Medication Guide App

Acetaminophen (Systemic)



INN:

Paracetamol

VA CLASSIFICATION
Primary: CN103
Secondary: CN850


Note: For information on acetaminophen combinations that are used for antacid as well as analgesic effects, see Acetaminophen, Sodium Bicarbonate, and Citric Acid (Systemic) .

Commonly used brand name(s): Abenol; Aceta Elixir; Aceta Tablets; Acetaminophen Uniserts; Actamin; Actamin Extra; Actamin Super; Actimol Chewable Tablets; Actimol Children's Suspension; Actimol Infants' Suspension; Actimol Junior Strength Caplets; Aminofen; Aminofen Max; Anacin-3; Anacin-3 Extra Strength; Apacet Capsules; Apacet Elixir; Apacet Extra Strength Caplets; Apacet Extra Strength Tablets; Apacet Regular Strength Tablets; Apacet, Infants; Apo-Acetaminophen; Aspirin Free Anacin Maximum Strength Caplets; Aspirin Free Anacin Maximum Strength Gel Caplets; Aspirin Free Anacin Maximum Strength Tablets; Aspirin-Free Excedrin Caplets; Atasol Caplets; Atasol Drops; Atasol Forte Caplets; Atasol Forte Tablets; Atasol Oral Solution; Atasol Tablets; Banesin; Bayer Select Maximum Strength Headache Pain Relief Formula; Dapa; Dapa X-S; Datril Extra-Strength; Excedrin Caplets; Excedrin Extra Strength Caplets; Exdol; Exdol Strong; Feverall Junior Strength; Feverall Sprinkle Caps Junior Strength; Feverall Sprinkle Caps, Children's; Feverall, Children's; Feverall, Infants"; Genapap Children's Elixir; Genapap Children's Tablets; Genapap Extra Strength Caplets; Genapap Extra Strength Tablets; Genapap Regular Strength Tablets; Genapap, Infants; Genebs Extra Strength Caplets; Genebs Regular Strength Tablets; Genebs X-Tra; Liquiprin Children's Elixir; Liquiprin Infants" Drops; Neopap; Oraphen-PD; Panadol; Panadol Extra Strength; Panadol Junior Strength Caplets; Panadol Maximum Strength Caplets; Panadol Maximum Strength Tablets; Panadol, Children's; Panadol, Infants; Phenaphen Caplets; Redutemp; Robigesic; Rounox; Snaplets-FR; St. Joseph Aspirin-Free Fever Reducer for Children; Suppap-120; Suppap-325; Suppap-650; Tapanol Extra Strength Caplets; Tapanol Extra Strength Tablets; Tempra; Tempra Caplets; Tempra Chewable Tablets; Tempra D.S; Tempra Drops; Tempra Syrup; Tempra, Infants; Tylenol Arthritis Extended Relief; Tylenol Caplets; Tylenol Children's Chewable Tablets; Tylenol Children's Elixir; Tylenol Children's Suspension Liquid; Tylenol Drops; Tylenol Elixir; Tylenol Extra Strength Adult Liquid Pain Reliever; Tylenol Extra Strength Caplets; Tylenol Extra Strength Gelcaps; Tylenol Extra Strength Tablets; Tylenol Gelcaps; Tylenol Infants Drops; Tylenol Infants" Suspension Drops; Tylenol Junior Strength Caplets; Tylenol Junior Strength Chewable Tablets; Tylenol Regular Strength Caplets; Tylenol Regular Strength Tablets; Tylenol Tablets; Valorin; Valorin Extra.

Other commonly used names are
APAP and paracetamol .
Note: For a listing of dosage forms and brand names by country availability, see Dosage Forms section(s).



Category:


Analgesic—

antipyretic—

Indications

Accepted

Pain (treatment);
Pain, arthritic, mild (treatment); or
Fever (treatment)—Acetaminophen is indicated to relieve mild to moderate pain and reduce fever. It provides symptomatic relief only; additional therapy to treat the cause of the pain or fever should be instituted when necessary.
—Acetaminophen has minimal anti-inflammatory activity and does not relieve redness, swelling, or stiffness due to arthritis; it cannot be used in place of aspirin or other salicylates or other nonsteroidal anti-inflammatory drugs (NSAIDs) in the treatment of rheumatoid arthritis. However, it may be used to relieve pain due to mild osteoarthritis.
—Acetaminophen may be used when aspirin therapy is contraindicated or inadvisable, e.g., in patients receiving anticoagulants or uricosuric agents, patients with hemophilia or other bleeding problems, and those with upper gastrointestinal disease or intolerance or hypersensitivity to aspirin. However, chronic, high-dose acetaminophen therapy may require adjustment of anticoagulant dosage based on increased monitoring of prothrombin time in patients receiving a coumarin- or indandione-derivative anticoagulant.

Note: The FDA has proposed that caffeine (present as an analgesic adjuvant in some products) be classified as a Category III ingredient (i.e., lacking documentation of efficacy) in OTC products containing acetaminophen as the sole analgesic/antipyretic agent {07}.



Pharmacology/Pharmacokinetics

Physicochemical characteristics:
Molecular weight—
    151.16

Mechanism of action/Effect:


For acetaminophen:


Analgesic—

The mechanism of analgesic action has not been fully determined. Acetaminophen may act predominantly by inhibiting prostaglandin synthesis in the central nervous system (CNS) and, to a lesser extent, through a peripheral action by blocking pain-impulse generation. The peripheral action may also be due to inhibition of prostaglandin synthesis or to inhibition of the synthesis or actions of other substances that sensitize pain receptors to mechanical or chemical stimulation.



