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Aspirin

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This product has been discontinued

Active ingredient
Aspirin 325 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 2010
Label revision date
April 17, 2011
Drug Information (PDF)
Prescribing information, PDF file
Active ingredient
Aspirin 325 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 2010
Label revision date
April 17, 2011
Manufacturer
Cispharma, Inc
Registration number
part343
NDC root
52204-111
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 Orange Tablets are a type of medication that contains 325 mg of aspirin, which is commonly 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 medication is typically indicated for alleviating various types of pain, providing you with a supportive option when you need relief.

Uses

If you're looking for relief from pain, this medication is designed to help you manage that discomfort effectively. It's important to note that this drug has been evaluated and does not have any teratogenic effects, meaning it does not cause birth defects if taken during pregnancy. Additionally, there are no nonteratogenic effects reported, which means it doesn't have harmful effects on the body outside of those related to pregnancy. Always consult with your healthcare provider to ensure this medication is right for you.

Dosage and Administration

When you need relief from your symptoms, adults and children aged 12 and older can take 1 to 2 tablets every 4 hours as needed. It's important to drink a full glass of water with each dose to help the medication work effectively. However, make sure not to exceed 12 tablets in a 24-hour period unless your doctor advises otherwise.

If you have a child under 12 years old, it's best to consult a doctor before giving them this medication. This ensures that they receive the appropriate care and dosage for their age. Always follow these guidelines to use the medication safely and effectively.

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 considering.

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, asthma symptoms (like wheezing), shock, or hives.

It's also important to note that if you drink three or more alcoholic beverages daily, you should talk to your doctor before using aspirin, as it may increase the risk of stomach bleeding. You should stop using the product and seek medical help if you experience any allergic reactions, worsening pain, redness or swelling, new symptoms, or ringing in the ears and hearing loss. Always consult your doctor if you have a history of stomach problems, bleeding issues, ulcers, or asthma before using this medication.

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 chickenpox or flu-like symptoms, you should not use this product, as it may lead to Reye's syndrome, a rare but serious illness. If you notice any changes in behavior along with nausea and vomiting, consult a doctor immediately. Additionally, be cautious of potential severe allergic reactions, which can include facial swelling, asthma (wheezing), shock, or 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 a history of allergic reactions to pain relievers, stomach problems (like heartburn or ulcers), bleeding issues, or asthma. It's also wise 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 also 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 drowsiness, confusion, or difficulty breathing.

Don’t wait for symptoms to worsen; getting prompt assistance can be vital. Always prioritize your safety and the safety of others by acting quickly in these situations.

Pregnancy Use

If you are pregnant or breastfeeding, it’s crucial to consult with a healthcare professional before using any medication. This is especially important for aspirin, which should generally be avoided during the last three months of pregnancy unless your doctor specifically advises you to take it. Using aspirin at this stage 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 guidance.

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 professional advice.

Pediatric Use

If you are considering this product for your child, it's important to be aware of some specific guidelines. Children and teenagers who have or are recovering from chickenpox or flu-like symptoms should not use this product, as it could increase the risk of Reye's syndrome (a rare but serious illness). If your child starts showing changes in behavior along with nausea and vomiting while using this product, you should consult a doctor immediately, as these could be early signs of Reye's syndrome.

For dosing, adults and children aged 12 and older can take 1 to 2 tablets every 4 hours as needed while symptoms persist. However, if your child is under 12 years old, you should consult a doctor before giving them this product. Always prioritize your child's safety and well-being by following these recommendations.

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 before starting the medication. 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 may affect you 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 determine the best course of action based on your kidney function and overall 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 may affect you differently due to your liver health.

Always consult your healthcare provider for personalized advice and to discuss any concerns you may have regarding your liver condition and the use of this medication. They can help ensure that you receive the safest and most effective treatment.

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 medications can interact in ways that may affect how well they work or increase 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 you to manage your health with confidence.

Storage and Handling

To ensure the best performance of your product, store it in a cool, dry place at temperatures below 25°C (77°F). Keeping it within this temperature range helps maintain its effectiveness and safety.

When handling the product, be sure to follow any specific instructions provided to avoid contamination or damage. Always ensure that your hands and any surfaces are clean to maintain a sterile environment, which means free from germs and contaminants. If you have any questions about disposal or further handling, please refer to the guidelines provided with your product.

Additional Information

You should take this medication orally. If you are pregnant or breastfeeding, it's important to consult with a healthcare professional before using it. Specifically, avoid using aspirin during the last three months of pregnancy unless your doctor has specifically instructed you to do so, as it can lead to issues for the unborn child or complications during delivery.

FAQ

What is the primary use of Aspirin Enteric Coated Orange Tablets?

Aspirin Enteric Coated Orange Tablets are indicated for pain relief.

What should I do if I experience an allergic reaction while taking aspirin?

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

How should adults and children over 12 take aspirin?

Adults and children 12 years of age and over should take 1 to 2 tablets every 4 hours while symptoms persist, but not more than 12 tablets in 24 hours unless directed by a doctor.

Are there any warnings for children using aspirin?

Children and teenagers recovering from chicken pox or flu-like symptoms should not use aspirin due to the risk of Reye's syndrome, a rare but serious illness.

What should I do if my pain lasts more than 10 days?

Stop use and ask a doctor if your pain gets worse or lasts more than 10 days.

Can I take aspirin if I have a history of stomach problems?

You should ask a doctor before using aspirin if you have stomach problems, bleeding issues, ulcers, or asthma.

Is it safe to take aspirin during pregnancy?

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

What should I do if I experience ringing in the ears or loss of hearing?

Stop use and call your doctor if you experience ringing in the ears or loss of hearing.

What is the recommended storage condition for aspirin?

Store aspirin below 25°C.

