Chewable Acetaminophen

Description

Acetaminophen (APAP) 80 mg is presented in a chewable tablet dosage form. Each bottle contains 30 tablets. The product is identified by the National Drug Code (NDC) 54738-092-30.

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 healthcare professionals should refer to the dosage chart to determine the appropriate dose based on the patient's weight or age. The following guidelines should be adhered to:

For patients weighing under 24 pounds or under 2 years of age, it is advised to consult a physician before administration. For patients weighing between 24 to 35 pounds (ages 2 to 3 years), the recommended dose is 2 tablets. For those weighing 36 to 47 pounds (ages 4 to 5 years), the dose increases to 3 tablets. Patients weighing 48 to 59 pounds (ages 6 to 8 years) should receive 4 tablets, while those weighing 60 to 71 pounds (ages 9 to 10 years) may be given 4 to 5 tablets. Finally, for patients weighing 72 to 95 pounds (ages 11 to 12 years), the recommended dose is 4 to 6 tablets.

Patients should chew the tablets thoroughly before swallowing, as the product is designed to soften in the mouth to facilitate this process. Dosing may be repeated every 4 hours as needed while symptoms persist, but it is crucial not to exceed 5 doses within a 24-hour period. Additionally, this product should not be administered for more than 5 consecutive days unless directed by a healthcare professional. It is imperative to adhere strictly to these guidelines to ensure safe and effective use.

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.

It is also essential to adhere to the recommended dosage, as exceeding this may lead to adverse effects.

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, which is the maximum daily amount, or concomitant use with other medications containing acetaminophen significantly increases the risk of liver injury.

Acetaminophen is associated with the potential for severe skin reactions. Symptoms indicative of such reactions may include skin reddening, blisters, and rash. In the event of a skin reaction, it is imperative to discontinue use immediately and seek medical assistance.

Healthcare providers should be vigilant regarding patients presenting with a sore throat. If the sore throat is severe, persists for more than two days, or is accompanied by fever, headache, rash, nausea, or vomiting, prompt consultation with a physician is warranted.

Patients should be instructed to discontinue use and consult a healthcare professional if any of the following occur: worsening pain lasting more than five days, worsening fever lasting more than 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.

In cases of accidental overdose, immediate medical attention is essential. Patients should be advised to contact a Poison Control Center at 1-800-222-1222 without delay, as prompt intervention is critical for both adults and children, even in the absence of noticeable signs or symptoms.

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 should also be alerted to the risk of severe skin reactions associated with acetaminophen, which may manifest as skin reddening, blisters, or rash. In the event of a skin reaction, it is imperative to discontinue use and seek medical assistance immediately.

Additionally, if a patient experiences a sore throat that is severe, persists for more than 2 days, or is accompanied by fever, headache, rash, nausea, or vomiting, they should consult a healthcare provider promptly.

This product should not be used 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. It is contraindicated in patients with a known allergy to acetaminophen or any inactive ingredients in the formulation.

Patients with liver disease should consult a doctor before using this product. Furthermore, those taking the blood-thinning medication warfarin should seek advice from a healthcare professional prior to use.

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

In cases of accidental overdose, immediate medical help should be sought, or contact with a Poison Control Center (1-800-222-1222) is advised. Prompt medical attention is essential for both adults and children, 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 Chewable Acetaminophen (acetaminophen). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients under 2 years of age should not use this product without consulting a doctor. For children aged 2 to 3 years weighing between 24-35 pounds, the recommended dosage is 2 tablets. For those aged 4 to 5 years and weighing 36-47 pounds, the dosage increases to 3 tablets. Children aged 6 to 8 years weighing 48-59 pounds should receive 4 tablets, while those aged 9 to 10 years weighing 60-71 pounds may take 4 to 5 tablets. Finally, children aged 11 to 12 years weighing 72-95 pounds can take 4 to 6 tablets.