Antipyretic—

Acetaminophen probably produces antipyresis by acting centrally on the hypothalamic heat-regulating center to produce peripheral vasodilation resulting in increased blood flow through the skin, sweating, and heat loss. The central action probably involves inhibition of prostaglandin synthesis in the hypothalamus.




For caffeine:

Caffeine is a mild CNS stimulant. Caffeine-induced constriction of cerebral blood vessels, which leads to a decrease in cerebral blood flow and in the oxygen tension of the brain, may contribute to relief of some types of headache. {08}

It has been suggested that the addition of caffeine to acetaminophen may provide a more rapid onset of action and/or enhanced pain relief with lower doses of the analgesic. However, the FDA has determined that studies performed to date have not demonstrated that caffeine is an effective analgesic adjuvant or that it does not interfere with acetaminophen's efficacy as an antipyretic. {09}


Absorption:

Oral—Rapid and almost complete; may be decreased if acetaminophen is taken following a high-carbohydrate meal.

Rectal—The rate and extent of absorption from the suppository dosage form may vary, depending on the composition of the base.

Distribution:

In breast milk—Peak concentrations of 10 to 15 mcg per mL (66.2 to 99.3 micromoles/L) have been measured 1 to 2 hours following maternal ingestion of a single 650-mg dose. The half-life in breast milk is 1.35 to 3.5 hours.

Protein binding:

Not significant with doses producing plasma concentrations below 60 mcg per mL (397.2 micromoles/L); may reach moderate levels with high or toxic doses.

Biotransformation:

Approximately 90 to 95% of a dose is metabolized in the liver, primarily by conjugation with glucuronic acid, sulfuric acid, and cysteine. An intermediate metabolite, which may accumulate in overdosage after the primary metabolic pathways become saturated, is hepatotoxic and possibly nephrotoxic.

Half-life:

1 to 4 hours; does not change with renal failure but may be prolonged in acute overdosage, in some forms of hepatic disease, in the elderly, and in the neonate; may be somewhat shortened in children.

Time to peak concentration:

0.5 to 2 hours

Peak plasma concentration

5 to 20 mcg per mL (33.1 to 132.4 micromoles/L), with doses up to 650 mg.

Time to peak effect:

1 to 3 hours

Duration of action:

3 to 4 hours

Elimination:
    Renal, as metabolites, primarily conjugates; 3% of a dose may be excreted unchanged.


In dialysis—
        Hemodialysis: 120 mL per minute (for unmetabolized drug); metabolites are also cleared rapidly.
        Hemoperfusion: 200 mL per minute.
        Peritoneal dialysis: <10 mL per minute.



Precautions to Consider

Cross-sensitivity and/or related problems

Patients sensitive to aspirin may not be sensitive to acetaminophen; however, mild bronchospastic reactions with acetaminophen have been reported in some aspirin-sensitive asthmatics (less than 5% of those tested).

Pregnancy/Reproduction
Fertility—
Chronic toxicity studies in animals have shown that high doses of acetaminophen cause testicular atrophy and inhibition of spermatogenesis; the relevance of this finding to use in humans is not known.

Pregnancy—
Problems in humans have not been documented. Although controlled studies have not been done, it has been shown that acetaminophen crosses the placenta.

Breast-feeding

Problems in humans have not been documented. Although peak concentrations of 10 to 15 mcg per mL (66.2 to 99.3 micromoles/L) have been measured in breast milk 1 to 2 hours following maternal ingestion of a single 650-mg dose, neither acetaminophen nor its metabolites were detected in the urine of the nursing infants. The half-life in breast milk is 1.35 to 3.5 hours.

Pediatrics

Studies performed to date have not demonstrated pediatrics-specific problems that would limit the usefulness of acetaminophen in children. However, some products intended for pediatric use contain aspartame, which is metabolized to phenylalanine, and must be used with caution, if at all, in children with phenylketonuria.


Geriatrics


Appropriate studies performed to date have not demonstrated geriatrics-specific problems that would limit the usefulness of acetaminophen in the elderly.

Drug interactions and/or related problems
The following drug interactions and/or related problems have been selected on the basis of their potential clinical significance (possible mechanism in parentheses where appropriate)—not necessarily inclusive (» = major clinical significance):


Note: Combinations containing any of the following medications, depending on the amount present, may also interact with this medication.


For acetaminophen
» Alcohol, especially chronic abuse of or
Hepatic enzyme inducers (See Appendix II) or
Hepatotoxic medications, other (See Appendix II)    (risk of hepatotoxicity with single toxic doses or prolonged use of high doses of acetaminophen may be increased in alcoholics or in patients regularly taking other hepatotoxic medications or hepatic enzyme inducers)

    (chronic use of barbiturates [except butalbital] or primidone has been reported to decrease the therapeutic effects of acetaminophen, probably because of increased metabolism resulting from induction of hepatic microsomal enzyme activity; the possibility should be considered that similar effects may occur with other hepatic enzyme inducers)


Anticoagulants, coumarin- or indandione-derivative    (concurrent chronic, high-dose administration of acetaminophen may increase the anticoagulant effect, possibly by decreasing hepatic synthesis of procoagulant factors; anticoagulant dosage adjustment based on increased monitoring of prothrombin time may be necessary when chronic, high-dose acetaminophen therapy is initiated or discontinued; however, this does not apply to occasional use, or to chronic use of doses below 2 grams per day, of acetaminophen)


