Acetaminophen

Description

ONCOR PHARMACEUTICALS offers a pediatric formulation of acetaminophen for pain and fever relief. This liquid preparation contains 160 mg of acetaminophen per 5 mL and is available in two sizes: 4 fl. oz. (118 mL) and 16 fl. oz. (473 mL). The product is alcohol-free, sugar-free, aspirin-free, and ibuprofen-free, with a cherry flavor for palatability. The National Drug Code (NDC) for this formulation is 83720-500-16.

Uses and Indications

This drug is indicated for the temporary relief of minor aches and pains associated with the common cold, flu, sore throat, headache, and toothache. Additionally, it is utilized to reduce fever.

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

Dosage and Administration

The enclosed dosing cup designed for use with this product must be utilized for accurate measurement. When determining the appropriate dose, weight should be used whenever possible; if weight is not available, age may be used as a guide.

Dosing recommendations are as follows:

• For patients weighing under 24 lbs. or under 2 years of age, consultation with a doctor is required prior to administration.

• For patients weighing 24 to 35 lbs. (ages 2 to under 4 years), the recommended dose is 5 mL (1 teaspoon).

• For patients weighing 36 to 47 lbs. (ages 4 to under 6 years), the recommended dose is 7.5 mL (1.5 teaspoons).

• For patients weighing 48 to 59 lbs. (ages 6 to under 9 years), the recommended dose is 10 mL (2 teaspoons).

• For patients weighing 60 to 71 lbs. (ages 9 to under 11 years), the recommended dose is 12.5 mL (2.5 teaspoons).

• For patients weighing 72 to 95 lbs. (ages 11 to under 12 years), the recommended dose is 15 mL (3 teaspoons).

Dosing may be repeated every 4 hours as needed while symptoms persist, up to a maximum of five times per day, or as directed by a healthcare professional.

Contraindications

There are no specific contraindications associated with this product. However, it is essential to keep the product out of reach of children to prevent accidental ingestion. In the event of an overdose, immediate medical assistance should be sought, or contact a Poison Control Center for guidance.

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 when this product is used in conjunction with other medications containing acetaminophen, as this can further increase the risk of liver injury.

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

Healthcare professionals should also 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, a prompt consultation with a physician is recommended.

It is crucial to avoid the concurrent use of this product with any other medications that contain acetaminophen, whether prescription or nonprescription. If there is uncertainty regarding the presence of acetaminophen in other medications, consultation with a doctor or pharmacist is advised.

Before administering this product, healthcare providers should inquire about any existing liver disease in the patient. Additionally, it is recommended to consult a doctor or pharmacist if the patient is currently taking the anticoagulant warfarin.

Patients should be instructed to discontinue use and seek medical advice if any of the following occur: pain worsens or persists beyond five days, fever worsens or lasts more than three days, redness or swelling is observed, or any new symptoms develop. These signs may indicate a serious underlying condition.

In cases of overdose, immediate medical attention is essential. Healthcare professionals should advise patients to 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 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 with liver disease should consult a doctor before use. Additionally, patients taking the blood-thinning medication warfarin should seek advice from a healthcare professional prior to using this product.

There is a risk of severe skin reactions associated with acetaminophen. Symptoms may include skin reddening, blisters, and rash. If any of these symptoms occur, patients should discontinue use immediately and seek medical assistance.

Patients experiencing a sore throat that is severe, persists for more than 2 days, or is accompanied by fever, headache, rash, nausea, or vomiting should consult a doctor promptly.

It is advised that patients do not use this product in conjunction with any other drug containing acetaminophen, whether prescription or nonprescription. If there is uncertainty regarding the presence of acetaminophen in another medication, patients should consult a doctor or pharmacist.

Patients should also discontinue use and seek medical advice if pain worsens or lasts more than 5 days, if fever worsens or lasts more than 3 days, if redness or swelling is present, or if any new symptoms appear, as these may indicate a serious condition.

