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Aspirin

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This product has been discontinued

Active ingredient
Aspirin 81 mg
Other brand names
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
October 30, 2023
Drug Information (PDF)
Prescribing information, PDF file
Active ingredient
Aspirin 81 mg
Other brand names
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
October 30, 2023
Manufacturer
Strategic Sourcing Services LLC
Registration number
M013
NDC root
62011-0019
Drug Information (PDF)
Prescribing information, PDF file
Packaging Info (2 NDCs)
Packaging & NDC Codes (2)

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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 the form of enteric-coated tablets, each containing 81 mg of aspirin. This medication is primarily used for the temporary relief of minor aches and pains, although it is important to note that it may not provide fast relief for headaches or other symptoms that require immediate attention.

If you're considering using Low Dose Aspirin, it's a good idea to talk to your doctor about its potential uses and whether it’s right for you.

Uses

This product is designed to provide temporary relief from minor aches and pains, such as those you might experience from headaches or muscle strains. However, keep in mind that it works gradually, so it may not be the best choice if you need quick relief for sudden discomfort.

If you're considering using this product for other purposes, it's a good idea to consult your doctor for guidance. They can help determine if it's suitable for your specific needs.

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 giving this medication to a child under 12 years old, it's essential to consult a doctor first to determine the appropriate dosage. Always follow these guidelines carefully to ensure safe and effective 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.

Side Effects

If you are considering using this product, be aware of some important warnings and potential side effects. Children and teenagers recovering from chickenpox or flu-like symptoms should avoid it, as it may lead to Reye’s syndrome, a rare but serious condition. Aspirin can also trigger 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 are taking certain medications like blood thinners or other NSAIDs. If you experience symptoms such as faintness, vomiting blood, or black stools, seek medical attention immediately. Additionally, consult a doctor if you have a history of stomach problems, high blood pressure, or asthma before using this product. If you are pregnant or breastfeeding, it's crucial to talk to a healthcare professional before use, particularly in the last three months of pregnancy.

Warnings and Precautions

You should avoid using this product if you are a child or teenager recovering from chickenpox or flu-like symptoms, as it could lead to a serious condition called Reye’s syndrome. If you notice any changes in behavior along with nausea and vomiting while using this product, consult your doctor immediately. 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.

Before using this product, talk to your doctor if you have any history of stomach problems, high blood pressure, heart disease, liver cirrhosis, or kidney disease. It’s also important to consult a healthcare professional if you are taking medications for diabetes, gout, or arthritis. If you suspect an overdose, seek medical help or contact a Poison Control Center immediately at 1-800-222-1222.

Stop using this product and call your doctor if you experience any signs of an allergic reaction, stomach bleeding (such as feeling faint, vomiting blood, or having bloody or black stools), worsening pain, or new symptoms. These could indicate a serious health issue that requires immediate attention.

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 take overdoses seriously. If you notice any of these symptoms or have concerns about your health, don’t hesitate to reach out for help right away. Your safety is 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 especially important for aspirin, which should generally be avoided during the last three months of pregnancy unless your doctor specifically advises you to take it. Using aspirin at this stage 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 professional guidance.

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 your child is recovering from chicken pox or has flu-like symptoms, it's important to avoid using this product, as it can increase the risk of a serious condition called Reye's syndrome (a rare but serious illness that can affect the brain and liver). If you notice any changes in your child's behavior along with nausea and vomiting, consult a doctor immediately, as these could be early signs of Reye’s syndrome.

For dosing, adults and children aged 12 and older can take 4 to 8 tablets every 4 hours, but they should not exceed 48 tablets in a 24-hour period unless directed by a doctor. If your child is under 12 years old, please consult a doctor before giving them this medication.

Geriatric Use

As you age, it's important to be aware that the risk of severe stomach bleeding increases if you are 60 years or older. This means that if you or a loved one falls into this age group, you should be particularly cautious about medications that may affect your stomach. Always consult with your healthcare provider about any medications you are taking, as they can help you understand the risks and adjust dosages if necessary to ensure your safety.

Taking these precautions can help you manage your health more effectively and reduce the likelihood of serious side effects. Remember, staying informed and communicating openly with your healthcare team is key to maintaining your well-being as you age.

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 (severe scarring of the liver), it's important to be cautious with certain medications. Your healthcare provider may need to adjust your dosage or closely monitor your treatment to ensure it's safe for you. This is especially true if you also have conditions like high blood pressure or heart disease, as these can complicate your overall health management.

Always communicate openly with your doctor about your liver health and any other medical conditions you have. They will guide you on the best approach to take, ensuring that your treatment is both effective and safe.

Drug Interactions

It's important to be aware that certain medications can interact with each other, potentially leading to serious health issues. For example, taking aspirin alongside blood thinners (medications that prevent blood clots) or other nonsteroidal anti-inflammatory drugs (NSAIDs) like ibuprofen or naproxen can significantly increase the risk of severe stomach bleeding.