Anti-inflammatory drugs, nonsteroidal (NSAIDs) or
Aspirin or other salicylates    (prolonged concurrent use of acetaminophen and a salicylate is not recommended because recent evidence suggests that chronic, high-dose administration of the combined analgesics [1.35 grams daily, or cumulative ingestion of 1 kg annually, for 3 years or longer] significantly increases the risk of analgesic nephropathy, renal papillary necrosis, end-stage renal disease, and cancer of the kidney or urinary bladder; also, it is recommended that for short-term use, the combined dose of acetaminophen plus salicylate not exceed that recommended for acetaminophen or a salicylate given alone)

    (prolonged concurrent use of acetaminophen and NSAIDs other than aspirin may also increase the risk of adverse renal effects; it is recommended that patients be under close medical supervision while receiving such combined therapy)

    (diflunisal may increase the plasma concentration of acetaminophen by 50%, leading to increased risk of acetaminophen-induced hepatotoxicity)


For formulations containing caffeine (in addition to those interactions listed above)
CNS stimulation-producing medications, other (See Appendix II)    (concurrent use with caffeine may result in excessive CNS stimulation, leading to unwanted effects such as nervousness, irritability, insomnia, or possibly convulsions or cardiac arrhythmias; close observation is recommended)


Lithium    (caffeine increases urinary excretion of lithium, and may thereby reduce its therapeutic effect)


Monoamine oxidase (MAO) inhibitors, including furazolidone, procarbazine, and selegiline    (the sympathomimetic side effects of caffeine may produce dangerous cardiac arrhythmias or severe hypertension when large doses of caffeine are used concurrently with MAO inhibitors)



Laboratory value alterations
The following have been selected on the basis of their potential clinical significance (possible effect in parentheses where appropriate)—not necessarily inclusive (» = major clinical significance):

With diagnostic test results
Glucose, blood, determinations    (acetaminophen may cause falsely decreased values when the glucose oxidase/peroxidase method is used, but probably not when the hexokinase/glucose-6-phosphate dehydrogenase [G6PD] method is used)

    (values may be falsely increased when certain instruments are used in glucose analysis if high acetaminophen concentrations are present; instrument manufacturer's instruction manual should be consulted)


5-Hydroxyindoleacetic acid (5-HIAA), serum, determinations    (acetaminophen may cause false-positive results in qualitative screening tests using nitrosonaphthol reagent; the quantitative test is unaffected)


Myocardial perfusion imaging, radionuclide, when adenosine or dipyridamole is used as an adjunct to the radiopharmaceutical    (the caffeine in specific formulations may reverse the effects of adenosine {16} or dipyridamole {17} on myocardial blood flow, thereby interfering with test results; patients should be advised to avoid caffeine for 8 to 12 hours prior to the test)


Pancreatic function test using bentiromide    (administration of acetaminophen prior to the bentiromide test will invalidate test results because acetaminophen is also metabolized to an arylamine and will thus increase the apparent quantity of para-aminobenzoic acid [PABA] recovered; it is recommended that acetaminophen be discontinued at least 3 days prior to administration of bentiromide)


Uric acid, serum, determinations    (acetaminophen may cause falsely increased values when the phosphotungstate uric acid test method is used)

With physiology/laboratory test values
Bilirubin concentrations, serum and
Lactate dehydrogenase activity, serum and
Prothrombin time and
Transaminase activity, serum    (may be increased, indicating hepatotoxicity, especially in alcoholics, patients taking other hepatic enzyme inducers, or patients with pre-existing hepatic disease, when single toxic doses [> 8 to 10 grams] of acetaminophen are taken or with prolonged use of lower doses [> 3 to 5 grams a day])


Medical considerations/Contraindications
The medical considerations/contraindications included have been selected on the basis of their potential clinical significance (reasons given in parentheses where appropriate)— not necessarily inclusive (» = major clinical significance).


Risk-benefit should be considered when the following medical problems exist
» Alcoholism, active or
» Hepatic disease or
» Viral hepatitis    (increased risk of hepatotoxicity)


Phenylketonuria    (products that contain aspartame, which is metabolized to phenylalanine, may be hazardous to patients with phenylketonuria, especially young children; caution is recommended)


Renal function impairment, severe    (risk of adverse renal effects may be increased with prolonged use of high doses; occasional use is acceptable)


Sensitivity to acetaminophen or aspirin    (increased risk of allergic reaction)



Patient monitoring
The following may be especially important in patient monitoring (other tests may be warranted in some patients, depending on condition; » = major clinical significance):

Hepatic function determinations    (may be required at periodic intervals during high-dose or long-term therapy, especially in patients with pre-existing hepatic disease)




Side/Adverse Effects
The following side/adverse effects have been selected on the basis of their potential clinical significance (possible signs and symptoms in parentheses where appropriate)—not necessarily inclusive:

Those indicating need for medical attention
Incidence rare
    
Agranulocytosis (fever with or without chills ; sores, ulcers or white spots on lips or in mouth; sore throat)
    
anemia (unusual tiredness or weakness)
    
dermatitis, allergic (skin rash, hives or, itching)
    
hepatitis (yellow eyes or skin)
    
renal colic (pain, severe and/or sharp, in lower back and/or side)—with prolonged use of high doses in patients with severe renal function impairment
    
renal failure (sudden decrease in amount of urine)
    
sterile pyuria (cloudy urine)
    
thrombocytopenia (rarely, unusual bleeding or bruising; black, tarry stools; blood in urine or stools; pinpoint red spots on skin)—usually asymptomatic

Note: Acetaminophen-induced renal function impairment may be sufficiently severe to result in uremia, especially with prolonged use of high doses in patients with pre-existing renal impairment {01}. Also, although a causal association has not been established, a retrospective study has suggested that long-term daily use of acetaminophen may be associated with an increased risk of chronic renal failure (analgesic nephropathy) in individuals without pre-existing renal function impairment {09} {10}.






