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Adult Low Dose Enteric Coated Aspirin

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Active ingredient
Aspirin 81 mg
Other brand names
Drug classes
Nonsteroidal Anti-inflammatory Drug, Platelet Aggregation Inhibitor
Dosage form
Tablet, Coated
Route
Oral
Prescription status
OTC (over the counter)
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Marketed in the U.S.
Since 2026
Label revision date
February 6, 2026
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, Coated
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 2026
Label revision date
February 6, 2026
Manufacturer
Sportpharm LLC
Registration number
M013
NDC root
85766-147
Drug Information (PDF)
Prescribing information, PDF file
Packaging Info (6 NDCs)
Packaging & NDC Codes (6)

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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 for more information on its potential uses.

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, it's important to follow the recommended dosage to ensure your safety and effectiveness. For adults and children aged 12 years and older, you should take 4 to 8 tablets every 4 hours as needed. However, do not exceed 48 tablets in a 24-hour period unless directed by your doctor.

Make sure to drink a full glass of water with each dose, and remember to swallow the tablets whole—do not chew or crush them. If you are considering this medication for a child under 12 years old, it's best to consult with a doctor first to determine the appropriate dosage. Always prioritize your health by adhering to these guidelines.

What to Avoid

You can feel reassured that there are no specific contraindications, controlled substance classifications, or risks of abuse or misuse associated with this medication. Additionally, there are no concerns regarding dependence (a condition where the body becomes reliant on a substance).

Since there are no "do not take" or "do not use" instructions provided, it suggests that this medication is generally safe for use as directed. However, always consult with your healthcare provider for personalized advice and to ensure it’s appropriate for your individual health needs.

Side Effects

You should be aware of some important side effects and warnings associated with this product. Children and teenagers recovering from chickenpox or flu-like symptoms should avoid using it, as it may lead to Reye's syndrome, a rare but serious illness. If you notice changes in behavior along with nausea and vomiting, consult a doctor immediately.

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 consume alcohol regularly. If you experience symptoms like feeling faint, vomiting blood, or having bloody or black stools, stop using the product and seek medical help right away. Always consult your doctor if you have any underlying health conditions or are taking other medications before using this product.

Warnings and Precautions

It's important to be aware of some serious warnings when using this product. If you are a child or teenager recovering from chicken pox or flu-like symptoms, you should not use this product due to the risk of Reye's syndrome, a rare but serious illness. If you notice changes in behavior along with nausea and vomiting while using it, consult your doctor immediately. Additionally, be cautious if you have a history of allergies, as this product can cause severe allergic reactions, including hives, facial swelling, and asthma symptoms.

This product contains a nonsteroidal anti-inflammatory drug (NSAID), which can lead to severe stomach bleeding, especially if you are over 60, have had stomach ulcers, or are taking blood thinners or other NSAIDs. If you experience symptoms like feeling faint, vomiting blood, or having bloody or black stools, stop using the product and seek medical help right away. Always consult your doctor before use if you have a history of stomach problems, high blood pressure, heart disease, or are taking other medications for diabetes, gout, or arthritis. In case of an overdose, get emergency medical help or contact a Poison Control Center immediately.

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.

Always err on the side of caution—if you think you or someone else may have taken too much of a medication, don’t wait for symptoms to appear. Getting prompt assistance can be vital for safety and recovery.

Pregnancy Use

If you are pregnant or breastfeeding, it’s essential to consult with a healthcare professional before using any medication. This is particularly important for aspirin; you should avoid taking it after 20 weeks of pregnancy unless your doctor specifically instructs you to do so. Using aspirin during this time can lead to potential issues for your unborn child or complications during delivery. Always prioritize your health and the health of your baby by seeking professional advice.

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 after 20 weeks of pregnancy, as it can potentially lead to issues for your unborn child or complications during delivery. Always prioritize your health and your baby's well-being by seeking guidance from your doctor.

Pediatric Use

If you are considering this medication for your child, it's important to be aware of some key guidelines. Children and teenagers who are currently experiencing or recovering from chickenpox or flu-like symptoms should not use this product, as it can increase the risk of Reye's syndrome (a rare but serious illness). If you notice any changes in your child's behavior accompanied by 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 essential to consult a doctor before giving them this medication.

Geriatric Use

As you age, it's important to be aware of certain health risks associated with medications. If you are 60 years or older, there is a higher risk of severe stomach bleeding when taking certain drugs. This means that you should be especially cautious and discuss any concerns with your healthcare provider. They can help you understand the risks and determine the best treatment options for your needs. Always prioritize your safety and well-being by staying informed and seeking guidance when necessary.

