Acetaminophen

Description

Acetaminophen Oral Solution USP is formulated to deliver 650 mg of acetaminophen per 20.3 mL. The product is packaged in a container that holds 5 cups. The National Drug Code (NDC) for this formulation is 55154-9449-5.

Uses and Indications

This drug is indicated for the temporary relief of minor aches and pains associated with various conditions, including headache, muscular aches, backache, minor pain of arthritis, the common cold, toothache, and premenstrual and menstrual cramps. Additionally, it is indicated for the temporary reduction of fever.

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

Dosage and Administration

For adults and children aged 12 years and older, the recommended dose is 20.3 mL (equivalent to 650 mg) administered every 4 to 6 hours as needed. The total daily dosage should not exceed 6 doses within a 24-hour period.

For children aged 6 to under 12 years, the appropriate dose is 10.15 mL (325 mg) given every 4 hours. The maximum allowable dosage for this age group is 5 doses in a 24-hour period.

In children aged 4 to under 6 years, the dosage is 7.5 mL (240 mg) every 4 hours, with a maximum of 5 doses permitted in a 24-hour period.

For children aged 2 to under 4 years, the recommended dose is 5 mL (160 mg) every 4 hours, also not to exceed 5 doses in a 24-hour period.

For children under 2 years of age, it is advised to consult a doctor before administration.

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.

• Known allergy to acetaminophen or any of the inactive ingredients in this product, as this may lead to severe allergic reactions.

• Uncertainty regarding the presence of acetaminophen in other medications; patients should consult a healthcare professional before use.

• Use beyond 10 days for pain or 3 days for fever is contraindicated unless directed by a healthcare provider, to prevent potential adverse effects.

Warnings and Precautions

This product contains acetaminophen, which poses a risk of severe liver damage under certain conditions. Healthcare professionals should advise patients that adults must not exceed 6 doses within a 24-hour period, while children should not take more than 5 doses in the same timeframe. Additionally, the risk of liver damage increases if acetaminophen is taken concurrently with other medications containing acetaminophen or if an adult consumes 3 or more alcoholic beverages daily while using this product.

Allergy Alert Acetaminophen may lead to severe skin reactions, which can manifest as skin reddening, blisters, or rash. If any of these symptoms occur, patients should be instructed to discontinue use immediately and seek medical assistance.

Sore Throat Warning Patients experiencing a severe sore throat that persists for more than 2 days, or is accompanied by fever, headache, rash, nausea, or vomiting, should be advised to consult a physician without delay.

Overdose Warning Healthcare providers must emphasize that exceeding the recommended dosage can result in liver damage. In the event of an overdose, immediate medical attention is crucial. Patients should be directed to contact a Poison Control Center at 1-800-222-1222, even if no symptoms are apparent.

Discontinuation of Use Patients should be instructed to stop using the product and consult a healthcare professional if symptoms do not improve, if new symptoms arise, or if pain or fever persists or worsens.

Pre-existing Conditions Before using this product, patients with liver disease should seek medical advice. Additionally, those taking the anticoagulant warfarin should consult a doctor or pharmacist prior to use to avoid potential interactions.

Emergency Medical Help In cases of overdose, it is imperative to obtain emergency medical help or contact a Poison Control Center immediately at 1-800-222-1222. Quick intervention is essential for both adults and children.

Side Effects

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

Severe liver damage may occur if an adult takes more than 6 doses in a 24-hour period, which is the maximum daily amount, or if a child takes more than 5 doses in the same timeframe. The risk of liver damage is also heightened when this product is taken in conjunction with other medications containing acetaminophen or if the adult consumes 3 or more alcoholic drinks daily while using this product.

Additionally, acetaminophen may cause severe skin reactions, which can manifest as skin reddening, blisters, or rash. If any of these symptoms occur, patients are advised to discontinue use immediately and seek medical assistance.

Overdose is another critical concern; taking more than the recommended dose can lead to liver damage. In the event of an overdose, it is imperative to seek medical help or contact a Poison Control Center without delay, as prompt medical attention is crucial for both adults and children, even if no signs or symptoms are immediately apparent.

Patients should stop using the product and consult a healthcare professional if symptoms do not improve, if new symptoms arise, or if pain or fever persists or worsens.

Before using this product, individuals with liver disease or those taking the blood-thinning medication warfarin should consult a doctor to ensure safe use.

Drug Interactions

Patients taking warfarin, a blood-thinning medication, should consult a healthcare professional prior to using this product. The interaction between this product and warfarin may necessitate careful monitoring of coagulation parameters to ensure therapeutic efficacy and minimize the risk of adverse effects. Adjustments to the dosage of either medication may be required based on clinical judgment and patient response.

