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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 2020
Label revision date
December 9, 2024
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 2020
Label revision date
December 9, 2024
Manufacturer
SPIRIT PHARMACEUTICALS LLC
Registration number
M013
NDC root
68210-5100
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 low-strength pain reliever that contains 81 mg of the active ingredient, making it a type of medication known as a nonsteroidal anti-inflammatory drug (NSAID). It is designed to provide temporary relief from minor aches and pains, although it is not intended for quick relief of headaches, fever, or other symptoms that require immediate attention due to its delayed action.

You may find Aspirin helpful for managing everyday discomfort, but it's always a good idea to consult your doctor about its uses and whether it’s right for you.

Uses

You can use this medication for the temporary relief of minor aches and pains, as advised by your doctor. However, keep in mind that it works slowly, so it may not be the best choice if you need quick relief from headaches, fever, or other symptoms that require immediate attention.

If you're curious about other potential uses for Aspirin 81 mg, it's a good idea to discuss this with your healthcare provider. They can provide you with more information tailored to your specific health 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 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 these guidelines carefully to ensure effective and safe use of the medication.

What to Avoid

If you are allergic to aspirin or any other pain reliever or fever reducer, it is important that you do not use this medication. Allergic reactions can be serious and may cause symptoms such as difficulty breathing, swelling, or rash.

Additionally, be aware that this medication is classified as a controlled substance, which means it has the potential for abuse or misuse. Misuse can lead to dependence (a condition where you feel a strong need to continue using the drug), so it’s crucial to follow your healthcare provider's instructions carefully and avoid using it in ways not prescribed. Always prioritize your safety and well-being by adhering to these guidelines.

Side Effects

If you experience an allergic reaction, such as difficulty breathing or swelling, seek medical help immediately. It's important to stop using the medication and consult a doctor if you notice any signs of stomach bleeding, which can include feeling faint, vomiting blood, having bloody or black stools, or experiencing stomach pain that worsens or lasts more than 10 days. Additionally, if you notice redness or swelling, new symptoms, or experience ringing in the ears or hearing loss, contact your healthcare provider.

Before using this medication, talk to your doctor if you have a history of stomach issues, high blood pressure, heart disease, liver cirrhosis, or kidney disease. You should also consult a healthcare professional if you are taking diuretics or have asthma. If you are on prescription medications for gout, diabetes, or arthritis, it's advisable to check with your doctor or pharmacist before starting this treatment.

Warnings and Precautions

It's important to be cautious when using this medication. Do not take it if you are allergic to aspirin or any other pain reliever or fever reducer. If you experience any signs of an allergic reaction, such as difficulty breathing or swelling, seek medical help immediately.

You should also stop using the medication and contact your doctor if you notice any symptoms of stomach bleeding, which can include feeling faint, vomiting blood, having bloody or black stools, or experiencing stomach pain that doesn't improve. Additionally, if you have pain that worsens or lasts more than 10 days, notice redness or swelling, develop new symptoms, or experience ringing in the ears or hearing loss, it's essential to reach out to your healthcare provider.

In case of an overdose, get emergency medical help or contact a Poison Control Center right away. Your safety is the top priority, so please take these warnings seriously.

Overdose

If you suspect an overdose, it's important to be aware that specific information about what to do in such a situation is not provided. However, general signs of an overdose can include unusual drowsiness, confusion, or difficulty breathing. If you notice any of these symptoms or suspect an overdose, seek immediate medical help.

In case of an overdose, contacting your local emergency services or going to the nearest hospital is crucial. Always err on the side of caution when it comes to your health.

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 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. Additionally, if you notice any changes in your child's behavior accompanied by nausea and vomiting, consult a doctor right away, as these could be early signs of Reye's syndrome, a rare but serious condition.

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 for appropriate dosing guidance.

Geriatric Use

As you age, it's important to be aware that the risk of 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 the 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 understand the risks and adjust dosages if necessary to ensure your safety. Taking these precautions can help you maintain your health and well-being as you age.

Renal Impairment

If you have kidney problems, it's important to know that you may need a lower dose of this medication. Your doctor will determine the right dosage based on your creatinine clearance levels, which is a test that measures how well your kidneys are filtering waste from your blood.

To ensure your safety while taking this medication, regular tests to check your kidney function are recommended. If you have severe kidney impairment, your healthcare provider may need to monitor you more closely. Always discuss any concerns with your doctor to ensure the best care for your condition.

Hepatic Impairment

If you have liver problems, it's important to know that your dosage of this medication may need to be adjusted. This is because your liver's ability to process the drug can be affected. Additionally, your healthcare provider will likely recommend special monitoring of your liver function tests (which check how well your liver is working) to ensure your safety while using this medication.

Caution is advised when taking this drug if you have liver impairment, as it may change how your body metabolizes (processes) the medication. Always discuss your liver health with your doctor to ensure you receive the appropriate care and adjustments needed for your treatment.

