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Aspirin 81mg

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This product has been discontinued

Active ingredient
Aspirin 81 mg
Other brand names
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 2025
Label revision date
December 26, 2025
Drug Information (PDF)
Prescribing information, PDF file
Active ingredient
Aspirin 81 mg
Other brand names
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 2025
Label revision date
December 26, 2025
Manufacturer
Innovida Pharmaeutique Corporation
Registration number
M013
NDC root
71800-040
Drug Information (PDF)
Prescribing information, PDF file
Packaging Info
Packaging & NDC Codes

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 medication commonly used for the temporary relief of minor aches and pains. It can help alleviate discomfort from headaches, muscle aches, and other similar conditions. If you're considering using aspirin for other purposes, it's a good idea to consult your doctor to discuss its potential benefits and uses tailored to your needs.

Uses

You can use this medication for the temporary relief of minor aches and pains, such as headaches, muscle aches, or minor arthritis discomfort. If you're curious about other potential uses for aspirin, it's a good idea to ask your doctor for more information.

Dosage and Administration

When taking this medication, make sure to drink a full glass of water with each dose. It's important to swallow the tablets whole, so do not chew or crush them. Always follow the recommended dosage and never exceed it.

For adults and children aged 12 years and older, you can take 4 to 8 tablets every 4 hours as needed, but be careful not to take more than 48 tablets in a 24-hour period unless directed by your doctor. If the patient is under 12 years old, please consult a doctor for the appropriate dosage.

What to Avoid

There are no specific contraindications, controlled substance classifications, or concerns regarding abuse, misuse, or dependence associated with this medication. Additionally, there are no explicit instructions indicating that you should not take or use this medication. Always consult with your healthcare provider for personalized advice and to ensure this medication is appropriate for you.

Side Effects

If you are a child or teenager recovering from chickenpox or flu-like symptoms, it's important not to use this product, as it may lead to Reye's syndrome, a rare but serious illness. If you notice changes in behavior along with nausea and vomiting while using this product, consult a 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 an 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. If you experience symptoms like feeling faint, vomiting blood, or having bloody or black stools, stop using the product and seek medical attention right away. Always consult a doctor if you notice any new symptoms or if your pain worsens or lasts longer than expected.

Warnings and Precautions

You should be aware of some important warnings and precautions when using this product. If you are a child or teenager recovering from chickenpox or flu-like symptoms, do not use this product, as it may lead to Reye's syndrome, a serious condition. Additionally, be cautious of severe allergic reactions, which can include hives, facial swelling, asthma (wheezing), or shock. This product contains a nonsteroidal anti-inflammatory drug (NSAID), which can cause severe stomach bleeding, especially if you are over 60, have a history of stomach ulcers, or are taking certain medications like blood thinners or steroids.

Before using this product, consult your doctor if you have any of the following: a history of stomach problems, high blood pressure, heart disease, liver cirrhosis, kidney disease, or asthma. If you experience any signs of stomach bleeding, such as feeling faint, vomiting blood, or having black stools, stop taking the product and call your doctor immediately. Seek emergency help if you suspect an overdose or if you have an allergic reaction. Also, contact your doctor if your pain worsens, lasts more than 10 days, or if you notice any new symptoms, including ringing in the ears or loss of hearing.

Overdose

If you suspect an overdose, it’s crucial to seek medical help immediately or contact a Poison Control Center. Signs of an overdose can vary, but they may include unusual symptoms that are more severe than what you typically experience with the medication.

Don’t wait for symptoms to worsen; acting quickly can make a significant difference in your safety. Always keep emergency contact information handy, and remember that it’s better to be cautious and seek help if you have any concerns about an overdose.

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 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 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 can increase the risk of a serious condition called Reye's syndrome (a rare but serious illness affecting the liver and brain). If your child experiences changes in behavior along with nausea and vomiting while using this product, 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 4-8 tablets every 4 hours as needed, 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 best to consult a doctor before giving them this product.

Geriatric Use

It's important to be aware that this product contains a type of medication called an NSAID (nonsteroidal anti-inflammatory drug), which can increase the risk of severe stomach bleeding, especially for older adults. If you are 60 or older, have a history of stomach ulcers or bleeding issues, or are taking blood thinners (medications that prevent blood clots) or steroids, you should be particularly cautious. The risk is also higher if you take other NSAIDs, such as aspirin or ibuprofen, or consume three or more alcoholic drinks daily while using this product.

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 further increase your risk of complications. Always consult with your healthcare provider if you have any concerns or questions about using this medication, especially if you have existing health conditions or are taking other medications.