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 6 to under 12 years may receive a dosage of 10.15 mL (325 mg) every 4 hours, with a maximum of 5 doses in a 24-hour period. For children aged 4 to under 6 years, the recommended dosage is 7.5 mL (240 mg) every 4 hours, also not to exceed 5 doses in a 24-hour period. Children aged 2 to under 4 years should be administered 5 mL (160 mg) every 4 hours, with the same maximum dosing limit.

For children under 2 years of age, it is advised to consult a doctor before administration.

Healthcare professionals should be aware of the overdose warning, emphasizing the importance of seeking quick medical attention for both adults and children, even in the absence of noticeable signs or symptoms.

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. Monitoring for potential adverse effects and therapeutic efficacy is recommended in this population.

Pregnancy

Pregnant patients and those who are breastfeeding should consult a healthcare professional prior to using this medication. The potential risks and benefits must be carefully weighed, as the effects on fetal outcomes and lactation are not fully established. It is essential for women of childbearing potential to seek medical advice to ensure safe use during pregnancy and lactation.

Lactation

Lactating mothers are advised to consult a health professional prior to using this medication. There is currently no available data regarding the excretion of this medication in human breast milk or its effects on breastfed infants. Therefore, caution is recommended when administering this medication to lactating individuals.

Renal Impairment

Patients with renal impairment have not been specifically addressed in the drug insert text regarding dosage adjustments, special monitoring, or safety considerations. 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. Regular monitoring of renal function may be advisable in these patients to ensure safety and efficacy.

Hepatic Impairment

Patients with hepatic impairment should consult a healthcare professional prior to using this product. Due to the presence of acetaminophen, there is a significant risk of severe liver damage under certain conditions. Specifically, adults should not exceed six doses within a 24-hour period, which constitutes the maximum daily amount. For children, the maximum is five doses in the same timeframe.

Additionally, caution is advised if this product is used concurrently with other medications containing acetaminophen, as this may increase the risk of liver injury. Patients who consume three or more alcoholic drinks daily should also exercise caution when using this product, as the combination may exacerbate the potential for liver damage.

In the event of an overdose, which is defined as taking more than the recommended dose, immediate medical assistance should be sought. It is crucial to contact a healthcare provider or a Poison Control Center without delay, as prompt medical attention is essential for both adults and children, even in the absence of noticeable symptoms.

Overdosage

Taking more than the recommended dose of this medication may lead to liver damage. It is essential for healthcare professionals to recognize the seriousness of an overdose and the potential for significant health consequences.

In the event of an overdose, immediate medical assistance should be sought. Healthcare providers are advised to contact a Poison Control Center without delay, utilizing the national hotline at 1-800-222-1222. Prompt intervention is crucial, as quick medical attention is necessary for both adults and children, even in the absence of noticeable signs or symptoms of overdose.

Monitoring and management of the patient should be initiated as soon as possible to mitigate the risk of severe liver injury and to ensure appropriate care is provided.

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 in these areas limits the understanding of the compound's safety profile in nonclinical settings.

Postmarketing Experience

There have been reports of severe skin reactions associated with acetaminophen use, including symptoms such as skin reddening, blisters, and rash. These events have been documented through voluntary reporting and surveillance programs.

Patient Counseling

Healthcare providers should advise patients to keep this medication out of reach of children to prevent accidental ingestion. It is important to inform patients that they should not use this product in conjunction with any other medication that contains acetaminophen, whether prescription or nonprescription. If patients are uncertain whether a drug contains acetaminophen, they should be encouraged to consult with a doctor or pharmacist before use.

Patients should be instructed not to use this medication for more than 10 days for pain or more than 3 days for fever unless directed by a healthcare professional. Additionally, patients should be made aware that they should not use this product if they have a known allergy to acetaminophen or any of the inactive ingredients contained in the formulation.

Healthcare providers should emphasize the importance of discontinuing use and seeking medical advice if symptoms do not improve, if new symptoms arise, or if pain or fever persists or worsens. It is also crucial to advise patients to consult a doctor before using this medication if they have liver disease. Furthermore, patients taking the blood-thinning medication warfarin should be encouraged to speak with a doctor or pharmacist prior to using this product.

Storage and Handling

The product is supplied in a configuration that includes specific NDC numbers, which are essential for identification and inventory management. It is crucial to store the product at a temperature range of 20° to 25°C (68° to 77°F), in accordance with USP Controlled Room Temperature guidelines.

To ensure the integrity of the product, it must be kept tightly closed and protected from light exposure. Proper handling and storage conditions are vital to maintain the product's efficacy and safety.

Additional Clinical Information

The medication is administered orally. Clinicians should counsel patients to consult a health professional if they are pregnant or breastfeeding. Additionally, patients with liver disease or those taking the blood-thinning medication warfarin should seek medical advice before use. Patients are advised to discontinue use and consult a doctor if symptoms do not improve, if new symptoms arise, or if pain or fever persists or worsens.

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)