Acetaminophen

Description

Acetaminophen Tablets are formulated to contain 500 mg of acetaminophen per tablet. This non-aspirin analgesic is indicated for the reduction of fever and the temporary relief of aches and pains. Each pack contains 2 tablets, with a total of 250 packs per box. The product is identified by NDC# 68599-4681-3 and is manufactured by McKesson under the manufacturer number 82468.

Uses and Indications

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

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

Dosage and Administration

Patients should adhere strictly to the recommended dosage. For adults and children aged 12 years and older, the recommended dosage is 2 tablets every 4 to 6 hours as needed. It is imperative that patients do not exceed a total of 8 tablets within a 24-hour period.

For children under 12 years of age, this medication is not indicated and should not be administered.

Contraindications

Use of this product is contraindicated in the following situations:

The product should not be used concurrently with any other medication containing acetaminophen, whether prescription or nonprescription, due to the risk of acetaminophen overdose.

Additionally, the product should not be used for more than 10 days for pain management unless specifically directed by a healthcare professional, as prolonged use may lead to adverse effects. For fever, the product should not be used for more than 3 days unless directed by a doctor, to prevent potential complications associated with extended use.

Warnings and Precautions

This product contains acetaminophen, which carries significant risks for liver damage. Healthcare professionals should advise patients that severe liver injury may occur if they exceed the maximum daily dosage of 8 tablets within a 24-hour period, use this product concurrently with other medications containing acetaminophen, or consume 3 or more alcoholic beverages daily while taking this product.

Allergy Alert Acetaminophen may lead to severe skin reactions. Symptoms indicative of such reactions include skin reddening, blisters, and rash. Should any of these symptoms manifest, patients must discontinue use immediately and seek medical assistance.

General Precautions Patients should be cautioned against using this product in conjunction with any other medications that contain acetaminophen, whether prescription or over-the-counter. If there is uncertainty regarding the presence of acetaminophen in other medications, patients are advised to consult a healthcare professional. Additionally, individuals with liver disease should seek medical advice prior to using this product. It is also recommended that patients consult a doctor or pharmacist if they are concurrently taking the anticoagulant warfarin.

Monitoring and Follow-Up Patients should be instructed to discontinue use and contact their healthcare provider if symptoms do not improve, if new symptoms arise, if pain or fever persists or worsens, or if there is any redness or swelling.

Emergency Situations In the event of an accidental overdose, immediate medical attention is essential. Patients should be directed to contact a Poison Control Center or seek emergency medical help without delay, as prompt intervention is critical for both adults and children, even in the absence of noticeable signs or symptoms.

Side Effects

Patients using this product should be aware of the potential for serious adverse reactions, particularly related to liver health and allergic responses.

Severe liver damage may occur if patients exceed the maximum recommended dosage of 8 tablets in a 24-hour period, take this product in conjunction with other medications containing acetaminophen, or consume 3 or more alcoholic drinks daily while using this product.

Additionally, there is an allergy alert associated with acetaminophen, which may lead to severe skin reactions. Symptoms of such reactions can include skin reddening, blisters, and rash. In the event of a skin reaction, patients are advised to discontinue use immediately and seek medical assistance.

These warnings highlight the importance of adhering to recommended dosages and being vigilant for signs of allergic reactions while using this product.

Drug Interactions

Patients taking warfarin, a blood-thinning medication, should consult with a healthcare professional prior to using this drug. The interaction between this medication and warfarin may necessitate careful monitoring of coagulation parameters to avoid potential adverse effects. Adjustments to the dosage of either drug may be required based on clinical judgment and patient response.

Packaging & NDC

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

Pediatric Use

Pediatric patients under 12 years of age should not be administered this medication. For adolescents aged 12 years and older, the recommended dosage is 2 tablets every 4 to 6 hours as needed, with a maximum of 8 tablets in a 24-hour period. Caution is advised when prescribing to this age group to ensure adherence to the recommended dosing guidelines.

Geriatric Use

Elderly patients may not have specific recommendations regarding age considerations, dosage adjustments, safety concerns, or special precautions. Therefore, healthcare providers should exercise caution when prescribing this medication to geriatric patients. It is advisable to monitor these patients closely for any adverse effects or changes in therapeutic response, given the potential for altered pharmacokinetics and pharmacodynamics 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 the safety of both the mother and the developing fetus.

Lactation

Lactating mothers are advised to consult a health professional prior to using this medication. There is no specific data available regarding the excretion of this medication in 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 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 maximum daily dosage of 8 tablets within a 24-hour period. Additionally, patients should avoid concomitant 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 3 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 dosage guidelines is essential for patients with hepatic impairment to minimize the risk of adverse effects.

Overdosage

In cases of overdosage, significant health risks are associated with exceeding the recommended dosage of this product.

Risk of Severe Liver Damage Taking more than 8 tablets within a 24-hour period, which constitutes the maximum daily dosage, can lead to severe liver damage. Healthcare professionals should be vigilant in assessing patients who may have exceeded this limit.

Additionally, the concomitant use of this product with other medications containing acetaminophen poses a further risk of severe liver damage. It is crucial for healthcare providers to inquire about all medications a patient is taking to prevent potential interactions that could exacerbate liver toxicity.

Alcohol Consumption Considerations Patients who consume three or more alcoholic drinks daily while using this product are also at an increased risk for severe liver damage. Healthcare professionals should advise patients on the dangers of combining alcohol with this medication and recommend monitoring for signs of liver impairment.

In the event of suspected overdosage, immediate medical evaluation is warranted. Monitoring liver function tests and providing supportive care are essential components of management.

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 in these areas limits the understanding of the compound's potential effects in nonclinical settings.

Postmarketing Experience

Postmarketing experience has identified severe skin reactions associated with acetaminophen use. Reported symptoms may include skin reddening, blisters, and rash. In the event of a skin reaction, it is advised that the use of acetaminophen be discontinued and medical assistance sought immediately.

Patient Counseling

Healthcare providers should advise patients to keep this medication out of reach of children to prevent accidental ingestion. In the event of an accidental overdose, it is crucial for patients to seek medical help or contact a Poison Control Center immediately, as prompt medical attention is essential for both adults and children, even if no signs or symptoms are apparent.

Patients should be informed not to use this medication in conjunction with any other drug containing acetaminophen, whether prescription or nonprescription. If patients are uncertain whether a drug contains acetaminophen, they should be encouraged to consult a doctor or pharmacist for clarification.

It is important to instruct patients not to use this medication for more than 10 days for pain or more than 3 days for fever unless directed by a healthcare professional. Patients should also be advised to consult a doctor before use if they have liver disease or if they are taking the blood-thinning medication warfarin.

Patients should be made aware that they need to stop using the medication and consult a doctor if their symptoms do not improve, if new symptoms occur, or if pain or fever persists or worsens. Additionally, they should be advised to seek medical advice if they notice any redness or swelling.

For patients who are pregnant or breastfeeding, it is essential to recommend that they consult a health professional before using this medication.

Storage and Handling

The product is supplied in tamper-evident sealed packets to ensure integrity and safety. It is essential to store the packets at room temperature, specifically within the range of 59ºF to 86ºF (15ºC to 30ºC). Care should be taken to avoid using any packets that are opened or torn, as this may compromise the product's quality and efficacy.

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)