Foster and Thrive Childrens Pain and Fever

Description

No description information is available for the specified drug.

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

Healthcare professionals should administer this product according to the following guidelines. Prior to use, it is essential to shake the product well. The appropriate dose should be determined using the dosage chart provided below, with weight being the preferred method for dosing. If weight is not available, age may be used as a secondary reference.

To administer the dose, remove the child protective cap and squeeze the prescribed amount into the enclosed dosing cup, which is specifically designed for use with this product. The dose may be repeated every 4 hours as needed while symptoms persist; however, it is critical not to exceed 5 doses within a 24-hour period.

Dosage Chart:

• For children weighing under 24 lb (under 2 years): Consult a doctor.

• For children weighing 24-35 lb (2-3 years): Administer 5 mL.

• For children weighing 36-47 lb (4-5 years): Administer 7.5 mL.

• For children weighing 48-59 lb (6-8 years): Administer 10 mL.

• For children weighing 60-71 lb (9-10 years): Administer 12.5 mL.

• For children weighing 72-95 lb (11 years): Administer 15 mL.

It is imperative to adhere strictly to the dosing recommendations and to consult a healthcare provider for any questions or concerns regarding the use of this product.

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 used in patients who have a history of allergic reactions to this product or any of its ingredients, as this may lead to severe adverse effects.

Additionally, it is essential to adhere to the recommended dosage guidelines, as exceeding the recommended dose poses a risk of overdose.

Warnings and Precautions

This product contains acetaminophen, which carries a significant risk of severe liver damage if not used according to guidelines. Healthcare professionals should advise caregivers that the maximum daily dosage for children is five doses within a 24-hour period. Caution is particularly warranted if the product is administered concurrently with other medications containing acetaminophen, as this may lead to unintentional overdose.

Severe skin reactions have been associated with acetaminophen use. 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.

Healthcare providers should also be vigilant regarding sore throat symptoms. If a child presents with a severe sore throat that persists for more than two days, or if it is accompanied by fever, headache, rash, nausea, or vomiting, prompt consultation with a physician is recommended.

Caregivers should be instructed to stop use and consult a healthcare professional if the following occur: pain worsens or lasts longer than five days, fever worsens or persists beyond three days, new symptoms develop, or if there is any redness or swelling, as these may indicate a serious underlying condition.

In cases of suspected overdose, immediate medical attention is crucial. Caregivers should be advised to contact a Poison Control Center at 1-800-222-1222, even if no signs or symptoms are apparent.

Before administering this product, it is essential for healthcare professionals to inquire about any pre-existing liver disease in the child. Additionally, consultation with a doctor or pharmacist is advised if the child is currently taking the anticoagulant warfarin, as potential interactions may necessitate careful monitoring.

Side Effects

Severe liver damage may occur in patients if more than 5 doses of the product are taken within a 24-hour period, which is the maximum daily amount. Additionally, the risk of severe liver damage increases if this product is used 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 sore throat. If the sore throat is severe, persists for more than 2 days, or is accompanied by fever, headache, rash, nausea, or vomiting, it is essential to consult a healthcare provider promptly.

Patients are advised to stop use and consult a doctor if pain worsens or lasts longer than 5 days, if fever worsens or lasts longer than 3 days, if new symptoms arise, or if redness or swelling is observed, as these may indicate a serious condition.

It is recommended that patients consult a doctor before using this product if they have liver disease. 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 elevate the risk of bleeding, necessitating careful monitoring and potential dosage adjustments of either medication based on clinical judgment.

No additional drug interactions or laboratory test interactions have been identified for this medication.

Packaging & NDC

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

Pediatric Use

Pediatric patients should not exceed the recommended dosage of this product. For children under 2 years of age and weighing less than 24 pounds, a healthcare professional should be consulted before administration. The following dosing guidelines apply based on weight and age:

• 24-35 pounds (2-3 years): 5 mL

• 36-47 pounds (4-5 years): 7.5 mL

• 48-59 pounds (6-8 years): 10 mL

• 60-71 pounds (9-10 years): 12.5 mL

• 72-95 pounds (11 years): 15 mL

It is essential to use only the enclosed dosing cup specifically designed for this product; other dosing devices should not be used.

Caution is advised due to the presence of acetaminophen, as severe liver damage may occur if more than 5 doses are taken within a 24-hour period, which is the maximum daily amount. Parents or guardians should consult a healthcare professional before use if the child has liver disease or is taking the blood-thinning medication warfarin.

This product should be kept 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 critical, even if no signs or symptoms are present.

Geriatric Use

Elderly patients may not have specific information regarding the use of this medication, including dosage adjustments, safety concerns, or special precautions. Therefore, healthcare providers should exercise caution when prescribing this medication to geriatric patients. It is advisable to monitor these patients closely for any adverse effects or changes in therapeutic response, given the lack of targeted data for this population.

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. There are no documented safety concerns, dosage modifications, or special precautions outlined for the use of acetaminophen in this population. Given the lack of information, it is advisable for women of childbearing potential to consult with their healthcare provider before using acetaminophen during pregnancy to ensure that potential risks and benefits are adequately assessed.

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 should consult a healthcare professional prior to use, particularly if there is a concurrent liver disease. It is essential to assess the patient's overall renal function and consider any necessary dosing adjustments or monitoring protocols based on the severity of renal impairment.

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 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 depending on the specific substance involved in the overdose. Therefore, a thorough assessment and monitoring of the patient are essential.

Management procedures may include supportive care and symptomatic treatment, tailored to the individual patient's needs. Continuous evaluation and appropriate interventions should be implemented to mitigate potential complications associated with the overdose.

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

Providers should also instruct patients not to exceed the recommended dose, highlighting the importance of adhering to dosage guidelines to prevent potential overdose.

Additionally, healthcare providers should encourage patients to consult with a doctor before using the medication if their child has liver disease. This precaution is essential to ensure the safety and appropriateness of the treatment.

Furthermore, it is important for healthcare providers to recommend that patients speak with a doctor or pharmacist prior to use if their child is currently taking the blood-thinning medication warfarin. This discussion is vital to avoid any potential interactions that could compromise the child's health.

Storage and Handling

The product is supplied in configurations that include specific NDC numbers, which should be referenced for accurate 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.

Healthcare professionals are advised to inspect the product prior to use; it should not be utilized if the printed neckband is broken or missing, as this may indicate potential tampering or compromise of the product's safety. Proper handling and storage conditions are crucial to ensure the product remains effective and safe for patient use.

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. In the event of an overdose, it is crucial for patients to seek immediate medical assistance or contact a Poison Control Center at 1-800-222-1222, as prompt medical attention is essential even if no symptoms are apparent.

Drug Information (PDF)

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

View product document (PDF)