Sunmark Arthritis 8 Hour

Description

Acetaminophen Extended-Release Tablets, USP, contain 650 mg of acetaminophen per tablet and are formulated as capsule-shaped tablets. Each bottle contains 50 caplets. This medication serves as a pain reliever and fever reducer, providing relief for up to 8 hours from minor muscular aches and pains. The product is labeled for professional use as part of the Sunmark brand.

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:

• 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 beverages daily while taking this product.

It is essential to exercise caution in specific patient populations. Patients with a history of liver disease should consult a healthcare provider prior to use. Additionally, individuals taking the anticoagulant warfarin should seek advice from a doctor or pharmacist before initiating treatment with this product, as potential interactions may occur.

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 vital for both adults and children.

Patients should discontinue use and consult a healthcare professional 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

Severe liver damage may occur in patients taking this product containing acetaminophen if they exceed the maximum daily amount of 6 caplets within 24 hours, 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.

Patients with liver disease should consult a doctor before using this product. Additionally, individuals taking the blood-thinning medication warfarin are advised to seek guidance from a healthcare professional prior to use.

Patients are instructed to discontinue use and consult a doctor if pain worsens or persists for more than 10 days, if fever intensifies or lasts longer than 3 days, if new symptoms arise, or if redness or swelling occurs, as these may indicate a serious condition.

In the event of an overdose, it is crucial for patients to seek medical assistance 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

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 bleeding complications. Adjustments to the dosage of warfarin may be required based on the clinical judgment of the healthcare provider.

Packaging & NDC

Below are the non-prescription pack sizes of Sunmark Arthritis 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, with a maximum of 6 caplets in a 24-hour period.

Healthcare professionals should be aware of the critical need for quick medical attention in cases of overdose, as this is essential for both adults and children, even in the absence of noticeable signs or symptoms.

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 and those who are breastfeeding should consult a healthcare professional prior to using this medication. It is important to assess the potential risks and benefits, as well as any available data regarding fetal outcomes and lactation. Healthcare providers can offer guidance tailored to individual circumstances, ensuring the safety of both the patient and the developing fetus or nursing infant.

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 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 individuals with reduced kidney function, as the absence of detailed guidance necessitates careful clinical judgment. Regular monitoring of renal function may be advisable in these patients to ensure safety and efficacy.

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 concurrent use of other medications containing acetaminophen and limit alcohol consumption to fewer than 3 drinks per day while using this product.

Before initiating treatment, patients with liver disease are advised to consult a healthcare professional to assess the appropriateness of this product for their condition. Monitoring of liver function may be warranted in patients with compromised liver function to prevent potential adverse effects.

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 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, there have been reports of acute liver failure in patients taking acetaminophen, particularly among those who exceed the recommended dosage or have underlying liver disease. Some patients have also experienced allergic reactions, including anaphylaxis, following the administration of acetaminophen. Furthermore, there are reports of renal impairment linked to the use of acetaminophen, especially in individuals 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 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) and to avoid exposure to excessive heat above 40° C (104° F). For batch number and expiration date, please refer to the end panel of the packaging.

Additional Clinical Information

Patients aged 12 years and older are advised to take 2 caplets orally every 8 hours with water. Clinicians should counsel patients to consult a health professional if they are pregnant or breastfeeding. It is important to keep the medication out of reach of children. In the event of an overdose, immediate medical assistance should be sought, or the Poison Control Center contacted at 1-800-222-1222, as prompt attention is crucial for both adults and children, even if no symptoms are apparent.

No additional information is available regarding laboratory tests, abuse potential, or postmarketing experience.

Drug Information (PDF)

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

View product document (PDF)