Childrens Pain Relief

Description

This product is a pediatric formulation intended for children aged 2 to 11 years, providing effective pain relief and fever reduction. Each chewable tablet contains 160 mg of acetaminophen as the active ingredient, which is comparable to the active ingredient found in Children's Tylenol® Chewables. The formulation is free from aspirin and ibuprofen, making it suitable for children with sensitivities to these compounds. The product is presented in a bubblegum flavor, enhancing palatability for young patients. Each package contains 24 chewable tablets, ensuring an adequate supply for treatment. The National Drug Code (NDC) for this product is 53943-837-76.

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 use in pediatric patients, and healthcare professionals should refer to the dosage chart below to determine the appropriate dose based on the patient's weight or age. It is essential to adhere to the recommended dosing guidelines and not exceed the maximum dosage to avoid the risk of overdose.

For administration, the tablets should be chewed thoroughly before swallowing, as they will soften in the mouth to facilitate easier chewing. Dosing may be repeated every 4 hours as needed while symptoms persist, but it is important not to administer more than 5 doses within a 24-hour period.

Dosage Chart:

• For patients weighing under 24 lb (under 2 years of age): Consult a physician for appropriate dosing.

• For patients weighing 24-35 lb (2-3 years of age): Administer 1 tablet.

• For patients weighing 36-47 lb (4-5 years of age): Administer 1½ tablets.

• For patients weighing 48-59 lb (6-8 years of age): Administer 2 tablets.

• For patients weighing 60-71 lb (9-10 years of age): Administer 2½ tablets.

• For patients weighing 72-95 lb (11 years of age): Administer 3 tablets.

Healthcare professionals should ensure that the patient does not exceed the maximum recommended doses and should monitor for any adverse effects during treatment.

Contraindications

Use of this product is contraindicated in the following situations:

• Co-administration with any other drug containing acetaminophen, whether prescription or nonprescription, 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.

• In patients with a known allergy to acetaminophen or any of the inactive ingredients in this product, as this may lead to severe allergic reactions.

• Exceeding the recommended dosage is contraindicated, as it may result in serious adverse effects.

Warnings and Precautions

This product contains acetaminophen, which carries specific warnings and precautions that healthcare professionals must communicate to patients and caregivers.

Liver Warning Severe liver damage may occur if the maximum daily dosage of acetaminophen is exceeded. Specifically, this risk is heightened if a child takes more than 5 doses within a 24-hour period or if acetaminophen is used concurrently with other medications containing acetaminophen. It is essential to monitor the total daily intake of acetaminophen to prevent potential hepatotoxicity.

Allergy Alert Acetaminophen has been associated with 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.

Sore Throat Warning Healthcare professionals should advise patients to consult a physician if a sore throat is severe, persists for more than 2 days, or is accompanied by additional symptoms such as fever, headache, rash, nausea, or vomiting. These symptoms may indicate a more serious underlying condition that requires prompt evaluation.

Emergency Medical Help In cases of suspected overdose, immediate medical attention is crucial. Patients or caregivers should contact a Poison Control Center (1-800-222-1222) or seek emergency medical help without delay, even if no signs or symptoms are apparent. This is critical for both adults and children.

Monitoring and Follow-Up Patients should be instructed to stop taking the medication and contact their healthcare provider if any of the following occur: pain worsens or persists beyond 5 days, fever worsens or lasts more than 3 days, new symptoms develop, or if redness or swelling is observed. These may be indicative of a serious condition requiring further medical assessment.

Side Effects

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

Severe liver damage may occur in patients who exceed the maximum daily dosage of acetaminophen, which is limited to 5 doses within a 24-hour period. Additionally, the risk of liver damage increases if the product is taken concurrently with other medications containing acetaminophen.

There is also an allergy alert associated with acetaminophen, as it may lead to severe skin reactions. Symptoms of such reactions can include skin reddening, blisters, and rash. In the event of a skin reaction, patients are advised to discontinue use immediately and seek medical assistance.

Patients should be vigilant for signs of a serious condition, particularly if they experience a sore throat that is severe, persists for more than 2 days, or is accompanied by fever, headache, rash, nausea, or vomiting. In these cases, it is crucial to consult a healthcare professional promptly.

Patients are advised to stop using the product and consult a doctor if pain worsens or lasts longer than 5 days, if fever worsens or persists for more than 3 days, if new symptoms arise, or if redness or swelling is observed.

Before using this product, it is recommended that patients consult a doctor if they have a history of liver disease. Additionally, 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. 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 Relief (acetaminophen). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients under 2 years of age should consult a doctor before use. For children aged 2 to 3 years weighing 24-35 lb, the recommended dose is 1 tablet. For those aged 4 to 5 years weighing 36-47 lb, the dose increases to 1½ tablets. Children aged 6 to 8 years weighing 48-59 lb may take 2 tablets, while those aged 9 to 10 years weighing 60-71 lb can take 2½ tablets. For children aged 11 years weighing 72-95 lb, the dose is 3 tablets.

