Childrens Pain Reliever

Description

Acetaminophen is the active ingredient in this formulation, providing 160 mg per chewable tablet. The dosage form is designed as chewable tablets, specifically indicated for use as a pain reliever and fever reducer. This product is intended for children aged 2 to 11 years. The tablets are flavored with grape to enhance palatability. Each package contains 24 chewable tablets. Administration requires that the tablets be chewed or crushed completely before swallowing; they should not be swallowed whole. The packaging includes tamper-evident features, and the product should not be used if the package is opened or if the blister unit is torn, broken, or shows any signs of tampering.

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

The recommended dosage of this product is determined primarily by the patient's weight; however, age may be used as an alternative if weight is not available. It is imperative that healthcare professionals do not exceed the maximum dosage as specified.

For patients weighing under 24 lb or under 2 years of age, it is advised to consult a physician for appropriate dosing. For those weighing between 24-35 lb (ages 2-3 years), the recommended dose is 1 chewable tablet. For patients weighing 36-47 lb (ages 4-5 years), the dose increases to 1 ½ tablets. Patients weighing 48-59 lb (ages 6-8 years) should receive 2 tablets, while those weighing 60-71 lb (ages 9-10 years) should be administered 2 ½ tablets. Finally, for patients weighing 72-95 lb (age 11 years), the appropriate dose is 3 tablets.

Tablets must be chewed or crushed completely before swallowing; they should not be swallowed whole. Dosing may be repeated every 4 hours as needed while symptoms persist, but it is crucial not to exceed 5 doses within a 24-hour period.

Contraindications

Use of this product is contraindicated in patients who are concurrently taking any other medication that contains acetaminophen, whether prescription or nonprescription. This is due to the potential risk of acetaminophen overdose, which can lead to severe liver damage. If there is uncertainty regarding the presence of acetaminophen in other medications, consultation with a healthcare professional is advised.

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 constitutes the maximum daily amount, or concomitant use with other medications containing acetaminophen can significantly increase the risk of liver injury.

Acetaminophen is also associated with the potential for severe skin reactions. 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.

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, prompt consultation with a healthcare provider is recommended.

General precautions should be observed. Caregivers are advised to consult a physician prior to administration if the child has a history of liver disease. Additionally, it is prudent to seek guidance from a doctor or pharmacist if the child is concurrently taking warfarin, a blood-thinning medication.

In the event of an overdose, immediate medical attention is essential. Caregivers should contact a Poison Control Center or seek emergency medical help without delay, as timely intervention is critical for both adults and children, even in the absence of overt symptoms.

Healthcare professionals should instruct caregivers to discontinue use and consult a physician if any of the following occur: worsening pain that persists beyond five days, fever that worsens or lasts more than three days, the emergence of new symptoms, or the presence of redness or swelling.

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 be vigilant for signs of liver injury and seek medical attention if they suspect an overdose.

Additionally, acetaminophen may cause severe skin reactions, which can manifest as skin reddening, blisters, or rash. If any of these symptoms occur, patients are advised to discontinue use immediately and seek medical help.

In cases where a sore throat is severe, persists for more than 2 days, or is accompanied by fever, headache, rash, nausea, or vomiting, it is crucial to consult a healthcare professional promptly.

Patients should also stop using the product and consult a doctor if pain worsens or lasts more than 5 days, if fever worsens or lasts more than 3 days, if any new symptoms appear, or if redness or swelling is present.

Before using this product, it is recommended that patients with liver disease consult a healthcare provider. Furthermore, patients taking the blood-thinning medication warfarin should seek advice from a doctor or pharmacist prior to use.

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

Pediatric Use

Pediatric patients aged 2 to 11 years may be treated with this medication, following a weight-based dosing chart. For children under 24 lb (under 2 years), consultation with a doctor is advised prior to use. For those weighing 24-35 lb (ages 2-3 years), the recommended dose is 1 tablet; for 36-47 lb (ages 4-5 years), 1 1/2 tablets; for 48-59 lb (ages 6-8 years), 2 tablets; for 60-71 lb (ages 9-10 years), 2 1/2 tablets; and for 72-95 lb (age 11 years), 3 tablets.

It is important 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. Prior to administration, healthcare providers should be consulted if the pediatric patient has liver disease or is concurrently taking the anticoagulant warfarin.

As with all medications, this 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

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

The available prescribing information does not provide specific data regarding the use of acetaminophen during pregnancy. Consequently, there are no established safety concerns, dosage modifications, or special precautions outlined for pregnant patients. Healthcare professionals should exercise caution and consider the potential risks and benefits when recommending acetaminophen to women of childbearing potential. Further research may be necessary to fully understand the implications of acetaminophen use during pregnancy and its effects on fetal outcomes.

Lactation

Lactating 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 patients with reduced kidney function, as the absence of detailed guidance necessitates careful clinical judgment. Regular monitoring of renal function may be advisable in these patients to ensure safety and efficacy.

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 that a healthcare professional be consulted 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 potential need for 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, even in the absence of noticeable signs or symptoms.

Healthcare professionals should be aware that the lack of immediate symptoms does not preclude the potential for serious health consequences. 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 understanding of the potential toxicological profile in nonclinical settings.

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 in the event of an overdose. It is essential to emphasize that prompt medical attention is critical for both adults and children, even if no signs or symptoms are initially apparent.

Patients should be informed not to use this medication in conjunction with any other drug that contains acetaminophen, whether prescription or nonprescription. If patients are uncertain about the presence of acetaminophen in any other medications they are taking, they should be encouraged to consult with a doctor or pharmacist for clarification.

Healthcare providers should instruct patients to discontinue use and consult a doctor if their pain worsens or persists for more than five days. Similarly, if a patient's fever worsens or lasts longer than three days, they should stop using the medication and seek medical advice. Patients should also be advised to stop use and contact a doctor if they experience any new symptoms, or if they notice redness or swelling.

For pediatric patients, it is important to recommend that parents or guardians consult a doctor before use if their child has liver disease. Additionally, they should be advised to speak with a doctor or pharmacist before administering this medication if their child is currently taking the blood-thinning medication warfarin.

Storage and Handling

The product is supplied in a tamper-evident package. It is essential to refrain from using the product if the outer package is opened or if the blister is torn or broken.

Storage conditions require the product to be maintained at a temperature of 25°C (77°F), with permissible excursions between 15°-30°C (59°-86°F). It is important to avoid high humidity during storage.

For tracking purposes, the expiration date and lot number can be found on the end flap of the packaging.

Additional Clinical Information

The medication is administered orally, with specific instructions for patients to chew or crush the tablets completely before swallowing; whole tablets should not be swallowed. Dosing can be repeated every 4 hours as needed, but should not exceed 5 doses within a 24-hour period. Additionally, the medication should not be used for more than 5 consecutive days unless directed by a healthcare professional.

Clinicians should counsel patients to keep the medication out of reach of children and to seek immediate medical assistance or contact a Poison Control Center in the event of an overdose. It is emphasized that prompt medical attention is crucial for both adults and children, even if no signs or symptoms are initially apparent.

Drug Information (PDF)

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

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