Acetaminophen

Description

The product is supplied in a 473 mL container.

Uses and Indications

This drug is indicated for the temporary relief of minor aches and pains associated with the common cold, flu, headache, sore throat, and toothache. Additionally, it is indicated for the temporary reduction of fever.

There are no teratogenic or nonteratogenic effects associated with this drug.

Dosage and Administration

The recommended dosage for the medication varies by age and weight. It is imperative that the maximum dosage is not exceeded, and healthcare professionals should refer to the overdose warning for guidance.

For children under 2 years of age (weighing less than 24 lbs), consultation with a physician is required before administration. For children aged 2 to 3 years (weighing between 24-35 lbs), the recommended dose is 1 teaspoonful (5 mL). For children aged 4 to 5 years (weighing between 36-47 lbs), the dosage increases to 1 1/2 teaspoonfuls (7.5 mL). Children aged 6 to 8 years (weighing between 48-59 lbs) should receive 2 teaspoonfuls (10 mL), while those aged 9 to 10 years (weighing between 60-71 lbs) should be given 2 1/2 teaspoonfuls (12.5 mL). For children aged 11 years (weighing between 72-95 lbs), the appropriate dosage is 3 teaspoonfuls (15 mL).

Adults and children aged 12 years and older are advised to take 4 teaspoonfuls (20 mL). If necessary, doses may be repeated every 4 hours, but no more than 5 doses should be administered within a 24-hour period. It is essential to follow these guidelines closely to ensure safe and effective use of the medication.

Contraindications

Use of this product is contraindicated in patients who are concurrently using any other product containing acetaminophen. This is due to the potential for acetaminophen overdose, which can lead to serious liver damage. Additionally, it is essential to adhere to the recommended dosage to avoid the risk of overdose.

Warnings and Precautions

Severe liver damage may occur with the use of this product, which contains acetaminophen. Healthcare professionals should advise patients to adhere strictly to the recommended dosage, as taking more than five doses per day, using other medications that contain acetaminophen, or consuming three or more alcoholic drinks daily while using this product significantly increases the risk of liver injury.

In cases of severe sore throat that persists for more than two days, or if it is accompanied or followed by fever, headache, rash, nausea, or vomiting, patients should be instructed to consult a physician promptly. Additionally, patients who consume three or more alcoholic beverages daily should seek medical advice regarding the use of acetaminophen or other pain relievers and fever reducers.

Patients are advised to discontinue use and consult a healthcare provider if new symptoms arise, if redness or swelling occurs, if pain worsens or persists for more than five days, or if fever worsens or lasts for more than three days.

In the event of an overdose, immediate medical assistance should be sought, or the local Poison Control Center should be contacted without delay. Quick medical attention is essential, even if the patient does not exhibit any immediate signs or symptoms of overdose.

Side Effects

Severe liver damage may occur in patients who exceed the recommended dosage of this product, specifically if they take more than five doses per day, use it in conjunction with other medications containing acetaminophen, or consume three or more alcoholic drinks daily while using this product.

Patients should be aware of the potential for serious adverse reactions, including the risk of overdose, which can lead to liver damage. In the event of an overdose, it is imperative to seek medical assistance or contact a Poison Control Center immediately, as prompt medical attention is crucial even if no symptoms are initially apparent.

Common adverse reactions may include the exacerbation of symptoms such as sore throat. Patients experiencing a severe sore throat that persists for more than two days, or is accompanied by fever, headache, rash, nausea, or vomiting, should consult a healthcare professional promptly.

Additionally, patients are advised to discontinue use and seek medical advice if new symptoms arise, if redness or swelling occurs, if pain worsens or lasts longer than five days, or if fever intensifies or persists for more than three days.

It is also important to note that this product should not be used in conjunction with any other products containing acetaminophen, and patients should adhere strictly to the recommended dosage to avoid adverse effects.

Drug Interactions

Co-administration of this product with any other product containing acetaminophen is contraindicated due to the risk of acetaminophen overdose, which can lead to severe liver damage.

In patients who consume three or more alcoholic beverages daily, it is advised to consult a healthcare professional before using acetaminophen or other pain relievers and fever reducers. Chronic alcohol consumption may increase the risk of hepatotoxicity associated with acetaminophen use. Monitoring of liver function may be warranted in these patients.

Packaging & NDC

Below are the non-prescription pack sizes of Acetaminophen. Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients under 2 years of age (weighing less than 24 lbs) should consult a healthcare professional before use. For children aged 2 to 3 years (weighing 24-35 lbs), the recommended dosage is 1 teaspoonful (5 mL). Children aged 4 to 5 years (weighing 36-47 lbs) may receive 1 1/2 teaspoonfuls (7.5 mL).

For children aged 6 to 8 years (weighing 48-59 lbs), the dosage increases to 2 teaspoonfuls (10 mL). Children aged 9 to 10 years (weighing 60-71 lbs) should be administered 2 1/2 teaspoonfuls (12.5 mL). For those aged 11 years (weighing 72-95 lbs), the recommended dosage is 3 teaspoonfuls (15 mL).

