Acetaminophen 8 Hour

Description

Acetaminophen extended-release tablets, USP, are formulated as capsule-shaped tablets, each containing 650 mg of acetaminophen. These tablets are designed for the relief of minor muscle aches and pain, providing therapeutic effects for up to 8 hours. The product is packaged in a bottle containing 100 caplets, intended for use as a pain reliever and fever reducer. This description pertains to the 100 count bottle carton label for Equaline acetaminophen (8 hour) extended-release tablets, USP 650 mg.

Uses and Indications

This drug is indicated for the temporary relief of minor aches and pains associated with muscular aches, backache, headache, and minor pain of arthritis. 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 must be swallowed whole and should 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, the use of this medication is not recommended.

Contraindications

Use of this product is contraindicated in the following situations:

• Co-administration with any other drug containing acetaminophen, whether prescription or nonprescription, is prohibited. If there is uncertainty regarding the presence of acetaminophen in another medication, consultation with a healthcare professional is advised.

• This product should not be used in individuals with a known allergy to acetaminophen or any of the inactive ingredients contained in the formulation.

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 the maximum daily dosage of 6 caplets within a 24-hour period, use other medications containing acetaminophen concurrently, or consume 3 or more alcoholic drinks daily while taking this product.

Patients with a history of liver disease should be cautioned to consult a physician prior to use. Additionally, individuals taking the anticoagulant warfarin should seek guidance from a healthcare provider or pharmacist before using this product, as potential interactions may occur.

In the event of an overdose, it is imperative to seek emergency medical assistance or contact a Poison Control Center immediately at 1-800-222-1222. Prompt medical attention is crucial for both adults and children, even if no symptoms are initially apparent.

Patients should be instructed to discontinue use and consult a physician 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 signs may indicate a serious underlying condition that requires medical evaluation.

Side Effects

Patients using this product should be aware of the potential for serious adverse reactions, particularly related to liver health. The product contains acetaminophen, and severe liver damage may occur if patients exceed the maximum daily dosage of 6 caplets within a 24-hour period, take it in conjunction with other medications containing acetaminophen, or consume 3 or more alcoholic drinks daily while using this product.

Patients are advised not to use this product if they are allergic to acetaminophen or any of the inactive ingredients. Additionally, it is important to consult a healthcare professional before use if the patient has liver disease or is taking the blood-thinning medication warfarin.

Patients should discontinue use and seek medical advice if they experience worsening pain that lasts more than 10 days, a fever that persists for more than 3 days, the emergence of new symptoms, or any signs of redness or swelling, as these may indicate a serious condition.

In the event of an overdose, immediate medical assistance should be sought, or the Poison Control Center should be contacted at 1-800-222-1222. Prompt medical attention is crucial for both adults and children, even if no signs or symptoms are initially apparent.

Drug Interactions

The concomitant use of acetaminophen and warfarin may elevate the risk of bleeding due to potential pharmacodynamic interactions. It is advisable to monitor patients closely for signs of increased bleeding and to consider adjusting the dosage of warfarin as necessary based on the patient's clinical response and INR levels. Regular monitoring of coagulation parameters is recommended to ensure patient safety.

Packaging & NDC

Below are the non-prescription pack sizes of Acetaminophen 8 Hour (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 2 caplets every 8 hours with water, not to exceed 6 caplets in a 24-hour period. The duration of use should not exceed 10 days unless directed by a healthcare professional.

It is important to note that quick medical attention is critical in cases of overdose for both adults and pediatric patients, even if no signs or symptoms are immediately apparent. Additionally, this medication should be kept out of reach of children to prevent accidental ingestion.

Geriatric Use

Elderly patients may not have specific dosage adjustments, safety concerns, or special precautions outlined in the prescribing information. 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 therapeutic response, given the general considerations for pharmacokinetics and pharmacodynamics in this population.

Pregnancy

Pregnant patients 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 are not fully established. It is essential for women of childbearing potential to seek medical advice to ensure appropriate management during pregnancy.

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 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 drug insert regarding dosage adjustments, special monitoring, or safety considerations. 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 may be advisable in these patients, although specific recommendations are not provided.

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. It is critical that patients do not exceed the maximum daily dosage of 6 caplets within a 24-hour period. Additionally, patients must avoid concurrent use with other medications containing acetaminophen to mitigate the risk of hepatotoxicity.

Patients with compromised liver function are advised to consult a healthcare professional prior to using this product, particularly if they have a history of liver disease. Furthermore, consumption of three or more alcoholic drinks daily while using this product is contraindicated, as it may significantly increase the risk of liver damage. Regular monitoring of liver function may be warranted in patients with existing hepatic impairment to ensure safety and efficacy during treatment.

Overdosage

In the event of an overdose, it is imperative to seek immediate medical assistance or contact a Poison Control Center at 1-800-222-1222. Prompt medical intervention is crucial for both adults and children, even in the absence of noticeable signs or symptoms.

Healthcare professionals should be aware that the severity of symptoms may vary, and early recognition and management are essential to mitigate potential complications. It is recommended that healthcare providers remain vigilant and prepared to initiate appropriate treatment protocols based on the specific circumstances of the overdose.

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 compound in these areas.

Postmarketing Experience

Postmarketing experience has identified rare cases of severe skin reactions, including Stevens-Johnson syndrome and toxic epidermal necrolysis, associated with the use of acetaminophen. Additionally, reports of acute liver failure have been documented, with some cases resulting in liver transplantation, particularly among patients who exceeded the recommended dose or used multiple acetaminophen-containing products. Instances of allergic reactions, including anaphylaxis, have also been reported. Furthermore, there have been cases of renal impairment and acute kidney injury linked to the use of acetaminophen, especially in patients with pre-existing renal conditions or those taking high doses.

Patient Counseling

Healthcare providers should advise patients on 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. It is crucial to emphasize that prompt medical attention is necessary for both adults and children, even if they do not exhibit any signs or symptoms of overdose. This information is vital for ensuring patient safety and effective management of potential overdose situations.

Storage and Handling

The product is supplied in a container that is tamper evident; it should not be used if the imprinted seal is broken or missing. It is essential to store the product at a temperature range of 20 to 25° C (68 to 77° F). Care should be taken to avoid exposure to excessive heat, specifically temperatures above 40° C (104° F). For batch number and expiration date, please refer to the end panel of the packaging.

Additional Clinical Information

The medication is administered orally. Clinicians should advise patients who are pregnant or breastfeeding to consult a health professional prior to use. No further information is available regarding laboratory tests, abuse potential, or postmarketing experiences.

Drug Information (PDF)

This file contains official product information for Acetaminophen 8 Hour, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

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