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Aspirin

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Active ingredient
Aspirin 81 mg
Other brand names
Drug classes
Nonsteroidal Anti-inflammatory Drug, Platelet Aggregation Inhibitor
Dosage form
Tablet, Chewable
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, 2024
Drug Information (PDF)
Prescribing information, PDF file
Active ingredient
Aspirin 81 mg
Other brand names
Drug classes
Nonsteroidal Anti-inflammatory Drug, Platelet Aggregation Inhibitor
Dosage form
Tablet, Chewable
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, 2024
Manufacturer
Time-Cap Labs, Inc
Registration number
M013
NDC root
49483-334
Drug Information (PDF)
Prescribing information, PDF file
Packaging Info (3 NDCs)
Packaging & NDC Codes (3)

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

81 mg orange chewable aspirin is a medication commonly used for the temporary relief of minor aches and pains. You may take it as recommended by your doctor for various discomforts. If you're curious about other potential uses, it's a good idea to consult with your healthcare provider for more information.

Uses

You can use this medication for the temporary relief of minor aches and pains, such as headaches, muscle aches, or other discomforts. If you're considering using it for a different purpose, it's a good idea to ask your doctor for guidance on other potential uses, especially if you're looking at the 81 mg orange chewable aspirin option.

Rest assured, there are no known teratogenic effects (which means it doesn't cause birth defects) associated with this medication, making it a safer choice for many individuals. Always consult with your healthcare provider to ensure it's appropriate for your specific needs.

Dosage and Administration

When taking this medication, it's important to drink a full glass of water with each dose to help with absorption. For adults and children aged 12 years and older, you should take 4 to 8 tablets every 4 hours. However, make sure not to exceed 48 tablets in a 24-hour period unless your doctor advises otherwise.

If you are considering this medication for a child under 12 years old, it's essential to consult a doctor first to ensure it's safe and appropriate for their age and weight. Always follow these guidelines carefully to ensure safe and effective use of the medication.

What to Avoid

You should avoid using this product if you are allergic to aspirin or any other pain reliever or fever reducer. Additionally, if you have ever had an allergic reaction to this product or any of its ingredients, do not use it. It's also important to refrain from using this product for at least 7 days after having a tonsillectomy or oral surgery, unless your doctor specifically advises otherwise. Always prioritize your safety and consult with a healthcare professional if you have any questions or concerns.

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. 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 lead to severe stomach bleeding, especially if you are over 60, have a history of stomach ulcers, or are taking certain medications like blood thinners. If you experience symptoms such as feeling faint, vomiting blood, or having bloody or black stools, you should stop using the product and seek medical help immediately. Always consult your doctor if you have a history of stomach problems, high blood pressure, or other serious health conditions before using this product.

Warnings and Precautions

You should be aware of some important warnings and precautions when using this product. If you are a child or teenager recovering from chickenpox or flu-like symptoms, do not use this product, as it may lead to Reye’s syndrome, a serious condition. Additionally, be cautious of severe allergic reactions, which can include hives, facial swelling, asthma (wheezing), or shock. This product contains a nonsteroidal anti-inflammatory drug (NSAID), which can cause severe stomach bleeding, especially if you are over 60, have a history of stomach ulcers, or are taking certain medications like blood thinners or steroids.

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. If you experience any signs of an allergic reaction or stomach bleeding—such as feeling faint, vomiting blood, or having bloody or black stools—stop using the product and seek medical help immediately. In case of an overdose, contact a Poison Control Center at 1-800-222-1222 right away. Always follow the recommended dosage and duration of use to minimize risks.

Overdose

If you suspect an overdose, it’s crucial to seek medical help immediately. You can contact a Poison Control Center at 1-800-222-1222 for guidance. Signs of an overdose can vary, but they may include unusual drowsiness, confusion, or difficulty breathing.

Always err on the side of caution—if you notice any concerning symptoms or if you’re unsure, don’t hesitate to get help right away. 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 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 guidance from your doctor.

Pediatric Use

If you are considering this product for your child, it's important to be aware of some key 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 (a rare but serious illness). 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 Reye’s syndrome.

For children under 12 years old, it's essential to 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 necessary.

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, there is a higher chance of experiencing severe stomach bleeding when taking certain drugs. This risk is something you should discuss with your healthcare provider, especially if you have any existing health conditions or are taking other medications.

Always make sure to inform your doctor about your age and any concerns you may have regarding your treatment. They can help you understand the risks and adjust your medication plan to keep you safe and healthy.

