Childrens Pain and Fever

Description

Acetaminophen is formulated as a liquid solution containing 160 mg of acetaminophen per 5 mL. It serves as an analgesic and antipyretic agent, indicated for use in pediatric patients aged 2 to 11 years. The formulation is free from alcohol, aspirin, ibuprofen, and gluten, making it suitable for a wide range of patients. The product is presented in a grape flavor to enhance palatability and includes a dosage cup for accurate administration.

Uses and Indications

This drug is indicated for the temporary reduction of fever and the temporary relief of minor aches and pains associated with conditions such as the common cold, influenza, headache, sore throat, and toothache.

There are no teratogenic or nonteratogenic effects associated with this drug.

Dosage and Administration

This product is intended for use in specific populations, and healthcare professionals should refer to the dosage chart to determine the appropriate dose based on the patient's weight or age.

Prior to administration, the product must be shaken well. It is essential to utilize only the enclosed dosing cup designed for this product; no other dosing devices should be employed to ensure accurate dosing.

The recommended dosing intervals are as follows: if necessary, the dose may be repeated every 4 hours while symptoms persist. However, it is critical not to exceed 5 doses within a 24-hour period. Additionally, treatment should not extend beyond 5 days unless directed by a physician.

The following dosage chart provides guidance based on weight and age:

• For patients weighing under 24 lb or under 2 years of age, the dose is to be determined by consulting a doctor.

• For patients weighing 24-35 lb and aged 2-3 years, the recommended dose is 5 mL.

• For patients weighing 36-47 lb and aged 4-5 years, the recommended dose is 7.5 mL.

• For patients weighing 48-59 lb and aged 6-8 years, the recommended dose is 10 mL.

• For patients weighing 60-71 lb and aged 9-10 years, the recommended dose is 12.5 mL.

• For patients weighing 72-95 lb and aged 11 years, the recommended dose is 15 mL.

Dosing may also be adjusted as directed by a healthcare professional. It is imperative to adhere to the specified dosing guidelines to avoid potential overdose.

Contraindications

Use of this product is contraindicated in the following situations:

• Co-administration with any other drug containing acetaminophen, whether prescription or non-prescription, 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 poses a risk of overdose.

Warnings and Precautions

This product contains acetaminophen, which poses a risk of severe liver damage if the maximum daily dosage is exceeded. Specifically, healthcare professionals should advise caregivers that no more than five doses should be administered within a 24-hour period. Additionally, caution is warranted when this product is used concurrently with other medications containing acetaminophen, as this may further increase the risk of liver injury.

Severe skin reactions have been associated with acetaminophen use. 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.

Healthcare providers should be vigilant regarding the management of sore throat symptoms. If a child presents with a sore throat that is severe, persists for more than two days, or is accompanied by fever, headache, rash, nausea, or vomiting, prompt consultation with a physician is recommended.

General precautions should be taken when administering this product. It is advisable to consult a physician prior to use if the child has a history of liver disease. Furthermore, caregivers should seek guidance from a doctor or pharmacist if the child is concurrently taking warfarin, a blood-thinning medication, to avoid potential interactions.

In cases of overdose, immediate medical attention is crucial. Caregivers should contact a Poison Control Center at 1-800-222-1222 or seek emergency medical help without delay, even if no symptoms are apparent.

Healthcare professionals should instruct caregivers to discontinue use and consult a physician if new symptoms arise, if redness or swelling occurs, if pain worsens or persists beyond five days, or if fever intensifies or lasts longer than three days. These symptoms 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 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 are advised to avoid using this product in conjunction with any other drug containing acetaminophen, whether prescription or non-prescription.

There is also an allergy alert associated with acetaminophen, as it may cause severe skin reactions. Symptoms of such reactions can include skin reddening, blisters, and rash. If any of these symptoms occur, patients should discontinue use immediately and seek medical assistance.

In cases of severe sore throat that persists for more than 2 days or is accompanied by fever, headache, rash, nausea, or vomiting, patients should consult a doctor promptly.

Patients with a history of liver disease should consult a doctor before using this product. Additionally, those taking the blood-thinning medication warfarin should seek advice from a doctor or pharmacist prior to use.

While using this product, it is crucial not to exceed the recommended dosage. Patients should stop use and consult a doctor if new symptoms arise, if redness or swelling occurs, if pain worsens or lasts more than 5 days, or if fever intensifies or lasts more than 3 days, as these may indicate a serious condition.

An overdose warning is also in place; taking more than the recommended dose may lead to liver damage. In the event of an overdose, it is imperative to seek medical help or contact a Poison Control Center immediately at 1-800-222-1222, as prompt medical attention is critical even if no signs or symptoms are initially apparent.

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 be heightened, leading to serious hepatic complications. 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 and Fever (acetaminophen). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

This product is indicated for use in pediatric patients aged 2 to 11 years. The recommended dosages vary by weight: for children weighing under 24 lb (under 2 years), consultation with a doctor is advised. For those weighing 24-35 lb (2-3 years), the dosage is 5 mL; for 36-47 lb (4-5 years), 7.5 mL; for 48-59 lb (6-8 years), 10 mL; for 60-71 lb (9-10 years), 12.5 mL; and for 72-95 lb (11 years), 15 mL.

