Acetaminophen Extended-Release Tablets, 650 mg

Description

Acetaminophen Extended-Release Tablets USP are formulated to provide relief from arthritis pain and muscle aches. Each tablet contains 650 mg of acetaminophen. The product is available in various packaging configurations, including 24 count and 100 count cartons and bottles, as well as 225 count and 290 count cartons and bottles. The National Drug Codes (NDC) associated with this formulation include 25000-071-02, 25000-071-08, 25000-071-10, 25000-071-11, 25000-071-45, 25000-108-02, and 25000-108-08.

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 and children aged 12 years and over 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 children under 12 years of age, it is recommended to consult a doctor 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 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 to adhere strictly to the following guidelines to minimize the risk of liver injury: do not exceed 6 caplets within a 24-hour period, avoid concurrent use with other medications containing acetaminophen, and limit alcohol consumption to fewer than 3 drinks per day while using this product.

Acetaminophen has been associated with severe skin reactions, which may manifest as skin reddening, blisters, or rash. In the event of any skin reaction, patients should 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 attention is crucial for both adults and children, even if no signs or symptoms are immediately apparent.

Patients should be instructed to stop taking the product and consult their healthcare provider if any of the following occur: pain worsens or persists for more than 10 days, fever intensifies or lasts longer than 3 days, new symptoms develop, or if redness or swelling is observed. These symptoms 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 related to liver health and allergic skin responses.

Severe liver damage may occur if patients exceed the maximum recommended dosage of 6 caplets in a 24-hour period, use other medications containing acetaminophen concurrently, or consume 3 or more alcoholic drinks daily while using this product.

Additionally, acetaminophen may cause severe skin reactions, which can manifest as skin reddening, blisters, or rash. In the event of any skin reaction, patients are advised to discontinue use immediately and seek medical assistance.

Patients should also be instructed to stop 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 there is any redness or swelling, as these may indicate a serious underlying condition.

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

Drug Interactions

Patients taking the anticoagulant warfarin should consult with a healthcare professional prior to using 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 either medication may be required based on clinical judgment and patient response.

Packaging & NDC

Below are the non-prescription pack sizes of Acetaminophen Extended-Release Tablets, 650 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 8 hours with water, not to exceed 6 caplets in a 24-hour period. Use should not extend beyond 10 days unless directed by a healthcare provider.

In the event of an overdose, prompt medical attention is essential for both adults and pediatric patients, even if no signs or symptoms are immediately apparent.

Geriatric Use

Elderly patients should consult a healthcare provider prior to use if they have liver disease, as this may affect the safety and efficacy of the medication. Additionally, it is important for geriatric patients to seek advice from a doctor or pharmacist if they are concurrently taking the anticoagulant warfarin, due to potential interactions that could increase the risk of bleeding.

For elderly patients, it is crucial to adhere to the recommended dosage guidelines. The maximum dosage should not exceed 6 caplets within a 24-hour period. Furthermore, the medication should not be used for more than 10 days unless specifically directed by a healthcare professional.

In the event of an overdose, prompt medical attention is essential for elderly patients, as well as for children, even if no immediate signs or symptoms are apparent. Monitoring for adverse effects and ensuring appropriate use is particularly important in this population to mitigate risks associated with medication use.

Pregnancy

Pregnant patients and those who are breastfeeding should consult a healthcare professional prior to 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 to weigh the benefits and risks associated with the use of this medication 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

There is no information available regarding dosage adjustments, special monitoring, or safety considerations for patients with renal impairment. Healthcare professionals should exercise caution and consider the lack of specific guidance when prescribing to patients with reduced kidney function.

Hepatic Impairment

Patients with hepatic impairment should exercise caution when using this product, which contains acetaminophen. The maximum recommended dosage is 6 caplets within a 24-hour period; exceeding this limit may result in severe liver damage.

Additionally, patients must be aware that taking this product in conjunction with other medications containing acetaminophen can also lead to severe liver damage.

Furthermore, the risk of liver damage is heightened for patients who consume three or more alcoholic drinks daily 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. Regular monitoring of liver function may be warranted in these patients to prevent potential adverse effects.

Overdosage

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

Maximum Daily Dosage Taking more than 6 caplets within a 24-hour period exceeds the maximum recommended daily dosage and may lead to significant hepatic injury. Healthcare professionals should advise patients to adhere strictly to dosing guidelines to mitigate the risk of overdosage.

Drug Interactions The concomitant use of this product with other medications containing acetaminophen can also precipitate severe liver damage. It is essential for healthcare providers to review a patient’s medication history thoroughly to identify any potential interactions that could increase the risk of hepatotoxicity.

Alcohol Consumption Patients consuming 3 or more alcoholic beverages daily while using this product are at an elevated risk for severe liver damage. Healthcare professionals should counsel patients on the dangers of alcohol consumption during treatment and recommend abstaining from alcohol to protect liver function.

In the event of suspected overdosage, immediate medical attention is warranted. Monitoring liver function tests and providing supportive care are critical 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 limits the assessment of potential risks associated with the use of the compound in question. Further studies may be necessary to elucidate these aspects of nonclinical 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 seek immediate medical assistance or contact a Poison Control Center at 1-800-222-1222 in the event of an overdose. It is important to emphasize that prompt medical attention is crucial for both adults and children, even if no signs or symptoms are initially apparent. Patients should be made aware of the seriousness of an overdose situation and the necessity of acting quickly to ensure their safety and well-being.

Storage and Handling

The product is supplied in a secure carton, and it is essential to ensure that the carton remains unopened prior to use. The product must be stored at a temperature range of 20-25°C (68-77°F) to maintain its integrity and efficacy.

Healthcare professionals should be aware that the product should not be used if the carton has been opened or if the foil inner seal is broken or missing, as this may compromise the product's safety and effectiveness. Proper handling and storage conditions are crucial to ensure the product remains suitable for use.

Additional Clinical Information

Patients aged 12 years and older are advised to take 2 caplets every 8 hours with water, ensuring they swallow the caplets whole without crushing, chewing, splitting, or dissolving them. The maximum dosage should not exceed 6 caplets in a 24-hour period, and use should not extend beyond 10 days unless directed by a healthcare professional.

Clinicians should counsel patients to consult a health professional if they are pregnant or breastfeeding. It is essential to keep the medication out of reach of children. In the event of an overdose, patients must seek immediate medical assistance or contact a Poison Control Center, as prompt attention is crucial for both adults and children, even if no symptoms are apparent.

Drug Information (PDF)

This file contains official product information for Acetaminophen Extended-Release Tablets, 650 mg, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

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