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Low Dose Aspirin

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Active ingredient
Aspirin 81 mg
Other brand names
Drug classes
Nonsteroidal Anti-inflammatory Drug, Platelet Aggregation Inhibitor
Dosage form
Tablet, Delayed Release
Route
Oral
Prescription status
OTC (over the counter)
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Marketed in the U.S.
Since 2011
Label revision date
October 16, 2024
Drug Information (PDF)
Prescribing information, PDF file
Active ingredient
Aspirin 81 mg
Other brand names
Drug classes
Nonsteroidal Anti-inflammatory Drug, Platelet Aggregation Inhibitor
Dosage form
Tablet, Delayed Release
Route
Oral
Prescription status
OTC (over the counter)
CSA schedule
Not a scheduled drug
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Marketed in the U.S.
Since 2011
Label revision date
October 16, 2024
Manufacturer
DISCOUNT DRUG MART
Registration number
M013
NDC root
53943-080
Drug Information (PDF)
Prescribing information, PDF file
Packaging Info (3 NDCs)
Packaging & NDC Codes (3)

If you are a healthcare professional or from the pharmaceutical industry please visit this version.

If you are a consumer or patient please visit this version.

Drug Overview

Aspirin is a low-dose pain reliever that belongs to a class of medications known as nonsteroidal anti-inflammatory drugs (NSAIDs). Each tablet contains 81 mg of aspirin, which is commonly used for the temporary relief of minor aches and pains. It is important to note that due to its delayed action, aspirin may not provide quick relief for headaches or other symptoms that require immediate attention.

In addition to its pain-relieving properties, aspirin is often recommended by healthcare providers for heart health. However, it's essential to consult with your doctor before using it for this purpose to ensure it is appropriate for your individual health needs.

Uses

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

If you're curious about other potential uses for this product, it's a good idea to consult your doctor for more information.

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 your healthcare provider's guidance for the best results.

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

Using this product may lead to some serious side effects. If you are a child or teenager recovering from chickenpox or flu-like symptoms, you should avoid it, as it could trigger Reye’s syndrome, a rare but serious illness. Be aware that aspirin can cause severe allergic reactions, which may include hives, facial swelling, wheezing, or even shock.

Additionally, 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 feeling faint, vomiting blood, or having bloody or black stools, seek medical attention immediately. Always consult your doctor if you have any underlying health conditions or if you notice any unusual symptoms while using this product.

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 may lead to 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, take blood thinners or steroids, consume three or more alcoholic drinks daily, or use it for longer than directed.

Before using this product, consult your doctor if you have any allergies to aspirin or other pain relievers, a history of stomach problems, high blood pressure, heart disease, liver cirrhosis, kidney disease, or if you are taking certain medications for diabetes, gout, or arthritis. 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 seek medical help immediately. In case of overdose, contact a Poison Control Center or seek emergency medical assistance right away.

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 overdosing 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 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 specifically advises 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 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. For children under 12 years old, you should consult a doctor before giving them this medication to ensure it's safe and appropriate for their age.

For older children and teenagers aged 12 and above, the recommended dosage is 4 to 8 tablets every 4 hours, but they should not take more than 48 tablets in a 24-hour period unless directed by a doctor. Always prioritize your child's health by seeking medical advice when needed.

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 when taking certain medications that can affect the stomach. Always consult with your healthcare provider about any medications you are considering, as they can help you understand the risks and determine the safest options for your health.

Renal Impairment

If you have kidney problems, it's important to consult your doctor before using this medication. This is especially crucial if you also have high blood pressure, heart disease, or liver cirrhosis, as these conditions can affect how your body processes the medication. Your healthcare provider will help determine if it's safe for you and may suggest adjustments to your dosage or additional monitoring to ensure your safety. Always prioritize open communication with your doctor regarding your health conditions.

Hepatic Impairment

If you have liver problems, such as liver cirrhosis (a severe scarring of the liver), it's important to consult your doctor before using this medication. Your healthcare provider can help determine if it's safe for you, especially if you also have other conditions like high blood pressure or heart disease.

Always prioritize your health by discussing any existing liver issues with your doctor to ensure proper care and monitoring.

Drug Interactions

It's important to be aware that certain medications can interact with each other, potentially leading to serious health issues. For instance, taking aspirin can increase the risk of severe stomach bleeding, particularly if you are also using blood thinners (medications that prevent blood clots) or steroids.

If you are on prescription medications for diabetes, gout, or arthritis, it's crucial to consult with your doctor or pharmacist before starting aspirin. They can help ensure that your medications work safely together and that you avoid any harmful interactions. Always prioritize open communication with your healthcare provider 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. It's important to consult your healthcare provider before using this product, especially if you have any heart-related concerns. They can provide guidance tailored to your specific health needs.

