dehydration or blood loss).

• Renal impairment: Use with caution in patients with severe renal impairment; consider dosing adjustments.

Other warnings/precautions:

• Dosage limit: Limit dose to <4 g/day.

• Self-medication (OTC use): When used for self-medication, patients should be instructed to contact healthcare provider if used for fever lasting >3 days or for pain lasting >10 days in adults or >5 days in children.

Adverse Reactions

Oral, Rectal: Frequency not defined:

Dermatologic: Rash

Endocrine & metabolic: May increase chloride, uric acid, glucose; may decrease sodium, bicarbonate, calcium

Hematologic: Anemia, blood dyscrasias (neutropenia, pancytopenia, leukopenia)

Hepatic: Bilirubin increased, alkaline phosphatase increased

Renal: Ammonia increased, nephrotoxicity with chronic overdose, analgesic nephropathy

Miscellaneous: Hypersensitivity reactions (rare)

I.V.:

>10%: Gastrointestinal: Nausea (adults 34%; children ≥5%), vomiting (adults 15%; children ≥5%)

1% to 10%:

Cardiovascular: Edema (peripheral), hypervolemia, hypo/hypertension, tachycardia

Central nervous system: Headache (adults 10%; children ≥1%), insomnia (adults 7%; children ≥1%), agitation (children ≥5%), anxiety, fatigue

Dermatologic: Pruritus (children ≥5%), rash

Endocrine & metabolic: Hypoalbuminemia, hypokalemia, hypomagnesemia, hypophosphatemia

Gastrointestinal: Constipation (children ≥5%), abdominal pain, diarrhea

Hematologic: Anemia

Hepatic: Transaminases increased

Local: Infusion site pain

Neuromuscular & skeletal: Muscle spasms, pain in extremity, trismus

Ocular: Periorbital edema

Renal: Oliguria (children ≥1%)

Respiratory: Atelectasis (children ≥5%), breath sounds abnormal, dyspnea, hypoxia, pleural effusion, pulmonary edema, stridor, wheezing

All formulations: <1%, postmarketing, and/or case reports: Anaphylaxis (rare), hypersensitivity reactions

Metabolism/Transport Effects

Substrate (minor) of CYP1A2, 2A6, 2C9, 2D6, 2E1, 3A4; Inhibits CYP3A4 (weak)

Drug Interactions

Anticonvulsants (Hydantoin): May increase the metabolism of Acetaminophen. This may 1) diminish the effect of acetaminophen; and 2) increase the risk of liver damage. Risk C: Monitor therapy

Barbiturates: May increase the metabolism of Acetaminophen. This may 1) diminish the effect of acetaminophen; and 2) increase the risk of liver damage. Risk C: Monitor therapy

CarBAMazepine: May increase the metabolism of Acetaminophen. This may 1) diminish the effect of acetaminophen; and 2) increase the risk of liver damage. Risk C: Monitor therapy

Cholestyramine Resin: May decrease the absorption of Acetaminophen. Effect is minimal if cholestyramine is administered 1 hour after acetaminophen. Risk D: Consider therapy modification

Conivaptan: May increase the serum concentration of CYP3A4 Substrates. Management: Upon completion/discontinuation of conivaptan, allow at least 7 days before initiating therapy with drugs that are CYP3A4 substrates. Risk D: Consider therapy modification

Dasatinib: Acetaminophen may enhance the hepatotoxic effect of Dasatinib. Dasatinib may increase the serum concentration of Acetaminophen. Risk D: Consider therapy modification

Imatinib: Acetaminophen may enhance the hepatotoxic effect of Imatinib. Imatinib may increase the serum concentration of Acetaminophen. Risk D: Consider therapy modification

Isoniazid: May enhance the adverse/toxic effect of Acetaminophen. Risk C: Monitor therapy

Metyrapone: May increase the serum concentration of Acetaminophen. More importantly, by inhibiting the conjugative metabolism of acetaminophen, metyrapone may shift the metabolism towards the oxidative route that produces a hepatotoxic metabolite. Risk C: Monitor therapy

Peginterferon Alfa-2b: May decrease the serum concentration of CYP2D6 Substrates. Risk C: Monitor therapy

