Premier Value Arthritis Pain Reliever

Description

Acetaminophen Extended-Release Tablets, USP, are formulated as gelatin-coated tablets, each containing 650 mg of acetaminophen. These tablets serve as a pain reliever and fever reducer, specifically indicated for the temporary relief of minor arthritis pain. The product is packaged in a bottle carton containing 80 geltabs, each designed for extended-release to provide prolonged therapeutic effects.

Uses and Indications

This drug is indicated for the temporary relief of minor aches and pains associated with various conditions, including muscular aches, backache, headache, toothache, the common cold, minor pain of arthritis, 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 geltabs every 8 hours, ensuring that only one geltab is swallowed at a time. Prior to swallowing each geltab, it is recommended to take a sip of water, and each geltab should be washed down with water, up to a full 8 oz. glass. Geltabs must be swallowed whole and should not be crushed, chewed, split, or dissolved. The maximum dosage should not exceed 6 geltabs 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 advised to consult a doctor before 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. If there is uncertainty regarding the presence of acetaminophen in other medications, consultation with a healthcare professional is advised.

• Patients who have difficulty swallowing large tablets or capsules should not use this product. This is particularly relevant for individuals over the age of 65, who may experience increased difficulty in swallowing.

• The product is contraindicated in individuals with a known allergy to acetaminophen or any of the inactive ingredients contained within this 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 geltabs within a 24-hour period, use this product concurrently with other medications containing acetaminophen, 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 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 healthcare professional if any of the following occur: worsening pain or pain lasting more than 10 days, worsening fever or fever lasting more than 3 days, the emergence of new symptoms, the presence of redness or swelling, or if a tablet becomes lodged in the throat. These symptoms 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 related to liver health. The product contains acetaminophen, and severe liver damage may occur if patients exceed the maximum daily dosage of 6 geltabs within a 24-hour period, use 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 currently taking any other drug that contains acetaminophen, whether prescription or nonprescription. Additionally, individuals who have difficulty swallowing large tablets or capsules, particularly those over the age of 65, should avoid this product. It is also contraindicated in patients with a known allergy to acetaminophen or any of the inactive ingredients present in the formulation.

Before using this product, patients should consult a healthcare professional if they have liver disease or are taking the anticoagulant medication warfarin, as these conditions may increase the risk of adverse effects.

Patients should discontinue use and seek medical advice 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, signs of redness or swelling, or if the tablet becomes lodged in the throat. These symptoms may indicate a serious underlying condition.

In the event of an overdose, it is crucial for patients to seek immediate medical assistance 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. It is advisable to monitor patients closely for signs of bleeding and to consider dosage adjustments of warfarin as necessary.

Acetaminophen should not be used in conjunction with other medications containing acetaminophen, whether prescription or nonprescription, to avoid the risk of overdose.

Additionally, the consumption of three or more alcoholic beverages daily while using acetaminophen may significantly increase the risk of liver damage. Patients should be counseled to limit alcohol intake during treatment with acetaminophen to mitigate this risk.

Packaging & NDC

Below are the non-prescription pack sizes of Premier Value 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 prior to use. It is important to assess the appropriateness of treatment and dosage for this population.

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. It is essential for women of childbearing potential to discuss their individual circumstances with their healthcare provider to weigh the benefits and risks associated with the use of this medication during pregnancy.

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 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 geltabs 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

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 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. The storage conditions require the product to be maintained at a temperature range of 20 to 25° C (68 to 77° F), with precautions taken to avoid high humidity. 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, with adults advised to take 2 geltabs every 8 hours. Each geltab should be swallowed whole, accompanied by a sip of water before and a full glass of water after, without crushing, chewing, splitting, or dissolving. The maximum dosage is 6 geltabs within a 24-hour period, and use should not exceed 10 days unless directed by a healthcare provider.

Clinicians should counsel patients to consult a doctor before use if they have liver disease or are taking the blood thinner warfarin. Pregnant or breastfeeding individuals should seek advice from a health professional prior to use. It is essential to keep the medication out of reach of children, and 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, regardless of the presence of symptoms.

Drug Information (PDF)

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

View product document (PDF)