Childrens Chewables

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 children and does not contain directions or complete warnings for adult use. Healthcare professionals should ensure that the dosage does not exceed the recommended limits.

The appropriate dose should be determined using the dosage chart provided below, prioritizing weight for dosing when possible; otherwise, age may be used.

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 it is important not to exceed 5 doses within a 24-hour period.

Dosage Chart:

• For children weighing under 24 lb or under 2 years of age: Consult a doctor for appropriate dosing.

• For children weighing 24-35 lb or aged 2-3 years: Administer 1 chewable tablet.

• For children weighing 36-47 lb or aged 4-5 years: Administer 1 ½ chewable tablets.

• For children weighing 48-59 lb or aged 6-8 years: Administer 2 chewable tablets.

• For children weighing 60-71 lb or aged 9-10 years: Administer 2 ½ chewable tablets.

• For children weighing 72-95 lb or aged 11 years: Administer 3 chewable tablets.

Dosing may also be adjusted as directed by a healthcare professional.

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 acetaminophen content of a medication, consultation with a healthcare professional is advised.

Warnings and Precautions

Severe liver damage may occur with the use of this product, which contains acetaminophen, if the maximum daily dosage is exceeded. Specifically, caregivers should be aware that administering more than 5 doses within a 24-hour period or combining this product with other medications containing acetaminophen significantly increases the risk of liver injury.

Acetaminophen is also associated with the potential for severe skin reactions. Symptoms indicative of such reactions may include 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, particularly if it persists for more than 2 days or is accompanied by fever, headache, rash, nausea, or vomiting, it is essential to consult a healthcare professional without delay.

General precautions should be observed prior to administration. Caregivers are advised to consult a physician if the child has a history of liver disease. Additionally, it is recommended to seek guidance from a healthcare provider or pharmacist if the child is concurrently taking warfarin, a blood-thinning medication.

In the event of an overdose, immediate medical attention is crucial. Caregivers should contact a Poison Control Center or seek emergency medical help right away, as prompt intervention is vital for both adults and children, even in the absence of noticeable symptoms.

Patients should discontinue use and contact a healthcare provider if any of the following occur: pain worsens or persists beyond 5 days, fever intensifies or lasts more than 3 days, new symptoms develop, or if there is any presence of redness or swelling.

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 with liver disease should consult a doctor before using this product.

Acetaminophen may also cause severe skin reactions, which can manifest as skin reddening, blisters, or rash. If any of these symptoms occur, patients are advised to 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 should stop using the product and seek medical advice if pain worsens or lasts more than 5 days, if fever worsens or lasts more than 3 days, if any new symptoms appear, or if redness or swelling is present.

Additionally, patients taking the blood-thinning medication warfarin should consult a doctor or pharmacist before using this product to avoid potential interactions.

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 Chewables (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 (lb) Age (yr) Dose (chewable tablets)

• Under 24: Under 2 years - Ask a doctor

• 24-35: 2-3 years - 1 tablet

• 36-47: 4-5 years - 1 1/2 tablets

• 48-59: 6-8 years - 2 tablets

• 60-71: 9-10 years - 2 1/2 tablets

• 72-95: 11 years - 3 tablets

Caution is advised due to the presence of acetaminophen, as severe liver damage may occur if more than 5 doses are taken within 24 hours, which includes any other medications containing acetaminophen. Parents or caregivers should consult a doctor before use if the child has liver disease or is taking the blood-thinning medication warfarin. It is essential to keep this product out of reach of children. In the event of an overdose, immediate medical assistance should be sought, and contacting a Poison Control Center is recommended, as prompt attention is critical for both children and adults, even if no symptoms are apparent.

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

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 lactating mothers. Additionally, there is no information available concerning the potential for excretion in breast milk or any associated effects on breastfed infants.

Renal Impairment

Patients with renal impairment have not been specifically studied in relation to dosage adjustments, special monitoring, or safety considerations. Therefore, there is no available information regarding the use of this medication in individuals with reduced kidney function. Healthcare professionals should exercise caution and consider the lack of data when prescribing this medication to patients with renal impairment.

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 patient is concurrently taking other medications that contain acetaminophen.

Before administration, it is advised to consult a healthcare professional if the patient has a history of liver disease. This precaution is essential to ensure the safety and efficacy of the treatment in individuals with compromised liver function.

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 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 that acetaminophen may be associated with severe skin reactions. Reported symptoms of these reactions include skin reddening, blisters, and rash. In the event of a skin reaction, it is advised to discontinue use immediately and seek medical assistance.

Additionally, cases of overdose have been reported, emphasizing the importance of obtaining medical help or contacting a Poison Control Center without delay. Prompt medical attention is critical for both adults and children, even in the absence of noticeable signs or symptoms.

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 products containing acetaminophen, whether prescription or nonprescription. If patients are uncertain about the presence of acetaminophen in other medications, they should be encouraged to consult with a doctor or pharmacist for clarification.

Providers should instruct patients to discontinue use and consult a doctor if pain worsens or persists for more than five days. Similarly, if a fever intensifies or lasts longer than three days, patients should stop using the medication and seek medical advice. Additionally, patients should be advised to stop use and contact a healthcare professional if any new symptoms arise or if there is any redness or swelling.

For pediatric patients, it is important to recommend that parents or guardians consult a doctor before use if their child has liver disease. Furthermore, they 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 a tamper-evident package. It should not be used if the outer package is opened or if the blister is torn or broken. The expiration date and lot number can be found on the end flap of the packaging.

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

Additional Clinical Information

The medication is administered orally, with specific instructions for patients to chew or crush the tablets completely before swallowing, as whole tablets should not be ingested. Dosing can be repeated every 4 hours as needed, but should not 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 in the event of an overdose. It is crucial to obtain prompt medical attention for both adults and children, even if no signs or symptoms are initially apparent.

Drug Information (PDF)

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

View product document (PDF)