Probenecid: May increase the serum concentration of Acetaminophen. Probenecid may also limit the formation of at least one major non-toxic metabolite, possibly increasing the potential for formation of the toxic NAPQI metabolite. Risk D: Consider therapy modification

SORAfenib: Acetaminophen may enhance the hepatotoxic effect of SORAfenib. SORAfenib may increase the serum concentration of Acetaminophen. Risk D: Consider therapy modification

Tocilizumab: May decrease the serum concentration of CYP3A4 Substrates. Risk C: Monitor therapy

Vitamin K Antagonists (eg, warfarin): Acetaminophen may enhance the anticoagulant effect of Vitamin K Antagonists. Most likely with daily acetaminophen doses >1.3 g for >1 week. Risk C: Monitor therapy

Ethanol/Nutrition/Herb Interactions

Ethanol: Excessive intake of ethanol may increase the risk of acetaminophen-induced hepatotoxicity. Avoid ethanol or limit to <3 drinks/day.

Food: Rate of absorption may be decreased when given with food.

Herb/Nutraceutical: St John's wort may decrease acetaminophen levels.

Storage

Injection: Store intact vials at room temperature of 20°C to 25°C (68°F to 77°F); do not refrigerate or freeze. Use within 6 hours of opening vial or transferring to another container. Discard any unused portion; single use vials only.

Oral formulations: Store at controlled room temperature.

Suppositories: Store at <27°C (80°F); do not freeze.

Reconstitution

Injectable solution may be administered directly from the vial without further dilution. For doses <1000 mg, withdraw the appropriate volume and transfer to a separate sterile container (eg, glass bottle, plastic I.V. container, syringe) for administration.

Compatibility

Do not combine with any other medications. Incompatible with chlorpromazine, diazepam.

Mechanism of Action

Although not fully elucidated, believed to inhibit the synthesis of prostaglandins in the central nervous system and work peripherally to block pain impulse generation; produces antipyresis from inhibition of hypothalamic heat-regulating center

Pharmacodynamics/Kinetics

Onset of action:

Oral: <1 hour

I.V.: Analgesia: 5-10 minutes; Antipyretic: Within 30 minutes

Peak effect: I.V.: Analgesic: 1 hour

Duration:

I.V., Oral: Analgesia: 4-6 hours

I.V.: Antipyretic: ≥6 hours

Absorption: Primarily absorbed in small intestine (rate of absorption dependent upon gastric emptying); minimal absorption from stomach; varies by dosage form

Distribution: ~1 L/kg at therapeutic doses

Protein binding: 10% to 25% at therapeutic concentrations; 8% to 43% at toxic concentrations

Metabolism: At normal therapeutic dosages, primarily hepatic metabolism to sulfate and glucuronide conjugates, while a small amount is metabolized by CYP2E1 to a highly reactive intermediate, N-acetyl-p-benzoquinone imine (NAPQI), which is conjugated rapidly with glutathione and inactivated to nontoxic cysteine and mercapturic acid conjugates. At toxic doses (as little as 4 g daily) glutathione conjugation becomes insufficient to meet the metabolic demand causing an increase in NAPQI concentrations, which may cause hepatic cell necrosis. Oral administration is subject to first pass metabolism.

Half-life elimination: Prolonged following toxic doses

Neonates: 7 hours (range: 4-10 hours)

Infants: ~4 hours (range: 1-7 hours)

Children: 3 hours (range: 2-5 hours)

Adolescents: ~3 hours (range: 2-4 hours)

Adults: ~2 hours (range: 2-3 hours); may be slightly prolonged in severe renal insufficiency (Clcr<30 mL/minute): 2-5.3 hours

Time to peak, serum: Oral: Immediate release: 10-60 minutes (may be delayed in acute overdoses); I.V.: 15 minutes

Excretion: Urine (<5% unchanged; 60% to 80% as glucuronide metabolites; 20% to 30% as sulphate metabolites; ~8% cysteine and mercapturic acid metabolites)

Dosage

Note: No dose adjustment required if converting between different acetaminophen formulations.

