Acetaminophen-Apap 8 Hour

Description

Acetaminophen Extended-Release Tablets, USP 650 mg, are capsule-shaped tablets formulated for extended-release. Each tablet contains 650 mg of acetaminophen, designed to provide relief over an 8-hour period. These tablets are distributed by American Sales Company and are packaged in a 24-count blister carton.

Uses and Indications

This drug is indicated for the temporary relief of minor aches and pains associated with muscular aches, headaches, minor arthritis pain, and backaches. 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:

Patients should not use this product in conjunction with any other medication containing acetaminophen, whether prescription or nonprescription. 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.

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 three or more alcoholic beverages 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, immediate medical assistance is essential. 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 critical for both adults and children.

Patients should discontinue use and consult a physician if any of the following occur: worsening pain lasting more than 10 days, fever that persists or worsens beyond 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

Severe liver damage may occur in patients taking this product containing acetaminophen if they exceed the maximum daily amount of 6 caplets within a 24-hour period, use it concurrently with other drugs containing acetaminophen, or consume 3 or more alcoholic drinks daily while using this product.

Patients should not use this product if they are allergic to acetaminophen or any of the inactive ingredients. Additionally, it is advised that patients consult a doctor before use if they have liver disease or are taking the blood-thinning medication warfarin.

Patients are instructed to discontinue use and seek medical advice if pain worsens or persists for more than 10 days, if fever worsens or lasts more than 3 days, if new symptoms occur, or if redness or swelling is present, as these may indicate a serious condition.

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

Packaging & NDC

Below are the non-prescription pack sizes of Acetaminophen-Apap 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. Treatment 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 children, 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 general considerations for age-related physiological changes that may affect drug metabolism and efficacy.

Pregnancy

Pregnant patients 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 before initiating treatment.

Lactation

Lactating mothers are advised to consult a health professional prior to using this medication. There is currently no available data on 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 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 impairment. Careful evaluation is necessary to ensure safe and effective use in this population.

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 depending on the specific substance involved in the overdose. Therefore, a thorough assessment and monitoring of the patient are essential.

Management of an overdose 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 noted, particularly in patients with underlying liver disease or those exceeding the recommended dosage. Instances of allergic reactions, including anaphylaxis, have also been documented in the postmarketing setting. Furthermore, there have been reports of renal impairment and acute kidney injury associated with acetaminophen use, especially in patients with pre-existing kidney conditions.

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 noticeable 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. Each container is labeled with the batch number and expiration date, which can be found on the end panel.

Storage conditions require the product to be maintained at a temperature range of 20 to 25° C (68 to 77° F). It is essential to avoid exposure to excessive heat, specifically temperatures exceeding 40° C (104° F), to ensure the integrity and efficacy of the product.

Additional Clinical Information

Patients aged 12 years and older are advised to take 2 caplets orally 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 doctor before use if they have liver disease or are taking the blood-thinning medication warfarin. Pregnant or breastfeeding individuals should seek advice from a health professional prior to use. It is crucial to keep the medication out of reach of children. In the event of an overdose, immediate medical assistance should be sought, or contact a Poison Control Center at 1-800-222-1222, as prompt attention is essential for both adults and children, even if no symptoms are apparent.

Drug Information (PDF)

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

View product document (PDF)