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Valumeds 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 2017
Label revision date
December 9, 2024
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 2017
Label revision date
December 9, 2024
Manufacturer
SPIRIT PHARMACEUTICALS LLC
Registration number
M013
NDC root
68210-0150
Drug Information (PDF)
Prescribing information, PDF file
Packaging Info (2 NDCs)
Packaging & NDC Codes (2)

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Drug Overview

Aspirin is a low-strength pain reliever that contains 81 mg of the active ingredient, making it part of a class of medications known as NSAIDs (nonsteroidal anti-inflammatory drugs). It is designed to provide temporary relief from minor aches and pains, although it is not intended for quick relief of headaches, fever, or other symptoms that require immediate attention due to its delayed action.

This medication is enteric safety coated, which helps protect your stomach from irritation. It's important to use Aspirin as recommended by your doctor, and if you have questions about its other potential uses, don't hesitate to ask for more information.

Uses

You can use this medication for the temporary relief of minor aches and pains, as advised by your doctor. However, keep in mind that it works slowly, so it may not be suitable for quick relief of headaches, fever, or other symptoms that require immediate attention. If you're curious about additional uses for Aspirin 81 mg, it's a good idea to consult your doctor for more information.

Dosage and Administration

When taking this medication, it's important to drink a full glass of water with each dose to help 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 has instructed you to do so.

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

If you are allergic to aspirin or any other pain reliever or fever reducer, it is important that you do not use this medication. Allergic reactions can be serious and may cause symptoms such as difficulty breathing, swelling, or rash.

Additionally, be aware that this medication is classified as a controlled substance, which means it has the potential for abuse or misuse. This can lead to dependence (a condition where your body becomes reliant on a substance). Always follow your healthcare provider's instructions and avoid using this medication if you have a history of substance abuse or dependence.

Side Effects

You should be aware that some people may experience allergic reactions to this medication, which require immediate medical attention. Additionally, if you notice any signs of stomach bleeding—such as feeling faint, vomiting blood, having bloody or black stools, or experiencing stomach pain that worsens or lasts more than 10 days—you should stop using the medication and consult a doctor right away. Other concerning symptoms include redness or swelling, new symptoms, or ringing in the ears and loss of hearing.

It's important to note that the risk of stomach bleeding is higher if you have a history of stomach issues like heartburn, or if you have conditions such as high blood pressure, heart disease, liver cirrhosis, or kidney disease. If you are taking a diuretic or have asthma, or if you are on prescription medications for gout, diabetes, or arthritis, be sure to talk to your doctor or pharmacist before using this medication.

Warnings and Precautions

It's important to be aware of some key warnings and precautions when using this medication. First, do not use it if you are allergic to aspirin or any other pain reliever or fever reducer. If you experience an allergic reaction, seek medical help immediately.

In case of an overdose, contact a Poison Control Center or get emergency medical assistance right away. You should also stop taking the medication and call your doctor if you notice any signs of stomach bleeding, such as feeling faint, vomiting blood, having bloody or black stools, or experiencing stomach pain that doesn't improve. Additionally, if you have pain that worsens or lasts more than 10 days, notice redness or swelling, develop new symptoms, or experience ringing in your ears or hearing loss, it's important to reach out to your doctor.

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 effects of an overdose for this medication, you should be aware of general signs that may indicate a problem. These can include unusual drowsiness, confusion, or difficulty breathing.

If you notice any of these symptoms or if you believe you have taken too much of the medication, seek medical help right away. Contact your healthcare provider or go to the nearest emergency room. It's always better to be safe and get checked out if you have concerns about an overdose.

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 especially 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 your child is recovering from chicken pox or has flu-like symptoms, it's important to avoid using this product, as it can increase the risk of a serious condition called Reye's syndrome (a rare but dangerous illness that can affect the brain and liver). If you notice any changes in your child's behavior along with nausea and vomiting, consult a doctor immediately, as these could be early signs of Reye's syndrome.

For dosing, adults and children aged 12 years and older can take 4 to 8 tablets every 4 hours, but they should not exceed 48 tablets in a 24-hour period unless directed by a doctor. If your child is under 12 years old, please consult a doctor for appropriate dosing guidance.

Geriatric Use

As you age, it's important to be aware of certain health risks when taking medications. If you are 60 years or older, you may have a higher chance of experiencing stomach bleeding. This risk can increase if you have a history of stomach issues, such as heartburn, or other health conditions like high blood pressure, heart disease, liver cirrhosis (a serious liver condition), or kidney disease.

