Infants Fever Reducer and Pain Reliever

Description

Acetaminophen is presented as an oral suspension containing 160 mg of acetaminophen per 5 mL. The formulation is cherry-flavored and is packaged in a 2 FL OZ (60 mL) bottle. This product is free from dyes and parabens, and does not contain aspirin or ibuprofen. It is specifically indicated for use in infants aged 2 to 3 years as a fever reducer and pain reliever. Administration should be performed 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 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, refer to the following chart:

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

• For children weighing between 24-35 lb or aged 2-3 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 in excess of 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, 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 dosage is contraindicated, as it poses a risk of overdose.

Warnings and Precautions

Severe liver damage may occur in children taking this product, which contains acetaminophen, if they exceed the maximum daily dosage of 5 doses within a 24-hour period or if they are concurrently using other medications that also contain acetaminophen. Healthcare professionals should monitor for signs of liver impairment in patients using this medication.

Acetaminophen has been associated with 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.

In cases of severe sore throat that persists for more than 2 days, or if it is accompanied or followed by fever, headache, rash, nausea, or vomiting, a prompt consultation with a healthcare provider is advised.

Prior to administration, it is essential to consult a physician if the child has a history of liver disease. Additionally, healthcare professionals should inquire about the use of anticoagulants, specifically warfarin, as this may necessitate further evaluation before use.

Patients should be advised to discontinue use and consult a healthcare provider if any of the following occur: worsening pain lasting more than 5 days, worsening fever lasting more than 3 days, the emergence of new symptoms, or the presence of redness or swelling, as these may indicate a serious underlying condition.

In the event of an overdose, immediate medical attention is crucial. Healthcare providers should instruct caregivers to contact a Poison Control Center at 1-800-222-1222 without delay, even if no signs or symptoms are initially apparent. Quick intervention is vital in managing potential overdose situations.

Side Effects

Severe liver damage may occur in patients who exceed the recommended dosage of more than 5 doses in a 24-hour period, which is the maximum daily amount. Additionally, the risk of severe liver damage increases if this product is taken 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 is also issued for patients experiencing a severe sore throat that persists for more than 2 days or is accompanied by fever, headache, rash, nausea, or vomiting; such individuals should consult a healthcare provider promptly.

Patients are advised against using this product in conjunction with any other drug containing acetaminophen, whether prescription or nonprescription. It is also contraindicated in patients with a known allergy to this product or any of its ingredients.

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

During the use of this product, it is crucial not to exceed the recommended dosage. Patients should discontinue use and consult a healthcare provider if pain worsens or persists beyond 5 days, if fever worsens or lasts more than 3 days, if new symptoms arise, or if redness or swelling occurs, as these may indicate a serious condition.

In the event of an overdose, patients should seek medical help or contact a Poison Control Center immediately at 1-800-222-1222. Prompt medical attention is essential, even if no signs or symptoms are 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 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 Infants Fever Reducer and Pain Reliever (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, the recommended dose is 5 mL for those weighing between 24-35 pounds. 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.

Healthcare professionals should be aware of specific warnings regarding the use of this product in pediatric patients. It should not be administered to children with a history of allergic reactions to this 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.

Proper storage of the product is essential; it should be kept at a temperature of 20-25ºC (68-77ºF). As with all medications, this product 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

The available prescribing information does not provide specific data regarding the use of acetaminophen during pregnancy. Consequently, healthcare professionals should exercise caution when recommending acetaminophen to pregnant patients, as the absence of safety concerns, dosage modifications, or special precautions leaves a gap in the understanding of its potential effects on fetal outcomes.

Given the lack of detailed information, it is advisable for women of childbearing potential to consult with their healthcare provider before using acetaminophen during pregnancy to ensure that any potential risks are adequately assessed and managed.

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 nursing infants 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 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 absence of guidance 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 assess liver function and consider potential dosage adjustments 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 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 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 compound in these areas.

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 medication in conjunction with any other products containing acetaminophen, whether 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 medication should not be administered to children who have 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 be advised to consult a doctor prior to use if their child has liver disease, as this condition may affect the safety and efficacy of the medication. Additionally, it is important to recommend that patients speak with a doctor or pharmacist if their child is currently taking the blood-thinning medication warfarin, to ensure there are no potential interactions.

Storage and Handling

This product is supplied in a specific packaging 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.

Healthcare professionals should ensure that the printed neckband is intact before use; the product must not be utilized if the neckband is broken or missing. Additionally, to maintain child resistance, the cap should be replaced tightly after each use. Proper handling and storage are critical to preserving the integrity of the product.

Additional Clinical Information

The medication is administered orally, with a recommended repeat dose every 4 hours as long as symptoms persist, not to exceed 5 doses within a 24-hour period. Clinicians should counsel patients to consult a doctor before use if the child has liver disease or is taking the anticoagulant warfarin.

Patients should be advised to discontinue use and seek medical attention 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 Infants Fever Reducer and Pain Reliever, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

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