Firstcare Childrens Pain Fever Acetaminophen

Description

No description information is available for the specified drug.

Uses and Indications

This drug is indicated for the temporary relief of minor aches and pains associated with the common cold, flu, headache, sore throat, and toothache. 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 pediatric use only, and healthcare professionals should refer to the dosage chart below to determine the appropriate dose based on the child's weight or age. It is essential to instruct the child to chew each chewable tablet thoroughly before swallowing.

Dosing should be repeated every 4 hours as needed while symptoms persist, with a maximum of 5 doses within a 24-hour period. It is critical not to exceed the recommended dosage, and healthcare professionals should be aware of the overdose warning associated with this product.

Dosage Chart:

• For children weighing under 24 lbs (under 2 years): Consult a doctor for the appropriate dose.

• For children weighing 24-35 lbs (2-3 years): Administer 2 chewable tablets.

• For children weighing 36-47 lbs (4-5 years): Administer 3 chewable tablets.

• For children weighing 48-59 lbs (6-8 years): Administer 4 chewable tablets.

• For children weighing 60-71 lbs (9-10 years): Administer 5 chewable tablets.

• For children weighing 72-95 lbs (11 years): Administer 6 chewable tablets.

Dosing may also be adjusted as directed by a healthcare professional.

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 other medications, consultation with a healthcare professional is advised.

• This product should not be used in patients with a known allergy to acetaminophen or any of the inactive ingredients contained in the formulation.

• Exceeding the recommended dosage while using this product 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 5 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 has been associated with severe skin reactions. Symptoms may include skin reddening, blisters, and rash. If any of these reactions occur, 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 fever, headache, rash, nausea, or vomiting, prompt consultation with a healthcare provider is recommended.

Before administering this product, healthcare professionals should inquire about any existing liver disease in the child. Additionally, it is crucial to consult a doctor or pharmacist if the child is currently taking warfarin, a blood-thinning medication, due to potential interactions.

Caregivers must be instructed not to exceed the recommended dosage, as outlined in the overdose warning. If pain worsens or persists beyond 5 days, or if fever worsens or lasts more than 3 days, or if new symptoms arise, or if redness or swelling is observed, it is essential to stop use and consult a healthcare provider, as these may indicate a serious condition.

In the event of an overdose, immediate medical attention is necessary. Caregivers should be advised to contact a Poison Control Center at 1-800-222-1222 without delay, as prompt medical intervention is critical for both adults and children, even in the absence of noticeable signs or symptoms.

Side Effects

Severe liver damage may occur in patients taking this product containing acetaminophen if they exceed 5 doses in a 24-hour period, which is the maximum daily amount, or if 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.

Patients experiencing a severe sore throat that persists for more than 2 days, or is accompanied by fever, headache, rash, nausea, or vomiting, should consult a healthcare professional promptly. This product should not be used in conjunction with any other drug containing acetaminophen, whether prescription or nonprescription. Patients should verify the presence of acetaminophen in other medications with a doctor or pharmacist if uncertain. Additionally, this product is contraindicated in patients with a known allergy to acetaminophen or any of the inactive ingredients.

Before using this product, patients with liver disease should consult a healthcare provider. Furthermore, patients taking the anticoagulant warfarin should seek advice from a doctor or pharmacist prior to use.

Patients are advised to discontinue use and consult a healthcare professional if pain worsens or persists for more than 5 days, if fever worsens or lasts more than 3 days, if new symptoms arise, or if redness or swelling occurs, as these may indicate a serious condition.

In the event of an overdose, it is crucial to seek medical help or contact a Poison Control Center immediately at 1-800-222-1222. Prompt medical attention is essential for both adults and children, even if no signs or symptoms are apparent.

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.

No additional drug interactions or laboratory test interactions have been identified.

Packaging & NDC

Below are the non-prescription pack sizes of Firstcare Childrens Pain Fever Acetaminophen (acetaminophen 80 mg). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients under 2 years of age should not use this medication without consulting a doctor. For children aged 2 to 3 years weighing 24-35 lbs, the recommended dose is 2 chewable tablets. For those aged 4 to 5 years weighing 36-47 lbs, the dose increases to 3 chewable tablets. Children aged 6 to 8 years weighing 48-59 lbs should take 4 chewable tablets, while those aged 9 to 10 years weighing 60-71 lbs may take 5 chewable tablets. Finally, children aged 11 years weighing 72-95 lbs can take 6 chewable tablets.