If you are currently on prescription medications for conditions such as diabetes, gout, or arthritis, it's crucial to consult your healthcare provider before using aspirin. They can help ensure that your medications work safely together and that you avoid any harmful interactions. Always prioritize open communication with your doctor about all the medications you are taking.

Storage and Handling

To ensure the best performance of your product, store it in a dry place at a temperature between 20°-25°C (68°-77°F). This temperature range helps maintain the product's effectiveness and safety. It's also important to keep the original carton, as it contains essential information and warnings that you may need to refer to later.

When handling the product, always do so with care to avoid any damage. Following these storage and handling 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 specifically instructed you to do so, as it may 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. Always drink a full glass of water with each dose.

Are there any contraindications for using Low Dose Aspirin?

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

What should I do if I experience an allergic reaction?

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

What are the risks of taking Low Dose Aspirin?

Low Dose Aspirin may cause severe stomach bleeding, especially if you are age 60 or older, have had stomach ulcers, or take blood thinning medications.

Can children use Low Dose Aspirin?

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

Is it safe to use Low Dose Aspirin during pregnancy?

If you are pregnant or breastfeeding, consult a health professional before use. It is especially important not to use aspirin during the last 3 months of pregnancy unless directed by a doctor.

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 have stomach pain that does not improve.

What should I ask my doctor before using Low Dose Aspirin?

Ask your doctor if you have a history of stomach problems, high blood pressure, heart disease, liver cirrhosis, or kidney disease before using this product.

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

This product is identified by NDC 62011-0019-1 and is a low dose aspirin formulation, specifically designed as a pain reliever classified as a nonsteroidal anti-inflammatory drug (NSAID). Each tablet contains 81 mg of the active ingredient, aspirin, and is presented in a dosage form of enteric-coated tablets. The product is packaged in a bottle containing 120 tablets, which are safety coated to enhance gastrointestinal tolerability. This formulation is comparable to Bayer® Low Dose Aspirin and is marketed under the Health Mart brand.

Uses and Indications

This drug is indicated for the temporary relief of minor aches and pains, as well as for other uses 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: Healthcare professionals are encouraged to inquire about additional indications for this product based on individual patient needs. 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 known allergy to aspirin or any other pain reliever or fever reducer. Due to the potential for severe allergic reactions, administration in these patients is not recommended.

Warnings and Precautions

Children and teenagers who have or are recovering from chickenpox or flu-like symptoms should not use this product. If behavioral changes accompanied by nausea and vomiting occur during use, it is imperative to consult a physician, as these symptoms may indicate the onset of Reye’s syndrome, a rare but serious condition.

Aspirin may induce severe allergic reactions, which can manifest as hives, facial swelling, asthma (wheezing), or shock. This product contains a nonsteroidal anti-inflammatory drug (NSAID), which carries the risk of severe stomach bleeding. The likelihood of such an event 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.

Individuals should refrain from using this product if they have a known allergy to aspirin or any other pain reliever or fever reducer. Prior to use, it is advisable to consult a healthcare professional if any of the following conditions apply: a history of stomach bleeding, existing stomach issues such as heartburn, high blood pressure, heart disease, liver cirrhosis, kidney disease, use of diuretics, or asthma. Additionally, consultation with a doctor or pharmacist is recommended for those taking prescription medications for diabetes, gout, or arthritis.

In the event of an overdose, immediate medical assistance should be sought, or contact a Poison Control Center at 1-800-222-1222.

Users should discontinue use and contact a healthcare provider if any of the following occur: signs of an allergic reaction, symptoms indicative of stomach bleeding (such as feeling faint, vomiting blood, having bloody or black stools, or experiencing persistent stomach pain), worsening pain lasting more than 10 days, presence of redness or swelling, emergence of new symptoms, or occurrences of ringing in the ears or hearing loss. These symptoms may signify a serious medical condition requiring prompt attention.

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 in these demographics should not use this product. If any changes in behavior accompanied by nausea and vomiting occur while using this product, it is crucial to consult a doctor, as these symptoms may indicate the onset of Reye's syndrome.

Aspirin, the active ingredient in this product, may cause severe allergic reactions. Symptoms of such reactions can include hives, facial swelling, asthma (wheezing), and shock. Patients experiencing any signs of an allergic reaction should seek medical help immediately.

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 60 years of age or older, have a history of stomach ulcers or bleeding problems, are taking anticoagulants or steroid medications, 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, or experiencing persistent stomach pain. Additionally, if pain worsens or lasts longer than 10 days, if redness or swelling occurs, if new symptoms arise, or if there is ringing in the ears or loss of hearing, medical advice should be sought.

Before using this product, patients should consult a doctor 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. Patients taking diuretics or those with asthma should also seek medical advice prior to use.

