Acetaminophen

Description

The product is identified by the National Drug Code (NDC) 76168-010, available in a packaging configuration of 100 count per unit.

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 allowable dosage is 6 caplets within a 24-hour period, unless otherwise directed by a healthcare professional. Treatment should not exceed 10 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 medications 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 healthcare provider or pharmacist before use, as there may be potential interactions.

Patients should be advised to discontinue use and contact their healthcare provider if they experience worsening pain that persists beyond 10 days, a fever that worsens or lasts more than 3 days, 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 initially apparent.

Side Effects

Severe liver damage may occur in patients who exceed 4000 mg of acetaminophen within a 24-hour period, use this product in conjunction with other medications containing acetaminophen, or consume three or more alcoholic drinks daily while using this product.

Patients should not use this product with any other drug containing acetaminophen, whether prescription or over-the-counter. If there is uncertainty regarding the presence of acetaminophen in a medication, it is advised to consult a doctor or pharmacist. Additionally, individuals with a history of allergic reactions to acetaminophen or any inactive ingredients in this product should refrain from its use.

Before using this product, patients should consult a doctor if they have liver disease or are taking the anticoagulant warfarin.

Patients are advised to discontinue use and seek medical advice 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 individuals, it is recommended to consult a health professional prior to use.

Drug Interactions

Patients taking warfarin, a blood-thinning medication, should consult their healthcare provider or pharmacist prior to initiating treatment with this drug. The interaction between this medication and warfarin may necessitate careful monitoring of coagulation parameters to ensure therapeutic efficacy and minimize the risk of adverse effects. Adjustments to the dosage of either medication may be required based on clinical judgment and patient response.

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 using this product. 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, the use of this product should not extend beyond 10 days unless specifically instructed by a doctor.

Geriatric Use

There is no specific information available 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 individual responses may vary. It is advisable to monitor these patients closely for any adverse effects or changes in efficacy.

Pregnancy

Pregnant patients and those who are breastfeeding should consult a healthcare professional prior to using this medication. The potential risks and benefits must be carefully weighed, as the effects on fetal outcomes and lactation are not fully established. It is essential for women of childbearing potential to seek medical advice to ensure safe use during pregnancy and lactation.

Lactation

Lactating mothers are advised to consult a health professional prior to using this medication. There is currently no available data on the excretion of this drug 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 4000 mg of acetaminophen in a 24-hour period, as exceeding this dosage, taking other medications containing acetaminophen concurrently, or consuming three or more alcoholic drinks daily while using this product may significantly increase the risk of liver injury.

Prior to use, patients with a history of liver disease are advised to consult a healthcare professional. Monitoring for adverse effects is essential; patients should discontinue use and seek medical advice if pain worsens or persists beyond 10 days, if fever intensifies or lasts more than 3 days, if there is any redness or swelling, or if new symptoms develop, as these may indicate a serious underlying condition.

Overdosage

In cases of overdosage, significant health risks are associated with acetaminophen intake.

Risk of Severe Liver Damage Acetaminophen is known to pose a risk of severe liver damage when dosages exceed 4000 mg within a 24-hour period. Healthcare professionals should be vigilant in monitoring patients who may have ingested amounts greater than this threshold.

Additionally, the concomitant use of acetaminophen with other medications that also contain acetaminophen can lead to similar risks of severe liver damage. It is crucial for healthcare providers to assess all medications a patient is taking to prevent unintentional overdosing.

Alcohol Consumption Considerations Patients who consume three or more alcoholic drinks daily while using acetaminophen are at an increased risk for severe liver damage. Healthcare professionals should advise patients on the dangers of combining alcohol with acetaminophen and consider alternative pain management strategies for those with a history of alcohol use.

In the event of suspected overdosage, immediate medical evaluation is recommended to assess liver function and initiate appropriate management protocols.

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

No postmarketing experience details are available in the insert text.

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. Emphasize that prompt 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, maintaining a range between 62°F and 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 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)