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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 2011
Label revision date
March 12, 2026
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 2011
Label revision date
March 12, 2026
Manufacturer
CVS Pharmacy
Registration number
M013
NDC root
59779-600
Drug Information (PDF)
Prescribing information, PDF file
Packaging Info (11 NDCs)
Packaging & NDC Codes (11)

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

Low Dose Aspirin is a type of pain reliever known as a nonsteroidal anti-inflammatory drug (NSAID). It comes in coated tablets, each containing 81 mg of the active ingredient, designed to provide temporary relief from minor aches and pains. However, it's important to note that it is not intended for quick relief of headaches or other symptoms that require immediate attention, as it has a delayed action.

Before using Low Dose Aspirin, especially for heart-related purposes, it's advisable to consult with your doctor or healthcare provider. This product is similar to Bayer® Low Dose Aspirin but is distributed by CVS Pharmacy, Inc.

Uses

This product is designed to help you find temporary relief from minor aches and pains, as advised by your doctor. It's important to note that due to its delayed action, it may not be suitable for quick relief of headaches or other symptoms that require immediate attention.

If you're considering using this product, keep in mind that it does not have any known teratogenic effects (which means it doesn't cause birth defects) or nonteratogenic effects. Always consult with your healthcare provider for personalized advice and recommendations.

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 advises otherwise.

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 without their guidance.

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

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 other NSAIDs, have a history of stomach ulcers, or consume alcohol regularly. If you experience symptoms such as vomiting blood, faintness, bloody or black stools, or persistent stomach pain, you should stop using the product and consult a doctor immediately. Other concerning signs include ringing in the ears, worsening pain, or new symptoms. Always seek medical advice if you notice 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 increase the risk of severe stomach bleeding, especially if you are over 60, have a history of stomach issues, or consume alcohol regularly.

Before using this product, consult your doctor if you have any history of stomach problems, high blood pressure, heart disease, liver cirrhosis, kidney disease, or asthma. It's also wise to check with your doctor or pharmacist if you are taking medications for 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 contact 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. Your health and safety are the top priority.

Pregnancy Use

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

Particularly, be cautious with aspirin. Avoid using it after 20 weeks of pregnancy unless your doctor specifically advises you to do so, as it 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 after 20 weeks of pregnancy, as it may pose risks to your unborn child or lead to complications during delivery. Always prioritize your health and the health of your baby by seeking guidance from your doctor.

Pediatric Use

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

For 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 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 tailor your treatment plan to minimize risks and keep you safe.

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 specific dosage adjustments or 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 medical issues with your doctor to ensure proper care and monitoring.

Drug Interactions

It's important to have open conversations with your healthcare provider about any medications or tests you may be taking. While there are no specific drug interactions or laboratory test interactions noted for this medication, your healthcare provider can help ensure that everything you are taking works well together and is safe for you. Always share your complete list of medications and any health conditions you have to receive the best care possible.

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 expiration date on the package and use the product before this date to guarantee its effectiveness.

When handling the product, make sure to do so with clean hands and in a safe environment to maintain its integrity. Proper storage and careful handling are key to ensuring your product remains safe and effective for use.

Additional Information

You should take this medication orally. If you are pregnant or breastfeeding, it’s important to consult with a healthcare professional before using it. Specifically, avoid using aspirin after 20 weeks of pregnancy unless your doctor has specifically instructed you to do so, as it can lead to issues for the unborn child or complications during delivery.

FAQ

What is Low Dose Aspirin used for?

Low Dose Aspirin is used for the temporary relief of minor aches and pains, or as recommended by your doctor.

How should I take Low Dose 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. Drink a full glass of water with each dose.

Are there any warnings for using Low Dose Aspirin?

Yes, do not use if you are allergic to aspirin or any other pain reliever. Be cautious of severe stomach bleeding, especially if you are age 60 or older or have a history of stomach problems.

Can children use Low Dose Aspirin?

Children under 12 years should not use this product unless directed by a doctor. Additionally, children and teenagers recovering from chicken pox or flu-like symptoms should avoid it due to the risk of Reye's syndrome.

What should I do if I experience an allergic reaction?

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

Is it safe to use Low Dose Aspirin during pregnancy?

If you are pregnant or breastfeeding, ask a health professional before use. It is especially important not to use aspirin at 20 weeks or later in pregnancy unless directed by a doctor.

What should I do if I miss a dose?

If you miss a dose, take it as soon as you remember. Do not double up on doses.

How should I store Low Dose Aspirin?

Store at 25°C (77°F); excursions are permitted between 15°-30°C (59°-86°F). Use by the expiration date on the package.

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

No description information is available for the specified drug.

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. 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. It is essential to drink a full glass of water with each dose 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 otherwise directed by a healthcare professional.

For children under 12 years of age, the use of this medication is not recommended unless specifically 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, a rare but serious illness. If any changes in behavior accompanied by nausea and vomiting occur while using this product, it is imperative to consult a healthcare professional immediately, as these may be early indicators of Reye's syndrome.

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 increases under certain conditions, including but not limited to: concurrent use of other NSAIDs (prescription or nonprescription), being aged 60 or older, exceeding the recommended dosage or duration of use, having a history of stomach ulcers or bleeding disorders, consuming three or more alcoholic beverages daily while using this product, or taking anticoagulants or steroid medications.

