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Aspirin 81mg Enteric Coated

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Active ingredient
Aspirin 81 mg
Other brand names
Drug classes
Nonsteroidal Anti-inflammatory Drug, Platelet Aggregation Inhibitor
Dosage form
Tablet, Delayed Release
Route
Oral
Prescription status
OTC (over the counter)
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Marketed in the U.S.
Since 2021
Label revision date
November 19, 2021
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, Delayed Release
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 2021
Label revision date
November 19, 2021
Manufacturer
Allegiant Health
Registration number
M013
NDC root
69168-006
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 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 you may need to alleviate discomfort.

It's important to note that aspirin has a delayed action, meaning it may not provide quick relief for symptoms that require immediate attention. This characteristic makes it suitable for managing ongoing discomfort rather than acute pain. Always consult with your doctor for personalized advice on its use.

Uses

This medication is designed to help you find temporary relief from minor aches and pains, as advised by your doctor. It's important to note that this product works gradually, so it may not be the best choice if you're looking for quick relief from 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 have a child under 12 years old, it's essential to consult a doctor before giving them this medication. They will provide guidance on the appropriate dosage for younger patients. Always follow these instructions carefully to ensure safe and effective use of the medication.

What to Avoid

You should avoid using this product 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, it is important not to use it. Taking this medication under these circumstances could lead to serious health issues. Always prioritize your safety and consult with a healthcare professional if you have any concerns.

Side Effects

Using this product may come with some serious risks. If you are a child or teenager recovering from chickenpox or flu-like symptoms, you should avoid it due to the risk of Reye’s syndrome, a rare but serious illness. Be aware that aspirin can cause severe allergic reactions, which may include hives, facial swelling, asthma (wheezing), or shock. Additionally, this product contains a nonsteroidal anti-inflammatory drug (NSAID) that can lead to severe stomach bleeding, especially if you are over 60, have a history of stomach ulcers, or are taking certain medications like blood thinners or steroids.

You should stop using this product and consult a doctor if you experience any signs of an allergic reaction or stomach bleeding, such as feeling faint, vomiting blood, or having bloody or black stools. It's also important to talk to your doctor if you have a history of stomach problems, high blood pressure, heart disease, liver cirrhosis, or kidney disease 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 if you have a history of allergies, as aspirin can cause severe allergic reactions, including hives and difficulty breathing. This product also contains a nonsteroidal anti-inflammatory drug (NSAID), which may increase the risk of severe stomach bleeding, especially if you are over 60, have a history of stomach ulcers, or consume alcohol regularly.

Before using this product, consult your doctor if you have any stomach issues, high blood pressure, heart disease, liver cirrhosis, or kidney disease. It's also wise to check with your healthcare provider if you are taking blood thinners or have conditions like diabetes or arthritis. If you experience any signs of an allergic reaction or stomach bleeding—such as feeling faint, vomiting blood, or having bloody stools—stop using the product and seek medical help immediately. In case of an overdose, contact a Poison Control Center or seek emergency medical assistance right away.

Overdose

If you suspect an overdose, it’s crucial to seek medical help immediately or contact a Poison Control Center. Signs of an overdose can vary, but they may include unusual symptoms that are more severe than what you typically experience with the medication.

Always err on the side of caution—if you notice anything concerning, don’t hesitate to reach out for assistance. Quick action can make a significant difference in your safety and health.

Pregnancy Use

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

Particularly, you should 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

If you are considering this product for your child, it's important to be aware of some key guidelines. Children and teenagers who are currently experiencing or recovering from chickenpox or flu-like symptoms should not use this product, as it may increase the risk of Reye’s syndrome (a rare but serious illness). If your child shows any changes in behavior along with nausea and vomiting while using this product, you should consult a doctor immediately, as these could be early signs of Reye’s syndrome.

For dosing, adults and children aged 12 years 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 associated with medications. If you are 60 years or older, there is a higher chance of experiencing severe stomach bleeding. This risk means that you should discuss any medications you are taking with your healthcare provider, especially if they are known to affect stomach health.

Always inform your doctor about your age and any other health conditions you may have, as they can help determine the safest options for you. Taking precautions can help protect your health and ensure that you receive the best care possible.

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 doctor 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 healthcare provider regarding your kidney health and any other medical conditions you may have.

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 of how certain medications can interact with each other. For instance, if you take aspirin along with a blood thinner (a type of medication that helps prevent blood clots), it may increase your risk of bleeding. Additionally, combining aspirin with other nonsteroidal anti-inflammatory drugs (NSAIDs) like ibuprofen or naproxen can significantly raise the chance of severe stomach bleeding.

Always discuss any medications you are taking with your healthcare provider, as they can help you understand these risks and ensure your treatment plan is safe and effective. Remember, your health and safety are the top priority, so open communication about your medications is essential.

Storage and Handling

To ensure the best performance and safety of your product, store it at room temperature. This helps maintain its effectiveness. Before using, always 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. Following these simple guidelines will help you use the product safely and effectively.

