Pain and Fever

Description

Acetaminophen is an oral suspension formulated to provide pain relief and reduce fever. Each 5 mL dose contains 160 mg of acetaminophen. This product is specifically designed for children aged 2 to 3 years and is presented in a 2 FL OZ (59 mL) bottle. The formulation is free from alcohol, aspirin, ibuprofen, and parabens, and is flavored with cherry to enhance palatability.

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

This product is intended for pediatric use only and does not contain complete directions or warnings for adult administration. Healthcare professionals should ensure that the dosage does not exceed the recommended limits, as indicated in the overdose warning.

Prior to administration, the product must be shaken well. The appropriate dose should be determined using the dosing chart provided, with weight being the preferred method for dosing; if weight is not available, age may be used as a secondary reference.

To prepare the dose, the following steps should be followed:

1. Push air out of the syringe before inserting the syringe tip into the bottle opening.

2. Invert the bottle and pull the yellow part of the syringe to the first dose line, then push the product back into the bottle.

3. Pull the yellow part of the syringe until it reaches and remains at the correct dose.

The liquid should be dispensed slowly into the child’s mouth, directed toward the inner cheek. Dosing may be repeated every 4 hours as needed while symptoms persist, but should not exceed 5 doses within a 24-hour period.

For dosing specifics:

• 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 to use only the enclosed syringe specifically designed for this product; no other dosing devices should be utilized. After use, the cap must be replaced tightly to ensure child resistance.

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 allergic responses.

• Exceeding the recommended dose is contraindicated due to the potential for overdose.

Warnings and Precautions

Severe liver damage may occur with the use of this product, which contains acetaminophen, if the maximum daily dosage of 5 doses within 24 hours is exceeded or if it is taken concurrently with other medications containing acetaminophen. Healthcare professionals should advise patients and caregivers to adhere strictly to dosing guidelines to mitigate the risk of liver injury.

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 is accompanied by additional symptoms such as fever, headache, rash, nausea, or vomiting, prompt consultation with a healthcare provider is recommended to rule out serious underlying conditions.

Healthcare professionals should inquire about the patient's medical history, particularly regarding liver disease, prior to recommending this product. Additionally, it is advisable to consult with a doctor or pharmacist if the patient is concurrently taking warfarin or other anticoagulants, as interactions may occur.

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 or seek emergency medical help, even if no symptoms are initially apparent.

Patients should be instructed to discontinue use and consult a healthcare provider if new symptoms arise, if pain worsens or persists beyond 5 days, if fever intensifies or lasts more than 3 days, or if there is any redness or swelling, as these may indicate a serious condition requiring further evaluation.

Side Effects

Severe liver damage may occur in patients if more than 5 doses of the product are taken within a 24-hour period, which is the maximum daily amount. Additionally, the risk of severe liver damage increases if this product is used concurrently with other medications containing acetaminophen.

Patients should be aware of the potential for 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.

A warning regarding sore throat is also pertinent; if a sore throat is severe, persists for more than 2 days, or is accompanied or followed by fever, headache, rash, nausea, or vomiting, patients should consult a healthcare professional promptly.

Patients are advised to stop use and consult a doctor if new symptoms arise, if pain worsens or lasts longer than 5 days, if fever intensifies or persists beyond 3 days, or if redness or swelling occurs, as these may indicate a serious condition.

Before using this product, it is essential for patients with liver disease to seek medical advice. Furthermore, patients taking the blood-thinning medication warfarin should consult a doctor or pharmacist prior to use.

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 increase the risk of bleeding due to potential pharmacodynamic interactions.

Additionally, this medication should not be used in conjunction with other products containing acetaminophen, whether prescription or over-the-counter. Co-administration may lead to an increased risk of acetaminophen-related hepatotoxicity. If there is uncertainty regarding the presence of acetaminophen in other medications, it is advisable to seek guidance from a healthcare provider.

Packaging & NDC

Below are the non-prescription pack sizes of Pain and Fever (acetaminophen). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients under 2 years of age should consult a doctor before use, particularly if they weigh less than 24 pounds. For children aged 2 to 3 years who weigh between 24 and 35 pounds, the recommended dose is 5 mL. Dosing should ideally be based on weight; if weight is not available, age may be used as a guide. Doses may be repeated every 4 hours as needed, but should not exceed 5 doses in a 24-hour period.

Healthcare professionals should advise caregivers to consult a doctor before administering this product if the child has liver disease or is taking the anticoagulant warfarin.

Storage conditions should be maintained at 20-25°C (68-77°F). It is important to note that this product does not include directions or complete warnings for adult use.

Geriatric Use

Elderly patients may require special consideration when using this product, as it does not contain directions or complete warnings for adult use. Healthcare providers should exercise caution and closely monitor geriatric patients for any adverse effects or complications that may arise due to the lack of specific guidance. It is advisable to assess the individual needs and health status of elderly patients before prescribing this product, as the absence of comprehensive information may necessitate dose adjustments or alternative therapeutic options.

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 this medication to pregnant patients. There are no documented safety concerns, dosage modifications, or special precautions outlined for the use of acetaminophen in this population. Given the lack of information, it is advisable for women of childbearing potential to consult with their healthcare provider before using acetaminophen during pregnancy to ensure that potential risks and benefits are adequately assessed.

Lactation

There are no specific statements regarding the use of this medication in nursing mothers or its effects during 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 available data 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 information necessitates careful clinical judgment and monitoring.

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 evaluate liver function and consider potential adjustments in dosage or monitoring requirements based on the severity of the impairment. Careful assessment 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 intervention is essential, as the absence of noticeable signs or symptoms does not preclude the potential for serious health consequences.

Healthcare professionals should be aware that quick medical attention is critical in managing overdose situations. Even in cases where patients do not exhibit any overt symptoms, the risk of delayed reactions necessitates thorough evaluation and monitoring. It is advisable to follow established protocols for overdose management, which may include supportive care and symptomatic treatment as indicated.

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 the following adverse reactions associated with acetaminophen: skin reddening, blisters, and rash. Additionally, there have been reports of severe skin reactions, which may manifest as symptoms including but not limited to those mentioned. In the event of a skin reaction, it is advised to discontinue use and seek medical assistance promptly.

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, emphasizing that 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 that contain 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 instruct patients not to use this product if their child has a history of allergic reactions to it or any of its ingredients. Patients should be advised to 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 there is any redness or swelling, as these may indicate a serious condition.

Patients must be cautioned against exceeding the recommended dosage, as this could lead to overdose. Additionally, healthcare providers should recommend that patients consult a doctor before using this product if their child has liver disease. Lastly, 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 configurations that include specific NDC numbers, which should be referenced for accurate identification. It is essential to store the product at a controlled temperature range of 20-25°C (68-77°F) to maintain its integrity and efficacy.

Healthcare professionals should ensure that the product is not utilized if the printed neckband is broken or missing, as this may indicate potential tampering or compromise of the product's safety. Proper handling and storage conditions are crucial for preserving the quality of the product.

Additional Clinical Information

Patients should be informed that the medication is administered orally, with a recommended repeat dose every 4 hours as needed, not to exceed 5 doses within a 24-hour period. Clinicians should advise patients to consult a doctor before use if the patient has liver disease or is taking the anticoagulant warfarin. Additionally, patients should be instructed to discontinue use and seek medical advice if new symptoms arise, if pain worsens or persists beyond 5 days, if fever intensifies or lasts more than 3 days, or if any redness or swelling occurs, as these may indicate a serious condition.

Drug Information (PDF)

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

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