Acetaminophen

Description

APAP 60 is a pharmaceutical formulation containing acetaminophen as the active ingredient. The chemical name for acetaminophen is N-(4-hydroxyphenyl)acetamide, with a molecular weight of 151.16 g/mol. The chemical formula is C8H9NO2. This product is presented in a dosage form suitable for administration, characterized by its specific appearance and formulation attributes.

Uses and Indications

This drug is indicated for the temporary reduction of fever.

There are no teratogenic effects associated with this drug. Additionally, no nonteratogenic effects have been reported.

Dosage and Administration

Adults and children aged 12 years and over are advised to take 2 caplets every 6 hours as needed while symptoms persist. The maximum dosage should not exceed 6 caplets within a 24-hour period, unless otherwise directed by a healthcare professional. Additionally, this product should not be used for more than 10 consecutive days unless specifically instructed by a doctor.

For children under 12 years of age, it is recommended to consult a healthcare professional for appropriate dosing guidance.

Contraindications

Use of this product is contraindicated in patients who exceed the recommended dosage, as this may lead to liver damage. No other specific contraindications have been identified in the available data.

Warnings and Precautions

Severe liver damage may occur with the use of this product, which contains acetaminophen. Healthcare professionals should advise patients that the risk of liver injury increases significantly if they exceed 4000 mg of acetaminophen within a 24-hour period, use this product concurrently with other medications containing acetaminophen, or consume three or more alcoholic beverages daily while using this product.

It is imperative that this product not be used in conjunction with any other drug containing acetaminophen, whether prescription or over-the-counter. Patients should be instructed to consult a healthcare provider if they are uncertain about the presence of acetaminophen in any medication. Additionally, individuals with a history of allergic reactions to acetaminophen or any inactive ingredients in this formulation should avoid its use. Patients with liver disease should seek medical advice prior to using this product. Furthermore, those taking the anticoagulant warfarin should consult their doctor or pharmacist before use, as interactions may occur.

Patients should be advised to discontinue use and contact their healthcare provider if they experience worsening pain that persists beyond 10 days, fever that lasts more than 3 days or worsens, any signs of redness or swelling, or the emergence of new symptoms, as these may indicate a serious underlying condition.

In the event of an overdose, immediate medical assistance should be sought, or the Poison Control Center should be contacted at 1-800-222-1222. Prompt medical attention is crucial for both adults and children, even if no signs or symptoms are immediately apparent.

Side Effects

Severe liver damage may occur in patients who exceed 4000 mg of acetaminophen within a 24-hour period, use other medications containing acetaminophen, or consume three or more alcoholic drinks daily while using this product. It is crucial for patients to avoid using this product in conjunction with any other drug containing acetaminophen, whether prescription or over-the-counter. Patients should consult a doctor or pharmacist if they are uncertain whether a drug contains acetaminophen.

Patients with a history of allergic reactions to acetaminophen or any of the inactive ingredients in this product should not use it. Additionally, individuals with liver disease or those taking the blood-thinning medication warfarin should seek medical advice before using this product.

Patients are advised to discontinue use and consult a doctor if pain worsens or persists for more than 10 days, if fever worsens or lasts more than 3 days, if redness or swelling occurs, or if new symptoms appear, as these may indicate a serious condition.

For pregnant or breastfeeding patients, it is recommended to consult a health professional prior to use.

Drug Interactions

Patients should consult their healthcare provider or pharmacist prior to using this medication if they are concurrently taking warfarin, a blood-thinning agent. The combination may increase the risk of bleeding due to potential pharmacodynamic interactions.

Additionally, this medication should not be used in conjunction with any other products containing acetaminophen, whether prescription or over-the-counter. Co-administration may lead to an increased risk of acetaminophen-related toxicity. If there is uncertainty regarding the presence of acetaminophen in other medications, patients are advised to seek guidance from a healthcare professional.

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 12 years of age should consult a healthcare professional before use. For adolescents aged 12 years and older, the recommended dosage is 2 caplets every 6 hours as needed for symptom relief. It is important not to exceed 6 caplets within a 24-hour period unless directed by a healthcare provider. Additionally, treatment should not extend beyond 10 days without medical advice.

