Pain Relief

Description

Acetaminophen is formulated as an oral suspension, providing 160 mg of acetaminophen per 5 mL. This preparation serves as a pain reliever and fever reducer. The formulation is alcohol-free, aspirin-free, and ibuprofen-free, making it suitable for a wide range of patients. It is presented with a cherry flavor to enhance palatability.

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 healthcare professionals should refer to the dosage chart to determine the appropriate dose based on the patient's weight and age. It is essential to shake the product well before each use. The enclosed dosing cup, specifically designed for this product, must be used; no other dosing devices should be employed.

The recommended dosing intervals are as follows: if necessary, the dose may be repeated every 4 hours while symptoms persist. However, it is crucial not to exceed 5 doses within a 24-hour period. Additionally, treatment should not extend beyond 5 days unless directed by a physician.

The following dosage chart provides guidance based on weight and age:

• For patients weighing less than 24 lb and under 2 years of age, consult a doctor for the appropriate dose.

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

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

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

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

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

Healthcare professionals should ensure that patients do not exceed the maximum dosage and should monitor for any signs 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 formulation, as this may lead to severe allergic reactions.

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

Warnings and Precautions

Severe liver damage may occur in children taking this product, which contains acetaminophen, if they exceed the maximum daily dosage of 5 doses within a 24-hour period or if they are concurrently using other medications that also contain acetaminophen. Healthcare professionals should monitor patients closely for adherence to dosing guidelines to prevent potential hepatotoxicity.

Acetaminophen has been associated with severe skin reactions, which may manifest as skin reddening, blisters, or rash. In the event of any skin reaction, it is imperative to 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 by additional symptoms such as fever, headache, rash, nausea, or vomiting, a prompt consultation with a physician is advised. These symptoms may indicate a more serious underlying condition that requires further evaluation.

Healthcare providers should instruct patients to discontinue use and consult a physician if new symptoms arise, if there is any redness or swelling, if pain worsens or lasts longer than 5 days, or if fever intensifies or persists beyond 3 days. These signs may suggest the presence of a serious medical issue that necessitates further investigation.

In the event of an overdose, immediate medical attention is crucial. Patients or caregivers should contact a Poison Control Center at 1-800-222-1222 without delay, even if no symptoms are apparent, as rapid intervention can be critical.

Prior to administration, it is essential to consult a physician if the child has a history of liver disease. Additionally, healthcare professionals should advise caution and recommend consulting a doctor or pharmacist if the child is currently taking the anticoagulant medication warfarin, as potential interactions may necessitate careful monitoring.

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 should also be alerted to the risk of severe skin reactions associated with acetaminophen, which may manifest as skin reddening, blisters, or rash. In the event of a skin reaction, it is imperative to discontinue use and seek medical assistance immediately.

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

This product should not be used in conjunction with any other drug containing acetaminophen, whether prescription or non-prescription. Patients should verify the presence of acetaminophen in other medications with a doctor or pharmacist if uncertain. It is also contraindicated in patients with a known allergy to acetaminophen or any inactive ingredients in the formulation.

Before using this product, patients with liver disease should consult a doctor. Furthermore, those taking the blood-thinning medication warfarin should seek advice from a healthcare professional prior to use.

While using this product, it is crucial not to exceed the recommended dosage. Patients should discontinue use and consult a doctor if new symptoms arise, if redness or swelling occurs, if pain worsens or persists for more than 5 days, or if fever intensifies or lasts more than 3 days, as these may indicate a serious condition.

An overdose warning is also pertinent; taking more than the recommended dose may lead to liver damage. In the event of an overdose, immediate medical help should be sought, or the Poison Control Center (1-800-222-1222) should be contacted without delay, as prompt medical attention is critical even if no signs or symptoms are initially apparent.

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 Relief (acetaminophen). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients aged 2 to 11 years may receive this medication according to the following dosing chart based on weight and age:

• Under 24 lb (Under 2 years): Consult a doctor.

• 24-35 lb (2-3 years): 5 mL.

• 36-47 lb (4-5 years): 7.5 mL.

• 48-59 lb (6-8 years): 10 mL.

