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Regular Strength Enteric Coated Aspirin

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Active ingredient
Aspirin 325 mg
Other brand names
Drug classes
Nonsteroidal Anti-inflammatory Drug, Platelet Aggregation Inhibitor
Dosage form
Tablet, 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 2000
Label revision date
October 26, 2023
Drug Information (PDF)
Prescribing information, PDF file
Active ingredient
Aspirin 325 mg
Other brand names
Drug classes
Nonsteroidal Anti-inflammatory Drug, Platelet Aggregation Inhibitor
Dosage form
Tablet, 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 2000
Label revision date
October 26, 2023
Manufacturer
Geri-Care Pharmaceutical Corp
Registration number
M013
NDC root
57896-921
Drug Information (PDF)
Prescribing information, PDF file
Packaging Info (5 NDCs)
Packaging & NDC Codes (5)

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Drug Overview

Aspirin is a medication commonly used for the temporary relief of minor aches and pains, such as headaches, muscle aches, and toothaches. It is a widely recognized and accessible option for managing discomfort in everyday situations.

If you're considering using aspirin, it's a good idea to consult your doctor about its other potential uses and to ensure it's appropriate for your specific health needs.

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 drink a full glass of water with each dose to help it work effectively. You should swallow the tablets whole, without chewing or crushing them, to ensure they release the medication properly.

For adults and children aged 12 years and older, the recommended dosage is 1 to 2 tablets every 4 hours as needed. However, you should not take more than 12 tablets in a 24-hour period unless your doctor advises otherwise. If you are considering giving this medication to a child under 12 years old, please consult a doctor first, as it should not be used without their guidance. Always remember to follow the recommended dose to avoid any potential risks.

What to Avoid

It's important to keep this medication out of reach of children to ensure their safety. If you suspect an overdose, seek medical help immediately or contact a Poison Control Center for assistance.

Currently, there are no specific contraindications, risks of abuse or misuse, or concerns about dependence associated with this medication. However, always use it responsibly and follow any additional guidance provided by your healthcare professional.

Side Effects

You should be aware of some important side effects and warnings associated with 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 rare but serious illness. Additionally, aspirin can cause severe allergic reactions, which may include hives, facial swelling, asthma (wheezing), or shock.

This product contains a nonsteroidal anti-inflammatory drug (NSAID), which can increase the risk of severe stomach bleeding, especially if you are over 60, have a history of stomach ulcers, or are taking certain medications like blood thinners or other NSAIDs. If you experience symptoms such as feeling faint, vomiting blood, or having bloody or black stools, stop using the product and consult a doctor immediately. Always seek medical advice if you have existing health conditions like high blood pressure, heart disease, or asthma, or if you are taking other medications.

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 changes in behavior along with nausea and vomiting, consult a doctor immediately. Additionally, be cautious if you have a history of allergies, as aspirin can cause severe allergic reactions, including hives, facial swelling, and difficulty breathing.

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 symptoms like faintness, vomiting blood, or black stools, stop using the product and seek medical attention right away. Always consult your doctor before use if you have certain health conditions, such as high blood pressure, heart disease, or kidney issues, or if you are taking other medications.

If you are pregnant or breastfeeding, it's crucial to talk to a healthcare professional before using this product, particularly after 20 weeks of pregnancy. In case of an overdose, seek 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 require prompt attention.

Always err on the side of caution—if you think you or someone else may have taken too much of a medication, don’t hesitate to reach out for professional assistance. Your health and safety are the top priority.

Pregnancy Use

If you are pregnant or breastfeeding, it’s crucial 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 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 advice.

Lactation Use

If you are pregnant or breastfeeding, it's important to consult with a healthcare professional before using any medication. Specifically, if you are considering taking aspirin, be aware that it is particularly risky to use after 20 weeks of pregnancy unless your doctor has specifically advised you to do so. Using aspirin during this time 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 professional guidance.

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. 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 only use this product if directed by a doctor. For those aged 12 and older, the recommended dosage is 1-2 tablets every 4 hours as needed, but do not exceed 12 tablets in a 24-hour period unless advised by a healthcare professional. Always prioritize your child's safety and consult with a doctor if you have any concerns.

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, you may have a higher chance of experiencing severe stomach bleeding. This risk is significant enough that you should consult your doctor if you have any concerns about this warning.

Additionally, older adults often have increased sensitivity to side effects from medications. This means that you might experience effects that younger individuals do not. Always discuss your health history and any medications you are taking with your healthcare provider to ensure safe and effective treatment.

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 whether 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 problems, such as liver cirrhosis (a severe scarring of the liver), it's important to consult your doctor before using this medication. Your healthcare provider will assess your overall health and may need to adjust your dosage or monitor your condition more closely.

