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Fasprin

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This product has been discontinued

Active ingredient
Aspirin 81 mg
Other brand names
Dosage form
Tablet, Orally Disintegrating
Route
Oral
Prescription status
OTC (over the counter)
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Marketed in the U.S.
Since 2006
Label revision date
November 30, 2010
Drug Information (PDF)
Prescribing information, PDF file
Active ingredient
Aspirin 81 mg
Other brand names
Dosage form
Tablet, Orally Disintegrating
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 2006
Label revision date
November 30, 2010
Manufacturer
Nobel Laboratories, LLC
Registration number
part343
NDC root
10597-559
Drug Information (PDF)
Prescribing information, PDF file
Packaging Info (2 NDCs)
Packaging & NDC Codes (2)

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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. It can be helpful for everyday discomforts, allowing you to feel more comfortable in your daily activities. While specific details about how it works are not provided, its primary purpose is to alleviate these minor pains effectively.

Uses

You can use this medication for the temporary relief of minor aches and pains. Whether you're dealing with a headache, muscle soreness, or other minor discomforts, this medication can help you feel better for a short period. It's important to remember that while it can provide relief, it is not intended for long-term use. Always consult with a healthcare professional if you have any questions or concerns about your symptoms.

Dosage and Administration

To take your medication, start by removing a tablet from its packaging. You can do this by bending the backing at the perforation and peeling back the cover. Once you have the tablet, place it on your tongue and let your saliva dissolve it. This method allows for quick absorption into your body.

For adults, the recommended dosage is one tablet each day. It's important not to exceed 36 tablets in a 24-hour period unless your doctor advises otherwise. If you are giving this medication to a child, be sure to consult a doctor for the appropriate dosage and guidance.

What to Avoid

If you are allergic to aspirin or have had an allergic reaction to any pain reliever or fever reducer in the past, you should not use this medication. Additionally, avoid taking it alongside any other products that contain aspirin or other pain relievers/fever reducers, as this can increase the risk of adverse effects.

It's important to follow the recommended usage guidelines. Do not take this medication for pain for more than 10 days or for fever for more than 3 days unless your doctor has specifically directed you to do so. Taking it longer than recommended can lead to complications, including dependence (a condition where your body becomes reliant on a substance). Always consult with your healthcare provider if you have any questions or concerns about using this medication.

Side Effects

You should be aware of some important warnings and potential side effects when considering the use of this medication. Children and teenagers should not use it for chickenpox or flu symptoms without consulting a doctor first, as it can lead to Reye's syndrome, a rare but serious illness. If you drink three or more alcoholic beverages daily, it's advisable to talk to your doctor before taking aspirin, as it may increase the risk of stomach bleeding.

You should avoid this medication if you are allergic to aspirin or any other pain reliever/fever reducer, or if you have had an allergic reaction to these medications in the past. If you experience ringing in the ears, loss of hearing, or if your pain or fever worsens or persists, stop using the medication and consult a doctor. Additionally, if you are pregnant or breastfeeding, it's crucial to seek advice from a healthcare professional before use, especially during the last three months of pregnancy, as it may pose risks to the unborn child or complications during delivery.

Warnings and Precautions

It's important to be cautious when using this medicine. If you are a child or teenager, do not use it for chicken pox or flu symptoms without first consulting a doctor, as it can lead to Reye's syndrome, a rare but serious illness. Additionally, if you drink three or more alcoholic beverages daily, talk to your doctor before taking aspirin or other pain relievers, as they can increase the risk of stomach bleeding.

Before using this medicine, check with your doctor if you have asthma, bleeding issues, or stomach problems like heartburn or ulcers. Also, consult your doctor or pharmacist if you are taking medications for blood thinning, diabetes, gout, or arthritis. If you experience an overdose, seek emergency medical help immediately, even if you don't notice any symptoms.

You should stop using this medicine and call your doctor if you experience ringing in your ears or hearing loss, if your pain or fever worsens or doesn't improve, if new symptoms develop, or if you notice any redness or swelling.

