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 headache, sore throat, flu, toothache, and the common cold. Additionally, it is indicated for the temporary reduction of fever.

There are no teratogenic or nonteratogenic effects associated with this drug.

Dosage and Administration

This product is intended for use in pediatric patients, and healthcare professionals should refer to the dosage chart to determine the appropriate dose based on the patient's weight or age. It is essential to adhere to the following guidelines:

For patients weighing under 24 pounds or under 2 years of age, consultation with a physician is required prior to administration. For patients weighing between 24 to 35 pounds or aged 2 to 3 years, the recommended dose is 1 tablet. For those weighing 36 to 47 pounds or aged 4 to 5 years, the dose is 1 ½ tablets. Patients weighing 48 to 59 pounds or aged 6 to 8 years should receive 2 tablets. For patients weighing 60 to 71 pounds or aged 9 to 10 years, the appropriate dose is 2 ½ tablets. Finally, for patients weighing 72 to 95 pounds or aged 11 years, the recommended dose is 3 tablets.

Tablets must be chewed or crushed completely before swallowing; they should not be swallowed whole. Dosing may be repeated every 4 hours as needed while symptoms persist, but it is critical not to exceed 5 doses within a 24-hour period. Healthcare professionals should ensure that patients do not receive more than the directed amount.

Contraindications

Use of this product is contraindicated in patients who are concurrently taking any other medication that contains acetaminophen, whether prescription or nonprescription. This precaution is necessary to avoid the risk of acetaminophen overdose, which can lead to serious liver damage. If there is uncertainty regarding the presence of acetaminophen in other medications, consultation with a healthcare professional is advised.

Warnings and Precautions

Severe liver damage may occur with the use of this product, which contains acetaminophen, if the maximum daily dosage is exceeded. Specifically, caregivers should be aware that administering more than 5 doses within a 24-hour period or combining this product with other medications containing acetaminophen significantly increases the risk of liver injury.

Acetaminophen is also associated with the potential for severe skin reactions. Symptoms indicative of such reactions may include skin reddening, blisters, or rash. In the event of any skin reaction, it is imperative to discontinue use immediately and seek medical assistance.

In cases of severe sore throat, particularly if it persists for more than 2 days or is accompanied by fever, headache, rash, nausea, or vomiting, it is essential to consult a healthcare professional without delay.

General precautions should be observed prior to administration. Caregivers are advised to consult a physician if the child has a history of liver disease. Additionally, it is recommended to seek guidance from a doctor or pharmacist if the child is concurrently taking the anticoagulant warfarin, as interactions may occur.

In the event of an overdose, immediate medical attention is crucial. Caregivers should contact a Poison Control Center or seek emergency medical help without hesitation, regardless of the presence of symptoms.

Patients should discontinue use and consult a healthcare provider if any of the following occur: worsening pain that lasts more than 5 days, worsening fever that persists beyond 3 days, the presence of redness or swelling, or the emergence of any new symptoms.

Side Effects

Patients using this product should be aware of several important warnings and potential adverse reactions.

Severe liver damage may occur if the maximum daily amount of acetaminophen, which is more than 5 doses in 24 hours, is exceeded or if it is taken concurrently with other medications containing acetaminophen. Patients with pre-existing liver disease should consult a doctor prior to use.

Acetaminophen may also cause severe skin reactions, which can manifest as skin reddening, blisters, or rash. In the event of a skin reaction, patients are advised to discontinue use immediately and seek medical assistance.

Additionally, if a patient experiences a sore throat that is severe, persists for more than 2 days, or is accompanied by fever, headache, rash, nausea, or vomiting, it is crucial to consult a healthcare professional promptly.

Patients should stop using the product and seek medical advice if pain worsens or lasts more than 5 days, if fever worsens or lasts more than 3 days, if redness or swelling is present, or if any new symptoms appear.

It is also recommended that patients consult a doctor or pharmacist before use if they are taking the blood-thinning medication warfarin.

Drug Interactions

Acetaminophen has been observed to enhance the anticoagulant effect of warfarin, which may lead to an increased risk of bleeding. When these medications are used concurrently, it is advisable to monitor the International Normalized Ratio (INR) closely to ensure safe and effective anticoagulation management.

No additional drug interactions or interactions with laboratory tests have been reported.

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 aged 2 to 11 years may use this medication, adhering strictly to the recommended dosages outlined in the dosing chart. For optimal dosing, weight should be used when possible; otherwise, age may be utilized. The following dosing recommendations apply:

• For children under 24 lb (under 2 years), consultation with a doctor is advised.

• For those weighing 24-35 lb (ages 2-3 years), the recommended dose is 1 tablet.

• For children weighing 36-47 lb (ages 4-5 years), the dose is 1 ½ tablets.

• For those weighing 48-59 lb (ages 6-8 years), the dose is 2 tablets.

• For children weighing 60-71 lb (ages 9-10 years), the dose is 2 ½ tablets.

