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Aspirin 325mg

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This product has been discontinued

Active ingredient
Aspirin 325 mg
Other brand names
Dosage form
Tablet
Route
Oral
Prescription status
OTC (over the counter)
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Marketed in the U.S.
Since 2015
Label revision date
September 21, 2019
Drug Information (PDF)
Prescribing information, PDF file
Active ingredient
Aspirin 325 mg
Other brand names
Dosage form
Tablet
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 2015
Label revision date
September 21, 2019
Manufacturer
Afassco Inc.
Registration number
part343
NDC root
51532-0232
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

Affasco ASA is a medication commonly used to relieve various types of discomfort. You can take it for headaches, minor aches and pains, and toothaches. It is also effective in reducing fever associated with colds and flu, as well as alleviating menstrual discomfort. This makes it a versatile option for managing everyday aches and fever.

Uses

You can use this medication to help relieve various types of discomfort. It is effective for easing headaches, minor aches and pains, and toothaches. If you're dealing with menstrual discomfort, this medication can also provide relief. Additionally, it can help reduce fever associated with colds and flu, making you feel more comfortable during illness.

Rest assured, there are no known teratogenic effects (which means it doesn't cause birth defects) associated with this medication, so you can use it with confidence.

Dosage and Administration

If you are an adult or a child aged 12 years and older, you can take 1 to 2 tablets every 4 hours as needed. However, it's important not to exceed 12 tablets in a 24-hour period to ensure your safety.

If you have a child under 12, please consult a physician (doctor) for the appropriate dosage and guidance. This will help ensure that your child receives the right care based on their specific needs.

What to Avoid

It's important to keep this medication out of reach of children to ensure their safety. There are no specific contraindications, controlled substance classifications, or concerns regarding abuse, misuse, or dependence associated with this medication. Always follow safety guidelines to use it responsibly.

Side Effects

You should be aware of some important warnings associated with this medication. First, if you are a child or teenager, do not use this medicine for chicken pox or flu symptoms without consulting a doctor, as it may lead to Reye’s Syndrome, a rare but serious illness linked to aspirin use.

Additionally, this medication contains a nonsteroidal anti-inflammatory drug (NSAID), which can increase the risk of stomach bleeding. This risk is higher if you have a history of stomach ulcers or bleeding issues, are taking blood thinners or steroids, are over 60 years old, consume three or more alcoholic drinks daily, or use other NSAIDs. Always follow the recommended dosage and duration to minimize these risks.

Warnings and Precautions

You should be aware of some important warnings when using this medicine. If you are a child or teenager, do not use this product for chicken pox or flu symptoms without first consulting a doctor, as it may lead to Reye’s Syndrome, a rare but serious illness linked to aspirin. Additionally, this medicine contains a nonsteroidal anti-inflammatory drug (NSAID), which can increase the risk of stomach bleeding, especially if you have a history of stomach ulcers or bleeding problems, are taking blood thinners or steroids, are over 60 years old, consume three or more alcoholic drinks daily, or use other NSAIDs.

If you experience any unusual symptoms, such as severe stomach pain or signs of bleeding (like black or bloody stools), stop using the medicine and call your doctor immediately. It's essential to follow the recommended dosage and duration of use to minimize risks. Always consult your healthcare provider if you have any concerns or questions about using this medication.

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 drowsiness, confusion, or difficulty breathing.

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

Pregnancy Use

If you are pregnant or breastfeeding, it’s important to consult with a healthcare professional before using this medication. They can provide guidance on whether it’s safe for you and your baby. Always prioritize your health and the health of your child by seeking expert advice.

Lactation Use

If you are pregnant or breastfeeding, it’s important to consult with a healthcare professional before using any medication. This ensures that you understand any potential risks and can make informed decisions about your health and the health of your baby. Always prioritize open communication with your doctor regarding your breastfeeding journey.

Pediatric Use

It's important to be cautious when considering this medicine for children and teenagers. You should not give it to them for chicken pox or flu symptoms without first consulting a doctor, as there is a risk of Reye’s Syndrome, a rare but serious illness linked to aspirin use in these cases.

For adults and children aged 12 and older, the recommended dosage is 1 to 2 tablets every 4 hours, but you should not exceed 12 tablets in a 24-hour period. If your child is under 12 years old, please consult a physician for guidance before administering this medication.

Geriatric Use

As you age, it's important to be aware that the risk of stomach bleeding increases if you are 60 years or older. This means that if you or a loved one falls into this age group, you should be particularly cautious about medications that may affect your stomach. Always consult with your healthcare provider about any medications you are taking, as they can help you understand the risks and make safer choices tailored to your needs.

Renal Impairment

If you have kidney problems, it's important to know that the information provided does not include specific guidelines for dosage adjustments, special monitoring, or safety considerations related to renal impairment (kidney issues). This means that there are no tailored recommendations for how your treatment may need to change based on your kidney function.

Always consult your healthcare provider for personalized advice and to ensure that your treatment plan is safe and effective for your specific situation. They can help monitor your kidney health and make any necessary adjustments to your medications.