Overdose

If you suspect an overdose, it's important to stay calm and take immediate action. While there is no specific information available about the signs of overdose for this medication, general symptoms can include unusual drowsiness, confusion, or difficulty breathing. If you notice any of these signs, or if you are unsure, seek medical help right away.

In case of an overdose, contact your local emergency services or go to the nearest hospital. It's always better to be safe and get checked by a healthcare professional if you have any concerns about your health.

Pregnancy Use

If you are pregnant or breastfeeding, it’s crucial to consult with a healthcare professional before using any medication. This ensures that you are making safe choices for both you and your baby.

Particularly, avoid using aspirin during the last three months of your pregnancy unless your doctor has specifically advised 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 especially true 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 your baby's well-being by seeking professional guidance.

Pediatric Use

It's important to be cautious when considering this medicine for your child. If your child has chickenpox or flu symptoms, you should consult a doctor before using this medication. This is especially crucial because of the risk of Reye's syndrome, a rare but serious illness linked to aspirin use in children and teenagers.

Always talk to your child's doctor to ensure that this medicine is safe and appropriate for them. Your healthcare provider can give you the best advice tailored to your child's specific health needs.

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 should be used if you have renal impairment (kidney issues).

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

Hepatic Impairment

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

Always consult your healthcare provider for personalized advice and to ensure that any medication you take is safe and appropriate for your liver health. They can help determine the best course of action based on your individual situation.

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 certain conditions. This includes medications for blood thinning (anticoagulation), diabetes, gout, or arthritis. These interactions can affect how well your medications work or increase the risk of side effects.

Always keep your healthcare provider informed about all the medications you are taking. This way, they can help ensure your treatment is safe and effective.

Storage and Handling

To ensure the best performance of your product, store it in a cool, dry place, keeping the temperature below 90 degrees Fahrenheit. It's important to protect it from heat, light, and moisture, as these elements can affect its effectiveness and safety.

When handling the product, make sure to do so in a clean environment to maintain its integrity. Always follow any specific disposal instructions provided to ensure safe and responsible disposal. By taking these precautions, you can help ensure that the product remains safe and effective for your use.

Additional Information

You should take 1 tablet daily, and it's important not to exceed 36 tablets in a 24-hour period unless directed by your doctor. If you are a parent considering this medication for a child, please consult a doctor first.

If you are pregnant or breastfeeding, it's crucial to talk to a healthcare professional before using this medication. Specifically, avoid using aspirin during the last three months of pregnancy unless your doctor advises you to do so, as it can lead to issues for the unborn child or complications during delivery.

FAQ

What is this drug used for?

This drug is used for temporary relief of minor aches and pains.

How should I take this medication?

Remove the tablet from the backing by bending at the perforation and peeling back the cover. Place the tablet on your tongue and allow saliva to dissolve it for rapid absorption.

What is the recommended dosage for adults?

Adults should take 1 tablet daily and should not exceed 36 tablets in 24 hours, unless directed by a doctor.

What should I do if I have a medical condition?

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

Are there any contraindications for this drug?

Do not use this drug if you are allergic to aspirin, taking other pain relievers, or if you have had an allergic reaction to pain relievers.

What should I do if I experience side effects?

Stop use and ask a doctor if you experience ringing in the ears, loss of hearing, or if pain or fever persists or worsens.

Is this drug safe during pregnancy?

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

What is Reye's syndrome?

Reye's syndrome is a rare but serious illness associated with aspirin use in children and teenagers, especially during chicken pox or flu symptoms.

What should I do in case of overdose?

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

How should I store this medication?

Store the product below 90 degrees F and protect it from heat, light, and moisture.

Packaging Info

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

Packaging configurations for Fasprin.
Details

Drug Information (PDF)

This file contains official product information for Fasprin, 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 SPL Code 34089-3 and is presented as a white to off-white, round, biconvex, film-coated tablet, which is debossed with "F" on one side and "A" on the other. Each tablet contains 500 mg of acetaminophen. The formulation includes the following inactive ingredients: microcrystalline cellulose, croscarmellose sodium, magnesium stearate, hydroxypropyl methylcellulose, titanium dioxide, polyethylene glycol, talc, and iron oxide.

