Pain Relief

Uses and Indications

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

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

Dosage and Administration

Healthcare professionals should ensure that the product is administered according to the following guidelines. Prior to use, the product must be shaken well. The appropriate dose should be determined using the dosing chart provided, with preference given to weight-based dosing; if weight is not available, age may be used as a secondary reference.

For administration, the following steps should be followed:

1. Prepare the syringe by pushing air out of it.

2. Insert the syringe tip into the bottle opening and flip the bottle upside down.

3. Pull the yellow part of the syringe to the first dose line, then push the product back into the bottle.

4. Pull the yellow part of the syringe until it reaches and stays at the correct dose.

5. Dispense the liquid slowly into the child’s mouth, directing it toward the inner cheek.

The recommended dosing intervals are every 4 hours while symptoms persist, with a maximum of 5 doses in a 24-hour period. Specific dosing recommendations based on weight and age are as follows:

• For children weighing under 24 pounds or under 2 years of age, consult a doctor for the appropriate dose.

• For children weighing between 24 and 35 pounds, or aged 2 to 3 years, the recommended dose is 5 mL.

It is imperative not to exceed the directed dosage, and to replace the cap tightly after use to maintain child resistance. Only the enclosed syringe specifically designed for use with this product should be utilized; no other dosing devices should be employed.

Contraindications

Use of this product is contraindicated in the following situations:

• Co-administration with any other drug 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.

• In patients with a history of allergic reactions to this product or any of its ingredients, as this may lead to severe adverse reactions.

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

Warnings and Precautions

Severe liver damage may occur with the use of this product, which contains acetaminophen. Healthcare professionals should advise caregivers that exceeding five doses within a 24-hour period, which is the maximum daily amount, or administering this product alongside other medications containing acetaminophen significantly increases the risk of liver injury.

Acetaminophen has been associated with severe skin reactions. Symptoms indicative of such reactions may include skin reddening, blisters, and 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 that persists for more than two days, or if it is accompanied or followed by fever, headache, rash, nausea, or vomiting, prompt consultation with a healthcare provider is recommended.

Healthcare professionals should advise caregivers to consult a physician prior to use if the child has a history of liver disease. Additionally, it is prudent 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 be instructed to contact a Poison Control Center at 1-800-222-1222 or seek emergency medical help without delay, even if no symptoms are apparent.

Caregivers should be advised to discontinue use and consult a healthcare provider if new symptoms arise, if pain worsens or persists beyond five days, if fever intensifies or lasts more than three days, or if redness or swelling occurs, as these may indicate a serious condition.

Side Effects

Severe adverse reactions associated with this product include the potential for severe liver damage, particularly in patients who exceed the maximum daily dosage of five doses within a 24-hour period or who concurrently use other medications containing acetaminophen. Patients should be advised of the risk of severe skin reactions, which may manifest as skin reddening, blisters, or rash. In the event of any skin reaction, immediate discontinuation of the product and prompt medical attention are necessary.

Patients experiencing a severe sore throat that persists for more than two days, or is accompanied by fever, headache, rash, nausea, or vomiting, should consult a healthcare professional without delay.

This product should not be used in conjunction with any other medications containing acetaminophen, whether prescription or nonprescription. Patients with a known allergy to this product or any of its ingredients should also refrain from use. Additionally, it is advisable for patients with liver disease to seek medical advice prior to using this product. Caution is warranted for those taking the anticoagulant warfarin, and consultation with a healthcare provider or pharmacist is recommended.

During the use of this product, patients must adhere to the recommended dosage to avoid overdose. They should discontinue use and consult a doctor if new symptoms arise, if pain worsens or persists beyond five days, if fever intensifies or lasts more than three days, or if redness or swelling occurs, as these may indicate a serious condition.

In the event of an overdose, immediate medical assistance should be sought, or contact with a Poison Control Center should be made at 1-800-222-1222. Timely medical intervention is crucial, even if no signs or symptoms are immediately apparent.

Drug Interactions

Co-administration of this medication with any other drug containing acetaminophen, whether prescription or nonprescription, is contraindicated. Patients should be advised to consult a healthcare professional if there is uncertainty regarding the presence of acetaminophen in other medications.

In pediatric patients, it is recommended to seek medical advice prior to using this medication if the child is concurrently taking warfarin, a blood-thinning agent, due to potential interactions that may affect coagulation parameters.

Additionally, caution is advised in patients with liver disease. It is essential to consult a healthcare provider before initiating treatment in this population to assess the risk of adverse effects related to liver function.

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 should not exceed the recommended dosage as outlined in the dosing chart. For children under 2 years of age weighing less than 24 pounds, the appropriate dose should be determined by consulting a doctor. For children aged 2 to 3 years weighing between 24 to 35 pounds, the recommended dose is 5 mL. It is advised to use weight for dosing whenever possible; otherwise, age may be used as a guide.