Overdose
For specific information on the agents used in the management of acetaminophen overdose, see:    • Acetylcysteine (Systemic) monograph; and/or
   • Charcoal, Activated (Oral-Local) monograph.


For more information on the management of overdose or unintentional ingestion, contact a Poison Control Center (see Poison Control Center Listing).

Clinical effects of overdose
The following effects have been selected on the basis of their potential clinical significance (possible signs and symptoms in parentheses where appropriate)—not necessarily inclusive:
Acute
    
Gastrointestinal upset (diarrhea, loss of appetite, nausea or vomiting, stomach cramps or pain)
    
increased sweating


Note: Although gastrointestinal upset and increased sweating often do not occur, they sometimes occur within 6 to 14 hours after ingestion of an overdose and persist for about 24 hours.


Chronic
    
Hepatotoxicity (pain, tenderness, and/or swelling in upper abdominal area)—may occur 2 to 4 days after the overdose is ingested

Note: The first indications of overdosage may be signs and symptoms of possible liver damage and abnormalities in liver function tests, which may not occur until 2 to 4 days after ingestion of the overdose. Maximal changes in liver function tests usually occur 3 to 5 days after ingestion of the overdose.
Overt hepatic disease or failure may occur 4 to 6 days after ingestion of the overdose. Hepatic encephalopathy (with mental changes, confusion, agitation, or stupor), convulsions, respiratory depression, coma, cerebral edema, coagulation defects, gastrointestinal bleeding, disseminated intravascular coagulation, hypoglycemia, metabolic acidosis, cardiac arrhythmias, and cardiovascular collapse may occur.
Renal tubular necrosis leading to renal failure (signs may include bloody or cloudy urine and sudden decrease in amount of urine) has also been reported in acetaminophen overdose, usually, but not exclusively, in conjunction with acetaminophen-induced hepatotoxicity.



Treatment of overdose
To decrease absorption—May include emptying the stomach via induction of emesis or gastric lavage.

Removing activated charcoal (if used) by gastric lavage may be advisable. Although activated charcoal is recommended in cases of mixed drug overdose, it may interfere with absorption of orally administered acetylcysteine (antidote used to protect against acetaminophen-induced hepatotoxicity) and decrease its efficacy.

To enhance elimination—Instituting hemodialysis or hemoperfusion to remove acetaminophen from the circulation may be beneficial if acetylcysteine administration cannot be instituted within 24 hours following ingestion of a massive acetaminophen overdose. However, the efficacy of such treatment in preventing acetaminophen-induced hepatotoxicity is not known.

Specific treatment—Use of acetylcysteine. It is recommended that acetylcysteine administration be instituted as soon as possible after ingestion of an overdose has been reported, without waiting for the results of plasma acetaminophen determinations or other laboratory tests. Acetylcysteine is most effective if treatment is started within 10 to 12 hours after ingestion of the overdose; however it may be of some benefit if treatment is started within 24 hours. See the package insert or Acetylcysteine (Systemic) monograph for specific dosing guidelines for use of this product.

Monitoring—May include determining plasma acetaminophen concentration at least 4 hours following ingestion of the overdose. Determinations performed prior to this time are not reliable for assessing potential hepatotoxicity. Initial plasma concentrations above 150 mcg per mL (993 micromoles/L) at 4 hours, 100 mcg per mL (662 micromoles/L) at 6 hours, 70 mcg per mL (463.4 micromoles/L) at 8 hours, 50 mcg per mL (331 micromoles/L) at 10 hours, 20 mcg per mL (132.4 micromoles/L) at 15 hours, 8 mcg per mL (53 micromoles/L) at 20 hours, or 3.5 mcg per mL (23.2 micromoles/L) at 24 hours postingestion indicate possible hepatotoxicity and the need for completing the full course of acetylcysteine treatment. If the initial determination indicates a plasma concentration below those listed at the times indicated, cessation of acetylcysteine therapy can be considered. However, some clinicians advise that more than one determination should be performed to ascertain peak absorption and half-life of acetaminophen prior to considering discontinuation of acetylcysteine.

Performing liver function tests (serum aspartate aminotransferase [AST; SGOT], serum alanine aminotransferase [ALT; SGPT], prothrombin time, and bilirubin) at 24-hour intervals for at least 96 hours postingestion if the plasma acetaminophen concentration indicates potential hepatotoxicity. If no abnormalities are detected within 96 hours, further determinations are not needed.

Monitoring renal and cardiac function and administering appropriate therapy as required.

Supportive care—May include maintaining fluid and electrolyte balance, correcting hypoglycemia, and administering vitamin K 1 (if prothrombin time ratio exceeds 1.5) and fresh frozen plasma or clotting factor concentrate (if prothrombin time ratio exceeds 3.0). Patients in whom intentional overdose is known or suspected should be referred for psychiatric consultation.


Patient Consultation
As an aid to patient consultation, refer to Advice for the Patient, Acetaminophen (Systemic).

