Childrens Acetaminophen

Description

No description information is available for the specified drug.

Uses and Indications

This drug is indicated for the temporary relief of minor aches and pains associated with headache, sore throat, flu, toothache, and the common cold. 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 specific dosing should be determined based on the patient's weight or age. Healthcare professionals are advised to refer to the following dosage chart to ascertain the appropriate dose:

• For patients weighing under 24 lb (under 2 years of age), the dose is to be determined by a physician.

• For patients weighing 24-35 lb (ages 2-3 years), the recommended dose is 1 chewable tablet.

• For patients weighing 36-47 lb (ages 4-5 years), the recommended dose is 1 ½ chewable tablets.

• For patients weighing 48-59 lb (ages 6-8 years), the recommended dose is 2 chewable tablets.

• For patients weighing 60-71 lb (ages 9-10 years), the recommended dose is 2 ½ chewable tablets.

• For patients weighing 72-95 lb (age 11 years), the recommended dose is 3 chewable tablets.

Patients should chew or crush the tablets completely before swallowing; whole tablets should not be swallowed. Dosing may be repeated every 4 hours as needed while symptoms persist, but should not exceed 5 doses within a 24-hour period. It is imperative to adhere to the recommended dosing guidelines and not exceed the directed amount. For any uncertainties or specific patient considerations, consultation with a physician is advised.

Contraindications

Use of this product is contraindicated in patients who are concurrently taking any other medication that contains acetaminophen, whether prescription or nonprescription. The combination may lead to an increased risk of acetaminophen-related hepatotoxicity. If there is uncertainty regarding the presence of acetaminophen in other medications, consultation with a healthcare professional is advised.

Warnings and Precautions

Severe liver damage may occur with the use of this product, which contains acetaminophen. Healthcare professionals should advise caregivers that exceeding five doses within a 24-hour period, or administering this product concurrently with other medications containing acetaminophen, significantly increases the risk of liver injury.

Acetaminophen has been associated with severe skin reactions. 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.

In cases of severe sore throat, particularly if it persists for more than two days or is accompanied by fever, headache, rash, nausea, or vomiting, prompt consultation with a healthcare provider is recommended.

Healthcare professionals should inquire about the patient's medical history, specifically regarding liver disease, prior to recommending this product. Additionally, it is advisable to consult with a doctor or pharmacist if the patient is concurrently taking warfarin or other blood-thinning medications.

In the event of an overdose, immediate medical attention is crucial. Caregivers should be instructed to contact a Poison Control Center or seek emergency medical help without delay, regardless of the presence of symptoms.

Patients should be advised to discontinue use and consult a healthcare provider if any of the following occur: worsening pain lasting more than five days, worsening fever lasting more than three days, presence of redness or swelling, or the emergence of any new symptoms.

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 may also experience 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.

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

Common adverse reactions necessitating medical consultation include worsening pain that lasts more than five days, fever that worsens or persists beyond three days, the presence of redness or swelling, or the emergence of any new symptoms.

It is advised that patients consult a doctor prior to use if there is a history of liver disease. Furthermore, patients taking the anticoagulant warfarin should seek guidance from a healthcare provider 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 necessitate careful monitoring of coagulation parameters to avoid potential adverse effects related to increased bleeding risk. Adjustments to the dosage of either medication may be required based on clinical judgment and patient response.

Packaging & NDC

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

Pediatric Use

Pediatric patients should not exceed the recommended dosage. The appropriate dose can be determined using the weight-based chart provided below; if weight is not available, age may be used as a guide. Tablets must be chewed or crushed completely before swallowing and should not be swallowed whole. Dosing may be repeated every 4 hours as needed, but should not exceed 5 doses in a 24-hour period.

Weight Age Dose (chewable tablets)

• Under 24 lb: Under 2 years - Ask a doctor

• 24-35 lb: 2-3 years - 1 tablet

• 36-47 lb: 4-5 years - 1 1/2 tablets

• 48-59 lb: 6-8 years - 2 tablets

• 60-71 lb: 9-10 years - 2 1/2 tablets

• 72-95 lb: 11 years - 3 tablets

Healthcare professionals should advise parents to consult a doctor before use if the child has liver disease or is taking the blood-thinning medication warfarin. In the event of an overdose, immediate medical assistance should be sought, and contacting a Poison Control Center is recommended. Prompt medical attention is crucial for both children and adults, even if no signs or symptoms are present.