Drug Interactions

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

If you are currently using prescription medications for conditions such as gout, diabetes, or arthritis, it's crucial to consult with your healthcare provider 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 about your medications to protect your health.

Storage and Handling

To ensure the best performance of your product, store it at room temperature. This helps maintain its effectiveness and safety. When handling the product, be sure to follow any specific instructions provided to avoid contamination or damage. Always keep it in a clean environment to ensure it remains safe for use.

If you have any questions about disposal or other safety measures, please refer to the guidelines provided with your product.

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, 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. Drink a full glass of water with each dose.

Are there any contraindications for using Aspirin?

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

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

Stop using Aspirin and call your doctor if you feel faint, vomit blood, have bloody or black stools, or experience stomach pain that does not improve.

Can I take Aspirin if I am pregnant or breastfeeding?

If you are pregnant or breastfeeding, ask 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 have a history of stomach problems?

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

What are the potential risks of taking Aspirin?

Aspirin may cause stomach bleeding, especially if taken with blood thinners or other NSAIDs. The risk is higher if you are age 60 or older.

What should I do if I am taking other medications?

Ask your doctor or pharmacist before using Aspirin if you are taking prescription drugs for gout, diabetes, or arthritis.

What are the storage instructions for Aspirin?

Store Aspirin at room temperature.

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

Aspirin is a nonsteroidal anti-inflammatory drug (NSAID) indicated for pain relief. Each tablet contains 81 mg of aspirin, formulated for adult low strength use. The product is presented in a dosage form of enteric safety coated tablets, designed to minimize gastrointestinal irritation. The package contains 120 tablets, providing a convenient supply for ongoing use. This formulation is comparable to the active ingredient found in Bayer® Low Dose Aspirin Regimen.

Uses and Indications

This drug is indicated for the temporary relief of minor aches and pains, or as recommended by a healthcare professional. Due to its delayed action, this product is not suitable for the fast relief of headaches, fever, or other symptoms requiring immediate alleviation.

Healthcare professionals are encouraged to inquire about additional uses for Aspirin 81 mg, as other indications may be applicable based on individual patient needs. There are no teratogenic or nonteratogenic effects mentioned in the available data.

Dosage and Administration

Patients should take the medication with a full glass of water to ensure proper administration and absorption.

For adults and children aged 12 years and older, the recommended dosage is 4 to 8 tablets every 4 hours. The total daily dosage 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

Patients should be aware of the following warnings and precautions associated with the use of this medication.

Warnings This medication should not be used by individuals who have a known allergy to aspirin or any other pain reliever or fever reducer.

General Precautions It is imperative to discontinue use and consult a healthcare professional if any signs of an allergic reaction occur. Immediate medical attention should be sought in such cases.

Signs of Serious Adverse Effects Patients are advised to stop taking the medication and contact their doctor if they experience any of the following symptoms, which may indicate serious complications such as stomach bleeding:

  • Feeling faint

  • Vomiting blood

  • Presence of bloody or black stools

  • Persistent stomach pain that does not improve

  • Worsening pain or pain lasting more than 10 days

  • Redness or swelling at the site of pain

  • Onset of new symptoms

  • Ringing in the ears or loss of hearing

Emergency Medical Assistance In the event of an overdose, it is crucial to seek emergency medical help or contact a Poison Control Center immediately.

No specific laboratory tests are recommended for monitoring during the use of this medication; however, healthcare professionals should remain vigilant for the aforementioned signs and symptoms in their patients.

Side Effects

Patients may experience a range of adverse reactions associated with the use of this medication. Serious adverse reactions include the potential for an allergic reaction, which necessitates immediate medical attention.

Patients should discontinue use and consult a healthcare professional if they exhibit any signs of stomach bleeding. These signs include feeling faint, vomiting blood, having bloody or black stools, experiencing stomach pain that does not improve, or if the pain worsens or persists for more than 10 days. Additional symptoms warranting medical consultation include the presence of redness or swelling, the occurrence of new symptoms, or experiencing ringing in the ears or a loss of hearing.

Before initiating treatment, patients should seek medical advice if they have a history of stomach problems, such as heartburn, or if the stomach bleeding warning applies to them. Those with high blood pressure, heart disease, liver cirrhosis, or kidney disease should also consult a healthcare provider. Furthermore, patients taking diuretics or those with asthma should discuss their conditions with a doctor prior to use.

Patients currently on prescription medications for gout, diabetes, or arthritis are advised to consult with a healthcare professional or pharmacist before using this product to avoid potential interactions.

Drug Interactions

Aspirin has the potential to increase the risk of gastrointestinal bleeding, particularly when co-administered with anticoagulants or other nonsteroidal anti-inflammatory drugs (NSAIDs) such as ibuprofen or naproxen. Clinicians should exercise caution and consider monitoring for signs of bleeding in patients receiving these combinations.

