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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
Route
Oral
Prescription status
OTC (over the counter)
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Marketed in the U.S.
Since 2014
Label revision date
November 7, 2018
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 2014
Label revision date
November 7, 2018
Manufacturer
Allegiant Health
Registration number
M013
NDC root
69168-318
Drug Information (PDF)
Prescribing information, PDF file
Packaging Info (3 NDCs)
Packaging & NDC Codes (3)

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Drug Overview

Aspirin is a medication commonly used for the temporary relief of minor aches and pains, such as headaches, muscle aches, and toothaches. It can also be recommended by your doctor for other specific uses. It's important to note that aspirin has a delayed action, meaning it may not provide quick relief for symptoms that require immediate attention.

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 because it works slowly, it may not be suitable for quick relief of headaches or other symptoms that require immediate attention.

Rest assured, there are no concerns regarding teratogenic effects (which are harmful effects on a developing fetus) or nonteratogenic effects (which are not related to fetal development) associated with this product. Always consult with your healthcare provider for personalized advice and recommendations.

Dosage and Administration

When taking this medication, it's important to drink a full glass of water with each dose to help with absorption. For adults and children aged 12 years and older, you should take 4 to 8 tablets every 4 hours. However, make sure not to exceed 48 tablets in a 24-hour period unless your doctor has instructed you otherwise.

If you have a child under 12 years old, it's essential to consult a doctor before giving them this medication to ensure it's safe and appropriate for their age. Always follow these guidelines carefully to ensure effective and safe use of the medication.

What to Avoid

If you are allergic to aspirin or any other pain reliever or fever reducer, you should not use this medication. Additionally, it is important to avoid taking aspirin during the last three months of pregnancy unless your doctor has specifically instructed you to do so, as it may lead to issues for the unborn child or complications during delivery. Always consult with your healthcare provider if you have any concerns or questions about using this medication.

Side Effects

You should be aware of some important side effects associated with this product. If you are a child or teenager recovering from chickenpox or flu-like symptoms, you should not use it, as it may lead to Reye’s syndrome, a rare but serious illness. If you notice changes in behavior along with nausea and vomiting, consult a doctor immediately.

There is also a risk of severe allergic reactions, which can include hives, facial swelling, asthma (wheezing), or shock. Additionally, this product 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 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, stop using the product and seek medical help right away.

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 severe allergic reactions, which may include hives, facial swelling, asthma (wheezing), or shock. 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 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 asthma. It's also wise to check with your doctor or pharmacist if you are taking any prescription medications for blood thinning, diabetes, gout, or arthritis. If you accidentally take too much, seek emergency medical help or contact a Poison Control Center immediately. Stop using the product and call your doctor if you experience any signs of an allergic reaction or stomach bleeding, such as feeling faint, vomiting blood, or having bloody or black stools.

Overdose

Taking too much aspirin can be very dangerous and may lead to serious health issues. If you or someone you know has taken an overdose, it's important to recognize the symptoms, which can include nausea, vomiting, and tinnitus (ringing in the ears). In more severe cases, an overdose can result in metabolic acidosis (an imbalance in the body's acid-base levels) and respiratory alkalosis (a condition where the body has too little carbon dioxide).

If you suspect an overdose, you should seek immediate medical attention. It's crucial to act quickly, as prompt treatment can help prevent serious complications. Always remember that safety comes first, so don’t hesitate to reach out for help if you need it.

Pregnancy Use

It is crucial to avoid using aspirin during the last three months of your pregnancy unless your doctor has specifically instructed you to do so. Taking aspirin at this stage can lead to potential issues for your unborn child and may cause complications during delivery. Always consult with your healthcare provider before taking any medication 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. 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 can 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 dosage, adults and children aged 12 years and older can take 4 to 8 tablets every 4 hours, but should not exceed 48 tablets in a 24-hour period unless directed by a doctor. If your child is under 12 years old, it’s essential to consult a doctor before giving them this product.

Geriatric Use

As you age, it's important to be aware of certain health risks when taking medications. If you are 60 years or older, you may have a higher chance of experiencing severe stomach bleeding. This risk is especially relevant if you have a history of stomach issues, high blood pressure, heart disease, liver cirrhosis (a liver condition), or kidney disease.

Before starting any new medication, it's wise to consult with your doctor, particularly if any of these warnings apply to you. Your healthcare provider can help ensure that your treatment is safe and appropriate for your specific health needs.

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 this treatment is safe for you and may suggest adjustments based on your kidney function. Always prioritize open communication with your doctor regarding your health conditions to ensure the best care.

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 talk to your doctor or pharmacist before using this medication, especially if you are currently taking any prescription drugs for anticoagulation (which help thin your blood). Combining these medications can increase the risk of serious side effects, such as severe stomach bleeding, particularly if you are also using steroid medications.

Always keep your healthcare provider informed about all the medications you are taking. This way, they can help ensure your treatment is safe and effective, minimizing any potential risks.