Healthcare professionals should be aware of several warnings associated with this medication. Severe liver damage may occur if a child exceeds 5 doses in a 24-hour period, which is the maximum daily amount. Acetaminophen may also cause severe skin reactions, including skin reddening, blisters, or rash; if any of these symptoms occur, use should be discontinued immediately, and medical help should be sought. Additionally, if a sore throat is severe, persists for more than 2 days, or is accompanied by fever, headache, rash, nausea, or vomiting, a doctor should be consulted promptly.

This medication should not be used in children who are allergic to acetaminophen or any inactive ingredients in the product. Consultation with a doctor is advised if the child has liver disease or is taking the blood-thinning medication warfarin. In the event of an overdose, immediate medical assistance should be sought, or the Poison Control Center should be contacted at 1-800-222-1222, as prompt medical attention is critical for both children and adults, 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 potential adverse effects or changes in efficacy, given the lack of targeted data for this population.

Pregnancy

There is no specific information available regarding the use of this product during pregnancy. The prescribing information does not mention any contraindications or risks associated with the use of acetaminophen during this period. Additionally, no dosage modifications for pregnant individuals are specified. The insert also does not include any special precautions regarding the use of this product in pregnant patients. As such, healthcare professionals should consider the absence of data when advising women of childbearing potential and pregnant patients about the use of this product.

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

There is no specific information regarding renal impairment, dosage adjustments, special monitoring, or safety considerations for patients with reduced kidney function in the provided drug insert text. Healthcare professionals should exercise caution and consider individual patient circumstances when prescribing this medication to patients with renal impairment.

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 or concomitant use with other medications containing acetaminophen may significantly increase the risk of liver injury.

Before administering this product, it is advisable to consult a healthcare professional if the patient has a history of liver disease. This precaution is essential to ensure the safety and efficacy of the treatment in patients with compromised liver function. Regular assessment of liver function may be warranted in these patients to mitigate potential risks.

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 for both adults and children, even in the absence of noticeable signs or symptoms.

Healthcare professionals should be aware that the severity of symptoms may vary, and early recognition and management are essential to mitigate potential complications. It is recommended that all cases of suspected overdose be treated as medical emergencies, and appropriate supportive care should be initiated as necessary.

Monitoring and supportive measures may be required based on the clinical presentation of the patient. Continuous assessment and intervention can significantly improve outcomes in overdose situations.

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 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

Healthcare providers should advise patients to keep this medication out of reach of children to prevent accidental ingestion. It is important to inform patients not to use this product in conjunction with any other medications that contain acetaminophen, whether prescription or nonprescription. If patients are uncertain about the presence of acetaminophen in other medications, they should be encouraged to consult a doctor or pharmacist for clarification.

Patients should be cautioned against using this product if their child has a known allergy to acetaminophen or any of the inactive ingredients included in the formulation. Healthcare providers should instruct patients to discontinue use and seek medical advice if the child's pain worsens or persists for more than five days, or if a fever worsens or lasts longer than three days. Additionally, patients should be advised to stop use and consult a doctor if new symptoms arise or if there is any redness or swelling, as these may indicate a serious condition.

It is essential to emphasize the importance of adhering to the recommended dosage and to inform patients about the risks associated with exceeding this dosage, as outlined in the overdose warning. Healthcare providers should also recommend that patients consult a doctor before using this product if their child has liver disease. Furthermore, 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 a Child Resistant Container. It is essential to store the product in a cool, dry place, maintaining a temperature range of 20-25°C (68-77°F). Users should ensure that the printed seal under the cap is intact; the product should not be used if the seal is broken or missing.

Additional Clinical Information

The medication is administered orally. Clinicians should instruct patients, particularly children, to chew each piece thoroughly before swallowing to ensure proper absorption and efficacy. No additional information is available regarding laboratory tests, abuse potential, or postmarketing experiences.

Drug Information (PDF)

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

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