Acetaminophen

Description

This product is available in three different National Drug Code (NDC) configurations: 54738-548-01, which contains 100 tablets of acetaminophen (APAP) at a dosage of 325 mg per tablet; 54738-548-03, which includes 1000 tablets of acetaminophen at the same dosage; and 54738-548-50, which offers 50 tablets of acetaminophen, also at 325 mg per tablet. Each tablet is formulated to provide effective pain relief and is manufactured to meet stringent quality standards.

Uses and Indications

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

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

Dosage and Administration

Adults and children aged 12 years and older are advised to take 2 tablets every 4 to 6 hours as needed for symptom relief, with a maximum dosage of 10 tablets within a 24-hour period. Continuous use should not exceed 10 days unless directed by a healthcare professional.

For children aged 6 to 11 years, the recommended dosage is 1 tablet every 4 to 6 hours while symptoms persist, not to exceed 5 tablets in a 24-hour period. This age group should not use the medication for more than 5 days unless instructed by a physician.

In children under 6 years of age, it is recommended to consult a healthcare provider for appropriate dosing guidance.

Contraindications

There are no contraindications listed for this product. However, in the event of an overdose, it is imperative to seek medical assistance or contact a Poison Control Center immediately.

Warnings and Precautions

Severe liver damage may occur with the use of this product, which contains acetaminophen, under the following circumstances: if an adult consumes more than 12 tablets within a 24-hour period, exceeding the maximum daily dosage; if a child consumes more than 5 tablets in a 24-hour period; if the product is taken concurrently with other medications containing acetaminophen; or if an adult consumes three or more alcoholic beverages daily while using this product.

Healthcare professionals are advised to caution patients against using this product in conjunction with any other medications that contain acetaminophen, whether prescription or over-the-counter. If there is uncertainty regarding the presence of acetaminophen in a medication, patients should be directed to consult a doctor or pharmacist. Additionally, it is imperative to seek medical advice prior to use if the patient has a history of liver disease or is currently taking the anticoagulant warfarin.

Patients should be instructed to discontinue use and contact their healthcare provider if any of the following occur: the adult's pain worsens or persists for more than 10 days; the child's pain worsens or lasts longer than 5 days; fever worsens or lasts more than 3 days; there is noticeable redness or swelling; or if any new symptoms develop.

In the event of an overdose, immediate medical assistance should be sought by contacting the Poison Control Center. Prompt medical attention is crucial for both adults and children, even in the absence of noticeable signs or symptoms.

Side Effects

Severe liver damage may occur in patients taking this product containing acetaminophen if the maximum daily dosage is exceeded. For adults, this is defined as more than 12 tablets in a 24-hour period, while for children, it is more than 5 tablets. The risk of liver damage is further increased if the product is taken in conjunction with other medications containing acetaminophen or if the adult consumes three or more alcoholic drinks daily while using this product.

Patients are advised not to use this product with any other drug containing acetaminophen, whether prescription or non-prescription. If there is uncertainty regarding the presence of acetaminophen in another medication, consultation with a doctor or pharmacist is recommended.

Patients with liver disease should seek medical advice before using this product. Additionally, those taking the anticoagulant warfarin should consult a healthcare professional prior to use.

Patients are instructed to discontinue use and consult a doctor if any of the following occur: worsening pain that lasts more than 10 days in adults or more than 5 days in children, fever that worsens or lasts more than 3 days, presence of redness or swelling, or the appearance of any new symptoms.

For pregnant or breastfeeding individuals, it is essential to seek guidance from a health professional before using this product.

In the event of an overdose, which may lead to liver damage, immediate contact with a Poison Control Center is crucial. Quick medical attention is necessary for both adults and children, even if no signs or symptoms are initially apparent.

Drug Interactions

Patients taking warfarin, a blood-thinning medication, should consult with 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 11 years may be administered 1 tablet every 4 to 6 hours as needed for symptom relief, with a maximum of 5 tablets in a 24-hour period. Treatment should not exceed 5 consecutive days unless directed by a healthcare professional. For children under 6 years of age, consultation with a doctor is advised prior to use.

Healthcare providers should be aware of the liver warning associated with exceeding the maximum daily dosage of 5 tablets. Additionally, caregivers should be instructed to discontinue use and seek medical advice if the child's pain worsens or persists beyond 5 days, or if fever worsens or lasts more than 3 days.

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 adverse effects or changes in therapeutic response, 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. It is important to assess the potential risks and benefits, as well as any available data regarding fetal outcomes and maternal health. Healthcare providers can offer guidance tailored to individual circumstances, ensuring the safety of both the patient 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 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 available data regarding dosage adjustments, special monitoring, or safety considerations. Therefore, healthcare professionals should exercise caution when prescribing this medication to patients with reduced kidney function, as the lack of information necessitates careful clinical judgment and monitoring.

Hepatic Impairment

Patients with hepatic impairment should be closely monitored when using this product, which contains acetaminophen. It is critical to note that severe liver damage may occur if an adult exceeds 12 tablets in a 24-hour period, which is the maximum daily amount. For children, the maximum daily amount is 5 tablets.

Additionally, patients should be aware that taking this product in conjunction with other medications containing acetaminophen can also lead to severe liver damage. Alcohol consumption further complicates the risk; adults who consume 3 or more alcoholic drinks daily while using this product are at an increased risk for liver damage.

It is advised that patients with liver disease consult a healthcare professional before using this product. In the event of an overdose, which may occur if the recommended dose is exceeded, immediate contact with a Poison Control Center is essential. Quick medical attention is critical for both adults and children, even if no signs or symptoms of overdose are initially apparent.

Overdosage

In the event of an overdose, it is crucial to recognize the potential for serious health consequences, particularly concerning liver damage. Taking more than the recommended dose may lead to significant hepatic injury, which underscores the importance of adhering to prescribed dosages.

Recommended Actions In the case of suspected overdose, immediate contact with a Poison Control Center is essential. Prompt medical intervention is critical for both adults and children, even in the absence of noticeable signs or symptoms. Healthcare professionals should advise patients and caregivers to seek medical attention without delay to mitigate potential risks associated with overdose.

Potential Symptoms While specific symptoms of overdose may not always be evident, vigilance is necessary. Healthcare providers should be aware that the absence of symptoms does not preclude the possibility of overdose-related complications, particularly liver damage.

Management Procedures Upon confirmation of an overdose, healthcare professionals should initiate appropriate management protocols, which may include monitoring liver function and providing supportive care as needed. Early intervention can significantly improve outcomes and reduce the risk of severe complications.

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

No postmarketing experience details are available in the insert text.

Patient Counseling

Healthcare providers should advise patients to keep the medication out of reach of children to prevent accidental ingestion. It is essential to emphasize the importance of seeking immediate medical assistance or contacting a Poison Control Center in the event of an overdose. Patients should be informed that prompt medical attention is critical for both adults and children, even if they do not exhibit any signs or symptoms of overdose. This proactive approach can help ensure the safety and well-being of all patients.

Storage and Handling

The product is supplied in a configuration that ensures tamper evidence; it should not be used if the imprinted safety seal under the cap is broken or missing.

For optimal storage, the product must be maintained at a temperature range of 15-30 °C (59-86 °F). Proper handling and storage conditions are essential to preserve the integrity and efficacy of the product.

Additional Clinical Information

The medication is administered orally. Clinicians should advise patients who are pregnant or breastfeeding to consult a health professional prior to use. No additional information is available regarding laboratory tests, abuse potential, or postmarketing experience.

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)