It is crucial not to exceed 5 doses in a 24-hour period and not to administer the medication for more than 5 days unless directed by a healthcare professional. There is a significant risk of severe liver damage if the maximum dosage is exceeded or if the product is taken concurrently with other medications containing acetaminophen.

Pediatric patients may experience severe skin reactions to acetaminophen, which can manifest as skin reddening, blisters, or rash. If any of these symptoms occur, the medication should be discontinued immediately, and medical assistance should be sought.

In cases of severe sore throat that persists for more than 2 days or is accompanied by fever, headache, rash, nausea, or vomiting, prompt consultation with a healthcare provider is recommended. Additionally, a doctor should be consulted before use if the child has liver disease or is taking the anticoagulant warfarin.

Parents and caregivers should be aware that an overdose may lead to liver damage. In the event of an overdose, immediate medical attention is essential, even if no symptoms are present.

Geriatric Use

There is no specific information regarding the use of Children's Pain and Fever (acetaminophen suspension) in geriatric patients. The prescribing information does not provide any recommended age considerations, dosage adjustments, safety concerns, or special precautions for elderly patients.

Healthcare providers should exercise caution when administering this medication to geriatric patients, as the absence of specific data necessitates careful monitoring and consideration of individual patient factors. It is advisable to assess the overall health status and potential comorbidities of elderly patients before prescribing this medication.

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

Lactating mothers should consult a doctor before using this product. There is a potential for excretion in breast milk. The effects of acetaminophen on a nursing infant are not well studied; therefore, caution is advised.

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 lack of information necessitates careful clinical judgment. Regular monitoring of renal function may be advisable in these patients, although specific guidelines are not provided.

Hepatic Impairment

Patients with hepatic impairment should be closely monitored when using this product, which contains acetaminophen. It is important to note that severe liver damage may occur if the maximum daily amount of more than 5 doses in 24 hours is exceeded or if the product is taken concurrently with other medications containing acetaminophen.

Prior to use, it is recommended that patients with liver disease consult a healthcare professional. In the event of an overdose, which may result from taking more than the recommended dose, immediate medical assistance should be sought. Patients or caregivers should contact a Poison Control Center at 1-800-222-1222 for guidance, as prompt medical attention is critical, even if no signs or symptoms of overdose are apparent.

Overdosage

In the event of an overdose, defined as the ingestion of more than the recommended dose, there is a significant risk of liver damage. Healthcare professionals should be aware that the severity of symptoms may not be immediately apparent, making it essential to act swiftly.

Immediate medical assistance is crucial. In cases of suspected overdose, it is imperative to seek medical help or contact a Poison Control Center without delay. The national Poison Control Center can be reached at 1-800-222-1222.

Even in the absence of noticeable signs or symptoms, prompt medical evaluation is necessary to mitigate potential complications associated with overdose. Early intervention can be critical in preventing serious health consequences.

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

Postmarketing experience has identified rare cases of severe skin reactions associated with acetaminophen use. Reported symptoms include skin reddening, blisters, and rash. These events were documented through voluntary reports and surveillance programs.

Patient Counseling

Healthcare providers should advise patients about the importance of adhering to the recommended dosage of this medication, as taking more than the recommended dose may lead to liver damage. In the event of an overdose, patients should be instructed to seek medical help immediately or contact a Poison Control Center at 1-800-222-1222, emphasizing that prompt medical attention is critical even if no signs or symptoms are apparent.

Patients should be cautioned against using this medication in conjunction with any other products containing acetaminophen, whether prescription or non-prescription. If patients are uncertain whether a drug contains acetaminophen, they should be encouraged to consult with a doctor or pharmacist.

It is essential to inform patients that this medication should not be used if their child has a known allergy to acetaminophen or any of the inactive ingredients present in the product. Patients should be instructed to discontinue use and consult a doctor if new symptoms arise, if there is any redness or swelling, if pain worsens or persists for more than five days, or if fever intensifies or lasts longer than three days, as these may indicate a serious condition.

Healthcare providers should remind patients to strictly adhere to the recommended dosage and to consult a doctor before use if their child has liver disease. Additionally, patients should be advised 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 packaging that includes specific NDC numbers, which can be referenced for identification. It is essential to store the product at a temperature range of 20-25ºC (68-77ºF). Refrigeration is not permitted, as it may compromise the integrity of the product. For traceability, the lot number and expiration date can be found on the bottom panel of the packaging. Proper adherence to these storage conditions is crucial for maintaining product efficacy and safety.

Additional Clinical Information

The medication is administered orally, with the option to repeat the dose every 4 hours as needed while symptoms persist. Clinicians should advise patients not to exceed 5 doses within a 24-hour period and to limit use to a maximum of 5 days unless otherwise directed by a healthcare professional.

Drug Information (PDF)

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

View product document (PDF)