Leader Childrens Pain and Fever

Description

Acetaminophen is formulated as an oral suspension containing 160 mg of acetaminophen per 5 mL. This preparation serves as a pain reliever and fever reducer, specifically designed for pediatric patients aged 2 to 11 years. The product is presented in a 4 FL OZ (118 mL) bottle and features a bubble gum flavor to enhance palatability. It is alcohol-free, aspirin-free, and ibuprofen-free, and does not contain parabens.

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 dosage chart to determine the appropriate dose based on the child's weight or age. Prior to administration, the product must be shaken well to ensure proper mixing.

To administer the dose, the child protective cap should be removed, and the prescribed amount should be squeezed into the enclosed dosing cup. The recommended dosing intervals are every 4 hours as needed while symptoms persist, with a maximum of 5 doses within a 24-hour period.

The following dosage chart provides specific dosing recommendations:

• For children weighing under 24 lb or under 2 years of age, consult a doctor for the appropriate dose.

• For children weighing 24-35 lb (2-3 years), the dose is 5 mL.

• For children weighing 36-47 lb (4-5 years), the dose is 7.5 mL.

• For children weighing 48-59 lb (6-8 years), the dose is 10 mL.

• For children weighing 60-71 lb (9-10 years), the dose is 12.5 mL.

• For children weighing 72-95 lb (11 years), the dose is 15 mL.

It is imperative not to exceed the recommended dosage, and healthcare professionals should be aware of the overdose warning associated with this product. Only the enclosed dosing cup should be used for measurement; other dosing devices are not appropriate for 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. 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 this product 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 with the use of this product, which contains acetaminophen. Healthcare professionals should advise caregivers that exceeding five doses within a 24-hour period, which is the maximum daily amount, or administering this product concurrently with other medications containing acetaminophen significantly increases the risk of liver injury.

Acetaminophen may also provoke severe skin reactions. Symptoms indicative of such reactions 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 two days, or if it is accompanied or followed by fever, headache, rash, nausea, or vomiting, prompt consultation with a healthcare provider is essential.

Healthcare professionals should exercise caution and recommend that caregivers consult a physician prior to use if the child has a history of liver disease. Additionally, it is advisable to seek guidance from a doctor or pharmacist if the child is concurrently taking the anticoagulant warfarin, as interactions may occur.

In the event of an overdose, immediate medical attention is crucial. Caregivers should be instructed to contact a Poison Control Center at 1-800-222-1222 or seek emergency medical help without delay, even if no symptoms are apparent.

Caregivers should be advised to discontinue use and consult a healthcare provider if the child experiences any of the following: worsening pain that lasts more than five days, worsening fever that persists for more than three 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

Severe liver damage may occur in patients who exceed the maximum daily dosage of five doses within a 24-hour period. This risk is further heightened if the product is taken concurrently with other medications containing acetaminophen.

Patients should be aware of the potential for severe skin reactions associated with acetaminophen use. 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 where a sore throat is severe, persists for more than two days, or is accompanied by additional symptoms such as fever, headache, rash, nausea, or vomiting, patients are advised to consult a healthcare professional without delay.

Patients should also discontinue use and consult a doctor if pain worsens or lasts longer than five days, if fever worsens or persists beyond three days, if new symptoms arise, or if redness or swelling is observed. These signs may indicate the presence of a serious condition requiring medical evaluation.

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. Co-administration may lead to an increased risk of acetaminophen-related toxicity. 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 Leader Childrens Pain and Fever (acetaminophen). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients aged 2 to 11 years are the intended population for this product. Dosing guidelines are as follows: for children under 24 lb (under 2 years), consultation with a doctor is required. For those weighing 24-35 lb (2-3 years), the recommended dose is 5 mL; for 36-47 lb (4-5 years), 7.5 mL; for 48-59 lb (6-8 years), 10 mL; for 60-71 lb (9-10 years), 12.5 mL; and for 72-95 lb (11 years), 15 mL. It is advised to use weight for dosing when possible; otherwise, age may be used.

The maximum dosage should not exceed 5 doses within a 24-hour period. Healthcare professionals should consult a doctor if the child has liver disease, is taking the blood-thinning medication warfarin, has a history of allergic reactions to this product or its ingredients, or if the child experiences a severe sore throat that persists for more than 2 days or is accompanied by fever, headache, rash, nausea, or vomiting.

Parents and caregivers should be advised to discontinue use if the child’s pain worsens or lasts more than 5 days, if fever worsens or lasts more than 3 days, if new symptoms occur, or if there is any redness or swelling present.

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 assess 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 data regarding the use of this product during pregnancy do not indicate any specific warnings or precautions. The prescribing information does not state whether the product is contraindicated in pregnant patients or if there are any associated risks to the fetus. Additionally, there are no recommendations for dosage modifications or special precautions for individuals who are pregnant. Healthcare professionals should consider the absence of specific data when advising women of childbearing potential and pregnant patients regarding the use of this product.

Lactation

Lactating mothers should consult a doctor before using this product. There is a potential for excretion in breast milk. The effects of this product 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 lack of data necessitates careful clinical judgment.

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 intervention is essential, as the absence of noticeable signs or symptoms does not preclude the potential for serious health consequences.

Healthcare professionals are advised to remain vigilant and act swiftly, as timely medical attention can significantly influence the outcome of an overdose situation. It is crucial to monitor the patient closely for any emerging symptoms, even if they initially appear asymptomatic.

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 elucidate these aspects of nonclinical toxicology.

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, emphasizing that prompt medical attention is crucial even if no signs or symptoms are apparent.

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

It is important to instruct patients not to use this product if their child has a history of allergic reactions to it or any of its ingredients. Additionally, patients should be advised to discontinue use and consult a doctor if pain worsens or persists for more than five days, if fever intensifies or lasts longer than three days, if new symptoms arise, or if there is any redness or swelling, as these may indicate a serious condition.

Patients must be cautioned against exceeding the recommended dose, as this could lead to overdose. Furthermore, healthcare providers should recommend that patients consult a doctor before using this product if their child has liver disease. Lastly, patients should be advised to speak with a doctor or pharmacist prior to use if their child is currently taking the blood-thinning medication warfarin.

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. Clinicians should advise patients to consult a doctor before use if the patient has liver disease or is taking the anticoagulant warfarin. Patients are instructed to discontinue use and seek medical advice 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. It is essential to keep the medication out of reach of children. In the event of an overdose, immediate medical assistance should be sought, or the Poison Control Center contacted at 1-800-222-1222, as prompt attention is crucial even in the absence of symptoms.

Drug Information (PDF)

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

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