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Aspirin

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Active ingredient
Aspirin 81 mg
Other brand names
Drug classes
Nonsteroidal Anti-inflammatory Drug, Platelet Aggregation Inhibitor
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 2023
Label revision date
January 31, 2023
Drug Information (PDF)
Prescribing information, PDF file
Active ingredient
Aspirin 81 mg
Other brand names
Drug classes
Nonsteroidal Anti-inflammatory Drug, Platelet Aggregation Inhibitor
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 2023
Label revision date
January 31, 2023
Manufacturer
Lodaat LLC
Registration number
M013
NDC root
83139-372
Drug Information (PDF)
Prescribing information, PDF file
Packaging Info
Packaging & NDC Codes

If you are a healthcare professional or from the pharmaceutical industry please visit this version.

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

Drug Overview

Aspirin 81mg EC is a medication commonly used for the temporary relief of minor aches and pains, such as headaches or muscle discomfort. It is often recommended by healthcare professionals for various situations where mild pain relief is needed.

This particular formulation of aspirin is designed to have a delayed action, meaning it may not provide immediate relief for symptoms that require quick action. It's important to consult with your doctor to determine if this medication is suitable for your needs.

Uses

You can use this medication for the temporary relief of minor aches and pains, as advised by your doctor. It's important to note that this product works slowly, so it may not be suitable for quick relief of headaches or other symptoms that require immediate attention.

Rest assured, there are no known teratogenic effects (which means it doesn't cause birth defects) associated with this medication, making it a safer option for those concerned about such risks.

Dosage and Administration

When taking this medication, it's important to drink a full glass of water with each dose to help with absorption. For adults and children aged 12 years and older, you should take 4 to 8 tablets every 4 hours. However, make sure not to exceed 48 tablets in a 24-hour period unless your doctor has instructed you otherwise.

If you are considering this medication for a child under 12 years old, it's essential to consult a doctor first to ensure it's safe and appropriate for their age and weight. Always follow your healthcare provider's guidance for the best results.

What to Avoid

It's important to be cautious when considering this medication. You should not use it if you are allergic to aspirin or any other pain reliever or fever reducer. Additionally, if you have ever experienced an allergic reaction to this product or any of its ingredients, you should avoid using it as well.

Taking these precautions helps ensure your safety and well-being. If you have any concerns or questions about your allergies or the ingredients in this medication, please consult with your healthcare provider.

Side Effects

It's important to be aware of potential side effects when using this product. Children and teenagers recovering from chickenpox or flu-like symptoms should avoid it due to the risk of Reye’s syndrome, a rare but serious condition. If you notice changes in behavior along with nausea and vomiting, consult a doctor immediately.

You should also be cautious of severe allergic reactions, which may include hives, facial swelling, asthma (wheezing), or shock. This product can increase the risk of severe stomach bleeding, especially if you are over 60, have a history of stomach ulcers, or are taking certain medications like blood thinners or other NSAIDs. If you experience symptoms such as feeling faint, vomiting blood, or having bloody or black stools, seek medical attention right away. Always consult your doctor if you have a history of stomach problems, high blood pressure, or other health conditions before using this product.

Warnings and Precautions

It's important to be aware of some serious warnings when using this product. If you are a child or teenager recovering from chickenpox or flu-like symptoms, you should not use this product, as it could lead to Reye’s syndrome, a rare but serious illness. Additionally, be cautious of potential severe allergic reactions, which may include hives, facial swelling, asthma (wheezing), or shock. This product can also cause severe stomach bleeding, especially if you are over 60, have a history of stomach ulcers, take blood thinners or steroids, consume alcohol regularly, or exceed the recommended dosage.

Before using this product, consult your doctor if you have a history of stomach problems, high blood pressure, heart disease, liver cirrhosis, kidney disease, or asthma. It's also wise to check with your doctor or pharmacist if you are taking medications for blood thinning, diabetes, gout, or arthritis. If you accidentally take too much, seek emergency medical help or contact a Poison Control Center immediately at 1-800-222-1222.