Geriatric Use

Elderly patients may not have specific information regarding the use of this medication, including dosage adjustments, safety concerns, or special precautions. Therefore, healthcare providers should exercise caution when prescribing this medication to geriatric patients. It is advisable to monitor these patients closely for any adverse effects or changes in therapeutic response, given the lack of targeted data for this population.

Pregnancy

Pregnant patients should be advised against the concurrent use of this medication with any other drug containing acetaminophen, whether prescription or nonprescription. It is essential for healthcare providers to inquire about all medications the patient may be taking to avoid potential overdose and associated risks.

In cases where the patient has a history of liver disease, consultation with a healthcare professional is recommended prior to use. Additionally, if the patient is taking anticoagulants such as warfarin, it is crucial to seek guidance from a doctor or pharmacist before administration, as interactions may pose significant risks.

In the event of an overdose, immediate medical assistance should be sought, and contacting a Poison Control Center is advised. Prompt medical attention is critical for both adults and children, regardless of the presence of symptoms.

The safety of this medication during pregnancy has not been established, and healthcare providers should weigh the potential benefits against the risks when considering its use in pregnant patients.

Lactation

There are no specific warnings or recommendations regarding the use of this product in lactating mothers. Additionally, there are no statements concerning 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 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 lack of data necessitates careful clinical judgment. Regular monitoring of renal function may be advisable in these patients, although specific recommendations are not provided.

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 of 5 doses within a 24-hour period to mitigate the risk of hepatotoxicity.

Before administration, it is advised that a healthcare professional be consulted if the patient has a history of liver disease. This precaution is essential to ensure the safe use of the product and to evaluate the need for any dosage adjustments or additional monitoring based on the patient's liver function status.

Overdosage

In the event of an overdose, it is imperative to seek immediate medical assistance or contact a Poison Control Center without delay. Prompt medical intervention is crucial for both adults and children, even in the absence of noticeable signs or symptoms.

Healthcare professionals should be aware that the lack of immediate symptoms does not preclude the potential for serious health consequences. Therefore, it is essential to monitor the patient closely and provide appropriate care as needed.

Nonclinical Toxicology

No information is available regarding teratogenic or non-teratogenic effects. Additionally, there is no data provided concerning nonclinical toxicology, animal pharmacology, or toxicology.

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 seek immediate medical assistance or contact a Poison Control Center in the event of an overdose. It is crucial to emphasize that prompt medical attention is necessary for both adults and children, even if no signs or symptoms are initially apparent.

Patients should be informed not to use this medication in conjunction with any other drug that contains acetaminophen, whether prescription or nonprescription. If patients are uncertain about the presence of acetaminophen in any medication, they should be encouraged to consult with a doctor or pharmacist for clarification.

Healthcare providers should instruct patients to discontinue use and consult a doctor if pain worsens or persists for more than five days. Similarly, patients should be advised to stop use and seek medical advice if fever intensifies or lasts longer than three days. Additionally, patients should be informed to stop use and consult a doctor if they notice any redness or swelling, or if any new symptoms arise.

It is important for healthcare providers to remind patients to consult a doctor before using this medication if their child has liver disease. Furthermore, patients should be advised to speak with a doctor or pharmacist prior to use if their child is currently taking the blood-thinning medication warfarin.

Storage and Handling

The product is supplied in tamper-evident packaging. It should not be used if the outer package is opened or if the blister is torn or broken.

Storage conditions require the product to be maintained at a temperature of 25°C (77°F), with permissible excursions between 15°C and 30°C (59°F to 86°F). It is important to avoid high humidity during storage.

Healthcare professionals should refer to the end flap of the packaging for the expiration date and lot number to ensure product integrity and safety.

Additional Clinical Information

Patients should chew or crush the tablets completely before swallowing, as they should not be swallowed whole. The recommended dosing frequency is every 4 hours while symptoms persist, with a maximum of 5 doses in a 24-hour period.

Clinicians should advise patients to keep the medication out of reach of children. In the event of an overdose, it is crucial to seek medical assistance or contact a Poison Control Center immediately, as prompt medical attention is essential for both adults and children, even if no signs or symptoms are apparent.

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)