Renal Impairment

If you have kidney problems, it's important to consult your doctor before using this medication. This is especially crucial if you also have high blood pressure, heart disease, or liver cirrhosis, as these conditions can affect how your body processes the medication. Your doctor will help determine if it's safe for you and may suggest adjustments to your dosage or additional monitoring to ensure your safety. Always prioritize open communication with your healthcare provider regarding your kidney health and any other medical conditions you may have.

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 of how certain medications can interact with each other. If you are taking other drugs that contain nonsteroidal anti-inflammatory drugs (NSAIDs), such as aspirin, ibuprofen, or naproxen, you may have an increased risk of stomach bleeding. Additionally, if you are on prescription medications for conditions like gout, diabetes, or arthritis, it's crucial to consult your healthcare provider to ensure your treatments are safe to use together.

While there are no specific laboratory test interactions noted, discussing all your medications and any tests you may undergo with your healthcare provider is essential. This helps to avoid any potential complications and ensures that you receive the best care possible. Always keep your doctor informed about what you are taking to maintain your health and safety.

Storage and Handling

To ensure the best performance of your product, store it at a temperature of 25°C (77°F). It can safely be kept within a range of 15°-30°C (59°-86°F) for short periods. Always check the expiration date on the package and use the product before this date to guarantee its effectiveness.

When handling the product, make sure to maintain a clean environment to avoid contamination. Following these guidelines will help you use the product safely and effectively.

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 81 mg orange chewable aspirin used for?

It is used for the temporary relief of minor aches and pains or as recommended by your doctor.

How should I take 81 mg orange chewable aspirin?

Adults and children 12 years and over should take 4 to 8 tablets every 4 hours, not exceeding 48 tablets in 24 hours unless directed by a doctor. Drink a full glass of water with each dose.

Are there any contraindications for using this aspirin?

Do not use if you are allergic to aspirin or any other pain reliever/fever reducer, or if you have had an allergic reaction to this product or its ingredients.

What should I do if I experience an allergic reaction?

Seek medical help right away if you experience symptoms of an allergic reaction, such as hives, facial swelling, or difficulty breathing.

Can children use 81 mg orange chewable aspirin?

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

What are the warnings associated with this medication?

Warnings include the risk of severe stomach bleeding, especially if you are over 60, have a history of stomach problems, or are taking other NSAIDs.

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

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

Is it safe to use this aspirin during pregnancy?

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

How should I store 81 mg orange chewable aspirin?

Store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F). Use by the expiration date on the package.

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

No specific description details are available for SPL code 34089-3.

Uses and Indications

This drug is indicated for the temporary relief of minor aches and pains, or as recommended by a healthcare professional. Healthcare providers may also consider other potential uses for the 81 mg orange chewable aspirin 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 for optimal efficacy.

For adults and children aged 12 years and older, the recommended dosage is 4 to 8 tablets every 4 hours. The total daily dosage must not exceed 48 tablets within a 24-hour period unless otherwise directed by a healthcare professional.

For children under 12 years of age, it is advised to consult a physician for appropriate dosing recommendations.

Contraindications

Use of this product is contraindicated in the following situations:

Patients with a known allergy to aspirin or any other pain reliever or fever reducer should not use this product due to the risk of severe allergic reactions. Additionally, the product should not be administered for at least 7 days following a tonsillectomy or oral surgery unless specifically directed by a healthcare professional, as this may increase the risk of complications. Furthermore, individuals who have previously experienced an allergic reaction to this product or any of its ingredients should avoid its use to prevent potential adverse effects.

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, facial swelling, asthma (wheezing), and shock. Healthcare professionals should be vigilant for these signs and advise patients to seek immediate medical attention if they occur.

This product contains a nonsteroidal anti-inflammatory drug (NSAID), which carries a risk of severe stomach bleeding. The likelihood of this adverse effect is increased in patients who are 60 years of age or older, have a history of stomach ulcers or bleeding 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 providers should advise patients to consult a physician prior to 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, or kidney disease. Additionally, patients taking diuretics or those with asthma should seek medical advice before use.

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

Patients should discontinue use and contact their healthcare provider if they experience any signs of an allergic reaction, such as hives or swelling. They should also seek medical attention if they notice any symptoms indicative of stomach bleeding, including feeling faint, vomiting blood, passing bloody or black stools, or experiencing persistent stomach pain. Furthermore, if pain worsens or lasts longer than 10 days, if fever intensifies or persists beyond three days, if redness or swelling occurs, if new symptoms arise, or if there is ringing in the ears or loss of hearing, patients should stop taking the product and consult their doctor.

