Symptom checker
Select audience type

Switch between content for healthcare professionals (PRO) and general audience (GEN).

ADD CONDITION

items per page

Aspirin

Last content change checked dailysee data sync status

This product has been discontinued

Active ingredient
Aspirin 81 mg
Other brand names
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 2011
Label revision date
April 17, 2011
Drug Information (PDF)
Prescribing information, PDF file
Active ingredient
Aspirin 81 mg
Other brand names
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 2011
Label revision date
April 17, 2011
Manufacturer
Cispharma, Inc
Registration number
part343
NDC root
52204-103
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 Enteric Coated Yellow Tablets, 81 mg, are a type of medication primarily used for pain relief. The enteric coating helps protect your stomach from irritation, making it easier to take for those who may be sensitive to regular aspirin. This formulation is designed to provide effective relief from various types of pain, allowing you to feel more comfortable in your daily activities.

Uses

You can use this medication for effective pain relief. It's important to note that there are no teratogenic effects (which means it does not cause birth defects) associated with this drug. Additionally, there are no nonteratogenic effects mentioned, ensuring its safety in that regard. Always consult with your healthcare provider for personalized advice and 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. If you are an adult or a child 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 advises otherwise.

For children under 12 years of age, it's essential to consult a doctor before giving them this medication. This ensures that they receive the appropriate dosage and guidance tailored to their needs. Always follow your healthcare provider's instructions for safe and effective use.

What to Avoid

You should avoid using this medication if you have ever experienced an allergic reaction to any other pain relievers or fever reducers. This is important to ensure your safety and prevent any adverse effects. Always consult with your healthcare provider if you have any concerns or questions about your medical history and the medications you are taking.

Side Effects

If you are considering using this product, be aware of some important warnings and potential side effects. Children and teenagers recovering from chickenpox or flu-like symptoms should avoid it due to the risk of Reye's syndrome, a rare but serious condition. If you notice changes in behavior accompanied by nausea and vomiting, consult a doctor immediately. Additionally, aspirin can cause severe allergic reactions, which may include facial swelling, wheezing, shock, or hives. If you drink three or more alcoholic beverages daily, check with your doctor before using aspirin, as it may increase the risk of stomach bleeding.

You should stop using this product and seek medical attention if you experience an allergic reaction, if your pain worsens or lasts more than 10 days, or if you notice redness, swelling, new symptoms, or ringing in the ears. It's also important to consult a doctor before use if you have a history of stomach issues, bleeding problems, ulcers, or asthma. Lastly, do not use this product if you have ever had an allergic reaction to other pain relievers or fever reducers.

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. If you notice any changes in behavior along with nausea and vomiting, consult a doctor immediately. Additionally, be cautious if you have a history of allergies to pain relievers, as aspirin can cause severe allergic reactions, including facial swelling, asthma (wheezing), shock, and hives. If you drink three or more alcoholic beverages daily, talk to your doctor before using aspirin, as it can increase the risk of stomach bleeding.

Before using this product, consult your doctor if you have ongoing stomach issues, bleeding problems, ulcers, or asthma. It's also important to check with your doctor or pharmacist if you are taking medications for diabetes, gout, arthritis, or blood thinning. If you experience an allergic reaction, seek emergency medical help right away. You should stop using the product and call your doctor if your pain worsens or lasts more than 10 days, if you notice redness or swelling, if new symptoms arise, or if you experience ringing in the ears or hearing loss.

Overdose

If you suspect an overdose, it’s crucial to seek medical help right away or contact a Poison Control Center. Signs of an overdose can vary, but they may include unusual symptoms that are more severe than what you would typically experience with the medication.

Always err on the side of caution—if you notice anything concerning, don’t hesitate to reach out for assistance. Your health and safety are the top priority, so getting prompt help is essential.

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, 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

It's important to be cautious when giving this product to children and teenagers. If your child has or is recovering from chickenpox or flu-like symptoms, they should not use this product, as it could lead to a serious condition called Reye's syndrome (a rare but serious illness). If you notice any changes in your child's behavior along with nausea and vomiting while using this product, consult a doctor immediately, as these could be early signs of Reye's syndrome.

For children under 12 years old, you should consult a doctor before use. For those aged 12 and older, the recommended dosage is 4 to 8 tablets every 4 hours, but do not exceed 48 tablets in a 24-hour period unless directed by a doctor. Always prioritize your child's safety and seek medical advice when in doubt.

Geriatric Use

When it comes to using this medication in older adults, there is no specific information available about dosage adjustments, safety concerns, or special precautions. This means that if you or a loved one is an older adult, it’s important to consult with a healthcare provider for personalized advice. They can help determine the best approach based on individual health needs and any other medications being taken. Always prioritize open communication with your healthcare team to ensure safe and effective treatment.

Renal Impairment

If you have kidney problems, it's important to know that the drug insert does not provide specific information about dosage adjustments, special monitoring, or safety considerations for your condition. This means that there are no tailored guidelines for how this medication should be used if you have renal impairment (kidney issues).