Stop using this product and call your doctor if you experience any signs of an allergic reaction, stomach bleeding (such as feeling faint, vomiting blood, or having bloody or black stools), or if new symptoms arise. You should also reach out if you notice ringing in your ears or loss of hearing. For any side effects, you can report them at 1-888-952-0050.

Overdose

If you suspect an accidental overdose, it’s important to seek medical help immediately. You can contact a Poison Control Center at 1-800-222-1222 for guidance. Signs of an overdose can vary, but they may include unusual drowsiness, confusion, or difficulty breathing.

Don’t wait to see if symptoms improve; getting prompt assistance can be crucial. Always err on the side of caution and reach out for help if you think an overdose has occurred.

Pregnancy Use

If you are pregnant or breastfeeding, it’s crucial to consult with a healthcare professional before using any medication. This is to ensure the safety of both you and your baby.

Particularly, avoid using aspirin during the last three months of your pregnancy unless your doctor has specifically instructed you to do so. Taking aspirin at this stage can lead to potential issues for your unborn child or complications during delivery. Always prioritize open communication with your healthcare provider regarding any medications you may consider.

Lactation Use

If you are pregnant or breastfeeding, it's important to consult with a healthcare professional before using any medication. This is particularly crucial if you are considering taking aspirin during the last three months of your pregnancy, as it can lead to potential issues for your unborn child or complications during delivery. Always prioritize your health and the health of your baby by seeking guidance from your doctor.

Pediatric Use

It's important to be cautious when giving this product to children and teenagers. If your child has or is recovering from chickenpox or flu-like symptoms, they should not use this product due to the risk of Reye’s syndrome (a rare but serious illness). If you notice any changes in your child's behavior along with nausea and vomiting while using this product, consult a doctor immediately, as these could be early signs of Reye’s syndrome.

For dosing, adults and children aged 12 and older can take 4 to 8 tablets every 4 hours, but they should not exceed 48 tablets in a 24-hour period unless directed by a doctor. If your child is under 12 years old, it's essential to consult a doctor before giving them this product.

Geriatric Use

As you age, it's important to be aware of certain health risks when taking medications. If you are 60 years or older, you may have a higher chance of experiencing severe stomach bleeding. This risk is especially relevant if you have a history of stomach issues, high blood pressure, heart disease, liver cirrhosis (a liver condition), or kidney disease.

Before starting any new medication, it's wise to consult with your doctor, particularly if any of these warnings apply to you. Your healthcare provider can help ensure that your treatment is safe and appropriate for your specific health needs.

Renal Impairment

If you have kidney problems, it's important to consult your doctor before using this medication. This is especially crucial if you also have high blood pressure, heart disease, or liver cirrhosis, as these conditions can affect how your body processes the medication. Your healthcare provider will help determine if it's safe for you and may suggest adjustments to your dosage or additional monitoring to ensure your safety. Always prioritize open communication with your doctor regarding your health conditions.

Hepatic Impairment

If you have liver problems, such as liver cirrhosis (a severe scarring of the liver), it's important to consult your doctor before using this medication. Your healthcare provider can help determine if it's safe for you, especially if you also have other conditions like high blood pressure or heart disease. Always prioritize open communication with your doctor to ensure your safety and well-being.

Drug Interactions

It's important to be aware that certain medications can interact with each other, potentially leading to serious side effects. For instance, if you are taking blood thinners (anticoagulants) or steroid medications, you may have an increased risk of stomach bleeding. Additionally, using other non-steroidal anti-inflammatory drugs (NSAIDs) like aspirin, ibuprofen, or naproxen alongside these medications can further elevate this risk.

Before starting any new medication, especially if you are already on a prescription anticoagulant, it's crucial to consult with your healthcare provider or pharmacist. They can help ensure that your medications are safe to use together and that any necessary lab tests are properly managed. Always prioritize open communication about your medications to protect your health.

Storage and Handling

To ensure the best performance of your product, store it at room temperature, ideally between 20° and 25°C (68° and 77°F). This temperature range helps maintain its effectiveness.

When handling the product, be sure to check that the imprinted seal under the safety cap is intact. If the seal is broken or missing, do not use the product, as this may indicate that it is no longer safe or effective. Always prioritize safety to ensure the best results.