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 if any adjustments to your dosage are necessary. Monitoring your kidney function may also be required to ensure your safety while using this treatment. Always prioritize open communication with your healthcare team regarding your kidney health.

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 need to adjust your dosage or monitor your liver function closely. Always prioritize your health by discussing any liver issues with your doctor before starting new medications.

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 share your complete list of medications and any health conditions you have to receive the best care possible.

Storage and Handling

To ensure the best performance of your product, store it at a temperature between 20-25°C (68-77°F). It’s acceptable for the temperature to occasionally range from 15°C to 30°C (59°F to 86°F), but try to keep it within the recommended limits as much as possible.

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 for use to ensure safety and effectiveness. If you have any questions about disposal or further handling, please refer to the guidelines provided with your product.

Additional Information

You can take this medication orally. For adults and children aged 12 and older, the recommended dosage is 4-8 tablets every 4 hours as needed, but do not exceed 48 tablets in a 24-hour period unless directed by a doctor. If the patient is under 12 years old, consult a doctor for the appropriate dosage.

If you are pregnant or breastfeeding, it's important to talk to a healthcare professional before using this medication. Specifically, avoid using aspirin after 20 weeks of pregnancy unless your doctor has specifically advised you to do so, as it may pose risks to the unborn child or lead to 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 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 at 20 weeks or later in pregnancy unless directed by a doctor.

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

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

What should children under 12 do?

Children under 12 should ask a doctor before using aspirin.

What are the warnings associated with aspirin?

Aspirin may cause severe allergic reactions, stomach bleeding, and should not be used by children recovering from chicken pox or flu-like symptoms due to the risk of Reye's syndrome.

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

If you experience signs of stomach bleeding, such as feeling faint, vomiting blood, or having bloody or black stools, stop using aspirin and seek medical help immediately.

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

If you have a history of stomach problems, such as heartburn, or conditions like high blood pressure or kidney disease, ask a doctor before using aspirin.

How should I take aspirin?

You should swallow aspirin tablets whole with a full glass of water, and not chew or crush them.

What should I do in case of an overdose?

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

Are there any contraindications for using aspirin?

You should not use aspirin if you are allergic to it or any other pain reliever/fever reducer, or if you have had an allergic reaction to it in the past.

Packaging Info

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

Packaging configurations for Adult Low Dose Enteric Coated Aspirin.
Details

Drug Information (PDF)

This file contains official product information for Adult Low Dose Enteric Coated 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 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 mentioned in the available data.

Dosage and Administration

Patients should adhere to the recommended dosage guidelines without exceeding the specified limits. For adults and children aged 12 years and older, the recommended dosage is 4 to 8 tablets every 4 hours as needed. The maximum allowable dosage is 48 tablets within a 24-hour period, unless otherwise directed by a healthcare professional.

For optimal administration, each dose should be taken with a full glass of water. Tablets must be swallowed whole; they should not be chewed or crushed to ensure proper release and absorption of the medication.

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

Contraindications

There are no contraindications associated with the use of this product. It is deemed safe for use in the absence of specific conditions or situations that would warrant avoidance.

Warnings and Precautions

Children and teenagers recovering from chickenpox or experiencing 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, which can manifest as hives, facial swelling, asthma (wheezing), or shock. Individuals with known allergies to aspirin or any other pain reliever or fever reducer should refrain from using this product. Additionally, those who have previously experienced an allergic reaction to this product or any of its components should avoid its use.

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 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, or exceed the recommended dosage or duration of use.

Before using this product, individuals should consult a healthcare provider if any of the following apply: the stomach bleeding warning is relevant, they are taking a diuretic, have a history of stomach issues such as heartburn, or have conditions such as high blood pressure, heart disease, liver cirrhosis, kidney disease, or asthma. Furthermore, it is advisable to seek guidance from a doctor or pharmacist if the individual is taking prescription medications for diabetes, gout, or arthritis.

Users should discontinue use and consult a healthcare professional if they experience any signs of an allergic reaction, such as difficulty breathing or swelling, or if they notice symptoms indicative of stomach bleeding, including feeling faint, vomiting blood, passing bloody or black stools, or experiencing persistent stomach pain. Additional reasons to stop use include worsening pain lasting more than 10 days, the presence of redness or swelling, a fever that worsens or persists beyond three days, the emergence of new symptoms, or any ringing in the ears or hearing loss.

In the event of an overdose, immediate medical assistance should be sought, or contact with a Poison Control Center is recommended.

Side Effects

Patients using this product should be aware of several potential adverse reactions, which can range from serious to common.

