Pain and Fever

Description

Acetaminophen oral suspension contains 160 mg of acetaminophen per 5 mL. This formulation serves as a pain reliever and fever reducer. The product is free from dyes, aspirin, ibuprofen, alcohol, parabens, and high fructose corn syrup. It is presented in a cherry flavor and is packaged in a 2 FL OZ (59 mL) bottle. Administration is recommended using only the enclosed syringe.

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, healthcare professionals should follow these steps:

1. Push the 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.

It is essential to securely replace the cap after each use to maintain child resistance. Only the enclosed syringe specifically designed for use with this product should be utilized; no other dosing devices are permitted.

The dosing chart is as follows:

• For children weighing under 24 lb or under 2 years of age, the dose is to be determined by a doctor.

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

*Dosing may also be as directed by a healthcare professional.

Contraindications

Use of this product is contraindicated in the following situations:

Co-administration with any other drug containing acetaminophen, whether prescription or nonprescription, is prohibited 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.

This product should not be used in patients who have a history of allergic reactions to this product or any of its ingredients, as this may lead to severe adverse effects.

Additionally, while using this product, it is essential not to exceed the recommended dosage to avoid the risk of overdose.

Warnings and Precautions

Severe liver damage may occur in children taking this product, which contains acetaminophen, if they exceed five doses within a 24-hour period or if they are concurrently using other medications that contain acetaminophen. Healthcare professionals should advise 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 two days, or if it is accompanied by 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 child’s medical history, particularly regarding liver disease, before recommending this product. Additionally, it is advisable to consult with a doctor or pharmacist if the child is currently taking warfarin or any other anticoagulant medication, as interactions may occur.

In the event of an overdose, immediate medical attention is crucial. Caregivers should contact a Poison Control Center at 1-800-222-1222 or seek emergency medical help, even if no symptoms are apparent, as rapid intervention can be critical.

Caregivers should be instructed to discontinue use and consult a healthcare provider if the child experiences worsening pain lasting more than five days, fever that worsens or persists beyond three days, the emergence of new symptoms, or any signs of redness or swelling, as these may indicate a serious condition requiring further evaluation.

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 aware that acetaminophen may also lead to severe skin reactions, which can manifest as skin reddening, blisters, or rash. In the event of any skin reaction, it is imperative to discontinue use and seek immediate medical assistance.

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 promptly.

It is advised that this product not be used in conjunction with any other medications containing acetaminophen, whether prescription or nonprescription. Patients should confirm the presence of acetaminophen in any other medications with a healthcare provider or pharmacist. Additionally, this product should not be administered to individuals with a known allergy to acetaminophen or any of its components.

Before using this product, patients with liver disease should seek medical advice. Furthermore, those taking the anticoagulant warfarin should consult a healthcare professional or pharmacist prior to use.

While using this product, patients must adhere to the recommended dosage and should discontinue use and consult a doctor if pain worsens or persists beyond five days, if fever worsens or lasts more than three days, if new symptoms arise, or if there is any redness or swelling, as these may indicate a serious condition.

In the event of an overdose, it is crucial to seek medical help or contact a Poison Control Center immediately at 1-800-222-1222, as prompt medical attention is essential 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 and Fever (acetaminophen). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients under 2 years of age should not be given this medication without consulting a doctor. For children aged 2 to 3 years, the recommended dose is 5 mL for those weighing between 24 to 35 pounds. It is advised to use weight for dosing whenever possible; otherwise, age may be used as a guide.

Healthcare professionals should be aware of specific warnings when administering this medication to pediatric patients. Parents or caregivers should consult a doctor if the child has liver disease or is taking the blood-thinning medication warfarin. It is crucial to adhere to the recommended dosing guidelines and not exceed the maximum dosage, which is 5 doses within a 24-hour period.

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, as prompt medical attention is essential even if no symptoms are apparent. Additionally, this medication should be kept out of reach of children to prevent accidental ingestion.

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 evaluate 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

There is no specific information available regarding the use of acetaminophen during pregnancy. The prescribing information does not indicate any contraindications or risks associated with the use of acetaminophen in pregnant individuals. Additionally, no dosage modifications for pregnant patients are specified. The insert does not include any special precautions regarding the use of this product during pregnancy. Healthcare professionals should consider the absence of data when advising pregnant patients and weigh the potential benefits against any unknown risks.

Lactation

There are no specific statements regarding the use of this medication in nursing mothers or during lactation. Additionally, there is no available data on the excretion of this medication in breast milk or its effects on breastfed infants. Healthcare professionals should consider the lack 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 individuals 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 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. Close monitoring of liver function tests may be warranted to ensure safety and efficacy 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 quick medical attention can significantly impact the outcome, 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 complications. Therefore, monitoring and evaluation should be conducted as soon as possible following an overdose incident.

Nonclinical Toxicology

No information is available regarding teratogenic or non-teratogenic effects. Additionally, there is no data provided concerning nonclinical toxicology, animal pharmacology, or toxicology.

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 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 emphasize that prompt medical attention is necessary, even if the patient does not exhibit any signs or symptoms of overdose.

Patients should be instructed not to exceed the recommended dose, as doing so may lead to serious health risks.

Additionally, healthcare providers should encourage patients to consult with a doctor before using this medication if their child has liver disease. It is also important to recommend that patients speak with a doctor or pharmacist prior to use if their child is currently taking the blood-thinning medication warfarin, to avoid potential interactions.

Storage and Handling

The product is supplied in a configuration that includes a specific enclosed syringe designed exclusively for its use. It is essential to store the product at a temperature range of 20-25ºC (68-77ºF) to maintain its integrity and efficacy.

Healthcare professionals should ensure that the printed neckband remains intact; the product should not be used if the neckband is broken or missing. Proper handling and adherence to these storage conditions are crucial for the safe and effective use of the product.

Additional Clinical Information

Patients should be informed that the medication is administered orally, with a recommended repeat dose every 4 hours while symptoms persist, not exceeding 5 doses within a 24-hour period.

Clinicians should counsel patients to consult a doctor before use if the patient has liver disease or is taking the anticoagulant warfarin. Patients are advised to discontinue use and seek medical advice if pain worsens or persists beyond 5 days, if fever worsens or lasts more than 3 days, if new symptoms arise, or if there is any redness or swelling. It is crucial to keep the medication out of reach of children, and in the event of an overdose, immediate medical assistance should be sought by contacting a Poison Control Center at 1-800-222-1222, as prompt attention is essential even if no symptoms are apparent.

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.

View product document (PDF)