Acetaminophen

Description

Acetaminophen Oral Solution USP is formulated to provide 160 mg of acetaminophen per 5 mL dose. This solution is alcohol-free and is intended for institutional use only. Each administration delivers a precise volume of 5 mL, ensuring accurate dosing for therapeutic applications.

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, with a maximum of 6 doses within a 24-hour period.

For children aged 6 to under 12 years, the appropriate dose is 10.15 mL (325 mg) every 4 hours, not to exceed 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 allowed 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 limited to 5 doses within a 24-hour period.

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

• In individuals with a known allergy to acetaminophen or any of the inactive ingredients in this formulation.

Additionally, the product should not be used for more than 10 days for pain or more than 3 days for fever unless directed by a healthcare professional. Prior to use, consultation with a healthcare provider is advised for patients with liver disease or those taking the anticoagulant warfarin.

Warnings and Precautions

Severe liver damage may occur with the use of this product, which contains acetaminophen. 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, caution is warranted if this product is taken concurrently with other medications containing acetaminophen or if the adult consumes 3 or more alcoholic drinks daily while using this product.

Acetaminophen has been associated with severe skin reactions. Symptoms may include skin reddening, blisters, and rash. If any of these reactions occur, patients should be instructed 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, rash, nausea, or vomiting, patients should be advised to consult a healthcare provider promptly.

General precautions include advising patients to consult a doctor prior to use if they have liver disease. Additionally, patients taking the anticoagulant warfarin should seek guidance from a healthcare professional or pharmacist before using this product.

In the event of an overdose, immediate medical attention is critical. Patients should be instructed to contact a Poison Control Center at 1-800-222-1222 or seek emergency medical help, even if no signs or symptoms are apparent.

Patients should also be advised to stop taking the product and contact their healthcare provider if symptoms do not improve, new symptoms arise, or if pain or fever persists or worsens.

Side Effects

Severe liver damage may occur in patients taking this product containing acetaminophen if they exceed the maximum daily dosage of 6 doses in 24 hours for adults or 5 doses for children. The risk of liver damage is heightened when acetaminophen is taken in conjunction with other medications containing acetaminophen or when an adult consumes 3 or more alcoholic drinks daily while using this product.

Patients should be aware of the potential for severe skin reactions associated with acetaminophen, which may manifest as skin reddening, blisters, or rash. In the event of a skin reaction, it is imperative to discontinue use and seek medical assistance immediately.

A sore throat warning is also applicable; if a sore throat is severe, persists for more than 2 days, or is accompanied by fever, headache, rash, nausea, or vomiting, patients should consult a healthcare professional promptly.

Patients are advised against using this product in conjunction with any other drug containing acetaminophen, whether prescription or nonprescription. It is crucial to verify the presence of acetaminophen in any other medications being taken. Additionally, the product should not be used for more than 10 days for pain or more than 3 days for fever unless directed by a healthcare provider. Individuals with a known allergy to acetaminophen or any inactive ingredients in this product should refrain from its use.

Patients should discontinue use and consult a doctor if symptoms do not improve, if new symptoms arise, or if pain or fever persists or worsens.

An overdose warning is also pertinent; taking more than the recommended dose may lead to liver damage. In cases of suspected overdose, it is essential 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

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. Co-administration may lead to an increased risk of acetaminophen-related hepatotoxicity. Monitoring for signs of liver damage is advised in patients who may inadvertently exceed the recommended dosage of acetaminophen.

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. In children aged 2 to under 4 years, the dosage is 5 mL (160 mg) every 4 hours, with the same maximum limit of 5 doses in a 24-hour period.

For children under 2 years of age, it is advised to consult a doctor before administration. It is critical to note that exceeding 5 doses in a 24-hour period may result in severe liver damage.

Geriatric Use

Elderly patients should consult a healthcare provider prior to use if they have liver disease, as this may affect the safety and efficacy of the medication. Additionally, it is important for geriatric patients to seek advice from a doctor or pharmacist if they are concurrently taking the anticoagulant warfarin, due to potential interactions that could increase the risk of bleeding.

Caution is advised regarding the risk of overdose, as taking more than the recommended dose may lead to liver damage. In the event of an overdose, it is crucial for elderly patients to seek immediate medical attention or contact a Poison Control Center, even if no signs or symptoms are apparent. Prompt medical intervention is essential for all patients, including the elderly, to mitigate potential health risks associated with overdose.

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 considered in these populations to ensure the safety of both the mother and the fetus or infant.

Lactation

Lactating mothers are advised to consult a health professional prior to using this medication. There is no specific data available regarding the excretion of this medication in 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 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 lack of data necessitates careful clinical judgment.

Hepatic Impairment

Patients with hepatic impairment should consult a healthcare professional prior to use of this product. It is important to note that exceeding the recommended dosage may lead to liver damage. Specifically, adults are at risk of severe liver damage if they consume more than six doses within a 24-hour period, which is the maximum daily limit. For pediatric patients, the threshold for severe liver damage is more than five doses in a 24-hour period.

Additionally, the risk of severe liver damage is heightened when this product is used concurrently with other medications containing acetaminophen. Patients with a history of alcohol consumption should exercise caution, as severe liver damage may occur in adults who consume three or more alcoholic drinks daily while using this product. Monitoring of liver function may be warranted in patients with compromised liver function to mitigate the risk of adverse effects.

Overdosage

Taking more than the recommended dose of this medication may lead to significant liver damage. It is imperative that healthcare professionals remain vigilant regarding the potential for overdose and its serious 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; the national hotline can be reached at 1-800-222-1222. Prompt intervention is crucial, as quick medical attention is essential 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 limits the assessment of potential risks associated with the use of the compound in these contexts.

Postmarketing Experience

Severe skin reactions have been reported in postmarketing experience with acetaminophen. Symptoms associated with these reactions may include skin reddening, blisters, and rash. In the event of a skin reaction, it is advised to discontinue use immediately and seek medical assistance. Additionally, serious side effects can be reported through the designated contact number.

Patient Counseling

Healthcare providers should advise patients about the potential risks associated with overdose, emphasizing that taking more than the recommended dose may lead to liver damage. In the event of an overdose, patients should be instructed to seek medical help immediately or contact a Poison Control Center at 1-800-222-1222, as prompt medical attention is crucial for both adults and children, even if no signs or symptoms are present.

Patients should be encouraged to consult with their healthcare provider before using the medication if they have a history of liver disease. Additionally, it is important to inform patients to discuss their current medications with their doctor or pharmacist, particularly if they are taking the blood-thinning medication warfarin, to avoid potential interactions.

Healthcare providers should instruct patients to discontinue use and seek medical advice if their symptoms do not improve, if new symptoms arise, or if pain or fever persists or worsens. This guidance is essential to ensure patient safety and effective management of their condition.

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 adherence to these storage and handling conditions is vital for maintaining the product's efficacy and safety.

Additional Clinical Information

Patients should be advised to consult a healthcare professional if they are pregnant or breastfeeding prior to use. Clinicians should recommend that patients with liver disease seek medical advice before using the product. Additionally, patients taking the anticoagulant warfarin should consult with a doctor or pharmacist before use. It is important for patients to discontinue use and contact a healthcare provider 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)