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 it. Specifically, avoid using aspirin during the last three months of pregnancy unless your doctor has instructed you to do so, as it can lead to issues for the unborn child or complications during delivery.

FAQ

What is Aspirin 81mg EC used for?

Aspirin 81mg EC is used for the temporary relief of minor aches and pain or as recommended by your doctor.

How should I take Aspirin 81mg EC?

Adults and children 12 years and over should take 4 to 8 tablets every 4 hours, not exceeding 48 tablets in 24 hours unless directed by a doctor. Drink a full glass of water with each dose.

Are there any warnings for using Aspirin 81mg EC?

Yes, do not use if you are allergic to aspirin or have had an allergic reaction to this product. Additionally, be cautious of Reye’s syndrome in children recovering from chicken pox or flu-like symptoms.

What should I do if I experience signs of stomach bleeding?

Stop using Aspirin 81mg EC and call your doctor if you feel faint, vomit blood, have bloody or black stools, or experience stomach pain that does not improve.

Can I use Aspirin 81mg EC if I am pregnant or breastfeeding?

If you are pregnant or breastfeeding, consult a health professional before use. It is especially important not to use aspirin during the last 3 months of pregnancy unless directed by a doctor.

What should I do in case of an accidental overdose?

In case of accidental overdose, get medical help or contact a Poison Control Center immediately.

What are the potential side effects of Aspirin 81mg EC?

Potential side effects include severe allergic reactions, stomach bleeding, and changes in behavior with nausea and vomiting, which may indicate Reye’s syndrome.

How should I store Aspirin 81mg EC?

Store Aspirin 81mg EC at room temperature between 20°–25°C (68°–77°F) and do not use if the imprinted seal under the safety cap is broken or missing.

Packaging Info

Below are the non-prescription pack sizes of Aspirin (aspirin 81 mg). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Aspirin.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

Aspirin 81 mg enteric-coated (EC) is a nonsteroidal anti-inflammatory drug (NSAID) with the chemical formula C9H8O4. It has a molecular weight of 180.16 g/mol. The enteric coating is designed to prevent the dissolution of the tablet in the stomach, allowing for absorption in the intestines. This formulation is typically presented as a round, white tablet.

Uses and Indications

This drug is indicated for the temporary relief of minor aches and pains, as recommended by a healthcare professional. Due to its delayed action, this product is not suitable for the immediate relief of headaches or other symptoms requiring prompt alleviation.

Limitations of Use: There are no known teratogenic or nonteratogenic effects associated with this drug.

Dosage and Administration

Patients should take the medication with a full glass of water for optimal efficacy.

For adults and children aged 12 years and older, the recommended dosage is 4 to 8 tablets every 4 hours. The total daily dosage must not exceed 48 tablets within a 24-hour period unless otherwise directed by a healthcare professional.

For children under 12 years of age, it is advised to consult a physician for appropriate dosing recommendations.

Contraindications

Use is contraindicated in patients with a known allergy to aspirin or any other pain reliever or fever reducer. Additionally, individuals who have previously experienced an allergic reaction to this product or any of its components should not use it.

Warnings and Precautions

Children and teenagers who are experiencing or recovering from chickenpox or flu-like symptoms should not use this product due to the risk of Reye’s syndrome, a rare but serious illness. If any changes in behavior accompanied by nausea and vomiting occur while using this product, it is imperative to consult a healthcare professional immediately, as these may be early signs of Reye’s syndrome.

Aspirin may induce severe allergic reactions, which can manifest as hives, facial swelling, asthma (wheezing), or shock. Healthcare professionals should be vigilant for these symptoms and advise patients to seek immediate medical attention if they occur.

This product contains a nonsteroidal anti-inflammatory drug (NSAID), which carries a risk of severe stomach bleeding. The likelihood of this adverse effect is increased in individuals who are 60 years of age or older, have a history of stomach ulcers or bleeding problems, are taking anticoagulants or steroid medications, are using other NSAIDs (including aspirin, ibuprofen, or naproxen), consume three or more alcoholic drinks daily, or exceed the recommended dosage or duration of use.