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. 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, an active ingredient in this product, may cause severe allergic reactions. Symptoms of such reactions can include hives, facial swelling, asthma (wheezing), and shock. Patients with a known allergy to aspirin or any other pain reliever or fever reducer should not use this product. Additionally, individuals who have previously experienced an allergic reaction to this product or any of its ingredients should refrain from its use.

This product contains a nonsteroidal anti-inflammatory drug (NSAID), which carries a warning for the potential of severe stomach bleeding. The risk of stomach bleeding is heightened 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, consume three or more alcoholic drinks daily, or use other NSAIDs (including aspirin, ibuprofen, or naproxen). Patients should not exceed the recommended dosage or duration of use.

Patients are advised to consult a doctor before using this product if any of the following apply: the stomach bleeding warning is relevant, they are taking a diuretic, or they have a history of stomach problems such as heartburn. Additionally, those with high blood pressure, heart disease, liver cirrhosis, kidney disease, or asthma should seek medical advice prior to use.

Patients should discontinue use and seek medical attention if they experience any signs of an allergic reaction or symptoms indicative of stomach bleeding, such as feeling faint, vomiting blood, having bloody or black stools, or experiencing persistent stomach pain. Other concerning symptoms include worsening pain lasting more than 10 days, redness or swelling, fever that worsens or lasts more than three days, the emergence of new symptoms, or ringing in the ears or loss of hearing. These symptoms may signify a serious condition requiring immediate medical evaluation.

Drug Interactions

There are currently no documented drug interactions associated with 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 Adult Low Dose Enteric Coated Aspirin (aspirin). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Adult Low Dose Enteric Coated Aspirin.
Details

Pediatric Use

Children and teenagers who have or are recovering from chicken pox or flu-like symptoms should not use this product due to the risk of Reye's syndrome, a rare but serious illness. If any changes in behavior accompanied by nausea and vomiting occur while using this product, it is essential to consult a doctor, as these may be early signs 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 healthcare professional. 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 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 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 pregnancy, particularly at 20 weeks gestation or later, is associated with potential risks. Specifically, it may lead to adverse effects on the unborn child and complications during delivery. Therefore, it is crucial that pregnant patients only use aspirin under the guidance of a healthcare provider, particularly in the later stages of pregnancy.

Lactation

Lactating mothers are advised to consult a health professional before using this medication. It is particularly important to avoid the use of aspirin at 20 weeks of pregnancy or later unless specifically directed by a physician, as it may pose risks to the unborn child or lead to complications during delivery. There is no specific data available regarding the excretion of this medication in breast milk or its effects on breastfed infants. Therefore, caution is recommended when considering the use of this medication during lactation.

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 vigilant in monitoring for symptoms that may arise from an overdose. While specific symptoms are not detailed in the provided information, it is essential to be aware that they can vary based on the substance involved and the individual’s health status.

Management of an overdose typically involves supportive care and symptomatic treatment. Healthcare providers should assess the patient's condition thoroughly and implement appropriate interventions based on clinical judgment and established protocols.

Nonclinical Toxicology

It is especially important not to use aspirin at 20 weeks or later in 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 have been identified in the available data. Additionally, there are no details provided regarding nonclinical toxicology or animal pharmacology and toxicology.

Postmarketing Experience

No postmarketing experience details are available in the insert.

Patient Counseling

Healthcare providers should advise patients to keep this medication out of reach of children to prevent accidental ingestion. It is crucial to emphasize the importance of safety in the home environment, particularly for households with young children.

In the event of an overdose, healthcare providers should instruct patients to seek medical help immediately or contact a Poison Control Center. Patients should be made aware of the signs of overdose and the urgency of obtaining assistance to ensure their safety and well-being.

Storage and Handling

The product is supplied in various package configurations, with specific NDC numbers available upon request. It should be stored at a temperature range of 20-25°C (68-77°F). Temporary excursions are permitted between 15°C and 30°C (59°F - 86°F). Proper storage conditions are essential to maintain the integrity and efficacy of the product.

Additional Clinical Information

Patients aged 12 years and older are advised to take 4-8 tablets orally every 4 hours as needed, with a maximum of 48 tablets in a 24-hour period, unless otherwise directed by a healthcare professional. For children under 12 years of age, consultation with a doctor is recommended prior to administration.

Clinicians should counsel patients regarding the use of this medication during pregnancy or breastfeeding. It is particularly important to avoid the use of aspirin after 20 weeks of pregnancy unless specifically instructed 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 Adult Low Dose Enteric Coated 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 Adult Low Dose Enteric Coated 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.