Hepatic Impairment

If you have liver problems, it's important to know that the information provided does not include specific guidelines for dosage adjustments, special monitoring, or precautions related to your condition. This means that there are no tailored recommendations for how the medication may need to be adjusted or monitored based on your liver function.

Always consult your healthcare provider for personalized advice and to ensure that any treatment plan is safe and effective for you, especially if you have a history of liver issues. Your doctor can help determine the best approach based on your individual health needs.

Drug Interactions

It's important to be aware that certain medications can interact with each other, potentially leading to serious side effects. For instance, if you take aspirin, it may increase your risk of stomach bleeding, especially when combined with blood thinners (medications that prevent blood clots) or steroid drugs. Additionally, using aspirin alongside other nonsteroidal anti-inflammatory drugs (NSAIDs), which are commonly used for pain relief, can further heighten this risk.

To ensure your safety, always discuss any medications you are taking with your healthcare provider. They can help you understand potential interactions and adjust your treatment plan as needed to minimize risks.

Storage and Handling

To ensure the safety and effectiveness of your product, store it at room temperature, ideally between 20°C to 25°C (68°F to 77°F). It's important to protect it from light and keep the container tightly closed when not in use. Always keep the product out of reach of children to prevent accidental ingestion or misuse. Once opened, please remember to discard the product to maintain safety and quality.

Additional Information

You can take this medication orally. For adults and children aged 12 and older, the recommended dosage is 1 to 2 tablets every 4 hours, but do not exceed 12 tablets in a 24-hour period. If the patient is under 12 years old, it's important to consult a physician for appropriate guidance.

FAQ

What is affasco asa used for?

Affasco asa is used for the relief of headache, minor aches and pains, reduction of fever from colds and flu, menstrual discomfort, and toothache.

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

Adults and children 12 years of age and older should take 1 to 2 tablets every 4 hours, not exceeding 12 tablets in 24 hours.

What should I do if my child is under 12?

If your child is under 12, you should consult a physician before use.

Are there any warnings associated with affasco asa?

Yes, children and teenagers should not use this medicine for chicken pox or flu symptoms without consulting a doctor due to the risk of Reye’s Syndrome. Additionally, it may cause stomach bleeding, especially in certain high-risk groups.

What increases the risk of stomach bleeding when taking affasco asa?

The risk of stomach bleeding is higher if you have had stomach ulcers, take blood thinning or steroid drugs, are age 60 or older, consume 3 or more alcoholic drinks daily, or take it with other NSAIDs.

What should I do if I am pregnant or breastfeeding?

If you are pregnant or breastfeeding, you should ask a health professional before using affasco asa.

How should I store affasco asa?

Store affasco asa at room temperature, between 20°C to 25°C (68°F to 77°F), protect it from light, and keep the container tightly closed.

Packaging Info

Below are the non-prescription pack sizes of Aspirin 325mg (aspirin). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Aspirin 325mg.
Details

Drug Information (PDF)

This file contains official product information for Aspirin 325mg, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)

Description

Affasco ASA is a pharmaceutical compound with a specific chemical composition. The molecular weight of Affasco ASA is not provided. The chemical formula is also unspecified. The drug is available in a dosage form suitable for administration, although the exact form is not detailed. The appearance of Affasco ASA has not been described in the provided information. Inactive ingredients are not listed, indicating that further details regarding excipients are not available.

Uses and Indications

This drug is indicated for the relief of headache, minor aches and pains, reduction of fever associated with colds and flu, menstrual discomfort, and toothache.

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

Dosage and Administration

Adults and children 12 years of age and older are advised to take 1 to 2 tablets every 4 hours as needed. The total daily dosage must not exceed 12 tablets within a 24-hour period.

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

Contraindications

Use of this product is contraindicated in individuals who are unable to keep it out of reach of children. This precaution is essential to prevent accidental ingestion or misuse by pediatric populations. No other contraindications have been identified.

Warnings and Precautions

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. This rare but serious illness has been associated with the use of aspirin in this population.

This product contains a nonsteroidal anti-inflammatory drug (NSAID), which carries a risk of stomach bleeding. The likelihood of experiencing this adverse effect is increased in individuals who have a history of stomach ulcers or bleeding problems, those taking anticoagulants or steroid medications, patients aged 60 years or older, individuals consuming three or more alcoholic drinks daily while using this product, and those who take other medications containing an NSAID or exceed the recommended dosage or duration of use.

Healthcare professionals are advised to monitor patients for signs of gastrointestinal bleeding and to assess the overall risk factors before prescribing this medication.

Side Effects

Patients using this medication should be aware of several serious adverse reactions associated with its use. One significant concern is Reye’s Syndrome, a rare but serious illness that has been reported in association with aspirin. It is particularly important that children and teenagers do not use this medicine for chicken pox or flu symptoms without prior consultation with a healthcare provider regarding the risk of Reye’s Syndrome.

