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Aurophen Extra Strength for Adults

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Active ingredient
Acetaminophen 500 mg
Other brand names
Dosage form
Tablet
Route
Oral
Prescription status
OTC (over the counter)
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Marketed in the U.S.
Since 2016
Label revision date
November 29, 2023
Drug Information (PDF)
Prescribing information, PDF file
Active ingredient
Acetaminophen 500 mg
Other brand names
Dosage form
Tablet
Route
Oral
Prescription status
OTC (over the counter)
CSA schedule
Not a scheduled drug
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Marketed in the U.S.
Since 2016
Label revision date
November 29, 2023
Manufacturer
Aurohealth LLC
Registration number
M013
NDC root
58602-755
Drug Information (PDF)
Prescribing information, PDF file
Packaging Info (10 NDCs)
Packaging & NDC Codes (10)

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If you are a consumer or patient please visit this version.

Drug Overview

Acetaminophen is a medication available in extra strength caplets, each containing 500 mg. It is primarily used as a pain reliever and fever reducer, helping to temporarily relieve minor aches and pains associated with various conditions such as the common cold, headaches, backaches, toothaches, muscular aches, and menstrual cramps. Additionally, it can help reduce fever.

This medication is suitable for adults and is comparable to the active ingredient found in Tylenol® Extra Strength Caplets. If you're looking for relief from discomfort or fever, acetaminophen may be a helpful option for you.

Uses

You can use this medication to temporarily relieve minor aches and pains caused by various conditions, including the common cold, headaches, backaches, arthritis, toothaches, muscular aches, and menstrual cramps. It is also effective in temporarily reducing fever.

This means that if you're experiencing discomfort from any of these issues, this medication can help provide some relief. Always remember to follow the recommended guidelines for use.

Dosage and Administration

If you are an adult or a child aged 12 years and older, you should take 2 caplets every 6 hours as long as you have symptoms. However, make sure not to exceed 6 caplets in a 24-hour period unless your doctor advises otherwise. It's also important to limit your use to no more than 10 days unless directed by a healthcare professional.

For children under 12 years old, it's best to consult a doctor before giving them this medication. Always follow your healthcare provider's instructions to ensure safe and effective use.

What to Avoid

It's important to be cautious when using this medication. You should not take it if you are allergic to acetaminophen or any of the inactive ingredients in the product. Additionally, avoid using it alongside any other medications that contain acetaminophen, whether they are prescription or over-the-counter. If you're unsure whether a medication contains acetaminophen, please consult your doctor or pharmacist for guidance. Taking these precautions can help ensure your safety and well-being.

Side Effects

This product contains acetaminophen, which can lead to severe liver damage if you exceed 4,000 mg in 24 hours, take it with other acetaminophen-containing medications, or consume three or more alcoholic drinks daily while using it. Additionally, be aware that acetaminophen may cause serious skin reactions, including skin reddening, blisters, or rash. If you notice any of these symptoms, stop using the product and seek medical help immediately.

You should also stop using this product and consult a doctor if your pain worsens or lasts more than 10 days, if your fever gets worse or lasts more than 3 days, or if you develop new symptoms, redness, or swelling, as these could indicate a serious condition. If you have liver disease or are taking the blood-thinning medication warfarin, it's important to talk to your doctor or pharmacist before using this product.

Warnings and Precautions

This product contains acetaminophen, which can lead to severe liver damage if you take more than 4,000 mg in a 24-hour period, use it with other medications that also contain acetaminophen, or consume three or more alcoholic drinks daily while using it. Additionally, be aware that acetaminophen may cause serious skin reactions, such as skin reddening, blisters, or rash. If you experience any of these symptoms, stop using the product and seek medical help immediately.

If you suspect an overdose, it’s crucial to get emergency medical assistance or contact a Poison Control Center at 1-800-222-1222 right away, even if you don’t notice any symptoms. You should also stop taking the product and call your doctor if your pain worsens or lasts more than 10 days, your fever gets worse or lasts more than 3 days, you develop new symptoms, or if you notice any redness or swelling, as these could indicate a serious condition.

Overdose

Taking too much acetaminophen can lead to serious health issues, particularly severe liver damage. You should be cautious not to exceed 4,000 mg of acetaminophen in a 24-hour period. Additionally, combining acetaminophen with other medications that also contain acetaminophen can increase your risk of liver damage. If you regularly consume three or more alcoholic drinks each day, using acetaminophen can further heighten this risk.

If you suspect an overdose, look out for signs such as nausea, vomiting, loss of appetite, confusion, or jaundice (yellowing of the skin or eyes). It’s crucial to seek immediate medical help if you experience any of these symptoms or if you believe you have taken too much acetaminophen. Always prioritize your health and safety by consulting a healthcare professional if you have any concerns.

Pregnancy Use

If you are pregnant or breastfeeding, it’s important to consult with a healthcare professional before using this medication. They can provide guidance on whether it’s safe for you and your baby. Always prioritize your health and the health of your child by seeking expert advice.