Storage and Handling

To ensure the safety and effectiveness of your product, store it at room temperature, ideally between 20°C to 25°C (68°F to 77°F). It's important to protect it from light and keep the container tightly closed when not in use. Always keep the product out of reach of children to prevent accidental ingestion or misuse. Once opened, be sure to discard the product to maintain safety and effectiveness.

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 during the last three months of pregnancy unless your doctor has instructed you to do so, as it can lead to issues for the unborn child or complications during delivery.

FAQ

What is aspirin used for?

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

How should I take aspirin?

Adults and children 12 years and over should take 4 to 8 tablets every 4 hours, not exceeding 48 tablets in 24 hours unless directed by a doctor. Drink a full glass of water with each dose.

Are there any contraindications for using aspirin?

Do not use aspirin if you are allergic to it or any other pain reliever/fever reducer.

What should I do if I experience an allergic reaction?

Stop use and seek medical help right away if an allergic reaction occurs.

Can I use aspirin during pregnancy?

You should not use aspirin during the last 3 months of pregnancy unless specifically directed by a doctor, as it may cause problems in the unborn child or complications during delivery.

What is Reye's syndrome?

Reye's syndrome is a rare but serious illness that can occur in children and teenagers recovering from chicken pox or flu-like symptoms. If you notice changes in behavior with nausea and vomiting while using aspirin, consult a doctor.

What are the warnings associated with aspirin?

Aspirin may cause severe allergic reactions, and it can increase the risk of stomach bleeding, especially in those over 60 or with certain medical conditions.

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 experience stomach pain that does not improve.

How should I store aspirin?

Store aspirin at room temperature between 20°C to 25°C (68°F to 77°F), protect it from light, and keep the container tightly closed.

Is there anything I should ask my doctor before using aspirin?

Yes, ask your doctor if you have high blood pressure, heart disease, liver cirrhosis, or kidney disease before using aspirin.

Packaging Info

Below are the non-prescription pack sizes of Aspirin (aspirin 81 mg). 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

Aspirin is a nonsteroidal anti-inflammatory drug (NSAID) with the chemical name acetylsalicylic acid. Its molecular formula is C9H8O4, and it has a molecular weight of 180.16 g/mol. Aspirin is typically presented in a solid dosage form, commonly as a tablet. The tablets are white to off-white in appearance and may be coated for ease of swallowing and to enhance stability.

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 are advised to take the medication with a full glass of water for optimal efficacy.

For adults and children aged 12 years and older, the recommended dosage is 4 to 8 tablets every 4 hours. The total daily intake should 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 essential to consult a doctor prior to administration to determine the appropriate dosage.

Contraindications

Use is contraindicated in patients with a known allergy to aspirin or any other pain reliever or fever reducer.

Additionally, aspirin should not be used during the last three months of pregnancy unless specifically directed by a healthcare professional, as it may pose risks to the unborn child or lead to complications during delivery.

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 Reye’s syndrome, a rare but serious condition.

Aspirin may provoke severe allergic reactions, which can manifest as hives, facial swelling, asthma (wheezing), or shock. Healthcare professionals should be vigilant for these signs and advise patients to seek immediate medical attention if they occur.

This product contains a nonsteroidal anti-inflammatory drug (NSAID), which carries a risk of severe stomach bleeding. The likelihood of this adverse effect is increased in individuals who are 60 years of age or older, have a history of stomach ulcers or bleeding disorders, are taking anticoagulants or steroid medications, are using other NSAIDs (including aspirin, ibuprofen, or naproxen), consume three or more alcoholic beverages daily while using this product, or exceed the recommended dosage or duration of use.

Healthcare providers should advise patients to consult a physician prior to use if they have a history of stomach issues, such as heartburn, or if they have conditions such as high blood pressure, heart disease, liver cirrhosis, or kidney disease. Additionally, patients with asthma or those taking diuretics should seek medical advice before using this product. It is also recommended that patients consult a doctor or pharmacist if they are currently taking prescription medications for anticoagulation, diabetes, gout, or arthritis.

In the event of an accidental overdose, immediate medical assistance should be sought, or the Poison Control Center (1-800-222-1222) should be contacted without delay.

Patients should discontinue use and contact a healthcare professional if they experience any signs of an allergic reaction. Immediate medical attention is warranted if symptoms of stomach bleeding arise, including feeling faint, vomiting blood, passing bloody or black stools, experiencing persistent stomach pain, or if pain worsens or lasts longer than 10 days. Additionally, patients should seek medical advice if new symptoms develop, or if they experience 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 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, asthma (wheezing), or shock. Patients experiencing any signs of an allergic reaction should stop using the product and seek medical assistance promptly.

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 blood-thinning medications or steroids, are using other NSAIDs (including aspirin, ibuprofen, or naproxen), consume three or more alcoholic drinks daily while using this product, or exceed the recommended dosage or duration of use.

Patients 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, experiencing stomach pain that does not improve, or if pain worsens or persists for more than 10 days. Additional symptoms that warrant medical attention include the presence of redness or swelling, the emergence of new symptoms, or occurrences of ringing in the ears or loss of hearing.

