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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, 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 2009
Label revision date
April 10, 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, 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 2009
Label revision date
April 10, 2025
Manufacturer
Walgreen Company
Registration number
M013
NDC root
0363-0587
Drug Information (PDF)
Prescribing information, PDF file
Packaging Info (2 NDCs)
Packaging & NDC Codes (2)

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

Dye-Free Aspirin 81 is a low-dose pain reliever that contains 81 mg of aspirin, which is classified as a nonsteroidal anti-inflammatory drug (NSAID). It is designed to provide temporary relief from minor aches and pains, making it a suitable option for those seeking a gentle approach to pain management. The enteric-coated formulation helps to minimize stomach irritation, allowing for a more comfortable experience when taking the medication.

This product is not intended for immediate relief of headaches or other acute symptoms, as it has a delayed action. It is important to consult with your doctor or healthcare provider before using this product, especially if you are considering it for heart-related purposes.

Uses

This product is designed to help you find temporary relief from minor aches and pains, but it's important to use it as directed by your doctor. Keep in mind that it works slowly, 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 product, making it a safer option for those concerned about such risks.

Dosage and Administration

When taking this medication, it’s important to follow the directions carefully. You should not take more than the recommended amount. For adults and children aged 12 years and older, the typical dosage is to take 4 to 8 tablets every 4 hours. However, you should not exceed 48 tablets in a 24-hour period unless your doctor has specifically instructed you to do so.

Make sure to drink a full glass of water with each dose to help the medication work effectively. If you are considering giving this medication to a child under 12 years old, please consult a doctor first, as it should not be used in that age group without medical advice.

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 use it if you have previously 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.

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, take blood thinners or steroids, have a history of stomach ulcers, or consume alcohol regularly. If you notice any signs of stomach bleeding, such as vomiting blood, having bloody or black stools, or experiencing severe stomach pain, seek medical attention immediately. Other concerning symptoms include ringing in the ears, worsening pain, or new symptoms that arise. Always consult your doctor if you experience any of these issues.

Warnings and Precautions

You should be aware of some important warnings and precautions when using this product. If you are a child or teenager recovering from chickenpox or flu-like symptoms, do not use this product, as it may lead to Reye’s syndrome, a rare but serious illness. Additionally, be cautious of 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 cause severe stomach bleeding, especially if you are over 60, take blood thinners or steroids, have a history of stomach ulcers, or consume three or more alcoholic drinks daily.

Before using this product, consult your doctor if you have asthma, a history of stomach problems, high blood pressure, heart disease, liver cirrhosis, or kidney disease. It's also wise to check with your doctor or pharmacist if you are taking medications for gout, diabetes, or arthritis. If you experience any signs of an allergic reaction, stomach bleeding (such as vomiting blood or having black stools), or if your pain or fever worsens or lasts too long, stop using the product and call your doctor immediately. In case of an overdose, seek emergency medical help or contact a Poison Control Center 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 typical side effects.

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 ensuring your safety and well-being.

Pregnancy Use

If you are pregnant or breastfeeding, it’s essential to consult with a healthcare professional before using any medication. This is particularly important for aspirin; using it after 20 weeks of pregnancy can lead to serious issues for your unborn child or complications during delivery. Always seek guidance from your doctor to ensure the safety of both you and your baby.

Lactation Use

If you are pregnant or breastfeeding, it's important to consult with a healthcare professional before using any medication. Specifically, if you are considering taking aspirin, be aware that it is particularly risky to use after 20 weeks of pregnancy unless your doctor has specifically advised you to do so. Taking aspirin during this time may lead to potential issues for your unborn child or complications during delivery. Always prioritize your health and your baby's well-being by seeking professional guidance.

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, consult a doctor immediately, as these could be early signs of Reye's syndrome, a rare but serious condition.

For children under 12 years old, you should only use this product if directed by a doctor. 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 advised by a healthcare professional. Always prioritize your child's safety and consult with a doctor if you have any concerns.

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 make sure to inform your doctor about your age and any other health conditions you may have, as they can help you manage your medications safely and effectively. 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 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 your health by discussing any existing liver issues with your doctor to ensure proper care and monitoring.

