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Aspirin Low Dose

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Active ingredient
Aspirin 81 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 2024
Label revision date
December 19, 2025
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
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 2024
Label revision date
December 19, 2025
Manufacturer
NUVICARE LLC
Registration number
M013
NDC root
84324-017
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

Safety Coated 81 mg Aspirin is a medication designed to provide temporary relief from minor aches and pains, such as headaches or muscle discomfort. It is important to note that due to its delayed action, it may not be suitable for immediate relief of symptoms that require quick action.

You may also want to consult your doctor about other potential uses for Safety Coated 81 mg Aspirin, as it can serve various purposes beyond just pain relief.

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 suitable for quick relief of headaches or other symptoms that require immediate attention. If you're curious about additional uses, 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 these guidelines carefully to ensure effective and safe use of the medication.

What to Avoid

It's important to keep this medication out of reach of children to prevent accidental ingestion. You should stop using it and consult your doctor immediately if you experience any signs of an allergic reaction or stomach bleeding. Signs of stomach bleeding include feeling faint, vomiting blood, having bloody or black stools, or experiencing stomach pain that doesn't improve. Additionally, if your pain worsens or lasts more than 10 days, if a fever persists for more than 3 days, or if you notice redness, swelling, new symptoms, or experience ringing in the ears or loss of hearing, seek medical attention right away.

Side Effects

Using this product may come with some serious risks. If you are a child or teenager recovering from chickenpox or flu-like symptoms, you should avoid it due to the potential for Reye's syndrome, a rare but serious illness. Be aware that aspirin can cause severe allergic reactions, which may include hives, facial swelling, asthma (wheezing), or even shock.

Additionally, 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. If you experience symptoms such as feeling faint, vomiting blood, or having bloody or black stools, you should stop using the product and consult a doctor immediately. Always talk to your healthcare provider if you have any underlying health conditions or are taking other medications before using this product.

Warnings and Precautions

You should be aware of some important warnings and precautions when using this product. If you are a child or teenager recovering from chickenpox or flu-like symptoms, do not use this product, as it may lead to Reye's syndrome, a serious condition. Additionally, be cautious if you have a history of allergies, as aspirin can cause severe allergic reactions, including 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 consume alcohol regularly.

If you experience any signs of an allergic reaction or symptoms of stomach bleeding—such as feeling faint, vomiting blood, or having bloody or black stools—stop using the product and seek medical help immediately. It's also important to consult your doctor if you have new symptoms, if your pain lasts longer than 10 days, or if your fever worsens after three days. In case of an overdose, contact a Poison Control Center or seek emergency medical assistance right away.

Overdose

It appears that there is no specific information available regarding overdosage for this medication. However, it's important to be aware of the general signs of an overdose, which can include symptoms like extreme drowsiness, confusion, or difficulty breathing. If you suspect an overdose, it is crucial to seek immediate medical attention.

In case of an emergency, call your local emergency services or go to the nearest hospital. Always keep the medication in its original packaging and provide it to the healthcare professionals to assist in your treatment. Remember, if you have any concerns about your medication or its effects, don’t hesitate to reach out to your healthcare provider for guidance.

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 it. 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 lead to potential 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 experiencing chickenpox or 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. This condition can affect the brain and liver and is particularly concerning for children and teenagers.

For children under 12 years old, you should consult a doctor before using this product to ensure it is safe and appropriate for their specific situation. Always prioritize your child's health and well-being by seeking professional advice when needed.

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 may affect your stomach or blood.

Always consult with your healthcare provider about any medications you are taking, especially if you have concerns about your stomach health or are experiencing any unusual symptoms. Taking these precautions can help ensure your safety and well-being.

Renal Impairment

If you have kidney problems, it's important to know that there are no specific guidelines or dosage adjustments mentioned for your condition in the available information. This means that the usual recommendations for monitoring or safety considerations related to renal impairment (kidney issues) are not provided.

Always consult your healthcare provider for personalized advice and to ensure that any medications you take are safe and appropriate for your kidney health. They can help you understand how your condition may affect your treatment plan.

Hepatic Impairment

If you have liver problems, it's important to know that there are no specific guidelines or dosage adjustments mentioned for your condition in the available information. This means that the standard recommendations apply, but you should always consult your healthcare provider for personalized advice. They can help determine the best approach for your treatment and monitor your liver function as needed.

Make sure to keep your doctor informed about your liver health, as they may want to conduct regular tests to ensure your safety while using any medication. Your well-being is a priority, and your healthcare team is there to support you.

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 recent lab tests to avoid any potential issues. Your health and safety should always come first.

