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Adult Low Dose Aspirin

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This product has been discontinued

Active ingredient
Aspirin 81 mg
Other brand names
Dosage form
Tablet, Delayed Release
Route
Oral
Prescription status
OTC (over the counter)
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Marketed in the U.S.
Since 2007
Label revision date
September 20, 2013
Drug Information (PDF)
Prescribing information, PDF file
Active ingredient
Aspirin 81 mg
Other brand names
Dosage form
Tablet, Delayed Release
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 2007
Label revision date
September 20, 2013
Manufacturer
Liberty Pharmaceuticals, Inc.
Registration number
part343
NDC root
0440-7135
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

This medication is designed to provide temporary relief from minor aches and pains, which can include discomfort from headaches, muscle strains, or other similar issues. It is important to note that this product may not offer quick relief for symptoms that require immediate attention, as it has a delayed action.

If you have specific questions about how this medication might be used for other conditions, it's a good idea to consult your doctor for personalized advice.

Uses

This product is designed to provide temporary relief from minor aches and pains, such as headaches or muscle discomfort. However, keep in mind that it may not work quickly, so it might not be the best choice for immediate relief of symptoms that require fast action.

If you're considering using this product, it's a good idea to talk to your doctor about any other potential uses that may be appropriate for you.

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 as long as your symptoms continue. However, make sure not to exceed 48 tablets in a 24-hour period unless directed otherwise by your doctor.

If you have a child under 12 years old, it's best to consult a physician before giving them this medication to ensure it's safe and appropriate for their age and condition. Always follow the guidance provided by your healthcare provider for the best results.

What to Avoid

You should avoid using this medication if you have ever had an allergic reaction to aspirin or any other pain reliever or fever reducer. It's important to prioritize your safety, so if you have a history of such allergies, please do not take this medication. Always consult with your healthcare provider if you have any questions or concerns about your medications.

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, you should not use this product due to the risk of Reye's syndrome, a rare but serious illness. If you notice changes in behavior along with nausea and vomiting, consult a doctor immediately.

This product may also cause severe allergic reactions, which can include hives, asthma (wheezing), facial swelling, or shock. Additionally, it contains an NSAID, which can lead to serious stomach bleeding, especially if you are over 60, have a history of stomach ulcers, or are taking certain medications. If you experience symptoms like feeling faint, vomiting blood, or having bloody or black stools, stop using the product and seek medical attention right away. Always consult your doctor if you notice any new symptoms or if your pain worsens or lasts longer than 10 days.

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 could lead to Reye's syndrome, a rare but serious illness. Additionally, be cautious of potential severe allergic reactions, which may include hives, asthma (wheezing), facial swelling, or shock. This product can also increase the risk of severe stomach bleeding, especially if you are over 60, have a history of stomach ulcers, take blood thinners or steroids, consume alcohol regularly, or exceed the recommended dosage.

Before using this product, consult your doctor if you have a history of stomach problems, high blood pressure, heart disease, liver cirrhosis, kidney disease, or asthma. It's also wise to check with your doctor or pharmacist if you are taking medications for gout, diabetes, or arthritis. If you accidentally take too much, seek emergency medical help immediately.

You should stop using this product and call your doctor if you notice any signs of stomach bleeding (like feeling faint, vomiting blood, or having black stools), experience an allergic reaction, if your pain worsens or lasts more than 10 days, or if you notice any new symptoms, including ringing in the ears or hearing loss.

Overdose

If you suspect an accidental overdose, it’s important to seek medical help immediately or contact a Poison Control Center. Signs of an overdose can vary, but they may include unusual symptoms that are not typical for you.

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

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 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

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 lead to a serious condition called Reye's syndrome. If your child experiences 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 this rare illness.

For dosing, adults and children aged 12 and older can take 4 to 8 tablets every 4 hours while symptoms persist, but they should not exceed 48 tablets in a 24-hour period unless directed by a physician. If your child is under 12 years old, it's essential to consult a physician before giving them this product.

