Acetaminophen

Description

No description information is available for the specified drug.

Uses and Indications

This drug is indicated for the temporary reduction of fever. It is also indicated for the temporary relief of minor aches and pains associated with the common cold, flu, headaches, sore throat, and toothaches.

Limitations of Use: This drug is not intended for the treatment of severe pain or for prolonged use without medical supervision.

Dosage and Administration

This product is intended for use in pediatric patients, and healthcare professionals should refer to the dosage chart below to determine the appropriate dose based on the patient's weight or age. Prior to administration, the product must be shaken well to ensure proper mixing.

Dosing should be repeated every 4 hours as needed while symptoms persist, with a maximum of 5 doses administered within a 24-hour period. It is imperative that the dosage does not exceed the recommended limits, and healthcare professionals should advise caregivers to consult a physician for patients weighing less than 24 pounds or under 2 years of age.

Dosage Chart:

• For patients weighing under 24 lb or under 2 years of age: Dose (mL) - Ask a doctor.

• For patients weighing 24 to 35 lb or aged 2 to 3 years: Dose (mL) - 5 mL.

• For patients weighing 36 to 47 lb or aged 4 to 5 years: Dose (mL) - 7.5 mL.

• For patients weighing 48 to 59 lb or aged 6 to 8 years: Dose (mL) - 10 mL.

• For patients weighing 60 to 71 lb or aged 9 to 10 years: Dose (mL) - 12.5 mL.

• For patients weighing 72 to 95 lb or aged 11 years: Dose (mL) - 15 mL.

• *Or as directed by a doctor.

Caregivers should be instructed to adhere strictly to the dosing recommendations and to seek medical advice if there are any uncertainties regarding the appropriate dosage.

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.

• This product should not be used in patients with a known allergy to acetaminophen or any of the inactive ingredients contained in the formulation.

• Exceeding the recommended dosage while using this product is contraindicated, as it may lead to serious adverse effects.

Warnings and Precautions

Severe liver damage may occur in children taking this product, which contains acetaminophen, if they exceed the maximum daily amount of 5 doses within a 24-hour period or if they are concurrently using other medications that contain 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.

In cases of severe sore throat that persists for more than 2 days or is accompanied by fever, headache, nausea, rash, or vomiting, prompt consultation with a healthcare provider is advised.

Healthcare professionals should inquire about the patient's medical history before recommending this product, particularly if the child has a history of liver disease. Additionally, it is essential to consult a doctor or pharmacist if the child is currently taking warfarin, a blood-thinning medication.

It is critical to adhere to the recommended dosing guidelines to avoid overdose. In the event of an overdose, immediate medical attention should be sought, or the Poison Control Center should be contacted without delay, as rapid intervention is crucial for both adults and children, even in the absence of noticeable symptoms.

Patients should be advised to discontinue use and consult a healthcare provider if symptoms do not improve, if new symptoms arise, if pain worsens or persists beyond 5 days, if fever intensifies or lasts more than 3 days, or if redness or swelling occurs, as these may indicate a serious underlying condition.

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 the product is taken concurrently with other drugs containing acetaminophen. Additionally, acetaminophen may cause severe skin reactions, which can manifest as skin reddening, blisters, or rash. In the event of a skin reaction, patients are advised to discontinue use immediately and seek medical assistance.

Patients should also be cautious if experiencing a severe sore throat that persists for more than 2 days or is accompanied by fever, headache, nausea, rash, or vomiting, as these symptoms warrant prompt consultation with a healthcare provider.

It is crucial to avoid using this product in conjunction with any other medication containing acetaminophen, whether prescription or nonprescription. Patients should consult a doctor or pharmacist if uncertain about the presence of acetaminophen in other medications. Furthermore, this product should not be used by individuals who are allergic to acetaminophen or any of the inactive ingredients.

Patients are advised to stop use and consult a doctor if symptoms do not improve, new symptoms arise, pain worsens or lasts more than 5 days, fever intensifies or lasts more than 3 days, or if redness or swelling occurs, as these may indicate a serious condition.

In the case of an overdose, it is imperative to seek medical help or contact a Poison Control Center immediately, as prompt medical attention is critical for both adults and children, even in the absence of noticeable signs or symptoms.

Drug Interactions

Acetaminophen has been shown to enhance the anticoagulant effects of warfarin, which may result in an elevated risk of bleeding complications. When these two agents are co-administered, it is recommended to closely monitor the International Normalized Ratio (INR) to ensure safe therapeutic levels are maintained. Adjustments to the warfarin dosage may be necessary based on INR results to mitigate the risk of adverse effects.

