Acetaminophen

Description

Acetaminophen is presented as an oral solution, conforming to USP standards. Each 10.15 mL dose contains 325 mg of acetaminophen and is formulated to be alcohol-free. The product should be stored at a temperature range of 20° to 25°C (68° to 77°F), in accordance with USP Controlled Room Temperature guidelines. This formulation is intended for institutional use only.

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 over, the recommended dosage is 20.3 mL (equivalent to 650 mg) administered every 4 to 6 hours as needed. It is important not to exceed 6 doses within a 24-hour period.

For children aged 6 to under 12 years, the appropriate dosage 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 the case of children under 6 years of age, it is advised to consult a healthcare professional for appropriate dosing recommendations.

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; consultation with a healthcare professional is advised 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

Severe liver damage may occur with the use of this product containing acetaminophen. Healthcare professionals should advise patients that the risk of liver damage increases under the following circumstances:

• An adult consumes more than 10 unit dose cups within a 24-hour period, which is the maximum daily amount.

• A child consumes more than 5 unit dose cups within a 24-hour period, which is the maximum daily amount.

• The product is taken concurrently with other medications containing acetaminophen.

• An adult consumes three or more alcoholic drinks daily while using this product.

Acetaminophen may also cause 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.

In the event of an overdose, which may lead to liver damage, it is imperative to seek medical help or contact a Poison Control Center (1-800-222-1222) without delay. Quick medical attention is crucial for both adults and children, even if no signs or symptoms are initially apparent.

Healthcare professionals should advise patients to consult a doctor prior to use if they have a history of liver disease. Additionally, it is recommended that patients taking the anticoagulant warfarin consult with a doctor or pharmacist before using this product.

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

Side Effects

Severe liver damage may occur in patients who exceed the recommended dosage of this product. Specifically, adults should not take more than 10 unit dose cups within a 24-hour period, while children should not exceed 5 unit dose cups in the same timeframe. The risk of liver damage is further heightened when this product is used in conjunction with other medications containing acetaminophen or when consumed by adults who regularly consume three or more alcoholic drinks daily.

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

In cases of severe sore throat that persists for more than two days or is accompanied by fever, headache, rash, nausea, or vomiting, patients are advised to consult a healthcare professional promptly.

Overdose of this product can lead to significant liver damage. Patients who suspect an overdose should seek medical help or contact a Poison Control Center without delay, as rapid medical intervention is crucial for both adults and children, even in the absence of noticeable symptoms.

Patients with liver disease should consult a healthcare provider before using this product. Additionally, individuals taking the blood-thinning medication warfarin should seek advice from a doctor or pharmacist prior to use.

Patients are advised to discontinue use and consult a healthcare professional if symptoms do not improve, if new symptoms arise, or if pain or fever persists or worsens. It is also important to avoid using this product in conjunction with any other medications containing acetaminophen, whether prescription or nonprescription. If there is uncertainty regarding the presence of acetaminophen in other medications, patients should consult a healthcare provider or pharmacist. 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. Finally, individuals with known allergies to acetaminophen or any inactive ingredients in this product should refrain from its use.

Drug Interactions

Patients should consult a healthcare professional, such as a doctor or pharmacist, 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 nonprescription. Co-administration may lead to an increased risk of acetaminophen-related hepatotoxicity. Monitoring for signs of liver damage is advised if acetaminophen is used concurrently.

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 under 6 years of age, it is advised to consult a doctor before administration.

It is important to note that exceeding 5 unit dose cups in a 24-hour period may pose a risk of liver damage. Careful monitoring of dosage is essential to ensure safety in pediatric patients.

Geriatric Use

Elderly patients may not have specific geriatric use information available in the prescribing information. The absence of recommended age considerations, dosage adjustments, safety concerns, or special precautions indicates that the data regarding the use of this medication in geriatric populations is limited.

Healthcare providers should exercise clinical judgment when prescribing this medication to elderly patients, considering individual patient factors and potential age-related physiological changes that may affect drug metabolism and response. Regular monitoring and assessment of therapeutic outcomes are advisable to ensure safety and efficacy 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 on 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 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 exercise caution when using this product, which contains acetaminophen. Severe liver damage may occur if the following conditions are met: an adult consumes more than 10 unit dose cups within a 24-hour period, a child exceeds 5 unit dose cups in the same timeframe, the product is taken concurrently with other medications containing acetaminophen, or an adult consumes three or more alcoholic drinks daily while using this product.

It is imperative that patients with liver disease consult a healthcare professional prior to using this product. The risk of liver damage increases significantly with any overdose, which is defined as taking more than the recommended dose. In the event of an overdose, immediate medical assistance should be sought, or a Poison Control Center should be contacted without delay. Prompt medical attention is crucial for both adults and children, even if no signs or symptoms of overdose are apparent.

Overdosage

Overdosage may result in significant liver damage, particularly when the recommended dosage is exceeded. It is imperative that healthcare professionals remain vigilant regarding the potential consequences of overdose.

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 rapid medical attention is essential for both adults and children, even in the absence of noticeable signs or symptoms.

Monitoring and management of the patient should be initiated as soon as possible to mitigate the risk of severe complications associated with liver damage.

Nonclinical Toxicology

If pregnant or breast-feeding, it is advised to consult a health professional before use. No specific non-teratogenic effects have been identified in the available data. Additionally, there are no detailed findings regarding nonclinical toxicology or animal pharmacology and toxicology provided in the current information.

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 to keep this medication out of reach of children to prevent accidental ingestion. Patients should be informed not to use this product in conjunction with any other medications that contain acetaminophen, whether prescription or nonprescription. If patients are uncertain whether a drug contains acetaminophen, they should be encouraged to consult a doctor or pharmacist for clarification.

It is important to instruct patients 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. 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 included in the formulation.

Patients should be counseled to stop using the medication and seek medical advice if their symptoms do not improve, if new symptoms arise, or if pain or fever persists or worsens. Additionally, patients should be advised to consult a doctor before using this medication if they have liver disease. If patients are taking the blood-thinning medication warfarin, they should be encouraged to speak with a doctor or pharmacist prior to use.

Storage and Handling

The product is supplied in accordance with the National Drug Code (NDC) specifications. It should be stored at a temperature range of 20° to 25°C (68° to 77°F), adhering to the guidelines set forth by the United States Pharmacopeia (USP) for Controlled Room Temperature. It is essential to protect the product from light to maintain its integrity and efficacy.

Additional Clinical Information

The medication is administered orally. Clinicians should counsel patients to consult a healthcare professional if they are pregnant or breastfeeding prior to use. Additionally, patients with liver disease or those taking the blood-thinning medication warfarin should seek medical advice before using this product. 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)