Acetaminophen

Description

Acetaminophen Extended-Release Tablets USP contain 650 mg of acetaminophen per tablet. This formulation is designed for the temporary relief of minor arthritis pain and functions as a pain reliever and fever reducer. The extended-release formulation allows for prolonged therapeutic effects, providing sustained relief. This product is comparable to Tylenol® 8 HR Arthritis Pain.

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, toothache, the common cold, and headache. 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 tablets every 8 hours with water. The tablets should be swallowed whole and must not be crushed, chewed, split, or dissolved. The maximum dosage should not exceed 6 tablets 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:

Patients should not use this product in conjunction with any other medication 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.

Additionally, this product is contraindicated in individuals with a known allergy to acetaminophen or any of the inactive ingredients contained in the formulation, as this may lead to severe allergic reactions.

Warnings and Precautions

This product contains acetaminophen, which carries specific warnings and precautions that healthcare professionals must communicate to patients to ensure safe use.

Liver Warning Severe liver damage may occur if the maximum daily dosage of 6 tablets is exceeded within a 24-hour period. Additionally, the risk of liver damage increases if this product is taken concurrently with other medications containing acetaminophen or if the patient consumes 3 or more alcoholic drinks daily while using this product. It is essential to monitor patients for signs of liver dysfunction, particularly in those who may be at higher risk due to concurrent medication use or alcohol consumption.

Allergy Alert Acetaminophen may lead to severe skin reactions, which can manifest as skin reddening, blisters, or rash. Healthcare professionals should advise patients to discontinue use immediately and seek medical assistance if any of these symptoms occur.

Emergency Medical Help In the event of an overdose, it is critical to seek emergency medical help or contact a Poison Control Center (1-800-222-1222) without delay. Prompt medical attention is vital for both adults and children, even if no signs or symptoms are immediately apparent.

Monitoring and Follow-Up Patients should be instructed to stop taking the product and consult their healthcare provider if any of the following occur: worsening pain that lasts more than 10 days, fever that worsens or persists for 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.

Pregnancy and Breastfeeding Healthcare professionals should advise patients who are pregnant or breastfeeding to consult with a health professional before using this product to ensure safety for both the mother and child.

Side Effects

Patients using this product should be aware of potential adverse reactions associated with its use, particularly those related to acetaminophen.

Severe liver damage may occur if patients exceed the maximum daily dosage of 6 tablets within 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.

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 redness or swelling is observed, as these may indicate a serious underlying condition.

For pregnant or breastfeeding individuals, it is recommended to consult a healthcare professional prior to use.

Drug Interactions

Patients should consult a healthcare professional prior to using this medication if they are concurrently taking warfarin, a blood-thinning agent. The combination may increase the risk of bleeding due to potential pharmacodynamic interactions.

Additionally, this medication should not be used in conjunction with any other products containing acetaminophen, whether prescription or over-the-counter. Co-administration may lead to an increased risk of acetaminophen-related hepatotoxicity. If there is uncertainty regarding the presence of acetaminophen in other medications, patients are advised to seek guidance from a healthcare provider.

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 before use. It is essential to evaluate the appropriateness of treatment and dosage for this population, as specific recommendations may vary based on individual health needs and conditions.

Geriatric Use

Elderly patients should exercise caution when using this medication, particularly those aged 65 and older. It is advisable for geriatric patients to consult a healthcare provider prior to use if they have a history of liver disease, as this may necessitate dosage adjustments or increased monitoring.

Additionally, elderly patients who are concurrently taking the anticoagulant warfarin should seek guidance from a doctor or pharmacist before initiating treatment with this medication, due to potential interactions that could affect bleeding risk.

For adults, including elderly patients, the maximum recommended dosage is 6 tablets within a 24-hour period. Furthermore, it is important for geriatric patients to refrain from using this medication for more than 10 days unless specifically directed by a healthcare provider, to mitigate the risk of adverse effects and ensure appropriate management of their condition.

Patients under 18 years of age should also consult a doctor prior to use, highlighting the importance of professional guidance across different age groups.

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 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 mothers.

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 to patients with reduced kidney function, as the lack of detailed guidance necessitates careful clinical judgment and individualized patient assessment. Regular monitoring of renal function is advisable to ensure patient safety and optimal therapeutic outcomes.

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 6 tablets within a 24-hour period. Additionally, the risk of liver damage increases if patients take other medications containing acetaminophen or consume 3 or more alcoholic drinks daily while using this product.

Due to the potential for increased risk of hepatotoxicity, patients with compromised liver function should be advised to adhere strictly to the recommended dosage and to avoid concurrent use of other acetaminophen-containing products and excessive alcohol consumption. Regular assessment of liver function may be warranted in these patients to ensure safety and prevent 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 Healthcare professionals should advise patients that exceeding the maximum recommended dosage of 6 tablets within a 24-hour period significantly increases the risk of severe liver damage.

Drug Interactions The concomitant use of this product with other medications containing acetaminophen can also lead to severe liver damage. It is essential for healthcare providers to review patients' medication regimens thoroughly to prevent such interactions.

Alcohol Consumption Patients should be cautioned against the consumption of 3 or more alcoholic drinks daily while using this product, as this behavior further elevates the risk of liver damage.

In the event of suspected overdosage, immediate medical attention is warranted. Healthcare professionals should monitor liver function and consider appropriate management strategies based on the severity of the symptoms presented.

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. Reported symptoms may include skin reddening, blisters, and rash. In the event of a skin reaction, it is advised that the use of the product be discontinued and medical assistance be sought immediately.

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 crucial to emphasize that prompt medical attention is necessary for both adults and children, even if no signs or symptoms are apparent.

Patients should be instructed to consult with their doctor before using the medication if they have a history of liver disease. Additionally, it is important for patients to discuss their current medications with their healthcare provider, particularly if they are taking the blood-thinning medication warfarin, as this may affect the safety and efficacy of the treatment.

Healthcare providers should inform patients to discontinue use and consult a doctor if their pain worsens or persists for more than 10 days. Similarly, patients should be advised to stop using the medication and seek medical advice if their fever intensifies or lasts longer than 3 days. They should also be instructed to report any new symptoms that arise during treatment.

Furthermore, patients should be made aware that the presence of redness or swelling may indicate a serious condition, warranting immediate consultation with a healthcare professional. Lastly, it is essential to remind patients who are pregnant or breastfeeding to seek guidance from a health professional before using the medication.

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 temperature range of 20°C to 25°C (68°F to 77°F). Care should be taken to avoid exposure to excessive heat, specifically temperatures exceeding 40°C (104°F). Proper storage conditions are crucial to maintain the integrity and efficacy of the product.

Additional Clinical Information

Laboratory tests for the product include a pending USP Dissolution test. The recommended route of administration is oral. For adults, the dosage is 2 tablets every 8 hours with water, to be swallowed whole without crushing, chewing, splitting, or dissolving. Patients should not exceed 6 tablets in a 24-hour period and should not use the product for more than 10 days unless directed by a healthcare professional. For individuals under 18 years of age, consultation with a doctor is advised prior to use.

Patients who are pregnant or breastfeeding should seek advice from a healthcare professional before using the product. There is no additional information available regarding abuse potential 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)