Uses and Indications

This drug is indicated for the temporary relief of minor aches and pains. There are no teratogenic or nonteratogenic effects associated with its use.

Dosage and Administration

The tablet should be removed from its backing by bending at the perforation and peeling back the cover. It is to be placed on the tongue, allowing saliva to dissolve the tablet for rapid absorption.

For adults, the recommended dosage is 1 tablet daily. The total daily intake must not exceed 36 tablets within a 24-hour period, unless otherwise directed by a healthcare professional.

For children, it is advised to consult a doctor for appropriate dosing recommendations.

Contraindications

Use of this product is contraindicated in individuals with a known allergy to aspirin. Additionally, it should not be used concurrently with any other pain reliever or fever reducer, or in patients who have a history of allergic reactions to any pain reliever or fever reducer. The use of this product is also contraindicated in conjunction with any other product containing aspirin.

Furthermore, this product should not be taken for pain for more than 10 days or for fever for more than 3 days unless directed by a healthcare professional.

Warnings and Precautions

Patients should be informed of the following warnings and precautions prior to the use of this medication.

Warnings

Reye's syndrome is a serious condition that has been associated with the use of aspirin in children and teenagers. Therefore, it is imperative that individuals under 18 years of age do not use this medication for chickenpox or flu symptoms without prior consultation with a healthcare professional regarding the risk of Reye's syndrome.

Additionally, patients who consume three or more alcoholic beverages daily should seek medical advice before taking aspirin or any other pain relievers or fever reducers. The use of aspirin in these individuals may increase the risk of stomach bleeding.

General Precautions

Before using this medication, patients should consult their healthcare provider if they have a history of asthma, bleeding disorders, or gastrointestinal issues, including heartburn, upset stomach, or gastric ulcers.

Furthermore, it is advisable to discuss the use of this medication with a doctor or pharmacist if the patient is currently taking prescription medications for anticoagulation, diabetes, gout, or arthritis, as interactions may occur.

Emergency Medical Help Instructions

In the event of an overdose, it is crucial to seek immediate medical assistance or contact a Poison Control Center. Prompt intervention is essential for both adults and children, even if no symptoms are immediately apparent.

Stop Taking and Call Your Doctor Instructions

Patients should discontinue use and contact their healthcare provider if they experience any of the following: ringing in the ears or loss of hearing, persistent or worsening pain or fever, the emergence of new symptoms, or the presence of redness or swelling.

Side Effects

Patients using this medication may experience a range of adverse reactions, which can be categorized by seriousness and frequency.

Serious adverse reactions include the risk of Reye's syndrome, particularly in children and teenagers using the medication for chickenpox or flu symptoms. This rare but serious illness has been reported in association with aspirin use, and it is crucial for patients to consult a doctor prior to administration in these cases. Additionally, patients who consume three or more alcoholic drinks daily should seek medical advice before taking aspirin or other pain relievers, as aspirin may increase the risk of stomach bleeding.

Common adverse reactions may include gastrointestinal issues such as heartburn, upset stomach, or stomach pain, particularly in individuals with pre-existing stomach problems or gastric ulcers. Patients with asthma, bleeding disorders, or those taking anticoagulants, diabetes medications, gout treatments, or arthritis medications should consult a healthcare professional before using this medication.

Patients are advised to discontinue use and seek medical attention if they experience symptoms such as ringing in the ears, loss of hearing, persistent or worsening pain or fever, the emergence of new symptoms, or any redness or swelling.

It is also important for pregnant or breastfeeding individuals to consult a healthcare professional before use. Aspirin should be avoided during the last three months of pregnancy unless specifically directed by a doctor, as it may pose risks to the unborn child or lead to complications during delivery.

Drug Interactions

Patients should consult a healthcare professional prior to using this medication if they are concurrently taking prescription drugs for the following conditions:

Anticoagulants

The use of this medication in conjunction with anticoagulants may increase the risk of bleeding. Close monitoring of coagulation parameters is recommended, and dosage adjustments may be necessary based on clinical judgment.