Lactation Use

If you are pregnant or breastfeeding, it’s important to consult with a healthcare professional before using any medication. This ensures that you understand any potential risks and can make informed decisions about your health and the health of your baby. Always prioritize open communication with your doctor regarding your breastfeeding journey.

Pediatric Use

If you have a child under 12 years old, it's important to consult a doctor before using this medication. For those aged 12 and older, the recommended dosage is 2 caplets every 6 hours as needed, but you should not exceed 6 caplets in a 24-hour period unless directed by a doctor. Additionally, do not use this medication for more than 10 days without a doctor's guidance.

Be aware that in case of an overdose, seeking quick medical attention is crucial for both adults and children, even if there are no immediate signs or symptoms. Always prioritize safety and follow these guidelines closely.

Geriatric Use

When it comes to using this medication in older adults, there is no specific information available about dosage adjustments, safety concerns, or special precautions. This means that if you or a loved one is an older adult, it’s important to consult with a healthcare provider for personalized advice. They can help determine the best approach based on individual health needs and any other medications being taken. Always prioritize open communication with your healthcare team to ensure safe and effective treatment.

Renal Impairment

If you have kidney problems, it's important to know that the information provided does not include specific guidelines for dosage adjustments, special monitoring, or safety considerations related to renal impairment (kidney issues). This means that there are no tailored recommendations for how your treatment may need to change based on your kidney function.

Always consult your healthcare provider for personalized advice and to ensure that your treatment is safe and effective for your specific condition. They can help you understand any necessary precautions or adjustments based on your kidney health.

Hepatic Impairment

It's important to be cautious if you have liver problems and are considering using this product, as it contains acetaminophen. Taking more than 4,000 mg of acetaminophen in a 24-hour period can lead to severe liver damage. Additionally, combining this product with other medications that also contain acetaminophen can increase your risk of liver harm.

If you regularly consume three or more alcoholic drinks each day, using this product may also pose a serious risk to your liver. Always consult with your healthcare provider to ensure safe use and to discuss any necessary adjustments to your dosage or monitoring based on your liver health.

Drug Interactions

It's important to talk to your doctor or pharmacist before using this medication, especially if you are taking warfarin, a blood thinner. Combining these can increase your risk of bleeding, so it's crucial to ensure your safety.

Additionally, avoid using this medication with any other products that contain acetaminophen, whether they are prescription or over-the-counter. If you're unsure whether a medication has acetaminophen, don't hesitate to ask your healthcare provider for clarification. Always prioritize open communication about your medications to help prevent any harmful interactions.

Storage and Handling

To ensure the safety and effectiveness of your product, store it in a cool, dry place at a temperature between 20° to 25°C (68° to 77°F). This temperature range helps maintain the product's quality.

When handling the product, be cautious not to use it if the carton is opened or if the printed foil seal under the cap is torn or missing. This ensures that you are using a product that is safe and has not been compromised. Always check these details before use to protect your health.

Additional Information

You should take this medication orally. If you are pregnant or breastfeeding, it's important to consult with a healthcare professional before using this medication to ensure it's safe for you and your baby.

FAQ

What is Acetaminophen used for?

Acetaminophen is a pain reliever and fever reducer that temporarily relieves minor aches and pains due to conditions like the common cold, headache, backache, toothache, and menstrual cramps.

What is the recommended dosage for adults and children 12 years and over?

You should take 2 caplets every 6 hours while symptoms last, but do not exceed 6 caplets in 24 hours unless directed by a doctor.

Are there any warnings associated with Acetaminophen?

Yes, severe liver damage may occur if you take more than 4,000 mg in 24 hours, use it with other acetaminophen-containing drugs, or consume 3 or more alcoholic drinks daily while using it.

What should I do if I experience a skin reaction?

If you notice symptoms like skin reddening, blisters, or rash, stop using Acetaminophen and seek medical help immediately.

Can I use Acetaminophen if I am pregnant or breastfeeding?

If you are pregnant or breastfeeding, you should ask a health professional before using Acetaminophen.

What should I do in case of an overdose?

In case of overdose, get medical help or contact a Poison Control Center right away, as quick medical attention is critical.

Who should not use Acetaminophen?

Do not use Acetaminophen if you are allergic to it or any of its inactive ingredients, or if you are taking another drug that contains acetaminophen.

What should I do if my pain or fever worsens?

If your pain gets worse or lasts more than 10 days, or if your fever lasts more than 3 days, stop using Acetaminophen and consult your doctor.

