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Low Dose 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, Coated
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
April 16, 2024
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, Coated
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
April 16, 2024
Manufacturer
P & L Development, LLC
Registration number
M013
NDC root
59726-065
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 81 mg is a type of pain reliever known as a nonsteroidal anti-inflammatory drug (NSAID). It is designed to provide temporary relief from minor aches and pains, and it comes in enteric-coated tablets, which help protect your stomach. While it can be effective for general discomfort, it's important to note that it may not provide quick relief for headaches or other symptoms that require immediate attention.

Before using aspirin, especially for heart-related purposes, it's advisable to consult with your doctor, as it may not be suitable for everyone. Additionally, there are other potential uses for this safety-coated 81 mg aspirin, so discussing your options with a healthcare provider can help you determine the best approach for your 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, it's a good idea to consult your doctor for more information regarding safety-coated 81 mg aspirin.

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 advises 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 to use the medication safely and effectively.

What to Avoid

You should avoid using this product if you are allergic to aspirin or any other pain reliever or fever reducer. Additionally, do not take it if you have ever experienced an allergic reaction to this product or any of its ingredients. It's important to prioritize your safety and well-being by adhering to these guidelines. If you have any concerns or questions, please consult with a healthcare professional.

Side Effects

You should be aware of some important side effects and warnings associated with this product. If you are a child or teenager recovering from chickenpox or flu-like symptoms, you should avoid using it, as it may lead to Reye's syndrome, a rare but serious illness. Additionally, be cautious of potential severe allergic reactions, which can include hives, facial swelling, shock, or asthma symptoms like wheezing.

This product contains a nonsteroidal anti-inflammatory drug (NSAID), which 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 steroids. If you experience symptoms such as feeling faint, vomiting blood, having bloody or black stools, or persistent stomach pain, you should stop using the product and consult a doctor immediately. Other signs to watch for include worsening pain, redness or swelling, ringing in the ears, or any new symptoms.

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 allergic reactions, which may include hives, facial swelling, shock, or asthma symptoms like wheezing. This product contains an NSAID, which 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 steroids.

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. 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 at 1-800-222-1222 right away. Always take this medication as directed and be mindful of any new or worsening symptoms.

Overdose

If you suspect an overdose, it’s crucial 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 vital. Always prioritize your health and safety by reaching out for help as soon as you notice any concerning symptoms.

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 specifically advises 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 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

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. Additionally, if you notice any changes in their behavior along with nausea and vomiting while using it, contact a doctor immediately, as these could be early signs of Reye's syndrome, a rare but serious condition.

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 best to consult a doctor before giving them this medication. Always keep this product out of reach of children to ensure their safety.

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 be particularly cautious and discuss any medications you are taking with your healthcare provider to ensure they are safe for you.

Always inform your doctor about your age and any other health conditions you may have, as they can help you manage your medications effectively and minimize potential risks. Your safety is a priority, so don't hesitate to ask questions or express any concerns you may have.

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 can help determine if this treatment is safe for you and whether any adjustments are needed based on your kidney function. Always prioritize open communication with your doctor regarding your health conditions.

Hepatic Impairment

If you have liver problems, such as liver cirrhosis, it's important to be aware of how this may affect your treatment. Your healthcare provider may need to adjust your medication dosage or monitor your liver function closely. This is because your liver plays a key role in processing medications, and any impairment can change how your body responds to them.

Make sure to discuss your liver condition with your doctor, especially if you have other health issues like high blood pressure or heart disease. They will guide you on the best approach to manage your health safely.

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 face a higher risk of severe stomach bleeding. Additionally, using other nonsteroidal anti-inflammatory drugs (NSAIDs) like aspirin, ibuprofen, or naproxen can also increase this risk. If you are on prescription medications for conditions such as gout, diabetes, or arthritis, it's crucial to consult your healthcare provider to ensure your safety.

While there are no specific interactions with laboratory tests noted, discussing all your medications with your doctor is essential. This helps them provide the best care and avoid any potential complications. Always keep your healthcare provider informed about what you are taking to ensure your treatment is safe and effective.

Storage and Handling

To ensure the safety and effectiveness of your product, store it in a cool, dry place at a temperature between 15-30ºC (59-86ºF). This temperature range helps maintain the integrity of the device.

When handling the product, be sure to do so with clean hands and in a sterile field (a clean area free from germs) to prevent contamination. Always follow any specific disposal instructions provided to ensure safe and responsible disposal of any components.

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 appropriate dosing.

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 81 mg used for?

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

How should I take Aspirin 81 mg?

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.

Are there any warnings associated with Aspirin 81 mg?

Yes, you should not use Aspirin if you are allergic to it or any other pain reliever. It may also cause severe stomach bleeding, especially if you are over 60, have a history of stomach problems, or take certain medications.

What should I do if I experience an allergic reaction?

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

Can I use Aspirin 81 mg 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 it during the last 3 months of pregnancy unless directed by a doctor.

What should I do if I have high blood pressure or heart disease?

You should ask a doctor before using Aspirin if you have high blood pressure, heart disease, liver cirrhosis, or kidney disease.

What is Reye's syndrome and how is it related to Aspirin?

Reye's syndrome is a rare but serious illness that can occur in children and teenagers recovering from chicken pox or flu-like symptoms. They should not use Aspirin, and if behavioral changes with nausea and vomiting occur, consult a doctor.

How should I store Aspirin 81 mg?

Store Aspirin 81 mg between 15-30ºC (59-86ºF) and keep it out of reach of children.

