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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 2020
Label revision date
November 11, 2020
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 2020
Label revision date
November 11, 2020
Manufacturer
Allegiant Health
Registration number
M013
NDC root
69168-372
Drug Information (PDF)
Prescribing information, PDF file
Packaging Info (5 NDCs)
Packaging & NDC Codes (5)

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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

You can use this product 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.

It's important to note that there are no reported teratogenic effects (which means it doesn't cause birth defects) or nonteratogenic effects 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 to do so.

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 your healthcare provider's guidance for the best results.

What to Avoid

You should avoid using this medication if you have ever experienced an allergic reaction to any other pain reliever or fever reducer. It's important to prioritize your safety, so if you have a history of such reactions, please do not take this medication. Always consult with your healthcare provider if you have any concerns or questions about your medications.

Side Effects

Using this product may come with some serious risks. If you are a child or teenager recovering from chickenpox or flu-like symptoms, you should avoid it due to the risk of Reye’s syndrome, a rare but serious illness. Be aware that aspirin can cause severe allergic reactions, which may include hives, facial swelling, asthma (wheezing), or shock. Additionally, this product contains a nonsteroidal anti-inflammatory drug (NSAID) that can lead to 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.

You should stop using this product and consult a 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. It's also important to talk to your doctor if you have a history of stomach problems, high blood pressure, heart disease, or if you are pregnant or breastfeeding, as there are specific considerations for these situations.

Warnings and Precautions

If you are a child or teenager recovering from chickenpox or flu-like symptoms, it’s important not to use this product, as it could lead to Reye’s syndrome, a rare but serious illness. If you notice any changes in behavior accompanied by nausea and vomiting while using this product, consult your doctor immediately.

Be aware that this product can cause severe allergic reactions, which may include hives, facial swelling, asthma (wheezing), or shock. Additionally, it contains a nonsteroidal anti-inflammatory drug (NSAID) that can lead to serious stomach bleeding, especially if you are over 60, have a history of stomach ulcers or bleeding, take blood thinners or steroids, consume three or more alcoholic drinks daily, or use other NSAIDs.

You should stop using this product and call your doctor if you experience any signs of an allergic reaction or stomach bleeding, such as feeling faint, vomiting blood, having bloody or black stools, or experiencing persistent stomach pain. In case of an accidental overdose, seek medical help or contact a Poison Control Center (1-800-222-1222) immediately.

Overdose

If you suspect an overdose, it's important to stay calm and take immediate action. While the specific signs of an overdose are not detailed, common symptoms can include unusual drowsiness, confusion, or difficulty breathing. If you notice any of these signs, or if you are unsure, seek medical help right away.

In case of an overdose, contact your local emergency services or go to the nearest hospital. It's crucial to provide them with as much information as possible about the substance taken and the amount, if known. Remember, acting quickly can make a significant difference in your health and safety.

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, 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 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 especially 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 could 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 dosing, 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, there is a higher chance of experiencing severe stomach bleeding. This risk is especially significant 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 adjust the dosage or monitor your condition more closely to ensure your safety. Always prioritize open communication with your doctor regarding your health status.

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.

Additionally, if you have other conditions like high blood pressure or heart disease, these may also influence your treatment plan. Always communicate openly with your healthcare team about your liver health and any other medical conditions you have to ensure you receive the safest and most effective care.

Drug Interactions

It's important to be aware that certain medications can interact with aspirin, which may lead to serious health risks. For instance, if you are taking blood thinners (anticoagulants), combining them with aspirin can significantly increase the risk of severe stomach bleeding. Similarly, using aspirin alongside other nonsteroidal anti-inflammatory drugs (NSAIDs) like ibuprofen or naproxen can also heighten this risk.

Additionally, aspirin may affect how diuretics work, which could impact your kidney function. If you are on medications for diabetes, gout, or arthritis, it's crucial to consult with your healthcare provider or pharmacist before using aspirin. Always discuss any medications or tests with your healthcare provider to ensure your safety and well-being.

Storage and Handling

To ensure the best performance of your product, store it at room temperature, ideally between 20° and 25°C (68° and 77°F). This temperature range helps maintain its effectiveness.

When handling the product, be sure to check that the imprinted seal under the safety cap is intact. If the seal is broken or missing, do not use the product, as this could compromise its safety and effectiveness. Always follow these guidelines to ensure safe and proper use.

Additional Information

No further information is available.