Geriatric Use

There is no specific information regarding the use of this medication in geriatric patients. The prescribing information does not provide any recommended age considerations, dosage adjustments, safety concerns, or special precautions for elderly patients.

Healthcare providers should exercise clinical judgment when prescribing this medication to geriatric patients, considering the absence of data specific to this population. Monitoring for efficacy and safety is advised, as individual responses may vary.

Pregnancy

Pregnant patients and those who are breastfeeding should consult a healthcare professional prior to using this medication. It is essential to evaluate the potential risks and benefits associated with its use during pregnancy and lactation. The safety of this medication in pregnant women has not been established, and caution is advised to ensure the well-being of both the mother and the fetus.

Lactation

Lactating mothers are advised to consult a health professional prior to using this medication. There is currently no available data regarding the excretion of this medication in human breast milk or its effects on breastfed infants. Therefore, caution is recommended when administering this medication to lactating individuals.

Renal Impairment

Patients with renal impairment have not been specifically addressed in the available data regarding dosage adjustments, special monitoring, or safety considerations. Therefore, healthcare professionals should exercise caution when prescribing this medication to patients with reduced kidney function, as the lack of information necessitates careful clinical judgment and monitoring.

Hepatic Impairment

Patients with hepatic impairment should exercise caution when using this product, as it contains acetaminophen, which is associated with the risk of severe liver damage. It is critical that patients do not exceed a maximum dosage of 4000 mg of acetaminophen within a 24-hour period. Additionally, the concurrent use of other medications containing acetaminophen or the consumption of three or more alcoholic drinks daily while using this product may further increase the risk of liver damage.

Patients with known liver disease are advised to consult a healthcare professional prior to using this product. Monitoring for signs of worsening pain, prolonged fever, redness, swelling, or the emergence of new symptoms is essential, as these may indicate a serious underlying condition. If any of these symptoms occur, patients should discontinue use and seek medical advice promptly.

Overdosage

In cases of overdosage, it is critical to recognize the potential for severe liver damage associated with acetaminophen.

Risk of Liver Damage Acetaminophen overdosage can lead to significant hepatic injury. Specifically, the risk of severe liver damage increases if an individual ingests more than 4000 mg of acetaminophen within a 24-hour period. Additionally, concurrent use of acetaminophen with other medications that also contain acetaminophen heightens this risk.

Furthermore, individuals who consume three or more alcoholic beverages daily while using acetaminophen are at an elevated risk for liver damage.

Recommended Actions Healthcare professionals should be vigilant in assessing patients for signs of acetaminophen overdosage, particularly in those who may have exceeded the recommended dosage or are using multiple acetaminophen-containing products. Immediate medical evaluation and intervention are advised in suspected cases of overdosage to mitigate the risk of severe hepatic injury.

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 compound in these areas.

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 resulting in liver transplantation, particularly among patients with underlying liver disease or those exceeding the recommended dosage. Instances of allergic reactions, including anaphylaxis, have also been reported. Furthermore, there have been cases of renal impairment and acute kidney injury linked to the use of acetaminophen, especially in patients with pre-existing renal conditions or those taking high doses.

Patient Counseling

Healthcare providers should advise patients to keep the medication out of reach of children to prevent accidental ingestion.

Patients should be informed about the risks associated with overdose. It is crucial to communicate that taking more than the recommended dose may lead to liver damage. In the event of an overdose, patients must seek medical help immediately or contact a Poison Control Center at 1-800-222-1222. Quick medical attention is essential for both adults and children, even if no signs or symptoms are apparent.

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 a controlled temperature range of 62° to 77°F to maintain its integrity and efficacy. Proper storage conditions must be adhered to, ensuring that the product is kept within this temperature range at all times.

Additional Clinical Information

The medication is administered orally. Clinicians should advise patients who are pregnant or breastfeeding to consult a health professional prior to use. No further information is available regarding laboratory tests, abuse potential, or postmarketing experiences.

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)