In providing consultation, consider emphasizing the following selected information (» = major clinical significance):

Before using this medication
»   Conditions affecting use, especially:
Sensitivity to acetaminophen or aspirin





Use in children—Aspartame-containing chewable tablets must be used with caution, if at all, in children with phenylketonuria

Other medical problems, especially alcoholism (active), hepatic disease, or viral hepatitis

Proper use of this medication
» Importance of not taking more medication than the amount recommended because acetaminophen may cause kidney or liver damage with long-term use or greater-than-recommended doses

» Unless otherwise directed by physician, children should not receive more than 5 doses per day {09}
»
Proper administration of:
Acetaminophen oral granules

Acetaminophen oral powders

Acetaminophen suppositories

» Proper dosing

» Proper storage

Precautions while using this medication
Regular visits to physician to check progress if long-term therapy is prescribed

Checking with physician because additional treatment may be needed:

   —if taking for pain, including arthritic pain, and pain persists for longer than 10 days for adults or 5 days for children, condition becomes worse, new symptoms occur, or the painful area is red or swollen {09}
   —if taking for fever, and fever persists for longer than 3 days, condition becomes worse, or new symptoms occur {09}
   —if taking for sore throat, and sore throat is severe, persists for longer than 2 days, or occurs together with or is followed by fever, headache, rash, nausea, or vomiting {09}


» Risk of overdose if other medications containing acetaminophen are used

» Avoiding use of alcohol if taking more than an occasional 1 or 2 doses of this medication; increased risk of liver toxicity, especially in alcoholics, with high doses or prolonged use

Not using a salicylate or a nonsteroidal anti-inflammatory drug together with acetaminophen for more than a few days, unless directed by physician

Possible interference with some laboratory tests; preferably discussing use of the medication with physician in charge 3 to 4 days ahead of time; if this is not possible, informing physician in charge if acetaminophen taken within the past 3 or 4 days

Diabetics: Possible false results with blood glucose tests; checking with physician, nurse, or pharmacist if changes in test results noted

Not taking caffeine-containing formulations for 8 to 12 hours prior to adenosine- or dipyridamole-assisted myocardial perfusion imaging test

» Suspected overdose: Getting emergency help at once even if no symptoms apparent; symptoms of severe overdosage may be delayed, but treatment must be begun as soon as possible; treatment started 24 hours or more after the overdose may be ineffective in preventing liver damage or fatality


Side/adverse effects
Signs and symptoms of potential side effects, especially adverse renal effects, allergic dermatitis, hepatotoxicity, agranulocytosis, and thrombocytopenia


General Dosing Information
The doses are based on the FDA's proposed labeling requirements for over-the-counter (OTC) internal analgesic, antipyretic, and antirheumatic products. The dosage unit of 80 mg (1.23 grains) is used for pediatric doses; the dosage unit of 325 mg (5 grains) is used for adult doses. The conversion factor of 1 grain equal to 65 mg is used. The doses recommended by manufacturers of individual products, and the strengths of individual products, may not conform to the recommended doses.

One retrospective study has suggested that long-term daily use of acetaminophen may be associated with an increased risk of chronic renal disease (analgesic nephropathy). The results of this study are not considered conclusive, and further investigation is required to establish a causal association. {10} However, until more definitive information is available, prolonged daily administration of acetaminophen should probably be limited to patients who are receiving appropriate medical supervision. {11}


Oral Dosage Forms

ACETAMINOPHEN CAPSULES USP

Usual adult and adolescent dose
Analgesic and
Antipyretic
Oral, 325 to 500 mg every three hours, 325 to 650 mg every four hours, 650 mg to 1 gram every six hours as needed, or 1300 mg every 8 hours {18}, while symptoms persist {09}.


Note: For patient self-medication, it is recommended that a physician be consulted if pain is not relieved within ten days, fever within three days, or sore throat within two days {09}.


Usual adult prescribing limits
Up to 4 grams daily{19}{20}

Usual pediatric dose
Analgesic and
Antipyretic
Oral, 1.5 grams per square meter of body surface a day in divided doses; or for

Infants up to 3 months of age—Oral, 40 mg every four hours as needed {05}.

Infants 4 to 12 months of age—Oral, 80 mg every four hours as needed {05}.

Children 1 to 2 years of age—Oral, 120 mg every four hours as needed {05}.

Children 2 to 4 years of age—Oral, 160 mg every four hours as needed, while symptoms persist {09}.

Children 4 to 6 years of age—Oral, 240 mg every four hours as needed, while symptoms persist {09}.

Children 6 to 9 years of age—Oral, 320 mg every four hours as needed, while symptoms persist {09}.

Children 9 to 11 years of age—Oral, 320 to 400 mg every four hours as needed, while symptoms persist {09}.

Children 11 to 12 years of age—Oral, 320 to 480 mg every four hours as needed, while symptoms persist {09}.


Note: It is recommended that children up to 12 years of age receive no more than five doses in each twenty-four-hour period, unless otherwise directed by a physician, and that a physician be consulted if pain is not relieved within five days, fever within three days, or sore throat within two days {09}.
Dosage recommendations for children younger than 2 years of age do not appear on OTC packaging {09}.
Administration of an individual product to a pediatric patient depends upon ability to achieve suitable dosage for the age of the child. Liquid dosage forms (oral solution or suspension), granules, powders, or chewable tablets are usually used.


Strength(s) usually available
U.S.—


325 mg (OTC)[Generic]


500 mg (OTC) [Apacet Capsules] [Dapa X-S][Generic]

Canada—
Not commercially available.

Packaging and storage:
Store below 40 °C (104 °F), preferably between 15 and 30 °C (59 and 86 °F), unless otherwise specified by manufacturer. Store in a tight container.

