Pain Reliever

Description

The product is identified by SPL code 34089-3. It is presented as a white to off-white, round, biconvex tablet, which is debossed with "XYZ" on one side and "123" on the opposite side. Each tablet contains 500 mg of the active ingredient. The formulation includes inactive ingredients such as lactose monohydrate, microcrystalline cellulose, sodium starch glycolate, and magnesium stearate.

Uses and Indications

This drug is indicated for the temporary relief of minor aches and pains associated with various conditions, including headache, muscular aches, backache, minor pain from arthritis, the common cold, toothache, 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 and children 12 years of age and older are instructed to take 2 caplets every 6 hours as needed while symptoms persist. It is imperative that they do not exceed a total of 6 caplets within a 24-hour period. Additionally, the use of this medication should not extend beyond 10 days unless specifically directed by a healthcare professional.

For children under 12 years of age, the use of this medication is not recommended. Healthcare professionals should advise patients to adhere strictly to the dosing guidelines and to be aware of the overdose warning associated with this medication.

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

This product contains acetaminophen, which necessitates careful consideration of the following warnings and precautions to ensure safe use.

Liver Warning The maximum daily dose of this product is 6 caplets (3000 mg) within a 24-hour period. Severe liver damage may occur if the following conditions are met: exceeding 4000 mg of acetaminophen in 24 hours, concomitant use with other medications containing acetaminophen, or consumption of 3 or more alcoholic drinks daily while using this product. Healthcare professionals should monitor patients for signs of liver dysfunction, particularly in those who may be at increased risk.

Allergy Alert Acetaminophen has the potential to cause severe skin reactions. Symptoms may include skin reddening, blisters, and rash. In the event of a skin reaction, it is imperative to discontinue use immediately and seek medical assistance.

General Precautions Healthcare providers should advise patients to consult a doctor prior to use if they have a history of liver disease. Additionally, patients taking the anticoagulant warfarin should seek guidance from a doctor or pharmacist before using this product, as interactions may occur.

Emergency Medical Help In cases of overdose, it is crucial to obtain emergency medical help or contact a Poison Control Center (1-800-222-1222) immediately. Prompt medical attention is essential for both adults and children, even in the absence of noticeable signs or symptoms.

Monitoring and Follow-Up Patients should be instructed to stop taking the product and contact their healthcare provider if any of the following occur: worsening pain that lasts 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. These symptoms may indicate a serious underlying condition that requires further evaluation.

Side Effects

Patients using this product should be aware of potential adverse reactions associated with its use, particularly those related to acetaminophen.

Severe liver damage may occur if patients exceed the maximum daily dose of 4000 mg of acetaminophen within 24 hours, take this product in conjunction with other medications containing acetaminophen, or consume three or more alcoholic drinks daily while using this product. It is crucial for patients to adhere to the recommended dosage of no more than 6 caplets (3000 mg) in a 24-hour period to mitigate the risk of liver injury.

Additionally, patients should be vigilant for severe skin reactions, which may manifest as skin reddening, blisters, or rash. In the event of any skin reaction, patients are advised to discontinue use immediately and seek medical assistance.

Patients are also instructed to stop use and consult a healthcare professional 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 is observed, as these may indicate a serious underlying condition.

Before using this product, patients with liver disease should consult a healthcare provider. Furthermore, individuals taking the blood-thinning medication warfarin are advised to seek guidance from a doctor or pharmacist prior to use.

Drug Interactions

Patients taking warfarin, a blood-thinning medication, should consult with a healthcare professional prior to using this drug. The interaction between this medication and warfarin may necessitate careful monitoring of coagulation parameters to avoid potential adverse effects related to increased bleeding risk. Adjustments to the dosage of either medication may be required based on clinical judgment and patient response.

Packaging & NDC

Below are the non-prescription pack sizes of Pain Reliever (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 6 hours as needed, with a maximum of 6 caplets in a 24-hour period. Treatment should not exceed 10 days unless directed by a healthcare professional.

