Acetaminophen

Description

NDC 0363-9605-07. This product is a chewable formulation of acetaminophen, containing 160 mg per tablet, designed for the relief of pain and reduction of fever in children aged 2 to 11 years. The product is aspirin-free and ibuprofen-free, and it is presented in a bubble gum flavor. Each package contains 24 chewable tablets, which should be chewed or crushed completely before swallowing. It is important to note that this product should not be used in conjunction with other medications containing acetaminophen.

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 specific dosing instructions must be followed to ensure safety and efficacy. Healthcare professionals should refer to the dosage chart below to determine the appropriate dose based on the patient's weight and age.

Tablets must be chewed or crushed completely before swallowing; they should not be swallowed whole. Dosing may be repeated every 4 hours as needed while symptoms persist, but it is essential not to exceed 5 doses within a 24-hour period.

Dosage Chart:

• For patients weighing under 24 lbs (under 2 years of age): Consult a doctor for appropriate dosing.

• For patients weighing 24 to 35 lbs (2 to 3 years of age): Administer 1 tablet.

• For patients weighing 36 to 47 lbs (4 to 5 years of age): Administer 1½ tablets.

• For patients weighing 48 to 59 lbs (6 to 8 years of age): Administer 2 tablets.

• For patients weighing 60 to 71 lbs (9 to 10 years of age): Administer 2½ tablets.

• For patients weighing 72 to 95 lbs (11 years of age): Administer 3 tablets.

Dosing may also be adjusted as directed by a healthcare professional. It is crucial to adhere to the maximum dosing limits to avoid the risk of overdose.

Contraindications

Use of this product is contraindicated in the following situations:

The product should not be administered concurrently 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.

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

Exceeding the recommended dosage is contraindicated due to the risk of overdose, which may lead to serious health complications.

Warnings and Precautions

Severe liver damage may occur with the use of this product, which contains acetaminophen. Healthcare professionals should advise patients that exceeding five doses within a 24-hour period, the maximum daily amount, or concomitant use 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, and rash. Should any of these symptoms manifest, 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, patients should be instructed to consult a physician without delay.

In the event of an overdose, immediate medical attention is crucial. Patients should be directed to contact a Poison Control Center at 1-800-222-1222 or seek emergency medical help, regardless of the presence of symptoms, as prompt intervention is essential for both adults and children.

Healthcare providers should also advise patients to discontinue use and contact their physician if any of the following occur: worsening pain lasting more than five days, fever that worsens or persists beyond three days, the emergence of new symptoms, or the presence of redness or swelling. 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 five 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. If any of these symptoms occur, patients are advised to discontinue use immediately and seek medical assistance.

Patients should be vigilant regarding sore throat symptoms. If a sore throat is severe, persists for more than two days, or is accompanied by fever, headache, rash, nausea, or vomiting, it is recommended that they consult a healthcare professional promptly.

Furthermore, patients are advised to stop using the product and consult a doctor if pain worsens or lasts longer than five days, if fever worsens or persists for more than three days, if new symptoms develop, or if there is any redness or swelling present. These signs may indicate a serious underlying condition that requires medical evaluation.

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 arise from unintentional duplication of therapy. 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 Acetaminophen. 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. Tablets must be chewed or crushed completely before swallowing; they should not be swallowed whole. 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. Dosing may be repeated every 4 hours as needed while symptoms persist, but should not exceed 5 doses in a 24-hour period.

Weight (lb) Age (yr) Dose (tablets)

• Under 24 lbs: Under 2 years - Ask a doctor.

• 24 to 35 lbs: 2 to 3 years - 1 tablet.

• 36 to 47 lbs: 4 to 5 years - 1½ tablets.

• 48 to 59 lbs: 6 to 8 years - 2 tablets.

• 60 to 71 lbs: 9 to 10 years - 2½ tablets.

• 72 to 95 lbs: 11 years - 3 tablets.

• Or as directed by a doctor.

Healthcare professionals are advised to monitor pediatric patients closely for efficacy and safety, adjusting dosages as necessary based on individual response and clinical judgment.

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 potential adverse effects or changes in therapeutic response, given the lack of targeted data for this population.

Pregnancy

The available prescribing information does not provide specific data regarding the use of acetaminophen during pregnancy. Consequently, there are no established safety concerns, dosage modifications, or special precautions outlined for pregnant patients. Healthcare professionals should exercise caution and consider the potential risks and benefits when recommending acetaminophen to women of childbearing potential. Further research may be necessary to fully understand the implications of acetaminophen use during pregnancy and its effects on fetal outcomes.

Lactation

Nursing mothers should consult a doctor before using this product. There is a potential for excretion in breast milk, and the effects of acetaminophen on a nursing infant are not well studied; therefore, caution is advised. It is recommended to monitor the infant for any adverse effects if the nursing mother takes this medication.

Renal Impairment

There is no information available regarding dosage adjustments, special monitoring, or safety considerations for patients with renal impairment. Healthcare professionals should exercise caution and consider the lack of specific guidance when prescribing to patients with reduced kidney function.

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 to adhere to the maximum daily dosage of 5 doses within a 24-hour period. Exceeding this limit, particularly in patients with compromised liver function, may significantly increase the risk of hepatotoxicity. Additionally, caution should be exercised if the patient is concurrently using other medications that contain acetaminophen, as this may further elevate the risk of liver injury. Regular assessment of liver function is recommended to ensure patient safety and to mitigate potential adverse effects associated with acetaminophen use in this population.

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 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 fully evaluate the nonclinical toxicology profile.

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 on the importance of seeking immediate medical assistance in the event of an overdose. Patients should be informed to contact a Poison Control Center at 1-800-222-1222 without delay.

It is crucial for patients to understand that quick medical attention is essential for both adults and children, even if they do not exhibit any noticeable signs or symptoms of overdose. Emphasizing this point can help ensure timely intervention and potentially mitigate serious health risks.

Storage and Handling

The product is supplied in a secure carton, and it is essential to store it at a temperature range of 20° to 25°C (68° to 77°F). Care should be taken to avoid exposure to high humidity and to protect the product from light to maintain its integrity.

Healthcare professionals should ensure that the carton remains unopened and that the printed seal on the blister is intact. If the carton is open or the seal is broken or missing, the product should not be used.

Additional Clinical Information

The medication is administered orally, with specific instructions for patients to chew or crush the tablets completely before swallowing, as swallowing them whole is not advised. Dosing can be repeated every 4 hours while symptoms persist, 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. Prompt medical attention is crucial for both adults and children, even if no signs or symptoms are initially apparent.

Drug Information (PDF)

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

View product document (PDF)