Acetaminophen

Description

342R Acetaminophen is available in a dosage form of 500 mg per tablet. The product is offered in two packaging sizes: 225 count and 100 count. Each tablet contains acetaminophen as the active ingredient, which is utilized for its analgesic and antipyretic properties. The formulation is designed for oral administration.

Uses and Indications

This drug is indicated for the temporary relief of minor aches and pains associated with the common cold, headache, backache, minor pain of arthritis, toothache, muscular aches, and premenstrual and menstrual cramps. Additionally, it is indicated for the temporary reduction of fever.

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

Dosage and Administration

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

Patients should not use this product in conjunction with any other medication containing acetaminophen, whether prescription or nonprescription, due to the risk of acetaminophen overdose. If there is uncertainty regarding the presence of acetaminophen in other medications, consultation with a healthcare professional is advised.

Additionally, this product is contraindicated in individuals with a known allergy to acetaminophen or any of the inactive ingredients contained in the formulation, as this may lead to severe allergic reactions.

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 4,000 mg of acetaminophen within a 24-hour period, use other medications containing acetaminophen concurrently, or consume three or more alcoholic beverages daily while taking this product.

Acetaminophen may also lead to severe skin reactions. Symptoms indicative of such reactions include skin reddening, blisters, and rash. In the event of a skin reaction, patients should be instructed to discontinue use immediately and seek medical assistance.

It is essential for patients to consult a healthcare provider prior to using this product if they have a history of liver disease. Additionally, patients taking the anticoagulant warfarin should seek advice from a doctor 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 any of the following: worsening pain that persists beyond 10 days, a fever that worsens or lasts more than 3 days, the emergence of new symptoms, or the presence of redness or swelling. These symptoms may indicate a serious underlying condition that requires further evaluation.

Side Effects

Severe liver damage may occur in patients taking this product containing acetaminophen if they exceed 4,000 mg in a 24-hour period, use other medications containing acetaminophen concurrently, or consume three or more alcoholic drinks daily while using this product. Patients should be aware of the potential for severe skin reactions associated with acetaminophen, which may manifest as skin reddening, blisters, or rash. In the event of a skin reaction, it is imperative to discontinue use and seek medical assistance immediately.

In cases of overdose, patients are advised to seek medical help or contact a Poison Control Center promptly, as rapid medical attention is crucial for both adults and children, even if no signs or symptoms are apparent.

Patients should discontinue use and consult a healthcare professional if pain worsens or persists beyond 10 days, if fever intensifies or lasts more than 3 days, if new symptoms arise, or if redness or swelling is observed, as these may indicate a serious underlying condition.

Individuals with liver disease should consult a doctor prior to using this product. Additionally, patients taking the blood-thinning medication warfarin are advised to seek guidance from a healthcare provider or pharmacist before use.

Drug Interactions

Patients taking the anticoagulant warfarin should consult a healthcare professional prior to initiating treatment with this medication. The interaction between this drug 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 warfarin may be required based on the clinical judgment of the healthcare provider.

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 tablets every 6 hours as needed for symptom relief, with a maximum of 6 tablets in a 24-hour period, unless otherwise directed by a physician. Treatment should not exceed 10 days without medical advice.

In the event of an overdose, immediate medical assistance is essential. Caregivers should contact a Poison Control Center at 1-800-222-1222, as prompt attention is crucial for both adults and children, even in the absence of noticeable symptoms.

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 individual responses may vary. Monitoring for potential adverse effects and therapeutic efficacy is recommended in this population.

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 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 may not have specific dosage adjustments, special monitoring, or safety considerations outlined in the prescribing information. Therefore, healthcare professionals should exercise caution when prescribing this medication to individuals with reduced kidney function, as the absence of detailed guidance necessitates careful clinical judgment and monitoring of these patients.

Hepatic Impairment

Patients with hepatic impairment should be closely monitored when using this product, which contains acetaminophen. It is important to note that severe liver damage may occur if patients exceed the recommended dosage of 4,000 mg of acetaminophen in a 24-hour period. Additionally, patients should avoid the concurrent use of other medications containing acetaminophen, as this can further increase the risk of liver injury.

Patients with compromised liver function are also advised to limit alcohol consumption. Specifically, the intake of three or more alcoholic drinks per day while using this product may significantly heighten the risk of liver damage. Therefore, careful consideration of liver function and adherence to recommended dosing guidelines is essential to minimize the potential for adverse effects in this population. Regular monitoring of liver function tests may be warranted in patients with existing hepatic impairment to ensure safety and efficacy during treatment.

Overdosage

In the event of an overdose, it is imperative to seek immediate medical assistance or contact a Poison Control Center at 1-800-222-1222. Prompt intervention is essential for both adults and children, even in the absence of noticeable signs or symptoms.

Healthcare professionals should be aware that the timely administration of appropriate medical care can significantly influence the outcome of an overdose situation. Therefore, vigilance in monitoring for any potential symptoms is crucial, as they may not be immediately apparent.

In summary, the necessity for rapid medical evaluation cannot be overstated, and all suspected overdose cases should be treated as emergencies, warranting swift action and thorough assessment.

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 understanding of potential risks associated with the compound in nonclinical settings.

Postmarketing Experience

No specific postmarketing experience details are available. As such, there are no additional adverse events or rare case reports to summarize at this time.

Patient Counseling

Healthcare providers should advise patients to keep this medication out of reach of children to prevent accidental ingestion. Patients should be informed not to use this product in conjunction with any other medications that contain acetaminophen, whether prescription or nonprescription. If patients are uncertain whether a drug contains acetaminophen, they should be encouraged to consult with a doctor or pharmacist.

It is crucial to inform patients that they should not use this medication if they have a known allergy to acetaminophen or any of the inactive ingredients present in the product. Patients should be instructed to discontinue use and seek medical advice if their pain worsens or persists for more than 10 days. Similarly, if a fever worsens or lasts longer than 3 days, patients should stop using the medication and consult a healthcare professional.

Patients should also be made aware that the emergence of new symptoms, or the presence of redness or swelling, warrants immediate medical consultation, as these may indicate a serious condition. Additionally, patients with liver disease should be advised to consult a doctor before using this medication. Lastly, those taking the blood-thinning medication warfarin should be encouraged to speak with a doctor or pharmacist prior to use to ensure safety and avoid potential interactions.

Storage and Handling

The product is supplied in various package configurations, with specific NDC numbers available upon request. It should be stored at a controlled room temperature of 25°C (77°F). Temporary excursions are permissible within the range of 15° to 30°C (59° to 86°F). It is essential to adhere to the expiration date indicated on the package to ensure product efficacy and safety.

Additional Clinical Information

No further data are available.

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)