Healthcare professionals should be aware of several warnings associated with this product. It contains acetaminophen, which can lead to severe liver damage if more than 5 doses are taken within a 24-hour period. Additionally, there is an allergy alert for potential severe skin reactions, including symptoms such as skin reddening, blisters, or rash. If any of these symptoms occur, use should be discontinued immediately, and medical assistance should be sought. A sore throat warning is also in place; if a sore throat is severe, persists for more than 2 days, or is accompanied by fever, headache, rash, nausea, or vomiting, a doctor should be consulted promptly.

This product should not be used in children who are allergic to acetaminophen or any inactive ingredients. Before administering, healthcare providers should inquire if the child has liver disease or is taking the blood-thinning medication warfarin.

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

In the event of an accidental overdose, immediate medical help should be sought, or the Poison Control Center (1-800-222-1222) should be contacted. Prompt medical attention is essential for both children and adults, even if no signs or symptoms are initially 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 potential adverse effects or changes in efficacy, given the lack of targeted data for this population.

Pregnancy

The safety of acetaminophen during pregnancy has not been established. Pregnant patients or those planning to become pregnant should consult a healthcare provider before use. Potential risks to the fetus have not been fully evaluated; therefore, caution is advised when considering the use of acetaminophen in this population.

Dosage adjustments may be necessary, and it is essential for healthcare providers to guide any modifications. Acetaminophen should only be used if clearly needed and after a thorough discussion with a healthcare professional regarding the potential risks and benefits.

Lactation

There are no specific warnings or recommendations regarding the use of this product in nursing mothers. Additionally, there is no information available about the potential for excretion in breast milk or any associated risks to breastfed infants.

Renal Impairment

Patients with renal impairment have no specific information regarding dosage adjustments, special monitoring, or safety considerations provided in the drug insert. 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.

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 that patients do not exceed five doses within a 24-hour period, as this is the maximum daily amount. Additionally, patients should avoid concomitant use with other medications containing acetaminophen to prevent the risk of liver toxicity.

Before initiating treatment, it is advisable for patients with liver disease to consult a healthcare professional. This precaution is essential to ensure the safe use of the product and to evaluate the potential need for dosage adjustments or alternative therapies based on the severity of the hepatic impairment. Regular monitoring of liver function may be warranted in these patients to detect any signs of liver damage early.

Overdosage

In the event of an accidental overdose, it is imperative to seek immediate medical assistance or contact a Poison Control Center at 1-800-222-1222. Prompt medical attention is crucial for both adults and children, even in the absence of noticeable signs or symptoms.

Healthcare professionals should be aware that the management of overdose cases may vary depending on the specific substance involved and the clinical presentation of the patient. Therefore, it is essential to conduct a thorough assessment and provide appropriate interventions based on the patient's condition and the guidance of poison control experts.

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 compound in these areas.

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 to seek immediate medical assistance or contact a Poison Control Center (1-800-222-1222) in the event of an accidental overdose. It is crucial to emphasize that prompt medical attention is necessary for both adults and children, even if no signs or symptoms are apparent.

Patients should be instructed not to exceed the recommended dosage of the medication. Additionally, healthcare providers should encourage patients to consult with a doctor before use if their child has liver disease, as this may affect the safety and efficacy of the treatment.

Furthermore, it is important for healthcare providers to remind patients to speak with a doctor or pharmacist prior to use if their child is currently taking the blood-thinning medication warfarin, to avoid potential interactions.

Storage and Handling

The product is supplied in various package configurations, with specific NDC numbers available upon request. It should be stored at a controlled room temperature of 25°C (77°F), with permissible excursions between 15°C and 30°C (59°F and 86°F). It is essential to avoid exposure to high humidity during storage to maintain product integrity.

Additional Clinical Information

The medication is administered orally. Clinicians should advise patients to keep the medication out of reach of children. In the event of an accidental overdose, it is crucial for patients to seek medical assistance immediately or contact a Poison Control Center at 1-800-222-1222. 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 Chewable Acetaminophen, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

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