Acetaminophen

Description

AUROHEALTH is a formulation containing acetaminophen as the active ingredient, designed for pain relief and fever reduction. Each caplet delivers 500 mg of acetaminophen, and the product is classified as an extra strength formulation intended for adult use. The product is packaged in a bottle containing 100 caplets. The National Drug Code (NDC) for this product is 58602-773-21. This formulation is comparable to the active ingredient found in Tylenol® Extra Strength Caplets.

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 advised to take 2 caplets every 6 hours as needed for symptom relief. The maximum dosage should not exceed 6 caplets 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 instructed 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. If there is uncertainty regarding the presence of acetaminophen in another medication, consultation with a healthcare professional is advised.

• This product should not be used in individuals with a known allergy to acetaminophen or any of the inactive ingredients contained in the formulation.

Warnings and Precautions

This product contains acetaminophen, which carries specific warnings regarding liver health. Severe liver damage may occur if the following conditions are met: the intake exceeds 4,000 mg of acetaminophen within a 24-hour period, the product is used concurrently with other medications containing acetaminophen, or if the individual consumes three or more alcoholic drinks daily while using this product.

Healthcare professionals should be vigilant for potential allergic reactions associated with acetaminophen. Severe skin reactions may manifest as skin reddening, blisters, or rash. Should any of these symptoms occur, it is imperative to discontinue use immediately and seek medical assistance.

In the event of an overdose, prompt medical intervention is essential. Patients or caregivers should contact a Poison Control Center (1-800-222-1222) without delay. Quick medical attention is critical for both adults and children, even in the absence of noticeable signs or symptoms.

Patients should be advised to stop taking the product and consult their healthcare provider if any of the following occur: pain worsens or persists beyond 10 days, fever intensifies or lasts more than 3 days, new symptoms develop, or if redness or swelling is observed. These symptoms may indicate a serious underlying condition that requires further evaluation.

Side Effects

Patients using this product should be aware of the potential for serious adverse reactions, particularly related to liver health and allergic skin responses.

Severe liver damage may occur if patients exceed 4,000 mg of acetaminophen within a 24-hour period, use other medications containing acetaminophen concurrently, or consume three or more alcoholic drinks daily while using this product. Patients with pre-existing liver disease should consult a healthcare professional before use.

Additionally, acetaminophen may cause 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 other signs that may indicate a serious condition. They are advised to stop use and consult a doctor if pain worsens or persists beyond 10 days, if fever intensifies or lasts more than 3 days, if new symptoms arise, or if redness or swelling is observed.

Furthermore, patients taking the blood-thinning medication warfarin should consult a doctor or pharmacist prior to using this product to avoid potential interactions.

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. For adolescents aged 12 years and older, the recommended dosage is 2 caplets every 6 hours as needed, with a maximum of 6 caplets in a 24-hour period, unless otherwise directed by a physician. Treatment should not exceed 10 days without medical advice.

In cases of overdose, prompt medical attention is essential for both pediatric and adult patients, even if no immediate signs or symptoms are apparent.

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.

For adults and children aged 12 years and older, the recommended dosage is 2 caplets every 6 hours as needed for symptom relief, with a maximum of 6 caplets in a 24-hour period unless otherwise directed by a healthcare professional. It is important for elderly patients to adhere to this dosage guideline and not exceed the recommended duration of use, which should not exceed 10 days unless specifically instructed by a doctor.

For children under 12 years of age, consultation with a healthcare provider is necessary before administration. Careful monitoring and adherence to these recommendations are essential to ensure the safe use of the medication in geriatric patients.

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 should consider individual circumstances and the specific needs of the patient when making recommendations.

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 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. It is critical to note that severe liver damage may occur if the total daily dose of acetaminophen exceeds 4,000 mg. Additionally, patients must be cautioned against the concurrent use of other medications containing acetaminophen, as this can also lead to severe liver damage.

Furthermore, patients with compromised liver function who consume three or more alcoholic drinks daily are at an increased risk for severe liver damage while using this product. Therefore, it is advisable for healthcare providers to assess liver function and consider dosage adjustments or alternative therapies for patients with hepatic impairment to mitigate the risk of hepatotoxicity. Regular monitoring of liver function tests may be warranted in these patients to ensure safety and efficacy.

Overdosage

In cases of overdosage, significant health risks are associated with the consumption of acetaminophen.

Risk of Severe Liver Damage Administration of acetaminophen in excess of 4,000 mg within a 24-hour period poses a substantial risk of severe liver damage. Healthcare professionals should be vigilant in assessing the total daily intake of acetaminophen, particularly in patients who may be using multiple products containing this active ingredient.

Additionally, the concomitant use of acetaminophen with other medications that also contain acetaminophen can lead to similar risks of severe liver damage. It is crucial for healthcare providers to review all medications a patient is taking to prevent unintentional overdose.

Alcohol Consumption Considerations Patients who consume three or more alcoholic beverages daily while using acetaminophen are at an increased risk for severe liver damage. Healthcare professionals should counsel patients on the dangers of combining alcohol with acetaminophen and consider alternative pain management strategies for those with a history of alcohol use.

Recommended Actions In the event of suspected overdosage, immediate medical evaluation is warranted. Healthcare providers should monitor liver function tests and consider the administration of N-acetylcysteine as an antidote, particularly if the overdose is identified within a critical time frame. Prompt intervention is essential to mitigate the risk of irreversible liver injury.

Nonclinical Toxicology

No relevant information is available regarding teratogenic effects, non-teratogenic effects, or nonclinical toxicology. Additionally, there is no pertinent data concerning animal pharmacology and toxicology.

Postmarketing Experience

Postmarketing experience has identified rare cases of severe skin reactions associated with acetaminophen use. Reported symptoms include skin reddening, blisters, and rash. These events were documented through voluntary reports and surveillance programs.

Patient Counseling

Healthcare providers should advise patients on the importance of seeking immediate medical assistance in the event of an overdose. Patients should be informed to contact a Poison Control Center at 1-800-222-1222 without delay.

It is crucial for patients to understand that quick medical attention is essential for both adults and children, even if they do not exhibit any noticeable signs or symptoms of overdose. Emphasizing this point can help ensure timely intervention and potentially prevent serious health consequences.

Storage and Handling

The product is supplied in configurations that include specific NDC numbers, which are essential for identification and inventory management. It is crucial to store the product at a controlled temperature range of 20° to 25°C (68° to 77°F) to maintain its efficacy and safety.

Healthcare professionals should ensure that the product is not utilized if the printed foil seal under the cap is torn or missing, as this may indicate potential contamination or compromise of the product's integrity. Proper handling and storage conditions are vital to ensure the product remains effective and safe for use.

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 further information is available regarding laboratory tests, abuse potential, or postmarketing experiences.

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)