Pain Reliever

Description

No description information is available for the specified drug.

Uses and Indications

This drug is indicated for the temporary reduction of fever and the temporary relief of minor aches and pains associated with conditions such as the common cold, influenza, headache, sore throat, and toothache.

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

Dosage and Administration

This product is intended for use in pediatric patients, and specific dosing instructions must be followed carefully. Prior to administration, the product should be shaken well. The enclosed dosing cup, specifically designed for this product, must be used; no other dosing devices should be utilized.

Dosing is determined primarily by weight; however, age may also be considered if weight is not available. The following dosing chart provides guidance:

• For patients weighing less than 24 lb or under 2 years of age, the dose should be determined by consulting a doctor.

• For patients weighing 24-35 lb and aged 2-3 years, the recommended dose is 5 mL.

• For patients weighing 36-47 lb and aged 4-5 years, the recommended dose is 7.5 mL.

• For patients weighing 48-59 lb and aged 6-8 years, the recommended dose is 10 mL.

• For patients weighing 60-71 lb and aged 9-10 years, the recommended dose is 12.5 mL.

• For patients weighing 72-95 lb and aged 11 years, the recommended dose is 15 mL.

If necessary, doses may be repeated every 4 hours while symptoms persist. However, it is important not to exceed 5 doses within a 24-hour period. Additionally, treatment should not extend beyond 5 days unless directed by a healthcare professional. Care should be taken to adhere to these guidelines to avoid the risk of overdose.

Contraindications

Use of this product is contraindicated in the following situations:

• Co-administration with any other drug containing acetaminophen, whether prescription or non-prescription, 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.

• In patients with a known allergy to acetaminophen or any of the inactive ingredients in this product, as this may lead to severe allergic reactions.

• Exceeding the recommended dose is contraindicated, as it poses a risk of overdose.

Warnings and Precautions

This product contains acetaminophen, which poses a significant risk of severe liver damage if the following conditions are met: exceeding 5 doses within a 24-hour period, which is the maximum daily amount, or concomitant use with other medications containing acetaminophen. Healthcare professionals should advise patients to adhere strictly to dosing guidelines to mitigate this risk.

Acetaminophen may also trigger severe skin reactions, characterized by symptoms such as skin reddening, blisters, and rash. In the event of any skin reaction, patients must discontinue use immediately and seek medical assistance without delay.

In cases of severe sore throat that persists for more than 2 days, or if it is accompanied or followed by fever, headache, rash, nausea, or vomiting, it is imperative for patients to consult a physician promptly.

Healthcare providers should instruct patients to discontinue use and seek medical advice if new symptoms arise, if redness or swelling occurs, if pain worsens or lasts longer than 5 days, or if fever intensifies or persists beyond 3 days. These symptoms may indicate a serious underlying condition that requires further evaluation.

In the event of an overdose, immediate medical attention is crucial. Patients should be directed to contact a Poison Control Center at 1-800-222-1222 or seek emergency medical help right away, even if no signs or symptoms are apparent. Quick intervention is essential to ensure patient safety.

Side Effects

Severe liver damage may occur in patients who exceed the maximum daily amount of five doses within a 24-hour period or who take the medication concurrently with other drugs containing acetaminophen. In cases of overdose, which may result from taking more than the recommended dose, immediate medical assistance is essential. Patients are advised to contact a Poison Control Center (1-800-222-1222) without delay, even if no signs or symptoms are initially apparent.

Patients should be aware of the potential for severe skin reactions associated with acetaminophen use. Symptoms may include skin reddening, blisters, and rash. If any of these reactions occur, it is imperative to discontinue use and seek medical attention immediately.

In instances where a sore throat is severe, persists for more than two days, or is accompanied by fever, headache, rash, nausea, or vomiting, patients should consult a healthcare provider promptly, as these may indicate a serious condition.

Patients are also advised to stop use and seek medical advice if new symptoms arise, if redness or swelling is observed, if pain worsens or lasts longer than five days, or if fever intensifies or persists beyond three days. These symptoms could signify a serious underlying condition that requires further evaluation.

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 necessitate careful monitoring of coagulation parameters due to the potential for altered anticoagulant effects. Adjustments to the dosage of warfarin may be required based on clinical judgment and laboratory results.