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, the risk of severe stomach bleeding increases. Additionally, if you are on a diuretic (a medication that helps remove excess fluid from the body), or if you take prescription drugs for gout, diabetes, or arthritis, you should consult your doctor or pharmacist before starting any new medication.

Always discuss your current medications and any planned treatments with your healthcare provider. This ensures that you receive safe and effective care tailored to your health needs.

Storage and Handling

To ensure the best performance of your product, store it at a temperature of 25°C (77°F). It can safely be kept within a range of 15°-30°C (59°-86°F) for short periods. Always check the end flap for the expiration date and lot number to confirm its validity before use.

When handling the product, make sure to do so in a clean environment to maintain its integrity. Proper storage and careful handling are essential for safety and effectiveness, so please follow these guidelines closely.

Additional Information

You should take this medication orally. Before using it for your heart, it's important to talk to your doctor or another healthcare provider to ensure it's appropriate for you. They can provide guidance tailored to your specific health needs.

FAQ

What is Dye-Free Aspirin 81 used for?

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

How should I take Dye-Free Aspirin 81?

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 age restrictions for using this product?

Children under 12 years should not use this product unless directed by a doctor.

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 Dye-Free Aspirin 81?

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.

Can I use Dye-Free Aspirin 81 if I am pregnant or breastfeeding?

If you are pregnant or breastfeeding, consult a health professional before use, especially after 20 weeks of pregnancy.

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

Stop use and call your doctor if you experience symptoms like vomiting blood, bloody or black stools, or stomach pain that does not improve.

Is there a risk of severe stomach bleeding?

Yes, the risk of severe stomach bleeding is higher if you take blood thinners, are over 60 years old, or have a history of stomach ulcers.

What should I do if I miss a dose?

If you miss a dose, take it as soon as you remember, but do not take more than directed.

Where should I store Dye-Free Aspirin 81?

Store at 25°C (77°F), with permitted excursions between 15°-30°C (59°-86°F).

Packaging Info

Below are the non-prescription pack sizes of Aspirin. 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

Dye-Free Aspirin 81 is an enteric-coated formulation containing 81 mg of aspirin, classified as a nonsteroidal anti-inflammatory drug (NSAID) indicated for pain relief. This low-dose preparation is designed to minimize gastrointestinal irritation. Each bottle contains 120 tablets, ensuring a sufficient supply for therapeutic use.

Uses and Indications

This drug is indicated for the temporary relief of minor aches and pains, as well as for use as recommended by a healthcare professional. It is important to note that 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 teratogenic or nonteratogenic effects associated with this drug.

Dosage and Administration

Patients should adhere strictly to the recommended dosage. Each dose should be taken with a full glass of water to ensure proper administration.

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 specifically directed by a healthcare professional.

For children under 12 years of age, the use of this medication is not advised unless directed by a physician.

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 taking anticoagulants or steroid medications, are aged 60 years or older, are using other NSAIDs (including aspirin, ibuprofen, or naproxen), have a history of stomach ulcers or bleeding disorders, exceed the recommended dosage or duration of use, or consume three or more alcoholic beverages daily while using this product.

Before initiating treatment, patients should consult a healthcare provider if they have a history of asthma, if the stomach bleeding warning applies to them, if they have experienced stomach issues such as heartburn, if they are taking diuretics, or if they have conditions such as high blood pressure, heart disease, liver cirrhosis, or kidney disease. Additionally, patients should seek advice from a doctor or pharmacist if they are currently taking prescription medications for gout, diabetes, or arthritis.

In the event of an overdose, it is crucial to seek emergency medical assistance or contact a Poison Control Center immediately.

Patients should discontinue use and contact their healthcare provider if they experience any signs of an allergic reaction, such as hives or swelling. They should also seek medical attention if they notice any symptoms indicative of stomach bleeding, including vomiting blood, passing bloody or black stools, feeling faint, or experiencing persistent stomach pain. Other concerning symptoms that warrant immediate medical consultation include ringing in the ears or hearing loss, worsening pain lasting more than 10 days, fever that worsens or persists beyond three days, visible redness or swelling, or the emergence of new symptoms, which may suggest a serious underlying condition.

