Acetaminophen

Description

This product is a children's liquid formulation designed as a pain reliever and fever reducer, containing acetaminophen as the active ingredient at a concentration of 160 mg per 5 mL. It is specifically formulated for children aged 2 to 11 years and is both aspirin-free and alcohol-free. The product is presented in an 8 fluid ounce (237 mL) bottle and features a fruit flavor to enhance palatability. The National Drug Code (NDC) for this formulation is 72091-004-01.

Uses and Indications

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

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

Dosage and Administration

Healthcare professionals should advise patients to adhere strictly to the recommended dosage and not exceed the directed amount. This product does not provide comprehensive directions or warnings for adult use.

For pediatric patients, the appropriate dosage should be determined using the following guidelines, prioritizing weight when possible; otherwise, age may be used as a reference. The dosage may be repeated every 4 hours as needed, or as directed by a physician, with a maximum of 5 doses within a 24-hour period.

The following dosing chart outlines the recommended dosages based on weight and age:

• For patients weighing under 24 lb or under 2 years of age, consultation with a physician is advised.

• For patients weighing 24-36 lb or aged 2-3 years, the recommended dosage is 5 mL.

• For patients weighing 36-47 lb or aged 4-5 years, the recommended dosage is 7.5 mL.

• For patients weighing 48-59 lb or aged 6-8 years, the recommended dosage is 10 mL.

• For patients weighing 60-71 lb or aged 9-10 years, the recommended dosage is 12.5 mL.

• For patients weighing 72-95 lb or aged 11 years, the recommended dosage is 15 mL.

It is important to note that 5 mL is equivalent to 1 teaspoon.

Contraindications

Use of this product is contraindicated in the following situations:

• Co-administration with any other drug containing acetaminophen, whether prescription or nonprescription, 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.

• In patients with a known allergy to acetaminophen or any of the inactive ingredients in this formulation, as this may lead to severe allergic reactions.

• Exceeding the recommended dose is contraindicated, as it may result in serious adverse effects.

Warnings and Precautions

This product contains acetaminophen, which carries specific warnings and precautions that healthcare professionals must communicate to patients and caregivers.

Liver Warning Severe liver damage may occur if the recommended dosage is exceeded. Specifically, it is critical to ensure that children do not take more than 5 doses within a 24-hour period, as this represents the maximum daily amount. Additionally, caution should be exercised when administering this product alongside other medications that contain acetaminophen, as this may increase the risk of liver damage.

Allergy Alert Acetaminophen has the potential to cause severe skin reactions. Symptoms indicative of such reactions may include skin reddening, blisters, or rash. In the event of a skin reaction, it is imperative to discontinue use immediately and seek medical assistance without delay.

Emergency Medical Help In cases of overdose, it is essential to obtain emergency medical help or contact a Poison Control Center immediately. Prompt medical attention is crucial, even if the patient does not exhibit any signs or symptoms of overdose.

Monitoring and Follow-Up Patients should be advised to stop taking the medication and consult a healthcare provider if any of the following occur:

• Pain worsens or persists for more than 5 days.

• Fever worsens or lasts longer than 3 days.

• New symptoms develop.

• Redness or swelling is observed.

These symptoms may indicate a serious underlying condition that requires further evaluation and intervention.

Side Effects

Patients using this product should be aware of potential adverse reactions associated with its use.

Severe liver damage may occur if the maximum daily amount of acetaminophen is exceeded, specifically if more than 5 doses are taken within a 24-hour period or if it is used concurrently with other medications containing acetaminophen. Patients should be vigilant for signs of liver damage and seek medical attention if they experience any concerning symptoms.

Additionally, there is an allergy alert associated with acetaminophen, as it may cause severe skin reactions. Symptoms of such reactions can include skin reddening, blisters, and rash. If any of these symptoms occur, patients should discontinue use immediately and seek medical help.

Patients are advised to stop using the product 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 is observed, as these may indicate a serious condition.

It is also recommended that patients consult a doctor before using this product if they have a history of liver disease. Furthermore, patients taking the blood-thinning medication warfarin should seek advice from a doctor or pharmacist prior to use.