Healthcare professionals should advise patients to consult a doctor prior to use if any of the following conditions apply: a history of stomach problems (such as heartburn), high blood pressure, heart disease, liver cirrhosis, kidney disease, or if they are taking diuretics or have asthma. Additionally, patients should seek guidance from a doctor or pharmacist if they are on prescription anticoagulants, or if they have diabetes, gout, or arthritis.

In the event of an accidental overdose, it is crucial to obtain emergency medical assistance or contact a Poison Control Center at 1-800-222-1222 immediately.

Patients should discontinue use and contact a healthcare provider if they experience any signs of an allergic reaction or symptoms indicative of stomach bleeding, which include feeling faint, vomiting blood, having bloody or black stools, experiencing persistent stomach pain, or if pain worsens or lasts longer than 10 days. Other concerning symptoms include the presence of redness or swelling, the emergence of new symptoms, or any ringing in the ears or loss of hearing. Side effects may also be reported to 1-888-952-0050.

Side Effects

Patients using this product should be aware of several serious and common adverse reactions associated with its use.

Reye’s syndrome is a rare but serious illness that may occur in children and teenagers who have or are recovering from chicken pox or flu-like symptoms. It is crucial for these individuals to avoid using this product. If patients experience changes in behavior accompanied by nausea and vomiting while using this product, they should consult a doctor immediately, as these symptoms could indicate the onset of Reye’s syndrome.

Aspirin, the active ingredient in this product, may cause severe allergic reactions in some patients. Symptoms of such reactions can include hives, facial swelling, asthma (wheezing), and shock. Patients experiencing any signs of an allergic reaction should seek medical help right away.

This product contains a nonsteroidal anti-inflammatory drug (NSAID), which may increase the risk of severe stomach bleeding. The likelihood of this adverse reaction is heightened in patients who are 60 years of age or older, have a history of stomach ulcers or bleeding problems, are taking blood-thinning medications or steroids, consume three or more alcoholic drinks daily, or use other NSAIDs concurrently. Patients should be advised to stop using the product and consult a doctor if they experience any signs of stomach bleeding, which may include feeling faint, vomiting blood, having bloody or black stools, or experiencing persistent stomach pain.

Patients are also encouraged to seek medical advice before using this product if they have a history of stomach problems, such as heartburn, or if they have conditions such as high blood pressure, heart disease, liver cirrhosis, or kidney disease. Additionally, those taking diuretics or with a history of asthma should consult a healthcare professional prior to use.

Other important considerations include the need for patients to inform their doctor or pharmacist if they are taking prescription medications for anticoagulation, have diabetes, gout, or arthritis, as these conditions may influence the safety and efficacy of the product.

Patients should be vigilant for any new symptoms or changes in their condition while using this product and report these to their healthcare provider.

Drug Interactions

The concomitant use of anticoagulants or steroid medications may elevate the risk of gastrointestinal bleeding. Healthcare professionals should exercise caution when prescribing these agents alongside the drug in question, and patients should be monitored for signs of bleeding.

Additionally, the use of non-steroidal anti-inflammatory drugs (NSAIDs), including both prescription and over-the-counter options such as aspirin, ibuprofen, and naproxen, can further increase the risk of stomach bleeding. It is advisable to avoid the concurrent use of these medications unless specifically directed by a healthcare provider.

Patients currently on prescription anticoagulants should consult with their healthcare provider or pharmacist prior to initiating treatment with this drug to ensure safe and effective use, as potential interactions may necessitate dosage adjustments or enhanced monitoring.

Packaging & NDC

Below are the non-prescription pack sizes of Aspirin (aspirin 81 mg). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Aspirin.
Details

Pediatric Use

Children and teenagers who have or are recovering from chicken pox or flu-like symptoms should not use this product due to the risk of Reye’s syndrome. If any changes in behavior accompanied by nausea and vomiting occur while using this product, it is important to consult a doctor, as these symptoms may indicate the onset of Reye’s syndrome, a rare but serious condition.

For dosing, adults and children aged 12 years and older are directed to take 4 to 8 tablets every 4 hours, with a maximum of 48 tablets in a 24-hour period unless otherwise directed by a healthcare professional. For children under 12 years of age, consultation with a doctor is advised before use.

