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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 (2 NDCs)
Packaging & NDC Codes (2)

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Drug Overview

Aspirin is a type of medication known as a nonsteroidal anti-inflammatory drug (NSAID). It is commonly used for the temporary relief of minor aches and pains, such as headaches or muscle discomfort, and may also be recommended by your doctor for other specific uses.

This particular formulation of aspirin is designed to be low strength and enteric coated, which means it is specially coated to help reduce stomach irritation and delay its release in the body. However, it's important to note that due to its delayed action, 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 gradually, 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 refer to substances that can 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 otherwise.

If you have a child under 12 years of age, 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

You should avoid using this medication if you are allergic to aspirin or any other pain reliever or fever reducer. Allergic reactions can be serious, so it's important to ensure that you do not have this allergy before taking the medication. Always consult with your healthcare provider if you have any concerns about allergies or if you are unsure about your medical history. Your safety is the top priority.

Side Effects

It's important to be aware of potential side effects when using this product. Children and teenagers recovering from chickenpox or flu-like symptoms should avoid it due to the risk of Reye’s syndrome, a rare but serious condition. If you notice changes in behavior accompanied by nausea and vomiting, consult a doctor immediately.

This product can also cause severe allergic reactions, which may include hives, facial swelling, asthma (wheezing), or shock. Additionally, it contains a nonsteroidal anti-inflammatory drug (NSAID) that may lead to serious stomach bleeding, especially if you are over 60, have a history of stomach ulcers, or are taking certain medications. If you experience symptoms like faintness, vomiting blood, or black stools, seek medical attention right away. Always consult your doctor if you have existing health conditions or are taking other medications before using this product.

Warnings and Precautions

If you are a child or teenager recovering from chickenpox or flu-like symptoms, you should not use this product, as it may increase the risk of 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.

If you experience any signs of an allergic reaction or stomach bleeding—such as feeling faint, vomiting blood, having bloody or black stools, or persistent stomach pain—stop using the product and contact your doctor right away. In case of an overdose, seek emergency medical help or call Poison Control at 1-800-222-1222.

Overdose

If you suspect an overdose, it’s crucial to seek medical help immediately. You can contact a Poison Control Center at 1-800-222-1222 for guidance. Signs of an overdose can vary, but they may include unusual drowsiness, confusion, or difficulty breathing.

Always err on the side of caution—if you notice any concerning symptoms or if you’re unsure, don’t hesitate to get help right away. Your health and safety are the top priority.

Pregnancy Use

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

Particularly, you should avoid using aspirin during the last three months of your pregnancy unless your doctor 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 particularly crucial if you are considering taking aspirin during the last three months of your pregnancy, as it can lead to potential 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 lead to a serious condition called 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 children under 12 years of age, it's essential to consult a doctor before use. 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 directed by a doctor. Always prioritize your child's safety and seek medical advice when necessary.

Geriatric Use

As you consider using this medication, it's important to be aware of certain risks, especially if you are 60 years or older. This product contains a type of pain reliever known as an NSAID (nonsteroidal anti-inflammatory drug), which can increase the risk of severe stomach bleeding. This risk is higher if you have a history of stomach ulcers or bleeding issues, are taking blood thinners (medications that prevent blood clots), or are using other NSAIDs like aspirin or ibuprofen. Additionally, consuming three or more alcoholic drinks daily while using this product can further elevate this risk.

To stay safe, make sure to follow the recommended dosage and duration of use. Taking more than directed or using it for an extended period can also increase the chances of complications. Always consult with your healthcare provider if you have any concerns or if you are taking other medications. Your health and safety are the top priority.

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 doctor 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 healthcare provider regarding your kidney health and any other medical conditions you may have.

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 will assess your overall health and may need to adjust your dosage or monitor your condition more closely. This is crucial to ensure your safety and the effectiveness of the treatment. Always keep your doctor informed about any existing health issues, including high blood pressure, heart disease, or kidney disease, as these can also affect your treatment plan.

Drug Interactions

It's important to talk to your doctor or pharmacist before using this product, especially if you are taking any prescription medications for blood thinning (anticoagulation). This is crucial because the product contains a type of pain reliever called an NSAID, which can increase the risk of severe stomach bleeding, particularly if you are also on blood thinners or steroids.

Additionally, if you have a history of stomach issues, high blood pressure, heart disease, liver cirrhosis, kidney disease, or if you are taking a diuretic (a medication that helps remove excess fluid from the body), you should consult your healthcare provider before using this product. Always ensure that you discuss any allergies, especially to aspirin or other pain relievers, with your healthcare team to avoid any serious reactions.

