Aspirin Regimen

Description

LEADER™ is a low dose, safety coated aspirin regimen formulated as delayed release tablets, each containing 81 mg of the active ingredient. This product is classified as a nonsteroidal anti-inflammatory drug (NSAID) and is intended for use as a pain reliever. The product is packaged in a bottle containing 120 enteric coated tablets. A tamper evident warning is included, stating: "DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING." LEADER™ is distributed by Cardinal Health, located in Dublin, Ohio 43017. For additional information, visit www.myleader.com or contact customer service at 1-800-200-6313. ©2025 Cardinal Health. All Rights Reserved.

Uses and Indications

This drug is indicated for the temporary relief of minor aches and pains, or as recommended by a healthcare professional.

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

Dosage and Administration

Patients should adhere strictly to the recommended dosage and administration guidelines. It is imperative not to exceed the directed dosage.

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

For children under 12 years of age, the use of this medication is not advised unless specifically directed by a physician.

Each dose should be taken with a full glass of water to ensure proper administration and absorption.

Contraindications

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

Warnings and Precautions

Children and teenagers who are experiencing or recovering from chickenpox or flu-like symptoms should not use this product due to the risk of Reye’s syndrome. If any changes in behavior accompanied by nausea and vomiting occur while using this product, it is imperative to consult a healthcare professional, as these symptoms may indicate the onset of this rare but serious condition.

Aspirin may provoke severe allergic reactions, which can manifest as hives, facial swelling, shock, or asthma (wheezing). Healthcare professionals should be vigilant for these signs and advise patients to seek immediate medical attention if they occur.

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

Prior to use, patients should consult a healthcare provider if any of the following conditions apply: a history of stomach problems such as heartburn, high blood pressure, heart disease, liver cirrhosis, kidney disease, or if they are taking diuretics or have asthma. Additionally, it is advisable to seek guidance from a doctor or pharmacist if the patient is currently prescribed medications for gout, diabetes, or arthritis.

In the event of an overdose, immediate medical assistance should be sought, or the Poison Control Center should be contacted without delay.

Patients are advised to discontinue use and contact a healthcare professional if they experience any signs of an allergic reaction, symptoms indicative of stomach bleeding (such as feeling faint, vomiting blood, having bloody or black stools, or persistent stomach pain), ringing in the ears or hearing loss, worsening pain lasting more than 10 days, fever that worsens or persists beyond three days, visible redness or swelling, or the emergence of any new symptoms.

Side Effects

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

Warnings 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. These individuals should not use this product. If patients experience changes in behavior accompanied by nausea and vomiting while using this product, they should consult a doctor immediately, as these symptoms could indicate the onset of Reye's syndrome.

An allergy alert is warranted, as aspirin may cause severe allergic reactions. Symptoms of such reactions can include hives, facial swelling, shock, and asthma (wheezing). Patients experiencing any signs of an allergic reaction should stop use and seek medical help right away.

This product contains a nonsteroidal anti-inflammatory drug (NSAID), which may increase the risk of severe stomach bleeding. The likelihood of this adverse reaction is heightened in patients who are taking blood thinners or steroid medications, are aged 60 or older, exceed the recommended dosage or duration of use, are using other NSAIDs (including prescription or nonprescription medications such as aspirin, ibuprofen, or naproxen), have a history of stomach ulcers or bleeding problems, or consume three or more alcoholic drinks daily while using this product.

Stop Use and Consult a Doctor Patients should discontinue use and seek medical advice if they experience any of the following: signs of an allergic reaction, symptoms indicative of stomach bleeding (such as feeling faint, vomiting blood, having bloody or black stools, or experiencing persistent stomach pain), ringing in the ears or loss of hearing, worsening pain lasting more than 10 days, fever that worsens or lasts more than three days, redness or swelling, or any new symptoms that arise.

Drug Interactions

The concomitant use of blood thinners (anticoagulants) or steroid medications increases the risk of severe stomach bleeding. Healthcare professionals should exercise caution when prescribing these medications alongside the drug in question, and patients should be monitored closely for any signs of gastrointestinal bleeding.

Additionally, it is advisable for patients to consult with a healthcare provider or pharmacist prior to using this drug if they are currently taking prescription medications for gout, diabetes, or arthritis. This precaution is essential to ensure safe and effective use, as potential interactions may necessitate dosage adjustments or increased monitoring.

Packaging & NDC

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

Pediatric Use

Pediatric patients, particularly those under 12 years of age, should not use this product unless directed by a healthcare professional. For children and teenagers who are experiencing or recovering from chicken pox or flu-like symptoms, the use of this product is contraindicated due to the risk of Reye’s syndrome, a rare but serious illness.