Storage and Handling

To ensure the best performance of your product, store it at room temperature, keeping it away from excessive heat. Temperatures above 40°C (104°F) can damage the product, so it's important to maintain a stable environment.

When handling the product, always do so with care to avoid any damage. Make sure to 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

No further information is available.

FAQ

What is Safety Coated 81 mg Aspirin used for?

Safety Coated 81 mg Aspirin is used for the temporary relief of minor aches and pains or as recommended by your doctor.

How should I take Safety Coated 81 mg 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. Always drink a full glass of water with each dose.

Are there any warnings for using Safety Coated 81 mg Aspirin?

Yes, you should not use this product if you are allergic to aspirin or have had an allergic reaction to it. Additionally, it may cause severe stomach bleeding, especially if you are over 60, have a history of stomach ulcers, or consume alcohol regularly.

What should I do if I experience an allergic reaction?

If you experience an allergic reaction, seek medical help right away.

Can children use Safety Coated 81 mg Aspirin?

Children under 12 years should consult a doctor before use. It is also not recommended for children and teenagers recovering from chickenpox or flu-like symptoms due to the risk of Reye's syndrome.

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

Stop using the product and ask a doctor if you feel faint, vomit blood, have bloody or black stools, or experience stomach pain that does not improve.

Is it safe to use Safety Coated 81 mg Aspirin during pregnancy?

If you are pregnant or breastfeeding, consult 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 in case of overdose?

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

Packaging Info

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

Packaging configurations for Aspirin Low Dose.
Details

Drug Information (PDF)

This file contains official product information for Aspirin Low Dose, 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, or 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.

Healthcare professionals are encouraged to inquire about additional uses for Safety Coated 81 mg Aspirin, as recommendations may vary based on individual patient needs.

There are no teratogenic or nonteratogenic effects associated with this product.

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 of this product is contraindicated in the following situations:

  • In the event of an allergic reaction, immediate medical attention is required.

  • If symptoms indicative of stomach bleeding occur, including feeling faint, vomiting blood, having bloody or black stools, or experiencing persistent stomach pain that worsens or lasts longer than 10 days.

  • If fever worsens or persists beyond 3 days, or if redness or swelling is observed.

  • The appearance of new symptoms or the occurrence of ringing in the ears or loss of hearing necessitates discontinuation and consultation with a healthcare professional.

Additionally, this product should be kept out of reach of children.

Warnings and Precautions

Children and teenagers who are experiencing or recovering from chickenpox or flu-like symptoms should not use this product due to the risk of Reye's syndrome, a rare but serious illness. If any changes in behavior accompanied by nausea and vomiting occur while using this product, it is imperative to consult a healthcare professional immediately, as these may be early signs of Reye's syndrome.

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

This product contains a nonsteroidal anti-inflammatory drug (NSAID), which carries a risk of severe stomach bleeding. The likelihood of this adverse effect is increased in patients who are 60 years of age or older, have a history of stomach ulcers or bleeding problems, are taking anticoagulants or steroid medications, are using other NSAIDs (including aspirin, ibuprofen, or naproxen), consume three or more alcoholic drinks daily, or exceed the recommended dosage or duration of use.

Patients should be advised against using this product if they have a known allergy to aspirin or any other pain reliever or fever reducer, or if they have previously experienced an allergic reaction to this product or any of its components.

Healthcare professionals should instruct patients to discontinue use and seek medical advice if any signs of an allergic reaction occur. Additionally, patients should be monitored for symptoms indicative of stomach bleeding, which may include feeling faint, vomiting blood, passing bloody or black stools, experiencing persistent stomach pain, or if pain worsens or lasts longer than 10 days. Patients should also be advised to seek medical attention if fever worsens or persists beyond three days, if redness or swelling is observed, if new symptoms arise, or if there is ringing in the ears or loss of hearing.

In the event of an overdose, immediate medical assistance should be sought, or the Poison Control Center (1-800-222-1222) should be contacted without delay.

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 chickenpox or flu-like symptoms. It is crucial for these individuals to avoid 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, 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 experiencing any signs of an allergic reaction should seek medical help right away.

This product contains a nonsteroidal anti-inflammatory drug (NSAID), which carries a risk of severe stomach bleeding. The likelihood of this adverse reaction is increased in patients who are 60 years of age or older, have a history of stomach ulcers or bleeding problems, are taking anticoagulants or steroid medications, consume three or more alcoholic drinks daily, or use other NSAIDs concurrently. Patients should be 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.

Patients should also be cautious and consult a doctor before using this product 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. Additionally, those taking diuretics or prescription medications for gout, diabetes, or arthritis should seek advice from a healthcare professional prior to use.