Side Effects

Patients using this product should be aware of several serious adverse reactions associated with its use. Notably, 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, the product carries an allergy alert, as aspirin may induce severe allergic reactions. Symptoms of such reactions can include hives, facial swelling, shock, and asthma (wheezing). Patients experiencing any signs of an allergic reaction should seek medical help right away.

The product also contains a nonsteroidal anti-inflammatory drug (NSAID), which may lead to severe stomach bleeding. The risk of this adverse reaction is heightened in patients who are taking blood thinners or steroid medications, are aged 60 or older, are using other NSAIDs (including prescription or nonprescription options such as aspirin, ibuprofen, or naproxen), have a history of stomach ulcers or bleeding problems, exceed the recommended dosage or duration of use, or consume three or more alcoholic drinks daily while using this product.

Patients are advised to stop using the product and consult a doctor if they experience any signs of stomach bleeding, which may include vomiting blood, having bloody or black stools, feeling faint, or experiencing persistent stomach pain. Other concerning symptoms that warrant medical attention include ringing in the ears or loss of hearing, worsening pain lasting more than 10 days, fever that worsens or lasts more than three days, redness or swelling, or the emergence of new symptoms. These could indicate a serious condition requiring prompt evaluation.

Drug Interactions

The concomitant use of anticoagulants or steroid medications may significantly increase the risk of severe gastrointestinal bleeding. Healthcare professionals should closely monitor patients who are prescribed these medications alongside the drug in question.

Patients taking diuretics are advised to consult with their healthcare provider prior to initiating therapy with this drug to ensure safe and effective use.

Additionally, individuals on prescription medications for gout, diabetes, or arthritis should seek guidance from a healthcare professional or pharmacist before starting this drug. This precaution is essential to avoid potential adverse interactions and to determine the appropriateness of dosage adjustments or enhanced monitoring.

Packaging & NDC

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

Packaging configurations for Aspirin.
Details

Pediatric Use

Pediatric patients, particularly those under 12 years of age, should not use this product unless directed by a healthcare professional. For children and teenagers who are experiencing or recovering from chicken pox or flu-like symptoms, the use of this product is contraindicated due to the risk of Reye’s syndrome, a rare but serious condition.

In the event of changes in behavior accompanied by nausea and vomiting while using this product, it is essential to consult a doctor, 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 healthcare provider.

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 and symptoms 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 is particularly cautioned against after 20 weeks of gestation unless explicitly directed by a physician, as it may pose risks to the developing fetus and lead to complications during delivery. Healthcare providers should carefully evaluate the potential benefits and risks when considering the use of this medication in pregnant patients.

Lactation

Lactating mothers are advised to consult a health professional before using this medication. It is particularly important to avoid the use of aspirin at 20 weeks of pregnancy or later 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 during lactation.

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 liver function to ensure safe and effective 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 aware that the specific symptoms of an overdose may vary depending on the substance involved. Therefore, a thorough assessment of the patient's condition is essential to determine the appropriate course of action.

Management of an overdose typically involves supportive care and symptomatic treatment. Continuous monitoring of the patient's vital signs and clinical status is recommended. In cases where the specific substance is known, targeted therapies may be employed as indicated.

It is essential for healthcare providers to remain vigilant and act swiftly in the management of overdose situations to ensure optimal patient outcomes.

Nonclinical Toxicology

It is especially important not to use aspirin at 20 weeks or later in pregnancy unless definitely directed to do so by a doctor, as it may cause problems in the unborn child or complications during delivery. No non-teratogenic effects have been specified. Additionally, there are no details provided regarding nonclinical toxicology or animal pharmacology and toxicology.

Postmarketing Experience

No postmarketing experience details are available in the insert text.

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 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 should be stored at a controlled room temperature of 25°C (77°F), with permissible excursions between 15°C and 30°C (59°F to 86°F).

Healthcare professionals are advised to check the end flap of the packaging for the expiration date and lot number to ensure proper tracking and usage.

Additional Clinical Information

The product is administered orally. Clinicians should advise patients to consult with their doctor or healthcare provider prior to using this product for heart-related conditions. No further information is available regarding laboratory tests, abuse potential, or postmarketing experiences.

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.