Acetaminophen 500 mg

Description

The product is identified by the National Drug Code (NDC) 72090-038-01 and is packaged in a high-density polyethylene (HDPE) bottle containing 500 units.

Uses and Indications

This drug is indicated for the temporary relief of minor aches and pains associated with various conditions, including the common cold, headache, backache, minor pain of arthritis, muscular aches, toothache, 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 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, the use of this medication should not extend beyond 10 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:

• Co-administration with any other drug 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.

• In individuals with a known allergy to acetaminophen or any of the inactive ingredients present in this 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 exceeding 4,000 mg of acetaminophen within a 24-hour period, particularly when combined with other medications containing acetaminophen, significantly increases the risk of liver injury. Additionally, consumption of three or more alcoholic drinks daily while using this product may also heighten the risk of liver damage.

It is essential to exercise caution and consult a healthcare provider prior to use in patients with liver disease. Furthermore, patients taking the anticoagulant warfarin should seek advice from a doctor or pharmacist before using this product, as potential interactions may occur.

In the event of an overdose, immediate medical assistance is crucial. Patients should be instructed to contact emergency medical services or reach out to Poison Control at 1-800-222-1222 without delay, as prompt intervention is vital for both adults and children, even in the absence of noticeable symptoms.

Patients should discontinue use and consult a healthcare professional if any of the following occur: worsening pain that persists beyond 10 days, a fever that worsens or lasts more than 3 days, the presence of redness or swelling, or the emergence of new symptoms. These signs may indicate a serious underlying condition that requires further evaluation.

Side Effects

Patients using this product should be aware of the potential for serious adverse reactions, particularly concerning liver health. The product contains acetaminophen, and severe liver damage may occur if patients exceed 4,000 mg of acetaminophen in a 24-hour period, especially when combined with other medications containing acetaminophen. Additionally, consumption of three or more alcoholic drinks daily while using this product may also increase the risk of liver damage.

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

It is recommended that patients with liver disease consult a healthcare provider before using this product. Furthermore, individuals taking the blood-thinning medication warfarin should seek advice from a doctor or pharmacist prior to use to avoid potential interactions.

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 and potential dosage adjustments to maintain therapeutic efficacy and minimize the risk of adverse effects.

Packaging & NDC

Below are the non-prescription pack sizes of Acetaminophen 500 mg (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, with a maximum of 6 caplets 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, prompt medical attention is essential for both adults and children, even if no immediate signs or symptoms are apparent. It is important to keep this medication out of reach of children to prevent accidental ingestion.

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 considered in these populations to ensure the safety of both the mother and the fetus or infant.

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

There is no specific information available regarding dosage adjustments, special monitoring, or safety considerations for patients with renal impairment. Healthcare professionals should exercise caution when prescribing to patients 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. It is critical to note that severe liver damage may occur if the total daily dosage of acetaminophen exceeds 4,000 mg, particularly when combined with other medications containing acetaminophen.

Additionally, patients who consume three or more alcoholic drinks daily while using this product are at an increased risk for severe liver damage. Therefore, it is recommended that patients with compromised liver function limit their intake of acetaminophen and alcohol to mitigate the risk of hepatotoxicity. Regular assessment of liver function may be warranted in these patients to ensure safety and efficacy of treatment.

Overdosage

In cases of overdosage, significant health risks are associated with the consumption of acetaminophen beyond the recommended limits.

Risk of Severe Liver Damage Healthcare professionals should be aware that severe liver damage may occur if a patient ingests more than 4,000 mg of acetaminophen within a 24-hour period, particularly when combined with other medications containing acetaminophen. This risk underscores the importance of monitoring total daily intake from all sources.

Additionally, the concurrent consumption of three or more alcoholic beverages daily while using acetaminophen-containing products can also lead to severe liver damage. It is crucial for healthcare providers to assess patients' alcohol consumption habits when prescribing or recommending acetaminophen.

Recommended Actions In the event of suspected overdosage, immediate medical evaluation is warranted. Healthcare professionals should initiate appropriate management procedures, which may include the administration of activated charcoal if the ingestion occurred within a suitable timeframe and the patient is alert. Monitoring liver function tests and considering the use of N-acetylcysteine as an antidote may be necessary, depending on the severity of the overdose and the time elapsed since ingestion.

Prompt recognition and intervention are essential to mitigate the risk of serious hepatic injury in cases of acetaminophen overdosage.

Nonclinical Toxicology

No information is available regarding teratogenic or non-teratogenic effects. Additionally, there is no data provided concerning nonclinical toxicology, animal pharmacology, or toxicology.

Postmarketing Experience

Postmarketing experience has identified that acetaminophen may be associated with severe skin reactions. Reports indicate that symptoms can include skin reddening, blisters, and rash. In the event of a skin reaction, it is advised to discontinue use immediately and seek medical assistance.

Patient Counseling

Healthcare providers should advise patients to keep the medication out of reach of children to prevent accidental ingestion. It is essential to emphasize the importance of seeking immediate medical assistance in the event of an overdose. Patients should be informed to contact a Poison Control Center at 1-800-222-1222 without delay. Quick medical attention is critical for both adults and children, even if no signs or symptoms of overdose 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 20º to 25ºC (68º to 77ºF) to maintain its efficacy and stability. Proper storage conditions should be ensured to prevent exposure to extreme temperatures, which may compromise the product's integrity.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

This file contains official product information for Acetaminophen 500 mg, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

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