Childrens Pain Relief

Description

This product is a children's pain relief formulation containing acetaminophen as the active ingredient, with a dosage of 160 mg per chewable tablet. It is designed for use in children aged 2 to 11 years and serves as both a pain reliever and fever reducer. The formulation is free from aspirin and ibuprofen, making it suitable for children who may have sensitivities to these compounds. Each package contains 24 chewable tablets, which are flavored with grape to enhance palatability. The product is identified by the National Drug Code (NDC) 53943-836-76 and is comparable to the active ingredient found in Children's Tylenol® Chewables.

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 maximum dosing recommendations to avoid overdose.

For administration, the product should be chewed thoroughly before swallowing, as it will soften in the mouth to facilitate ease of chewing. Dosing may be repeated every 4 hours as needed while symptoms persist, but it should not exceed 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 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

Severe liver damage may occur in patients taking this product, which contains acetaminophen, if the following conditions are met: exceeding 5 doses within a 24-hour period, which is the maximum daily amount, or concomitant use with other medications containing acetaminophen. Healthcare professionals should monitor patients for signs of liver dysfunction, particularly in those who may be at increased risk.

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 or followed by fever, headache, rash, nausea, or vomiting, prompt consultation with a healthcare provider is advised. These symptoms may indicate a more serious underlying condition.

Healthcare professionals should be vigilant regarding the risk of overdose, which can lead to liver damage. Patients should be instructed to seek immediate medical help or contact a Poison Control Center (1-800-222-1222) if they suspect an overdose, even in the absence of symptoms. Timely medical intervention is crucial for both adults and children.

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 requiring further evaluation.

Side Effects

Severe adverse reactions associated with this product include the potential for severe liver damage, particularly in patients who exceed the maximum daily dosage of five doses within a 24-hour period or who concurrently use other medications containing acetaminophen. Patients should be advised of the risk of 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 and seek immediate medical attention.

Patients experiencing a severe sore throat that persists for more than two days, or is accompanied by fever, headache, rash, nausea, or vomiting, should consult a healthcare professional promptly.

Additional adverse reactions warranting medical consultation include worsening pain lasting more than five days, fever that worsens or persists beyond three days, the emergence of new symptoms, or the presence of redness or swelling, as these may indicate a serious underlying condition.

It is recommended that patients with a history of liver disease consult a healthcare provider prior to use. Furthermore, patients taking the anticoagulant warfarin should seek advice from a doctor or pharmacist before using this product.

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 is 1½ tablets. Children aged 6 to 8 years weighing 48-59 lb should receive 2 tablets, while those aged 9 to 10 years weighing 60-71 lb may take 2½ tablets. For children aged 11 years weighing 72-95 lb, the dose is 3 tablets.

Severe liver damage may occur if a child takes more than 5 doses in a 24-hour period, which is the maximum daily amount. Acetaminophen may also cause severe skin reactions, including skin reddening, blisters, and rash; if any skin reaction occurs, use should be discontinued immediately, and medical help should be sought. 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.

Parents should seek medical advice before use if their child has liver disease or is taking the blood-thinning medication warfarin. An overdose may lead to liver damage; in such cases, immediate medical attention is critical, even if no signs or symptoms are present. For assistance, contact a Poison Control Center at 1-800-222-1222.

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. Monitoring for potential adverse effects and therapeutic efficacy is recommended in 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 available prescribing information. There are no dosage adjustments, special monitoring requirements, or safety considerations outlined for individuals with reduced kidney function. Healthcare professionals should exercise caution and consider the lack of data when prescribing to this patient population.

Hepatic Impairment

Patients with hepatic impairment should be closely monitored when using this product, as it contains acetaminophen, which poses a risk of severe liver damage. It is critical that patients do not exceed the maximum daily amount of 5 doses within a 24-hour period. Additionally, patients must avoid concomitant use with other medications that contain acetaminophen to mitigate the risk of liver injury.

Healthcare providers should assess liver function prior to initiating treatment and consider regular monitoring throughout the course of therapy, particularly in patients with known liver conditions. Adjustments to dosing or alternative therapies may be necessary based on the severity of hepatic impairment and the patient's overall clinical status.

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 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 protocols, 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 compound in these areas.

Postmarketing Experience

Postmarketing experience has identified the potential for severe skin reactions associated with acetaminophen use. 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 immediate medical assistance.

Additionally, there is a warning regarding the risk of liver damage from acetaminophen overdose. It is crucial for individuals to adhere to the recommended dosage. In cases of overdose, prompt medical attention is essential for both adults and children, even if no signs or symptoms are immediately apparent. For assistance, contacting a Poison Control Center at 1-800-222-1222 is recommended.

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 consult a doctor before use if their child has liver disease. Additionally, it is advisable for patients to seek guidance from a doctor or pharmacist if their 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

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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