Oral, rectal:

Children <12 years: 10-15 mg/kg/dose every 4-6 hours as needed; do not exceed 5 doses (2.6 g) in 24 hours; alternatively, the following age-based doses may be used; see table.

Acetaminophen Dosing (Oral and Rectal Formulations) Age Dosage (mg) Age Dosage (mg) 0-3 mo 40 4-5 y 240 4-11 mo 80 6-8 y 320 1-2 y 120 9-10 y 400 2-3 y 160 11 y 480 Table has been converted to the following text. Acetaminophen Dosing (Oral and Rectal Formulations) • 0-3 months: 40 mg • 4-11 months: 80 mg • 1-2 years: 120 mg • 2-3 years: 160 mg • 4-5 years: 240 mg • 6-8 years: 320 mg • 9-10 years: 400 mg • 11 years: 480 mg

Note: Higher rectal doses have been studied for use in preoperative pain control in children. However, specific guidelines are not available and dosing may be product dependent. The safety and efficacy of alternating acetaminophen and ibuprofen dosing has not been established.

Adults: 325-650 mg every 4-6 hours or 1000 mg 3-4 times/day; do not exceed 4 g/day

I.V.:

Children 2-12 years: 15 mg/kg every 6 hours or 12.5 mg/kg every 4 hours; maximum single dose: 15 mg/kg/dose; maximum daily dose: 75 mg/kg/day (≤3.75 g/day)

Adolescents >12 years and Adults:

<50 kg: 15 mg/kg every 6 hours or 12.5 mg/kg every 4 hours; maximum single dose: 750 mg/dose; maximum daily dose: 75 mg/kg/day (≤3.75 g/day)

≥50 kg: 650 mg every 4 hours or 1000 mg every 6 hours; maximum single dose: 1000 mg/dose; maximum daily dose: 4 g/day

Dosing interval in renal impairment:

Oral (Aronoff, 2007):

Children:

Clcr <10 mL/minute: Administer every 8 hours

Intermittent hemodialysis or peritoneal dialysis: Administer every 8 hours

CRRT: No adjustments necessary

Adults:

Clcr 10-50 mL/minute: Administer every 6 hours

Clcr <10 mL/minute: Administer every 8 hours

Intermittent hemodialysis or peritoneal dialysis: No adjustment necessary

CRRT: Administer every 8 hours

I.V.: Clcr ≤30 mL/minute: Use with caution; consider decreasing daily dose and extending dosing interval

Dosing adjustment/comments in hepatic impairment: Use with caution. Limited, low-dose therapy is usually well tolerated in hepatic disease/cirrhosis. However, cases of hepatotoxicity at daily acetaminophen dosages <4 g/day have been reported. Avoid chronic use in hepatic impairment.

Dental Usual Dosing

Postoperative pain: Oral, rectal:

Children <12 years: 10-15 mg/kg/dose every 4-6 hours as needed; do not exceed 5 doses (2.6 g) in 24 hours; alternatively, the following age-based doses may be used

Adults: 325-650 mg every 4-6 hours or 1000 mg 3-4 times/day; do not exceed 4 g/day

Administration: Oral

Shake suspension well before pouring dose.

Administration: I.V.

For I.V. infusion only. May administer undiluted over 15 minutes.

Doses <1000 mg (<50 kg): Withdraw appropriate dose from vial and place into separate empty, sterile container prior to administration. Small volume pediatric doses (up to 60 mL) may be placed in a syringe and infused over 15 minutes via syringe pump.

Doses of 1000 mg (≥50 kg): Insert vented I.V. set through vial stopper.

Administration: I.V. Detail

pH: 5.5

Monitoring Parameters

Relief of pain or fever

Dietary Considerations

Some products may contain phenylalanine.

Patient Education

Take with food or milk. While using this medication, avoid or limit alcohol to <3 drinks/day and avoid other prescription or OTC medications that contain acetaminophen. Maintain adequate hydration, unless instructed to restrict fluid intake. This medication will not reduce inflammation; consult prescriber for anti-inflammatory, if needed. Report unusual bleeding (stool, mouth, urine) or bruising, unusual fatigue and weakness, change in elimination patterns, or change in color of urine or stool.