Always consult your healthcare provider for personalized advice and to ensure that any medication you take is safe and appropriate for your health situation. They can help you understand how to manage your treatment effectively while considering your kidney health.

Hepatic Impairment

If you have liver problems, it's important to know that the drug insert does not provide specific information about dosage adjustments, special monitoring, or precautions for your condition. This means that there are no tailored guidelines for how this medication should be used if you have hepatic impairment (liver issues).

Always consult your healthcare provider for personalized advice and to ensure that any medication you take is safe and appropriate for your liver health. They can help you understand any potential risks and monitor your condition effectively.

Drug Interactions

It's important to talk to your doctor or pharmacist before using this medication, especially if you are currently taking any prescription drugs for diabetes, gout, arthritis, or blood thinning (anticoagulation). These conditions can interact with the medication, potentially affecting how well it works or increasing the risk of side effects.

Always keep your healthcare provider informed about all the medications you are taking. This helps ensure your treatment is safe and effective, allowing for the best possible care tailored to your needs.

Storage and Handling

To ensure the best performance of your product, store it at room temperature. This means keeping it in a place that is neither too hot nor too cold, typically between 68°F and 77°F (20°C to 25°C).

When handling the product, make sure to do so with clean hands and in a clean environment to maintain its safety and effectiveness. Always follow any specific instructions provided with the product for optimal use.

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 the primary use of Aspirin Enteric Coated Yellow Tablets?

Aspirin Enteric Coated Yellow Tablets are indicated for pain relief.

What should I do if I have an allergic reaction to pain relievers?

Do not use Aspirin if you have ever had an allergic reaction to any other pain relievers or fever reducers.

How should I take Aspirin Enteric Coated Yellow Tablets?

Adults and children 12 years and older should take 4 to 8 tablets every 4 hours, not exceeding 48 tablets in 24 hours unless directed by a doctor. Children under 12 years should consult a doctor.

Are there any warnings for children using this product?

Children and teenagers 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.

What should I do if I experience side effects?

Stop use and ask a doctor if you experience an allergic reaction, if pain worsens or lasts more than 10 days, or if new symptoms occur.

Can I take Aspirin if I consume alcohol?

If you consume 3 or more alcoholic drinks daily, consult your doctor before taking Aspirin, as it may cause stomach bleeding.

Is it safe to use Aspirin during pregnancy?

If you are pregnant or breastfeeding, consult a health professional before use. Avoid using Aspirin during the last 3 months of pregnancy unless directed by a doctor.

What should I do if I have stomach problems before taking Aspirin?

Ask a doctor before use if you have stomach problems, bleeding issues, ulcers, or asthma.

How should I store Aspirin Enteric Coated Yellow Tablets?

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 enteric coated yellow tablets contain 81 mg of aspirin per tablet. These tablets are designed for oral administration and feature an enteric coating to minimize gastrointestinal irritation. The bulk formulation allows for convenient dispensing and storage.

Uses and Indications

This drug is indicated for the relief of pain. There are no teratogenic effects associated with its use, nor are there any nonteratogenic effects reported.

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 history of allergic reactions to any pain relievers or fever reducers. Due to the potential for severe allergic responses, administration in these patients is not recommended.

Warnings and Precautions

Patients should be advised of the following warnings and precautions associated with the use of this product.

Reye's Syndrome Children and teenagers who are experiencing or recovering from chickenpox or flu-like symptoms should not use this product. If any changes in behavior accompanied by nausea and vomiting occur during use, it is imperative to consult a healthcare professional, as these symptoms may indicate the onset of Reye's syndrome, a rare but serious condition.

Allergy Alert Aspirin has the potential to cause severe allergic reactions. Symptoms may include facial swelling, asthma (wheezing), shock, and hives. Immediate medical attention should be sought if an allergic reaction occurs.

Alcohol Warning Patients who consume three or more alcoholic beverages daily should consult their healthcare provider regarding the use of aspirin or other pain relievers/fever reducers, as aspirin may increase the risk of stomach bleeding.

General Precautions This product should not be used by individuals with a known allergy to any other pain relievers or fever reducers. Prior to use, patients should consult a healthcare professional if they have any of the following conditions:

  • Persistent or recurrent stomach problems (such as heartburn, upset stomach, or stomach pain)

  • Bleeding disorders

  • History of ulcers

  • Asthma

Additionally, patients taking prescription medications for diabetes, gout, arthritis, or anticoagulation (blood thinning) should seek advice from a healthcare provider or pharmacist before using this product.

Emergency Medical Help In the event of an allergic reaction, immediate medical assistance is required.

Discontinuation of Use Patients should stop taking this product and contact their healthcare provider if any of the following occur:

  • An allergic reaction

  • Worsening pain or pain that persists for more than 10 days

  • Presence of redness or swelling

  • Onset of new symptoms

  • Ringing in the ears or loss of hearing

Side Effects

Patients using this product may experience a range of adverse reactions, some of which may be serious.

