Aspirin

Description

Marlex Pharmaceuticals, Inc. distributes this product, which is identified by the National Drug Code (NDC) numbers 10135-0729-10 and 10135-0729-62. The company is located at New Castle, DE 19720. Additional information can be found on their website at www.marlexpharm.com.

Uses and Indications

This drug is indicated for the temporary relief of minor aches and pains. It is essential for patients to consult their healthcare provider for any additional uses beyond this indication.

Limitations of use include a recommendation against usage for more than 10 days without prior consultation with a healthcare professional, as serious side effects may occur with prolonged use.

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 should 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 patients with a history of stomach bleeding or stomach problems, including heartburn. It is also contraindicated in individuals with high blood pressure, heart disease, liver cirrhosis, or kidney disease due to potential exacerbation of these conditions. Patients currently taking diuretics should not use this product, as it may lead to adverse effects. Additionally, individuals with asthma, those who have not been adequately hydrated, or those who have experienced significant fluid loss from vomiting or diarrhea should avoid use.

In the event of an overdose, immediate medical assistance or contact with a Poison Control Center is required.

Warnings and Precautions

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. 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 illness.

Aspirin may provoke severe allergic reactions, which can manifest as hives, facial swelling, shock, or asthma symptoms such as wheezing. Individuals with known allergies to aspirin or other pain relievers/fever reducers should avoid using this product.

This product contains a nonsteroidal anti-inflammatory drug (NSAID), which carries a risk of severe stomach bleeding. The likelihood of this adverse effect is increased in individuals who are 60 years of age or older, have a history of stomach ulcers or bleeding problems, are taking anticoagulants or steroid medications, are using other NSAIDs (including aspirin, ibuprofen, or naproxen), consume three or more alcoholic drinks daily, or exceed the recommended dosage or duration of use.

Healthcare professionals should advise patients to seek medical guidance before using this product if any of the following conditions apply: a history of stomach problems such as heartburn, high blood pressure, heart disease, liver cirrhosis, kidney disease, current use of diuretics, asthma, inadequate fluid intake, or significant fluid loss due to vomiting or diarrhea. Additionally, patients should consult a doctor or pharmacist if they are taking prescription medications for diabetes, gout, or arthritis, are under medical care for any serious condition, or are using any other medications.

In the event of an overdose, immediate medical assistance should be sought, or contact with a Poison Control Center is recommended.

Patients should discontinue use and contact a healthcare provider if they experience any signs of stomach bleeding, such as feeling faint, having bloody or black stools, vomiting blood, or experiencing persistent stomach pain. Other concerning symptoms include worsening pain lasting more than 10 days, fever that worsens or lasts more than three days, redness or swelling in the painful area, the emergence of new symptoms, or any ringing in the ears or loss of hearing.

Side Effects

Patients using this product should be aware of several serious and common adverse reactions associated with its use.

Reye’s syndrome is a rare but serious illness that may occur in children and teenagers who have or are recovering from chickenpox or flu-like symptoms. Patients should be advised not to use this product under these circumstances. If any changes in behavior accompanied by nausea and vomiting occur, it is essential to consult a healthcare professional, as these may be early signs of Reye’s syndrome.

Aspirin may also cause severe allergic reactions in some patients. Symptoms of such reactions can include hives, facial swelling, shock, and asthma (wheezing). Patients with a known allergy to aspirin or any other pain reliever or fever reducer should not use this product.

The product contains a nonsteroidal anti-inflammatory drug (NSAID), which carries a warning for the potential of severe stomach bleeding. The risk of this adverse reaction is heightened in patients who are 60 years of age or older, have a history of stomach ulcers or bleeding problems, are taking 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 be instructed to stop using the product and seek medical attention if they experience any signs of stomach bleeding, which may include feeling faint, having bloody or black stools, vomiting blood, or experiencing stomach pain that does not improve. Additional warning signs include worsening pain lasting more than 10 days, fever that worsens or lasts more than three days, redness or swelling in the painful area, the appearance of any new symptoms, or symptoms such as ringing in the ears or loss of hearing.

It is crucial for patients to be informed of these potential adverse reactions to ensure their safety while using this product.

Drug Interactions

The concomitant use of anticoagulants or steroid medications may elevate the risk of gastrointestinal bleeding. Healthcare professionals should exercise caution when prescribing these agents alongside the drug in question.

Additionally, the use of nonsteroidal anti-inflammatory drugs (NSAIDs), including but not limited to aspirin, ibuprofen, and naproxen, may further increase the risk of stomach bleeding. It is advisable for patients to consult with their healthcare provider prior to initiating therapy with this drug if they are currently taking any NSAIDs.

