Childrens Fever Reducer and Pain Reliever

Description

This oral suspension contains acetaminophen at a concentration of 160 mg per 5 mL, serving as a children's fever reducer and pain reliever. It is formulated for children aged 2 to 11 years and is free from parabens, alcohol, aspirin, and ibuprofen. The product is presented in a 4 FL OZ (118 mL) bottle and features a bubble gum flavor.

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 does not contain directions or complete warnings for adult use. Healthcare professionals should ensure that the dosage is not exceeded, adhering to the overdose warning.

Prior to administration, the product must be shaken well. The appropriate dose should be determined using the dosage chart provided, with weight being the preferred method for dosing; if weight is not available, age may be used as an alternative.

To administer the dose, the child protective cap should be removed, and the prescribed amount should be squeezed into the enclosed dosing cup. The dose may be repeated every 4 hours as needed while symptoms persist, but it is imperative not to exceed 5 doses within a 24-hour period.

Dosage Chart:

• 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 or aged 2-3 years, the dose is 5 mL.

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

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

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

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

Dosing should be as directed by a healthcare professional. It is essential to use only the enclosed dosing cup specifically designed for this product and to refrain from using any other dosing device.

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 administered to children who have a history of allergic reactions to this product or any of its components, as this may lead to severe allergic responses.

Warnings and Precautions

Severe liver damage may occur with the use of this product, which contains acetaminophen. Healthcare professionals should advise patients that exceeding five doses within a 24-hour period, which is the maximum daily amount, or concomitant use with other medications containing acetaminophen significantly increases the risk of liver injury.

Acetaminophen is associated with the potential for 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, particularly if it persists for more than two days or is accompanied by fever, headache, rash, nausea, or vomiting, patients should be instructed to consult a healthcare provider without delay.

In the event of an overdose, immediate medical attention is crucial. Patients or caregivers should be directed to contact a Poison Control Center at 1-800-222-1222, even if no signs or symptoms are apparent, as prompt intervention is essential.

Healthcare professionals should also advise patients to discontinue use and seek medical advice if any of the following occur: worsening pain lasting more than five days, fever that worsens or 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 further evaluation.

Side Effects

Severe adverse reactions associated with the use of this product include the potential for severe liver damage, particularly if a child exceeds 5 doses within a 24-hour period or if the product is taken concurrently with other medications containing acetaminophen. Patients should be advised to seek immediate medical attention in the event of an overdose, as prompt intervention is crucial, even in the absence of noticeable symptoms.

Allergic reactions may manifest as severe skin reactions, which can include symptoms such as skin reddening, blisters, and rash. Should any of these symptoms occur, it is imperative to discontinue use and seek medical assistance without delay.

In cases of severe sore throat that persists for more than 2 days or is accompanied by additional symptoms such as fever, headache, rash, nausea, or vomiting, patients should consult a healthcare professional promptly.

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

Prior to use, it is recommended that patients with a history of liver disease consult a healthcare provider. Additionally, those taking the anticoagulant warfarin should seek advice from a doctor or pharmacist before using this product.

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 Childrens Fever Reducer and Pain Reliever (acetaminophen). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients aged 2 to 11 years may receive this medication with dosing based on weight or age. The recommended doses are as follows:

• For patients under 24 lb and under 2 years, consultation with a doctor is advised.

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

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

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

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

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

It is important to administer no more than 5 doses within a 24-hour period. The use of this medication is contraindicated with other drugs containing acetaminophen. Prior to administration, healthcare professionals should inquire about any existing liver disease in the child. Additionally, consultation with a doctor or pharmacist is recommended if the child is taking the anticoagulant warfarin.

Healthcare professionals should advise caregivers to discontinue use and seek medical advice if the child's pain worsens or persists beyond 5 days, if fever worsens or lasts more than 3 days, if new symptoms arise, or if there is any redness or swelling.

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 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, and caution is advised when administering this product to nursing mothers.

Renal Impairment

Patients with renal impairment have not been specifically addressed in the available data 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 lack of information 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 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 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 crucial, 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 essential 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 these contexts.

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 beyond five days, if fever intensifies or lasts more than three days, if new symptoms arise, or if there is any redness or swelling, as these may indicate a serious condition.

Patients should also be encouraged to seek medical advice before using this product if their child has liver disease. Furthermore, it is advisable for patients to consult 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. It should be stored at a temperature range of 20-25°C (68-77°F) to ensure optimal stability 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 compromised integrity. Proper handling and storage conditions are essential to maintain the quality of the product.

Additional Clinical Information

The medication is administered orally. 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 medical assistance or contact a Poison Control Center immediately at 1-800-222-1222, as prompt medical attention is essential even if no signs or symptoms are apparent.

Drug Information (PDF)

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

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