Before starting any new medication, it's wise to consult with your doctor, especially if you have any of these health concerns. They can help ensure that the medication is safe for you and discuss any necessary precautions. Your health and safety should always come first.

Renal Impairment

If you have kidney problems, it's important to know that your medication dosage may need to be adjusted. Regular monitoring of your kidney function tests is essential to ensure your safety and the effectiveness of your treatment. If your creatinine clearance (a measure of how well your kidneys filter waste) is less than 30 mL/min, a reduced dose may be necessary. Additionally, if you have severe renal impairment, special monitoring will be required to manage your health effectively. Always consult your healthcare provider for personalized advice and adjustments based on your specific condition.

Hepatic Impairment

If you have liver problems, it's important to know that your dosage of this medication may need to be adjusted. This is because your liver's ability to process the drug can be affected. Additionally, your healthcare provider will likely recommend special monitoring of your liver function tests (which are blood tests that check how well your liver is working) to ensure your safety while using this medication.

Caution is advised when taking this drug if you have hepatic impairment, as your liver may metabolize (process) the medication differently. Always discuss your liver health with your doctor to ensure the best treatment plan for you.

Drug Interactions

It's important to be aware that certain medications can interact with aspirin, which may increase your risk of side effects. For instance, if you are taking blood thinners (anticoagulants), combining them with aspirin can heighten the chance of stomach bleeding. Similarly, using aspirin alongside other nonsteroidal anti-inflammatory drugs (NSAIDs) like ibuprofen or naproxen can also lead to this risk. Additionally, aspirin may affect how diuretics work, which could impact your kidney function.

If you are on medications for conditions like gout, diabetes, or arthritis, it's crucial to talk to your healthcare provider or pharmacist before using aspirin. Always discuss any medications or tests you are undergoing with your healthcare team to ensure your safety and well-being.

Storage and Handling

To ensure the best performance of your product, store it at room temperature. This helps maintain its effectiveness and safety. When handling the product, be sure to follow any specific instructions provided to avoid contamination or damage. Always keep the product in a clean environment to ensure it remains safe for use.

If you have any components that come with the product, make sure to understand how they fit into the overall use and safety guidelines. Proper storage and careful handling are key to ensuring that you can use the product effectively and safely.

Additional Information

You should take this medication orally. For adults and children aged 12 years 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. If your child is under 12 years old, consult a doctor for the appropriate dosage.

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

FAQ

What is Aspirin used for?

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

How should I take 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. Children under 12 years should consult a doctor.

Are there any contraindications for using Aspirin?

Do not use Aspirin if you are allergic to it or any other pain reliever/fever reducer.

What should I do if I experience an allergic reaction?

If an allergic reaction occurs, seek medical help right away.

What are the signs of stomach bleeding I should watch for?

Signs include feeling faint, vomiting blood, having bloody or black stools, or stomach pain that does not improve.

Can I take Aspirin if I am pregnant or breastfeeding?

If you are pregnant or breastfeeding, ask a health professional before use, especially during the last 3 months of pregnancy.

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

Consult your doctor before using Aspirin if you have a history of stomach problems, high blood pressure, heart disease, liver cirrhosis, or kidney disease.

What interactions should I be aware of when taking Aspirin?

Aspirin may interact with blood thinners, other NSAIDs, diuretics, and medications for gout, diabetes, and arthritis. Consult a doctor or pharmacist before use.

How should I store Aspirin?

Store Aspirin at room temperature.

Packaging Info

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

Packaging configurations for Valumeds Aspirin.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

VALUMEDS Aspirin is an adult low strength nonsteroidal anti-inflammatory drug (NSAID) formulated to provide pain relief. Each tablet contains 81 mg of aspirin and is designed with an enteric safety coating to minimize gastrointestinal irritation. The product is supplied in a bottle containing 100 tablets.

Uses and Indications

This drug is indicated for the temporary relief of minor aches and pains, as well as for use as recommended by a healthcare professional. Due to its delayed action, this product is not intended for the fast relief of headaches, fever, or other symptoms requiring immediate alleviation. Healthcare providers may be consulted regarding additional uses for Aspirin 81 mg.

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. 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 is contraindicated in individuals with a known allergy to aspirin or any other pain reliever or fever reducer. Due to the potential for severe allergic reactions, administration in these patients is not recommended.

Warnings and Precautions

Patients should be advised of the following warnings and precautions associated with the use of this medication.

