Aurophen Regular Strength

Description

Acetaminophen Tablets are formulated as a pain reliever and fever reducer, each tablet containing 325 mg of acetaminophen. The product is packaged in a bottle containing 100 tablets, providing a convenient dosage form for therapeutic use.

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 instructed to take 2 tablets every 4 to 6 hours as needed for symptom relief. The maximum dosage should not exceed 10 tablets within a 24-hour period unless otherwise directed by a healthcare professional. Additionally, this medication should not be used for more than 10 consecutive days without medical advice.

For children aged 6 years to under 12 years, the recommended dosage is 1 tablet every 4 to 6 hours while symptoms persist. The total daily intake must not exceed 5 tablets, and use should be limited to a maximum of 5 days unless directed by a physician.

In the case of children under 6 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:

• 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 significant risks for liver damage. The maximum daily dosage for adults is limited to 10 tablets (3,250 mg) within a 24-hour period, while for children, the maximum is 5 tablets (1,625 mg) in the same timeframe. Severe liver damage may occur if an adult exceeds 4,000 mg of acetaminophen in 24 hours, if a child takes more than 5 doses in 24 hours, if the product is taken concurrently with other medications containing acetaminophen, or if an adult consumes 3 or more alcoholic beverages daily while using this product.

Healthcare professionals 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 immediately and seek medical assistance.

General precautions should be taken prior to use. Patients with a history of liver disease should consult a physician before using this product. Additionally, individuals taking the anticoagulant warfarin should seek advice from a healthcare provider or pharmacist before use.

In cases of overdose, immediate medical attention is crucial. Patients or caregivers should contact a Poison Control Center at 1-800-222-1222 without delay, even if no symptoms are apparent, as prompt intervention is essential for both adults and children.

Patients should be advised to discontinue use and consult a physician if any of the following occur: pain worsens or persists beyond 10 days in adults, pain lasts more than 5 days in children under 12 years, fever worsens or lasts more than 3 days, new symptoms arise, 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, which constitutes the maximum daily amount. The risk of liver damage is further heightened if acetaminophen is taken in conjunction with other medications containing acetaminophen or if the patient 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 immediately and seek medical assistance.

Patients are advised to stop using acetaminophen and consult a healthcare professional if pain worsens or persists beyond 10 days in adults, or if pain lasts more than 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 indicate a serious condition, warranting immediate medical evaluation.

Before using acetaminophen, patients with liver disease should consult a healthcare provider. Furthermore, individuals taking the blood-thinning medication warfarin should seek guidance 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 over-the-counter. Patients are advised to verify the presence of acetaminophen in other medications by consulting a healthcare provider or pharmacist to avoid unintentional overdose and associated adverse effects.

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 years to under 12 years may take 1 tablet every 4 to 6 hours as needed for symptoms, with a maximum of 5 tablets (1,625 mg) in a 24-hour period. Use should not exceed 5 consecutive days unless directed by a healthcare professional.

For children under 6 years, it is advised to consult a doctor prior to use.

Healthcare providers should be aware that if pain in pediatric patients under 12 years worsens or persists for more than 5 days, or if fever lasts more than 3 days or worsens, medical advice should be sought.

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 important for geriatric patients to seek advice from a doctor or pharmacist if they are concurrently taking the anticoagulant warfarin, due to potential interactions that could increase the risk of bleeding.

In the event of an overdose, prompt medical attention is crucial for elderly patients, as well as for children, even if no immediate signs or symptoms are apparent. This underscores the importance of careful monitoring and adherence to prescribed dosages in this population.

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 the safety of both the mother and the developing fetus.

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

There is no information available regarding dosage adjustments, special monitoring, or safety considerations for patients with renal impairment. Healthcare professionals should exercise caution and consider the lack of specific guidance when prescribing to patients with reduced kidney function.

Hepatic Impairment

Patients with hepatic impairment should be closely monitored when using this product, which contains acetaminophen. The maximum daily dose for adults is limited to 10 tablets (3,250 mg) within a 24-hour period, while for children, the maximum is 5 tablets (1,625 mg) in the same timeframe.

Severe liver damage may occur if the following conditions are met: an adult consumes more than 4,000 mg of acetaminophen in a 24-hour period, a child exceeds 5 doses in 24 hours, the product is taken concurrently with other medications containing acetaminophen, or an adult consumes 3 or more alcoholic drinks daily while using this product.

Due to the potential for increased risk of liver toxicity, it is recommended that patients with compromised liver function adhere strictly to the prescribed dosage and avoid concurrent use of other acetaminophen-containing products. Regular monitoring of liver function tests may be warranted in these patients to ensure safety and prevent adverse effects.

Overdosage

In cases of overdosage, it is critical to adhere to the established dosage guidelines to prevent severe adverse effects. The maximum recommended daily dose for adults is 10 tablets, equating to 3,250 mg of acetaminophen within a 24-hour period. For pediatric patients, the maximum is limited to 5 tablets, or 1,625 mg, in the same timeframe.

Risk of Severe Liver Damage

Overdosage can lead to severe liver damage, particularly under specific circumstances. Adults are at risk if they exceed 4,000 mg of acetaminophen within 24 hours. For children, the risk of severe liver damage arises if they consume more than 5 doses in a 24-hour period, which represents the maximum daily allowance. Additionally, the concurrent use of this product with other medications containing acetaminophen significantly increases the risk of liver damage.

Another critical factor to consider is alcohol consumption. Adults who consume three or more alcoholic drinks daily while using this product are at an elevated risk for severe liver damage.

Recommended Actions

In the event of suspected overdosage, immediate medical attention is essential. Healthcare professionals should assess the patient's condition and consider the administration of activated charcoal if the ingestion occurred within a suitable timeframe. Monitoring liver function tests and providing supportive care are crucial components of management. In cases of confirmed acetaminophen toxicity, the use of N-acetylcysteine as an antidote should be initiated as per established protocols.

Nonclinical Toxicology

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

Postmarketing Experience

Postmarketing experience has identified that acetaminophen may be associated with severe skin reactions. Reports indicate that symptoms can include skin reddening, blisters, and rash. In the event of a skin reaction, it is advised to discontinue use immediately and seek medical assistance.

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 quick 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 that contains 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, they should stop use and seek medical advice if fever worsens or lasts more than 3 days, if new symptoms arise, or if there is any redness or swelling, as these may indicate a serious condition.

It is also advisable for healthcare providers to recommend that patients consult a doctor before using this medication if they have liver disease. Furthermore, patients taking the blood-thinning medication warfarin should be encouraged to speak with a doctor or pharmacist prior to use.

Storage and Handling

The product is supplied in a secure carton, and it is essential to ensure that the carton remains unopened and that the printed foil seal under the cap is intact.

For optimal storage, the product should be maintained at a temperature range of 20° to 25°C (68° to 77°F). Proper handling and storage conditions are crucial to preserve the integrity and efficacy of the product.

Additional Clinical Information

Patients aged 12 years and older are advised to take 2 tablets every 4 to 6 hours as needed for symptom relief, while those aged 6 to under 12 years should take 1 tablet every 4 to 6 hours. Clinicians should counsel patients to consult a doctor prior to use if they have liver disease or are taking the anticoagulant warfarin. Additionally, pregnant or breastfeeding individuals should seek advice from a healthcare professional before use.

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)