Renal Impairment

If you have kidney disease, it's important to consult your doctor before using this medication. Your healthcare provider can help determine if it's safe for you and may need to adjust your dosage or monitor your kidney function closely. Always prioritize your health by discussing any concerns with your doctor.

Hepatic Impairment

If you have liver cirrhosis (a severe liver condition), it’s important to consult your doctor before using this medication. Your healthcare provider can help determine if this treatment is safe for you and may suggest necessary adjustments to your dosage or monitoring based on your liver function. Always prioritize open communication with your doctor regarding your liver health to ensure safe and effective use of any medication.

Drug Interactions

It's important to have open conversations with your healthcare provider about any medications or tests you may be taking. While there are no specific drug interactions or laboratory test interactions noted for this medication, your healthcare provider can help ensure that everything you are taking works well together and is safe for you.

Always feel free to ask questions and share your complete list of medications and any lab tests you may be undergoing. This way, you can receive the best possible care tailored to your needs.

Storage and Handling

To ensure the best performance and safety of your product, store it at a controlled room temperature. This means keeping it in a place that is neither too hot nor too cold, typically around 20°C to 25°C (68°F to 77°F).

When handling the product, make sure to do so with clean hands and in a clean environment to maintain its integrity. Always follow any specific instructions provided with the product for safe use and disposal.

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 can lead to issues for the unborn child or complications during delivery.

FAQ

What is aspirin used for?

Aspirin is used for the temporary relief of minor aches and pains. You should ask your doctor about other potential uses for aspirin.

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 get better, stop using aspirin and call your doctor immediately.

Can children use aspirin?

Children under 12 years should ask a doctor before using aspirin. It is not recommended for children and teenagers recovering from chicken pox or flu-like symptoms due to the risk of Reye's syndrome.

What are the dosage instructions for adults and children 12 years and older?

Adults and children 12 years and older can take 4-8 tablets every 4 hours as needed, not exceeding 48 tablets in 24 hours, or as directed by a doctor.

What precautions should I take if I am pregnant or breastfeeding?

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

What should I do if I have an allergic reaction to aspirin?

If you experience symptoms of a severe allergic reaction, such as hives, facial swelling, or difficulty breathing, seek medical help right away.

How should I take aspirin?

You should swallow aspirin tablets whole with a full glass of water. Do not chew or crush the tablets.

What should I avoid while taking aspirin?

Avoid taking more than the recommended dose and consult your doctor if you are taking other NSAIDs, blood thinners, or have a history of stomach problems.

Packaging Info

Below are the non-prescription pack sizes of Aspirin 81mg (aspirin). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Aspirin 81mg.
Details

Drug Information (PDF)

This file contains official product information for Aspirin 81mg, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)

Description

No description information is available for the specified drug.

Uses and Indications

This drug is indicated for the temporary relief of minor aches and pains. Healthcare professionals are advised to consult with patients regarding other potential uses for aspirin.

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. It is important to swallow the tablets whole; they should not be chewed or crushed to ensure proper release and absorption of the active ingredients.

For adults and children aged 12 years and older, the recommended dosage is 4 to 8 tablets every 4 hours as needed. 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. It is crucial to adhere to the recommended dosage and not exceed the specified limits to avoid potential adverse effects.

Contraindications

There are no contraindications listed for this product. It is important to evaluate each patient's individual circumstances and medical history when considering its use.

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 may provoke severe allergic reactions in some individuals. Symptoms of such reactions can include hives, facial swelling, asthma (wheezing), and shock. Healthcare professionals should be vigilant for these signs and advise patients to seek immediate medical attention if they occur.

This product contains a nonsteroidal anti-inflammatory drug (NSAID), which carries a risk of severe stomach bleeding. The likelihood of this adverse effect is increased in patients 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, or exceed the recommended dosage or duration of use.

Patients 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 for patients to consult a healthcare provider if any of the following conditions apply: the stomach bleeding warning is relevant, they are taking diuretics, have a history of gastrointestinal issues such as heartburn, or have conditions such as high blood pressure, heart disease, liver cirrhosis, kidney disease, or asthma.

Additionally, patients should seek guidance from a healthcare professional or pharmacist before using this product if they are currently taking any other NSAIDs (whether prescription or over-the-counter), anticoagulants, steroid medications, or prescription drugs for diabetes, gout, or arthritis.

In the event of an overdose, immediate medical assistance should be sought, or the Poison Control Center should be contacted without delay.

Patients are advised to discontinue use and contact their healthcare provider if they experience any of the following: signs of stomach bleeding (such as feeling faint, vomiting blood, having bloody or black stools, or persistent stomach pain), any allergic reactions, worsening pain lasting more than 10 days, redness or swelling, fever that worsens or persists beyond three days, the emergence of new symptoms, or symptoms such as ringing in the ears or loss of hearing.