It is important to note that this product should not be used by individuals who are allergic to aspirin or any other pain reliever or fever reducer. Pregnant or breastfeeding patients should consult a healthcare professional before use, particularly during the last three months of pregnancy, as aspirin may pose risks to the unborn child or lead to complications during delivery.

Drug Interactions

Aspirin has the potential to cause severe gastrointestinal bleeding, particularly when co-administered with anticoagulant medications or other nonsteroidal anti-inflammatory drugs (NSAIDs) such as ibuprofen or naproxen. This interaction is primarily pharmacodynamic in nature, as both classes of drugs can increase the risk of bleeding.

Patients are advised to consult a healthcare professional prior to using aspirin if they are concurrently taking prescription medications for diabetes, gout, or arthritis. This recommendation is crucial to ensure safe and effective use, as these conditions may influence the pharmacokinetics and pharmacodynamics of aspirin and its interactions with other medications. Monitoring for adverse effects is recommended in these scenarios.

Packaging & NDC

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

Packaging configurations for Aspirin.
Details

Pediatric Use

Pediatric patients, particularly children and teenagers, should not use this product if they have or are recovering from chicken pox or flu-like symptoms due to the risk of Reye's syndrome. Healthcare professionals are advised to consult a doctor if any changes in behavior accompanied by nausea and vomiting occur, as these may indicate the onset of Reye’s syndrome.

For dosing recommendations, 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. For children under 12 years of age, it is essential to consult a doctor prior to use.

Geriatric Use

Elderly patients, particularly those aged 60 years and older, may have an increased risk of severe stomach bleeding. It is essential for healthcare providers to exercise caution when prescribing this medication to geriatric patients.

Monitoring for gastrointestinal adverse effects is recommended, and dose adjustments may be necessary based on the individual patient's health status and concurrent medications. Careful assessment of the benefits and risks should be conducted to ensure the safety of elderly patients receiving this treatment.

Pregnancy

Pregnant patients and those who are breastfeeding should consult a healthcare professional prior to use. The use of aspirin during the last trimester of pregnancy is particularly cautioned against, as it may lead to adverse effects on fetal outcomes or complications during delivery. Therefore, it is essential that pregnant patients only use aspirin in this period if explicitly directed by a physician.

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 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 while breastfeeding.

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 due to compromised liver function. It is essential to assess liver function prior to initiating treatment and to monitor liver parameters throughout the course of therapy.

In patients with liver cirrhosis, dosage adjustments may be necessary to mitigate the risk of adverse effects. Close monitoring of liver function tests, including alanine aminotransferase (ALT), aspartate aminotransferase (AST), and bilirubin levels, is recommended to ensure patient safety and therapeutic efficacy.

Additionally, patients with a history of high blood pressure, heart disease, or kidney disease should be evaluated for potential interactions and contraindications related to their hepatic condition. It is crucial to tailor treatment plans based on the severity of hepatic impairment to optimize outcomes while minimizing risks.

Overdosage

In the event of an overdose, it is imperative to seek immediate medical assistance or contact a Poison Control Center without delay. Healthcare professionals are advised to call the Poison Control Center at 1-800-222-1222 for guidance on managing the situation effectively.

Prompt intervention is crucial, as symptoms of overdose may vary depending on the substance involved. Therefore, a thorough assessment and appropriate management strategies should be implemented based on the specific clinical scenario presented.

Nonclinical Toxicology

It is especially important not to use aspirin during the last three months of pregnancy unless specifically directed by a healthcare professional, as it may lead to complications for the unborn child or 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 keep the medication out of reach of children to prevent accidental ingestion. In the event of an overdose, patients should be instructed to seek medical help immediately or contact a Poison Control Center at 1-800-222-1222.

Patients must be informed not to use the medication if they have a known allergy to aspirin or any other pain reliever or fever reducer. They should be counseled to stop use and consult a doctor if they experience any signs of an allergic reaction, which requires immediate medical attention. Additionally, patients should be made aware of the signs of stomach bleeding, including feeling faint, vomiting blood, having bloody or black stools, or experiencing persistent stomach pain. They should also be advised to seek medical advice if their pain worsens or lasts longer than 10 days, if redness or swelling occurs, if new symptoms develop, or if they experience ringing in the ears or loss of hearing, as these may indicate a serious condition.

Healthcare providers should encourage patients to consult a doctor before using the 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, as well as those taking diuretics or who have asthma, should also be advised to seek medical guidance prior to use.

Furthermore, patients should be encouraged to ask a doctor or pharmacist before using the medication if they are currently taking prescription drugs for diabetes, gout, or arthritis, to ensure safe and effective use.

Storage and Handling

The product is supplied in a carton that contains essential information and warnings. It should be stored in a dry place at a temperature range of 20°-25°C (68°-77°F) to ensure optimal stability and efficacy. It is recommended to retain the carton for reference to complete product information and any relevant warnings.

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 aspirin during the last trimester of pregnancy 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

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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.