Acetaminophen 8 Hour

Description

Acetaminophen Extended-Release Tablets, USP, contain 650 mg of acetaminophen per tablet. These capsule-shaped tablets are formulated as a pain reliever and fever reducer, providing relief for up to 8 hours from minor muscular aches and pains. Each bottle contains 100 caplets. The product is gluten-free and dye-free. It is distributed by CVS Pharmacy, Inc.

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 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, 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 necessitate closer monitoring.

In the event of an overdose, immediate medical assistance is crucial. Patients should be instructed to contact a Poison Control Center at 1-800-222-1222 or seek emergency medical help without delay, regardless of the presence of symptoms, as prompt intervention is essential for both adults and children.

Patients should 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 further 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 avoid concurrent use with any other drug containing acetaminophen, whether prescription or nonprescription. If there is uncertainty regarding the presence of acetaminophen in other medications, patients should consult a healthcare professional.

Before using this product, patients with liver disease should seek medical advice. Furthermore, those taking the blood-thinning medication warfarin should consult a doctor or pharmacist prior to use.

Patients should discontinue use and seek medical attention 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 the presence of redness or swelling, as these may indicate a serious condition.

In the event of an overdose, it is critical for patients to obtain medical help immediately or contact a Poison Control Center at 1-800-222-1222. Prompt medical attention is essential for both adults and children, even if no signs or symptoms are initially apparent.

Drug Interactions

The concomitant use of acetaminophen with warfarin may elevate the risk of bleeding due to the anticoagulant effects of warfarin. It is advisable to monitor patients closely for signs of increased bleeding and to consider dosage adjustments of warfarin as necessary.

Additionally, acetaminophen should not be used in conjunction with any other medications that contain acetaminophen, whether prescription or nonprescription. This precaution is essential to avoid the risk of acetaminophen overdose, which can lead to severe hepatic injury.

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 patients aged 12 years and older, the recommended dosage is 2 caplets every 8 hours with water, to be swallowed whole without crushing, chewing, splitting, or dissolving. 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.

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. It is important to keep this medication 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 clinical judgment 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 variability in pharmacokinetics and pharmacodynamics that can occur with aging.

Pregnancy

Pregnant patients are advised to consult a healthcare professional prior to using this medication. The potential risks and benefits should be carefully considered, as the effects on fetal outcomes are not fully established. It is essential for women of childbearing potential to seek guidance 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 individuals.

Renal Impairment

Patients with renal impairment should consult a healthcare professional prior to use, particularly if they have concurrent liver disease. It is essential to assess renal function and consider potential dosing adjustments or monitoring requirements based on the degree of renal impairment. Careful evaluation of the patient's overall health status is recommended to ensure safe and effective use of the medication.

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 should avoid concomitant use with other medications containing acetaminophen, as this may further increase the risk of liver injury.

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 per day while using this product is strongly discouraged, as it may exacerbate 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 based on the specific substance involved in the overdose. Therefore, a thorough assessment and monitoring of the patient are essential.

Management procedures may include supportive care and symptomatic treatment, tailored to the individual’s clinical presentation. Continuous evaluation and appropriate interventions should be initiated as necessary to mitigate potential complications associated with 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 use of the compound in these contexts.

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 necessitating liver transplantation, particularly among patients who exceed the recommended dosage or use acetaminophen in conjunction with other products containing the same active ingredient. Instances of allergic reactions, including anaphylaxis, have also been reported. Furthermore, there have been observations of renal impairment and acute kidney injury linked to acetaminophen use, especially in patients with pre-existing renal conditions or those consuming 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 proactive approach can significantly impact the outcome in such 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. The recommended storage temperature is between 20 to 25° C (68 to 77° F). It is essential 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

Patients should be informed that the medication is administered orally. For adults and children aged 12 years and older, the recommended dosage is 2 caplets every 8 hours, taken with water. It is important to swallow the caplets whole without crushing, chewing, splitting, or dissolving them. Patients should not exceed 6 caplets in a 24-hour period and should not use the medication for more than 10 days unless directed by a healthcare professional.

Clinicians should counsel patients to consult a doctor before use if they have liver disease or are taking the blood-thinning medication warfarin. Additionally, pregnant or breastfeeding patients should seek advice from a health professional prior to use.

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.

View product document (PDF)