Childrens Pain and Fever

Description

NDC 70677-1286-1. Foster & Thrive™ Children’s Pain & Fever Acetaminophen is an oral suspension formulated to provide pain relief and reduce fever in children aged 2 to 11 years. Each 5 mL dose contains 160 mg of acetaminophen. The product is alcohol-free and ibuprofen-free, presented in a 16 FL OZ (473 mL) bottle. It features a strawberry flavor and includes a dosing cup for accurate measurement. The packaging is tamper-evident; do not use if the printed wrap is broken or missing. This product is not manufactured or distributed by Kenvue Inc., the owner of the registered trademark Children’s Tylenol® Oral Suspension. Distributed by McKesson Corp., via Strategic Sourcing Services LLC, Memphis, TN 38141. Money Back Guarantee available at www.fosterandthrive.com. ©2023 McKesson Corporation.

Uses and Indications

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

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

Dosage and Administration

This product is intended for use in pediatric patients, and healthcare professionals should ensure that dosing is based on the patient's weight whenever possible. If weight is not available, age may be used as a secondary guide.

Prior to administration, the product must be shaken well. The provided dose cup should be utilized to measure the correct dosage. The following dosing recommendations are based on weight and age:

• For patients weighing under 24 lb or under 2 years of age, it is advised to consult a doctor for appropriate dosing.

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

• For patients weighing between 36-47 lb or aged 4-5 years, the recommended dose is 7.5 mL.

• For patients weighing between 48-59 lb or aged 6-8 years, the recommended dose is 10 mL.

• For patients weighing between 60-71 lb or aged 9-10 years, the recommended dose is 12.5 mL.

• For patients weighing between 72-95 lb or aged 11 years, the recommended dose is 15 mL.

Dosing may be repeated every 4 hours as needed while symptoms persist, but it is critical not to exceed 5 doses within a 24-hour period. Healthcare professionals should ensure that patients do not receive more than the directed amount.

Contraindications

Use of this product is contraindicated in patients who are concurrently taking any other medication that contains acetaminophen, whether prescription or nonprescription. The combination may lead to an increased risk of acetaminophen-related hepatotoxicity. If there is uncertainty regarding the presence of acetaminophen in other medications, consultation with a healthcare professional is advised.

Warnings and Precautions

Severe liver damage may occur with the use of this product, which contains acetaminophen, if the maximum daily dosage is exceeded. Specifically, healthcare professionals should advise that no more than five doses should be administered within a 24-hour period. Additionally, caution is warranted when this product is used in conjunction with other medications containing acetaminophen, as this can further increase the risk of liver injury.

Acetaminophen has been associated with severe skin reactions. Symptoms indicative of such reactions may include skin reddening, blisters, and rash. In the event of any skin reaction, it is imperative to discontinue use immediately and seek medical assistance without delay.

Healthcare providers should be vigilant regarding sore throat symptoms. If a sore throat is severe, persists for more than two days, or is accompanied by fever, headache, rash, nausea, or vomiting, it is essential to consult a physician promptly.

Before administering this product, it is advisable to consult a healthcare professional if the child has a history of liver disease. Furthermore, if the child is concurrently taking the anticoagulant warfarin, consultation with a doctor or pharmacist is recommended to avoid potential interactions.

In cases of overdose, immediate medical attention is critical. Healthcare professionals should instruct caregivers to seek emergency medical help or contact a Poison Control Center right away, regardless of whether any signs or symptoms are present.

Patients should be advised to discontinue use and contact a healthcare provider if any of the following occur: pain worsens or persists beyond five days, fever worsens or lasts more than three days, new symptoms develop, or if there is any redness or swelling.

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 five doses within a 24-hour period, or who take this product concurrently with other medications containing acetaminophen.

Additionally, there is an allergy alert associated with acetaminophen, as it may lead to severe skin reactions. Symptoms of such reactions can include skin reddening, blisters, and rash. In the event of a skin reaction, patients are advised to discontinue use immediately and seek 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.

Patients should also stop using the product and consult a doctor if pain worsens or lasts longer than five days, if fever worsens or lasts more than three days, if any new symptoms appear, or if there is any redness or swelling present.