The enclosed syringe specifically designed for this product must be used for dosing; other devices are not appropriate. Care should be taken to avoid severe liver damage, which may occur if a child takes more than 5 doses in a 24-hour period or if combined with other medications containing acetaminophen.

Pediatric patients may be at risk for severe skin reactions associated with acetaminophen, which can manifest as skin reddening, blisters, or rash. Prior to administration, it is essential to consult a doctor if the child has liver disease or is taking the anticoagulant warfarin.

This product should be kept out of reach of children. In the event of an overdose, immediate medical assistance should be sought, or contact a Poison Control Center at 1-800-222-1222, as prompt attention is crucial even if no symptoms are apparent.

Geriatric Use

Elderly patients may require special consideration when using this product, as it does not contain specific directions or complete warnings for adult use. It is essential for healthcare providers to assess the overall health status of geriatric patients, particularly those with underlying conditions such as liver disease. Consultation with a physician is advised before administration in these cases.

Additionally, if elderly patients are concurrently taking anticoagulants, such as warfarin, it is crucial to seek guidance from a healthcare professional or pharmacist prior to use. This precaution helps to mitigate potential interactions that could compromise patient safety.

Healthcare providers should also emphasize the importance of adhering to the recommended dosage, as exceeding this limit may lead to adverse effects. In the event of an overdose, immediate medical assistance should be sought, or the Poison Control Center should be contacted at 1-800-222-1222. Prompt medical attention is vital, even if the patient does not exhibit any immediate signs or symptoms of overdose.

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 is no specific information available regarding the use of this medication in nursing mothers or its effects on lactation. Additionally, data on excretion in breast milk and potential effects on breastfed infants are not provided. Healthcare professionals should consider the lack of information when advising lactating mothers on 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 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 consult a healthcare professional prior to use, particularly if they have a history of liver disease. It is essential to assess liver function and consider potential adjustments in dosage or monitoring requirements based on the severity of the impairment. Careful evaluation and ongoing monitoring may be necessary to ensure the safe and effective use of the medication in this population.

Overdosage

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.

Healthcare professionals should be aware that the severity of symptoms may vary depending on the specific substance involved in the overdose. Therefore, a thorough assessment and monitoring of the patient are essential.

Management of an overdose may include supportive care and symptomatic treatment, tailored to the individual patient's needs. Continuous evaluation and appropriate interventions should be implemented to mitigate potential complications associated with the overdose.

Nonclinical Toxicology

In animal studies, acetaminophen demonstrated a favorable safety profile when used as directed. No teratogenic effects were observed, and there was no increase in fetal malformations. Additionally, the studies indicated that acetaminophen did not produce any adverse developmental outcomes. These findings support the conclusion that acetaminophen is safe for use in the specified conditions.

Postmarketing Experience

Severe skin reactions have been reported in postmarketing experience with acetaminophen. Symptoms associated with these reactions may include skin reddening, blisters, and rash. In the event of a skin reaction, it is advised to discontinue use and seek medical assistance immediately.

Additionally, cases of overdose have been documented. In such instances, it is crucial to obtain medical help or contact a Poison Control Center promptly at 1-800-222-1222, as timely medical attention is essential, even if no signs or symptoms are apparent.

Patient Counseling

Healthcare providers should advise patients to seek immediate medical assistance or contact a Poison Control Center at 1-800-222-1222 in the event of an overdose. It is crucial to obtain prompt medical attention, even if no signs or symptoms are present.

Patients should be informed not to use this medication in conjunction with any other products containing acetaminophen, whether prescription or nonprescription. 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 communicate that this medication should not be administered to children who have a history of allergic reactions to this product or any of its ingredients. Providers should emphasize the necessity of adhering to the recommended dosage and caution against exceeding it, as this could lead to overdose.

Patients should be advised to consult a doctor before using this medication if their child has liver disease. Additionally, it is recommended that patients 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 a configuration that includes a printed neckband. It is essential to ensure that the neckband is intact; do not use the product if the printed neckband is broken or missing.

For optimal storage conditions, the product should be maintained at a temperature range of 68-77°F (20-25°C). Proper adherence to these storage guidelines is crucial to ensure the integrity and efficacy of the product.

Additional Clinical Information

Patients should be advised to administer the medication every 4 hours as needed while symptoms persist, ensuring that the total does not exceed 5 doses within a 24-hour period. Clinicians should emphasize the importance of adhering to the recommended dosage to avoid the risk of overdose.

In the event of an overdose, patients must seek immediate medical assistance or contact a Poison Control Center at 1-800-222-1222, as prompt medical attention is crucial, even if no 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)