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, extra caution should be taken when using certain medications that can affect the stomach. 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. Your safety and well-being are the top priority, so don't hesitate to ask questions and seek guidance tailored to your needs.

Renal Impairment

If you have kidney problems, it's important to consult your doctor before using this medication. Your healthcare provider will need to know about any existing conditions, including high blood pressure, heart disease, or liver cirrhosis, as these can affect how the medication works in your body.

Always prioritize your health by discussing any concerns with your doctor to ensure safe and effective treatment tailored to your needs.

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 can help determine if it's safe for you, especially if you also have other conditions like high blood pressure or heart disease.

Always prioritize your health by discussing any existing liver issues with your doctor to ensure proper care and monitoring.

Drug Interactions

It's important to be aware that taking aspirin can lead to serious stomach bleeding, particularly if you are also using blood thinners (medications that help prevent blood clots) or other nonsteroidal anti-inflammatory drugs (NSAIDs) like ibuprofen or naproxen. This risk highlights the need for open communication with your healthcare provider about all the medications you are taking.

If you are on prescription medications for conditions such as gout, diabetes, or arthritis, it's crucial to consult your doctor before starting aspirin. These medications may interact with aspirin, potentially leading to unwanted side effects. Always discuss your full medication list with your healthcare provider to ensure your safety and well-being.

Storage and Handling

To ensure the safety and effectiveness of your product, always check that the safety seal under the cap is intact before use. If the seal is broken or missing, do not use the product.

Store the product at room temperature, ideally between 15° and 30°C (59° to 86°F). It's important to keep it away from excessive heat and moisture, as these conditions can affect its quality. By following these simple guidelines, you can help maintain the product's integrity and ensure safe handling.

Additional Information

You should take this medication orally. For adults and children aged 12 and over, the recommended dosage is 4 to 8 tablets every 4 hours while symptoms persist, but do not exceed 48 tablets in a 24-hour period unless directed by a physician. If your child is under 12 years old, consult a physician for appropriate dosing.

If you are pregnant or breastfeeding, it's important to consult a healthcare professional before using this medication. Avoid using aspirin during the last three months of pregnancy unless specifically instructed by your doctor, as it may pose risks to the unborn child or lead to complications during delivery.

FAQ

What is the drug indicated for?

The drug is indicated for the temporary relief of minor aches and pains or as recommended by your doctor.

How should I take this drug?

Adults and children 12 years and over should take 4 to 8 tablets every 4 hours while symptoms persist, without exceeding 48 tablets in 24 hours. Children under 12 years should consult a physician.

What should I do if I experience stomach bleeding?

Stop use and ask a doctor if you feel faint, vomit blood, have bloody or black stools, or have stomach pain that does not get better.

Are there any warnings for children using this drug?

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 have an allergic reaction?

If you experience symptoms like hives, asthma (wheezing), facial swelling, or shock, stop using the drug and seek medical help immediately.

Can I use this drug if I am pregnant or breastfeeding?

If you are pregnant or breastfeeding, ask a health professional before use. It is especially important not to use this drug during the last 3 months of pregnancy unless directed by a doctor.

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

Ask a doctor before use if you have a history of stomach problems, high blood pressure, heart disease, liver cirrhosis, or kidney disease.

Who is the repackager of this product?

The repackager of the product is Aidarex Pharmaceuticals LLC, located in Corona, CA 92880.

What should I do if the safety seal is broken or missing?

Do not use the product if the safety seal under the cap is broken or missing.

Packaging Info

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

Packaging configurations for Adult Low Dose Aspirin.
Details

Drug Information (PDF)

This file contains official product information for Adult Low Dose Aspirin, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)

Description

Aidarex Pharmaceuticals LLC, located in Corona, CA 92880, is the repackager of this pharmaceutical product.

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 may not provide immediate relief for headaches or other symptoms requiring prompt alleviation.