Additional Information

You should take this medication orally. For adults and children aged 12 and over, the recommended dosage is 4 to 8 tablets every 4 hours, but do not exceed 48 tablets in a 24-hour period unless directed by a doctor. If the patient is under 12 years old, consult a doctor for the appropriate dosage.

If you are pregnant or breastfeeding, it's important to consult a healthcare professional before using this medication. Avoid using aspirin during the last three months of pregnancy unless specifically instructed by a doctor, as it may pose risks to the unborn child or lead to complications during delivery.

FAQ

What is Aspirin used for?

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

How should I take Aspirin?

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. Children under 12 years should consult a doctor.

What should I do if I experience an allergic reaction?

If you experience an allergic reaction, seek medical help right away.

Are there any warnings associated with Aspirin?

Yes, Aspirin may cause severe allergic reactions, stomach bleeding, and should not be used by children recovering from chicken pox or flu-like symptoms due to the risk of Reye’s syndrome.

Can I take Aspirin if I am pregnant or breastfeeding?

If you are pregnant or breastfeeding, ask 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 if I experience signs of stomach bleeding?

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

What should I avoid while taking Aspirin?

Avoid taking Aspirin if you are allergic to it or any other pain reliever/fever reducer, and consult a doctor if you have a history of stomach problems, high blood pressure, or other serious health conditions.

How should I store Aspirin?

Store Aspirin at room temperature and do not use it if the imprinted seal under the safety cap is broken or missing.

Packaging Info

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

Packaging configurations for Aspirin 81mg Enteric Coated.
Details

Drug Information (PDF)

This file contains official product information for Aspirin 81mg Enteric Coated, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)

Description

Aspirin is a nonsteroidal anti-inflammatory drug (NSAID) with the chemical name acetylsalicylic acid. Its molecular formula is C9H8O4, and it has a molecular weight of 180.16 g/mol. Aspirin is typically presented in tablet form for oral administration. The tablets are white, round, and may be coated to facilitate swallowing and enhance stability. Aspirin exhibits analgesic, antipyretic, and anti-inflammatory properties, making it effective in the management of pain, fever, and inflammation.

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 of this product is contraindicated in individuals with a known allergy to aspirin or any other pain reliever or fever reducer. Additionally, it should not be used in patients who have a history of allergic reactions to this product or any of its components.

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. If any changes in behavior accompanied by nausea and vomiting occur while using this product, it is imperative to consult a healthcare professional, as these symptoms may indicate the onset of this rare but serious condition.

Aspirin may provoke severe allergic reactions, which can manifest as hives, facial swelling, asthma (wheezing), or shock. Healthcare professionals should be vigilant for these signs 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 disorders, are taking anticoagulants or steroid medications, are using other NSAIDs (including aspirin, ibuprofen, or naproxen), consume three or more alcoholic beverages daily, or exceed the recommended dosage or duration of use.

Healthcare providers should advise patients to consult a physician prior to 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, patients taking diuretics or those with asthma should seek medical advice before use. It is also recommended that patients inform their healthcare provider or pharmacist if they are taking prescription medications for anticoagulation, or if they have diabetes, gout, or arthritis.

In the event of an overdose, immediate medical assistance should be sought, or the Poison Control Center should be contacted without delay.

Patients should discontinue use and contact their healthcare provider if they experience any signs of an allergic reaction or any of the following symptoms indicative of stomach bleeding: feeling faint, vomiting blood, passing bloody or black stools, experiencing persistent stomach pain, or if pain worsens or lasts longer than 10 days. Additional symptoms warranting medical attention include redness or swelling, the emergence of new symptoms, or the occurrence of ringing in the ears or loss of hearing. Side effects may 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 chickenpox or flu-like symptoms. It is crucial that these individuals do not use 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 may also cause severe allergic reactions, which can manifest as hives, facial swelling, asthma (wheezing), or 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 carries a risk of severe stomach bleeding. The likelihood of this adverse reaction is increased 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, are using other NSAIDs (including aspirin, ibuprofen, or naproxen), consume three or more alcoholic drinks daily while using this product, or exceed the recommended dosage or duration of use.

Patients should discontinue use and consult a doctor if they experience any signs of stomach bleeding, which may include feeling faint, vomiting blood, having bloody or black stools, experiencing stomach pain that does not improve, or if pain worsens or persists for more than 10 days. Additional symptoms warranting medical attention include the presence of redness or swelling, the emergence of new symptoms, or ringing in the ears or loss of hearing.

Before using this product, patients should consult a doctor 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 a diuretic. Furthermore, patients should seek advice from a doctor or pharmacist if they are taking prescription medications for anticoagulation, have diabetes, gout, or arthritis.

Drug Interactions

Co-administration of aspirin with anticoagulant medications may elevate the risk of bleeding complications. Healthcare professionals should exercise caution when prescribing these agents together and consider monitoring for signs of hemorrhage.