• 60-71 lb (9-10 years): 12.5 mL.

• 72-95 lb (11 years): 15 mL.

It is important to note that pediatric patients should not exceed 5 doses within a 24-hour period and should not be treated for more than 5 days unless directed by a healthcare professional. Prior to administration, consultation with a doctor is advised if the child has liver disease or is concurrently taking the anticoagulant warfarin. Additionally, this medication should be kept out of reach of children to prevent accidental ingestion.

Geriatric Use

There is no specific information regarding the use of this drug in geriatric patients. Therefore, healthcare providers should exercise caution when prescribing this medication to elderly patients. It is advisable to closely monitor this population for any potential adverse effects or changes in drug efficacy, given the physiological changes associated with aging that may affect drug metabolism and response. Additionally, consideration should be given to the presence of comorbidities and polypharmacy, which are common in geriatric patients and may necessitate dosage adjustments or increased monitoring.

Pregnancy

The available prescribing information does not provide specific data regarding the use of acetaminophen during pregnancy. 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 in this population. Given the lack of detailed information, healthcare providers are encouraged to weigh the potential benefits against any unknown risks when considering acetaminophen for women of childbearing potential. Further research may be necessary to establish a clearer understanding of the implications of acetaminophen use during pregnancy.

Lactation

There are no specific warnings or recommendations regarding the use of this product in nursing mothers. Additionally, there is no information available about the potential for excretion in breast milk or any associated risks to breastfed infants.

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 individuals 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 be closely monitored when using this product, which contains acetaminophen. It is important to note that severe liver damage may occur if the maximum daily amount of more than 5 doses in 24 hours is exceeded or if the product is taken concurrently with other medications containing acetaminophen.

Prior to use, it is recommended that a healthcare professional be consulted if the patient has a history of liver disease. In the event of an overdose, which is defined as taking more than the recommended dose, immediate medical assistance should be sought, or the Poison Control Center (1-800-222-1222) should be contacted. Quick medical attention is critical, even if the patient does not exhibit any signs or symptoms of liver damage.

Due to the potential for serious adverse effects, careful consideration and monitoring of liver function are essential in patients with compromised liver function.

Overdosage

Taking more than the recommended dose of this medication may lead to liver damage. In the event of an overdose, it is imperative to seek medical assistance immediately or contact a Poison Control Center at 1-800-222-1222.

Recommended Actions

Prompt medical attention is crucial, even if the individual does not exhibit any signs or symptoms of overdose. Healthcare professionals should be prepared to assess the patient's condition and initiate appropriate management procedures based on the severity of the overdose and the clinical presentation.

Potential Symptoms

While specific symptoms of overdose may not be detailed, the risk of liver damage underscores the importance of vigilance and timely intervention. Monitoring for any signs of hepatic impairment is essential in the management of an overdose situation.

In summary, immediate action and professional medical evaluation are vital in cases of overdose to mitigate potential risks and ensure patient safety.

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

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 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 even if no signs or symptoms are apparent.

Patients should be informed not to use this product in conjunction with any other medications containing acetaminophen, whether prescription or non-prescription. If there is uncertainty regarding the presence of acetaminophen in other medications, patients are encouraged to consult with a doctor or pharmacist.

It is important to instruct patients to avoid using this product if their child has a known allergy to acetaminophen or any of the inactive ingredients contained in the formulation. Additionally, patients should be advised to discontinue use and consult a doctor if new symptoms arise, if there is any redness or swelling, if pain worsens or persists beyond five days, or if fever intensifies or lasts more than three days, as these may indicate a serious condition.

While using this product, patients must be reminded not to exceed the recommended dosage, reiterating the overdose warning. Healthcare providers should also recommend that patients consult a doctor before use if their child has liver disease or is currently taking the blood-thinning medication warfarin.

Storage and Handling

The product is supplied in packaging that includes specific NDC numbers, which can be found on the label. 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. Patients should not use the medication for more than 5 consecutive days unless directed by a healthcare professional.

Clinicians should counsel patients to keep the medication out of reach of children. Patients are advised to discontinue use and consult a doctor if new symptoms arise, if redness or swelling occurs, 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 Relief, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

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