Anesthesia and Critical Care Concerns/Other Considerations

Evidence-Based Information: The 2002 ACCM/SCCM guidelines for analgesia (critically-ill adult) recommend prescribing <2 g/day for patients with a significant alcohol history or those with malnutrition. All other patients should be limited to ≤4 g/day when used for acute pain or fever (American Pain Society, 2008). If possible, long-term administration of acetaminophen should not exceed 3000 mg/day, based on evidence demonstrating an increased risk of hepatotoxicity compared to patients not receiving acetaminophen (Watkins, 2006). Susceptibility to acetaminophen hepatotoxicity may be due to induction of hepatic enzymes caused by chronic alcohol ingestion and/or concurrent use of cytochrome P450 1A2/2E1 inducers (eg, isoniazid), and impaired glucuronidation caused by fasting (American Pain Society, 2008; Brackett, 2000; Zenger, 2004).

Dental Health: Effects on Dental Treatment

No significant effects or complications reported (see Dental Health Professional Considerations)

Dental Health: Vasoconstrictor/Local Anesthetic Precautions

No information available to require special precautions

Dental Comment

Hepatotoxicity caused by acetaminophen is potentiated by chronic alcohol consumption. People who are taking acetaminophen, even at therapeutic doses, and consume alcohol are at risk of developing hepatotoxicity.

Acetaminophen may increase the levels and enhance the anticoagulant effects of vitamin K antagonists acenocoumarol and warfarin (Coumadin®). Studies have reported that acetaminophen has increased the INR in warfarin treated patients with daily acetaminophen doses as low as 2 g, particularly when taking acetaminophen for >1 week (Antlitz, 1968; Boeijinga, 1982; Gebauer, 2003; Hylek, 1998; Rubin, 1984). In addition, case reports of bleeding as a result of increased INR have been published (Bagheri, 1999; Bartle, 1991). There is no known mechanism of the interaction; furthermore, some studies have failed to demonstrate this interaction (Gadisseur, 2003; Kwan, 1995; van den Bemt, 2002). In terms of risk, the data suggest that acetaminophen and warfarin could interact in some clinically significant manner but that the benefits of concomitant use of acetaminophen for pain control in dental patients taking warfarin usually outweigh the risks. An appropriate monitoring plan should be in place to identify potential negative effects and dosage adjustments may be necessary in a minority of patients. The interaction may be more likely to occur with daily acetaminophen doses of >1.3 g for >1 week.

There are no reports of acetaminophen interacting with antiplatelet drugs such as aspirin, clopidogrel (Plavix®), or prasugrel (Effient™). Also, there are no reports of acetaminophen in combination with hydrocodone, codeine, or oxycodone interacting with warfarin (Coumadin®).

Mental Health: Effects on Mental Status

None reported

Mental Health: Effects on Psychiatric Treatment

Barbiturates and carbamazepine may increase the hepatotoxic potential of acetaminophen

Nursing: Physical Assessment/Monitoring

Assess patient for history of liver disease or ethanol abuse (acetaminophen and excessive ethanol may have adverse liver effects).

Dosage Forms

Excipient information presented when available (limited, particularly for generics); consult specific product labeling. [DSC] = Discontinued product

Caplet, oral: 500 mg

Cetafen® Extra: 500 mg

Mapap® Extra Strength: 500 mg

Mapap® Extra Strength: 500 mg [scored]

Pain Eze: 650 mg

Tylenol®: 325 mg

Tylenol® Extra Strength: 500 mg

Caplet, extended release, oral:

Mapap® Arthritis Pain: 650 mg

Tylenol® 8 Hour: 650 mg

Tylenol® Arthritis Pain Extended Relief: 650 mg

Capsule, oral:

Mapap® Extra Strength: 500 mg

Captab, oral: 500 mg

Elixir, oral:

Mapap® Children's: 160 mg/5 mL (118 mL, 480 mL) [ethanol free; contains benzoic acid, propylene glycol, sodium benzoate; cherry flavor]

Gelcap, oral:

Mapap®: 500 mg

Gelcap, rapid release, oral:

Tylenol® Extra Strength: 500 mg

Geltab, oral:

Excedrin® Tension Headache: 500 mg [contains caffeine 65 mg/geltab]

Injection, solution [preservative free]:

Ofirmev™: 10 mg/mL (100 mL)

Liquid, oral:

APAP 500: 500 mg/5 mL (237 mL) [ethanol free, sugar free; cherry flavor]

Silapap Children's: 160 mg/5 mL (118 mL, 237 mL, 473 mL) [ethanol free, sugar free; contains propylene glycol, sodium benzoate; cherry flavor]

Tylenol® Extra Strength: 500 mg/15 mL (240 mL) [ethanol free; contains propylene glycol, sodium benzoate; cherry flavor]

Solution, oral: 160 mg/5 mL (5 mL, 10 mL, 20 mL)

Pain & Fever Children's: 160 mg/5 mL (118 mL, 473 mL) [ethanol free; contains benzoic acid, propylene glycol, sodium benzoate; cherry flavor]

Solution, oral [drops]: 80 mg/0.8 mL (15 mL)

Infantaire: 80 mg/0.8 mL (15 mL, 30 mL)

Little Fevers™: 80 mg/mL (30 mL) [dye free, ethanol free, gluten free; contains propylene glycol, sodium benzoate; berry flavor]

Mapap®: 80 mg/0.8 mL (15 mL) [fruit flavor]

Silapap Infant's: 80 mg/0.8 mL (15 mL, 30 mL) [ethanol free; contains propylene glycol, sodium benzoate; cherry flavor]

Suppository, rectal: 120 mg (12s, 50s [DSC], 100s [DSC]); 325 mg (12s); 650 mg (12s, 50s [DSC], 100s [DSC])

Acephen™: 120 mg (12s, 50s, 100s); 325 mg (6s, 12s, 50s, 100s); 650 mg (12s, 50s, 100s, 500s [DSC])

Feverall®: 80 mg (6s, 50s); 120 mg (6s, 12s [DSC], 50s); 325 mg (6s, 12s [DSC], 50s); 650 mg (12s [DSC], 50s, 500s [DSC])

Suspension, oral: 160 mg/5 mL (5 mL, 10 mL, 10.15 mL, 20 mL, 20.3 mL)

Mapap® Children's: 160 mg/5 mL (118 mL) [ethanol free; contains propylene glycol, sodium benzoate; cherry flavor]

Nortemp Children's: 160 mg/5 mL (118 mL) [ethanol free; contains propylene glycol, sodium benzoate; cotton candy flavor]

Tylenol® Children's: 160 mg/5 mL (120 mL) [dye free, ethanol free; contains propylene glycol, sodium benzoate; cherry flavor]

Tylenol® Children's: 160 mg/5 mL (120 mL) [ethanol free; contains propylene glycol, sodium 2 mg/5 mL, sodium benzoate; bubblegum flavor]

Tylenol® Children's: 160 mg/5 mL (60 mL, 120 mL) [ethanol free; contains propylene glycol, sodium 2 mg/5 mL, sodium benzoate; cherry flavor]

Tylenol® Children's: 160 mg/5 mL (120 mL) [ethanol free; contains propylene glycol, sodium 2 mg/5 mL, sodium benzoate; grape flavor]

Tylenol® Children's: 160 mg/5 mL (120 mL) [ethanol free; contains propylene glycol, sodium 2 mg/5 mL, sodium benzoate; strawberry flavor]

Suspension, oral [drops]:

Mapap® Infant's: 80 mg/0.8 mL (15 mL, 30 mL) [ethanol free; contains propylene glycol, sodium benzoate; cherry flavor]

Tylenol® Infant's Concentrated: 80 mg/0.8 mL (30 mL) [dye free; contains propylene glycol; cherry flavor]

Tylenol® Infant's Concentrated: 80 mg/0.8 mL (15 mL, 30 mL) [ethanol free; contains sodium benzoate; cherry flavor]

Tylenol® Infant's Concentrated: 80 mg/0.8 mL (15 mL, 30 mL) [ethanol free; contains sodium benzoate; grape flavor]

Syrup, oral:

Triaminic™ Children's Fever Reducer Pain Reliever: 160 mg/5 mL (118 mL) [contains benzoic acid, sodium 6 mg/5 mL; bubblegum flavor]

Triaminic™ Children's Fever Reducer Pain Reliever: 160 mg/5 mL (118 mL) [contains sodium 5 mg/5 mL, sodium benzoate; grape flavor]

Tablet, oral: 325 mg, 500 mg

Aspirin Free Anacin® Extra Strength: 500 mg

Cetafen®: 325 mg

Mapap®: 325 mg

Tylenol®: 325 mg

Valorin: 325 mg [sugar free]

Valorin Extra: 500 mg [sugar free]

Tablet, chewable, oral: 80 mg

Mapap® Children's: 80 mg [fruit flavor]

Tablet, orally disintegrating, oral:

Mapap® Children's: 80 mg [bubblegum flavor]

Mapap® Children's: 80 mg [grape flavor]

Mapap® Junior Rapid Tabs: 160 mg [bubblegum flavor]

Tylenol® Children's Meltaways: 80 mg [scored; bubblegum flavor]

Tylenol® Children's Meltaways: 80 mg [scored; grape flavor]

Tylenol® Jr. Meltaways: 160 mg [bubblegum flavor]

Tylenol® Jr. Meltaways: 160 mg [grape flavor]

Pricing: U.S. (www.drugstore.com)

Tablet, controlled release (Tylenol 8 Hour)

650 mg (50): $17.99

Tablet, controlled release (Tylenol Arthritis Pain)

650 mg (100): $22.99

Tablets (Tylenol)

325 mg (100): $17.99

References

American Academy of Pediatrics Committee on Drugs, "Acetaminophen Toxicity in Children,” Pediatrics, 2001, 108(4):1020-4.

American Academy of Pediatrics Committee on Drugs, "Transfer of Drugs and Other Chemicals Into Human Milk," Pediatrics, 2001, 108(3):776-89.

Anderson PO, Sauberan JB, Lane JR, et al, “Hydrocodone Excretion Into Breast Milk: The First Two Reported Cases,” Breastfeed Med, 2007, 2(1):10-4.

Antlitz AM, Mead JA Jr, and Tolentino MA, “Potentiation of Oral Anticoagulant Therapy by Acetaminophen,” Curr Ther Res Clin Exp, 1968, 10(10):501-7.

Bagheri H, Bernhard NB, and Montastruc JL, “Potentiation of the Acenocoumarol Anticoagulant Effect by Acetaminophen,” Ann Pharmacother, 1999, 33(4):506.

Barker JD Jr, de Carle DJ, and Anuras S, “Chronic Excessive Acetaminophen Use in Liver Damage,” Ann Intern Med, 1977, 87(3):299-301.

Bartle WR and Blakely JA, “Potentiation of Warfarin Anticoagulation by Acetaminophen,” JAMA, 1991, 265(10):1260.

Birmingham PK, Tobin MJ, Fisher DM, et al, “Initial and Subsequent Dosing of Rectal Acetaminophen in Children: A 24-Hour Pharmacokinetic Study of New Dose Recommendations,” Anesthesiology, 2001, 94(3):385-9.

Boeijinga JJ, Boerstra EE, Ris P, et al, “Interaction Between Paracetamol and Coumarin Anticoagulants,” Lancet, 1982, 1(8270):506.

Brackett CC and Bloch JD, “Phenytoin as a Possible Cause of Acetaminophen Hepatotoxicity: Case Report and Review of the Literature,” Pharmacotherapy, 2000, 20(2):229-33.

Bradley JD, Brandt KD, Katz BP, et al, “Comparison of an Antiinflammatory Dose of Ibuprofen, an Analgesic Dose of Ibuprofen, and Acetaminophen in the Treatment of Patients With Osteoarthritis of the Knee,” N Engl J Med, 1991, 325(2):87-91.

Buck ML, “Perioperative Use of High-Dose Rectal Acetaminophen,” Pediatr Pharmacol (New York), 2001, 7(9). Available at http://www.medscape.com/viewarticle/415082_2

Burkhart KK, Janco N, Kulig KW, et al, “Cimetidine as Adjunctive Treatment for Acetaminophen Overdose,” Hum Exp Toxicol, 1995, 14(3):299-304.