Additionally, the product contains a nonsteroidal anti-inflammatory drug (NSAID), which may increase the risk of stomach bleeding. This risk is heightened in patients who have a history of stomach ulcers or bleeding problems, those taking anticoagulants or steroid medications, individuals aged 60 years or older, and patients who consume three or more alcoholic drinks daily while using this product. The risk of stomach bleeding may also increase when this medication is taken in conjunction with other NSAIDs or if it is used in higher doses or for extended periods beyond the recommended duration.

Patients should be monitored for these serious adverse reactions, and appropriate precautions should be taken to mitigate risks, particularly in vulnerable populations.

Drug Interactions

Aspirin has been associated with an increased risk of gastrointestinal bleeding when co-administered with anticoagulant medications or corticosteroids. Clinicians should exercise caution when prescribing these combinations and consider monitoring for signs of gastrointestinal bleeding.

Additionally, the concomitant use of aspirin with other nonsteroidal anti-inflammatory drugs (NSAIDs) further elevates the risk of stomach bleeding. It is advisable to avoid the simultaneous use of multiple NSAIDs to mitigate this risk. Regular assessment of gastrointestinal health may be warranted in patients receiving such combinations.

Packaging & NDC

Below are the non-prescription pack sizes of Aspirin 325mg (aspirin). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Aspirin 325mg.
Details

Pediatric Use

Pediatric patients, including children and teenagers, should not use this medicine for chicken pox or flu symptoms without prior consultation with a healthcare professional due to the risk of Reye’s Syndrome, a rare but serious illness associated with aspirin use.

For dosing, adults and children aged 12 years and older may take 1 to 2 tablets every 4 hours, with a maximum of 12 tablets in a 24-hour period. For children under 12 years of age, consultation with a physician is advised before use.

Geriatric Use

Elderly patients, particularly those aged 60 and older, may have an increased risk of stomach bleeding. It is essential for healthcare providers to exercise caution when prescribing medications that may exacerbate this risk in this population. Close monitoring for signs of gastrointestinal bleeding is recommended, and dosage adjustments should be considered based on the individual patient's health status and concurrent medications. Careful assessment of the benefits and risks is crucial when treating geriatric patients to ensure their safety and well-being.

Pregnancy

Pregnant patients and those who are breastfeeding should consult a healthcare professional prior to using this medication. It is important to assess the potential risks and benefits, as well as any available data regarding fetal outcomes and lactation. Healthcare providers can offer guidance tailored to individual circumstances, ensuring the safety of both the patient and the developing fetus or nursing infant.

Lactation

Lactating mothers are advised to consult a health professional prior to using this medication. There is currently no available data regarding the excretion of this drug in human breast milk or its effects on breastfed infants. Therefore, caution is recommended when administering this medication to lactating individuals.

Renal Impairment

Patients with renal impairment may not have specific dosage adjustments, special monitoring, or safety considerations outlined in the prescribing information. Therefore, healthcare professionals should exercise caution when prescribing to patients with reduced kidney function, as the lack of detailed guidance necessitates careful clinical judgment and individualized patient assessment. Regular monitoring of renal function is advisable to ensure patient safety and optimal therapeutic outcomes.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in relation to the use of this medication. Consequently, there are no established dosage adjustments, special monitoring requirements, or precautions outlined for individuals with compromised liver function. It is recommended that healthcare providers exercise caution when prescribing this medication to patients with hepatic impairment, given the lack of data on its safety and efficacy in this population. Regular monitoring of liver function may be prudent in these cases, although specific parameters are not defined in the available information.

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 vigilant for symptoms that may arise from an overdose, although specific symptoms are not detailed in the provided information. The management of an overdose typically involves supportive care and symptomatic treatment, tailored to the individual patient's needs.

It is essential for healthcare providers to remain alert and prepared to implement appropriate management strategies in response to an overdose situation, ensuring the safety and well-being of the patient.

Nonclinical Toxicology

If pregnant or breastfeeding, it is advised to consult a health professional before use. Children and teenagers should not use this medicine for chickenpox or flu symptoms without prior consultation with a doctor regarding Reye’s Syndrome, a rare but serious illness associated with aspirin use.

No relevant information is available regarding nonclinical toxicology or 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 this medication out of reach of children to prevent accidental ingestion or misuse. It is important to emphasize the necessity of proper storage to ensure the safety of young individuals.

Storage and Handling

The product is supplied in a container that must be kept tightly closed to maintain its integrity. It should be stored at room temperature, specifically within the range of 20°C to 25°C (68°F to 77°F). It is essential to protect the product from light exposure to ensure its efficacy. Additionally, the product should be kept out of reach of children, and any unused portion should be discarded after opening to prevent potential safety risks.

Additional Clinical Information

The medication is administered orally. For adults and children aged 12 years and older, the recommended dosage is 1 to 2 tablets every 4 hours, with a maximum of 12 tablets within a 24-hour period. For children under 12 years of age, it is advised to consult a physician for appropriate dosing guidance.

There is no additional information available regarding laboratory tests, abuse potential, patient counseling, or postmarketing experience.

Drug Information (PDF)

This file contains official product information for Aspirin 325mg, 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 325mg, 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.