Acetaminophen

Description

Acetaminophen Oral Solution USP is formulated to contain 160 mg of acetaminophen per 5 mL. This solution is alcohol-free and is provided in a package that is not child-resistant. It is manufactured by Pharmaceutical Associates, Inc., located in Greenville, SC 29605.

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 dosage 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 dosage 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 appropriate dose 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 dosage is 5 mL (160 mg) every 4 hours, also limited to 5 doses in a 24-hour period.

For children under 2 years of age, it is advised to consult a doctor for appropriate dosing recommendations.

Contraindications

Use of this product is contraindicated in the following situations:

The product should not be used in conjunction with any other medication containing acetaminophen, whether prescription or nonprescription, due to the risk of acetaminophen overdose. Additionally, individuals with a known allergy to acetaminophen or any of the inactive ingredients in this formulation should avoid its use.

Patients who are uncertain whether a drug contains acetaminophen are advised to consult a healthcare professional before use. Furthermore, the product should not be used for more than 10 days for pain or more than 3 days for fever unless directed by a physician.

Warnings and Precautions

This product contains acetaminophen, which poses a significant 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 concurrent use of other medications containing acetaminophen can increase the risk of liver damage. Patients who consume 3 or more alcoholic beverages daily should be cautioned against using this product, as this can further exacerbate the risk of liver injury.

Acetaminophen may also trigger severe skin reactions, which can manifest as skin reddening, blisters, or rash. In the event of any skin reaction, patients must be instructed to discontinue use immediately and seek medical assistance.

Healthcare providers should be vigilant regarding patients presenting with a sore throat. If the sore throat is severe, persists for more than 2 days, or is accompanied by fever, headache, rash, nausea, or vomiting, prompt medical consultation is warranted.

Overdose of acetaminophen can lead to liver damage. In cases of suspected overdose, immediate medical attention is essential. Patients should be advised to contact a Poison Control Center (1-800-222-1222) without delay, even if no symptoms are apparent, as timely intervention is critical for both adults and children.

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.

Before initiating treatment with this product, it is crucial for healthcare providers to inquire about any existing liver disease in the patient. Additionally, patients taking the anticoagulant warfarin should consult with their doctor or pharmacist prior to use, as there may be potential interactions.

In the event of a severe skin reaction, patients must be advised to stop using the product and seek emergency medical help immediately.

Side Effects

Severe liver damage may occur in patients who exceed the recommended dosage of this product. Specifically, adults should not take more than 6 doses in a 24-hour period, while children should not exceed 5 doses within the same timeframe. The risk of liver damage is further heightened if the 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.

Patients should be aware of the potential for severe skin reactions associated with acetaminophen. 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 2 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 timely medical intervention is crucial for both adults and children, even in the absence of noticeable symptoms.

Patients are also advised to stop use and consult a doctor if symptoms do not improve, if new symptoms arise, or if pain or fever persists or worsens. It is recommended that individuals with liver disease consult a healthcare provider before using this product. Additionally, patients taking the blood-thinning medication warfarin should seek advice from a doctor or pharmacist prior to use.

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 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 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.

It is important to note that exceeding 5 doses in a 24-hour period may lead to severe liver damage in pediatric patients.

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 advisable for geriatric patients to seek guidance 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 warranted 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 those in the geriatric population, 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, 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 the safety of both the mother and the developing fetus or nursing infant.

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 drug 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 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 absence of detailed guidance 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 be closely monitored when using this product, which contains acetaminophen. It is essential to note that severe liver damage may occur if the maximum daily dosage is exceeded. For adults, this maximum is 6 doses within a 24-hour period, while for children, it is 5 doses. Additionally, the risk of liver damage increases if this product is taken concurrently with other medications containing acetaminophen or if the patient consumes 3 or more alcoholic drinks daily while using this product.

Patients with a history of liver disease are advised to consult a healthcare professional before using this product. In the event of an overdose, which is defined as taking more than the recommended dose, immediate medical attention is crucial. Symptoms of overdose may not be immediately apparent, making it imperative to seek help from a medical professional or contact a Poison Control Center without delay. Quick intervention is critical for both adults and children to mitigate the risk of liver damage.

Overdosage

In the event of an overdose, defined as the administration of a dose exceeding the recommended amount, there is a significant risk of liver damage. This potential complication underscores the importance of prompt medical intervention.

Healthcare professionals are advised to seek immediate medical assistance or contact a Poison Control Center at 1-800-222-1222 without delay. It is crucial to act swiftly, as timely medical attention is essential for both adults and children, even in the absence of observable signs or symptoms of overdose.

Monitoring and management of the patient should be initiated as soon as possible to mitigate the risks associated with overdose 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 and seek medical assistance immediately. Additionally, serious side effects can be reported to the designated contact number: 1-800-845-8210.

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 discontinue use and seek medical advice if their symptoms do not improve, if new symptoms arise, or if pain or fever persists or worsens.

Patients with a known allergy to acetaminophen or any of the inactive ingredients in this product should be advised against its use. Additionally, healthcare providers should recommend that patients consult a doctor before using this medication if they have liver disease. Patients taking the blood-thinning medication warfarin should also be advised to speak with a doctor or pharmacist prior to using this product.

Storage and Handling

The product is supplied in a configuration that ensures optimal preservation of its integrity. It should be stored at a temperature range of 20° to 25°C (68° to 77°F), in accordance with USP Controlled Room Temperature guidelines.

To maintain the quality of the product, it is essential to keep the container tightly closed when not in use. Additionally, the product must be protected from light to prevent any potential degradation. Proper adherence to these storage and handling conditions is crucial for ensuring the efficacy and safety of the product.

Additional Clinical Information

Patients should be advised to consult a health professional if they are pregnant or breastfeeding before using the medication. It is important to keep the product out of reach of children. In the event of an overdose, immediate medical assistance should be sought, or a Poison Control Center should be contacted, as prompt attention is crucial for both adults and children, even in the absence of noticeable signs or symptoms.

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)