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 orange tablets contain 325 mg of aspirin per tablet. The enteric coating is designed to protect the active ingredient from degradation in the stomach, allowing for targeted release in the intestines. These tablets are formulated for bulk distribution and are characterized by their orange color.

Uses and Indications

This drug is indicated for the relief of pain. There are no teratogenic effects associated with its use, and no nonteratogenic effects have been reported.

Dosage and Administration

Adults and children 12 years of age and over are instructed to take 1 to 2 tablets every 4 hours as needed while symptoms persist. Each dose should be accompanied by a full glass of water to ensure proper hydration and absorption.

It is imperative that patients do not exceed a total of 12 tablets within a 24-hour period unless specifically directed by a healthcare professional.

For children under 12 years of age, consultation with a doctor is required prior to administration to determine appropriate dosing and safety.

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, such patients should not be administered this product.

Warnings and Precautions

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

Warnings

Reye's syndrome is a serious condition that can occur in children and teenagers who have or are recovering from chickenpox or flu-like symptoms. It is imperative that this product not be used in these populations. If any changes in behavior accompanied by nausea and vomiting occur while using this product, a healthcare professional should be consulted immediately, as these may be early signs of Reye's syndrome.

An allergy alert is warranted, as aspirin may induce severe allergic reactions. Symptoms may include facial swelling, asthma (wheezing), shock, and hives. Immediate medical attention should be sought if an allergic reaction occurs.

Additionally, an alcohol warning is in place. Patients who consume three or more alcoholic drinks 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), a history of allergic reactions to aspirin, bleeding disorders, ulcers, or asthma.

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

Emergency Medical Help Instructions

In the event of an allergic reaction, patients should seek emergency medical assistance immediately.

Stop Taking and Call Your Doctor Instructions

Patients are advised to discontinue use and consult a healthcare professional if any of the following occur: an allergic reaction, worsening pain or pain lasting more than 10 days, presence of redness or swelling, emergence of new symptoms, or symptoms such as ringing in the ears or loss of hearing.

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 that these individuals do not use 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 may also provoke severe allergic reactions in some patients. Symptoms of such reactions can include facial swelling, asthma (wheezing), shock, and hives. Patients are advised to stop using the product and seek medical attention if any signs of an allergic reaction occur.

Additionally, patients who consume three or more alcoholic drinks daily should consult their doctor before using aspirin or other pain relievers/fever reducers, as aspirin may increase the risk of stomach bleeding.

Common adverse reactions may include gastrointestinal issues. Patients should discontinue use and consult a doctor if pain worsens or persists for more than 10 days, if redness or swelling is observed, if new symptoms arise, or if they experience ringing in the ears or loss of hearing.

Before using this product, patients should seek medical advice if they have a history of stomach problems (such as heartburn, upset stomach, or stomach pain), bleeding disorders, ulcers, or asthma. It is also important to note that individuals who have previously experienced an allergic reaction to any other pain relievers or fever reducers should not use this product.

Drug Interactions

Patients should consult a healthcare professional prior to using this medication if they are concurrently 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 efficacy and safety.

  • 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 with their healthcare provider to ensure safe and effective use of this drug.

Packaging & NDC

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

Packaging configurations for Aspirin.
Details

Pediatric Use

Pediatric patients, particularly 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. Healthcare professionals should advise caregivers to seek medical attention if changes in behavior accompanied by nausea and vomiting occur, as these may indicate the onset of Reye's syndrome, a rare but serious condition.

For dosing, adults and children aged 12 years and older are directed to take 1 to 2 tablets every 4 hours while symptoms persist. For children under 12 years of age, consultation with a doctor is recommended prior to use.

Geriatric Use

Elderly patients may not have specific information regarding the use of this medication, including dosage adjustments, safety concerns, or special precautions. Therefore, healthcare providers should exercise caution when prescribing this medication to geriatric patients. It is advisable to monitor these patients closely for any potential adverse effects or changes in therapeutic response, given the lack of targeted data for this population.

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 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 not been specifically studied in relation to dosage adjustments, special monitoring, or safety considerations. Therefore, there is no available information regarding the use of this medication in individuals with reduced kidney function. Healthcare professionals should exercise caution and consider the lack of data when prescribing this medication to patients with renal impairment.

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 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 informed about the appropriate protocols for managing overdose situations, ensuring that patients receive timely and effective care.

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 provided regarding nonclinical toxicology or animal pharmacology and toxicology.

Postmarketing Experience

No postmarketing experience details are available in the insert text.

Patient Counseling

Patients should be advised to keep this medication out of reach of children to prevent accidental ingestion. It is important to inform patients that they should not use this medication if they have ever experienced an allergic reaction to any other pain relievers or fever reducers.

Healthcare providers should instruct patients to stop using the medication and seek medical attention if any of the following occur: an allergic reaction, worsening pain that lasts more than 10 days, the presence of redness or swelling, the emergence of new symptoms, or if they experience ringing in the ears or loss of hearing.

Patients may use this medication for the temporary relief of minor aches and pains associated with headaches, minor arthritis, colds, muscle pain, toothaches, menstrual pain, or as directed by their healthcare provider.

Before initiating treatment, healthcare providers should encourage patients to consult with them if they have any of the following conditions: stomach problems such as heartburn, upset stomach, or stomach pain that persists or recurs; a history of allergic reactions to aspirin; bleeding problems; 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.

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 temperatures below 25°C to maintain its integrity and efficacy. Proper storage conditions must be adhered to, ensuring that the product is kept in a suitable container to prevent exposure to excessive heat or moisture. Special handling requirements should be observed to ensure the product remains within the recommended temperature range throughout its storage and handling processes.

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. No further information is available regarding laboratory tests, abuse potential, or postmarketing experiences.

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

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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.