Drug Interactions

Patients should consult a healthcare professional prior to using this medication if they are concurrently taking prescription anticoagulants. The combination of this medication with anticoagulants may increase the risk of adverse effects.

In particular, the concomitant use of this medication with blood thinners or steroid drugs has been associated with an elevated risk of severe gastrointestinal bleeding. Therefore, careful monitoring is advised for patients receiving these combinations to mitigate potential complications.

Packaging & NDC

Below are the non-prescription pack sizes of Aspirin (aspirin 81 mg). 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 without consulting a doctor. 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 immediately, 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, with a maximum of 48 tablets in a 24-hour period unless otherwise directed by a physician. Specific dosing recommendations for children under 12 years are not provided, emphasizing the necessity of consulting a healthcare provider for appropriate guidance.

Geriatric Use

Elderly patients, particularly those aged 60 and older, are at an increased risk for severe stomach bleeding. It is essential for healthcare providers to exercise caution when prescribing this medication to geriatric patients, especially if they have a history of stomach problems, high blood pressure, heart disease, liver cirrhosis, or kidney disease.

Before initiating treatment, healthcare providers should inquire about the presence of any of these conditions in elderly patients, as they may necessitate closer monitoring or alternative therapeutic strategies. The potential for adverse effects, such as gastrointestinal bleeding, should be carefully weighed against the benefits of treatment in this population.

Pregnancy

It is especially important for pregnant patients to avoid the use of aspirin during the last trimester of pregnancy unless specifically directed by a healthcare provider. The use of aspirin in this period may pose risks to the unborn child and can lead to complications during delivery. Healthcare professionals should counsel women of childbearing potential regarding these risks and consider alternative treatments when appropriate.

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 should consult a healthcare professional prior to use, particularly if they have comorbid 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 degree 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 use of the medication. Adjustments to dosage may be necessary based on the severity of liver impairment, and ongoing assessment of liver function is recommended throughout the treatment period.

Overdosage

Overdosage of aspirin can result in significant harm to the patient. Healthcare professionals should be vigilant in recognizing the symptoms associated with aspirin overdose, which may include nausea, vomiting, and tinnitus (ringing in the ears).

In instances of severe overdose, patients may experience more critical complications such as metabolic acidosis and respiratory alkalosis, among other serious health issues. These conditions necessitate prompt and effective medical intervention.

In the event of an overdose, it is imperative to seek immediate medical attention. Timely management is crucial to mitigate the potential adverse effects and ensure the safety of the patient.

Nonclinical Toxicology

It is especially important not to use aspirin during the last three months of pregnancy unless specifically directed to do so by a doctor, as it may cause problems in the unborn child or complications during delivery. No non-teratogenic effects have been provided in the available data. Additionally, there is no information regarding animal pharmacology and toxicology.

Postmarketing Experience

Postmarketing experience has included voluntary reports of side effects associated with the use of the product. Healthcare professionals and patients are encouraged to report any adverse events to the designated contact number, 1-888-952-0050. This information contributes to ongoing safety monitoring and helps ensure the continued assessment of the product's risk-benefit profile.

Patient Counseling

Healthcare providers should advise patients to seek immediate medical assistance or contact a Poison Control Center (1-800-222-1222) in the event of an accidental overdose. Patients should be informed not to use the medication if they have a known allergy to aspirin or any other pain reliever or fever reducer.

It is essential for healthcare providers to encourage patients to consult with a doctor before using the medication if any of the following conditions apply: a history of stomach bleeding, previous stomach problems such as heartburn, high blood pressure, heart disease, liver cirrhosis, kidney disease, or asthma. Additionally, patients taking diuretics should also seek medical advice prior to use.

Patients should be instructed to ask a doctor or pharmacist before using the medication if they are currently taking prescription drugs for anticoagulation (blood thinning), diabetes, gout, or arthritis.

Healthcare providers should inform patients to discontinue use and consult a doctor if they experience any signs of an allergic reaction, such as difficulty breathing or swelling of the face, lips, or throat. Patients should also be advised to seek medical attention if they notice any symptoms indicative of stomach bleeding, including feeling faint, vomiting blood, having bloody or black stools, experiencing persistent stomach pain, or if new symptoms arise. They should be particularly vigilant for symptoms such as ringing in the ears or loss of hearing.

Patients who are pregnant or breastfeeding should be encouraged to consult a health professional before using the medication. It is crucial to emphasize that aspirin should not be used 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.

Patients may report any side effects to 1-888-952-0050.

Storage and Handling

The product is supplied in a container that must be kept tightly closed to maintain its integrity. It should be stored at room temperature, specifically within the range of 20°C to 25°C (68°F to 77°F). It is essential to protect the product from light exposure to ensure its stability and effectiveness. Additionally, the product should be kept out of reach of children, and any unused portion should be discarded after opening to prevent potential misuse or degradation.

Additional Clinical Information

The route of administration for the medication is oral. Clinicians should advise patients who are pregnant or breastfeeding to consult a health professional prior to use. It is particularly crucial to avoid 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.

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.