Drug Interactions

Co-administration of this medication with any other drug containing acetaminophen, whether prescription or nonprescription, is contraindicated due to the risk of acetaminophen overdose, which can lead to severe liver damage.

In pediatric patients, it is advisable to consult a healthcare professional, such as a doctor or pharmacist, prior to use if the child is concurrently taking warfarin, a blood-thinning agent. This is important to ensure appropriate monitoring and to mitigate the risk of potential interactions that may affect coagulation parameters.

Packaging & NDC

Below are the non-prescription pack sizes of Acetaminophen. Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients under 2 years of age (weighing less than 24 lbs) should consult a doctor before use. For children aged 2 to under 4 years (weighing 24 to 35 lbs), the recommended dosage is 5 mL (1 tsp). For those aged 4 to under 6 years (weighing 36 to 47 lbs), the dosage increases to 7.5 mL (1 1/2 tsp). Children aged 6 to under 9 years (weighing 48 to 59 lbs) should receive 10 mL (2 tsp), while those aged 9 to under 11 years (weighing 60 to 71 lbs) may take 12.5 mL (2 1/2 tsp). For children aged 11 to under 12 years (weighing 72 to 95 lbs), the dosage is 15 mL (3 tsp).

The maximum daily amount should not exceed 5 doses within a 24-hour period. Caution is advised, as severe liver damage may occur if the maximum daily amount is exceeded or if the child is taking other medications containing acetaminophen. Parents or caregivers should consult a doctor before use if the child has liver disease or is taking the blood-thinning medication warfarin. Additionally, if pain worsens or persists for more than 5 days, if fever worsens or lasts more than 3 days, or if any new symptoms appear, use should be discontinued and a doctor should be consulted.

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 acetaminophen during pregnancy. Consequently, healthcare professionals should exercise caution when recommending acetaminophen to pregnant patients. There are no documented safety concerns, dosage modifications, or special precautions outlined for its use in this population. Given the lack of detailed 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

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

Renal Impairment

Patients with renal impairment have not been specifically addressed in the available data regarding dosage adjustments, special monitoring, or safety considerations. Therefore, healthcare professionals should exercise caution when prescribing this medication to patients with reduced kidney function, as the lack of information necessitates careful clinical judgment and monitoring.

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 assess liver function and consider potential adjustments in dosage or monitoring requirements based on the severity of the impairment. Close monitoring of liver function tests may be warranted to ensure safety and efficacy in this patient 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 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 immediate symptoms does not preclude the potential for serious health consequences. Therefore, it is essential to monitor the patient closely and provide appropriate medical care as needed.

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 these contexts.

Postmarketing Experience

Reports of side effects associated with the use of the product have been received through voluntary submissions and surveillance programs. Healthcare professionals and patients are encouraged to report any adverse events to Oncor Pharmaceuticals at 1-443-876-7600, available from 9 a.m. to 5 p.m. EST, or to the FDA at 1-800-FDA-1088.

Patient Counseling

Healthcare providers should advise patients to keep the medication out of reach of children to prevent accidental ingestion. It is essential to emphasize the importance of seeking immediate medical assistance or contacting a Poison Control Center in the event of an overdose. Patients should be informed that prompt medical attention is critical for both adults and children, even if they do not exhibit any signs or symptoms of overdose. This proactive approach can help ensure the safety and well-being of all patients.

Storage and Handling

Dispensed product should be provided in a tight, light-resistant container equipped with a child-resistant cap.

Storage conditions require maintaining a temperature range of 20°C to 25°C (68°F to 77°F), with permissible excursions between 15°C and 30°C (59°F and 86°F). Proper handling and storage are essential to ensure the integrity and efficacy of the product.

Additional Clinical Information

The medication is administered orally, with the dose potentially repeatable every 4 hours while symptoms persist, up to a maximum of five times a day or as directed by a healthcare professional.

Clinicians should counsel patients to keep the medication out of reach of children. In the event of an overdose, it is crucial to seek medical assistance or contact a Poison Control Center immediately, as 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 Acetaminophen, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)