Packaging & NDC

Below are the non-prescription pack sizes of Childrens 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 weighing 24 to 35 lb, the recommended dose is 5 mL. For those aged 4 to 5 years weighing 36 to 47 lb, the dose increases to 7.5 mL. Children aged 6 to 8 years weighing 48 to 59 lb should receive 10 mL, while those aged 9 to 10 years weighing 60 to 71 lb may take 12.5 mL. For children aged 11 years weighing 72 to 95 lb, the dose is 15 mL.

Severe liver damage may occur if a child takes more than 5 doses in 24 hours or uses other medications containing acetaminophen. Acetaminophen may also cause severe skin reactions, including skin reddening, blisters, or rash; if any of these symptoms occur, use should be stopped immediately, and medical help should be sought. Parents should be aware that if a sore throat is severe, persistent for more than 2 days, or accompanied by fever, headache, nausea, rash, or vomiting, a doctor should be consulted promptly.

This product should not be used with any other drug containing acetaminophen, and it is contraindicated in children with known allergies to acetaminophen or any inactive ingredients in the formulation. Before use, consultation with a doctor is advised if the child has liver disease or is taking the blood-thinning medication warfarin.

Parents should discontinue use and consult a doctor if symptoms do not improve, new symptoms arise, pain worsens or lasts more than 5 days, fever worsens or lasts more than 3 days, or if redness or swelling is present. In the event of an overdose, immediate medical attention or contact with a Poison Control Center is critical, even if no signs or symptoms are observed.

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

There is no specific information available regarding the use of this medication during pregnancy, including safety concerns, dosage modifications, or special precautions. Healthcare professionals should consider the lack of data when prescribing this medication to pregnant patients. It is advisable to weigh the potential benefits against any unknown risks to fetal outcomes. Women of childbearing potential should be counseled on the importance of effective contraception during treatment and the need to inform their healthcare provider if they become pregnant or plan to become pregnant while using this medication.

Lactation

There are no specific warnings or recommendations regarding the use of this product by 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 should consult a healthcare professional prior to use, particularly if there is a history of liver disease. Additionally, it is advisable for patients to seek guidance from a doctor or pharmacist if they are concurrently taking the anticoagulant warfarin. Monitoring and appropriate dosing adjustments may be necessary to ensure safety and efficacy in this population.

Hepatic Impairment

Patients with hepatic impairment should consult a healthcare professional prior to use, particularly if they have a history of liver disease. It is essential to evaluate liver function and consider potential adjustments in dosage or monitoring requirements based on the severity of the impairment. Careful assessment and ongoing monitoring may be necessary to ensure the safe and effective use of the medication in this population.

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 observable signs or symptoms.

Healthcare professionals should be aware that the lack of immediate symptoms does not preclude the potential for serious health consequences. Therefore, vigilance and timely action are essential in managing overdose situations effectively.

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 keep this medication out of reach of children to prevent accidental ingestion. It is crucial to inform patients not to use this product in conjunction with any other medications containing acetaminophen, whether prescription or nonprescription. If patients are uncertain about the presence of acetaminophen in other medications, they should be encouraged to consult a doctor or pharmacist for clarification.

Patients should be cautioned against using this product if their child has a known allergy to acetaminophen or any of the inactive ingredients included in the formulation. Additionally, healthcare providers should recommend that patients seek medical advice before using this product if their child has liver disease.

It is important for patients to consult a doctor or pharmacist prior to use if their child is currently taking the blood-thinning medication warfarin. Providers should emphasize the necessity of adhering to the recommended dosage and inform patients about the risks associated with exceeding this dosage, including the potential for overdose.

Patients should be instructed to discontinue use and consult a doctor if symptoms do not improve, if new symptoms arise, or if pain worsens or persists for more than five days. Similarly, they should seek medical advice if a fever worsens or lasts longer than three days. Patients should also be advised to stop use and contact a doctor if any redness or swelling occurs, as these may indicate a serious underlying condition.

Storage and Handling

The product is supplied in various package configurations, with specific NDC numbers available upon request. It should be stored at a temperature range of 20°C to 25°C (68°F to 77°F), in accordance with USP Controlled Room Temperature guidelines. It is essential to protect the product from freezing to maintain its integrity and efficacy. Proper handling and storage conditions must be adhered to in order to ensure optimal product performance.

Additional Clinical Information

No further data are available.

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)