Infants Pain and Fever

Description

Acetaminophen is formulated as a liquid solution containing 160 mg of acetaminophen per 5 mL. It serves as a pain reliever and fever reducer, specifically indicated for use in pediatric patients aged 2 to 3 years. The formulation is free of alcohol, parabens, and high fructose corn syrup, and is dye-free. It is presented in a cherry flavor to enhance palatability. The product is packaged in a 2 FL OZ (59 mL) bottle and includes one dosing syringe, which is part of a pediatrician-preferred dosing system. Use of the enclosed syringe is recommended 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 healthcare professionals should refer to the dosing chart for appropriate administration. It is essential to shake the product well before use. The correct dose should be determined based on the child's weight; if weight is not available, age may be used as a guide.

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

1. Push air out of the enclosed syringe and insert the syringe tip into the bottle opening.

2. 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.

3. 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. Dosing may be repeated every 4 hours as needed while symptoms persist, but it is crucial not to exceed 5 doses in 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 and to avoid using any other dosing device. After use, the cap should be replaced tightly to maintain child resistance. Healthcare professionals should also be aware that this product does not contain complete warnings for adult use and should not be administered beyond the directed dosage.

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. If there is uncertainty regarding the presence of acetaminophen in a medication, consultation with a healthcare professional is advised.

• This product should not be administered to children who have a history of allergic reactions to it or any of its components.

• Exceeding the recommended dosage is contraindicated due to 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, a prompt consultation with a healthcare provider is recommended to rule out serious underlying conditions.

Before administering this product, it is essential to consult a physician if the child has a history of liver disease. Additionally, caregivers should seek advice from a healthcare professional 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 also be instructed 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 there is any 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 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.

It is contraindicated to use this product in conjunction with any other drug containing acetaminophen, whether prescription or nonprescription. Additionally, patients with a known allergy to this product or any of its ingredients should not use it.

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

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, it is critical to seek medical assistance or contact a Poison Control Center immediately, as prompt medical intervention is essential even in the absence of noticeable signs or symptoms.

This product should be kept out of reach of children to prevent accidental ingestion.

Drug Interactions

The concomitant use of this medication with warfarin, a blood-thinning agent, should be approached with caution. It is advisable for patients to consult a healthcare professional, such as a doctor or pharmacist, prior to initiating treatment if they are currently taking warfarin. This is to ensure appropriate monitoring and management of potential interactions that may affect coagulation parameters.

Additionally, this medication should not be used in conjunction with other products containing acetaminophen, whether they are prescription or nonprescription. Patients are encouraged to verify the presence of acetaminophen in any other medications they may be taking. If there is uncertainty regarding the contents of a medication, it is recommended to seek guidance from a healthcare professional to avoid the risk of acetaminophen overdose.

Packaging & NDC

Below are the non-prescription pack sizes of Infants 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 product without consulting a doctor. For children aged 2 to 3 years who weigh between 24 to 35 pounds, the recommended dose is 5 mL, or as directed by a healthcare professional. It is advised to use weight for dosing whenever possible; if weight is not available, age may be used as a guide.

Healthcare professionals should be aware of specific warnings associated with this product. It should not be administered to children with a known allergy to the product or any of its ingredients. Additionally, consultation with a doctor is necessary if the child has liver disease or is taking the blood-thinning medication warfarin.

When administering the product, it is crucial to use only the enclosed syringe designed for this specific formulation. Other dosing devices should not be used to ensure accurate dosing.

In the event of an overdose, immediate medical assistance should be sought, or contact a Poison Control Center at 1-800-222-1222. Prompt medical attention is essential, even if no signs or symptoms are apparent.

Geriatric Use

Elderly patients may not receive comprehensive directions or warnings regarding the use of this product. Therefore, healthcare providers should exercise caution when prescribing this product to geriatric patients. It is essential to consider the unique physiological changes and potential comorbidities that may affect the safety and efficacy of the treatment in this population.

Healthcare providers are advised to closely monitor elderly patients for any adverse effects and to adjust dosages as necessary, taking into account the individual patient's health status and response to therapy.

Pregnancy

The available prescribing information does not provide specific data regarding the use of acetaminophen during pregnancy. Consequently, there are no established safety concerns, dosage modifications, or special precautions outlined for pregnant patients. Healthcare professionals should consider the lack of information when advising women of childbearing potential and weigh the potential benefits against any unknown risks associated with the use of acetaminophen during pregnancy. It is advisable to monitor emerging data and guidelines to inform clinical decision-making in this population.

Lactation

Nursing mothers should consult a doctor before using this product. There is a potential for excretion in breast milk, and the effects of acetaminophen on a nursing infant are not well studied; therefore, caution is advised. It is recommended to monitor the infant for any adverse effects if the nursing mother takes 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 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 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, and early recognition and management are essential to mitigate potential complications. It is recommended that all cases of suspected overdose be treated as medical emergencies, necessitating thorough evaluation and appropriate therapeutic measures.

Monitoring and supportive care may be required, depending on the clinical presentation. Continuous assessment of the patient's condition is advised to ensure timely intervention and to address any emerging symptoms effectively.

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

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

It is essential to communicate that this product should not be used if the child has a history of allergic reactions to this product or any of its ingredients. Providers should stress the importance of adhering to the recommended dosage and caution against exceeding it, as this could lead to overdose.

Patients should also be advised to consult a doctor before using this product if their child has liver disease. Additionally, it is 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 ensure safety and avoid potential interactions.

Storage and Handling

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

For optimal handling, the product should not be used if the printed neckband is broken or missing, as this may indicate tampering or compromise of the product's integrity. Additionally, to maintain child resistance, the cap must be replaced tightly after each use.

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 to exceed 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 should be advised to seek immediate medical attention if a skin reaction occurs. Additionally, if a sore throat is severe, lasts more than 2 days, or is accompanied by fever, headache, rash, nausea, or vomiting, a doctor should be consulted promptly. Patients should discontinue use and contact a healthcare provider if new symptoms arise, if pain worsens or lasts more than 5 days, if fever worsens or lasts more than 3 days, or if redness or swelling is observed.

Drug Information (PDF)

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

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