Acetaminophen

Description

Acetaminophen Oral Solution USP is formulated to provide effective pain relief and fever reduction. Each 5 mL dose contains 160 mg of acetaminophen. This solution is sugar-free, alcohol-free, and aspirin-free, making it suitable for a wide range of patients. The product is presented in a cherry flavor for palatability. The total volume of the solution is 16 fl. oz. (473 mL). The National Drug Code (NDC) for this formulation is 57237-304-16.

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, arthritis, the common cold, toothache, and menstrual cramps. Additionally, it is indicated for the reduction of fever.

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

Dosage and Administration

Adults and children 12 years of age and older are advised to take 2 teaspoonfuls (10 mL) every 6 hours as needed. The maximum dosage should not exceed 8 teaspoonfuls (40 mL) within a 24-hour period.

For children under 12 years of age, administration should occur only under the direct guidance of a licensed healthcare professional, such as a doctor or pharmacist. It is essential to follow the specific recommendations provided by the healthcare provider regarding dosage and frequency for this age group.

Contraindications

Use of this product is contraindicated in the following situations:

Patients should not use this product in conjunction with any other medication 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.

This product is contraindicated in individuals with a known allergy to acetaminophen or any of the inactive ingredients contained in the formulation.

Additionally, the product should not be used for pain relief for more than 10 days or for fever for more than 3 days unless directed by a healthcare provider.

Warnings and Precautions

Severe liver damage may occur with the use of this product, which contains acetaminophen. Healthcare professionals should advise patients that the risk of liver injury increases significantly if they exceed the maximum daily dosage of 8 teaspoonfuls (40 mL) within a 24-hour period, use other medications containing acetaminophen concurrently, or consume three or more alcoholic beverages daily while taking this product.

Patients should be informed of the potential for severe skin reactions associated with acetaminophen. Symptoms may include skin reddening, blisters, and rash. In the event of any skin reaction, patients must discontinue use immediately and seek medical assistance.

It is essential for patients to consult a healthcare provider prior to using this product if they have any underlying health conditions, particularly liver disease. Additionally, patients should be advised to discuss their current medication regimen with a doctor or pharmacist, especially if they are taking anticoagulants such as warfarin.

In cases of overdose, immediate medical attention is crucial. Patients should be instructed to contact a Poison Control Center or seek emergency medical help without delay, even if they do not exhibit any signs or symptoms of overdose.

Patients should also be advised to discontinue use and contact their healthcare provider if they experience new symptoms such as rash, hives, itching, or hoarseness; if redness or swelling occurs; if pain worsens or persists for more than 10 days; if fever intensifies or lasts longer than 3 days; or if symptoms do not improve. These may indicate a serious condition requiring further evaluation.

Side Effects

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

Severe liver damage is a significant concern, particularly in patients who exceed the maximum daily dosage of 8 teaspoonfuls (40 mL) within a 24-hour period, use other medications containing acetaminophen concurrently, or consume three or more alcoholic drinks daily while using this product.

Additionally, acetaminophen may lead to severe skin reactions, which can manifest as skin reddening, blisters, or rash. In the event of a skin reaction, patients are advised to discontinue use immediately and seek medical assistance.

Patients should also be vigilant for new symptoms that may arise during treatment. These include rash, hives, itching, or hoarseness, as well as any redness or swelling. If pain persists or worsens beyond 10 days, or if fever intensifies or lasts longer than 3 days, patients should consult a healthcare professional. The presence of these symptoms may indicate a serious condition, warranting further evaluation.

Drug Interactions

Patients should consult a healthcare professional prior to using this medication if they are concurrently taking other drugs, particularly anticoagulants such as warfarin. The combination may increase the risk of bleeding, necessitating careful monitoring of coagulation parameters.

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. If there is uncertainty regarding the presence of acetaminophen in other medications, patients are advised 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 under 12 years of age should use this medication only under the direct guidance of a licensed healthcare professional, such as a doctor or pharmacist.

