Childrens Pain and Fever Relief

Description

No description information is available for the drug.

Uses and Indications

This drug is indicated for the temporary relief of minor aches and pains associated with headache, sore throat, flu, toothache, and the common cold. 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 use in pediatric patients, and healthcare professionals should refer to the dosage chart to determine the appropriate dose based on the patient's weight or age.

For patients weighing under 24 pounds or under 2 years of age, it is advised to consult a doctor before administration. For those weighing between 24 to 35 pounds or aged 2 to 3 years, the recommended dose is 1 chewable tablet. Patients weighing 36 to 47 pounds or aged 4 to 5 years should receive 1.5 chewable tablets. For patients weighing 48 to 59 pounds or aged 6 to 8 years, the dose is 2 chewable tablets. Patients weighing 60 to 71 pounds or aged 9 to 10 years should be given 2.5 chewable tablets, while those weighing 72 to 95 pounds or aged 11 years should receive 3 chewable tablets.

Tablets must be chewed or crushed completely before swallowing; they should not be swallowed whole. The dosing interval is every 4 hours as needed while symptoms persist, with a maximum of 5 doses in a 24-hour period. Treatment should not exceed 5 consecutive days unless directed by a healthcare professional. It is imperative to adhere strictly to the recommended dosing guidelines and not exceed the maximum dosage.

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 another medication, consultation with a healthcare professional is advised.

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

• Exceeding the recommended dosage is contraindicated.

Warnings and Precautions

This product contains acetaminophen, which poses a risk of severe liver damage if the maximum daily dosage is exceeded. Specifically, healthcare professionals should advise that no more than five doses should be administered within a 24-hour period. Additionally, caution is warranted when this product is used in conjunction with other medications containing acetaminophen, as this may further increase the risk of liver injury.

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 without delay.

Healthcare providers should also be vigilant regarding sore throat symptoms. If a sore throat is severe, persists for more than two days, or is accompanied by fever, headache, rash, nausea, or vomiting, it is essential to consult a physician promptly.

General precautions should be taken when administering this product. It is advisable to consult a healthcare professional prior to use if the child has a history of liver disease. Furthermore, if the child is concurrently taking the anticoagulant warfarin, consultation with a doctor or pharmacist is recommended to avoid potential interactions.

In cases of overdose, immediate medical attention is critical. Healthcare professionals should instruct caregivers to seek emergency medical help or contact a Poison Control Center right away, regardless of whether any signs or symptoms are present.

Patients should be advised to discontinue use and consult a physician if any of the following occur: pain worsens or persists beyond five days, fever intensifies or lasts more than three days, new symptoms arise, or if redness or swelling is observed. These may be indicative of a serious underlying condition that requires further evaluation.

Side Effects

Patients using this product should be aware of several important warnings and potential adverse reactions.

Severe liver damage may occur if the maximum daily amount of acetaminophen, which is more than 5 doses in 24 hours, is exceeded, or if it is taken concurrently with other medications containing acetaminophen. Patients should also be alerted to the risk of 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.

Additionally, if a patient experiences a severe sore throat that persists for more than 2 days or is accompanied by fever, headache, rash, nausea, or vomiting, they should consult a healthcare professional promptly.

Patients are advised against using this product in conjunction with any other drug containing acetaminophen, whether prescription or nonprescription. It is also contraindicated in individuals with a known allergy to acetaminophen or any inactive ingredients in the formulation.

Before using this product, patients should consult a doctor if they have liver disease or are taking the anticoagulant warfarin.

While using this product, it is crucial not to exceed the recommended dosage. Patients should discontinue use and seek medical advice if pain worsens or lasts 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 cases of overdose, immediate medical attention is essential. Patients should contact a Poison Control Center or seek medical help right away, as prompt intervention is critical for both adults and children, even in the absence of noticeable signs or symptoms.

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 due to potential pharmacodynamic interactions.

No additional drug interactions or laboratory test interactions have been identified for this medication. Therefore, routine monitoring or dosage adjustments are not specified beyond the aforementioned consideration with warfarin.

Packaging & NDC

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

Pediatric Use

Pediatric patients should not exceed the recommended dosage. Chewable tablets must be completely chewed or crushed before swallowing; they should not be swallowed whole. Dosing may be repeated every 4 hours as needed, but should not occur more than 5 times within a 24-hour period. Use should not extend beyond 5 days unless directed by a healthcare professional.

The recommended dosing based on weight and age for chewable tablets is as follows: for children under 24 lb (under 2 years), consultation with a doctor is advised; for those weighing 24-35 lb (2-3 years), 1 tablet is recommended; for 36-47 lb (4-5 years), 1 1/2 tablets; for 48-59 lb (6-8 years), 2 tablets; for 60-71 lb (9-10 years), 2 1/2 tablets; and for 72-95 lb (11 years), 3 tablets.