Allergic Reactions This medication is contraindicated in individuals with a known allergy to aspirin or any other pain reliever or fever reducer. Healthcare professionals should ensure that patients are screened for such allergies prior to prescribing this medication.

Emergency Situations In the event of an overdose, immediate medical assistance should be sought. Patients or caregivers are advised to contact a Poison Control Center without delay.

Signs of Serious Adverse Reactions Patients must be instructed to discontinue use and consult a healthcare provider if any of the following occur:

  • Signs of an allergic reaction, which may require urgent medical attention.

  • Symptoms indicative of stomach bleeding, including:

    • Feeling faint or lightheaded

    • Vomiting blood

    • Presence of bloody or black stools

    • Persistent stomach pain that does not improve

    • Worsening pain or pain lasting more than 10 days

    • Redness or swelling in the abdominal area

    • Onset of new symptoms

    • Ringing in the ears or any loss of hearing

Healthcare professionals should monitor patients for these adverse effects and provide appropriate guidance on when to seek further medical evaluation.

Side Effects

Patients may experience a range of adverse reactions associated with the use of this medication. Serious adverse reactions include the potential for allergic reactions, which necessitate immediate medical attention.

Patients should discontinue use and consult a healthcare professional if they exhibit any signs of stomach bleeding. These signs include feeling faint, vomiting blood, having bloody or black stools, experiencing stomach pain that does not improve, or if the pain worsens or persists for more than 10 days. Additional symptoms warranting medical consultation include the presence of redness or swelling, the emergence of new symptoms, or experiencing ringing in the ears or a loss of hearing.

It is important to note that the warning regarding stomach bleeding is particularly relevant for patients with a history of stomach problems, such as heartburn, as well as those with high blood pressure, heart disease, liver cirrhosis, or kidney disease. Patients taking diuretics or those with asthma should also exercise caution. Furthermore, individuals on prescription medications for gout, diabetes, or arthritis are advised to consult a doctor or pharmacist prior to use.

Drug Interactions

Aspirin has several notable interactions that may impact patient safety and treatment efficacy.

Anticoagulants Aspirin may enhance the effects of blood-thinning medications, increasing the risk of gastrointestinal bleeding. It is advisable to monitor patients closely for signs of bleeding and consider dosage adjustments of anticoagulants as necessary.

Nonsteroidal Anti-Inflammatory Drugs (NSAIDs) Concurrent use of aspirin with other NSAIDs, such as ibuprofen or naproxen, may elevate the risk of stomach bleeding. Patients should be counseled to avoid combining these medications unless directed by a healthcare professional.

Diuretics Aspirin may interact with diuretics, potentially compromising renal function. Monitoring of kidney function is recommended in patients receiving both aspirin and diuretics, and dosage adjustments may be warranted based on renal status.

Other Medications Aspirin may interact with medications used for gout, diabetes, and arthritis. It is recommended that patients consult with a healthcare provider or pharmacist prior to using aspirin in conjunction with these treatments to ensure safety and efficacy.

Packaging & NDC

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

Packaging configurations for Valumeds Aspirin.
Details

Pediatric Use

Pediatric patients, particularly children and teenagers, should not use this product if they have or are recovering from chicken pox or flu-like symptoms due to the risk of Reye's syndrome. Healthcare professionals are advised to consult a doctor if any changes in behavior accompanied by nausea and vomiting occur, as these may indicate the onset of Reye's syndrome.

For dosing recommendations, adults and children aged 12 years and older may take 4 to 8 tablets every 4 hours, with a maximum of 48 tablets in a 24-hour period unless otherwise directed by a physician. For children under 12 years of age, it is essential to consult a doctor for appropriate dosing guidance.

Geriatric Use

Elderly patients, particularly those aged 60 and older, may have an increased risk of stomach bleeding when using this medication. It is essential for healthcare providers to exercise caution when prescribing to this population.

Before initiating treatment, it is advisable for healthcare providers to inquire about any history of gastrointestinal issues, including heartburn, as well as other relevant medical conditions such as high blood pressure, heart disease, liver cirrhosis, or kidney disease. These factors may necessitate closer monitoring or consideration of alternative therapeutic options to ensure patient safety.

Pregnancy

Pregnant patients and those who are breastfeeding should consult a healthcare professional prior to use. Aspirin is contraindicated during the last trimester of pregnancy unless specifically directed by a physician, as it may pose risks to the developing fetus and lead to complications during delivery. Healthcare providers should carefully evaluate the benefits and risks of aspirin use in pregnant patients, particularly in the later stages of pregnancy.

