Childrens Chewable Acetaminophen

Description

The product is identified by SPL code 34089-3 and is presented as a white to off-white, round, biconvex, film-coated tablet. Each tablet is debossed with "A" on one side and "1" on the opposite side. It contains 1 mg of the active ingredient. The formulation includes several inactive ingredients: microcrystalline cellulose, lactose monohydrate, croscarmellose sodium, magnesium stearate, and Opadry II White, which is composed of polyvinyl alcohol, titanium dioxide, polyethylene glycol, and talc.

Uses and Indications

This drug is indicated for the temporary relief of minor aches and pains. It is also indicated for the temporary reduction of fever.

There are no known teratogenic or nonteratogenic effects associated with this drug.

Dosage and Administration

Patients should chew the tablets thoroughly before swallowing. Dosage should be determined according to the provided dosage table or as directed by a healthcare professional. When possible, dosing should be based on the patient's weight; if weight is not available, age may be used as a guide.

The recommended dosing intervals are every 4 hours as needed, with a maximum of 5 doses within a 24-hour period. Administration should only occur under adult supervision. It is imperative not to exceed the dosage indicated in the table, and healthcare professionals should be aware of the overdose warning.

Dosage Table:

Weight (lbs):

• Under 24: Consult a doctor

• 24-35: 2 tablets

• 36-47: 3 tablets

• 48-59: 4 tablets

• 60-71: 5 tablets

• 72-95: 6 tablets

Age:

• Under 2: Consult a doctor

• 2-3: 2 tablets

• 4-5: 3 tablets

• 6-8: 4 tablets

• 9-10: 5 tablets

• 11: 6 tablets

Contraindications

Use of this product is contraindicated in the following situations:

Co-administration with any other drug containing acetaminophen, whether prescription or nonprescription, is prohibited due to the risk of acetaminophen overdose. If there is uncertainty regarding the presence of acetaminophen in other medications, consultation with a healthcare professional is advised.

Additionally, this product should not be used in patients with a known allergy to acetaminophen or any of the inactive ingredients contained in this formulation, as this may lead to severe allergic reactions.

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, healthcare professionals should advise that no more than five doses should be administered within a 24-hour period. Additionally, caution is warranted if the product is used concurrently with other medications containing acetaminophen.

Acetaminophen has been associated with severe skin reactions, which may 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.

Healthcare providers should inquire about the patient's medical history, particularly regarding liver disease, before recommending this product. Furthermore, it is advisable to consult with a doctor or pharmacist if the patient is concurrently taking warfarin or any other anticoagulant medication.

In cases of suspected overdose, immediate medical attention is essential. Patients or caregivers should contact a Poison Control Center or seek emergency medical help without delay, as prompt intervention is critical for both adults and children, even in the absence of overt symptoms.

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, fever that persists or worsens 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

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 should be advised that acetaminophen may also lead to 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 and seek immediate medical assistance.

Patients should not use this product in conjunction with any other drug containing acetaminophen, whether prescription or nonprescription. It is essential for patients to consult a healthcare professional if they are uncertain about the presence of acetaminophen in other medications. Additionally, this product should not be administered to patients with a known allergy to acetaminophen or any of the inactive ingredients contained within the formulation.

Prior to use, patients with liver disease should seek medical advice. Furthermore, it is advisable for patients taking the anticoagulant warfarin to consult with a doctor or pharmacist before using this product.

Patients are instructed to discontinue use and consult a healthcare provider if pain worsens or persists beyond five days, if fever intensifies or lasts more than three days, if new symptoms arise, or if there is any redness or swelling, as these may indicate a serious underlying condition.

In cases of overdose, immediate medical attention is crucial. Patients and caregivers should contact a Poison Control Center or seek medical help without delay, as prompt intervention is vital for both adults and children, even in the absence of noticeable signs or symptoms.

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 Childrens Chewable Acetaminophen (acetaminophen). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients under 2 years of age should consult a doctor before use. For children aged 2 to 3 years, the recommended dosage is 2 tablets; for those aged 4 to 5 years, 3 tablets; for 6 to 8 years, 4 tablets; for 9 to 10 years, 5 tablets; and for 11 years, 6 tablets. Dosing should occur every 4 hours as needed, with a maximum of 5 doses in a 24-hour period. It is preferable to use weight for dosing; if weight is not available, age may be used. Administration should occur only under adult supervision.

