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Bayer Genuine Aspirin

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Active ingredient
Aspirin 325 mg
Other brand names
Drug classes
Nonsteroidal Anti-inflammatory Drug, Platelet Aggregation Inhibitor
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 2014
Label revision date
December 4, 2025
Drug Information (PDF)
Prescribing information, PDF file
Active ingredient
Aspirin 325 mg
Other brand names
Drug classes
Nonsteroidal Anti-inflammatory Drug, Platelet Aggregation Inhibitor
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 2014
Label revision date
December 4, 2025
Manufacturer
Bayer HealthCare LLC.
Registration number
M013
NDC root
0280-2000
Drug Information (PDF)
Prescribing information, PDF file
Packaging Info (7 NDCs)
Packaging & NDC Codes (7)

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Drug Overview

Aspirin is a medication classified as a Non-Steroidal Anti-Inflammatory Drug (NSAID). It is commonly used to relieve pain and reduce fever. You can take aspirin to temporarily alleviate various types of discomfort, including headaches, muscle pain, toothaches, menstrual cramps, and minor arthritis pain. Additionally, it can help reduce fever associated with colds.

Each tablet contains 325 mg of aspirin, and the product typically comes in a package of 100 coated tablets, with an extra 24 tablets offered for free.

Uses

You can use this medication to temporarily relieve various types of pain and discomfort. It is effective for headaches, muscle pain, toothaches, and menstrual pain. Additionally, it can help reduce pain and fever associated with colds, as well as minor pain related to arthritis.

This medication is designed to provide you with quick relief, allowing you to feel more comfortable during those times when pain can be a distraction. Always consult with a healthcare professional if you have any questions or concerns about using this medication.

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 can take either 1 or 2 tablets every 4 hours, or 3 tablets every 6 hours. However, make sure not to exceed a total of 12 tablets in a 24-hour period to avoid potential side effects.

If you have children under 12 years old, it's best to consult a doctor before giving them this medication. They can provide guidance on the appropriate dosage and ensure it's safe for your child. Always follow these instructions carefully to ensure the medication works effectively and safely.

What to Avoid

You should avoid using this medication if you are allergic to aspirin or any other pain reliever or fever reducer. Allergic reactions can be serious, so it's important to ensure that you do not have this allergy before taking the medication. Always consult with your healthcare provider if you have any concerns about allergies or if you are unsure about your medical history.

Side Effects

If you are considering using this product, it's important to be aware of potential side effects. Children and teenagers recovering from chickenpox or flu-like symptoms should avoid it, as it may lead to Reye's syndrome, a rare but serious condition. You should also be cautious of severe allergic reactions, which can include hives, facial swelling, asthma (wheezing), and shock.

This product contains a nonsteroidal anti-inflammatory drug (NSAID), which can increase the risk of severe stomach bleeding, especially if you are over 60, have a history of stomach ulcers, or are taking certain medications like blood thinners or other NSAIDs. If you experience symptoms such as feeling faint, vomiting blood, or having bloody or black stools, seek medical attention immediately. Additionally, if you have any history of stomach problems, high blood pressure, heart disease, or asthma, consult your doctor before use. Always stop using the product and contact a healthcare professional if you notice any unusual symptoms or if your pain worsens or lasts longer than expected.

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 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 gout, diabetes, or arthritis. If you experience any signs of an allergic reaction, stomach bleeding (such as feeling faint, vomiting blood, or having black stools), or if your pain worsens or lasts more than 10 days, stop using the product and contact your doctor. In case of an overdose, seek medical help or contact a Poison Control Center right away.

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 typical side effects.

Don’t wait for symptoms to worsen; acting quickly can make a significant difference in your safety. Always prioritize your health and well-being by reaching out for professional assistance in these situations.

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

For dosing, adults and children aged 12 years and older can take 1 or 2 tablets every 4 hours or 3 tablets every 6 hours, but they should not exceed 12 tablets in a 24-hour period. 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 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, extra caution should be taken when using certain medications, especially those that can irritate the stomach.

Always consult with your healthcare provider about any medications you are taking, as they can help you understand the risks and adjust dosages if necessary to ensure your safety. Being proactive about your health can help you manage these risks effectively.

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 can help determine if this treatment is safe for you and whether any adjustments are needed based on your kidney function. Always prioritize open communication with your doctor regarding your health conditions.

Hepatic Impairment

If you have liver problems, such as liver cirrhosis, it's important to be aware of how this may affect your treatment. Your healthcare provider may need to adjust your medication dosage or monitor your liver function closely. This is because your liver plays a crucial role in processing medications, and any impairment can change how your body responds to them.

