Acetaminophen

Description

Acetaminophen Extended-release Tablets are formulated to provide temporary relief of minor arthritis pain. Each tablet contains 650 mg of acetaminophen, serving as a pain reliever and fever reducer. The product is available in a package containing 100 caplets. The National Drug Code (NDC) for this product is 37835-512-01. It is important to note that this product is not manufactured or distributed by the owner of the registered trademark Tylenol® 8 HR Arthritis Pain. Distribution is handled by BI-MART, located in Eugene, OR 97402.

Uses and Indications

This drug is indicated for the temporary relief of minor aches and pains associated with various conditions, including minor pain of arthritis, muscular aches, backache, premenstrual and menstrual cramps, the common cold, headache, and toothache. 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 are instructed to take 2 caplets every 8 hours with water. The caplets should be swallowed whole and must not be crushed, chewed, split, or dissolved. The maximum dosage should not exceed 6 caplets within a 24-hour period. Additionally, the use of this medication should not extend beyond 10 days unless directed by a healthcare professional.

For individuals under 18 years of age, it is recommended to consult a doctor prior to use.

Contraindications

Use of this product is contraindicated in the following situations:

• Co-administration with any other drugs 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.

• Known allergy to acetaminophen or any of the inactive ingredients in this formulation, as this may lead to severe allergic reactions.

Warnings and Precautions

This product contains acetaminophen, which carries a significant risk of severe liver damage under certain conditions. Healthcare professionals should advise patients that the maximum daily dosage is limited to 6 caplets within a 24-hour period. Patients must be cautioned against concurrent use with other medications containing acetaminophen, as well as the consumption of three or more alcoholic drinks daily while using this product.

Acetaminophen may also provoke severe skin reactions, which can manifest as skin reddening, blisters, or rash. In the event of any skin reaction, patients should be instructed to discontinue use immediately and seek medical assistance.

In cases of suspected overdose, it is imperative to obtain emergency medical help or contact a Poison Control Center (1-800 222-1222) without delay. Prompt medical intervention is crucial for both adults and children, even if no immediate signs or symptoms are apparent.

Patients should be advised to stop taking the product and consult 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.

General precautions should include a recommendation for patients with liver disease to consult a healthcare professional prior to use. Additionally, patients taking the anticoagulant warfarin should seek advice from a doctor or pharmacist before using this product, as it may interact with their medication regimen.

Side Effects

Severe liver damage may occur in patients who exceed the maximum daily dosage of six caplets within a 24-hour period, use the product in conjunction with other medications containing acetaminophen, 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.

Patients are advised to stop 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 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 anticoagulant warfarin should seek advice from a healthcare provider or pharmacist before 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 medication and warfarin may necessitate careful monitoring of coagulation parameters to avoid potential adverse effects related to increased bleeding risk. 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 18 years of age should consult a healthcare professional prior to use. It is important to assess the appropriateness of treatment and dosage for this population, as specific recommendations may vary based on individual health needs and conditions.

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. It is advisable to monitor these patients closely for any 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 before using this medication. The safety of this drug during pregnancy has not been established, and potential risks to fetal outcomes are not fully understood. Therefore, it is essential for women of childbearing potential to seek medical advice prior to use to ensure appropriate management and consideration of any potential risks.

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 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 patients with reduced kidney function, as the lack of data necessitates careful clinical judgment. Regular monitoring of renal function is advisable to ensure patient safety and therapeutic efficacy.

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. The maximum recommended dosage is 6 caplets in a 24-hour period; exceeding this limit may lead to significant hepatic injury.

Additionally, patients should be aware that the concurrent use of this product with other medications containing acetaminophen can further increase the risk of severe liver damage.

Alcohol consumption should also be carefully monitored; patients who consume 3 or more alcoholic drinks daily are at an elevated risk for liver damage while using this product. It is advisable for patients with compromised liver function to consult with a healthcare professional before using this product to ensure safe and appropriate use.

Overdosage

In cases of overdosage, significant health risks are associated with the consumption of this product, particularly concerning liver function.

Risk of Severe Liver Damage Healthcare professionals should be aware that severe liver damage may occur if a patient exceeds the maximum recommended dosage of 6 caplets within a 24-hour period. This threshold is critical for maintaining liver health and preventing toxicity.

Additionally, the concomitant use of this product with other medications containing acetaminophen poses a substantial risk for severe liver damage. It is imperative for healthcare providers to assess a patient's complete medication history to avoid potential interactions that could exacerbate liver toxicity.

Alcohol Consumption 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 counsel patients on the dangers of alcohol consumption during treatment and consider monitoring liver function in those who may be at risk.

Recommended Actions In the event of suspected overdosage, immediate medical attention is warranted. Healthcare providers should initiate appropriate management procedures, which may include supportive care and monitoring of liver function tests. It is essential to educate patients on the importance of adhering to recommended dosages and the potential consequences of exceeding them.

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 use of the compound in these contexts.

Postmarketing Experience

Postmarketing experience has identified rare cases of severe skin reactions associated with acetaminophen use. Reported symptoms include skin reddening, blisters, and rash. These events were documented through voluntary reports and surveillance programs.

Patient Counseling

Healthcare providers should advise patients to seek immediate medical assistance or contact a Poison Control Center (1-800 222-1222) in the event of an overdose, emphasizing that prompt medical attention is crucial 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 drugs that contain acetaminophen, whether prescription or nonprescription. If patients are uncertain about the presence of acetaminophen in their medications, they should be encouraged to consult with a doctor or pharmacist for clarification.

It is important to instruct patients to avoid using this product if they have a known allergy to acetaminophen or any of the inactive ingredients included in the formulation.

Patients should be counseled to discontinue use and consult a doctor if their pain worsens or persists for more than 10 days. Similarly, they should stop using the medication and seek medical advice if their fever worsens or lasts longer than 3 days. Additionally, patients should be advised to stop use and contact a healthcare professional if they experience new symptoms or notice any redness or swelling, as these may indicate a serious condition.

Healthcare providers should also recommend that patients consult a doctor before using this medication if they have liver disease. Furthermore, patients taking the blood-thinning medication warfarin should be advised to speak with a doctor or pharmacist prior to using this product to ensure safety and avoid potential interactions.

Storage and Handling

The product is supplied in a configuration that includes an NDC number for identification. It should be stored at a temperature range of 20-25°C (68-77°F) to maintain its integrity and efficacy.

Healthcare professionals are advised to inspect the product prior to use; it must not be used if the printed seal under the cap is missing or damaged, as this may compromise the product's safety and effectiveness. Proper handling and storage conditions are essential to ensure the quality of the product throughout its shelf life.

Additional Clinical Information

The medication is administered orally. For adults, the recommended dosage is 2 caplets every 8 hours, taken with water. Patients should swallow the caplets whole and must not crush, chew, split, or dissolve them. It is important for patients not to exceed 6 caplets within a 24-hour period and to avoid using the medication for more than 10 days unless directed by a healthcare professional.

No additional information is available regarding laboratory tests, abuse potential, patient counseling, or postmarketing experience.

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)