Adults and children aged 12 years and older may take 4 teaspoonfuls (20 mL).

Geriatric Use

There is no specific information regarding the use of this medication in geriatric patients, including dosage adjustments, safety concerns, or special precautions. Healthcare providers should exercise caution when prescribing this medication to elderly patients, as they may have altered pharmacokinetics and pharmacodynamics. Close monitoring is recommended to ensure safety and efficacy in this population.

Pregnancy

The safety of acetaminophen during pregnancy has not been established. Acetaminophen is contraindicated in pregnant patients who have a known hypersensitivity to acetaminophen or any of the inactive ingredients. There may be potential risks to the fetus; therefore, it is essential for pregnant women to consult a healthcare provider before using this medication.

Dosage adjustments may be necessary for pregnant individuals, and healthcare providers should be consulted for recommendations specific to this population. Pregnant women should use acetaminophen only if clearly needed and after thorough consultation with a healthcare professional to ensure the benefits outweigh any potential risks.

Lactation

Lactating mothers should consult a doctor before using this product. There is a potential for excretion in breast milk. The effects of acetaminophen on a nursing infant are not well studied; therefore, caution is advised.

Renal Impairment

Patients with renal impairment have no specific information regarding dosage adjustments, special monitoring, or safety considerations provided in the drug insert. Therefore, healthcare professionals should exercise caution when prescribing this medication to individuals with reduced kidney function, as the lack of data necessitates careful clinical judgment. Regular monitoring of renal function may be advisable in these patients to ensure safety and efficacy.

Hepatic Impairment

Patients with hepatic impairment should be closely monitored when using this product, which contains acetaminophen. Severe liver damage may occur if patients exceed five of the recommended doses per day, combine this product with other medications containing acetaminophen, or consume three or more alcoholic drinks daily while using this product.

It is advised that patients who regularly consume three or more alcoholic drinks per day consult their healthcare provider to determine the appropriateness of using acetaminophen or other pain relievers and fever reducers.

In the event of an overdose, which is defined as taking more than the recommended dose, patients may be at risk for liver damage. Immediate medical attention is essential, and patients should seek help or contact a Poison Control Center without delay, even if they do not exhibit any signs or symptoms of overdose.

Overdosage

Taking more than the recommended dose of this medication may lead to significant liver damage. In the event of an overdose, it is imperative to seek medical assistance immediately or contact a Poison Control Center. Prompt medical attention is crucial, even if the individual does not exhibit any immediate signs or symptoms of overdose.

Healthcare professionals should be aware that the absence of symptoms does not preclude the possibility of serious complications. Therefore, monitoring and evaluation should be conducted as soon as an overdose is suspected.

Nonclinical Toxicology

No teratogenic or non-teratogenic effects have been reported in the available nonclinical studies. Additionally, there is no information regarding animal pharmacology and toxicology. The absence of data limits the assessment of potential risks associated with the use of the compound in these contexts.

Postmarketing Experience

Postmarketing experience has identified rare cases of severe skin reactions, including Stevens-Johnson syndrome and toxic epidermal necrolysis, associated with the use of acetaminophen. Additionally, reports of acute liver failure have been documented, with some cases necessitating liver transplantation, particularly among patients who exceed the recommended dose or use acetaminophen in conjunction with other products containing acetaminophen. Instances of allergic reactions, including anaphylaxis, have also been reported. Furthermore, there have been cases of renal impairment linked to the use of acetaminophen, especially in patients with pre-existing renal conditions or those consuming high doses.

Patient Counseling

Healthcare providers should advise patients to keep this product out of reach of children to prevent accidental ingestion. It is important to inform patients that they should not use this product in conjunction with any other medications that contain acetaminophen, as this may lead to an increased risk of adverse effects.

Patients should be instructed to stop using the product and consult a doctor if they experience any new symptoms, or if they notice redness or swelling at the site of application. Additionally, they should be made aware that if their pain worsens or persists for more than five days, or if their fever increases or lasts longer than three days, they should seek medical advice.

Healthcare providers should emphasize the importance of adhering to the recommended dosage and caution patients against exceeding this limit, as doing so may lead to serious health risks.

Storage and Handling

The product is supplied in various package configurations, with specific NDC numbers available for identification. It is essential to store the product at room temperature, maintaining a range of 20° to 25°C (68° to 77°F). Proper storage conditions are crucial to ensure the integrity and efficacy of the product.

Additional Clinical Information

The medication is administered orally. Clinicians should advise patients to keep the medication out of reach of children. In the event of an overdose, it is crucial for patients to seek medical assistance or contact a Poison Control Center immediately, as prompt medical attention is essential even if no signs or symptoms are apparent.

Drug Information (PDF)

This file contains official product information for Acetaminophen, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)