Storage and Handling

To ensure the best performance and safety of your product, store it at room temperature. It's important to check the safety seal under the cap before use; do not use the product if this seal is broken or missing, as this could indicate that the product is compromised. Following these guidelines will help you use the product safely and effectively.

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 pain 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. Always drink a full glass of water with each dose.

Are there any warnings associated with aspirin?

Yes, aspirin may cause severe allergic reactions, stomach bleeding, and should not be used by children and teenagers recovering from chicken pox or flu-like symptoms due to the risk of Reye’s syndrome.

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

If you feel faint, vomit blood, have bloody or black stools, or have stomach pain that does not improve, stop using aspirin and seek medical help immediately.

Can I use aspirin if I am pregnant or breastfeeding?

If you are pregnant or breastfeeding, consult a health professional before using aspirin, especially during the last 3 months of pregnancy.

Who should not use aspirin?

Do not use aspirin if you are allergic to it or other pain relievers/fever reducers, or if you have a history of stomach problems, high blood pressure, heart disease, liver cirrhosis, or kidney disease without consulting a doctor.

What is the mechanism of action of aspirin?

Aspirin is classified as a nonsteroidal anti-inflammatory drug (NSAID), which helps reduce pain and inflammation.

What should I do if the safety seal under the cap is broken or missing?

Do not use the product if the imprinted safety seal under the 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) formulated as a low strength regimen of 81 mg. It is presented in a safety-coated, enteric-coated dosage form designed for delayed release. This formulation aims to minimize gastrointestinal irritation while providing the therapeutic effects associated with aspirin.

Uses and Indications

This drug is indicated for the temporary relief of minor aches and pains, 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.

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 to ensure proper administration and absorption.

For adults and children aged 12 years and older, the recommended dosage is 4 to 8 tablets every 4 hours. The total daily dosage 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 advised to consult a physician for appropriate dosing recommendations.

Contraindications

Use is contraindicated in individuals with a known allergy to aspirin or other pain reliever/fever reducers. Due to the potential for severe allergic reactions, administration in these patients may pose significant health risks.

Warnings and Precautions

Patients, particularly children and teenagers, should be cautioned against the use of this product if they have or are recovering from chickenpox or flu-like symptoms due to the risk of Reye’s syndrome. This rare but serious condition may present with changes in behavior accompanied by nausea and vomiting. Should these symptoms arise, it is imperative to consult a healthcare professional promptly.

Aspirin is associated with the potential for severe allergic reactions. Healthcare providers should be vigilant for signs of such reactions, which may include hives, facial swelling, asthma (wheezing), and shock. Immediate medical attention is warranted if any of these symptoms occur.

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

In the event of an overdose, it is critical to seek emergency medical assistance or contact a Poison Control Center immediately at 1-800-222-1222.

Patients should discontinue use and consult a healthcare provider if they experience any signs of an allergic reaction or symptoms indicative of stomach bleeding. These symptoms include feeling faint, vomiting blood, passing bloody or black stools, experiencing persistent stomach pain, or if pain worsens or lasts longer than 10 days. Additional concerns such as redness or swelling, the emergence of new symptoms, or auditory disturbances like ringing in the ears or loss of hearing should also prompt immediate medical consultation. Serious side effects can be reported to 1-888-952-0050 for further evaluation.

Side Effects

Patients using this product may experience a range of adverse reactions, some of which can be serious.

Reye’s syndrome is a rare but serious condition that may occur in children and teenagers who have or are recovering from chicken pox or flu-like symptoms. It is crucial for these individuals to avoid using this product. If patients exhibit changes in behavior accompanied by nausea and vomiting while using this product, they should consult a healthcare professional immediately, as these symptoms could indicate the onset of Reye’s syndrome.

Severe allergic reactions to aspirin may occur, presenting as hives, facial swelling, asthma (wheezing), or shock. Patients experiencing any signs of an allergic reaction should seek medical attention promptly.

This product contains a nonsteroidal anti-inflammatory drug (NSAID), which carries a risk of severe stomach bleeding. The likelihood of this adverse reaction is increased in patients who are 60 years of age or older, have a history of stomach ulcers or bleeding problems, are taking anticoagulants or steroid medications, consume three or more alcoholic drinks daily while using this product, or exceed the recommended dosage or duration of use.

Patients should discontinue use and consult a healthcare provider if they experience any signs of stomach bleeding, which may include feeling faint, vomiting blood, having bloody or black stools, or experiencing persistent stomach pain that worsens or lasts more than 10 days. Additional symptoms warranting medical consultation include the presence of redness or swelling, the emergence of new symptoms, or ringing in the ears or loss of hearing.