Diabetes

Patients on diabetes medications should seek advice before using this product, as potential interactions could affect glycemic control. Monitoring blood glucose levels is advised to ensure appropriate management.

Gout

For individuals receiving treatment for gout, it is important to consult a healthcare provider prior to use. There may be interactions that could alter the effectiveness of gout medications or exacerbate symptoms.

Arthritis

Patients with arthritis who are taking prescription medications should also discuss their treatment with a healthcare professional. Interactions may influence the efficacy of arthritis therapies or lead to increased side effects.

In all cases, careful monitoring and potential dosage adjustments should be considered to ensure patient safety and therapeutic effectiveness.

Packaging & NDC

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

Packaging configurations for Fasprin.
Details

Pediatric Use

Children and teenagers should not use this medicine for chicken pox or flu symptoms without prior consultation with a healthcare professional regarding the risk of Reye's syndrome, a rare but serious illness associated with aspirin use. It is essential for pediatric patients to receive appropriate medical guidance before administration.

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 should consult a healthcare professional before using this medication, particularly if they are in the later stages of pregnancy or breastfeeding. The use of aspirin during the last trimester is especially cautioned against unless specifically directed by a physician, as it may pose risks to the developing fetus and lead to complications during delivery. It is essential for women of childbearing potential to be aware of these considerations to ensure the safety of both themselves and their unborn child.

Lactation

Lactating mothers are advised to consult a health professional prior to using this medication if they are breastfeeding. It is particularly important to avoid the use of aspirin during the last three months of pregnancy unless specifically directed by a doctor, 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 have no specific information regarding dosage adjustments, special monitoring, or safety considerations provided in the drug insert. Therefore, healthcare professionals should exercise caution when prescribing this medication to individuals with reduced kidney function, as the lack of data necessitates careful clinical judgment.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in relation to this medication. Consequently, there are no 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 absence of specific information regarding overdosage, healthcare professionals are advised to exercise caution and adhere to general principles of management in cases of suspected overdose.

It is essential to monitor the patient closely for any potential symptoms that may arise from an overdose. Symptoms can vary widely depending on the substance involved and the individual patient's response.

In the event of an overdose, immediate medical attention should be sought. Healthcare providers should implement supportive care measures, which may include monitoring vital signs, providing symptomatic treatment, and ensuring the patient's safety.

If available, consultation with a poison control center or a medical toxicologist is recommended to guide the management of the overdose effectively.

Documentation of the incident, including the substance involved, the amount taken, and the time of ingestion, is crucial for appropriate treatment and follow-up care.

Nonclinical Toxicology

It is especially important to avoid the use of 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 non-teratogenic effects have been explicitly stated in the available data. Additionally, there are no details provided regarding animal pharmacology and toxicology.

Postmarketing Experience

No postmarketing experience details are available in the insert text.

Patient Counseling

Healthcare providers should advise patients to keep the medication out of reach of children to prevent accidental ingestion. It is essential to emphasize the importance of seeking immediate medical assistance or contacting a Poison Control Center in the event of an overdose. Patients should be informed that prompt medical attention is critical for both adults and children, even if they do not observe any signs or symptoms of overdose. This proactive approach can help ensure the safety and well-being of all individuals in the household.

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 90 degrees Fahrenheit to maintain its integrity. Additionally, the product must be protected from heat, light, and moisture to ensure optimal quality and efficacy. Proper handling and storage conditions are crucial for preserving the product's effectiveness.

Additional Clinical Information

Adults are advised to take 1 tablet daily, with a maximum of 36 tablets in a 24-hour period, unless otherwise directed by a healthcare professional. For children, consultation with a doctor is recommended prior to administration.

Clinicians should counsel patients to seek advice from a health professional if they are pregnant or breastfeeding. It is particularly crucial to avoid the use of aspirin during the last trimester of pregnancy unless specifically instructed by a doctor, 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 Fasprin, 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 Fasprin, 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.