Geriatric Use

Elderly patients, particularly those aged 60 and older, are at an increased risk for severe stomach bleeding. It is essential for healthcare providers to exercise caution when prescribing this medication to geriatric patients, especially if they have a history of stomach problems, high blood pressure, heart disease, liver cirrhosis, or kidney disease.

Before initiating treatment, healthcare providers should inquire about the presence of any of these conditions in elderly patients, as they may necessitate closer monitoring or alternative therapeutic strategies. The potential for adverse effects, such as gastrointestinal bleeding, should be carefully weighed against the benefits of treatment in this population.

Pregnancy

Pregnant patients and those who are breastfeeding should consult a healthcare professional before using this medication. The use of aspirin during the last trimester of pregnancy is particularly cautioned against, as it may lead to adverse effects on fetal outcomes or complications during delivery. Therefore, it is essential that pregnant patients only use aspirin in this period if specifically directed by a healthcare provider.

Lactation

Lactating mothers are advised to consult a health professional prior to using this medication if they are pregnant or breastfeeding. It is particularly important to avoid the use of aspirin during the last three months of pregnancy unless specifically directed by a healthcare provider, as it may pose risks to the unborn child or lead to complications during delivery. There is no specific data available regarding the excretion of this medication in breast milk or its effects on breastfed infants.

Renal Impairment

Patients with renal impairment should consult a healthcare professional prior to use, particularly if they have a history of high blood pressure, heart disease, liver cirrhosis, or kidney disease. It is essential to assess renal function and consider potential dosing adjustments or monitoring requirements based on the degree of renal impairment.

Hepatic Impairment

Patients with hepatic impairment should consult a healthcare professional prior to use, particularly if they have conditions such as liver cirrhosis. It is essential for these patients to receive appropriate evaluation and monitoring of their liver function to ensure safe use of the medication. Adjustments to dosage may be necessary based on the severity of hepatic impairment, and ongoing assessment of liver function is recommended throughout the treatment period.

Overdosage

In the event of an accidental overdose, it is imperative to seek immediate medical assistance. Healthcare professionals should advise patients or caregivers to contact a Poison Control Center at 1-800-222-1222 without delay.

Prompt intervention is crucial in managing potential overdose situations. Symptoms of overdose may vary depending on the specific substance involved, and healthcare providers should be prepared to assess and address these symptoms accordingly.

Management procedures may include supportive care and symptomatic treatment, tailored to the individual patient's needs. Continuous monitoring and evaluation are essential to ensure patient safety and effective resolution of the overdose.

Nonclinical Toxicology

It is especially important not to use aspirin during the last three months of pregnancy unless specifically directed to do so by a doctor, as it may cause problems in the unborn child or complications during delivery. No specific non-teratogenic effects have been identified in the available data. Additionally, there are no details regarding nonclinical toxicology or animal pharmacology and toxicology provided in the current information.

Postmarketing Experience

Postmarketing experience has identified that side effects may be reported voluntarily by healthcare professionals and patients. Reports can be submitted to the designated contact number, 1-888-952-0050. This information is collected through various surveillance programs to monitor the safety profile of the product.

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 accidental overdose. It is crucial for patients to understand the importance of prompt action in such situations to ensure their safety.

Additionally, healthcare providers should encourage patients to report any side effects they experience while using the medication. Patients can do this by calling 1-888-952-0050. This reporting is vital for monitoring the safety and efficacy of the treatment and can help in managing any potential adverse effects.

Storage and Handling

The product is supplied in a configuration that includes an imprinted seal under the safety cap. It is essential to ensure that this seal is intact before use, as the product should not be utilized if the seal is broken or missing.

For optimal storage, the product must be kept at room temperature, specifically within the range of 20° to 25°C (68° to 77°F). Proper handling and storage conditions are crucial to maintain 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. It is particularly crucial to avoid aspirin during the last trimester of pregnancy unless directed by a physician, as it may pose risks to the unborn child or lead to complications during delivery.

Drug Information (PDF)

This file contains official product information for Aspirin, 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 Aspirin, 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

Last AI update:

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.