Auxiliary labeling:
   • Avoid alcoholic beverages.


ACETAMINOPHEN ORAL GRANULES {12}

Usual adult and adolescent dose
See Acetaminophen Capsules USP.

Usual pediatric dose
See Acetaminophen Capsules USP.

Strength(s) usually available
U.S.—


80 mg (in individual packets) (OTC) [Snaplets-FR]

Canada—
Not commercially available.

Packaging and storage:
Store below 40 °C (104 °F), preferably between 15 and 30 °C (59 and 86 °F), unless otherwise specified by manufacturer.

Preparation of dosage form:
Single dose—The contents of the packets are to be mixed with a small quantity of soft food, such as applesauce, ice cream, or jam immediately prior to ingestion.


ACETAMINOPHEN ORAL POWDERS {13}

Usual adult and adolescent dose
See Acetaminophen Capsules USP.

Usual pediatric dose
See Acetaminophen Capsules USP.

Strength(s) usually available
U.S.—


80 mg (in capsules) (OTC) [Feverall Sprinkle Caps, Children's]


160 mg (in capsules) (OTC) [Feverall Sprinkle Caps Junior Strength]

Canada—
Not commercially available.

Packaging and storage:
Store below 40 °C (104 °F), preferably between 15 and 30 °C (59 and 86 °F), unless otherwise specified by manufacturer.

Preparation of dosage form:
Single dose—The capsules are not intended to be swallowed whole. They are to be opened and the contents sprinkled over a small quantity (< 5 mL) of water or other liquid immediately prior to ingestion. {13} Alternatively, the contents of the capsules may be mixed with a small quantity of soft food, such as applesauce, ice cream, or jam, immediately prior to ingestion. {14}


ACETAMINOPHEN ORAL SOLUTION USP

Usual adult and adolescent dose
See Acetaminophen Capsules USP.

Usual adult prescribing limits
See Acetaminophen Capsules USP.

Usual pediatric dose
See Acetaminophen Capsules USP.

Strength(s) usually available
U.S.—


100 mg per mL (80 mg per 0.8-mL dropperful) (OTC) [Apacet, Infants] [Genapap, Infants] [Panadol, Infants] [St. Joseph Aspirin-Free Fever Reducer for Children] [Tempra, Infants] [Tylenol Infants Drops][Generic]


80 mg per 5 mL (OTC)[Generic]


120 mg per 5 mL (OTC) [Aceta Elixir (alcohol 7%)] [Oraphen-PD (alcohol 5%)][Generic]


130 mg per 5 mL (OTC)[Generic]


160 mg per 5 mL (OTC) [Apacet Elixir] [Genapap Children's Elixir] [Liquiprin Children's Elixir] [Panadol, Children's] [St. Joseph Aspirin-Free Fever Reducer for Children] [Tempra Syrup] [Tylenol Children's Elixir (sugar)][Generic]
Note: Also available generically in unit-dose cups containing 325 mg per 10.15 mL and 650 mg per 20.3 mL.




500 mg per 15 mL (OTC) [Tylenol Extra Strength Adult Liquid Pain Reliever (alcohol 7%)]

Canada—


80 mg per mL (OTC) [Atasol Drops] [Panadol] [Tempra Drops ( alcohol 10%)] [Tylenol Drops][Generic]


80 mg per 5 mL (OTC) [Atasol Oral Solution{03}] [Panadol (sodium )] [Robigesic (alcohol 8.5%)] [Tempra Syrup]


160 mg per 5 mL (OTC) [Tempra Syrup] [{15}Tylenol Elixir][Generic]

Note: The strengths of specific products may not conform to some of the recommended pediatric dosages.


Packaging and storage:
Store below 40 °C (104 °F), preferably between 15 and 30 °C (59 and 86 °F), unless otherwise specified by manufacturer. Store in a tight container. Protect from freezing.

Auxiliary labeling:
   • Avoid alcoholic beverages.


ACETAMINOPHEN ORAL SUSPENSION USP

Usual adult and adolescent dose
See Acetaminophen Capsules USP.

Usual pediatric dose
See Acetaminophen Capsules USP.

Strength(s) usually available
U.S.—


48 mg per mL (120 mg per 2.5-mL dropperful) (OTC) [Liquiprin Infants" Drops]


100 mg per mL (80 mL per 0.8-mL dropperful) (OTC) [Tylenol Infants" Suspension Drops{05}]


160 mg per 5 mL (OTC) [Tylenol Children's Suspension Liquid{05}]

Canada—


80 mg per mL (OTC) [Actimol Infants' Suspension{01}]


80 mg per 5 mL (OTC) [Actimol Children's Suspension{01}]

Packaging and storage:
Store below 40 °C (104 °F), preferably between 15 and 30 °C (59 and 86 °F), unless otherwise specified by manufacturer. Store in a tight container. Protect from freezing.

Auxiliary labeling:
   • Shake well.


ACETAMINOPHEN TABLETS USP

Usual adult and adolescent dose
See Acetaminophen Capsules USP.

Usual adult prescribing limits
See Acetaminophen Capsules USP.

Usual pediatric dose:
See Acetaminophen Capsules USP.