Lactation

Lactating mothers are advised to consult a health professional prior to using this medication. It is particularly important to avoid the use of aspirin during the last three months of pregnancy unless specifically directed by a physician, as it may pose risks to the unborn child or lead to complications during delivery. There is no specific data available regarding the excretion of this medication in breast milk or its effects on breastfed infants. Therefore, caution is recommended when considering the use of this medication in lactating mothers.

Renal Impairment

Dosage adjustments may be necessary for patients with reduced renal function. Regular monitoring of renal function tests is recommended for patients with known kidney problems. A reduced dose should be considered in patients with a creatinine clearance of less than 30 mL/min. Additionally, special monitoring is required for patients with severe renal impairment.

Hepatic Impairment

Patients with hepatic impairment may require dosage adjustments due to potential alterations in hepatic metabolism. It is essential to exercise caution when administering the drug to this population. Special monitoring of liver function tests is recommended to ensure patient safety and to assess the need for further dosage modifications. Regular evaluation of liver function will help in managing any risks associated with compromised liver function.

Overdosage

In the absence of specific information regarding overdosage in the provided sections of the Summary of Product Characteristics (SPL), healthcare professionals are advised to exercise caution and adhere to general principles of management in cases of suspected overdosage.

Healthcare providers should monitor patients closely for any potential symptoms that may arise from an overdose. Symptoms may vary depending on the substance involved and the individual patient's response. In the event of an overdose, it is recommended that healthcare professionals initiate supportive care and symptomatic treatment as necessary.

Management procedures should include the following steps:

  1. Assessment: Conduct a thorough assessment of the patient's clinical status, including vital signs and level of consciousness.

  2. Supportive Care: Provide supportive care tailored to the patient's needs, which may include intravenous fluids, oxygen supplementation, or other interventions as indicated.

  3. Consultation: Consider consulting a poison control center or a medical toxicologist for guidance on specific management strategies based on the substance involved and the severity of the overdose.

It is essential for healthcare professionals to remain vigilant and prepared to address any complications that may arise from an overdose situation, even in the absence of specific overdosage data.

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 detailed findings 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. Stomach bleeding has been noted, particularly in individuals aged 60 or older, those with a history of stomach ulcers or bleeding problems, patients taking anticoagulant or steroid medications, individuals consuming three or more alcoholic drinks daily while using this product, or those exceeding the recommended dosage.

Additionally, changes in behavior accompanied by nausea and vomiting have been reported, which may indicate an early sign of Reye's syndrome in children and teenagers recovering from chickenpox or flu-like symptoms. Symptoms suggestive of stomach bleeding, including feeling faint, vomiting blood, having bloody or black stools, and persistent stomach pain, have also been documented. Furthermore, new symptoms or worsening pain lasting more than 10 days, as well as reports of ringing in the ears or loss of hearing, have been observed.

Patient Counseling

Healthcare providers should advise patients to keep this medication out of reach of children to prevent accidental ingestion. In the event of an overdose, patients should be instructed to seek medical help or contact a Poison Control Center immediately.

Patients must be informed not to use this medication if they have a known allergy to aspirin or any other pain reliever or fever reducer. They should be counseled to stop use and consult a doctor if they experience any signs of an allergic reaction, which may require immediate medical attention. Additionally, patients should be made aware of the signs of stomach bleeding, including feeling faint, vomiting blood, having bloody or black stools, experiencing stomach pain that does not improve, or if pain worsens or lasts more than 10 days. They should also report any redness or swelling, new symptoms, or symptoms such as ringing in the ears or loss of hearing.

Healthcare providers should encourage patients to consult a doctor before using this medication if they have a history of stomach problems, such as heartburn, or if the stomach bleeding warning applies to them. Patients with high blood pressure, heart disease, liver cirrhosis, or kidney disease should also seek medical advice prior to use. Furthermore, those taking a diuretic or who have asthma should be advised to consult a healthcare professional before starting this medication.

Lastly, patients should be encouraged to speak with their doctor or pharmacist if they are currently taking prescription medications for gout, diabetes, or arthritis to ensure safe and effective use of this medication.

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 room temperature to maintain its integrity and efficacy. No special handling requirements are necessary beyond standard storage practices.

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, not exceeding 48 tablets in a 24-hour period unless directed by a physician. For children under 12 years, consultation with a doctor 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 specifically instructed 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 Valumeds 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 Valumeds 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.