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. 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 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?

Stop using ASPIRIN and seek medical help if you feel faint, vomit blood, have bloody or black stools, or have stomach pain that does not improve.

Can I use ASPIRIN if I am pregnant or breastfeeding?

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

Who should not use ASPIRIN?

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

What should I do in case of an overdose?

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

How should I store ASPIRIN?

Store ASPIRIN between 20°-25°C (68°-77°F) in a dry place and retain the carton for complete product information and warnings.

Packaging Info

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

Packaging configurations for Low Dose Aspirin.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

Low Dose Aspirin is a nonsteroidal anti-inflammatory drug (NSAID) indicated for pain relief. Each tablet contains 81 mg of aspirin. The product is available in a dosage form of enteric-coated tablets, with a total of 120 tablets per bottle. The National Drug Code (NDC) for this formulation is 53943-080-01.

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.

Healthcare professionals are encouraged to consult with patients regarding additional potential uses for this product. There are no teratogenic or nonteratogenic effects associated with this drug.

Dosage and Administration

Patients are advised to take a full glass of water with each dose to ensure proper hydration and facilitate the medication's effectiveness.

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 before administration to determine the appropriate dosage and ensure safety.

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 any changes in behavior accompanied by nausea and vomiting occur while using this product, 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 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.

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 a diagnosis of 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 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 this product. 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.

Aspirin may cause severe allergic reactions in some patients, which can manifest as hives, facial swelling, asthma (wheezing), or shock. Patients should seek immediate medical attention if they experience any signs of an allergic reaction.

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, 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.

Drug Interactions

Aspirin has the potential to cause severe gastrointestinal bleeding, particularly when co-administered with anticoagulants or steroid medications. This interaction is primarily pharmacodynamic in nature, as both aspirin and these classes of drugs can increase the risk of bleeding.

Patients taking prescription medications for diabetes, gout, or arthritis should consult a healthcare professional prior to using aspirin. This recommendation is crucial to ensure safe and effective management of their conditions, as potential interactions may necessitate dosage adjustments or increased monitoring.

Packaging & NDC

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

Packaging configurations for Low Dose Aspirin.
Details

Pediatric Use

Pediatric patients, particularly 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. For children under 12 years, it is advised to consult a doctor prior to use.

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 healthcare professional.

Geriatric Use

Elderly patients, particularly those aged 60 and older, may have an increased risk of severe stomach bleeding. Healthcare providers should exercise caution when prescribing medications that may exacerbate this risk in this population. It is advisable to closely monitor these patients for any signs of gastrointestinal bleeding and to consider appropriate dose adjustments or alternative therapies as necessary to ensure their safety.

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 concerning, as it may lead to adverse effects on fetal outcomes or complications during delivery. Therefore, it is crucial that pregnant patients only use aspirin in this period if explicitly directed by a healthcare provider.

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 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 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 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 their liver function to ensure safe use of the medication. Adjustments to dosage may be necessary based on the severity of hepatic impairment, and ongoing assessment of liver function is recommended throughout the treatment period.

Overdosage

In the event of an overdose, it is imperative to seek immediate medical assistance or contact a Poison Control Center without delay. The national Poison Control Center can be reached at 1-800-222-1222.

Healthcare professionals should be aware that timely intervention is crucial in managing overdose situations. Symptoms of overdose may vary depending on the substance involved, and it is essential to monitor the patient closely for any signs of adverse reactions.

Management procedures may include supportive care and symptomatic treatment, tailored to the specific symptoms presented by the patient. Continuous assessment and monitoring of vital signs are recommended to ensure patient safety and to guide further therapeutic interventions.

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 detailed findings 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 this medication out of reach of children to prevent accidental ingestion. In the event of an overdose, patients should be instructed to seek medical help immediately or contact a Poison Control Center at 1-800-222-1222.

Patients must be informed not to use this 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 may require 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 stomach pain that does not improve. They should also be advised to seek medical advice if their pain worsens or persists for more 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.

It is important for healthcare providers to ask patients about their medical history before recommending this medication. Patients should be advised to consult a doctor prior to use 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 be encouraged to seek medical advice before using this medication.

Furthermore, patients should be instructed to consult a doctor or pharmacist before using this medication if they are currently taking prescription drugs for diabetes, gout, or arthritis, to avoid potential interactions.

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 details.

Additional Clinical Information

The product is administered orally. Clinicians should advise patients to consult their healthcare provider prior to using this product for heart-related conditions. No additional information is available regarding laboratory tests, abuse potential, or postmarketing experiences.

Drug Information (PDF)

This file contains official product information for Low Dose 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 Low Dose 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.