Make sure to communicate openly with your doctor about your liver condition and any other health issues you may have, like high blood pressure or heart disease. This will help ensure that you receive the safest and most effective care tailored to your needs.

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

It's important to store your product at room temperature to ensure its effectiveness. Make sure to keep the original carton, as it contains essential directions and warnings that you will need for safe use.

When handling the product, always follow the instructions provided in the carton to maintain safety and effectiveness. If you have any questions about the proper use or disposal, refer back to the carton for guidance.

Additional Information

You can take this medication orally. For adults and children aged 12 and over, the recommended dosage is 1 or 2 tablets every 4 hours, or 3 tablets every 6 hours, but do not exceed 12 tablets in a 24-hour period. If your child is under 12 years old, please consult a doctor for appropriate dosing.

If you are pregnant or breastfeeding, it's important to talk to a healthcare professional before using this medication. Avoid using aspirin during the last three months of pregnancy unless your doctor specifically advises it, as it may pose risks to your unborn child or lead to complications during delivery.

FAQ

What is ASPIRIN used for?

ASPIRIN is used as a pain reliever and fever reducer. It temporarily relieves headaches, muscle pain, toothaches, menstrual pain, pain and fever of colds, and minor arthritis pain.

What is the recommended dosage for adults and children over 12?

Adults and children 12 years and over should take 1 or 2 tablets every 4 hours or 3 tablets every 6 hours, not exceeding 12 tablets in 24 hours.

What should I do if I am under 12 years old?

If you are under 12 years old, consult a doctor before using ASPIRIN.

Are there any contraindications for using ASPIRIN?

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

What are the warnings associated with ASPIRIN?

ASPIRIN may cause severe allergic reactions, stomach bleeding, and should not be used by children or teenagers 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?

If you feel faint, vomit blood, have bloody or black stools, or have stomach pain that does not improve, stop using ASPIRIN and consult a doctor immediately.

Can I take ASPIRIN if I am pregnant or breastfeeding?

If you are pregnant or breastfeeding, ask a health professional before using ASPIRIN, especially during the last 3 months of pregnancy.

What should I do if I have a history of stomach problems?

If you have a history of stomach problems, high blood pressure, heart disease, liver cirrhosis, or kidney disease, consult a doctor before using ASPIRIN.

How should I take ASPIRIN?

Take ASPIRIN with a full glass of water and follow the dosage instructions on the packaging.

What should I do in case of an overdose?

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

Packaging Info

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

Packaging configurations for Bayer Genuine Aspirin.
Details

Drug Information (PDF)

This file contains official product information for Bayer Genuine Aspirin, 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 drug.

Uses and Indications

This drug is indicated for the temporary relief of various types of pain and discomfort, including headache, muscle pain, toothache, menstrual pain, and minor pain associated with arthritis. Additionally, it is effective in alleviating pain and fever associated with colds.

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 to ensure proper administration and absorption.

For adults and children aged 12 years and older, the recommended dosage is 1 or 2 tablets every 4 hours, or alternatively, 3 tablets every 6 hours. The total daily dosage must not exceed 12 tablets within a 24-hour period.

For children under 12 years of age, it is advised to consult a healthcare professional for appropriate dosing recommendations.

Contraindications

Use is contraindicated in individuals with a known allergy to aspirin or any other pain reliever or fever reducer. Due to the potential for severe allergic reactions, administration in these patients is not recommended.

Warnings and Precautions

Children and teenagers who have or are recovering from chickenpox or flu-like symptoms should not use this product. If 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 such an event is increased in individuals who are 60 years of age or older, have a history of stomach ulcers or bleeding disorders, are taking anticoagulants or steroid medications, are using other NSAIDs (including aspirin, ibuprofen, or naproxen), consume three or more alcoholic beverages daily while using this product, or exceed the recommended dosage or duration of use.

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

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

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 that lasts more than 10 days, presence of redness or swelling, fever lasting more than three days, emergence of new symptoms, or occurrences of ringing in the ears or hearing loss.

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 using 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, the active ingredient in this product, may cause severe allergic reactions in some patients. Symptoms of such reactions can include hives, facial swelling, asthma (wheezing), and shock. Patients should seek medical attention promptly 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 more than 10 days, if redness or swelling occurs, if fever persists for more than three days, 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

There are currently no documented drug interactions associated with this medication. Additionally, there are no known 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 Bayer Genuine Aspirin (aspirin). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Bayer Genuine Aspirin.
Details

Pediatric Use

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

For dosing recommendations, adults and children aged 12 years and older may take 1 or 2 tablets every 4 hours or 3 tablets every 6 hours, with a maximum of 12 tablets in a 24-hour period. For children under 12 years of age, it is essential to consult a doctor for appropriate dosing guidance.