Prior to administration, it is important to consult a healthcare provider if the child has liver disease or is taking the anticoagulant warfarin. The product should be kept out of reach of children. In the event of an overdose, immediate medical assistance or contact with a Poison Control Center is essential.

Geriatric Use

There is no specific information regarding the use of this medication in geriatric patients. The prescribing information primarily emphasizes pediatric use and does not provide any recommendations concerning age considerations, dosage adjustments, safety concerns, or special precautions for elderly patients.

Healthcare providers should exercise caution when prescribing this medication to geriatric patients, as the absence of data may necessitate careful monitoring and individualized assessment of treatment risks and benefits.

Pregnancy

Pregnant patients should be advised against the use of this product if they have a known allergy to acetaminophen or any of the inactive ingredients contained within. It is essential for healthcare providers to assess the potential risks associated with the use of this product in pregnant patients, particularly those with pre-existing liver disease, as this may exacerbate underlying conditions.

Additionally, pregnant patients who are concurrently taking anticoagulants, such as warfarin, should consult with their healthcare provider or pharmacist prior to using this product to evaluate any potential interactions that may affect maternal or fetal health.

Healthcare professionals should emphasize the importance of keeping this product out of reach of children. In the event of an overdose, immediate medical assistance should be sought, and patients should be informed that prompt medical attention is critical for both adults and children, even in the absence of noticeable signs or symptoms.

Lactation

Nursing mothers should consult a doctor before using this product. There is a potential for excretion of acetaminophen in breast milk. Caution is advised when administering this product to nursing mothers due to the potential risk to the infant.

Renal Impairment

Patients with renal impairment have not been specifically addressed in the drug insert regarding dosage adjustments, special monitoring, or safety considerations. Therefore, healthcare professionals should exercise caution when prescribing this medication to individuals with reduced kidney function, as there is no available data to guide treatment decisions in this population. Regular monitoring of renal function may be warranted in these patients, although specific recommendations are not provided.

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 to mitigate the risk of hepatotoxicity.

Before administration, it is advised to consult a healthcare professional if the patient has a history of liver disease. This precaution is essential to ensure the safe use of the product and to evaluate the need for any dosage adjustments or additional monitoring based on the severity of the hepatic impairment.

Overdosage

In the event of an overdose, it is imperative to seek immediate medical assistance or contact a Poison Control Center without delay. Prompt medical intervention is crucial for both adults and children, regardless of whether any signs or symptoms are apparent.

Healthcare professionals should be aware that the absence of symptoms does not preclude the possibility of serious complications arising from an overdose. Therefore, it is essential to monitor the patient closely and provide appropriate care as needed.

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. Reported symptoms of these reactions include skin reddening, blisters, and rash. In the event of a skin reaction, it is advised to discontinue use and seek medical assistance immediately.

Additionally, cases of overdose have been reported, emphasizing the importance of obtaining medical help or contacting a Poison Control Center without delay. Prompt medical attention is critical for both adults and children, even in the absence of noticeable signs or symptoms.

Patient Counseling

Healthcare providers should advise patients to seek immediate medical assistance or contact a Poison Control Center in the event of an overdose. It is crucial to emphasize that prompt medical attention is necessary for both adults and children, even if no signs or symptoms are apparent.

Patients should be instructed not to exceed the recommended dosage of the medication. This is important to prevent potential adverse effects and ensure safe usage.

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 avoid complications that may arise from the use of the medication in such cases.

Furthermore, it is advisable for patients to speak with a doctor or pharmacist prior to use if their child is currently taking the blood-thinning medication warfarin. This discussion is important to ensure safe and effective use of the medication, considering potential interactions.

Storage and Handling

The product is supplied in configurations that include specific NDC numbers, which can be found on the packaging. It should be stored at a controlled room temperature of 25°C (77°F), with permissible excursions between 15°C and 30°C (59°F and 86°F). Care should be taken to avoid exposure to high humidity during storage. For reference, the expiration date and lot number are located on the end flap of the packaging.

Additional Clinical Information

The medication is administered orally, with a recommended repeat dose every 4 hours while symptoms persist. Clinicians should advise patients not to exceed 5 doses within a 24-hour period and to limit use to no more than 5 days unless directed by a healthcare professional.

Patients should be counseled to keep the medication out of reach of children. In the event of an overdose, it is crucial to seek medical assistance or contact a Poison Control Center immediately, as prompt medical attention is essential for both adults and children, even if no symptoms are apparent.

Drug Information (PDF)

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

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