Side Effects

Patients using this product should be aware of the potential for serious adverse reactions, including Reye's syndrome, which is a rare but serious illness. Children and teenagers who have or are recovering from chickenpox or flu-like symptoms should not use this product. If patients experience changes in behavior accompanied by nausea and vomiting, they should consult a doctor immediately, as these may be early signs of Reye's syndrome.

Aspirin may also cause severe allergic reactions in some individuals. 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 right away.

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

Patients are advised to stop using the product and consult a doctor if they experience any signs of stomach bleeding, which may include feeling faint, vomiting blood, having bloody or black stools, or experiencing persistent stomach pain. Additionally, medical attention should be sought if an allergic reaction occurs, if pain worsens or lasts longer than 10 days, if redness or swelling is present, if fever worsens or lasts more than three days, if any new symptoms arise, or if there is ringing in the ears or loss of hearing.

Drug Interactions

There are currently no documented drug interactions associated with the use of this medication. Additionally, there is no information available regarding interactions with laboratory tests. As such, no specific recommendations for dosage adjustments or monitoring are warranted at this time.

Packaging & NDC

Below are the non-prescription pack sizes of Aspirin 81mg (aspirin). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Aspirin 81mg.
Details

Pediatric Use

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

For dosing, adults and children aged 12 years and older may take 4-8 tablets every 4 hours as needed, with a maximum of 48 tablets in a 24-hour period, unless otherwise directed by a doctor. For children under 12 years of age, it is advised to consult a doctor for appropriate dosing recommendations.

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 nonprescription, such as aspirin, ibuprofen, or naproxen.

Healthcare providers should exercise caution when prescribing this product to geriatric patients, especially if they consume three or more alcoholic drinks daily while using the medication. It is essential to monitor these patients closely for any signs of gastrointestinal bleeding and to consider dose adjustments or alternative therapies as necessary. Additionally, patients should be advised to adhere strictly to the recommended dosage and duration of use to minimize 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 fetal outcomes or complications during delivery. Therefore, it is essential 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 prior to 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 its use in lactating individuals.

Renal Impairment

Patients with renal impairment should consult a healthcare professional prior to use, particularly if they have a history of kidney disease. It is essential to assess renal function and consider potential dosing adjustments or monitoring requirements based on the degree of impairment.

Hepatic Impairment

Patients with hepatic impairment, particularly those with liver cirrhosis, should consult a healthcare professional prior to use. It is essential to evaluate liver function and consider potential adjustments in dosage or treatment plans based on the severity of hepatic impairment. Monitoring of liver function tests may be warranted to ensure patient safety and therapeutic efficacy.

Overdosage

In the event of an overdose, it is imperative to seek immediate medical assistance or contact a Poison Control Center without delay. Prompt intervention is crucial to mitigate potential adverse effects associated with the overdose.

Healthcare professionals should be aware that the specific symptoms of an overdose may vary depending on the substance involved. Therefore, a thorough assessment of the patient's condition is essential to determine the appropriate course of action.

Management of an overdose typically involves supportive care and symptomatic treatment. Continuous monitoring of the patient's vital signs and clinical status is recommended. In cases where the specific substance is known, targeted therapies may be employed as indicated.

It is essential for healthcare providers to remain vigilant and act swiftly in the management of overdose situations to ensure optimal patient outcomes.

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

Postmarketing experience has identified several adverse reactions associated with the use of the product. These include gastrointestinal bleeding, allergic reactions such as anaphylaxis, Reye's syndrome in children and teenagers recovering from chickenpox or flu-like symptoms, asthma exacerbation, stomach ulcers, liver damage, kidney damage, tinnitus (ringing in the ears), and hearing loss.

Additionally, safety updates from postmarketing experience indicate an increased risk of gastrointestinal bleeding in patients over 60 years of age or those with a history of ulcers or bleeding disorders. Caution is advised for patients concurrently taking anticoagulants, steroids, or other nonsteroidal anti-inflammatory drugs (NSAIDs).

Patient Counseling

Healthcare providers should advise patients to keep this medication out of the reach of children to prevent accidental ingestion or misuse. It is important for patients to understand the potential risks associated with improper access to the medication by young children. Providers should emphasize the necessity of storing the medication in a secure location, away from children's sight and reach, to ensure safety.

Storage and Handling

The product is supplied in various package configurations, with specific NDC numbers assigned for identification. It is essential to store the product at controlled room temperature to maintain its integrity and efficacy. Proper handling should be observed to ensure that the product remains within the recommended temperature range throughout its storage period.

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 81mg, 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 81mg, 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.