Additionally, if you have other health issues like high blood pressure, heart disease, kidney disease, or asthma, make sure to inform your doctor as these conditions can also affect your treatment plan. Always prioritize open communication with your healthcare team to ensure your safety and well-being.

Drug Interactions

It's important to talk to your healthcare provider before using this medication, especially if you are taking a diuretic (a type of medication that helps remove excess fluid from your body). You should also consult with your doctor or pharmacist if you are on prescription medications for diabetes, gout, or arthritis, as these can interact with the treatment.

Be aware that if you are taking blood thinners (anticoagulants) or steroid medications, your risk of stomach bleeding may increase. Additionally, using this medication alongside other nonsteroidal anti-inflammatory drugs (NSAIDs) like aspirin, ibuprofen, or naproxen can also raise this risk. Always discuss your current medications and any lab tests with your healthcare provider to ensure your safety.

Storage and Handling

To ensure the best performance of your product, store it in a cool, dry place at a temperature between 20°C and 25°C (68°F and 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 as close to the recommended range as possible.

When handling the product, make sure to maintain a clean environment to avoid contamination. Always follow any specific instructions provided for safe use and disposal to ensure your safety and the effectiveness of the product.

Additional Information

You should take this medication orally. For adults and children aged 12 years and older, the recommended dose is 1-2 tablets every 4 hours as needed, but do not exceed 12 tablets in a 24-hour period unless directed by a doctor. If your child is under 12 years old, consult a doctor before use.

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 your 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.

What should I do if I miss a dose?

If you miss a dose, take it as soon as you remember. If it's almost time for your next dose, skip the missed dose and continue with your regular schedule.

How should I take Aspirin?

You should swallow Aspirin whole with a full glass of water. Do not chew or crush the tablets.

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

Adults and children 12 years and older can take 1-2 tablets every 4 hours as needed, not exceeding 12 tablets in 24 hours, or as directed by a doctor.

Can children under 12 use Aspirin?

Children under 12 years should not use Aspirin unless directed by a doctor.

What should I do in case of an overdose?

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

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 symptoms like feeling faint, vomiting blood, or having bloody or black stools, stop using Aspirin and consult a doctor immediately.

Is it safe to use Aspirin during pregnancy?

If you are pregnant or breastfeeding, consult a health professional before use. It is especially important not to use Aspirin at 20 weeks or later in pregnancy unless directed by a doctor.

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

You should ask a doctor before using Aspirin if you have a history of stomach problems, such as heartburn, or if the stomach bleeding warning applies to you.

Packaging Info

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

Packaging configurations for Regular Strength Enteric Coated Aspirin.
Details

Drug Information (PDF)

This file contains official product information for Regular Strength Enteric Coated Aspirin, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)

Description

The product is identified by the SPL code 34089-3. No additional specific description details are provided in the available data.

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 take the medication with a full glass of water for optimal efficacy. It is essential to swallow the tablets whole; they should not be chewed or crushed to maintain the integrity of the formulation.

For adults and children aged 12 years and older, the recommended dosage is 1 to 2 tablets every 4 hours as needed. The total daily dosage must not exceed 12 tablets within a 24-hour period, unless otherwise directed by a healthcare professional.

For children under 12 years of age, the use of this medication is not recommended unless specifically directed by a physician. It is crucial to adhere to the recommended dosing guidelines and not to exceed the advised dosage to ensure safety and effectiveness.

Contraindications

There are no specific contraindications associated with this product. However, it is essential to keep the product out of reach of children to prevent accidental ingestion. In the event of an overdose, immediate medical assistance should be sought, or contact a Poison Control Center for guidance.

Warnings and Precautions

Children and teenagers who are experiencing or recovering from chickenpox or flu-like symptoms should avoid using 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, as these may be early signs of Reye's syndrome.

Aspirin may induce 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 not use this product. Additionally, those who have previously experienced an allergic reaction to this product or any of its components should refrain from 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 while using this product, or exceed the recommended dosage or duration of use.

Healthcare professionals should be consulted prior to use if the stomach bleeding warning is applicable, if the patient is taking a diuretic, or if there is a history of gastrointestinal issues such as heartburn. Patients with high blood pressure, heart disease, liver cirrhosis, kidney disease, or asthma should also seek medical advice before using this product. Furthermore, it is advisable to consult a doctor or pharmacist if the patient is currently taking prescription medications for diabetes, gout, or arthritis.

Patients should discontinue use and seek medical attention if they experience any signs of stomach bleeding, such as feeling faint, vomiting blood, having bloody or black stools, or experiencing persistent stomach pain. Immediate medical help should be sought if an allergic reaction occurs. Additionally, if pain worsens or persists for more than 10 days, if redness or swelling develops, if fever worsens or lasts more than three days, if any new symptoms arise, or if there is ringing in the ears or loss of hearing, medical advice should be obtained.

