Acetaminophen

Description

Acetaminophen is a pharmaceutical compound with the National Drug Code (NDC) 10: 135-152-01. It is available in a dosage form of 500 mg. Acetaminophen is commonly utilized for its analgesic and antipyretic properties.

Uses and Indications

This drug is indicated for the temporary relief of minor aches and pains associated with various conditions, including the common cold, headache, backache, minor pain of arthritis, toothache, muscular aches, 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

Adults and children aged 12 years and over are instructed to take 2 tablets every 6 hours as needed while symptoms persist. The maximum dosage should not exceed 6 tablets within a 24-hour period, unless otherwise directed by a healthcare professional. Additionally, the use of this medication should not extend beyond 10 days unless specifically advised by a doctor.

For children under 12 years of age, it is recommended to consult a healthcare professional for appropriate dosing guidance.

Contraindications

Use of this product is contraindicated in the following situations:

Co-administration with any other drug containing acetaminophen, whether prescription or nonprescription, is prohibited 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.

Additionally, this product should not be used in individuals with a known allergy to acetaminophen or any of the inactive ingredients contained in this formulation, as this may lead to severe allergic reactions.

Warnings and Precautions

This product contains acetaminophen, which poses a significant risk of liver damage if not used according to the specified guidelines. The maximum recommended daily dosage is 6 tablets, equating to 3,000 mg within a 24-hour period. Severe liver injury may occur if the following conditions are met: exceeding 4,000 mg of acetaminophen in a 24-hour timeframe, concomitant use with other medications containing acetaminophen, or consumption of three or more alcoholic beverages daily while using this product.

Healthcare professionals should advise patients to consult a physician prior to use if they have a history of liver disease. Additionally, it is crucial to seek guidance from a healthcare provider or pharmacist if the patient is concurrently taking warfarin, a blood-thinning medication, as interactions may occur.

Patients should be instructed to discontinue use and contact their healthcare provider if any of the following occur: pain worsens or persists for more than 10 days, fever intensifies or lasts longer than 3 days, new symptoms develop, or if there is any redness or swelling, as these may indicate a serious underlying condition.

No specific instructions for obtaining emergency medical assistance are provided; however, it is always prudent for patients to seek immediate care if they experience severe adverse effects or symptoms that are concerning.

Side Effects

Patients using this product should be aware of the potential for serious adverse reactions, particularly related to liver health. The product contains acetaminophen, and exceeding the maximum daily dose of 6 tablets (3,000 mg) within 24 hours may lead to severe liver damage. This risk is heightened if patients take more than 4,000 mg of acetaminophen in a 24-hour period, use other medications containing acetaminophen concurrently, or consume three or more alcoholic drinks daily while using this product.

In the event of an overdose, which may occur if the recommended dose is exceeded, patients are advised to seek immediate medical assistance or contact a Poison Control Center. Prompt medical attention is crucial for both adults and children, even if no signs or symptoms of overdose are initially apparent.

Patients should discontinue use and consult a healthcare professional if pain worsens or persists for more than 10 days, if fever intensifies or lasts longer than 3 days, if new symptoms arise, or if there is any redness or swelling, as these may indicate a serious underlying condition.

Additionally, patients with liver disease should consult a doctor before using this product. It is also recommended that individuals taking the blood-thinning medication warfarin seek advice from a healthcare provider 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 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 consult a healthcare professional before use. It is important for both children and adults to seek quick medical attention, even in the absence of noticeable signs or symptoms.

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 lactation. 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 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 available prescribing information. There are no dosage adjustments, special monitoring requirements, or safety considerations outlined for individuals with reduced kidney function. Healthcare professionals should exercise caution and consider the lack of data when prescribing to this patient population.

Hepatic Impairment

Patients with hepatic impairment should be closely monitored when using this product, which contains acetaminophen. The maximum daily dose for patients is limited to 6 tablets (3,000 mg) within a 24-hour period. It is critical to note that severe liver damage may occur if patients exceed 4,000 mg of acetaminophen in a 24-hour period, take other medications containing acetaminophen concurrently, or consume 3 or more alcoholic drinks daily while using this product.

Due to the potential for increased risk of liver toxicity, patients with compromised liver function should be advised to adhere strictly to the recommended dosage and to avoid the aforementioned risk factors. Regular assessment of liver function may be warranted in these patients to ensure safety and prevent adverse effects.

Overdosage

In cases of overdose, the ingestion of more than the recommended dose may lead to significant liver damage. It is imperative that individuals seek immediate medical assistance or contact a Poison Control Center at 1-800-222-1222 without delay.

Importance of Prompt Medical Attention

Quick medical intervention is crucial for both adults and children, even in the absence of noticeable signs or symptoms. Healthcare professionals should be aware that the lack of immediate symptoms does not preclude the potential for serious health consequences. Therefore, it is essential to act swiftly and ensure that appropriate medical care is provided.

Nonclinical Toxicology

There is no information available regarding teratogenic effects. For non-teratogenic effects, it is advised that individuals who are pregnant or breastfeeding consult a health professional prior to use. Additionally, there is no information provided in the nonclinical toxicology section, nor is there any data available concerning animal pharmacology and toxicology.

Postmarketing Experience

No postmarketing experience details are available in the insert text.

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 with a doctor or pharmacist.

It is crucial to inform patients that they should not use this medication if they have a known allergy to acetaminophen or any of the inactive ingredients present in the product. Patients should be instructed to discontinue use and seek medical advice if their pain worsens or persists for more than 10 days, or if their fever worsens or lasts longer than 3 days. Additionally, patients should be advised to stop using the medication and consult a doctor if they experience new symptoms, or if they notice any redness or swelling, as these may indicate a serious condition.

Patients with liver disease should be encouraged to consult a doctor before using this medication. Furthermore, those taking the blood-thinning medication warfarin should be advised to speak with a doctor or pharmacist prior to use to ensure safety and avoid potential interactions.

Storage and Handling

The product is supplied in configurations that include specific NDC numbers, which can be found on the packaging. It is essential to store the product at a temperature range of 20-25 ˚C (68-77 ˚F) to maintain its efficacy.

Healthcare professionals should also note that the lot number and expiration date are located on the end panel of the packaging. Proper handling and storage conditions are crucial to ensure the integrity of the product throughout its shelf life.

Additional Clinical Information

No further data are available.

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)