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Low Dose Aspirin 81mg

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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
February 5, 2025
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
February 5, 2025
Manufacturer
BETTER LIVING BRANDS LLC.
Registration number
M013
NDC root
21130-481
Drug Information (PDF)
Prescribing information, PDF file
Packaging Info (4 NDCs)
Packaging & NDC Codes (4)

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

Enteric coated 81 mg Aspirin is a medication commonly used for the temporary relief of minor aches and pains, such as headaches or muscle discomfort. The enteric coating allows the aspirin to dissolve in the intestines rather than the stomach, which can help reduce stomach irritation. However, it's important to note that due to its delayed action, it may not provide quick relief for symptoms that require immediate attention.

If you're considering using enteric coated 81 mg Aspirin, it's a good idea to consult your doctor about its potential uses and whether it's the right choice for your specific needs.

Uses

You can use this medication for the temporary relief of minor aches and pains, as advised by your doctor. However, keep in mind that it works slowly, so it may not be suitable for quick relief of headaches or other symptoms that require immediate attention. If you're curious about additional uses for enteric coated 81 mg Aspirin, it's a good idea to consult your doctor for more information.

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 these guidelines 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 about allergies or reactions.

Side Effects

You should be aware of some important warnings and potential side effects when using this product. It is not recommended for children and teenagers recovering from chickenpox or flu-like symptoms due to the risk of Reye’s syndrome, a rare but serious illness. If you notice changes in behavior accompanied by nausea and vomiting, consult a doctor immediately. Additionally, aspirin can cause severe allergic reactions, which may include hives, facial swelling, asthma (wheezing), or shock.

This product contains a nonsteroidal anti-inflammatory drug (NSAID), which can lead to serious 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. It's also important to stop using the product and consult a doctor if your pain worsens or lasts more than 10 days, or if you develop new symptoms. Always talk to your doctor before using this product if you have a history of stomach problems, high blood pressure, heart disease, or other specific health conditions.

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 may lead to Reye’s syndrome, a rare but serious illness. Additionally, be cautious of potential allergic reactions, which can include hives, facial swelling, asthma (wheezing), or shock. This product also contains a nonsteroidal anti-inflammatory drug (NSAID), which can cause 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 a history of stomach problems, high blood pressure, heart disease, liver cirrhosis, kidney disease, or if you are taking certain medications like diuretics or other NSAIDs. If you experience any signs of an allergic reaction or stomach bleeding—such as feeling faint, vomiting blood, or having bloody or black 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

Taking too much of this product can lead to serious health issues. If you or someone you know has taken an overdose, it's important to be aware of the symptoms, which may include nausea (feeling sick), vomiting, and stomach pain.

If you suspect an overdose, seek immediate medical attention or contact a Poison Control Center right away. Acting quickly can make a significant difference in ensuring safety and health.

Pregnancy Use

If you are pregnant or breastfeeding, it’s crucial to consult with a healthcare professional before using any medication. This is especially important for aspirin, which should generally be avoided during the last three months of pregnancy unless your doctor specifically advises you to take it. Using aspirin at this stage 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 professional guidance.

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 potentially lead to 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 have or are 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 experiences 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 children under 12 years old, it's essential to consult a doctor before use. For those aged 12 and older, 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. Always prioritize your child's safety and seek medical advice when necessary.

Geriatric Use

As you age, it's important to be aware that the risk of severe stomach bleeding increases if you are 60 years or older. This means that if you or a loved one falls into this age group, extra caution should be taken when using certain medications, especially those that can irritate the stomach.

Always consult with your healthcare provider about the safest options for you, and make sure to discuss any medications you are taking to help minimize potential risks. Your health and safety are paramount, so staying informed and proactive is key.

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 determine the best approach for managing your health, especially if you have concerns about your kidneys.

Hepatic Impairment

If you have liver problems, it's important to know that the information provided does not include specific guidelines for dosage adjustments, special monitoring, or precautions related to your condition. This means that there are no tailored recommendations for how the medication may affect you differently due to your liver health.

Always consult your healthcare provider for personalized advice and to ensure that any treatment plan is safe and effective for your specific situation. They can help you understand how to manage your health while considering your liver condition.

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 (medications that help prevent blood clots) or steroids, using this product may increase your risk of stomach bleeding. Additionally, combining it with other nonsteroidal anti-inflammatory drugs (NSAIDs) like aspirin, ibuprofen, or naproxen can further heighten this risk.

