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Aspirin 81 mg

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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 11, 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 11, 2024
Manufacturer
Meijer
Registration number
M013
NDC root
41250-780
Drug Information (PDF)
Prescribing information, PDF file
Packaging Info (4 NDCs)
Packaging & NDC Codes (4)

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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). It is commonly used to provide temporary relief from minor aches and pains, such as headaches or muscle discomfort. However, it's important to note that aspirin is not designed for fast relief, as it has a delayed action.

In addition to its pain-relieving properties, aspirin is often used in specific regimens for heart health, but you should consult your healthcare provider before using it for this purpose. Always discuss with your doctor if you have questions about how aspirin may be beneficial for you.

Uses

This product is designed to provide temporary relief from minor aches and pains, such as headaches or muscle discomfort, as advised by your doctor. However, keep in mind that it works gradually, so it may not be suitable for immediate relief of symptoms that require quick action.

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

You should be aware of some important side effects and warnings associated with this product. It can cause severe allergic reactions, which may include hives, facial swelling, asthma (wheezing), and shock. Additionally, there is a risk of Reye's syndrome, a serious illness, particularly in children and teenagers recovering from chickenpox or flu-like symptoms. If you notice changes in behavior along with nausea and vomiting, consult a doctor immediately.

This product contains a nonsteroidal anti-inflammatory drug (NSAID), which can lead to severe stomach bleeding, especially if you are over 60, have a history of stomach ulcers, or are taking certain medications like blood thinners or other NSAIDs. Be alert for signs of stomach bleeding, such as feeling faint, vomiting blood, or having black stools, and seek medical help if these occur. If you have any underlying health conditions, such as high blood pressure or asthma, or if you are taking other medications, it's best to consult with a doctor before 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 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.

You should 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 like ringing in the ears or loss of hearing. These could indicate a serious condition that requires prompt medical attention.

Overdose

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

Do not wait for symptoms to worsen; getting prompt assistance can be vital. Always keep emergency contact information handy and be aware of the signs of overdose to ensure your safety and well-being.

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 you are considering this product for your child, it's important to know that it should not be used by children and teenagers who have or are recovering from chicken pox or flu-like symptoms. Additionally, 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, a rare but serious condition.

For children under 12 years old, 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 healthcare professional. Always prioritize your child's safety and well-being by following these guidelines.

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 can affect your stomach, such as certain pain relievers or anti-inflammatory drugs.

Always consult with your healthcare provider about the safest options for managing pain or other conditions, as they can help you navigate these risks and adjust dosages if necessary. Taking these precautions can help ensure your health and 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 (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 taking aspirin can lead to serious stomach bleeding, particularly if you are also using blood thinners (medications that prevent blood clots), steroids, or other nonsteroidal anti-inflammatory drugs (NSAIDs) like ibuprofen or naproxen. This risk highlights the need to discuss all your current medications with your healthcare provider.

If you are on prescription medications for diabetes, gout, or arthritis, make sure to consult with your doctor or pharmacist before using aspirin. They can help ensure that your treatment plan is safe and effective, minimizing any potential risks. Always prioritize open communication about your medications to protect your health.

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. This ensures that the medication is appropriate for 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. It is important to note that it has a delayed action and will not provide fast relief for headaches or other symptoms needing immediate relief.

What should I do if I am allergic to aspirin?

Do not use Aspirin if you are allergic to it or any other pain reliever/fever reducer. Consult your doctor for alternatives.

What are the dosage instructions for adults and children over 12?

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.

Are there any warnings for children and teenagers?

Children and teenagers recovering from chicken pox or flu-like symptoms should not use Aspirin, as it may lead to Reye's syndrome, a rare but serious illness.

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

Stop using Aspirin and consult a doctor if you experience symptoms such as feeling faint, vomiting blood, or having bloody or black stools.

Can I take Aspirin if I am pregnant or breastfeeding?

If you are pregnant or breastfeeding, consult a healthcare 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 are the storage instructions for Aspirin?

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

What should I do in case of an overdose?

In case of overdose, seek medical help or contact a Poison Control Center immediately at 1-800-222-1222.

Packaging Info

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

Packaging configurations for Aspirin 81 mg.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

This product contains 81 mg of Aspirin, classified as a nonsteroidal anti-inflammatory drug (NSAID) and serves as a pain reliever. It is presented in a low-dose formulation, specifically designed for an Aspirin regimen. The product is available in a package containing 120 enteric-coated tablets, which are formulated to reduce gastrointestinal irritation. The National Drug Code (NDC) for this product is 41250-780-01. This formulation is comparable to the active ingredient found in Bayer® Low Dose Aspirin.

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 fast relief of headaches or other symptoms requiring immediate alleviation.

Limitations of Use: Healthcare professionals are encouraged to inquire about additional uses for this product, as specific indications may vary based on individual patient needs. 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 administration.

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 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.

Warnings and Precautions

Children and teenagers who have or are recovering from chickenpox or flu-like symptoms should not use this product. If 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 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 problems 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 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 chickenpox or flu-like symptoms. It is crucial that these individuals do not use 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.

Aspirin, a component of this product, may provoke severe allergic reactions in some patients. Symptoms of such reactions can include hives, facial swelling, asthma (wheezing), and 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, 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 discontinue use 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 healthcare professional if any of the following apply: they have a history of stomach problems such as heartburn, high blood pressure, heart disease, liver cirrhosis, or kidney disease; they are taking diuretics; or they have asthma. Furthermore, patients should seek guidance from a doctor or pharmacist if they are currently taking prescription medications for diabetes, gout, or arthritis.

Drug Interactions

Aspirin has the potential to cause severe gastrointestinal bleeding, particularly when co-administered with anticoagulants, corticosteroids, or other nonsteroidal anti-inflammatory drugs (NSAIDs) such as ibuprofen or naproxen.

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 precaution is essential to ensure safe and effective use, as interactions may necessitate dosage adjustments or increased monitoring for adverse effects.

Packaging & NDC

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

Packaging configurations for Aspirin 81 mg.
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. For children under 12 years of age, it is advised to consult a doctor prior to use.

In 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.

Healthcare providers should be vigilant for changes in behavior accompanied by nausea and vomiting, as these may indicate the onset of Reye’s syndrome, a rare but serious condition.

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 this medication to geriatric patients, considering the potential for heightened adverse effects.

It is advisable to closely monitor elderly patients for any signs of gastrointestinal bleeding and to evaluate the necessity of dosage adjustments based on individual patient factors. Careful assessment of the risk-benefit profile is essential in this population to ensure safe and effective use of the medication.

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 development 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 explicitly 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 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 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. Healthcare professionals are advised to call 1-800-222-1222 for expert guidance.

Prompt intervention is crucial in managing overdose situations to mitigate potential adverse effects and ensure patient safety.

Nonclinical Toxicology

It is especially important not to use aspirin during the last three months of pregnancy unless definitely directed to do so by a doctor, as it may cause problems in the unborn child or complications during delivery. No relevant information is available regarding non-teratogenic effects, nonclinical toxicology, or animal pharmacology and toxicology.

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 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 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.

Patients should be encouraged 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. It is also important to discuss any existing conditions such as high blood pressure, heart disease, liver cirrhosis, or kidney disease, as well as the use of diuretics or asthma medications.

Furthermore, patients should be advised to speak with their doctor or pharmacist before using the 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 information.

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 Aspirin 81 mg, 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 81 mg, 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.