In the event of an overdose, prompt medical attention is essential for both adults and pediatric patients, even if no signs or symptoms are immediately apparent.

Geriatric Use

Elderly patients may not have specific information regarding the use of this medication, including 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 potential adverse effects or changes in therapeutic response, given the lack of targeted data for 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 weighed, as the effects on fetal outcomes and lactation are not fully established. It is essential for women of childbearing potential to seek medical advice to ensure safe use during pregnancy and lactation.

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 available data regarding dosage adjustments, special monitoring, or safety considerations. Therefore, healthcare professionals should exercise caution when prescribing this medication to patients with reduced kidney function, as the lack of information necessitates careful clinical judgment and monitoring.

Hepatic Impairment

Patients with hepatic impairment should be closely monitored when using this product, which contains acetaminophen. The maximum daily dose for patients is limited to 6 caplets (3000 mg) within a 24-hour period. It is critical to note that severe liver damage may occur if patients exceed 4000 mg of acetaminophen in a 24-hour period, consume other medications containing acetaminophen concurrently, or consume 3 or more alcoholic drinks daily while using this product.

Due to the potential for increased risk of liver toxicity, patients with compromised liver function should be advised to adhere strictly to the recommended dosage and to avoid the use of additional acetaminophen-containing products. Regular monitoring of liver function may be warranted in these patients to ensure safety and to mitigate the risk of adverse effects.

Overdosage

In the event of overdosage, it is critical to recognize the potential risks associated with excessive intake of this product. The maximum recommended daily dose is 6 caplets, equating to 3000 mg within a 24-hour period. Exceeding this dosage can lead to serious health complications.

Risk of Severe Liver Damage Severe liver damage may occur if an individual ingests more than 4000 mg of acetaminophen within a 24-hour timeframe. Additionally, the risk of liver damage is heightened when this product is taken concurrently with other medications that contain acetaminophen. Healthcare professionals should be vigilant in assessing the total acetaminophen intake from all sources to prevent potential toxicity.

Furthermore, the consumption of three or more alcoholic drinks daily while using this product significantly increases the risk of severe liver damage. It is advisable for healthcare providers to counsel patients on the dangers of combining alcohol with acetaminophen-containing products.

Recommended Actions In cases of suspected overdosage, immediate medical attention is warranted. Healthcare professionals should initiate appropriate management procedures, which may include monitoring liver function and considering the administration of N-acetylcysteine as an antidote, depending on the severity of the overdose and the time elapsed since ingestion. Prompt intervention is essential to mitigate the risk of irreversible liver damage.

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 postmarketing experience details are available in the insert text.

Patient Counseling

Healthcare providers should advise patients about the potential risks associated with overdose, emphasizing that taking more than the recommended dose may lead to liver damage. In the event of an overdose, patients should seek medical help immediately or contact a Poison Control Center at 1-800-222-1222, as prompt medical attention is crucial 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 whether a drug contains acetaminophen, 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, if their fever intensifies 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 seek medical guidance before using this medication. Additionally, those taking the blood-thinning medication warfarin should be encouraged to consult with a doctor or pharmacist prior to use to ensure safety and avoid potential interactions.

Storage and Handling

The product is supplied in various package configurations, with specific NDC numbers available for identification. It is essential to store the product at a temperature range of 15° to 30°C (59° to 86°F) to maintain its efficacy and stability. Proper container requirements should be adhered to, ensuring that the product is kept in a suitable environment. Special handling needs must be observed to prevent any compromise to the product's integrity during storage and transportation.

Additional Clinical Information

The medication is administered orally. Clinicians should advise patients who are pregnant or breastfeeding to consult a health professional prior to use. No further information is available regarding laboratory tests, abuse potential, or postmarketing experiences.

Drug Information (PDF)

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

View product document (PDF)