Additionally, the concomitant use of aspirin with other nonsteroidal anti-inflammatory drugs (NSAIDs), such as ibuprofen or naproxen, significantly increases the likelihood of severe gastrointestinal bleeding. It is advisable to avoid the simultaneous use of these medications to mitigate this risk.

No specific interactions with laboratory tests have been identified in the available data.

Packaging & NDC

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

Packaging configurations for Aspirin 81mg Enteric Coated.
Details

Pediatric Use

Pediatric patients, particularly 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. Healthcare professionals should advise that if any changes in behavior accompanied by nausea and vomiting occur while using this product, a doctor should be consulted, as these may be early signs of this rare but serious illness.

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

Geriatric Use

Elderly patients, particularly those aged 60 and older, may have an increased risk of severe stomach bleeding. It is essential for healthcare providers to exercise caution when prescribing this medication to geriatric patients.

Monitoring for signs of gastrointestinal bleeding is advised, and dosage adjustments may be necessary based on the individual patient's health status and concurrent medications. Careful assessment of the risks versus benefits should be conducted to ensure the safety of elderly patients receiving this treatment.

Pregnancy

Pregnant patients and those who are breastfeeding should consult a healthcare professional prior to use. The use of aspirin during the last trimester of pregnancy is particularly cautioned against, as it may lead to adverse effects on the unborn child or complications during delivery. Therefore, it is essential for healthcare providers to evaluate the risks and benefits before recommending aspirin to pregnant patients, especially in the later stages of pregnancy.

Lactation

Lactating mothers are advised to consult a health professional prior to using this medication. It is particularly important to avoid the use of aspirin during the last three months of pregnancy unless specifically directed by a physician, 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. Therefore, caution is recommended when considering the use of this medication while breastfeeding.

Renal Impairment

Patients with renal impairment should consult a healthcare professional prior to use, particularly if they have conditions such as 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 severity 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 overdose, it is imperative to seek immediate medical assistance or contact a Poison Control Center without delay. Prompt intervention is crucial to mitigate potential adverse effects associated with the overdose.

Healthcare professionals should be vigilant in monitoring for symptoms that may arise from an overdose. While specific symptoms are not detailed in the provided information, it is essential to assess the patient for any signs of toxicity or distress.

Management of an overdose should be guided by established protocols, which may include supportive care and symptomatic treatment as necessary. Continuous evaluation of the patient's condition is recommended to ensure appropriate interventions are implemented in a timely manner.

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 or additional nonclinical toxicology details are available in the provided data. Furthermore, there are no specific findings related to animal pharmacology and toxicology.

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 in the event of an overdose. It is crucial to inform patients not to use the product if they have a known allergy to aspirin or any other pain reliever or fever reducer. Additionally, patients should be cautioned against using the product if they have previously experienced an allergic reaction to it or any of its ingredients.

Patients should be instructed to discontinue use and consult a doctor if they experience any signs of an allergic reaction, and to seek medical help immediately in such cases. They should also be made aware of the signs of potential stomach bleeding, which include feeling faint, vomiting blood, having bloody or black stools, experiencing stomach pain that does not improve, or if pain worsens or lasts more than 10 days. Patients should be advised to stop use and consult a doctor if redness or swelling occurs, new symptoms arise, or if they experience ringing in the ears or loss of hearing.

Healthcare providers should encourage patients to report any side effects to the designated number, 1-888-952-0050. It is important to ask patients if the warning regarding stomach bleeding applies to them and to recommend consulting a doctor before use if they have a history of stomach problems, such as heartburn. Patients with high blood pressure, heart disease, liver cirrhosis, or kidney disease should also be advised to seek medical advice prior to using the product.

Furthermore, patients taking diuretics, those with asthma, or individuals on prescription medications for anticoagulation should be encouraged to consult a doctor or pharmacist before use. Lastly, patients with diabetes, gout, or arthritis should also be advised to seek guidance from a healthcare professional before using the product.

Storage and Handling

The product is supplied in a configuration that includes an imprinted seal under the safety cap. It is essential to store the product at room temperature to maintain its integrity and effectiveness. Healthcare professionals should ensure that the product is not used if the imprinted seal is broken or missing, as this may indicate compromised safety or quality.

Additional Clinical Information

The medication is administered orally, with specific dosing guidelines for different age groups. Adults and children aged 12 years and older are advised to take 4 to 8 tablets every 4 hours, not exceeding 48 tablets in a 24-hour period unless directed by a physician. For children under 12 years, consultation with a doctor is recommended prior to use.

Clinicians should counsel patients regarding the use of this medication during pregnancy and breastfeeding, advising them to consult a healthcare professional before use. It is particularly important to avoid aspirin during the last trimester of pregnancy unless specifically instructed by a doctor, 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 81mg Enteric Coated, 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 81mg Enteric Coated, 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.

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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.