Before starting this product, you should also consult with your healthcare provider if you are taking prescription medications for conditions like gout, diabetes, or arthritis. Discussing all your medications and any lab tests with your doctor or pharmacist is crucial to ensure your safety and well-being.

Storage and Handling

To ensure the best performance of your product, store it at room temperature, keeping it away from excessive heat. Temperatures above 40°C (104°F) can damage the product, so it's important to maintain a stable environment.

When handling the product, always do so with clean hands and in a clean area to prevent contamination. If you have any specific disposal instructions, be sure to follow them carefully to ensure safety.

Additional Information

No further information is available.

FAQ

What is enteric coated 81 mg Aspirin used for?

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

How should I take enteric coated 81 mg 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. Always drink a full glass of water with each dose.

Are there any contraindications for using enteric coated 81 mg Aspirin?

Do not use this product if you are allergic to aspirin or any other pain reliever/fever reducer, or if you have ever had an allergic reaction to it or its ingredients.

What should I do if I experience an allergic reaction?

If an allergic reaction occurs, seek medical help right away.

What are the warnings associated with enteric coated 81 mg Aspirin?

Warnings include the risk of Reye’s syndrome in children recovering from chicken pox or flu-like symptoms, severe allergic reactions, and the potential for stomach bleeding, especially in older adults or those with certain medical conditions.

Can I use enteric coated 81 mg 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 use and call your doctor if you feel faint, vomit blood, have bloody or black stools, or have stomach pain that does not get better.

Is there a risk of drug interactions with enteric coated 81 mg Aspirin?

Yes, taking this product may increase the risk of stomach bleeding if you are on blood thinners or other NSAIDs. Consult your doctor or pharmacist if you are taking prescription drugs for gout, diabetes, or arthritis.

What should I do in case of overdose?

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

Packaging Info

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

Packaging configurations for Low Dose Aspirin 81mg.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

The product is identified by the SPL Code 34089-3. No additional specific description details are provided in the available data.

Uses and Indications

This drug is indicated for the temporary relief of minor aches and pains, or as recommended by a healthcare professional. Due to its delayed action, this product is not suitable for the fast relief of headaches or other symptoms requiring immediate alleviation. Healthcare providers may consider discussing additional uses for enteric coated 81 mg Aspirin with patients.

There are no teratogenic or nonteratogenic effects associated with this drug.

Dosage and Administration

Patients should take the medication with a full glass of water to ensure proper administration and absorption.

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 individuals with a known allergy to aspirin or any other pain reliever or fever reducer. Additionally, the product should not be administered to 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 in some individuals. Symptoms of such reactions can include hives, facial swelling, asthma (wheezing), and 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 patients 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 while using this product, or exceed the recommended dosage or duration of use.

Healthcare providers 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.

In the event of an overdose, immediate medical assistance should be sought, or the Poison Control Center (1-800-222-1222) should be contacted.

Patients should be instructed to discontinue use and contact their healthcare provider if they experience any signs of an allergic reaction, symptoms indicative of stomach bleeding (such as feeling faint, vomiting blood, having bloody or black stools, or persistent stomach pain), worsening pain lasting more than 10 days, fever lasting more than 3 days, redness or swelling, the emergence of new symptoms, or any ringing in the ears or loss of hearing.

Side Effects

Patients using this product should be aware of several serious adverse reactions associated with its use. Reye’s syndrome is a rare but serious illness that can occur in children and teenagers who have or are recovering from chickenpox or flu-like symptoms. If patients experience changes in behavior accompanied by nausea and vomiting while using this product, they should consult a doctor immediately, as these may be early signs of Reye’s syndrome.

Additionally, this product may cause severe allergic reactions in some individuals. 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.

The 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 anticoagulants or steroid medications, 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 are 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 stomach pain that does not improve. Other reasons to seek medical advice include worsening pain lasting more than 10 days, fever that worsens or lasts more than three days, presence of redness or swelling, occurrence of new symptoms, or symptoms such as ringing in the ears or loss of hearing.

Before using this product, patients should consult a doctor if any of the following apply: they have a history of stomach problems such as heartburn, high blood pressure, heart disease, liver cirrhosis, or kidney disease; they are taking diuretics; or they have asthma. Furthermore, patients should seek advice from a doctor or pharmacist if they are taking prescription medications for gout, diabetes, or arthritis.

Drug Interactions

Taking this product concurrently with anticoagulants or steroid medications may elevate the risk of gastrointestinal bleeding. This risk is further compounded in patients who are also using other nonsteroidal anti-inflammatory drugs (NSAIDs), including but not limited to aspirin, ibuprofen, and naproxen.