For adolescents aged 12 years and older, the recommended dosage is 2 teaspoonfuls (10 mL) every 6 hours, with a maximum of 8 teaspoonfuls (40 mL) within a 24-hour period. Careful adherence to these dosing guidelines is essential to ensure safety and efficacy in this age group.

Geriatric Use

Elderly patients may not have specific information regarding the use of this medication, including dosage adjustments, safety concerns, or special precautions. Therefore, healthcare providers should exercise caution when prescribing this medication to geriatric patients. It is advisable to monitor these patients closely for any potential adverse effects or changes in efficacy, given the lack of targeted data for 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 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 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 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 be aware that this product contains acetaminophen, which carries a risk of severe liver damage. It is crucial for patients to adhere to the following guidelines to minimize the risk of hepatotoxicity.

The maximum recommended dosage is 8 teaspoonfuls (40 mL) within a 24-hour period. Exceeding this dosage can lead to severe liver damage. Additionally, patients should avoid concomitant use of other medications containing acetaminophen, as this can further increase the risk of liver injury.

Patients with compromised liver function are also advised to limit alcohol consumption. Specifically, the intake of three or more alcoholic drinks per day while using this product may significantly heighten the risk of liver damage.

Before using this product, patients with any health issues, particularly those related to liver disease, should consult a healthcare professional for guidance. Monitoring of liver function may be warranted in these patients to ensure safety and efficacy.

Overdosage

In the event of an overdose, it is imperative to seek immediate medical assistance or contact a Poison Control Center without delay. Prompt medical attention is crucial, even in the absence of noticeable signs or symptoms. Healthcare professionals should be aware that early intervention can significantly impact patient outcomes in cases of overdosage.

Monitoring and supportive care may be necessary, depending on the specific circumstances and the substance involved. It is essential to assess the patient's condition thoroughly and provide appropriate management based on clinical guidelines and the nature of the overdose.

Nonclinical Toxicology

If pregnant or breastfeeding, it is advised to consult a health professional prior to use. Acetaminophen has been associated with severe skin reactions, which may manifest as skin reddening, blisters, or rash.

No specific information regarding nonclinical toxicology or animal pharmacology and toxicology is provided in the insert.

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 immediately and seek medical assistance.

Patient Counseling

Healthcare providers should advise patients to keep this medication out of reach of children to prevent accidental ingestion. In the event of an overdose, it is crucial for patients to seek medical help or contact a Poison Control Center immediately, as prompt medical attention is essential even if no signs or symptoms are present.

Patients should be informed not to use this medication in conjunction with any other drug containing 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 also be cautioned against using this medication if they have a known allergy to acetaminophen or any of the inactive ingredients in the product.

Patients should be advised to discontinue use and consult a doctor if they experience new symptoms such as rash, hives, itching, or hoarseness. Additionally, they should stop use and seek medical advice if they notice redness or swelling, if their pain worsens or persists beyond 10 days, if their fever worsens or lasts more than 3 days, or if their symptoms do not improve, as these may indicate a serious condition.

Healthcare providers should recommend that patients ask a doctor before using this medication if they have any health issues, particularly liver disease. Furthermore, patients should be encouraged to consult a doctor or pharmacist before use if they are taking other medications, including blood thinners such as warfarin.

Storage and Handling

Dispensed product should be provided in a tight, light-resistant container equipped with a child-resistant cap. It is recommended to store the product at 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).

Additional Clinical Information

Patients aged 12 years and older are advised to take 2 teaspoonfuls (10 mL) every 6 hours, with a maximum of 8 teaspoonfuls (40 mL) in a 24-hour period. For children under 12 years of age, administration should occur only under the direct guidance of a licensed professional, doctor, or pharmacist.

Clinicians should counsel patients to consult a health professional if they are pregnant or breastfeeding before use. It is essential to keep the medication out of reach of children. In the event of an overdose, patients should seek medical help or contact a Poison Control Center immediately, as prompt medical attention is critical, even if no signs or symptoms are present.

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)