Childrens Pain 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 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 potential 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 doctor 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.

Dosing should 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, 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 formulation, as this may lead to severe allergic reactions.

Additionally, exceeding the recommended dosage is contraindicated to prevent potential toxicity.

Warnings and Precautions

Severe liver damage may occur in pediatric patients taking this product, which contains acetaminophen, if they exceed the maximum daily dosage of 5 doses within a 24-hour period or if they are concurrently using other medications that also contain acetaminophen. Healthcare professionals should monitor patients for signs of liver impairment and educate caregivers on the importance of adhering to dosing guidelines.

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 if it is accompanied by fever, headache, rash, nausea, or vomiting, prompt consultation with a healthcare provider is advised. These symptoms may indicate a more serious underlying condition that requires further evaluation.

Healthcare professionals should be vigilant regarding the risk of overdose, which can lead to significant liver damage. If an overdose is suspected, immediate medical attention should be sought, or the Poison Control Center (1-800-222-1222) should be contacted without delay. It is crucial to emphasize that prompt medical intervention is necessary for both adults and children, even in the absence of overt symptoms.

Patients should be advised to discontinue use and consult a healthcare provider 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. These signs may indicate a serious medical condition that warrants further investigation and management.

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 five doses within a 24-hour period, or who take this product in conjunction with other medications containing acetaminophen.

Additionally, there is 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 also be cautious 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 recommended that they consult a healthcare professional promptly.

Furthermore, patients are advised to 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 present. These symptoms may indicate a serious underlying condition that requires medical evaluation.

Drug Interactions

Patients should consult a healthcare professional prior to using acetaminophen if they are concurrently taking warfarin, a blood-thinning medication. The combination may lead to potential interactions that could affect the efficacy and safety of warfarin therapy.

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

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 who weigh less than 24 lb should not be given this medication without consulting a doctor. For children aged 2 to 3 years weighing between 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 who weigh 48-59 lb should receive 2 tablets, while those aged 9 to 10 years weighing 60-71 lb may take 2½ tablets. Finally, for children aged 11 years weighing between 72-95 lb, the dose is 3 tablets.

Healthcare professionals should be aware of several warnings associated with this medication. Severe liver damage may occur if a child takes more than 5 doses in 24 hours or if used concurrently with other drugs containing acetaminophen. Additionally, acetaminophen may cause severe skin reactions, including symptoms such as skin reddening, blisters, or rash; if any of these occur, use should be discontinued immediately, and medical assistance 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.

This medication should not be used in children who are allergic to acetaminophen or any inactive ingredients in the product, nor should it be used with any other drug containing acetaminophen. Parents or caregivers should consult a doctor or pharmacist if unsure whether a drug contains acetaminophen.

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

An overdose of this medication may lead to liver damage. In the event of an overdose, immediate medical help should be sought, or contact a Poison Control Center (1-800-222-1222). Prompt medical attention is critical for both children and adults, even if no signs or symptoms are apparent.

Geriatric Use

There is no specific information regarding the use of this medication in geriatric patients, including dosage adjustments, safety concerns, or special precautions. Healthcare providers should exercise caution when prescribing this medication to elderly patients, as individual responses may vary. It is advisable to monitor these patients closely for any adverse effects or changes in efficacy, given the lack of targeted data for this population.

Pregnancy

The safety of acetaminophen use during pregnancy has not been established, as the prescribing information does not provide specific data regarding its use in this population. Consequently, healthcare professionals should exercise caution when recommending acetaminophen to pregnant patients. There are no documented safety concerns, dosage modifications, or special precautions outlined for its use in pregnant women. Given the lack of information, it is advisable for healthcare providers to weigh the potential benefits against any unknown risks when considering acetaminophen for women of childbearing potential. Further research may be necessary to clarify the implications of acetaminophen use during pregnancy.

Lactation

There are no specific warnings or recommendations regarding the use of this product in lactating mothers. Additionally, there is no information available about the potential for excretion in breast milk or any associated risks to breastfed infants.

Renal Impairment

Patients with renal impairment have not been specifically addressed in the available data 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 lack of information necessitates careful clinical judgment and monitoring.

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 recommendations to mitigate this risk. Specifically, patients must not exceed 5 doses within a 24-hour period, as this represents the maximum daily amount.

Additionally, patients should avoid concomitant use of other medications that contain acetaminophen, as this can further increase the risk of liver injury. Regular assessment of liver function may be warranted in patients with pre-existing liver conditions to ensure safety and efficacy while using this product.

Overdosage

In cases of overdosage, it is critical to recognize the potential for severe liver damage, particularly in pediatric patients. Administration of more than five doses of acetaminophen within a 24-hour period exceeds the maximum recommended daily amount and significantly increases the risk of hepatotoxicity.

Healthcare professionals should be vigilant for symptoms indicative of liver injury, which may include nausea, vomiting, loss of appetite, confusion, jaundice, and abdominal pain. Early identification of these symptoms is essential for effective management.

In the event of suspected overdosage, immediate medical intervention is warranted. The recommended action includes contacting a poison control center or seeking emergency medical assistance. Treatment may involve the administration of N-acetylcysteine (NAC), an antidote that can mitigate liver damage if given promptly.

Monitoring of liver function tests and supportive care should be initiated as part of the management protocol for patients exhibiting signs of acetaminophen overdosage.

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

There have been reports of severe skin reactions associated with acetaminophen, including symptoms such as skin reddening, blisters, and rash. In cases where a skin reaction occurs, it is advised to discontinue use and seek medical assistance immediately.

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. It is crucial to obtain prompt medical attention 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 that contain 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.

For pediatric patients, it is important to ensure that the child is not allergic to acetaminophen or any of the inactive ingredients in the product. Healthcare providers should instruct patients 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.

Patients must be reminded to adhere strictly to the recommended dosage and to seek medical advice before using the product if their child has liver disease. Additionally, it is advisable to consult a doctor or pharmacist if the child is currently taking the blood-thinning medication warfarin.

Storage and Handling

The product is supplied in a tamper-evident carton. It is essential to refrain from using 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 conditions to ensure the integrity and efficacy of the product.

Additional Clinical Information

Patients should be informed that the medication is administered orally, with a recommended repeat dose every 4 hours as needed for symptom relief, not to exceed 5 doses within a 24-hour period.

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 (1-800-222-1222) in the event of an overdose. Prompt medical attention is crucial for both adults and children, even if no signs or symptoms are apparent.

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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