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

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 any other products containing acetaminophen, whether prescription or over-the-counter. The risk of acetaminophen overdose and associated hepatotoxicity is heightened when multiple sources of acetaminophen are used simultaneously. 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 Childrens Pain and Fever (acetaminophen). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

For pediatric patients under 2 years of age, it is recommended to consult a doctor before use. For children aged 2 to 3 years, the appropriate dosage is 5 mL; for those aged 4 to 5 years, 7.5 mL; for children aged 6 to 8 years, 10 mL; for children aged 9 to 10 years, 12.5 mL; and for children aged 11 years, 15 mL. Dosing may be repeated every 4 hours while symptoms persist, but should not exceed 5 doses in a 24-hour period.

Caution is advised as severe liver damage may occur if the maximum daily dosage is exceeded. Parents and caregivers should consult a doctor if a child's sore throat is severe, persists for more than 2 days, or is accompanied by fever, headache, rash, nausea, or vomiting. Additionally, it is important to seek medical advice before use if the child has liver disease or is taking the anticoagulant warfarin.

Safety precautions include keeping the medication out of reach of children. In the event of an overdose, immediate medical assistance should be sought, or contact a Poison Control Center, as prompt attention is critical for both children and adults, even if no signs or symptoms are apparent.

Geriatric Use

Elderly patients may not have specific information regarding the use of this product, as the prescribing information does not provide guidance on geriatric use. The product is primarily indicated for children aged 2 to 11 years, and there are no documented dosage adjustments or safety considerations specifically for geriatric patients.

Healthcare providers should exercise caution when prescribing this product to elderly patients, given the absence of data on its safety and efficacy in this population. Monitoring for potential adverse effects is advisable, as the pharmacokinetics and pharmacodynamics may differ in geriatric patients compared to younger populations.

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 this product in pregnant patients. Additionally, no dosage modifications for pregnant individuals are specified. The insert also 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 warnings or recommendations regarding the use of this product in nursing mothers. Additionally, there is no information available about the potential for excretion in breast milk or any associated risks to breastfed infants.

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 patients 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 be closely monitored when using this product, as it contains acetaminophen, which is associated with the risk of severe liver damage. It is critical to adhere to the maximum daily dosage of 5 doses within a 24-hour period to mitigate the risk of hepatotoxicity.

Before administration, it is advised that a healthcare professional be consulted if the patient has a history of liver disease. This precaution is essential to ensure the safe use of the product and to evaluate the potential need for dosage adjustments or additional monitoring based on the severity of the hepatic impairment.

Overdosage

In the event of an overdose, it is imperative to seek immediate medical assistance or contact a Poison Control Center without delay. Prompt medical intervention is crucial for both adults and children, regardless of whether any signs or symptoms are apparent.

Healthcare professionals should be aware that the absence of symptoms does not preclude the possibility of serious complications arising from an overdose. Therefore, it is essential to monitor the patient closely and provide appropriate care as needed.

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

Patient Counseling

Patients should be advised to seek immediate medical assistance or contact a Poison Control Center in the event of an overdose. It is crucial to emphasize that prompt medical attention is necessary for both adults and children, even if no signs or symptoms are initially apparent.

Healthcare providers should instruct patients not to use this medication in conjunction with any other drug that contains acetaminophen, whether prescription or nonprescription. If patients are uncertain about the presence of acetaminophen in any other medications they are taking, they should be encouraged to consult with a doctor or pharmacist for clarification.

Patients should be informed to discontinue use and consult a doctor if they experience any of the following: worsening pain that persists beyond 5 days, a fever that worsens or lasts more than 3 days, the emergence of any new symptoms, or the presence of redness or swelling.

Additionally, it is important to advise patients to consult a doctor before using this medication if their child has liver disease. Patients should also be reminded to seek guidance from a doctor or pharmacist if their child is currently taking the blood-thinning medication warfarin.

Storage and Handling

The product is supplied in various package configurations, with specific NDC numbers available for reference. It should be stored at a controlled room temperature of 25°C (77°F), with permissible excursions between 15°C and 30°C (59°F to 86°F).

Healthcare professionals are advised to check the end flap of the packaging for the expiration date and lot number to ensure proper inventory management and product safety.

Additional Clinical Information

The medication is administered orally, with a recommended repeat dose every 4 hours as needed for symptom relief, not to exceed 5 doses within a 24-hour period. Clinicians should advise patients to keep the medication out of reach of children and to seek immediate medical assistance or contact a Poison Control Center in the event of an overdose, as prompt attention is crucial for both adults and children, regardless of the presence of symptoms.

Drug Information (PDF)

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

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