Geriatric Use

Elderly patients, particularly those aged 60 years 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 ratio 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 and 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 if they are pregnant or breastfeeding. It is particularly important to avoid the use of aspirin during the last three months of pregnancy unless specifically directed by a healthcare provider, 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.

Renal Impairment

Patients with renal impairment should consult a healthcare professional prior to use, particularly if they have conditions such as high blood pressure, heart disease, liver cirrhosis, or kidney disease. It is essential to assess renal function and consider potential dosing adjustments or monitoring requirements based on the severity of renal impairment.

Hepatic Impairment

Patients with hepatic impairment may experience altered pharmacokinetics of the drug due to compromised liver function. It is essential to assess the severity of liver impairment prior to initiating treatment.

For patients with liver cirrhosis, careful consideration should be given to the potential need for dosage adjustments. Monitoring of liver function tests is recommended to evaluate the patient's hepatic status throughout the treatment course.

Additionally, patients with concurrent conditions such as high blood pressure, heart disease, or kidney disease may require more frequent monitoring and a tailored therapeutic approach to ensure safety and efficacy.

Healthcare providers should remain vigilant for any signs of adverse effects related to hepatic function and adjust treatment as necessary based on clinical judgment and laboratory findings.

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 vigilant for symptoms that may arise from an overdose, although specific symptoms are not detailed in the provided information. The management of an overdose typically involves supportive care and symptomatic treatment, tailored to the individual patient's needs.

It is essential for healthcare providers to remain alert and prepared to implement appropriate management strategies in response to an overdose situation, ensuring the safety and well-being of the patient.

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 specific non-teratogenic effects or additional nonclinical toxicology details are available in the provided data. Furthermore, there are no specific findings related to animal pharmacology and toxicology.

Postmarketing Experience

Postmarketing experience has indicated that aspirin may lead to severe allergic reactions, which can manifest as hives, facial swelling, asthma (wheezing), and shock. Additionally, there have been reports of stomach bleeding associated with aspirin use, particularly in specific populations. These populations include patients aged 60 years or older, individuals with a history of stomach ulcers or bleeding problems, those taking blood-thinning (anticoagulant) or steroid medications, patients using other drugs containing prescription or nonprescription nonsteroidal anti-inflammatory drugs (NSAIDs), and individuals who consume three or more alcoholic drinks daily while using aspirin. Furthermore, prolonged use or higher-than-recommended dosages may also increase the risk of stomach bleeding.

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. It is crucial to instruct patients to stop using the medication and consult a doctor if they experience any signs of an allergic reaction, such as difficulty breathing or swelling of the face or throat, and to seek medical assistance right away.

Patients should be made aware of the signs of potential stomach bleeding, which include feeling faint, vomiting blood, having bloody or black stools, or experiencing stomach pain that does not improve. They should also be advised to discontinue use and consult a healthcare professional if their pain worsens or persists for more than 10 days, if redness or swelling occurs, if a fever lasts more than 3 days, if new symptoms arise, or if they experience ringing in the ears or a loss of hearing.

Before initiating treatment, healthcare providers should encourage patients to consult with a doctor 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, or kidney disease, if they are taking a diuretic, or if they have asthma.

Additionally, patients should be advised to speak with 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 a carton that contains essential directions and warnings, which should be retained for reference. It is recommended to store the product at room temperature to maintain its integrity and effectiveness.

Additional Clinical Information

The medication is administered orally. For adults and children aged 12 years and older, the recommended dosage is 1 or 2 tablets every 4 hours or 3 tablets every 6 hours, with a maximum of 12 tablets in a 24-hour period. For children under 12 years, it is advised to consult a healthcare professional for appropriate dosing.

Clinicians should counsel patients regarding the use of this medication during pregnancy and breastfeeding. It is particularly important to avoid aspirin in the last trimester of pregnancy unless specifically directed by a healthcare provider, 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 Bayer Genuine 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 Bayer Genuine 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.

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Orange Book data shown on this page are limited to Regulatory Status (Rx), Established Pharmacologic Class (EPC), and Mechanism of Action (MoA).

Regulatory data notice: Information on this page is reproduced verbatim from FDA public databases (NSDE, Orange Book, Purple Book, DailyMed SPL). NDA/ANDA drugs are FDA-approved, BLA biologics are FDA-licensed. Inclusion alone does not guarantee current market availability or imply FDA endorsement.

Medical disclaimer: This AI-generated content is provided for educational purposes only and does not constitute medical advice. Always consult a licensed healthcare professional for diagnosis or treatment decisions.