Healthcare professionals are encouraged to inquire about additional uses for this product based on individual patient needs.

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

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 as needed while symptoms persist. It is important not to exceed a total of 48 tablets within a 24-hour period unless otherwise directed by a physician.

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 aspirin or any other pain reliever or fever reducer. Due to the potential for severe allergic responses, such patients should avoid this product.

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. If any changes in behavior accompanied by nausea and vomiting occur while using this product, it is imperative to consult a healthcare professional, as these symptoms may indicate the onset of this rare but serious condition.

Aspirin may provoke severe allergic reactions in some individuals. Symptoms of such reactions can include hives, wheezing, facial swelling, and shock. Immediate medical attention should be sought if any of these symptoms 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 individuals who are 60 years of age or older, have a history of stomach ulcers or bleeding disorders, are taking anticoagulants or steroid medications, are using other NSAIDs (including aspirin, ibuprofen, or naproxen), consume three or more alcoholic beverages daily, or exceed the recommended dosage or duration of use.

Healthcare professionals should advise patients to consult a doctor prior to use if any of the following conditions apply: a history of stomach problems such as heartburn, high blood pressure, heart disease, liver cirrhosis, kidney disease, or asthma; or if the patient is currently taking a diuretic. Additionally, it is recommended that patients seek guidance from a doctor or pharmacist if they are on prescription medications for gout, diabetes, or arthritis.

In the event of an accidental overdose, immediate medical assistance should be sought, or the Poison Control Center should be contacted without delay.

Patients should discontinue use and contact their healthcare provider if they experience any signs of stomach bleeding, such as feeling faint, vomiting blood, passing bloody or black stools, or experiencing persistent stomach pain. Other reasons to stop use include the occurrence of an allergic reaction, worsening pain that lasts more than 10 days, the presence of redness or swelling, the 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 adverse reactions associated with its use. Notably, 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. If patients experience changes in behavior accompanied by nausea and vomiting while using this product, they should consult a doctor immediately, as these symptoms may indicate the onset of Reye's syndrome.

Additionally, there is an allergy alert associated with this product. Aspirin may cause severe allergic reactions, which can manifest as hives, asthma (wheezing), facial swelling, or shock. Patients should seek immediate medical attention if they experience any signs of an allergic reaction.

The product contains a nonsteroidal anti-inflammatory drug (NSAID), which carries a warning for the potential of severe stomach bleeding. The risk of this adverse reaction is heightened in patients who are 60 years of age or older, have a history of stomach ulcers or bleeding problems, are taking blood-thinning medications or steroids, are using other NSAIDs (including aspirin, ibuprofen, or naproxen), consume three or more alcoholic drinks daily while using this product, or exceed the recommended dosage or duration of use.

Patients are 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. Furthermore, if an allergic reaction occurs, if pain worsens or lasts longer than 10 days, if redness or swelling is present, if any new symptoms arise, or if there is ringing in the ears or loss of hearing, patients should seek medical advice, as these could be indicative of serious conditions.

Drug Interactions

Aspirin has the potential to cause severe gastrointestinal bleeding, particularly when co-administered with anticoagulants or other nonsteroidal anti-inflammatory drugs (NSAIDs), such as ibuprofen or naproxen. The risk of bleeding is significantly heightened in patients taking these medications concurrently.

Additionally, caution is advised for patients who are on prescription medications for gout, diabetes, or arthritis. These drugs may interact with aspirin, and it is recommended that patients consult their healthcare provider to evaluate the potential for adverse interactions and to discuss appropriate management strategies. Monitoring and dosage adjustments may be necessary based on the specific medications involved and the patient's overall health status.

Packaging & NDC

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

Packaging configurations for Adult Low Dose 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 physician, as these may be early signs of Reye's syndrome.

For dosing, adults and children aged 12 years and older are directed to take 4 to 8 tablets every 4 hours while symptoms persist, with a maximum of 48 tablets in 24 hours unless otherwise directed by a physician. For children under 12 years of age, consultation with a physician is recommended prior to use.