Common adverse reactions may include symptoms that warrant medical attention, such as fever that worsens or lasts more than three days, redness or swelling, new symptoms, or ringing in the ears or loss of hearing. If any of these symptoms occur, patients should stop using the product and consult a healthcare provider.

Drug Interactions

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

Packaging & NDC

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

Packaging configurations for Aspirin Low Dose.
Details

Pediatric Use

Pediatric patients, particularly children and teenagers, should not use this product if they have or are recovering from chickenpox or flu-like symptoms due to the risk of Reye's syndrome. It is advised to consult a doctor prior to use in children under 12 years of age.

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 when treating this population to ensure optimal safety and efficacy.

Pregnancy

Pregnant patients and those who are breastfeeding should consult a healthcare professional before using this medication. The use of aspirin during the last trimester of pregnancy is particularly cautioned against, as it may lead to adverse effects on fetal outcomes or complications during delivery. Therefore, it is essential that pregnant patients only use aspirin in this period if explicitly directed by a healthcare provider.

Lactation

Lactating mothers are advised to consult a health professional prior to using this medication. It is particularly important to avoid the use of aspirin during the last three months of pregnancy unless 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 have not been specifically addressed in the available data regarding dosage adjustments, special monitoring, or safety considerations. Therefore, healthcare professionals should exercise caution when prescribing this medication to patients with reduced kidney function, as the lack of information necessitates careful clinical judgment and monitoring.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in relation to the use of this medication. Consequently, there are no established dosage adjustments, special monitoring requirements, or precautions outlined for individuals with compromised liver function. It is recommended that healthcare providers exercise caution when prescribing this medication to patients with hepatic impairment, given the lack of data on its safety and efficacy in this population. Regular monitoring of liver function may be prudent in these cases, although specific parameters are not defined in the available information.

Overdosage

In the absence of specific overdosage information, it is essential for healthcare professionals to remain vigilant regarding the potential for overdose with this medication. In cases where an overdose is suspected, immediate medical attention should be sought.

Healthcare providers are advised to monitor patients closely for any signs or symptoms that may arise from an overdose. Common symptoms may include, but are not limited to, severe drowsiness, confusion, respiratory distress, or any other unusual clinical manifestations.

Management of an overdose should be tailored to the individual patient and may involve supportive care, including monitoring vital signs and providing symptomatic treatment as necessary. In cases of significant overdose, consultation with a poison control center or a medical toxicologist is recommended to determine the most appropriate course of action.

It is crucial for healthcare professionals to educate patients and caregivers about the importance of adhering to prescribed dosages and to provide guidance on what to do in the event of a suspected overdose.

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 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 patients aged 60 or older, those with a history of stomach ulcers or bleeding problems, individuals taking anticoagulant or steroid medications, users of other NSAIDs, those consuming three or more alcoholic drinks daily, or patients exceeding the recommended dosage.

Patients are advised to seek medical assistance if they experience any signs of stomach bleeding, which may manifest as feeling faint, vomiting blood, having bloody or black stools, or experiencing persistent stomach pain. Furthermore, the emergence of new symptoms or a worsening of pain or fever should prompt consultation with a healthcare professional. Reports of tinnitus (ringing in the ears) or hearing loss have also been documented.

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 should be informed to discontinue use and consult a doctor if they experience any signs of an allergic reaction, and to seek medical assistance without delay. Additionally, they should be made aware of specific symptoms that may indicate stomach bleeding, including feeling faint, vomiting blood, having bloody or black stools, experiencing stomach pain that does not improve, or if pain worsens or persists for more than 10 days. Patients should also be advised to seek medical attention if fever worsens or lasts more than three days, if redness or swelling occurs, if new symptoms arise, or if they experience ringing in the ears or loss of hearing.

Healthcare providers should encourage patients 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 advise patients to seek medical advice if they have high blood pressure, heart disease, liver cirrhosis, or kidney disease. Patients taking diuretics or those with asthma should be encouraged to discuss their conditions with a healthcare provider prior to use. Furthermore, patients should be advised to consult a doctor or pharmacist if they are currently taking prescription medications for gout, diabetes, or arthritis.

Storage and Handling

The product is supplied in various package configurations, with specific NDC numbers available for identification. It is essential to store the product at room temperature, ensuring that it is kept away from excessive heat, particularly temperatures exceeding 40°C (104°F). Proper storage conditions are crucial to maintain the integrity and efficacy of the product.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

This file contains official product information for Aspirin Low Dose, 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 Low Dose, 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.