Childrens Acetaminophen

Description

No relevant information is available for SPL code 34089-3.

Uses and Indications

This drug is indicated for use in pediatric patients. Prior to administration, it is essential for healthcare professionals to inquire whether the child is concurrently taking the anticoagulant warfarin, as this may influence the safety and efficacy of the treatment.

There are no teratogenic effects associated with this drug, and no nonteratogenic effects have been reported.

Dosage and Administration

This product is intended for use in pediatric patients, and healthcare professionals should refer to the dosage chart to determine the appropriate dose based on the patient's weight or age. It is essential to shake the product well before each use.

The recommended dosing intervals are every 4 hours while symptoms persist, with a maximum of 5 doses within a 24-hour period. The following dosage chart provides specific dosing recommendations:

• For patients weighing under 24 lbs. or under 2 years of age, consult a doctor for appropriate dosing.

• For patients weighing 24 to 35 lbs. or aged 2 to 3 years, the recommended dose is 1 teaspoon (5 mL).

• For patients weighing 36 to 47 lbs. or aged 4 to 5 years, the recommended dose is 1 1/2 teaspoons (7.5 mL).

• For patients weighing 48 to 59 lbs. or aged 6 to 8 years, the recommended dose is 2 teaspoons (10 mL).

• For patients weighing 60 to 71 lbs. or aged 9 to 10 years, the recommended dose is 2 1/2 teaspoons (12.5 mL).

• For patients weighing 72 to 95 lbs. or aged 11 years, the recommended dose is 3 teaspoons (15 mL).

It is crucial to use only the enclosed dosing cup designed for this product and to avoid using any other dosing devices. Healthcare professionals should ensure that patients do not exceed the recommended dosage and should be aware of the overdose warning associated with this product.

Contraindications

Use of this product is contraindicated in patients who exceed the recommended dose, as this may lead to overdose. No other specific contraindications have been identified in the available data.

Warnings and Precautions

Severe liver damage may occur in children taking this product, which contains acetaminophen, if they exceed the maximum daily amount of 5 doses within 24 hours or if they are concurrently using other medications that contain acetaminophen.

Acetaminophen may also lead to severe skin reactions, including symptoms such as skin reddening, blisters, and rash. In the event of a skin reaction, it is imperative to discontinue use immediately and seek medical assistance.

Healthcare professionals should be vigilant regarding sore throat symptoms. If a sore throat is severe, persists for more than 2 days, or is accompanied by fever, headache, rash, nausea, or vomiting, prompt consultation with a physician is advised.

Before administering this product, it is essential to consult a doctor or pharmacist if the child has a history of liver disease. Additionally, if the child is currently taking the anticoagulant warfarin, professional guidance should be sought prior to use. It is critical to adhere to the recommended dosage to avoid the risk of overdose.

In cases of suspected overdose, immediate medical attention is necessary. Contact the Poison Control Center at 1-800-222-1222 without delay, as rapid intervention is crucial, even in the absence of noticeable symptoms.

Discontinuation of the product and consultation with a healthcare provider is warranted if pain worsens or persists beyond 5 days, if fever intensifies or lasts more than 3 days, or if new symptoms arise, including redness or swelling, which may indicate a serious underlying condition.

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. Additionally, acetaminophen may cause severe skin reactions, which can manifest as skin reddening, blisters, or 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 2 days, or is accompanied by fever, headache, rash, nausea, or vomiting, it is recommended to consult a healthcare professional promptly.

It is crucial to avoid using this product in conjunction with any other drug containing acetaminophen, whether prescription or nonprescription. Patients should verify the presence of acetaminophen in other medications with a doctor or pharmacist if uncertain. Furthermore, individuals with known allergies to acetaminophen or any inactive ingredients in this product should refrain from use.

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, or if new symptoms arise, including redness or swelling, as these may indicate a serious condition.

In the case of an overdose, it is imperative to seek medical help or contact the Poison Control Center at 1-800-222-1222 immediately. Quick medical attention is critical, even if no signs or symptoms are initially apparent.

Drug Interactions

Co-administration of this medication with any other drug containing acetaminophen, whether prescription or nonprescription, is contraindicated due to the risk of acetaminophen overdose, which can lead to severe liver damage.

In pediatric patients, it is advised to consult a healthcare professional, such as a doctor or pharmacist, prior to use if the child is concurrently taking warfarin, a blood-thinning agent. This is essential to ensure appropriate monitoring and to mitigate the risk of potential interactions that may affect coagulation parameters.

Packaging & NDC

Below are the non-prescription pack sizes of Childrens Acetaminophen (childrens acetaminophen oral). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients should not exceed the recommended dosage, as outlined in the overdose warning. Dosing should ideally be based on weight; however, age may be used if weight is not available. The following dosing chart provides guidance:

• For patients under 24 lbs or under 2 years of age, consult a doctor before use.