Packaging Info

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

Packaging configurations for Aurophen Extra Strength for Adults.
Details

Drug Information (PDF)

This file contains official product information for Aurophen Extra Strength for Adults, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)

Description

AUROHEALTH is a formulation containing acetaminophen as the active ingredient, designed for pain relief and fever reduction. Each caplet contains 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, each delivering the specified dosage of 500 mg. The 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 older are instructed to take 2 caplets every 6 hours as needed while symptoms persist. The maximum allowable dosage is 6 caplets within a 24-hour period, unless otherwise directed by a healthcare professional. Additionally, the use of this medication should not exceed 10 consecutive 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:

Patients should not use this product in conjunction with any other medication containing acetaminophen, whether prescription or nonprescription, 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 is contraindicated in individuals with a known allergy to acetaminophen or any of the inactive ingredients contained in the formulation, as this may lead to severe allergic reactions.

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) or seek emergency medical help 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: worsening pain that persists beyond 10 days, a fever that worsens or lasts more than 3 days, the emergence of new symptoms, or the presence of redness or swelling. These signs 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. The product contains acetaminophen, which can lead to severe liver damage if the following conditions are met: exceeding 4,000 mg of acetaminophen within a 24-hour period, concurrent use with other medications containing acetaminophen, or consumption of three or more alcoholic drinks daily while using this product.

Additionally, there is an allergy alert associated with acetaminophen, as it may cause severe skin reactions. Symptoms of such reactions can include skin reddening, blisters, and rash. In the event of a skin reaction, patients are advised to discontinue use immediately and seek medical assistance.

Patients should also be instructed to stop using the product and consult a healthcare professional if pain worsens or persists beyond 10 days, if fever intensifies or lasts more than 3 days, if new symptoms arise, or if there is any redness or swelling, as these may indicate a serious underlying condition.

It is recommended that patients with liver disease consult a doctor prior to using this product. Furthermore, individuals taking the blood-thinning medication warfarin should seek advice from a healthcare provider or pharmacist before use 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 Aurophen Extra Strength for Adults (acetaminophen). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Aurophen Extra Strength for Adults.
Details

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 healthcare provider. 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 signs or symptoms are immediately apparent.

Geriatric Use

There is no specific information regarding the use of this medication in geriatric patients, including dosage adjustments, safety concerns, or special precautions. Healthcare providers should exercise caution when prescribing this medication to elderly patients, as individual responses may vary. It is advisable to monitor these patients closely for any adverse effects or changes in efficacy.

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 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 recommended that patients with hepatic impairment limit their alcohol intake and consult with a healthcare professional regarding the safe use of acetaminophen and any other medications they may be taking. Regular monitoring of liver function may be warranted in these patients to prevent potential adverse effects.

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 exacerbate the risk of liver injury. 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 regarding the dangers of alcohol consumption during acetaminophen therapy and consider alternative pain management strategies for those with a history of alcohol use.

Recommended Actions In the event of suspected overdosage, immediate medical attention is warranted. Healthcare providers should initiate appropriate management protocols, which may include monitoring liver function tests and considering the administration of N-acetylcysteine as an antidote in cases of significant overdose. Prompt recognition and intervention are critical to mitigate the potential for severe hepatic injury.

Nonclinical Toxicology

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

Postmarketing Experience

No postmarketing experience details are available in the insert text.

Patient Counseling

Healthcare providers should advise patients about 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 an overdose. Emphasizing this point can help ensure timely intervention and potentially prevent serious health consequences.

Storage and Handling

The product is supplied in a carton that must remain unopened until use. It is essential to inspect the carton and the printed foil seal under the cap prior to administration; the product should not be used if the carton is opened or if the foil seal is torn or missing.

Storage conditions require that the product be maintained at a temperature range of 20° to 25°C (68° to 77°F). Proper handling and storage are crucial to ensure 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 further information is available regarding laboratory tests, abuse potential, or postmarketing experiences.

Drug Information (PDF)

This file contains official product information for Aurophen Extra Strength for Adults, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)

Data Generation & Sources

This page was automatically generated and is maintained by the AllDrugs AI Data-Science Team. It was built from the FDA Structured Product Label (DailyMed) for Aurophen Extra Strength for Adults, retrieved by a validated AI data-extraction workflow.

All FDA-listed dosage forms and strengths are shown in the Packaging & NDC Codes section above. Regulatory status appears in the Summary Information panel above and was verified in the FDA National Drug Code directory and the NSDE NDC Directory daily file.

Note: an automated daemon monitors NSDE checksums; when the record for this NDC changes, the new file is pulled instantly and this page is refreshed.

No human clinician has reviewed this version.

Learn more in our Editorial Policy

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Primary FDA sources:

Orange Book data shown on this page are limited to Regulatory Status (Rx), Established Pharmacologic Class (EPC), and Mechanism of Action (MoA).

Regulatory data notice: Information on this page is reproduced verbatim from FDA public databases (NSDE, Orange Book, Purple Book, DailyMed SPL). NDA/ANDA drugs are FDA-approved, BLA biologics are FDA-licensed. Inclusion alone does not guarantee current market availability or imply FDA endorsement.

Medical disclaimer: This AI-generated content is provided for educational purposes only and does not constitute medical advice. Always consult a licensed healthcare professional for diagnosis or treatment decisions.