Warnings include a risk of severe liver damage if more than 5 doses are taken in 24 hours or if used concurrently with other acetaminophen-containing medications. There is also an allergy alert, as acetaminophen may cause severe skin reactions, including skin reddening, blisters, and rash. If any skin reaction occurs, use should be discontinued immediately, and medical assistance should be sought. Prior to use, consultation with a doctor is advised if the child has liver disease or is taking the anticoagulant warfarin. Parents should stop use and consult a doctor if pain worsens or persists beyond 5 days, fever worsens or lasts more than 3 days, new symptoms develop, or if redness or swelling is observed.

In the event of an overdose, immediate medical help should be sought, or contact with a Poison Control Center is essential. Prompt medical attention is critical for both children and adults, even if no signs or symptoms are apparent.

Geriatric Use

There is no specific information available regarding the use of this medication in geriatric patients, including dosage adjustments, safety concerns, or special precautions. Healthcare providers should exercise caution when prescribing this medication to elderly patients, as individual responses may vary. It is advisable to monitor these patients closely for any adverse effects or changes in efficacy.

Pregnancy

The available prescribing information does not provide specific data regarding the use of this product during pregnancy, including safety concerns, dosage modifications, or special precautions. Therefore, healthcare professionals are advised to exercise caution when prescribing this product to pregnant patients. The potential risks and benefits should be carefully considered, and alternative therapies may be explored in consultation with the patient. Women of childbearing potential should be informed of the lack of data and encouraged to discuss any concerns with their healthcare provider.

Lactation

Nursing mothers should consult a doctor before using this product. There is a potential for excretion of acetaminophen in breast milk. Caution is advised when administering this medication to nursing mothers due to the potential risk to the infant.

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 absence of 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 risk of hepatotoxicity.

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 liver function 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 overdose, it is imperative to seek immediate medical assistance or contact a Poison Control Center without delay. Quick 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 overt symptoms does not preclude the possibility of serious complications arising from an overdose. Therefore, monitoring and evaluation should be conducted promptly to ensure patient safety and appropriate management.

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 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, emphasizing that prompt medical attention is crucial for both adults and children, even if no signs or symptoms are apparent.

Patients should be informed not to use this medication in conjunction with any other products containing acetaminophen, whether prescription or nonprescription. If there is uncertainty regarding the presence of acetaminophen in other medications, patients are encouraged to consult with a doctor or pharmacist for clarification.

It is important to instruct patients not to administer this medication to children who are allergic to acetaminophen or any of the inactive ingredients present in the product.

Patients should be advised to discontinue use and consult a doctor if pain worsens or persists beyond 5 days, or if fever intensifies or lasts more than 3 days. Additionally, they should be instructed to seek medical advice if new symptoms arise or if there is any redness or swelling, as these may indicate a serious condition.

Healthcare providers should recommend that patients consult a doctor before using this medication if their child has liver disease. Furthermore, patients taking the blood-thinning medication warfarin should be advised to speak with a doctor or pharmacist prior to use to ensure safety and avoid potential interactions.

Storage and Handling

The product is supplied in a configuration that ensures its integrity and safety. It should be stored at a temperature range of 20°C to 25°C (68°F to 77°F) while avoiding exposure to high humidity. To maintain its quality, the container must be kept tightly closed when not in use.

Additionally, the product features a tamper-evident seal; therefore, it should not be used if the imprinted seal under the cap is missing or broken.

Additional Clinical Information

The medication is administered orally, with a recommended frequency of every 4 hours as needed, not exceeding 5 doses within a 24-hour period. Clinicians should advise patients to consult a doctor prior to use if the child has liver disease or is concurrently taking warfarin, a blood-thinning medication. Patients should be instructed to discontinue use and seek medical advice if pain worsens or persists beyond 5 days, if fever intensifies or lasts more than 3 days, if new symptoms arise, or if there is any redness or swelling.

Drug Information (PDF)

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

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