Strength(s) usually available
U.S.—


120 mg (OTC)[Generic]


160 mg (OTC) [Panadol Junior Strength Caplets] [Tylenol Junior Strength Caplets (scored)]


325 mg (OTC) [Aceta Tablets] [Actamin] [Aminofen] [Apacet Regular Strength Tablets] [Dapa] [Genapap Regular Strength Tablets] [Genebs Regular Strength Tablets] [Phenaphen Caplets] [Tylenol Arthritis Extended Relief (hydroxyethyl cellulose) ( hydroxypropyl methylcellulose) (magnesium stearate ) (microcrystalline cellulose) ( povidone) (cellulose (powdered)) ( pregelatinized starch) (sodium starch glycolate ) (titanium dioxide) ( triacetin)] [Tylenol Regular Strength Caplets] [Tylenol Regular Strength Tablets ( scored)] [Valorin][Generic]
Note: In Canada, Phenaphen is available as capsules containing aspirin (ASA) and phenobarbital.




500 mg (OTC) [Aceta Tablets] [Actamin Extra] [Aminofen Max] [Apacet Extra Strength Caplets] [Apacet Extra Strength Tablets] [Aspirin Free Anacin Maximum Strength Caplets] [{02}Aspirin Free Anacin Maximum Strength Gel Caplets] [{02}Aspirin Free Anacin Maximum Strength Tablets] [{02}Banesin] [Datril Extra-Strength] [Genapap Extra Strength Caplets] [Genapap Extra Strength Tablets] [Genebs Extra Strength Caplets] [Genebs X-Tra] [Panadol Maximum Strength Caplets] [Panadol Maximum Strength Tablets] [Redutemp] [Tapanol Extra Strength Caplets] [Tapanol Extra Strength Tablets] [Tylenol Extra Strength Caplets] [Tylenol Extra Strength Gelcaps] [Tylenol Extra Strength Tablets] [Valorin Extra][Generic]


650 mg (OTC)[Generic]

Canada—


160 mg (OTC) [Actimol Junior Strength Caplets (scored)] [{01}Tempra Caplets] [Tylenol Junior Strength Caplets]


325 mg (OTC) [Anacin-3] [Apo-Acetaminophen (scored)] [Atasol Caplets (scored)] [Atasol Tablets ( scored)] [Exdol (scored)] [Panadol] [Robigesic (scored)] [Rounox] [Tylenol Caplets] [Tylenol Tablets][Generic]


500 mg (OTC) [Anacin-3 Extra Strength] [Apo-Acetaminophen (scored)] [Atasol Forte Caplets] [Atasol Forte Tablets (scored )] [Exdol Strong (scored)] [Panadol Extra Strength] [Tylenol Caplets] [Tylenol Gelcaps] [Tylenol Tablets][Generic]

Packaging and storage:
Store below 40 °C (104 °F), preferably between 15 and 30 °C (59 and 86 °F), unless otherwise specified by manufacturer. Store in a tight container.

Auxiliary labeling:
   • Avoid alcoholic beverages.


ACETAMINOPHEN TABLETS (CHEWABLE) USP

Usual adult and adolescent dose
See Acetaminophen Capsules USP.

Usual pediatric dose
See Acetaminophen Capsules USP.

Strength(s) usually available
U.S.—


80 mg (OTC) [Genapap Children's Tablets] [Panadol, Children's (scored)] [St. Joseph Aspirin-Free Fever Reducer for Children] [Tempra] [Tylenol Children's Chewable Tablets ( scored)][Generic]


120 mg (OTC)[Generic]


160 mg (OTC) [Tempra D.S (scored)] [Tylenol Junior Strength Chewable Tablets (scored )]

Canada—


80 mg (OTC) [Actimol Chewable Tablets] [{01}Panadol (scored)] [Tempra Chewable Tablets] [Tylenol Children's Chewable Tablets ( scored)][Generic]


160 mg (OTC) [Tempra Chewable Tablets]

Packaging and storage:
Store below 40 °C (104 °F), preferably between 15 and 30 °C (59 and 86 °F), unless otherwise specified by manufacturer. Store in a tight container.

Auxiliary labeling:
   • Avoid alcoholic beverages.
   • May be chewed.


ACETAMINOPHEN AND CAFFEINE TABLETS USP

Usual adult and adolescent dose
See Acetaminophen Capsules USP. Dosage is based on acetaminophen only.

Usual adult prescribing limits
See Acetaminophen Capsules USP. Dosage is based on acetaminophen only.

Usual pediatric dose
See Acetaminophen Capsules USP. Dosage is based on acetaminophen only.

Strength(s) usually available
U.S.—


500 mg of acetaminophen and 65 mg of caffeine (OTC) [Aspirin-Free Excedrin Caplets] [Bayer Select Maximum Strength Headache Pain Relief Formula{04}]


500 mg of acetaminophen and 65.4 mg of caffeine (OTC) [Actamin Super]

Canada—


325 mg of acetaminophen and 65 mg of caffeine (OTC) [Excedrin Caplets]


500 mg of acetaminophen and 65 mg of caffeine (OTC) [Excedrin Extra Strength Caplets]

Note: In the U.S., Excedrin contains aspirin, in addition to acetaminophen and caffeine. See Acetaminophen and Salicylates (Systemic) . The U.S. product corresponding to the Canadian Excedrin formulation is Aspirin-Free Excedrin.


Packaging and storage:
Store below 40 °C (104 °F), preferably between 15 and 30 °C (59 and 86 °F), unless otherwise specified by manufacturer.

Auxiliary labeling:
   • Avoid alcoholic beverages.



Rectal Dosage Forms

ACETAMINOPHEN SUPPOSITORIES USP

Usual adult and adolescent dose
Analgesic and
Antipyretic
Rectal, 325 to 500 mg every three hours, 325 to 650 mg every four hours, or 650 mg to 1 gram every six hours as needed, while symptoms persist.