Side Effects

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

Reye’s syndrome is a rare but serious condition 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 exhibit changes in behavior accompanied by nausea and vomiting while using this product, they should consult a healthcare professional immediately, as these symptoms could indicate the onset of Reye’s syndrome.

Severe allergic reactions to aspirin may occur, presenting as hives, facial swelling, asthma (wheezing), or shock. Patients experiencing any signs of an allergic reaction should seek medical attention promptly.

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, 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 should 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, if pain worsens or lasts longer than 10 days, fever intensifies or persists beyond three days, redness or swelling occurs, new symptoms arise, or there is ringing in the ears or loss of hearing, medical advice should be sought.

Before using this product, patients should consult a healthcare provider if they have a history of stomach problems, such as heartburn, or if they have high blood pressure, heart disease, liver cirrhosis, or kidney disease. Those taking diuretics or with a history of asthma should also seek medical advice prior to use.

Patients should not use this product if they are allergic to aspirin or any other pain reliever or fever reducer. Furthermore, it is advised that this product not be used for at least seven days following a tonsillectomy or oral surgery unless directed by a healthcare professional.

Drug Interactions

Co-administration of this medication with other drugs containing prescription or nonprescription nonsteroidal anti-inflammatory drugs (NSAIDs), such as aspirin, ibuprofen, or naproxen, may elevate the risk of gastrointestinal bleeding. It is advisable for patients to consult their healthcare provider if they are concurrently taking prescription medications for conditions such as gout, diabetes, or arthritis to ensure safe and effective use.

No specific interactions with laboratory tests have been identified in the available data.

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, a healthcare professional should be consulted, as these may be early signs of Reye’s syndrome.

For children under 12 years of age, it is advised to consult a doctor before 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 healthcare professional.

Geriatric Use

Elderly patients, particularly those aged 60 and older, are at an increased risk of severe stomach bleeding. This heightened risk necessitates careful consideration when prescribing medications that may contribute to gastrointestinal bleeding.

Healthcare providers should closely monitor geriatric patients for any signs of gastrointestinal distress or bleeding, especially when initiating treatment or adjusting dosages. It is advisable to evaluate the overall health status and concurrent medications of elderly patients to mitigate potential adverse effects.

Due to these safety considerations, dosage adjustments may be warranted based on the individual patient's health profile and response to therapy. Regular assessment and vigilant monitoring are essential to ensure the safe use of medications 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 if they are pregnant or breastfeeding. It is particularly important to avoid the use of aspirin during the last three months of pregnancy unless specifically directed by a healthcare provider, 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.

Renal Impairment

Patients with renal impairment should consult a healthcare professional prior to use, particularly if they have comorbid 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 degree 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 overdose, it is imperative to seek immediate medical assistance. Healthcare professionals are advised to contact a Poison Control Center at 1-800-222-1222 for guidance on managing the situation effectively.

Prompt intervention is crucial to mitigate potential adverse effects associated with an overdose. Symptoms may vary depending on the substance involved, and healthcare providers should be prepared to assess and manage these symptoms accordingly.

Management procedures may include supportive care and symptomatic treatment, tailored to the specific clinical presentation of the patient. Continuous monitoring and evaluation are essential to ensure patient safety and to address any complications that may arise during the course of treatment.

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

Postmarketing experience has identified several adverse reactions reported voluntarily or through surveillance programs. These include allergic reactions such as hives, facial swelling, asthma (wheezing), and shock. Additionally, cases of stomach bleeding have been noted, particularly in individuals aged 60 or older, those with a history of stomach ulcers or bleeding problems, patients taking blood thinners or steroid medications, individuals consuming three or more alcoholic drinks daily, or those exceeding the recommended dosage.

Furthermore, there have been reports of Reye’s syndrome in children and teenagers who have or are recovering from chickenpox or flu-like symptoms.

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 at 1-800-222-1222. Patients should be made aware of the potential seriousness of an overdose and the importance of prompt action in such situations.

Storage and Handling

The product is supplied in various package configurations, with specific NDC numbers available upon request. It should be stored at a controlled room temperature of 25°C (77°F). Temporary excursions are permissible within the range of 15° to 30°C (59° to 86°F). It is essential to adhere to the expiration date indicated on the package to ensure product efficacy and safety.

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 additional information is available regarding laboratory tests, abuse potential, or postmarketing experience.

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.