Childrens Pain Relief

Description

AUROHEALTH is a pediatric formulation designed for pain relief and fever reduction in children aged 2 to 11 years. Each chewable tablet contains 160 mg of acetaminophen as the active ingredient, providing an effective alternative for managing discomfort. This product is free from both aspirin and ibuprofen, making it suitable for children with sensitivities to these compounds. The tablets are flavored with grape to enhance palatability. Each package contains 24 chewable tablets, and the product is comparable to the active ingredient found in Children's Tylenol® Chewables. The National Drug Code (NDC) for this formulation is 58602-765-76.

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 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.

Healthcare professionals should ensure that the patient does not receive more than the directed amount and should monitor for any adverse effects during treatment.

Contraindications

Use of this product is contraindicated in the following situations:

The product should not be used in conjunction with any other medication containing acetaminophen, whether prescription or nonprescription. If there is uncertainty regarding the presence of acetaminophen in a medication, consultation with a healthcare professional is advised.

This product is contraindicated in patients with a known allergy to acetaminophen or any of the inactive ingredients contained within the formulation.

Additionally, exceeding the recommended dosage is contraindicated.

Warnings and Precautions

This product contains acetaminophen, which carries a significant risk of severe liver damage if not used according to the recommended guidelines. Healthcare professionals should advise caregivers that the maximum daily dosage for children is five doses within a 24-hour period. Caution is particularly warranted when this product is administered concurrently with other medications containing acetaminophen, as this can lead to unintentional overdose.

Acetaminophen may also provoke severe skin reactions, which can 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.

Healthcare providers should be vigilant regarding patients presenting with a sore throat. If the sore throat is severe, persists for more than two days, or is accompanied by fever, headache, rash, nausea, or vomiting, prompt consultation with a physician is essential.

Overdose is a critical concern with acetaminophen. Ingesting more than the recommended dose can result in liver damage. In cases of suspected overdose, immediate medical attention is necessary. Caregivers should be instructed to contact a Poison Control Center at 1-800-222-1222 without delay, as timely intervention is crucial for both adults and children, even in the absence of overt symptoms.

Patients should be advised to discontinue use and consult a healthcare professional if any of the following occur: pain worsens or persists beyond five days, fever intensifies or lasts more than three days, new symptoms develop, or if redness or swelling is observed. These signs may indicate 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 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 particularly cautious if they experience a severe sore throat that persists for more than 2 days or is accompanied by fever, headache, rash, nausea, or vomiting, as these symptoms warrant prompt consultation with a healthcare provider.

Additional adverse reactions may necessitate discontinuation of the product and consultation with a healthcare professional. Patients should stop use and seek medical advice if pain worsens or lasts longer than 5 days, if fever intensifies or persists beyond 3 days, if new symptoms arise, or if there is any redness or swelling, as these may indicate a serious condition.

It is recommended that patients consult a doctor before using this product if they have a history of liver disease. Furthermore, patients taking the blood-thinning medication warfarin should seek advice from a healthcare provider 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 toxicity. 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, the recommended dosage is 1 tablet; for those aged 4 to 5 years, 1½ tablets; for ages 6 to 8 years, 2 tablets; for 9 to 10 years, 2½ tablets; and for 11 years, 3 tablets. When determining the appropriate dose, weight should be used if possible; otherwise, age may be utilized. It is important not to exceed 5 doses in a 24-hour period, with doses repeated every 4 hours as needed while symptoms persist.

Warnings specific to pediatric use include a liver warning indicating that severe liver damage may occur if more than 5 doses are taken in 24 hours or if used concurrently with other medications containing acetaminophen. An allergy alert is also present, as acetaminophen may cause severe skin reactions, including skin reddening, blisters, and rash. If any skin reaction occurs, use should be discontinued immediately, and medical assistance should be sought. Additionally, 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 also seek medical advice before use if their child has liver disease or is taking the blood-thinning medication warfarin.

An overdose warning is critical, as taking more than the recommended dose may lead to liver damage. In the event of an overdose, immediate medical help should be sought or a Poison Control Center contacted, as prompt medical attention is essential for both children and adults, even if no signs or symptoms are apparent.

Geriatric Use

Elderly patients may not have specific information regarding the use of this product, as the prescribing information does not provide guidance on geriatric use. Additionally, the absence of directions or complete warnings for adult use suggests that the product may not be intended for use in this population.

Healthcare providers should exercise caution when considering this product for geriatric patients, as the lack of data may indicate potential safety concerns or the need for careful monitoring. It is advisable to evaluate the risks and benefits on a case-by-case basis, taking into account the unique health considerations of elderly 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 thoroughly evaluated.

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

There is no specific information regarding renal impairment, dosage adjustments, special monitoring, or safety considerations for patients with reduced kidney function. Healthcare professionals should exercise caution and consider individual patient factors when prescribing to patients with renal impairment, as the absence of detailed guidance necessitates careful clinical judgment.

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 dosage of 5 doses within a 24-hour period. Additionally, patients must avoid concomitant use with other medications containing acetaminophen to prevent the risk of hepatotoxicity.

Healthcare providers should assess liver function prior to initiating treatment and consider regular monitoring of liver enzymes during therapy, particularly in patients with known liver conditions. Adjustments to dosing or alternative therapies may be necessary based on the severity of hepatic impairment.

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 exceeds the maximum recommended daily amount and significantly increases the risk of severe liver damage. Healthcare professionals should be vigilant in monitoring patients who may have ingested excessive doses.

Additionally, co-administration of this product with other medications containing acetaminophen can also lead to severe liver damage. It is essential to assess the patient's medication history to identify any concurrent use of acetaminophen-containing products.

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 injury.

Prompt recognition and management of acetaminophen overdosage can significantly improve patient outcomes.

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

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 immediate medical assistance.

Additionally, cases of overdose have been documented, which may lead to liver damage. It is crucial for individuals who exceed the recommended dosage 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. It is crucial to obtain prompt medical attention for both adults and children, even if no signs or symptoms are initially 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 any 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

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 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.

View product document (PDF)