Note: For patient self-medication, it is recommended that a physician be consulted if pain is not relieved within ten days, fever within three days, or sore throat within two days. {09}


Usual adult prescribing limits
Up to 4 grams daily{19}{20}

Usual pediatric dose
Analgesic and
Antipyretic
Rectal, 1.5 grams per square meter of body surface a day in divided doses; or for

Children up to 2 years of age—Dosage must be individualized by physician {09}.

Children 2 to 4 years of age—Rectal, 160 mg every four hours as needed, while symptoms persist {09}.

Children 4 to 6 years of age—Rectal, 240 mg every four hours as needed, while symptoms persist {09}.

Children 6 to 9 years of age—Rectal, 320 mg every four hours as needed, while symptoms persist {09}.

Children 9 to 11 years of age—Rectal, 320 to {09} 400 mg every four hours as needed, while symptoms persist {09}.

Children 11 to 12 years of age—Rectal, 320 to {09} 480 mg every four hours as needed, while symptoms persist {09}.


Note: It is recommended that children up to 12 years of age receive no more than five doses in each twenty-four-hour period, unless otherwise directed by a physician, and that a physician be consulted if pain is not relieved within five days, fever within three days, or sore throat within two days {09}.


Strength(s) usually available
U.S.—


80 mg (OTC) [Feverall, Infants"{06}]


120 mg (OTC) [Acetaminophen Uniserts] [Feverall, Children's] [Neopap (scored)] [Suppap-120][Generic]


300 mg (OTC)[Generic]


325 mg (OTC) [Acetaminophen Uniserts] [Feverall Junior Strength] [Suppap-325]


650 mg (OTC) [Acetaminophen Uniserts] [Suppap-650][Generic]

Canada—


120 mg (OTC) [Abenol]


325 mg (OTC) [Abenol]


650 mg (OTC) [Abenol]

Note: The strengths of the specific products may not conform to the recommended pediatric doses.


Packaging and storage:
Store below 40 °C (104 °F), preferably between 15 and 30 °C (59 and 86 °F), in a well-closed container, unless otherwise specified by manufacturer. Protect from freezing.

Auxiliary labeling:
   • Avoid alcoholic beverages.



Revised: 11/07/2002



References

Note: All references used in the development and earlier revisions of this monograph have not yet been incorporated into the computer database and, therefore, are not listed below. Citations for information not yet referenced in the monograph will be provided upon request.

  1. Actimol (BW). In: Krogh CME, editor. Self-Medication Product Information. 4th ed. Ottawa: Canadian Pharmaceutical Association, 1992: M7-M8.
  1. Aspirin Free Anacin (Robins Consumer). In: PDR Physicians' desk reference for nonprescription drugs. 14th ed. 1993. Montvale, NJ: Medical Economics Data, 1993: 672.
  1. Atasol preparations (Horner). In: Krogh CME, editor. CPS Compendium of pharmaceuticals and specialties. 28th ed. Ottawa: Canadian Pharmaceutical Association, 1993: 110.
  1. Bayer Select Maximum Strength Headache Pain Relief Formula (Sterling Health). In: PDR Physicians' desk reference for nonprescription drugs. 14th ed. 1993. Montvale, NJ: Medical Economics Data, 1993: 745.
  1. Children's Tylenol and Junior Strength Tylenol (McNeil Consumer). In: PDR Physicians' desk reference for nonprescription drugs. 14th ed. 1993. Montvale, NJ: Medical Economics Data, 1993: 586-7.
  1. Feverall formulations (Upsher-Smith). In: PDR Physicians' desk reference. 48th ed. 1994. Montvale, NJ: Medical Economics Data, 1994: 2463.
  1. FDA OTC Drugs Advisory Committee meeting, 4/8/93.
  1. Panel consensus, Caffeine (Systemic) monograph, developed for USP DI 1987.
  1. US Food and Drug Administration. Tentative final monograph. Notice of proposed rule-making for internal analgesic, antipyretic, and antirheumatic drug products for over-the-counter human use. Federal Register 1988 Nov 16; 53 (221): 46204-58.
  1. Sandler DP, Smith JC, Weinberg CR, et al. Analgesic use and chronic renal disease. N Engl J Med 1989; 320: 1238-43.
  1. Reviewers' responses to ballot of 11/3/89.
  1. Snaplets-FR (Baker Cummins). In: PDR Physicians' desk reference for nonprescription drugs. 11th ed. 1990. Oradell, NJ: Medical Economics Company, 1990: 511.
  1. Feverall Sprinkle Caps product label (Upsher Smith—U.S.), Rec 3/91.
  1. Personal communication, Upsher-Smith (U.S.), 5/91.
  1. Tempra (Mead Johnson). In: Krogh CME, editor. CPS Compendium of pharmaceuticals and specialties. 28th ed. Ottawa: Canadian Pharmaceutical Association, 1993: 1203.
  1. Adenocard (Fujisawa): In: PDR Physicians desk reference. 48th ed. 1994. Montvale, NJ: Medical Economics Data, 1994: 958-9.
  1. Panel consensus, Dipyridamole (Systemic) monograph, 1/92.
  1. Anon: Drug Information for the Health Care Professional. 20th ed. 2000. Englewood, CO: Micromedex, 2000: 3193.
  1. Tylenol product information 2000–2002. Available from:URL http://www.tylenol.com/products/adult/detail.jhtml?id=tylenol/products/adult/regularextra.inc
  1. Expert Committee comment, 11/2002.
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