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 have ever had an allergic reaction to any other pain reliever or fever reducer.

What should I do if I experience an allergic reaction?

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

What are the risks of stomach bleeding with Aspirin?

Aspirin may cause severe stomach bleeding, especially if you are age 60 or older, have had stomach ulcers, or take blood thinners or other NSAIDs.

Can children use Aspirin?

Children and teenagers recovering from chicken pox or flu-like symptoms should not use Aspirin due to the risk of Reye’s syndrome.

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

Stop using Aspirin and consult a doctor if you feel faint, vomit blood, have bloody or black stools, or experience stomach pain that does not improve.

Is it safe to use Aspirin during pregnancy?

Consult a health professional before using Aspirin if you are pregnant or breastfeeding, especially during the last 3 months of pregnancy.

What should I do in case of an overdose?

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

How should I store Aspirin?

Store Aspirin at room temperature between 20°–25°C (68°–77°F) and do not use if the imprinted seal under the safety cap is broken or missing.

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 tablet form, which may vary in dosage strength. The tablets are usually white to off-white in appearance and may be coated for ease of swallowing and to protect the active ingredient from degradation. Inactive ingredients may include starch, cellulose, and various excipients, depending on the specific formulation.

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 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 dosage must not exceed 48 tablets within a 24-hour period unless otherwise directed by a healthcare professional.

For children under 12 years of age, it is advised to consult a physician for appropriate dosing recommendations.

Contraindications

Use is contraindicated in individuals with a history of allergic reactions to any other pain reliever or fever reducer. Due to the potential for severe allergic responses, administration in these patients is not recommended.

Warnings and Precautions

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

Aspirin has the potential to cause severe allergic reactions, which may 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 an allergic reaction occurs.

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 meet any of the following criteria:

  • Are aged 60 years or older

  • Have a history of stomach ulcers or bleeding disorders

  • Are concurrently taking anticoagulants or steroid medications

  • Are using other medications that contain NSAIDs, whether prescription or over-the-counter (such as aspirin, ibuprofen, or naproxen)

  • Consume three or more alcoholic beverages daily while using this product

  • Exceed the recommended dosage or duration of use.

Patients should be instructed to discontinue use and consult a healthcare provider if they experience any signs of stomach bleeding, which may include feeling faint, vomiting blood, passing bloody or black stools, or experiencing persistent stomach pain that worsens or lasts longer than 10 days. Additionally, any new symptoms, redness or swelling, or symptoms such as ringing in the ears or loss of hearing should prompt immediate medical consultation.

In the event of an accidental overdose, it is crucial to seek medical assistance or contact a Poison Control Center (1-800-222-1222) without delay.

Side Effects

Patients using this product should be aware of several serious and common adverse reactions associated with its use.

Reye’s syndrome is a rare but serious illness that can occur in children and teenagers who have or are recovering from chickenpox or flu-like symptoms. Patients should not use this product under these circumstances. If any changes in behavior accompanied by nausea and vomiting occur, it is crucial to consult a healthcare professional, as these may be early signs of Reye’s syndrome.

Aspirin may also cause severe allergic reactions, which can manifest as hives, facial swelling, asthma (wheezing), or shock. Patients experiencing any signs of an allergic reaction should seek medical help immediately.

The 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 60 years of age or older, have a history of stomach ulcers or bleeding problems, are taking anticoagulants or steroid medications, consume three or more alcoholic drinks daily while using the product, or exceed the recommended dosage or duration of use. Patients should stop using the product and consult a doctor if they experience symptoms indicative of stomach bleeding, such as feeling faint, vomiting blood, having bloody or black stools, or experiencing persistent stomach pain.

Additional precautions should be taken by patients with a history of stomach problems, high blood pressure, heart disease, liver cirrhosis, or kidney disease. It is advisable for these patients to consult a healthcare professional before using this product. Furthermore, patients taking prescription medications for diabetes, gout, or arthritis should also seek advice from a doctor or pharmacist prior to use.

For pregnant or breastfeeding patients, it is essential to consult a healthcare professional before using this product. Aspirin should be avoided 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.

Drug Interactions

Aspirin has several notable drug interactions that may impact patient safety and treatment efficacy.

Anticoagulants Aspirin may enhance the effects of anticoagulant medications, leading to an increased risk of severe gastrointestinal bleeding. It is advisable to monitor patients closely for signs of bleeding and consider dosage adjustments of anticoagulants as necessary.

