Aurophen Regular Strength

Description

AUROHEALTH (NDC 58602-754-21) offers AUROPHEN, an acetaminophen formulation designed for pain relief and fever reduction. Each tablet contains 325 mg of acetaminophen, comparable to the active ingredient found in Tylenol® Regular Strength tablets. The product is supplied in a bottle containing 100 tablets, suitable for oral administration.

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

Adults and children aged 12 years and older are advised to take 2 tablets every 4 to 6 hours as needed while symptoms persist. The maximum dosage should not exceed 10 tablets within a 24-hour period. Continuous use beyond 10 days is not recommended 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 last. The total daily intake should not surpass 5 tablets within a 24-hour period. Prolonged use beyond 5 days is not advised unless instructed by a physician.

For children under 6 years of age, it is essential to consult a doctor for appropriate dosing recommendations.

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 this formulation.

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 4,000 mg of acetaminophen within a 24-hour period; if a child takes more than 5 doses in 24 hours; if it is taken concurrently with other medications containing acetaminophen; or if an adult consumes 3 or more alcoholic beverages daily while using this product.

Acetaminophen may also cause severe skin reactions, which can manifest as skin reddening, blisters, or rash. In the event of a skin reaction, it is imperative to discontinue use immediately and seek medical assistance.

Healthcare professionals should advise patients to consult a doctor prior to use if they have a history of liver disease. Additionally, it is recommended that patients taking the anticoagulant warfarin consult with a healthcare provider or pharmacist before using this product.

In cases of overdose, immediate medical attention is essential. Patients should be instructed to contact a Poison Control Center at 1-800-222-1222 or seek emergency medical help without delay, regardless of the presence of symptoms.

Patients should discontinue use and contact their healthcare provider if any of the following occur: pain worsens or persists for more than 10 days in adults; pain worsens or lasts more than 5 days in children under 12 years; fever worsens 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

Severe liver damage may occur in patients who exceed the recommended dosage of acetaminophen. Specifically, adults should not take more than 4,000 mg in a 24-hour period, and children should not exceed 5 doses within the same timeframe. The risk of liver damage is heightened if acetaminophen is taken in conjunction with other medications containing acetaminophen or if an adult consumes three or more alcoholic drinks daily while using this product.

Patients should be aware of the potential for severe skin reactions associated with acetaminophen use. 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.

Participants in clinical settings are advised to stop use and consult a healthcare professional if pain worsens or persists beyond 10 days in adults or 5 days in children under 12 years. Additionally, if fever worsens or lasts more than 3 days, or if new symptoms arise, medical advice should be sought. The presence of redness or swelling may also indicate a serious condition requiring attention.

Patients with liver disease should consult a doctor prior to using this product. Furthermore, individuals taking the blood-thinning medication warfarin are advised to seek guidance from a healthcare provider or pharmacist before 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. Patients are advised to verify the presence of acetaminophen in any other medications they are taking by consulting a doctor or pharmacist to avoid the risk of acetaminophen overdose.

Packaging & NDC

Below are the non-prescription pack sizes of Aurophen Regular Strength (acetaminophen). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients aged 6 to 11 years may take 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, it is advised to consult a doctor prior to use.

Geriatric Use

Elderly patients should consult a healthcare provider prior to use if they have a history of liver disease. This precaution is essential to ensure the safe administration of the medication, as hepatic function may be compromised in this population, potentially affecting drug metabolism and clearance.

In the event of an overdose, it is crucial for elderly patients to seek prompt medical attention, regardless of whether any signs or symptoms are present. This vigilance is important due to the increased risk of adverse effects and complications associated with overdose in geriatric patients.

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 weighed, 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 safe use during pregnancy and lactation.

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 4,000 mg of acetaminophen within a 24-hour period. For pediatric patients, the risk of severe liver damage increases if more than 5 doses are administered in a 24-hour timeframe.

Additionally, patients should be advised against the concurrent use of other medications containing acetaminophen, as this may further elevate the risk of severe liver damage. Furthermore, adults who consume 3 or more alcoholic drinks daily while using this product are at an increased risk for severe liver damage.

Due to these considerations, it is recommended that healthcare providers assess liver function and consider dosage adjustments or alternative therapies for patients with compromised liver function. Regular monitoring of liver enzymes may be warranted to ensure patient safety.

Overdosage

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

Adult Overdosage An adult who ingests more than 4,000 mg of acetaminophen within a 24-hour period is at risk of experiencing severe liver damage. It is crucial for healthcare professionals to monitor patients for signs of hepatic impairment and to initiate appropriate management strategies promptly.

Pediatric Overdosage For pediatric patients, the risk of severe liver damage arises if a child takes more than five doses of acetaminophen within a 24-hour timeframe. Healthcare providers should be vigilant in assessing the child's medication history and ensuring that dosing guidelines are strictly followed.

Combination with Other Medications The concomitant use of acetaminophen with other medications that also contain acetaminophen can exacerbate the risk of severe liver damage. It is essential for healthcare professionals to review all medications a patient is taking to prevent unintentional overdose.

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

In the event of suspected overdosage, immediate medical attention is warranted. Monitoring liver function tests and providing supportive care are critical components of management.

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 question. Further studies may be necessary to elucidate these aspects of nonclinical toxicology.

Postmarketing Experience

Postmarketing experience has identified the potential for severe skin reactions associated with acetaminophen use. Reported symptoms of these reactions may include skin reddening, blisters, and rash. In the event of a skin reaction, it is advised to discontinue use immediately and seek medical assistance.

Additionally, there is a warning regarding the risk of overdose. In cases of suspected overdose, it is crucial to obtain medical help or contact a Poison Control Center promptly at 1-800-222-1222. Timely medical intervention is essential for both adults and children, even in the absence of noticeable signs or symptoms.

Patient Counseling

Healthcare providers should advise patients to seek immediate medical assistance or contact a Poison Control Center at 1-800-222-1222 in the event of an overdose. It is important to emphasize that prompt medical attention is critical for both adults and children, even if no signs or symptoms are initially apparent.

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 about the presence of acetaminophen in other medications, they should be encouraged to consult with a doctor or pharmacist.

Healthcare providers must caution patients against using this product if they have a known allergy to acetaminophen or any of the inactive ingredients contained within the formulation.

Patients should be instructed to discontinue use and consult a doctor if their pain worsens or persists for more than 10 days in adults, or for more than 5 days in children under 12 years. Additionally, if a fever worsens or lasts more than 3 days, or if new symptoms arise, patients should be advised to stop use and seek medical advice. They should also be made aware that the presence of redness or swelling could indicate a serious condition, warranting immediate consultation with a healthcare professional.

Furthermore, patients with liver disease should be advised to consult a doctor before using this medication. It is also important to recommend that patients taking the blood-thinning medication warfarin speak with a doctor or pharmacist prior to use.

Storage and Handling

The product is supplied in a carton that must remain unopened and with an intact seal under the cap to ensure its integrity. It should be stored at a controlled room temperature of 20° to 25°C (68° to 77°F). Any product with an opened carton or a torn or missing seal under the cap should not be used.

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 Aurophen Regular Strength, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)