Additionally, it is advisable for patients to consult with a healthcare professional prior to using aspirin if they are concurrently taking prescription medications for gout, diabetes, or arthritis. This precaution is essential to ensure safe and effective use of aspirin in conjunction with these therapies.

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, including children and teenagers, should not use this product if they have or are recovering from chicken pox or flu-like symptoms. It is important to consult a doctor if any changes in behavior occur alongside nausea and vomiting, as these may indicate the onset of Reye's syndrome, a rare but serious condition.

For dosing, adults and children aged 12 years and older may take 4 to 8 tablets every 4 hours, with a maximum of 48 tablets in 24 hours unless otherwise directed by a healthcare professional. For children under 12 years of age, consultation with a doctor is advised to determine appropriate dosing.

Geriatric Use

Elderly patients, particularly those aged 60 years and older, may have an increased risk of 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 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 the unborn child 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 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 its use in lactating individuals.

Renal Impairment

Patients with renal impairment may require a reduced dose of the medication. Dosage adjustments should be based on creatinine clearance levels to ensure safety and efficacy. Regular renal function tests are recommended to monitor kidney function in patients receiving this medication. Additionally, special monitoring may be necessary for patients with severe renal impairment to mitigate potential risks associated with reduced kidney function.

Hepatic Impairment

Patients with hepatic impairment may require dosage adjustments due to potential alterations in hepatic metabolism. It is essential to exercise caution when administering the drug to this population. Special monitoring of liver function tests is recommended to ensure patient safety and to assess the need for further dosage modifications. Regular evaluation of liver function will help in managing any risks associated with compromised liver function effectively.

Overdosage

In the absence of specific information regarding overdosage in the provided sections of the Summary of Product Characteristics (SPL), healthcare professionals are advised to exercise caution and adhere to general principles of management in cases of suspected overdosage.

Recommended Actions In the event of an overdosage, it is essential for healthcare providers to assess the patient's clinical status and initiate appropriate supportive measures. Monitoring of vital signs and symptomatic treatment should be implemented as necessary.

Potential Symptoms While specific symptoms of overdosage are not detailed, healthcare professionals should remain vigilant for any unusual or severe reactions that may arise, given the pharmacological profile of the medication.

Management Procedures In the absence of detailed overdosage information, healthcare professionals are encouraged to consult established guidelines for the management of drug overdosage. This may include contacting a poison control center for expert advice and considering the use of activated charcoal if the patient presents within a suitable timeframe post-ingestion.

Overall, due diligence and a thorough evaluation of the patient's condition are paramount in managing any suspected overdosage effectively.

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 reported voluntarily or through surveillance programs. These include allergic reactions such as hives, facial swelling, asthma (wheezing), and shock. Additionally, cases of stomach bleeding have been noted, particularly in individuals aged 60 or older, those with a history of stomach ulcers or bleeding problems, patients taking blood-thinning (anticoagulant) or steroid medications, individuals consuming three or more alcoholic drinks daily, or those exceeding the recommended dosage.

Reports of Reye's syndrome have been documented in children and teenagers who have or are recovering from chickenpox or flu-like symptoms. Furthermore, new symptoms such as tinnitus (ringing in the ears) and hearing loss have also been observed.

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 or contact a Poison Control Center immediately.

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, experiencing stomach pain that does not improve, or if pain worsens or lasts more than 10 days. They should also report any redness or swelling, new symptoms, or symptoms such as ringing in the ears or loss of hearing.

Healthcare providers should encourage patients to consult a doctor before using this medication if they have a history of stomach problems, such as heartburn, or if the stomach bleeding warning applies to them. Patients with high blood pressure, heart disease, liver cirrhosis, or kidney disease should also seek medical advice prior to use. Furthermore, those taking diuretics or who have asthma should be advised to discuss their situation with a healthcare professional.

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

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 room temperature to maintain its integrity and efficacy. No special handling requirements are noted; however, standard precautions should be observed to ensure optimal storage conditions.

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 specifically directed by a physician, as it may pose risks to the unborn child or lead to complications during delivery.

Drug Information (PDF)

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

View product document (PDF)

Data Generation & Sources

This page was automatically generated and is maintained by the AllDrugs AI Data-Science Team. It was built from the FDA Structured Product Label (DailyMed) for Aspirin, retrieved by a validated AI data-extraction workflow.

All FDA-listed dosage forms and strengths are shown in the Packaging & NDC Codes section above. Regulatory status appears in the Summary Information panel above and was verified in the FDA National Drug Code directory and the NSDE NDC Directory daily file.

Note: an automated daemon monitors NSDE checksums; when the record for this NDC changes, the new file is pulled instantly and this page is refreshed.

No human clinician has reviewed this version.

Learn more in our Editorial Policy

Last AI update:

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.