• For those weighing 72-95 lb (age 11 years), the dose is 3 tablets.

Tablets should be chewed or crushed completely before swallowing; they must not be swallowed whole. Doses may be repeated every 4 hours while symptoms persist, but no more than 5 doses should be administered within a 24-hour period.

Caution is warranted due to potential severe liver damage if the maximum daily amount of 5 doses is exceeded or if used concurrently with other medications containing acetaminophen. Additionally, acetaminophen may cause severe skin reactions, including skin reddening, blisters, and rash. If any skin reaction occurs, use should be discontinued immediately, and medical assistance should be sought.

Parents or caregivers should consult a doctor before use if the child has liver disease or is taking the blood-thinning medication warfarin. It is essential to keep this medication out of reach of children. In the event of an overdose, immediate medical help or contact with a Poison Control Center is critical, as prompt attention is necessary for both children and adults, even if no symptoms are apparent.

Geriatric Use

Elderly patients should be aware that this product does not contain directions or complete warnings specifically for adult use. It is essential for geriatric patients to consult a healthcare provider before using this product, particularly if they have underlying health conditions such as liver disease.

In the event of an overdose, it is crucial for elderly patients to seek immediate medical assistance or contact a Poison Control Center. Prompt medical attention is vital for adults, including geriatric patients, even if no signs or symptoms of overdose are apparent. Careful monitoring and adherence to medical advice are recommended to ensure safety in this population.

Pregnancy

There are no specific statements regarding the use of this product during pregnancy. Additionally, no safety concerns related to pregnancy have been identified in the available data. There are no recommended dosage modifications for pregnant individuals, nor are there any special precautions regarding the use of this product during pregnancy. Healthcare professionals should consider the absence of data when advising pregnant patients or women of childbearing potential.

Lactation

There are no specific statements regarding the use of this medication in nursing mothers or its effects on lactation. Additionally, there is no available data on the excretion of this medication in breast milk or its potential effects on breastfed infants. Healthcare professionals should consider the absence of information when advising lactating mothers about the use of this medication.

Renal Impairment

Patients with renal impairment have not been specifically addressed in the drug insert 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 data necessitates careful clinical judgment. Regular monitoring of renal function may be advisable in these patients, although specific recommendations are not provided.

Hepatic Impairment

Patients with hepatic impairment should be closely monitored when using this product, as it contains acetaminophen, which poses a risk of severe liver damage. It is critical to adhere to the maximum daily dosage of 5 doses within a 24-hour period to mitigate the risk of hepatotoxicity.

Before administration, it is advised to consult a healthcare professional if the patient has a history of liver disease. This precaution is essential to ensure the safe use of the product and to evaluate the potential need for dosage adjustments or additional monitoring based on the severity of the hepatic impairment.

Overdosage

In the event of an 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 health consequences. Therefore, it is essential to monitor the patient closely and provide appropriate care as needed.

Nonclinical Toxicology

There is currently no available data regarding teratogenic or non-teratogenic effects. Additionally, no information has been provided concerning nonclinical toxicology, animal pharmacology, or toxicology. As such, no conclusions can be drawn from the existing nonclinical study data.

Postmarketing Experience

No postmarketing experience details are available in the insert text.

Patient Counseling

Healthcare providers should advise patients to seek immediate medical assistance or contact a Poison Control Center in the event of an overdose, emphasizing that 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 drug that contains acetaminophen, whether prescription or nonprescription. If patients are uncertain about the presence of acetaminophen in their medications, they should be encouraged to consult with a doctor or pharmacist for clarification.

Healthcare providers should instruct patients to discontinue use and consult a doctor if their pain worsens or persists for more than five days. Similarly, patients should be advised to stop using the medication and seek medical advice if their fever worsens or lasts longer than three days. Additionally, patients should be informed to stop use and consult a doctor if they notice any redness or swelling, or if any new symptoms arise.

It is important for healthcare providers to recommend that patients consult a doctor before using this medication if their child has liver disease. Furthermore, patients should be advised to speak with a doctor or pharmacist prior to use if their child is currently taking the blood-thinning medication warfarin.

Storage and Handling

The product is supplied in tamper-evident packaging. It is essential to refrain from using the product if the outer package is opened or if the blister is torn or broken.

Storage conditions require the product to be maintained at a temperature of 25°C (77°F), with permissible excursions between 15°C and 30°C (59°F to 86°F). It is important to avoid high humidity during storage.

For reference, the expiration date and lot number can be found on the end flap of the packaging.

Additional Clinical Information

Patients should chew or crush the tablets completely before swallowing, as they should not be swallowed whole. The recommended dosing frequency is every 4 hours while symptoms persist, with a maximum of 5 doses in a 24-hour period.

Clinicians should advise patients to seek immediate medical assistance or contact a Poison Control Center in the event of an overdose, as prompt attention is crucial 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)