Nonsteroidal Anti-Inflammatory Drugs (NSAIDs) Concurrent use of aspirin with other NSAIDs, such as ibuprofen or naproxen, may significantly elevate the risk of severe stomach bleeding. Patients should be counseled to avoid the combination of these medications unless specifically directed by a healthcare provider.

Diuretics Aspirin may interact with diuretics, potentially compromising renal function. Monitoring of kidney function is recommended for patients receiving both aspirin and diuretics, and dosage adjustments may be warranted based on renal status.

Other Medications Aspirin may interact with medications used for diabetes, gout, and arthritis. It is essential for patients to consult with a healthcare professional before initiating aspirin therapy in conjunction with these medications to ensure safe and effective use.

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

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, a rare but serious illness. If any changes in behavior accompanied by nausea and vomiting occur while using this product, it is essential 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, with a maximum of 48 tablets in a 24-hour period unless otherwise directed by a doctor. For children under 12 years of age, consultation with a doctor is advised before use.

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, particularly gastrointestinal bleeding, underscores the importance of individualized assessment and management in this population.

Pregnancy

Pregnant patients should consult a healthcare professional before using this medication, particularly if they are in the later stages of pregnancy or breastfeeding. The use of aspirin during the last trimester is contraindicated unless specifically directed by a physician, as it may pose risks to the unborn child 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 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 mothers.

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, necessitating careful consideration of dosage adjustments and monitoring. In individuals with compromised liver function, particularly those with liver cirrhosis, the risk of adverse effects may be increased.

It is recommended that healthcare providers assess liver function prior to initiating treatment and periodically thereafter. Monitoring parameters may include liver enzyme levels, bilirubin, and overall liver function tests to ensure patient safety and therapeutic efficacy.

Due to the potential for increased sensitivity to the drug in this population, dosage modifications may be required. Healthcare professionals should evaluate the severity of hepatic impairment and adjust the dosage accordingly to mitigate risks associated with treatment.

Patients with a history of high blood pressure, heart disease, or kidney disease should also be monitored closely, as these conditions may further complicate the management of therapy in the context of hepatic impairment.

Overdosage

In the absence of specific information regarding overdosage, healthcare professionals are advised to exercise caution and adhere to general principles of management in cases of suspected overdose.

It is essential to monitor the patient closely for any potential symptoms that may arise from an overdose. Symptoms can vary widely depending on the substance involved and the individual patient's response.

In the event of an overdose, immediate medical attention should be sought. Healthcare providers should implement supportive care measures, which may include maintaining airway patency, providing supplemental oxygen, and monitoring vital signs.

Additionally, it is recommended to consult local poison control centers or relevant toxicology resources for guidance on specific management protocols and antidotes, if applicable.

Documentation of the incident, including the substance involved, estimated dose, and time of ingestion, is crucial for effective management and treatment planning.

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 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 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 (1-800-222-1222) in the event of an accidental overdose. It is crucial to inform patients that they should not use this medication if they have ever experienced an allergic reaction to any other pain reliever or fever reducer.

Patients should be instructed to discontinue use and consult a doctor if they experience any signs of an allergic reaction, and to seek medical help right away. Additionally, they should be made aware of the signs of potential stomach bleeding, which include feeling faint, vomiting blood, having bloody or black stools, experiencing stomach pain that does not improve, or if pain worsens or lasts more than 10 days. Patients should also be vigilant for redness or swelling, the occurrence of new symptoms, or any ringing in the ears or loss of hearing.

Healthcare providers should encourage patients to consult a doctor before using this medication if they have a history of stomach problems, such as heartburn, or if the stomach bleeding warning applies to them. It is also important to advise patients to seek medical advice if they have high blood pressure, heart disease, liver cirrhosis, or kidney disease. Patients taking a diuretic or those with asthma should also be encouraged to consult a doctor prior to use.

Finally, healthcare providers should recommend that patients speak with their doctor or pharmacist before using this medication if they are currently taking a prescription drug for diabetes, gout, or arthritis.

Storage and Handling

The product is supplied in a configuration that includes an imprinted seal under the safety cap. It is essential to ensure that this seal is intact before use, as the product should not be utilized if the seal is broken or missing.

For optimal storage, the product must be kept at room temperature, specifically within the range of 20° to 25°C (68° to 77°F). Proper handling and storage conditions are crucial to maintain the integrity and efficacy of the product.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

This file contains official product information for 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.

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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.