Healthcare professionals should be aware of several warnings associated with this product. It contains acetaminophen, which can lead to severe liver damage if more than 5 doses are taken within a 24-hour period. Additionally, acetaminophen may cause severe skin reactions, including symptoms such as skin reddening, blisters, or rash. If any skin reaction occurs, use should be discontinued immediately, and medical assistance should be sought. A sore throat that is severe, persists for more than 2 days, or is accompanied by fever, headache, rash, nausea, or vomiting warrants prompt consultation with a doctor.

Before administering this medication, it is advisable to consult a doctor if the pediatric patient has liver disease or is taking the blood-thinning medication warfarin.

In cases of overdose, which may result in liver damage, immediate medical help should be sought, or the Poison Control Center (1-800-222-1222) should be contacted. Prompt medical attention is crucial 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 product, as the prescribing information does not provide guidance tailored to this population. Additionally, the absence of directions or complete warnings for adult use suggests that caution should be exercised when considering this product for geriatric patients.

Healthcare providers are advised to carefully evaluate the potential risks and benefits when prescribing this product to elderly patients, taking into account the lack of established safety and efficacy data in this demographic. Monitoring for adverse effects and adjusting dosages as necessary may be prudent in the management of geriatric patients.

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

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 available regarding dosage adjustments, special monitoring, or safety considerations for patients with renal impairment. Healthcare professionals should exercise caution when prescribing 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 this patient population.

Hepatic Impairment

Patients with hepatic impairment should be closely monitored when using this product, which contains acetaminophen. It is critical to adhere to the recommended dosage guidelines to prevent severe liver damage. Specifically, patients must not exceed 5 doses within a 24-hour period, as this represents the maximum daily amount. Additionally, caution is advised when administering this product in conjunction with other medications that also contain acetaminophen, as this may further increase the risk of liver injury. Regular assessment of liver function may be warranted in patients with compromised liver health to ensure safety and efficacy.

Overdosage

In cases of overdosage, it is critical to recognize the potential for severe liver damage, particularly in pediatric patients.

Risk of Liver Damage Administration of more than five doses within a 24-hour period, which exceeds the maximum recommended daily amount, poses a significant risk of severe liver damage. Healthcare professionals should be vigilant in monitoring for signs of hepatotoxicity in children who may have ingested excessive doses.

Additionally, the concomitant use of this product with other medications containing acetaminophen can further exacerbate the risk of liver injury. It is essential to assess the patient's medication history thoroughly to identify any potential interactions that could lead to an overdose scenario.

Recommended Actions In the event of suspected overdosage, immediate medical evaluation is warranted. Healthcare providers should initiate appropriate management procedures, which may include supportive care and monitoring of liver function tests. Early intervention is crucial to mitigate the risk of long-term hepatic complications.

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

Severe skin reactions have been reported in association with acetaminophen use, including symptoms such as 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 documented, which may lead to liver damage. It is crucial for individuals who suspect an overdose to obtain medical help or contact a Poison Control Center (1-800-222-1222) without delay. Prompt medical attention is essential for both adults and children, even in the absence of noticeable signs or symptoms.

Patient Counseling

Healthcare providers should advise patients about the potential risks associated with overdose, emphasizing that taking more than the recommended dose may lead to liver damage. In the event of an overdose, patients should seek medical help immediately or contact a Poison Control Center at 1-800-222-1222, as prompt medical attention is crucial for both adults and children, even if no signs or symptoms are apparent.

Patients should be informed not to use this product in conjunction with any other medications containing 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 known allergy to acetaminophen or any of the inactive ingredients contained in the formulation. Additionally, patients should be advised to discontinue use and consult a doctor if pain worsens or persists for more than five days, if fever intensifies or lasts longer than three days, if new symptoms arise, or if there is any redness or swelling, as these may indicate a serious condition.

Healthcare providers should remind patients to adhere strictly to the recommended dosage and to seek medical advice before use if their child has liver disease. Furthermore, patients should be encouraged 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 a tamper-evident package. It is essential to inspect the carton for any signs of tampering; do not use the product if the carton is open or if the printed seal on the blister is broken or missing.

For optimal storage, the product should be maintained at a temperature range of 20° to 25°C (68° to 77°F). It is important to avoid exposure to high humidity to ensure the integrity and efficacy of the product.

Additional Clinical Information

The medication is administered orally, with a recommended repeat dose every 4 hours as long as symptoms persist. Clinicians should ensure that patients do not exceed 5 doses within a 24-hour period. There are no additional details available regarding laboratory tests, abuse information, patient counseling, or postmarketing experience.

Drug Information (PDF)

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

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