Pain and Fever

Description

Acetaminophen is presented in a suspension liquid form, containing 160 mg of acetaminophen per 5 mL. This formulation is alcohol-free, aspirin-free, and ibuprofen-free, ensuring it is suitable for a wide range of patients. The product does not contain high fructose corn syrup and is dye-free, making it appropriate for those with sensitivities to these ingredients. It is flavored with cherry to enhance palatability. The product is packaged in a 2 FL OZ (59 mL) bottle and is intended for use with the enclosed syringe for accurate dosing.

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 directions or complete warnings for adult use. Healthcare professionals should ensure that the dosage is not exceeded, adhering to the overdose warning.

Prior to administration, the product must be shaken well. The appropriate dose should be determined using the provided dosing chart, which recommends using the child's weight for dosing whenever possible; otherwise, age may be used as a guide.

To prepare the dose, healthcare professionals should follow these steps:

1. Push the air out of the syringe.

2. Insert the syringe tip into the bottle opening.

3. Flip the bottle upside down and 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.

The liquid should be dispensed slowly into the child’s mouth, directed toward the inner cheek. The recommended dosing interval is every 4 hours while symptoms persist, with a maximum of 5 doses in a 24-hour period.

It is essential 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.

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 dose is 5 mL.

Dosing may also be adjusted 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 administered to children who have a history of allergic reactions to this product or any of its components, as this may lead to severe allergic responses.

• Exceeding the recommended dosage 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 patients that exceeding five doses within a 24-hour period, which constitutes the maximum daily amount, or concomitant use with other medications containing acetaminophen significantly increases the risk of liver injury.

Acetaminophen is also associated with the potential for severe skin reactions. Symptoms indicative of such reactions may include skin reddening, blisters, and rash. In the event of a skin reaction, it is imperative to discontinue use immediately and seek medical assistance.

Healthcare providers should be vigilant regarding patients presenting with a sore throat. If the sore throat is severe, persists for more than two days, or is accompanied by fever, headache, rash, nausea, or vomiting, prompt consultation with a physician is warranted.

Patients should be instructed to stop use and consult a healthcare professional if any of the following occur: pain worsens or persists beyond five days, fever intensifies or lasts more than three days, new symptoms develop, or if redness or swelling is observed. These signs may indicate a serious underlying condition that requires further evaluation.

In cases of suspected overdose, immediate medical attention is crucial. Patients or caregivers should be advised to contact a Poison Control Center at 1-800-222-1222 without delay, even if no signs or symptoms are apparent, as timely intervention is essential.

Side Effects

Severe liver damage may occur in patients taking this product containing acetaminophen if they exceed five doses within a 24-hour period, which is the maximum daily amount, or if they use it 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 sore throat warning is also applicable; if 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 doctor promptly.

Patients are advised to stop use and seek medical advice if pain worsens or lasts longer than five days, if fever worsens or persists for more than three days, if new symptoms arise, or if redness or swelling occurs, as these may indicate a serious condition.

Before using this product, it is recommended that patients consult a doctor if they have liver disease. Additionally, patients taking the blood-thinning medication warfarin should seek advice from a doctor or pharmacist prior to use.

In cases of overdose, immediate medical help should be sought, or contact with a Poison Control Center (1-800-222-1222) is essential. Quick medical attention is critical, even if no signs or symptoms are immediately 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 interaction between this medication and warfarin may necessitate careful monitoring of coagulation parameters to ensure patient safety and efficacy of treatment. Adjustments to the dosage of either medication 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 use this product 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 essential to adhere to the recommended dosage and not exceed it, as indicated in the overdose warning.

Healthcare professionals should advise parents to seek medical advice before using this product if their child has liver disease. Additionally, parents should be instructed to stop use and consult a doctor if the child's pain worsens or persists for more than 5 days, if fever worsens or lasts more than 3 days, if new symptoms arise, or if there is any redness or swelling, as these may indicate a serious condition.

It is crucial to keep this product 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 medical attention is vital even if no signs or symptoms are observed.

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

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. Due to the lack of safety concerns, dosage modifications, or special precautions outlined in the insert, the potential risks and benefits should be carefully considered on a case-by-case basis. It is advisable for women of childbearing potential to consult with their healthcare provider before using acetaminophen during pregnancy to ensure appropriate management and monitoring.

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 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 lack of data 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. Close monitoring of liver function tests may be warranted to ensure safety and efficacy in this patient 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 the absence of overt symptoms, the risk of delayed reactions necessitates thorough evaluation and monitoring of the patient.

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 question. Further studies may be necessary to elucidate these aspects of nonclinical 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, 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. Additionally, patients should be advised to discontinue use and consult a doctor if pain worsens or persists for more than five days, if fever intensifies or lasts longer than three days, if new symptoms arise, or if there is any redness or swelling, as these may indicate a serious condition.

Patients must be cautioned against exceeding the recommended dose, as this could lead to overdose. Furthermore, 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 a configuration that includes a specific enclosed syringe designed exclusively for use with it. 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 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. Patients are also instructed to discontinue use and seek medical advice if pain worsens or persists beyond 5 days, if fever intensifies or lasts more than 3 days, if new symptoms arise, or if there is any redness or swelling, 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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