Clissold SP, “Paracetamol and Phenacetin,” Drugs, 1986, 32(Suppl 4):46-59.

Dionne RA, Campbell RA, Cooper SA, et al, “Suppression of Postoperative Pain by Preoperative Administration of Ibuprofen in Comparison to Placebo, Acetaminophen, and Acetaminophen Plus Codeine,” J Clin Pharmacol, 1983, 23(1):37-43.

“Drugs for Pain,” Med Lett Drugs Ther, 2000, 42(1085):73-8.

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Gadisseur AP, Van Der Meer FJ, and Rosendaal FR, “Sustained Intake of Paracetamol (Acetaminophen) During Oral Anticoagulant Therapy With Coumarins Does Not Cause Clinically Important INR Changes: A Randomized Double-Blind Clinical Trial,” J Thromb Haemost, 2003, 1(4):714-7.

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International Brand Names

  • A-Mol (TH)
  • Acamol (CN, IL)
  • Acamol To-Go (IL)
  • Acamoli Baby (IL)
  • Acamoli Forte suppositories for Kids (IL)
  • Acet (PH)
  • ACET suppositories (SG)
  • Acetalgin (CH)
  • Acetamol (IT)
  • Adinol (MX)
  • Adorem (CO)
  • Afebrin (HK)
  • Afebryl (LU)
  • Alcocin (IN)
  • Alginox (EC)
  • Alvedon (SE)
  • Amol (AE, BH, CY, EG, IQ, IR, JO, KW, LB, LY, OM, QA, SA, SY, YE)
  • Analgiser (AE, BH, CY, EG, IQ, IR, JO, KW, LB, LY, OM, QA, SA, SY, YE)
  • Analphen (MX)
  • Angela (TH)
  • Aptamol (IN)
  • Arfen (BF, BJ, CI, ET, GH, GM, GN, KE, LR, ML, MR, MU, MW, MY, NE, NG, SC, SD, SL, SN, TN, TZ, UG, ZM, ZW)
  • Atamel (PE)
  • Avadol (MY)
  • Ben-U-Ron (CH, PT)
  • ben-u-ron (HU)
  • Benuron (JP)
  • Biogesic (PH, SG)
  • Biogesic Suspension (HK)
  • Biopain (PH)
  • Calapol (ID)
  • Calpol (AE, BF, BH, BJ, CI, CY, EG, ET, GH, GM, GN, IE, IQ, IR, JO, JP, KE, KW, LB, LR, LY, ML, MR, MU, MW, NE, NG, OM, PR, QA, SA, SC, SD, SL, SN, SY, TH, TN, TZ, UG, YE, ZM, ZW)
  • Causalon (AR)
  • Cemol (TH)
  • Cetta (TH)
  • Children's S Tylenol (KP)
  • Christamol (HK)
  • Claradol (MA)
  • Cotemp (TH)
  • Croix Blanche (LU)
  • Curpol (LU)
  • Dafalgan (BE, LU)
  • Dafalgan odis (LU)
  • Daga (TH)
  • Denamol (TH)
  • Dirox (AR)
  • Dismifen (MX)
  • Dol-Stop (LU)
  • Dolan Infantil (GT, HN, NI, SV)
  • Dolex (UY)
  • Dolgesic (ES)
  • Doliprane (FR, IN, MA)
  • Dolitabs (FR)
  • Dolomol (AE, BH, CY, EG, IQ, IR, JO, KW, LB, LY, OM, QA, SA, SY, YE)
  • Dolorol (ZA)
  • Dolprone (LU)
  • Doluvital (MX)
  • Dolviran (MX)
  • Dymadon (AU)
  • Efferalgan (HU, LU)
  • Efferalgan 500 (CR, DO, EE, GT, HN, NI, PA, SV)
  • Efferalganodis (FR)
  • Enelfa (LU)
  • Europain (HK)
  • Febridol (AU)
  • Fervex (BR)
  • Filanc (MX)
