Acetaminophen 500 mg

Description

This product is identified by NDC 69618-011-01 and is classified as an Extra Strength formulation. Each tablet contains 500 mg of Acetaminophen USP, serving as a pain reliever and fever reducer. The product is packaged in a bottle containing 100 tablets. It is comparable to the active ingredient found in Extra Strength Tylenol®.

Uses and Indications

This drug is indicated for the temporary relief of minor aches and pains associated with various conditions, including headache, muscular aches, backache, minor pain of arthritis, the common cold, 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 advised to take 1 tablet every 3 to 4 hours, or 2 tablets every 6 hours, as needed while symptoms persist. The maximum recommended dosage is 8 tablets within a 24-hour period.

Use is not recommended for children under 12 years of age.

Contraindications

The use of this product is contraindicated in patients who are concurrently taking any other medication that contains acetaminophen, whether prescription or nonprescription. This precaution is necessary to avoid the risk of acetaminophen overdose, which can lead to serious liver damage. If there is uncertainty regarding the presence of acetaminophen in other medications, consultation with a healthcare professional is advised.

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, which is the maximum recommended daily dosage. Additionally, the concurrent use of other medications containing acetaminophen, whether prescription or nonprescription, should be strictly avoided. Patients should also be cautioned against the consumption of three or more alcoholic beverages daily while using this product, as this can further elevate the risk of liver damage.

It is imperative that patients do not use this product in conjunction with any other drug containing acetaminophen. If there is uncertainty regarding the presence of acetaminophen in other medications, patients should be encouraged to consult with a healthcare provider or pharmacist for clarification.

In the event of an overdose, immediate medical assistance should be sought, or the local Poison Control Center should be contacted without delay. Prompt medical intervention is crucial for both adults and children, even in the absence of noticeable signs or symptoms of overdose.

Patients should be instructed to 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 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 it in conjunction with other medications containing acetaminophen, or consume three or more alcoholic drinks daily while using this product.

Patients are advised to stop use and consult a doctor if pain worsens or persists for more than 10 days, if fever intensifies or lasts longer than 3 days, if new symptoms arise, or if redness or swelling is observed, as these may indicate a serious condition.

Individuals with liver disease should seek medical advice before using this product. Additionally, patients taking the blood-thinning medication warfarin are encouraged to consult a doctor or pharmacist prior to use.

Drug Interactions

Patients taking warfarin, a blood-thinning medication, should consult with a healthcare professional prior to using this drug. The interaction between this drug and warfarin may necessitate careful monitoring of coagulation parameters to ensure therapeutic efficacy and minimize the risk of bleeding complications. 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 500 mg (acetaminophen). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients under 12 years of age should not use this medication. For adolescents aged 12 years and older, the recommended dosage is 1 tablet every 3-4 hours or 2 tablets every 6 hours, as needed for symptom relief. The maximum allowable dosage is 8 tablets within a 24-hour period.

In the event of an overdose, it is essential to seek medical assistance or contact a Poison Control Center immediately, as prompt medical attention is crucial for both adults and children, regardless of the presence of symptoms.

Geriatric Use

Elderly patients may not have specific information regarding the use of this medication, including 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 potential adverse effects or changes in efficacy, given the lack of targeted data for 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 maternal and fetal safety.

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 prescribing information. There are no dosage adjustments, special monitoring requirements, or safety considerations outlined for individuals with reduced kidney function. Healthcare professionals should exercise caution and consider the lack of data when prescribing to this patient population.

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 4,000 mg of acetaminophen within 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 dosage guidelines is essential to minimize the potential for adverse effects in this patient population. Regular monitoring of liver function tests may be warranted to ensure patient safety.

Overdosage

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

Maximum Daily Dosage Healthcare professionals should advise patients that the maximum recommended daily dosage of acetaminophen is 4,000 mg. Exceeding this limit within a 24-hour period significantly increases the risk of severe liver damage.

Concurrent Use with Other Acetaminophen-Containing Products It is essential to caution patients against the concurrent use of this product with other medications that also contain acetaminophen. Such combinations can lead to an unintentional overdose, further elevating the risk of liver injury.

Alcohol Consumption Patients should be informed that the risk of severe liver damage is heightened if they consume three or more alcoholic drinks daily while using this product. Healthcare providers should assess patients' alcohol intake and provide guidance on safe usage to mitigate this risk.

Recommended Actions In the event of suspected overdosage, immediate medical attention is warranted. Healthcare professionals should initiate appropriate management procedures, which may include monitoring liver function and considering the administration of N-acetylcysteine as an antidote, depending on the severity of the situation.

Nonclinical Toxicology

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

Postmarketing Experience

Postmarketing experience has identified the potential for severe skin reactions associated with acetaminophen use. Reported symptoms of these reactions may include skin reddening, blisters, and rash. In the event of a skin reaction, it is advised to discontinue use and seek medical assistance immediately.

Additionally, there is a warning regarding the risk of overdose. Taking more than the recommended dose of acetaminophen may lead to liver damage. In cases of suspected overdose, it is crucial to obtain medical help or contact a Poison Control Center promptly, as timely medical intervention is essential for both adults and children, even in the absence of noticeable signs or symptoms.

Patient Counseling

Healthcare providers should advise patients to keep this medication out of reach of children to prevent accidental ingestion. It is important to inform patients about the risks associated with overdose, emphasizing that taking more than the recommended dose may lead to liver damage. In the event of an overdose, patients should seek medical help or contact a Poison Control Center immediately, as prompt medical attention is crucial for both adults and children, even if no signs or symptoms are apparent.

Patients should be cautioned against using this medication in conjunction with any other drug that contains acetaminophen, whether prescription or nonprescription. If patients are uncertain whether a medication contains acetaminophen, they should be encouraged to consult with a doctor or pharmacist for clarification.

Healthcare providers should instruct patients to discontinue use and seek medical advice if they experience any of the following: worsening pain that lasts more than 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.

Additionally, patients should be advised to consult a doctor before using this medication if they have a history of liver disease. It is also important to recommend that patients speak with a doctor or pharmacist prior to use if they are currently taking the blood-thinning medication warfarin, as potential interactions may exist.

Storage and Handling

The product is supplied in various package configurations, with specific NDC numbers available upon request. It is essential to store the product at a temperature range of 15º to 30ºC (59º to 86ºF) to ensure its stability and efficacy. Proper container requirements must be adhered to, and special handling needs should be observed to maintain the integrity of the product throughout its shelf life.

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.

View product document (PDF)