Healthcare providers should advise patients to consult a physician 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, asthma, or if they are currently taking diuretics. Additionally, patients should seek guidance from a doctor or pharmacist if they are on 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, feeling faint, passing bloody or black stools, 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, as these may signal 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, there is a significant risk of severe allergic reactions to aspirin, which may manifest as hives, facial swelling, shock, or asthma (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 may lead to severe stomach bleeding. The risk of this adverse reaction is heightened in patients who are taking other NSAIDs, are aged 60 or older, exceed the recommended dosage or duration of use, have a history of stomach ulcers or bleeding problems, consume three or more alcoholic drinks daily while using the product, or are taking blood-thinning (anticoagulant) or steroid medications.

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, feeling faint, having bloody or black stools, 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

There are currently no documented drug interactions associated with this medication. Additionally, there are no known interactions with laboratory tests. As such, no specific recommendations for dosage adjustments or monitoring are warranted at this time.

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

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

For pediatric patients under 12 years of age, the use of this product is not recommended unless directed by a healthcare provider. For those 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 professional.

Geriatric Use

Elderly patients, particularly those aged 60 years 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 elderly 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 in this population to ensure safe and effective use of the medication.

Pregnancy

Pregnant patients and those who are breastfeeding should consult a healthcare professional before using this medication. The use of aspirin during pregnancy, particularly at 20 weeks gestation or later, is associated with potential risks. Specifically, it may lead to adverse effects on fetal outcomes or complications during delivery. Therefore, it is crucial that pregnant patients only use aspirin under the guidance of a qualified healthcare provider if deemed necessary.

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 underlying 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 patients with compromised liver function to receive appropriate medical guidance to ensure safe and effective use of the medication. Monitoring of liver function may be necessary, and any dosage adjustments should be made based on the healthcare provider's assessment of the patient's overall health status and liver function.

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 remain alert to any signs of toxicity or adverse reactions that may develop.

Management of an overdose should be guided by established protocols, which may include supportive care and symptomatic treatment as necessary. The involvement of poison control experts can provide additional guidance on the appropriate management strategies tailored to the specific circumstances of the overdose.

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 specific non-teratogenic effects have been identified in the available data. Additionally, there are no specific details regarding nonclinical toxicology or animal pharmacology and toxicology provided in the current information.

Postmarketing Experience

Postmarketing experience has revealed that aspirin may lead to severe allergic reactions, which can manifest as hives, facial swelling, shock, and asthma (wheezing). Additionally, it has been indicated that aspirin may cause severe stomach bleeding, particularly in specific populations. Those at increased risk include individuals who concurrently use other nonsteroidal anti-inflammatory drugs (NSAIDs), are aged 60 or older, exceed the recommended dosage, have a history of stomach ulcers or bleeding disorders, consume three or more alcoholic beverages daily while using the product, or are taking anticoagulant or steroid medications.

Patient Counseling

Healthcare providers should advise patients to keep this medication out of reach of children to prevent accidental ingestion. In the event of an overdose, patients should be instructed to seek medical help or contact a Poison Control Center immediately.

Patients must be informed not to use this product 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. In the case of an allergic reaction, patients should be instructed to stop use and seek medical assistance right away.

Healthcare providers should counsel patients to discontinue use and consult a doctor if they experience any signs of stomach bleeding, which may include vomiting blood, feeling faint, having bloody or black stools, or experiencing stomach pain that does not improve. Patients should also be advised to stop use and seek medical attention if they notice ringing in the ears or a loss of hearing, if pain worsens or persists for more than 10 days, if fever intensifies or lasts longer than 3 days, if redness or swelling occurs, or if new symptoms arise that could indicate a serious condition.

It is important for healthcare providers to recommend that patients 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 be advised to seek medical guidance prior to use. Furthermore, patients with asthma or those taking a diuretic should consult a doctor before using this product. Lastly, patients should be encouraged to speak with a doctor or pharmacist if they are taking prescription medications for gout, diabetes, or arthritis.

Storage and Handling

The product is supplied in accordance with the following specifications. It should be stored at a controlled room temperature of 25°C (77°F). Temporary excursions are permissible between 15°C and 30°C (59°F to 86°F).

Healthcare professionals are advised to adhere to the expiration date indicated on the package to ensure product efficacy and safety.

Additional Clinical Information

The medication is administered orally. Clinicians should advise patients who are pregnant or breastfeeding to consult a health professional prior to use. It is particularly crucial to avoid the use of aspirin at 20 weeks of gestation or later unless explicitly directed by a physician, as it may pose risks to the unborn child or lead to complications during delivery.

Drug Information (PDF)

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

View product document (PDF)

Data Generation & Sources

This page was automatically generated and is maintained by the AllDrugs AI Data-Science Team. It was built from the FDA Structured Product Label (DailyMed) for Aspirin, retrieved by a validated AI data-extraction workflow.

All FDA-listed dosage forms and strengths are shown in the Packaging & NDC Codes section above. Regulatory status appears in the Summary Information panel above and was verified in the FDA National Drug Code directory and the NSDE NDC Directory daily file.

Note: an automated daemon monitors NSDE checksums; when the record for this NDC changes, the new file is pulled instantly and this page is refreshed.

No human clinician has reviewed this version.

Learn more in our Editorial Policy

Last AI update:

Primary FDA sources:

Orange Book data shown on this page are limited to Regulatory Status (Rx), Established Pharmacologic Class (EPC), and Mechanism of Action (MoA).

Regulatory data notice: Information on this page is reproduced verbatim from FDA public databases (NSDE, Orange Book, Purple Book, DailyMed SPL). NDA/ANDA drugs are FDA-approved, BLA biologics are FDA-licensed. Inclusion alone does not guarantee current market availability or imply FDA endorsement.

Medical disclaimer: This AI-generated content is provided for educational purposes only and does not constitute medical advice. Always consult a licensed healthcare professional for diagnosis or treatment decisions.