For individuals who are pregnant or breastfeeding, it is crucial to consult a healthcare professional before using this product. Aspirin should be avoided after 20 weeks of pregnancy unless specifically directed by a physician, as it may pose risks to the unborn child or lead to complications during delivery.

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 serious and common adverse reactions associated with its use.

Reye's syndrome is a rare but serious illness that may occur in children and teenagers who have or are recovering from chicken pox or flu-like symptoms. 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, a component of this product, may cause severe allergic reactions in some individuals. 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.

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 seek medical attention if they experience signs of stomach bleeding, such as feeling faint, vomiting blood, having bloody or black stools, or experiencing persistent stomach pain.

Patients are also cautioned to consult a doctor before using this product if they have a history of stomach problems, such as heartburn, or if they have conditions such as high blood pressure, heart disease, liver cirrhosis, kidney disease, or asthma. Additionally, those taking diuretics or prescription medications for diabetes, gout, or arthritis should seek medical advice prior to use.

Common adverse reactions that warrant discontinuation of the product and consultation with a healthcare provider include worsening pain that lasts more than 10 days, redness or swelling, fever that worsens or lasts more than three days, the emergence of any new symptoms, and symptoms such as ringing in the ears or loss of hearing.

Drug Interactions

Patients should consult a healthcare professional prior to using this medication if they are concurrently taking a diuretic.

For individuals on prescription medications for diabetes, gout, or arthritis, it is advisable to seek guidance from a doctor or pharmacist before initiating treatment with this drug.

The concomitant use of blood thinners (anticoagulants) or steroid medications may increase the risk of gastrointestinal bleeding. Therefore, careful monitoring is recommended for patients on these therapies.

Additionally, the risk of stomach bleeding is elevated in patients who are taking other nonsteroidal anti-inflammatory drugs (NSAIDs), including but not limited to aspirin, ibuprofen, and naproxen. It is prudent to assess the necessity of concurrent NSAID therapy and consider dosage adjustments or alternative treatments as appropriate.

Packaging & NDC

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

Packaging configurations for Regular Strength 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 changes in behavior accompanied by nausea and vomiting occur while using this product, it is important to consult a doctor, as these symptoms may indicate the onset of Reye's syndrome.

For pediatric patients under 12 years of age, the product should not be used unless directed by a healthcare professional. For those aged 12 years and older, the recommended dosage is 1-2 tablets every 4 hours as needed, with a maximum of 12 tablets in a 24-hour period, or as directed by a doctor.

Geriatric Use

Elderly patients, particularly those aged 60 and older, are at an increased risk for severe stomach bleeding. It is essential for healthcare providers to consult with patients regarding this risk, especially if they fall within this age group.

Additionally, geriatric patients may exhibit heightened sensitivity to side effects associated with the medication. Therefore, careful monitoring and consideration of dose adjustments may be warranted to ensure safety and efficacy in this population.

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 fetal outcomes or complications during delivery. Therefore, it is crucial that pregnant patients only use aspirin under the guidance of a qualified healthcare provider if deemed necessary.

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 gestation 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 should consult a healthcare professional prior to use, particularly if they have a history of liver cirrhosis. It is essential to assess liver function and consider potential dosage adjustments based on the severity of hepatic impairment. Monitoring of liver function tests may be warranted to ensure patient safety and therapeutic efficacy. Additionally, patients with compromised liver function should be evaluated for any concurrent conditions, such as high blood pressure, heart disease, kidney disease, or asthma, which may influence treatment decisions.

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 aware that the specific symptoms of an overdose may vary depending on the substance involved. Therefore, a thorough assessment of the patient's condition is essential to determine the appropriate course of action.

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 the substance is known, specific antidotes or treatments may be indicated, and healthcare providers should refer to established guidelines for the management of the particular overdose scenario.

It is vital for healthcare professionals to remain vigilant and act swiftly in the event of an overdose to ensure the best possible outcomes for affected individuals.

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 regarding nonclinical toxicology or animal pharmacology and toxicology provided in the text.

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. 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°C to 25°C (68°F to 77°F). Temporary excursions are permissible between 15°C and 30°C (59°F and 86°F). Proper storage conditions are essential to maintain the integrity of the product.

Additional Clinical Information

Patients aged 12 years and older are advised to take 1-2 tablets orally every 4 hours as needed, with a maximum of 12 tablets in a 24-hour period, unless otherwise directed by a healthcare professional. For children under 12 years, use is not recommended unless specifically directed by a doctor.

Clinicians should counsel patients regarding the use of the medication during pregnancy and breastfeeding. It is particularly important to avoid aspirin use after 20 weeks of pregnancy unless explicitly 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 Regular Strength 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 Regular Strength 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.