Childrens Pain and Fever

Description

The product is identified by the SPL code 34089-3. No specific description details are provided in the available data.

Uses and Indications

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

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

Dosage and Administration

For patients weighing under 24 lbs (under 2 years), it is recommended to consult a physician prior to administration. For those weighing between 24-35 lbs (ages 2-3 years), the appropriate dosage is 1 Single-Use Vial (5 mL). Patients weighing 36-47 lbs (ages 4-5 years) should also seek medical advice before administration.

For children weighing 48-71 lbs (ages 6-10 years), the dosage is 2 Single-Use Vials (10 mL). For patients weighing 72-95 lbs (ages 11 years and older), the recommended dosage is 3 Single-Use Vials (15 mL).

The medication is to be administered using Single-Use Vials. It is essential to follow the specified dosing guidelines and consult a healthcare professional for any uncertainties regarding the appropriate dosage for individual patients.

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.

Additionally, this product should not be administered to children with a known allergy to acetaminophen or any of the inactive ingredients contained in this formulation.

Warnings and Precautions

Severe liver damage may occur with the use of this product, which contains acetaminophen, if the maximum daily dosage of 5 doses within 24 hours is exceeded or if it is taken concurrently with other medications containing acetaminophen. Healthcare professionals should advise caregivers to adhere strictly to dosing guidelines to mitigate the risk of hepatotoxicity.

Acetaminophen has been associated with severe skin reactions, which may 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 is accompanied by additional symptoms such as fever, headache, rash, nausea, or vomiting, prompt consultation with a healthcare provider is recommended to rule out serious underlying conditions.

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, even if no symptoms are apparent, as early intervention can be critical.

Healthcare professionals should advise caregivers to discontinue use and consult a physician if any of the following occur: worsening pain lasting more than 5 days, worsening fever lasting more than 3 days, the emergence of new symptoms, or the presence of redness or swelling, as these may indicate a serious medical condition.

Before administering this product, it is essential to consult a healthcare provider if the child is currently taking warfarin, a blood-thinning medication, or if there is a history of liver disease. This precaution is necessary to prevent potential drug interactions and complications.

Side Effects

Severe liver damage may occur in patients who exceed the maximum daily dosage of five doses within a 24-hour period or who concurrently use other medications containing acetaminophen. Participants 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 any skin reaction, it is imperative to discontinue use and seek immediate 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.

It is advised that patients stop use and consult a doctor if pain worsens or lasts longer than five days, if fever intensifies or persists beyond three days, if new symptoms arise, or if there is any redness or swelling, as these may indicate a serious condition.

Before using this product, patients should seek guidance from a doctor or pharmacist if they are taking the anticoagulant warfarin or if they have a history of liver disease.

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 may arise from unintentional duplication of therapy. 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

Pediatric patients should not receive more than the directed dosage, and healthcare professionals are advised to consult the dosing chart to confirm the appropriate dose based on weight or age.

For children under 24 lbs or under 2 years of age, it is recommended to consult a doctor before administration. For those weighing between 24-35 lbs (2-3 years), the appropriate dose is 1 Single-Use Vial (5 mL). Children weighing 36-47 lbs (4-5 years) should also consult a doctor prior to use. For pediatric patients weighing 48-71 lbs (6-10 years), the recommended dose is 2 Single-Use Vials (10 mL), while those weighing 72-95 lbs (11 years) should receive 3 Single-Use Vials (15 mL).

It is important to note that this medication should not be administered for more than 5 days unless directed by a healthcare professional.

Geriatric Use

There is no specific information regarding the use of this product in geriatric patients. Additionally, the prescribing information does not include directions or complete warnings for adult use. Therefore, healthcare providers should exercise caution when considering this product for elderly patients. It is advisable to monitor these patients closely for any adverse effects or complications, given the lack of established guidelines and safety data in this population. Dose adjustments may be necessary based on individual patient factors, including overall health status and the presence of comorbidities.

Pregnancy

There are no specific statements regarding the use of this product during pregnancy. The prescribing information does not provide any data on safety concerns, dosage modifications, or special precautions for pregnant patients. Additionally, there are no contraindications mentioned for use during pregnancy. Healthcare professionals should consider the lack of information when prescribing this product to women of childbearing potential and weigh the potential risks and benefits.

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 during lactation.

Renal Impairment

There is no specific information regarding renal impairment, dosage adjustments, special monitoring, or safety considerations for patients with reduced kidney function. Healthcare professionals should exercise caution when prescribing to patients with renal impairment, as the absence of detailed guidance necessitates careful clinical judgment and monitoring of these patients.

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. Exceeding this limit, particularly in conjunction with other medications containing acetaminophen, may significantly increase the risk of liver injury.

Before administering this product, it is advisable for caregivers to consult a healthcare professional if the patient has a history of liver disease. This precaution is essential to ensure the safety and appropriateness of treatment in patients with compromised liver function.

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 early intervention can significantly impact patient outcomes in cases of overdosage.

Monitoring and supportive care may be necessary, depending on the specific circumstances and the substance involved. It is essential to assess the patient's condition thoroughly and provide appropriate management based on clinical judgment and established protocols.

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

Acetaminophen has been associated with severe skin reactions, which may manifest as skin reddening, blisters, or rash. In the event of a skin reaction, it is advised to discontinue use immediately and seek medical assistance.

Additionally, in cases of overdose, it is crucial to obtain medical help or contact a Poison Control Center promptly at 1-800-222-1222. Timely medical intervention is essential, even if no signs or symptoms are apparent.

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 critical even if no signs or symptoms are apparent.

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

It is essential to discuss the potential for allergic reactions; patients should be instructed to discontinue use and consult a doctor if they experience any allergic reactions to acetaminophen or any inactive ingredients in the product.

Patients should be advised to stop using the medication and seek medical advice if pain worsens or persists for more than 5 days, or if fever worsens or lasts longer than 3 days. Additionally, they should be instructed to consult a doctor if new symptoms arise or if there is any redness or swelling, as these may indicate a serious condition.

Finally, healthcare providers should recommend that patients consult 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 a tamper-evident carton. It is essential to inspect the packaging before use; do not utilize the product if the top flap of the carton is open or if any vials are found to be open or broken.

For optimal storage, the product should be maintained at a temperature range of 68-77ºF (20-25ºC). Proper handling and storage conditions are crucial to ensure the integrity and efficacy of the product.

Additional Clinical Information

No further data are available.

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.

View product document (PDF)