Geriatric Use

Elderly patients, particularly those aged 60 and older, may have an increased risk of severe stomach bleeding. Healthcare providers should exercise caution when prescribing this medication to geriatric patients, considering the potential for heightened adverse effects.

It is advisable to closely monitor elderly patients for 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 in this population to ensure safe and effective use of the medication.

Pregnancy

Pregnant patients and those who are breastfeeding should consult a healthcare professional before using this medication. The use of aspirin during 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 before using this medication. It is particularly important to avoid the use of aspirin during the last three months of pregnancy, 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 should consult a healthcare professional prior to use, particularly if they have conditions such as high blood pressure, heart disease, liver cirrhosis, or kidney disease. It is essential to assess renal function and consider potential dosing adjustments or monitoring requirements based on the severity of renal impairment.

Hepatic Impairment

Patients with hepatic impairment should consult a healthcare professional prior to use, particularly if they have conditions such as liver cirrhosis. It is essential for these patients to receive appropriate evaluation and monitoring of their liver function to ensure safe use of the medication. Adjustments to dosage may be necessary based on the severity of hepatic impairment, and ongoing assessment of liver function is recommended throughout the treatment period.

Overdosage

In the event of an accidental 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 overdosage.

Healthcare professionals should be aware that the symptoms of overdose may vary depending on the specific 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 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 emergency protocols in the event of an overdose, ensuring the best possible outcomes for affected individuals.

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

Postmarketing experience has identified the following adverse reactions reported voluntarily or through surveillance programs: gastrointestinal bleeding and allergic reactions, which include hives, asthma (wheezing), facial swelling, and shock.

Patient Counseling

Healthcare providers should advise patients to seek immediate medical assistance or contact a Poison Control Center in the event of an accidental overdose. It is crucial to inform patients that they should not use this medication if they have a history of allergic reactions to aspirin or any other pain reliever or fever reducer.

Patients should be instructed to discontinue use 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. Additionally, they should stop use and seek medical advice if they notice any allergic reactions, if their pain worsens or lasts longer than 10 days, if there is any redness or swelling, or if new symptoms arise. Patients should also be made aware that ringing in the ears or loss of hearing could indicate a serious condition, warranting immediate medical consultation.

Healthcare providers should encourage patients to ask a doctor before using this medication if the warning regarding stomach bleeding applies to them. It is important to discuss any history of stomach problems, such as heartburn, as well as conditions like high blood pressure, heart disease, liver cirrhosis, or kidney disease. Patients with asthma should also be advised to consult a doctor prior to use. Furthermore, patients taking diuretics or prescription medications for gout, diabetes, or arthritis should be encouraged to speak with their doctor or pharmacist before starting this medication.

Storage and Handling

The product is supplied in a tamper-evident container. It should not be used if the safety seal under the cap is broken or missing.

For optimal storage, the product must be kept at room temperature, specifically within the range of 15° to 30°C. It is essential to avoid exposure to excess heat and moisture to maintain the integrity of the product.

Additional Clinical Information

The medication is administered orally, with specific dosing guidelines for different age groups. Adults and children aged 12 years and older are advised to take 4 to 8 tablets every 4 hours while symptoms persist, without exceeding 48 tablets in a 24-hour period unless directed otherwise by a physician. For children under 12 years, consultation with a physician is recommended prior to use.

Clinicians should counsel patients regarding the use of this medication during pregnancy and breastfeeding. It is particularly important to avoid aspirin in the last trimester of pregnancy unless explicitly directed by a healthcare professional, as it may pose risks to the unborn child or lead to complications during delivery.

Drug Information (PDF)

This file contains official product information for Adult Low Dose Aspirin, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)

Data Generation & Sources

This page was automatically generated and is maintained by the AllDrugs AI Data-Science Team. It was built from the FDA Structured Product Label (DailyMed) for Adult Low Dose 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.