Patients who are on prescription medications for diabetes, gout, or arthritis should seek guidance from a healthcare professional or pharmacist before using this drug to ensure safe and effective treatment.

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.

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 any 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 dosing, adults and children aged 12 years and over may take 4 to 8 tablets every 4 hours, not exceeding 48 tablets in a 24-hour period unless directed by a doctor. For children under 12 years of age, consultation with a healthcare professional is advised before use.

Geriatric Use

Elderly patients, particularly those aged 60 and older, are at an increased risk of severe stomach bleeding when using this product, which contains a nonsteroidal anti-inflammatory drug (NSAID). It is crucial for healthcare providers to assess the individual risk factors of geriatric patients prior to prescribing this medication.

Before initiating treatment, healthcare providers should inquire about any history of stomach problems, such as heartburn, as well as any existing conditions including high blood pressure, heart disease, liver cirrhosis, or kidney disease. These factors may further elevate the risk of adverse effects associated with NSAID use.

Particular caution should be exercised in elderly patients with a history of stomach ulcers or bleeding problems, as well as those concurrently taking blood thinners or other NSAIDs. Monitoring for signs of gastrointestinal bleeding is recommended in this population to ensure patient safety and to mitigate potential complications.

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. It is particularly important to avoid the use of aspirin during the last three months of pregnancy unless explicitly 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 while breastfeeding.

Renal Impairment

Patients with renal impairment may require careful consideration regarding dosing adjustments and monitoring. In individuals with reduced kidney function, particularly those with high blood pressure, heart disease, liver cirrhosis, or kidney disease, it is essential to assess renal function prior to initiating treatment. Regular monitoring of renal parameters is recommended to ensure safety and efficacy. Adjustments to dosing may be necessary based on the severity of renal impairment to avoid potential adverse effects and to optimize therapeutic outcomes.

Hepatic Impairment

Patients with hepatic impairment may experience altered pharmacokinetics of the drug due to compromised liver function. It is essential to assess liver function prior to initiating treatment and to monitor liver parameters throughout the course of therapy.

In patients with liver cirrhosis, dosage adjustments may be necessary to mitigate the risk of adverse effects. Close monitoring of liver function tests, including alanine aminotransferase (ALT), aspartate aminotransferase (AST), and bilirubin levels, is recommended to ensure patient safety and therapeutic efficacy.

Additionally, patients with concurrent conditions such as high blood pressure, heart disease, or kidney disease should be evaluated for potential interactions and the overall impact on treatment outcomes. It is advisable to consult with a healthcare professional to determine the most appropriate management strategy for patients with hepatic impairment.

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 aware that the specific symptoms of an overdose may vary depending on the substance involved. Therefore, a thorough assessment of the patient's condition is essential to determine the appropriate course of action.

Management of an overdose typically involves supportive care and symptomatic treatment. Continuous monitoring of the patient's vital signs and clinical status is recommended. In cases where the specific substance is known, targeted therapies may be employed as indicated.

It is essential for healthcare providers to remain vigilant and act swiftly in the management of overdose situations to ensure optimal patient outcomes.

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 pose risks to the unborn child or lead to complications 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

No specific postmarketing experience details are available. As such, there are no additional adverse events or rare case reports to summarize at this time.

Patient Counseling

Healthcare providers should advise patients to seek immediate medical assistance or contact a Poison Control Center in the event of an overdose.

Patients should be encouraged to consult with their healthcare provider before using the medication if any of the following conditions apply: they have a warning for stomach bleeding, a history of stomach problems such as heartburn, high blood pressure, heart disease, liver cirrhosis, or kidney disease. Additionally, patients should inform their healthcare provider if they are taking a diuretic, have asthma, have not been adequately hydrating, or have experienced significant fluid loss due to vomiting or diarrhea.

Furthermore, patients should be instructed to speak with their doctor or pharmacist prior to use if they are currently taking a prescription medication for diabetes, gout, or arthritis, are under medical supervision for any serious health condition, or are taking any other medications. This ensures a comprehensive understanding of potential interactions and risks associated with the medication.

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 between 15-30°C (59-86°F). It is essential to adhere to the expiration date indicated on the package to ensure product efficacy and safety.

Additional Clinical Information

Patients should take the medication with a full glass of water. For adults and children aged 12 years and older, the recommended dosage is 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 advised 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 Aspirin, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)