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 aged 2 to 11 years may use this medication with specific dosage recommendations based on weight and age. For children under 2 years, consultation with a healthcare provider is advised. The recommended dosages for children aged 2 to 11 years are as follows: 5 mL for ages 2-3 years, 7.5 mL for ages 4-5 years, 10 mL for ages 6-8 years, 12.5 mL for ages 9-10 years, and 15 mL for age 11 years. It is important not to exceed 5 doses within a 24-hour period.

Healthcare professionals should advise caution if the pediatric patient has liver disease or is taking the anticoagulant warfarin, as these conditions may necessitate further evaluation before use. A liver warning is in place, indicating that severe liver damage may occur if the patient exceeds the recommended dosage or combines this medication with other products containing acetaminophen.

Additionally, there is an allergy alert for acetaminophen, which may lead to severe skin reactions, including symptoms such as skin reddening, blisters, or rash. If any skin reaction occurs, the medication should be discontinued immediately, and medical assistance should be sought.

It is crucial to keep this medication out of reach of children. In the event of an overdose, immediate medical help or contact with a Poison Control Center is essential, even if no signs or symptoms are present.

Geriatric Use

There is no specific information 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, 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. As such, healthcare professionals should exercise caution when recommending this medication to pregnant patients. There are no documented safety concerns, dosage modifications, or special precautions outlined for the use of acetaminophen in this population. Given the lack of information, it is advisable for women of childbearing potential to consult with their healthcare provider before using acetaminophen during pregnancy to ensure that potential risks and benefits are adequately assessed.

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 nursing infants 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

Patients with renal impairment have not been specifically addressed in the available prescribing information. There are no dosage adjustments, special monitoring requirements, or safety considerations outlined for individuals with reduced kidney function. Healthcare professionals should exercise caution and consider the lack of data when prescribing to this patient population.

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 to adhere to the recommended dosage guidelines to minimize this risk. Specifically, patients should not exceed five doses within a 24-hour period, as this represents the maximum daily amount. Additionally, caution is advised when this product is taken concurrently with other medications containing acetaminophen, as this may further increase the risk of liver injury. Regular assessment of liver function may be warranted in patients with compromised liver function to ensure safety and efficacy.

Overdosage

In cases of overdosage, it is critical to recognize the potential for severe liver damage, particularly in pediatric patients. Administration of more than five doses within a 24-hour period, which exceeds the maximum recommended daily amount, poses a significant risk. Additionally, the concomitant use of other medications containing acetaminophen can further exacerbate this risk.

Healthcare professionals should be vigilant in monitoring for symptoms indicative of liver injury, which may include nausea, vomiting, loss of appetite, confusion, jaundice, and abdominal pain. Prompt recognition of these symptoms is essential for effective management.

In the event of suspected overdosage, immediate medical intervention is warranted. It is recommended that healthcare providers initiate supportive care and consider the use of N-acetylcysteine as an antidote, particularly if the overdosage is identified within a critical time frame post-ingestion. Continuous assessment of liver function and supportive measures should be implemented as necessary to mitigate the risk of severe hepatic injury.

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.

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 and seek medical assistance immediately.

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, even if the patient does not exhibit any signs or symptoms of overdose.

Patients should be instructed not to exceed the recommended dose of the medication. This is important to prevent potential adverse effects and ensure safe usage.

Additionally, healthcare providers should encourage patients to consult with a doctor before using the medication if their child has a liver disease. This precaution is essential to avoid complications that may arise from the interaction between the medication and the child's condition.

Furthermore, it is advisable for patients to speak with a doctor or pharmacist prior to use if their child is currently taking the blood-thinning medication warfarin. This discussion is important to assess any potential interactions and ensure the safety of the treatment regimen.

Storage and Handling

The product is supplied in packaging that includes specific NDC numbers. It should be stored at room temperature, within the range of 15° to 30°C (59° to 86°F). Care must be taken to protect the product from freezing and from exposure to light. Additionally, it is imperative that the product is not used if the imprinted seal under the cap is broken or missing, as this may compromise the integrity of the product.

Additional Clinical Information

No further data are available.

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)