• For patients weighing 24 to 35 lbs (ages 2 to 3 years), the recommended dose is 1 tsp (5 mL).

• For patients weighing 36 to 47 lbs (ages 4 to 5 years), the recommended dose is 1 1/2 tsp (7.5 mL).

• For patients weighing 48 to 59 lbs (ages 6 to 8 years), the recommended dose is 2 tsp (10 mL).

• For patients weighing 60 to 71 lbs (ages 9 to 10 years), the recommended dose is 2 1/2 tsp (12.5 mL).

• For patients weighing 72 to 95 lbs (age 11 years), the recommended dose is 3 tsp (15 mL).

Doses may be repeated every 4 hours while symptoms persist, but should not exceed 5 doses in a 24-hour period.

Healthcare professionals should advise caregivers to consult a doctor or pharmacist prior to use if the child has liver disease or is taking the anticoagulant warfarin. It is essential to keep this medication out of reach of children.

Geriatric Use

The prescribing information for Children's Acetaminophen Oral Suspension does not provide specific details regarding geriatric use. There are no recommended age considerations, dosage adjustments, safety concerns, or special precautions for elderly patients mentioned in the text. Therefore, healthcare providers should exercise clinical judgment when prescribing this medication to geriatric patients, as individual patient factors may influence treatment decisions. Monitoring for efficacy and safety is advised, given the absence of specific guidance in 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 during pregnancy. Given the lack of information, it is advisable for women of childbearing potential to consult with their healthcare provider before using acetaminophen to weigh the potential risks and benefits.

Lactation

There are no specific warnings or recommendations regarding the use of this product by nursing mothers. Additionally, there are no considerations or precautions mentioned concerning lactation or the potential for excretion in breast milk.

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 individuals with reduced kidney function, as the absence of detailed guidance necessitates careful clinical judgment. Regular monitoring of renal function may be advisable in these patients to ensure safety and efficacy.

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 that patients do not exceed five doses within a 24-hour period, as this represents the maximum daily amount. Additionally, patients should avoid concomitant use with other medications containing acetaminophen to prevent the potential for hepatotoxicity.

Before administration, it is advisable for caregivers to consult with a healthcare professional if the patient has a history of liver disease. This precaution is essential to ensure the safe use of the product and to mitigate the risk of adverse effects related to compromised liver function.

Overdosage

In the event of an overdose, it is imperative to seek immediate medical assistance. Healthcare professionals are advised to contact the Poison Control Center at 1-800-222-1222 without delay. Prompt medical intervention is crucial, even in the absence of noticeable signs or symptoms of overdose.

The potential consequences of an overdose can vary, and early recognition and management are essential to mitigate risks. Therefore, healthcare providers should remain vigilant and proactive in addressing any suspected cases of overdose.

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 in these areas limits the understanding of the compound's potential effects in nonclinical settings.

Postmarketing Experience

Postmarketing experience has identified that acetaminophen may be associated with severe skin reactions. Reports indicate that symptoms can include skin reddening, blisters, and rash. In the event of a skin reaction, it is advised to discontinue use immediately and seek medical assistance.

Patient Counseling

Healthcare providers should advise patients to keep the medication out of reach of children to prevent accidental ingestion. Patients should be instructed to stop using the medication and consult a doctor if their pain worsens or persists for more than 5 days, if their fever worsens or lasts longer than 3 days, or if new symptoms arise, including redness or swelling, as these may indicate a serious condition.

In the event of an overdose, patients must seek immediate medical assistance or contact the Poison Control Center at 1-800-222-1222, as prompt medical attention is crucial, even if no signs or symptoms are apparent.

Healthcare providers should also recommend that patients consult a doctor or pharmacist before using the medication if the child has liver disease. Additionally, it is important to inquire whether the child is taking the blood-thinning medication warfarin, as this may affect the safety of using the product. Patients should be reminded not to exceed the recommended dose, in line with the overdose warning.

Storage and Handling

The product is supplied in various package configurations, with specific NDC numbers available upon request. It should be stored at room temperature, within the range of 20° to 25°C (68° to 77°F). Care must be taken to protect the product from freezing, as well as from exposure to light to ensure its integrity and efficacy.

Additional Clinical Information

Patients should be advised that the medication is administered orally, with a recommended repeat dose every 4 hours as needed, not to exceed 5 doses within a 24-hour period. Clinicians should counsel patients to consult a doctor or pharmacist prior to use if the child has liver disease or is taking the anticoagulant warfarin.

In the event of a skin reaction, patients must discontinue use and seek immediate medical attention. Additionally, if a sore throat is severe, persists beyond 2 days, or is accompanied by fever, headache, rash, nausea, or vomiting, patients should promptly consult a healthcare professional.

Drug Information (PDF)

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

View product document (PDF)