  • Gelocatil (ES)
  • Geluprane 500 (FR)
  • Hedex (IE)
  • Hoemal (MY, SG)
  • Lekadol (HR)
  • Lemgrip (BE, LU)
  • Lonarid mono (LU)
  • Lotemp (TH)
  • Lupocet (HR)
  • Mebinol (PE)
  • Mejoralito Junior (MX)
  • Mejoralito Pediátrico (MX)
  • Metagesic (PH)
  • Mexalen (AT, CZ, HU)
  • Minopan (KP)
  • Momentum (LU)
  • Mypara (TH)
  • Nalgesik (ID)
  • Napafen (EC)
  • Napamol (ZA)
  • Napran (PH)
  • Naprex (ID)
  • NEBS (JP)
  • Neuridon (LU)
  • Nordinet Infantil (MX)
  • Pacimol (IN)
  • Pamol (DK, NZ)
  • Panadol (AE, BE, BF, BG, BH, BJ, CH, CI, CN, CY, CZ, EE, EG, ET, FI, FR, GB, GH, GM, GN, GR, HK, HU, ID, IE, IQ, IR, IT, JO, KE, KP, KW, LB, LR, LU, LY, ML, MR, MU, MW, NE, NG, NL, OM, PK, PL, QA, RU, SA, SC, SD, SL, SN, SY, TH, TN, TW, TZ, UG, UY, YE, ZM, ZW)
  • Panadol Actifast (MY, SG)
  • Panadon (HR)
  • Panamax (AU)
  • Panodil (DK, NO, SE)
  • Paracet (NO)
  • Paracetamol (HR)
  • Paracetamol Pharmavit (HU)
  • Paracetamol-ratiopharm (LU)
  • Parageniol (PY)
  • Paragin (TH)
  • Paramidol (PE)
  • Paramol (IL, TW)
  • Paramol Kat Drops (IL)
  • Parapaed (DE)
  • Parapaed Junior (NZ)
  • Parapaed Six Plus (NZ)
  • Parcemol (HK)
  • Parcemol Forte (HK)
  • Parvid (PH)
  • Paximol (SG)
  • Pe-Tam (LU)
  • Pedipan (KP)
  • Penral-Night (KP)
  • Perdolan Mono (LU)
  • Pharmacen-M (MX)
  • Pinex (NO)
  • Plicet (HR)
  • Poro (MY, PH, SG)
  • Raperon (KP)
  • Rapidol (CN)
  • Reliv (SE)
  • Remedol (PR)
  • Revanin (BF, BJ, CI, ET, GH, GM, GN, KE, LR, ML, MR, MU, MW, NE, NG, SC, SD, SL, SN, TN, TZ, UG, ZM, ZW)
  • Rhinapen elixir (KP)
  • Rubophen (HU)
  • Salzone (BF, BJ, CI, ET, GH, GM, GN, KE, LR, ML, MR, MU, MW, NE, NG, SC, SD, SL, SN, TN, TZ, UG, ZM, ZW)
  • Saridon (CO)
  • Sedalito (MX)
  • Selegesic (PH)
  • Sensamol (IL)
  • Serimol (HK)
  • Setopain (KP)
  • Setopain ER (KP)
  • Sinedol (DO, MX)
  • Supadol mono (LU)
  • Suspen ER (KP)
  • Tasmen (KP)
  • Tempol (MY)
  • Tempra (EC, ID, JP, LU, MX, TH)
  • Teramol (PH)
  • Teramol Forte (PH)
  • Toniker (TW)
  • Turpan (ID)
  • Tylenol (BR, CH, DE, JP, KP, MX, PH, PT, TH, VE)
  • Tylenol 8-hour (TH)
  • Tylenol Acetaminophen Extended Relief (CL)
  • Tylenol Extra Fuerte (PY)
  • Tylenol Forte (AE, BH, CY, EG, IQ, IR, JO, KW, LB, LY, OM, QA, SA, SY, YE)
  • Tylex (BB, BM, BS, BZ, GY, JM, MX, SR, TT)
  • Winadol (CO, VE)
  • Xebramol (TH)
  • XL-Dol Infantil (MX)

Lexi-Comp.com

Last full review/revision May 2011

Content last modified May 2011

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