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 aged 2 to 11 years may receive dosing based on weight and age. For children under 24 lb (under 2 years), consultation with a doctor is advised prior to administration. Recommended dosages for children aged 2 to 11 years are as follows: 5 mL for those weighing 24-35 lb (2-3 years), 7.5 mL for those weighing 36-47 lb (4-5 years), 10 mL for those weighing 48-59 lb (6-8 years), 12.5 mL for those weighing 60-71 lb (9-10 years), and 15 mL for those weighing 72-95 lb (11 years).

It is important to limit administration to no more than 5 doses within a 24-hour period and to avoid use for more than 5 consecutive days unless directed by a healthcare professional. Prior to use, healthcare providers should be consulted if the pediatric patient has liver disease or is taking the anticoagulant warfarin.

Parents and caregivers should ensure that the medication is kept out of reach of children. An overdose may lead to liver damage; therefore, in the event of an overdose, immediate medical assistance or contact with a Poison Control Center is essential.

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 adverse effects or changes in therapeutic response, given the lack of targeted data for this population.

Pregnancy

The safety of acetaminophen use during pregnancy has not been established, as the prescribing information does not provide specific data regarding its use in this population. Consequently, healthcare professionals should exercise caution when recommending acetaminophen to pregnant patients. There are no documented safety concerns, dosage modifications, or special precautions outlined for its use during pregnancy. Given the lack of information, it is advisable for women of childbearing potential to consult with their healthcare provider before using acetaminophen to weigh the potential risks and benefits.

Lactation

Nursing mothers should consult a doctor before using this product. There is a potential for excretion of acetaminophen in breast milk. Caution is advised when administering this product to nursing mothers due to the potential risk to the infant.

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 absence of 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 be aware that this product contains acetaminophen, which carries a risk of severe liver damage. It is critical that patients do not exceed 5 doses within a 24-hour period, as this represents the maximum daily amount. Additionally, patients should avoid the concurrent use of other medications containing acetaminophen to prevent the risk of liver injury.

Before using this product, it is advisable for patients with liver disease, particularly children, to consult a healthcare professional. Monitoring of liver function may be warranted in these patients to ensure safety and prevent potential adverse effects associated with acetaminophen use.

Overdosage

Taking more than the recommended dose of this medication may lead to significant liver damage. 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, even in the absence of noticeable signs or symptoms of overdose. Healthcare professionals should be aware that early recognition and management of overdose can significantly impact patient outcomes.

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 safety profile in nonclinical settings.

Postmarketing Experience

Postmarketing experience has identified rare cases of severe skin reactions associated with acetaminophen use. Reported symptoms include skin reddening, blisters, and rash. These events were documented through voluntary reports and surveillance programs.

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 be instructed to seek medical help immediately or contact a Poison Control Center at 1-800-222-1222, as prompt medical attention is crucial even if no signs or symptoms are apparent.

Patients should be cautioned against using this product in conjunction with any other medications that contain acetaminophen, whether prescription or non-prescription. If patients are uncertain whether a drug contains acetaminophen, they should be encouraged to consult with a doctor or pharmacist for clarification.

It is important to inform patients that this product should not be used if their child has a known allergy to acetaminophen or any of the inactive ingredients present in the formulation. Additionally, patients should be instructed to discontinue use and consult a doctor if new symptoms arise, if there is any redness or swelling, if pain worsens or persists for more than five days, or if fever intensifies or lasts longer than three days, as these may indicate a serious underlying condition.

While using this product, patients must be reminded not to exceed the recommended dose, reiterating the overdose warning. Furthermore, healthcare providers should recommend that patients consult a doctor before use if their child has liver disease or is currently taking the blood-thinning medication warfarin, to ensure safe and effective use of the product.

Storage and Handling

The product is supplied in configurations that include specific NDC numbers, which can be found on the packaging. It is essential to store the product at a temperature range of 20-25ºC (68-77ºF). Refrigeration is not recommended, as it may compromise the integrity of the product. For traceability, the lot number and expiration date are located on the bottom panel of the packaging. Proper adherence to these storage conditions is crucial for maintaining product efficacy and safety.

Additional Clinical Information

The medication is administered orally, with a recommended dosing frequency of every 4 hours as needed, not to exceed 5 doses within a 24-hour period. Continuous use should not extend beyond 5 days unless directed by a healthcare professional.

Clinicians should counsel patients to consult a doctor prior to use if the child has liver disease or is concurrently taking warfarin, a blood-thinning medication. Patients are advised to discontinue use and seek medical advice if new symptoms arise, if there is redness or swelling, if pain worsens or persists beyond 5 days, or if fever intensifies or lasts more than 3 days.

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)