Infants Pain and Fever Cherry Flavor

Description

Acetaminophen is an oral suspension available in a strength of 160 mg per 5 mL. It is presented in a 2 fl oz (59 mL) bottle and has a cherry flavor.

Uses and Indications

This drug is indicated for the temporary reduction of fever and the relief of minor aches and pains associated with the common cold, headache, toothache, influenza, and sore throat.

There are no teratogenic or nonteratogenic effects associated with this drug.

Dosage and Administration

Healthcare professionals should instruct caregivers to shake the product well before each use. Dosing should be determined primarily by the child's weight; however, if weight is not available, age may be used as a secondary guide.

For children weighing under 24 lbs or under 2 years of age, caregivers are advised to consult a physician for appropriate dosing. For children weighing between 24-35 lbs or aged 2-3 years, the recommended dose is 5 mL.

To administer the medication, caregivers should follow these steps:

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

2. Invert the bottle and pull the white part of the syringe to the correct dose.

3. Dispense the liquid slowly into the child's mouth, directing it 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. After use, caregivers must ensure the cap is replaced tightly to maintain child-resistant packaging. It is imperative to use only the enclosed syringe specifically designed for this product; no other dosing devices should be utilized.

Contraindications

Use of this product is contraindicated in patients who are concurrently taking any other medication that contains acetaminophen, whether prescription or nonprescription. This is due to the potential for acetaminophen overdose, which can lead to serious liver damage. If there is uncertainty regarding the presence of acetaminophen in other medications, consultation with a healthcare professional is advised.

Additionally, it is contraindicated to exceed the recommended dosage of this product, as doing so may increase the risk of overdose and associated adverse effects.

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 contain acetaminophen.

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 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, it is essential to consult a healthcare professional promptly.

Healthcare providers should inquire about the presence of liver disease before recommending this product for children. Additionally, it is advisable to consult a doctor or pharmacist if the child is currently taking the anticoagulant warfarin, as interactions may occur.

In the event of an overdose, immediate medical attention is crucial. Parents or caregivers should contact a Poison Control Center at 1-800-222-1222 or seek emergency medical help, even if no symptoms are apparent.

Discontinuation of the product and consultation with a healthcare provider is warranted if any of the following occur: worsening pain that lasts more than 5 days, worsening fever that persists for more than 3 days, the emergence of new symptoms, or the presence of redness or swelling. These signs may indicate a serious underlying condition that requires medical evaluation.

Side Effects

Patients using this product should be aware of several important warnings and potential adverse reactions.

Severe liver damage may occur in patients who exceed the maximum daily dosage of acetaminophen, which is limited to 5 doses within a 24-hour period. Additionally, the risk of liver damage increases if the product is taken concurrently with other medications containing acetaminophen.

Patients should also be alert for severe skin reactions associated with acetaminophen use. Symptoms may include skin reddening, blisters, and rash. In the event of a skin reaction, it is crucial to discontinue use immediately and seek medical assistance.

Furthermore, if a patient experiences a sore throat that is severe, persists for more than 2 days, or is accompanied by fever, headache, rash, nausea, or vomiting, they should consult a healthcare professional promptly.

Patients are advised to stop using the product and seek medical advice if any of the following occur: pain worsens or lasts longer than 5 days, fever worsens or lasts longer than 3 days, new symptoms develop, or if redness or swelling is observed. These symptoms may indicate a serious underlying condition that requires medical evaluation.

Drug Interactions

Acetaminophen has been observed to enhance the anticoagulant effects of warfarin, which may result in an elevated risk of bleeding. It is recommended that the International Normalized Ratio (INR) be monitored closely in patients who are receiving both acetaminophen and warfarin concurrently to ensure safe therapeutic levels and to mitigate the risk of adverse effects.

No additional drug interactions or interactions with laboratory tests have been reported.

Packaging & NDC

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

Pediatric Use

Pediatric patients under 24 lbs and under 2 years of age should consult a doctor before use. For children weighing between 24-35 lbs and aged 2-3 years, the recommended dosage is 5 mL.

It is important to ask a doctor before administering this medication if the child has liver disease. Additionally, consultation with a doctor or pharmacist is advised if the child is concurrently taking the blood-thinning medication warfarin.

Dosing should primarily be based on the child's weight; if weight is not available, age may be used as a secondary guide. Care should be taken not to exceed the recommended dosage, with a maximum of 5 doses allowed within a 24-hour period. Doses may be repeated every 4 hours as needed while symptoms persist.

Geriatric Use

The prescribing information for Infants' Pain and Fever Cherry Flavor (acetaminophen suspension) does not provide specific guidance regarding the use of this medication in geriatric patients. There are no recommended age considerations, dosage adjustments, or safety concerns outlined for elderly patients.

Healthcare providers should exercise caution when considering the use of this medication in geriatric patients, as the absence of specific data necessitates careful monitoring and assessment of individual patient needs. It is advisable to evaluate the overall health status and potential comorbidities of elderly patients before prescribing this medication, given the lack of targeted information in the prescribing insert.

Pregnancy

The safety of acetaminophen during pregnancy has not been established. Pregnant patients or those planning to become pregnant should consult a healthcare professional before use. While potential risks to the fetus are not clearly defined, caution is advised when considering the use of acetaminophen during pregnancy. There are no specific dosage modifications for pregnant individuals; therefore, it is essential to seek guidance from a healthcare professional regarding appropriate use.

Lactation

Lactating mothers should consult a doctor before using this product. There is a potential for excretion in breast milk. The effects of acetaminophen on a nursing infant are not well studied; therefore, caution is advised.

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. 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 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 medical attention is crucial, even in the absence of noticeable signs or symptoms.

Healthcare professionals should be aware that the management of an overdose may require specific interventions based on the substance involved and the clinical presentation of the patient. Continuous monitoring and supportive care may be necessary to address any potential complications that arise from the overdose.

It is essential to maintain a high index of suspicion for overdose in patients presenting with unexplained symptoms, as early recognition and treatment can significantly improve outcomes.

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 fully evaluate the nonclinical toxicology profile.

Postmarketing Experience

Postmarketing experience has identified rare cases of severe skin reactions associated with acetaminophen. Reported symptoms include skin reddening, blisters, and rash. These events were documented through voluntary reports and surveillance programs.

Patient Counseling

Healthcare providers should advise patients to keep this medication out of reach of children to prevent accidental ingestion. It is important to inform patients not to use this product in conjunction with any other medications that contain acetaminophen, whether prescription or nonprescription. If patients are uncertain whether a drug contains acetaminophen, they should be encouraged to consult with a doctor or pharmacist for clarification.

Patients should be instructed to stop using the medication and seek medical advice if they experience any of the following: worsening pain that lasts more than 5 days, a fever that worsens or persists for more than 3 days, the emergence of new symptoms, or the presence of redness or swelling. These symptoms may indicate a serious underlying condition that requires further evaluation.

While using this product, patients must be cautioned against exceeding the recommended dose, as this could lead to overdose. Additionally, healthcare providers should recommend that patients consult a doctor before use if their child has liver disease. It is also advisable for patients to speak with a doctor or pharmacist before using this medication if their child is currently taking the blood-thinning medication warfarin, to ensure safety and avoid potential interactions.

Storage and Handling

The product is supplied in various package configurations, with specific NDC numbers available for 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. Proper storage conditions must be adhered to, ensuring that the product is kept within the specified temperature limits to prevent degradation.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

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

View product document (PDF)