Before using this product, patients should seek medical advice if they have a history of stomach problems, such as heartburn, or if they have high blood pressure, heart disease, liver cirrhosis, or kidney disease. It is also advisable to consult a healthcare professional if the patient is taking diuretics or has asthma.

Patients taking prescription medications for anticoagulation, diabetes, gout, or arthritis should consult a doctor or pharmacist prior to use to avoid potential interactions.

For serious side effects, patients are encouraged to report them to 1-888-952-0050.

Drug Interactions

Patients should consult a healthcare professional prior to using this product if they are currently prescribed anticoagulant medications, as the combination may increase the risk of bleeding. The use of this product, which contains a nonsteroidal anti-inflammatory drug (NSAID), is associated with a heightened risk of severe stomach bleeding, particularly in patients concurrently taking blood thinners or steroid medications.

Additionally, individuals with a known allergy to aspirin or other pain relievers/fever reducers should refrain from using this product.

Patients with a history of gastrointestinal issues, including heartburn, or those with conditions such as high blood pressure, heart disease, liver cirrhosis, or kidney disease should seek medical advice before use. This is particularly important for those who are also taking diuretics, as these factors may necessitate dosage adjustments or increased monitoring for adverse effects.

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 consult a doctor before using this product. 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, 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 doctor.

Geriatric Use

Elderly patients, particularly those aged 60 years and older, are at an increased risk of severe stomach bleeding when using this product, which contains a nonsteroidal anti-inflammatory drug (NSAID). This risk is further heightened in individuals with a history of stomach ulcers or bleeding problems, those who are concurrently using blood-thinning medications (anticoagulants) or steroid drugs, and patients taking other NSAIDs, whether prescription or over-the-counter, such as aspirin, ibuprofen, or naproxen.

It is essential for healthcare providers to exercise caution when prescribing this product to geriatric patients. Monitoring for signs of gastrointestinal bleeding is advised, especially in those who consume three or more alcoholic drinks daily while using this medication. Additionally, healthcare providers should ensure that elderly patients do not exceed the recommended dosage or duration of use, as prolonged or excessive use may further increase the risk of adverse effects.

Pregnancy

Pregnant patients and those who are breastfeeding should consult a healthcare professional before using this medication. The use of aspirin during the last trimester of pregnancy is particularly cautioned against, as it may lead to adverse effects on the unborn child or complications during delivery. Therefore, it is essential for healthcare providers to evaluate the risks and benefits before recommending this medication to pregnant women, especially in the later stages of pregnancy.

Lactation

Lactating mothers are advised to consult a healthcare 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 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 medical guidance to assess the potential risks and benefits associated with the use of this medication. Monitoring of liver function may be necessary to ensure safety and efficacy in this population. Adjustments to dosage or treatment regimens may be required based on the severity of hepatic impairment and the patient's overall health status.

Overdosage

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

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

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

Nonclinical Toxicology

It is especially important not to use aspirin during the last three months of pregnancy unless specifically directed 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

Serious side effects have been reported voluntarily or identified through surveillance programs. Healthcare professionals and patients are encouraged to report any serious adverse events to the designated contact number, 1-888-952-0050.

Patient Counseling

Patients should be advised to keep this medication out of reach of children to prevent accidental ingestion. In the event of an overdose, it is crucial to seek medical assistance immediately or contact a Poison Control Center at 1-800-222-1222.

Patients with a known allergy to aspirin or other pain reliever/fever reducers should be instructed not to use this medication. They should also be informed to discontinue use and consult a doctor if they experience any signs of an allergic reaction, and to seek medical help without delay.

Healthcare providers should counsel patients to stop using the medication and seek medical advice if they notice any signs of stomach bleeding, which may include feeling faint, vomiting blood, having bloody or black stools, or experiencing stomach pain that does not improve. Additionally, patients should be made aware that they should seek medical attention if pain worsens or lasts more than 10 days, if redness or swelling occurs, if new symptoms arise, or if they experience ringing in the ears or loss of hearing.

Patients should be encouraged to report any serious side effects to 1-888-952-0050. It is also important for healthcare providers to remind 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.

Furthermore, patients should be advised to seek medical guidance before use if they have high blood pressure, heart disease, liver cirrhosis, or kidney disease. Those taking diuretics or who have asthma should also consult a doctor prior to use. Lastly, patients should be encouraged to speak with their doctor or pharmacist if they are currently taking prescription medications for anticoagulation, diabetes, gout, or arthritis.

Storage and Handling

The product is supplied in a configuration that includes an imprinted safety seal under the cap. It is essential to store the product at room temperature to maintain its integrity and efficacy. Healthcare professionals should ensure that the product is not used if the safety seal is broken or missing, as this may indicate potential tampering or contamination.

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 trimester 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

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Primary FDA sources:

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

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

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