Serious Adverse Reactions Reye's syndrome is a rare but serious illness that can occur in children and teenagers who have or are recovering from chickenpox or flu-like symptoms. Patients should be advised not to use this product under these circumstances. If changes in behavior accompanied by nausea and vomiting occur, it is crucial to consult a doctor, as these may be early signs of Reye's syndrome. Additionally, aspirin may cause severe allergic reactions, which can manifest as facial swelling, asthma (wheezing), shock, or hives. In the event of an allergic reaction, patients should seek medical help immediately.

Common Adverse Reactions Patients are advised to stop using this product and consult a doctor if they experience worsening pain that lasts more than 10 days, redness or swelling, new symptoms, or symptoms such as ringing in the ears or loss of hearing.

Precautions Patients with a history of allergic reactions to any other pain relievers or fever reducers should not use this product. It is also recommended that patients consult a doctor before use if they have stomach problems (such as heartburn, upset stomach, or stomach pain), bleeding problems, ulcers, or asthma.

Alcohol Warning Patients who consume three or more alcoholic drinks daily should seek medical advice regarding the use of aspirin or other pain relievers/fever reducers, as aspirin may increase the risk of stomach bleeding.

Drug Interactions

Patients should consult a healthcare professional, such as a doctor or pharmacist, prior to using this medication if they are currently taking prescription drugs for the following conditions:

Pharmacodynamic Interactions

  • Diabetes: Caution is advised as the interaction may affect glycemic control.

  • Gout: Potential interactions could influence uric acid levels and management of gout symptoms.

  • Arthritis: There may be implications for anti-inflammatory treatment and pain management.

  • Anticoagulation: The use of this medication alongside anticoagulants may increase the risk of bleeding; careful monitoring of coagulation parameters is recommended.

It is essential for patients to discuss their current medications and health conditions with their healthcare provider to ensure safe and effective use of this medication.

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

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 changes in behavior accompanied by nausea and vomiting occur while using this product, it is important to consult a doctor, as these may be early signs of Reye's syndrome.

For children under 12 years of age, consultation with a doctor is advised prior to use. For adults and children aged 12 years and older, the recommended dosage is 4 to 8 tablets every 4 hours, with a maximum of 48 tablets in a 24-hour period unless otherwise directed by a doctor.

Geriatric Use

There is no specific information available regarding the use of this medication in geriatric patients, including dosage adjustments, safety concerns, or special precautions. Healthcare providers should exercise caution when prescribing this medication to elderly patients, as individual responses may vary. Monitoring for potential adverse effects and therapeutic efficacy is recommended in this population.

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 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 the use of this medication while breastfeeding.

Renal Impairment

Patients with renal impairment have no specific information regarding dosage adjustments, special monitoring, or safety considerations provided in the drug insert. Therefore, healthcare professionals should exercise caution when prescribing this medication to individuals with reduced kidney function, as the lack of data necessitates careful clinical judgment. Regular monitoring of renal function may be advisable in these patients to ensure safety and efficacy.

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 prescribing information.

Overdosage

In the event of an overdose, it is imperative to seek 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 aware that the symptoms of overdose may vary depending on the substance involved. Therefore, a thorough assessment of the patient's condition is essential.

Management of an overdose typically involves supportive care and symptomatic treatment. Continuous monitoring of the patient's vital signs and clinical status is recommended. In cases where specific antidotes are available, their administration should be considered based on the clinical scenario and the substance involved.

It is essential for healthcare providers to remain vigilant and prepared to implement appropriate interventions to ensure patient safety and optimal outcomes following an overdose incident.

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

No postmarketing experience details are available in the insert text.

Patient Counseling

Healthcare providers should advise patients to keep this medication out of reach of children to prevent accidental ingestion. Patients must be informed not to use the product if they have a history of allergic reactions to any other pain relievers or fever reducers.

Patients should be instructed to stop using the medication and seek medical attention if they experience any signs of an allergic reaction, if their pain worsens or persists for more than 10 days, if they notice redness or swelling, if new symptoms arise, or if they experience ringing in the ears or loss of hearing.

This medication is intended for the temporary relief of minor aches and pains or as directed by a healthcare provider. It is important to communicate that due to its delayed release action, this product will not provide immediate relief for headaches or other symptoms requiring prompt alleviation.

Patients should be encouraged to consult with their healthcare provider before using this medication if they have any of the following conditions: stomach problems (such as heartburn, upset stomach, or stomach pain) that are persistent or recurrent, bleeding disorders, ulcers, or asthma.

Additionally, patients should be advised to speak with their doctor or pharmacist prior to use if they are currently taking prescription medications for diabetes, gout, arthritis, or anticoagulation therapy, as interactions may occur.

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 to maintain its integrity and efficacy. No special handling requirements are noted, ensuring straightforward management within standard 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.