Arthritis Pain Reliever

Description

Acetaminophen Extended-Release Tablets, USP, contain 650 mg of acetaminophen per tablet and are formulated as capsule-shaped tablets. This product serves as a pain reliever and fever reducer, specifically indicated for the temporary relief of minor arthritis pain. Each bottle contains 50 caplets. The formulation is comparable to the active ingredient found in Tylenol Arthritis Pain. It is important to note that this product is not manufactured or distributed by McNeil Consumer Healthcare, Inc., and the registered trademark Tylenol is owned by the Tylenol Company.

Uses and Indications

This drug is indicated for the temporary relief of minor aches and pains associated with various conditions, including minor pain of arthritis, muscular aches, backache, headache, toothache, the common cold, and premenstrual and menstrual cramps. 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 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 individuals under 18 years of age, it is recommended to consult a doctor prior to use.

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 due to the risk of acetaminophen overdose. If there is uncertainty regarding the presence of acetaminophen in other medications, consultation with a healthcare professional is advised.

Additionally, this product should not be used in individuals with a known allergy to acetaminophen or any of the inactive ingredients contained in this formulation, as this may lead to severe allergic reactions.

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 healthcare provider prior to use. Additionally, individuals taking the anticoagulant warfarin should seek guidance 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 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 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

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.

Common adverse reactions may include worsening pain or fever that lasts beyond the recommended duration. Patients should discontinue use and seek medical advice if pain persists for more than 10 days, fever lasts more than 3 days, new symptoms arise, or if there is any 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 of overdose are initially apparent.

Drug Interactions

Patients should consult a healthcare professional prior to using this medication if they are concurrently taking warfarin, a blood-thinning agent. The combination may increase the risk of bleeding due to potential pharmacodynamic interactions.

Additionally, this medication should not be used in conjunction with any other products containing acetaminophen, whether prescription or over-the-counter. Co-administration may lead to an increased risk of acetaminophen-related hepatotoxicity. If there is uncertainty regarding the presence of acetaminophen in other medications, patients are advised to seek guidance from a healthcare provider.

Packaging & NDC

Below are the non-prescription pack sizes of Arthritis Pain Reliever (acetaminophen). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients under 18 years of age should consult a healthcare professional before use. In cases of overdose, it is critical to seek immediate medical attention for both children and adults, even if no signs or symptoms are apparent.

Geriatric Use

Elderly patients may not have specific recommendations regarding age considerations, dosage adjustments, safety concerns, or special precautions. Therefore, healthcare providers should exercise caution when prescribing this medication to geriatric patients. It is advisable to monitor these patients closely for any adverse effects or changes in therapeutic response, given the potential for altered pharmacokinetics and pharmacodynamics in this population.

Pregnancy

Pregnant patients and those who are breastfeeding should consult a healthcare professional prior to using this medication. The potential risks and benefits must be carefully considered in these populations to ensure the safety of both the mother and the fetus or 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 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 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 information is available regarding teratogenic or non-teratogenic effects. Additionally, there is no data provided concerning nonclinical toxicology, animal pharmacology, or toxicology.

Postmarketing Experience

Postmarketing experience has identified several adverse reactions reported voluntarily or through surveillance programs. These include allergic reactions, such as skin reactions characterized by rash, urticaria, and angioedema. Instances of liver injury have been noted, including cases of acute liver failure, with some requiring liver transplantation. Renal injury has also been reported, specifically acute kidney injury.

Gastrointestinal bleeding has been documented, along with serious skin reactions, including Stevens-Johnson syndrome and toxic epidermal necrolysis. Hematologic reactions, such as thrombocytopenia and leukopenia, have been observed. Additional reactions reported include nausea, vomiting, and abdominal pain. The frequency of these adverse reactions is not known.

Reports of overdose have been received, with symptoms including nausea, vomiting, and abdominal pain. Some cases of overdose have resulted in severe liver injury and death. Patients are advised to seek immediate medical attention in the event of an overdose.

Patient Counseling

Healthcare providers should advise patients to seek immediate medical assistance or contact a Poison Control Center at 1-800-222-1222 in the event of an overdose. It is crucial to emphasize that prompt medical attention is necessary for both adults and children, even if no signs or symptoms are apparent.

Patients should be informed not to use this medication in conjunction with any other products containing acetaminophen, whether prescription or nonprescription. If patients are uncertain about the presence of acetaminophen in other medications, they should be encouraged to consult with a doctor or pharmacist.

It is important to instruct patients to discontinue use and consult a doctor if their pain worsens or persists for more than 10 days. Similarly, they should stop use and seek medical advice if their fever worsens or lasts longer than 3 days, if new symptoms arise, or if they notice any redness or swelling, as these may indicate a serious condition.

Patients with a history of liver disease should be advised to consult a doctor before using this medication. Additionally, those taking the blood-thinning medication warfarin should be encouraged to speak with a doctor or pharmacist prior to use to ensure safety and avoid potential interactions.

Storage and Handling

The product is supplied in a tamper-evident container. It is essential to inspect the imprinted seal; do not use the product if the seal is broken or missing.

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

This packaging is intended for households without young children, and it is important to adhere to these storage and handling guidelines to ensure product integrity and safety.

Additional Clinical Information

The medication is administered orally, with adults advised to take 2 caplets every 8 hours with water, ensuring they are swallowed whole without crushing, chewing, splitting, or dissolving. 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. For individuals under 18 years of age, consultation with a doctor is recommended prior to use.

Clinicians should counsel patients to seek advice from a health professional if they are pregnant or breastfeeding. 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 with a Poison Control Center (1-800-222-1222) is advised, as prompt attention is essential for both adults and children, regardless of the presence of symptoms.

Drug Information (PDF)

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

View product document (PDF)