Patients on prescription medications for gout, diabetes, or arthritis should consult with a healthcare professional prior to using this product to ensure safe co-administration and to evaluate the need for dosage adjustments or enhanced monitoring.

Packaging & NDC

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

Packaging configurations for Low Dose Aspirin 81mg.
Details

Pediatric Use

Pediatric patients, particularly those under 12 years of age, should consult a doctor before using this product. It is contraindicated in children and teenagers who have or are recovering from chickenpox or flu-like symptoms 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, a healthcare professional should be consulted, as these may be early signs of Reye’s syndrome.

For patients aged 12 years and older, the recommended dosage is 4 to 8 tablets every 4 hours, with a maximum of 48 tablets in a 24-hour period unless otherwise directed by a doctor.

Geriatric Use

Elderly patients, particularly those aged 60 and older, may have an increased risk of severe stomach bleeding. Healthcare providers should exercise caution when prescribing this medication to geriatric patients, considering the potential for heightened adverse effects.

It is advisable to closely monitor these patients for any signs of gastrointestinal bleeding and to evaluate the necessity of dosage adjustments based on individual patient factors. Careful assessment of the risk-benefit ratio is essential when treating elderly patients with this medication.

Pregnancy

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

Lactation

Lactating mothers are advised to consult a health professional before 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 doctor, 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 its use in 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 have not been specifically studied in relation to the use of this medication. Consequently, there are no established dosage adjustments, special monitoring requirements, or precautions outlined for individuals with compromised liver function. It is recommended that healthcare providers exercise caution when prescribing this medication to patients with hepatic impairment, given the lack of data on its safety and efficacy in this population. Regular monitoring of liver function may be prudent in these cases, although specific parameters are not defined in the available information.

Overdosage

Overdosage of this product can lead to significant adverse effects. Healthcare professionals should be aware that symptoms associated with an overdose may include nausea, vomiting, and abdominal pain.

In the event of an overdose, it is imperative to seek immediate medical attention. Additionally, contacting a Poison Control Center is strongly recommended to ensure appropriate management and intervention. Prompt action is crucial to mitigate potential harm and address any complications that may arise from the overdosage.

Nonclinical Toxicology

It is especially important not to use aspirin during the last three months of pregnancy unless specifically directed by a healthcare professional, as it may lead to complications for the unborn child or 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 several adverse reactions reported voluntarily or through surveillance programs. These include allergic reactions such as hives, facial swelling, asthma (wheezing), and shock. Additionally, cases of stomach bleeding have been noted, particularly in patients who are 60 years of age or older, have a history of stomach ulcers or bleeding problems, are taking blood-thinning (anticoagulant) or steroid medications, are using other drugs that contain prescription or nonprescription NSAIDs, consume three or more alcoholic drinks daily while using this product, or exceed the recommended duration or dosage.

Patient Counseling

Patients should be advised to keep this medication out of reach of children to prevent accidental ingestion. In the event of an overdose, it is crucial to seek medical assistance immediately or contact a Poison Control Center at 1-800-222-1222.

Patients must be informed not to use this medication if they have a known allergy to aspirin or any other pain reliever or fever reducer. Additionally, they should avoid use if they have previously experienced an allergic reaction to this product or any of its ingredients. If an allergic reaction occurs, patients should stop using the medication and seek medical help right away.

Healthcare providers should instruct patients to 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, or experiencing stomach pain that does not improve. Patients should also be advised to stop use and seek medical advice if their pain worsens or persists for more than 10 days, if their fever worsens or lasts more than 3 days, if redness or swelling is present, if new symptoms arise, or if they experience ringing in the ears or a loss of hearing.

It is important for patients to consult a doctor before using this medication if they have a history of stomach problems, such as heartburn, or if the stomach bleeding warning applies to them. Patients with high blood pressure, heart disease, liver cirrhosis, or kidney disease should also seek medical advice prior to use. Furthermore, patients taking diuretics, those with asthma, or individuals on prescription medications for gout, diabetes, or arthritis should consult a doctor or pharmacist before using this product.

Storage and Handling

The product is supplied in various package configurations, with specific NDC numbers available for identification. It is essential to store the product at room temperature, ensuring that it is kept away from excessive heat, particularly temperatures exceeding 40°C (104°F). Proper storage conditions are crucial to maintain the integrity and efficacy of the product.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

This file contains official product information for Low Dose Aspirin 81mg, 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 Low Dose Aspirin 81mg, 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.