Arthritis 8 Hour

Description

Acetaminophen is an extended-release formulation available in tablet form, specifically designed for the relief of minor muscle aches and pain, as well as for fever reduction. Each tablet contains 650 mg of acetaminophen and is capsule-shaped. The product is packaged in a bottle containing 100 caplets. This formulation provides relief for up to 8 hours. Acetaminophen extended-release tablets are distributed by Safeway Inc.

Uses and Indications

This drug is indicated for the temporary relief of minor aches and pains associated with muscular aches, backache, headache, toothache, 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, 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.

• Patients who have difficulty swallowing large tablets or capsules should not use this product. Special consideration should be given to individuals over the age of 65, as they may experience increased difficulty in swallowing these forms of medication.

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 concerning 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, or if they have difficulty swallowing large tablets or capsules. Special caution is warranted for individuals over the age of 65, as they may experience challenges in swallowing these tablets.

Before using this product, patients should consult a healthcare professional if they have liver disease or are taking the blood-thinning medication warfarin.

Patients should discontinue use and seek medical advice if they experience worsening pain lasting 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, as these may indicate a serious condition.

In the event of an overdose, which may occur if the recommended dose is exceeded, patients should seek immediate medical assistance or contact a Poison Control Center at 1-800-222-1222. Prompt medical attention is crucial for both adults and children, even if no signs or symptoms of overdose 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 clinical judgment and INR (International Normalized Ratio) results. Regular monitoring of coagulation parameters is recommended to ensure patient safety.

Packaging & NDC

Below are the non-prescription pack sizes of 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, 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 adolescents and adults, even if no immediate signs or symptoms are present.

Geriatric Use

Elderly patients, particularly those aged 65 and older, may experience difficulty swallowing the tablets. This consideration is important when prescribing this medication, as it may impact adherence to the treatment regimen. Healthcare providers should assess the ability of geriatric patients to swallow the tablets and consider alternative formulations or methods of administration if necessary to ensure effective treatment and patient compliance.

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 discuss their individual circumstances and any potential risks with their healthcare provider before initiating treatment.

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 no specific information regarding dosage adjustments, special monitoring, or safety considerations provided in the drug insert. Therefore, healthcare professionals should exercise caution when prescribing this medication to individuals with reduced kidney function, as the lack of data necessitates careful clinical judgment.

Hepatic Impairment

Patients with hepatic impairment should be aware that this product contains acetaminophen, which carries a risk of severe liver damage. It is crucial for these patients to adhere to the following guidelines to minimize the risk of liver injury:

• The maximum recommended dosage is 6 caplets in a 24-hour period. Exceeding this limit may lead to significant liver damage.

• Patients should avoid the concurrent use of other medications containing acetaminophen, as this can increase the risk of overdose and subsequent liver damage.

• Consumption of 3 or more alcoholic drinks daily while using this product is not advised, as it may exacerbate the risk of liver injury.

Before using this product, patients with liver disease should consult a healthcare professional to assess the appropriateness of use.

In the event of an overdose, which may occur if the recommended dose is exceeded, immediate medical attention is essential. Patients should seek help or contact a Poison Control Center (1-800-222-1222) without delay, as prompt intervention is critical for both adults and children, even in the absence of noticeable signs or symptoms.

Overdosage

Taking more than the recommended dose of this medication may lead to significant liver damage. It is crucial for healthcare professionals to recognize the seriousness of an overdose and the potential for severe health consequences.

In the event of an overdose, immediate medical assistance should be sought. Healthcare providers are advised to contact a Poison Control Center at 1-800-222-1222 for guidance on management and treatment protocols. Quick medical attention is essential for both adults and children, even in the absence of noticeable signs or symptoms of overdose. Prompt intervention can be critical in mitigating the risks associated with overdose and ensuring patient safety.

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

No specific postmarketing experience details are available. As such, there are no additional adverse events or rare case reports to summarize at this time.

Patient Counseling

Healthcare providers should advise patients about the risks associated with overdose. It is important to communicate that taking more than the recommended dose may lead to liver damage. Patients should be informed that in the event of an overdose, they must seek medical help immediately or contact a Poison Control Center at 1-800-222-1222.

Emphasize the urgency of obtaining quick medical attention, highlighting that this is critical for both adults and children, even if they do not exhibit any signs or symptoms of overdose. This information is essential for ensuring patient safety and promoting appropriate responses in emergency 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 from the bottle. 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

The medication is administered orally, with specific guidelines for dosing. Adults and children aged 12 years and older are instructed to take 2 caplets every 8 hours with water, ensuring that the caplets are swallowed whole without crushing, chewing, or dissolving. Patients should not exceed 6 caplets within a 24-hour period and should not use the medication for more than 10 days unless directed by a healthcare professional. The medication is not recommended for children under 12 years of age.

No additional information is available regarding laboratory tests, abuse potential, patient counseling, or postmarketing experiences.

Drug Information (PDF)

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

View product document (PDF)