Pain Relief

Description

No description information is available for the specified drug.

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, the common cold, toothache, 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 and children aged 12 years and older are instructed to take 2 caplets every 6 hours as needed while symptoms persist. The maximum dosage should not exceed 6 caplets within a 24-hour period, unless otherwise directed by a healthcare professional. Additionally, the duration of use should not exceed 10 days unless advised by a doctor.

For children under 12 years of age, it is recommended to consult a healthcare professional for appropriate dosing guidance.

Contraindications

Use of this product is contraindicated in the following situations:

Patients should not use this product in conjunction with any other medication containing acetaminophen, whether prescription or nonprescription, 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 is contraindicated in individuals with a known allergy to acetaminophen or any of the inactive ingredients contained in the formulation, as this may lead to severe allergic reactions.

Warnings and Precautions

This product contains acetaminophen, which carries specific warnings and precautions that healthcare professionals should be aware of to ensure safe use.

Liver Warning Severe liver damage may occur if acetaminophen is taken in conjunction with other medications containing acetaminophen, if the total daily dosage exceeds 4,000 mg, or if the patient consumes three or more alcoholic drinks daily while using this product. It is imperative to 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. Should any of these symptoms occur, it is crucial to discontinue use immediately and seek medical assistance.

General Precautions Healthcare professionals 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 the event of an accidental overdose, it is essential to obtain medical help or contact a Poison Control Center immediately. Prompt medical attention is critical for both adults and children, even if no signs or symptoms are initially apparent.

Discontinuation and Consultation Patients should be instructed to stop taking this product and consult a doctor if they experience redness or swelling, if pain worsens or persists beyond 10 days, if fever intensifies or lasts more than 3 days, or if new symptoms arise. These may indicate a serious underlying condition that requires further evaluation.

Side Effects

Patients using this product should be aware of potential adverse reactions, particularly those related to liver health and allergic responses.

Severe liver damage may occur if patients take this product in conjunction with other medications containing acetaminophen, exceed a dosage of 4,000 mg of acetaminophen within a 24-hour period, or consume three or more alcoholic drinks daily while using this product.

Additionally, there is an allergy alert associated with acetaminophen, which may lead to severe skin reactions. Symptoms of such reactions can include skin reddening, blisters, and rash. In the event of a skin reaction, patients are advised to discontinue use immediately and seek medical assistance.

Patients should not use this product if they are allergic to acetaminophen or any of the inactive ingredients contained within. It is also recommended that patients consult a doctor before use if they have liver disease or are taking the blood-thinning medication warfarin.

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

Drug Interactions

Patients taking warfarin, a blood-thinning medication, should consult with a healthcare professional prior to using this drug. The interaction between this drug and warfarin may necessitate careful monitoring of coagulation parameters to ensure therapeutic efficacy and safety. 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 Relief (acetaminophen). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients under 12 years of age should consult a healthcare professional before use. 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, unless otherwise directed by a physician. Treatment should not exceed 10 days without medical advice.

In the event of an accidental overdose, immediate medical assistance should be sought, or contact with a Poison Control Center is advised. Prompt medical attention is essential for both adults and pediatric patients, even in the absence of noticeable signs or symptoms.

Geriatric Use

Elderly patients should consult a healthcare provider prior to using this medication, particularly if they have a history of liver disease. It is also advisable for geriatric patients to seek guidance from a doctor or pharmacist if they are concurrently taking warfarin, a blood-thinning medication, due to potential interactions that may necessitate dosage adjustments or increased monitoring.

Additionally, it is crucial to keep this medication out of reach of children. In the event of an accidental overdose, immediate medical assistance should be sought, or the Poison Control Center should be contacted without delay. Prompt medical attention is essential for both adults and children, even if no signs or symptoms of overdose are apparent.

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

There is no specific information regarding dosage adjustments, special monitoring, or safety considerations for patients with renal impairment. Healthcare professionals should exercise caution when prescribing to patients 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 for patients to avoid taking this product in conjunction with other medications that contain acetaminophen, as this can significantly increase the risk of hepatotoxicity.

Additionally, patients should not exceed a total daily dose of 4,000 mg of acetaminophen, as higher doses may lead to severe liver injury. Consumption of three or more alcoholic drinks per day while using this product is also contraindicated, as it may exacerbate the risk of liver damage.

Patients with known liver disease are advised to consult a healthcare professional prior to using this product to ensure safe and appropriate use. Monitoring of liver function may be warranted in patients with compromised liver function to prevent potential adverse effects.

Overdosage

In the event of an accidental overdose, it is imperative to seek immediate medical assistance or contact a Poison Control Center without delay. 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 lack of immediate symptoms does not preclude the potential for serious adverse effects. Therefore, vigilance and timely action are essential in managing overdose situations effectively.

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 in these areas limits the understanding of the compound's potential effects in nonclinical settings.

Postmarketing Experience

Postmarketing experience has identified that acetaminophen may be associated with severe skin reactions. Reports indicate that symptoms can include skin reddening, blisters, and rash. In the event of a skin reaction, it is advised to discontinue use immediately and seek medical assistance.

Patient Counseling

Healthcare providers should advise patients about the importance of seeking immediate medical assistance in the event of an accidental overdose. Patients should be informed to contact a Poison Control Center or seek medical help right away, as prompt medical attention is critical for both adults and children. It is essential to emphasize that even if no signs or symptoms are apparent, medical evaluation is necessary to ensure safety and appropriate care.

Storage and Handling

The product is supplied with specific labeling that includes the expiration date and lot number, which can be found on the end flap of the packaging. It is essential to store the product at a controlled room temperature of 25°C (77°F). Temporary excursions from this temperature are permissible, provided they remain within the range of 15°C to 30°C (59°F to 86°F). Proper storage conditions are crucial to maintain the integrity and efficacy of the product.

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. In the event of an accidental overdose, it is crucial for patients to seek medical assistance or contact a Poison Control Center immediately, as prompt medical attention is essential for both adults and children, even if no signs or symptoms are apparent.

Drug Information (PDF)

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

View product document (PDF)