Packaging Info

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

Packaging configurations for Low Dose Aspirin.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

Low Dose Aspirin is formulated as enteric-coated tablets, each containing 81 mg of aspirin, a nonsteroidal anti-inflammatory drug (NSAID) utilized for its analgesic properties. The enteric coating is designed to minimize gastrointestinal irritation and protect against stomach upset. This product is not intended for households with young children. It features a tamper-evident safety seal; do not use if the printed safety seal under the cap is broken or missing. Low Dose Aspirin is distributed by PL Developments, located at 200 Hicks Street, Westbury, NY 11590.

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 professionals are encouraged to inquire about additional uses for safety coated 81 mg aspirin. There are no teratogenic or nonteratogenic effects associated with this medication.

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 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 illness.

Aspirin may provoke severe allergic reactions in some individuals. Symptoms of such reactions can include hives, facial swelling, shock, and asthma (wheezing). 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 without delay.

Patients should be instructed to discontinue use and contact their healthcare provider if they experience any of the following: 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 that lasts more than 10 days, redness or swelling, ringing in the ears, loss of hearing, or the emergence of new symptoms. These may signify a serious condition requiring prompt medical evaluation.

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 may 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 symptoms could indicate the onset of Reye's syndrome.

Additionally, there is an allergy alert associated with this product. Aspirin may cause severe allergic reactions, which can manifest as hives, facial swelling, shock, or asthma symptoms such as wheezing. 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 warning for the potential of severe stomach bleeding. The risk of stomach bleeding is heightened 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 an allergic reaction or symptoms indicative of stomach bleeding, such as feeling faint, vomiting blood, having bloody or black stools, or experiencing persistent stomach pain. Furthermore, if pain worsens or lasts longer than 10 days, if redness or swelling occurs, if there is ringing in the ears or loss of hearing, or if new symptoms arise, medical advice should be sought, as these could be signs of a serious condition.

Drug Interactions

The concomitant use of anticoagulants or steroid medications may significantly elevate the risk of severe gastrointestinal bleeding. Healthcare professionals should exercise caution when prescribing these agents together and consider monitoring for signs of bleeding.

Additionally, the use of nonsteroidal anti-inflammatory drugs (NSAIDs), including both prescription and over-the-counter options such as aspirin, ibuprofen, and naproxen, can further increase the risk of severe stomach bleeding when taken concurrently with the aforementioned medications. It is advisable to assess the necessity of NSAID therapy in patients already on anticoagulants or steroids.

Patients who are prescribed medications for gout, diabetes, or arthritis should consult their healthcare provider to evaluate potential interactions and the need for dosage adjustments or enhanced monitoring.

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

Packaging & NDC

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

Packaging configurations for Low Dose Aspirin.
Details

Pediatric Use

Children and teenagers who have or are 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 important to consult a doctor, as these may be early signs of Reye's syndrome.

For dosing, adults and children aged 12 years and older may take 4 to 8 tablets every 4 hours, not to exceed 48 tablets in a 24-hour period unless directed by a doctor. For children under 12 years of age, consultation with a doctor is advised before use. Additionally, this product should be kept out of reach of children to ensure safety.

Geriatric Use

Elderly patients, particularly those aged 60 and older, are at an increased risk of severe stomach bleeding. It is essential for healthcare providers to exercise caution when prescribing medications that may exacerbate this risk in this population.

Close monitoring of gastrointestinal symptoms is recommended for geriatric patients, especially when initiating treatment or adjusting dosages. Healthcare providers should consider the overall health status and concurrent medications of elderly patients to mitigate potential adverse effects.

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 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 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 may experience altered pharmacokinetics of the drug due to compromised liver function. It is essential to assess liver function prior to initiating treatment and to monitor liver parameters throughout the course of therapy.

In patients with liver cirrhosis, dosage adjustments may be necessary to mitigate the risk of adverse effects. Close monitoring of liver function tests, including alanine aminotransferase (ALT), aspartate aminotransferase (AST), and bilirubin levels, is recommended to ensure patient safety and therapeutic efficacy.

Additionally, patients with a history of high blood pressure, heart disease, or kidney disease should be evaluated for potential interactions and contraindications related to their hepatic condition. It is crucial to tailor treatment plans based on the severity of hepatic impairment to optimize outcomes while minimizing risks.

Overdosage

In the event of an overdose, it is imperative to seek immediate medical assistance. Healthcare professionals are advised to contact a Poison Control Center at 1-800-222-1222 for guidance on managing the situation effectively.

Prompt intervention is crucial in mitigating potential adverse effects associated with an overdose. Symptoms may vary depending on the substance involved, and healthcare providers should be prepared to assess and manage these symptoms accordingly.

Management procedures may include supportive care and symptomatic treatment, tailored to the specific clinical presentation of the patient. Continuous monitoring and evaluation are essential to ensure patient safety and to address any complications that may arise during the course of treatment.

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

No specific postmarketing experience details have been reported in the available data. As such, there are no additional adverse events or rare case reports to summarize at this time.

Patient Counseling

Healthcare providers should advise patients to seek immediate medical assistance or contact a Poison Control Center at 1-800-222-1222 in the event of an overdose. It is essential for patients to understand the importance of prompt action in such situations to ensure their safety and well-being.

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 a temperature range of 15-30ºC (59-86ºF) to maintain its efficacy and stability. Proper storage conditions must be adhered to, ensuring that the product is kept within the specified temperature limits to prevent degradation.

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. It is particularly important to avoid aspirin in the last trimester of pregnancy unless explicitly directed by a healthcare professional, 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 Low Dose 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 Low Dose 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

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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.