In the event of changes in behavior accompanied by nausea and vomiting while using this product, it is essential to consult a doctor, as these may be early signs of Reye's syndrome.

For adolescents aged 12 years and older, the recommended dosage is 4 to 8 tablets every 4 hours, with a maximum of 48 tablets in a 24-hour period, unless otherwise directed by a healthcare provider.

Geriatric Use

Elderly patients, particularly those aged 60 and older, may have an increased risk of severe stomach bleeding. Healthcare providers should exercise caution when prescribing this medication to geriatric patients, considering the potential for heightened adverse effects.

It is advisable to closely monitor elderly patients for signs of gastrointestinal bleeding and to evaluate the necessity of dosage adjustments based on individual health status and concurrent medications. Careful assessment of the risk-benefit ratio is essential in this population to ensure safe and effective treatment.

Pregnancy

Pregnant patients and those who are breastfeeding should consult a healthcare professional before using this medication. The use of aspirin during pregnancy, particularly at 20 weeks gestation or later, is associated with potential risks. Specifically, it may lead to adverse effects on fetal development and complications during delivery. Therefore, it is crucial that pregnant patients only use aspirin under the guidance of a physician if deemed necessary.

Lactation

Lactating mothers are advised to consult a health professional before using this medication. It is particularly important to avoid the use of aspirin at 20 weeks of pregnancy or later 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 its use during lactation.

Renal Impairment

Patients with renal impairment should consult a healthcare professional prior to use, particularly if they have high blood pressure, heart disease, liver cirrhosis, or kidney disease. It is essential to assess renal function and consider potential dosing adjustments or monitoring requirements based on the severity of renal impairment.

Hepatic Impairment

Patients with hepatic impairment should consult a healthcare professional prior to use, particularly if they have conditions such as liver cirrhosis. It is essential to assess liver function and consider potential dosage adjustments or monitoring requirements based on the severity of hepatic impairment. Close monitoring of liver function tests may be warranted to ensure patient safety and therapeutic efficacy.

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 in monitoring for symptoms that may arise from an overdose. While specific symptoms are not detailed in the provided information, it is essential to be aware that they can vary based on the substance involved and the individual patient’s condition.

Management of an overdose typically involves supportive care and symptomatic treatment. The healthcare provider should assess the patient's clinical status and initiate appropriate interventions based on the severity of the symptoms and the specific circumstances of the overdose.

In summary, timely medical intervention and appropriate management strategies are vital in addressing overdose situations effectively.

Nonclinical Toxicology

It is especially important not to use aspirin at 20 weeks or later in pregnancy unless definitely directed to do so by a doctor, as it may cause problems in the unborn child or complications during delivery. No specific non-teratogenic effects have been identified in the available data. Additionally, there are no details regarding nonclinical toxicology or animal pharmacology and toxicology provided in the text.

Postmarketing Experience

No postmarketing experience details are available in the insert text.

Patient Counseling

Healthcare providers should advise patients to seek immediate medical assistance or contact a Poison Control Center in the event of an overdose. It is crucial to inform patients that they should not use this medication if they have a history of allergic reactions to any other pain reliever or fever reducer.

Patients should be instructed to discontinue use and consult a doctor if they experience any signs of an allergic reaction, such as difficulty breathing or swelling of the face, lips, or throat. They should also be made aware of the symptoms indicative of stomach bleeding, which include feeling faint, vomiting blood, having bloody or black stools, or experiencing persistent stomach pain. Additionally, patients should be cautioned to seek medical attention if they experience ringing in the ears, a loss of hearing, worsening pain that lasts more than 10 days, a fever that worsens or lasts more than 3 days, any redness or swelling, or the emergence of new symptoms.

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 be advised to seek medical guidance prior to use. Furthermore, those taking diuretics or who have asthma should be encouraged to discuss their conditions with a healthcare professional.

Lastly, patients should be advised to consult a doctor or pharmacist before using this medication if they are currently taking prescription drugs for gout, diabetes, or arthritis.

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), with permissible excursions between 15°C and 30°C (59°F to 86°F).

Healthcare professionals are advised to check the end flap of the packaging for the expiration date and lot number to ensure proper inventory management and product safety.

Additional Clinical Information

The medication is administered orally. Clinicians should advise patients who are pregnant or breastfeeding to consult a healthcare professional prior to use. It is particularly crucial to avoid the use of aspirin after 20 weeks of pregnancy unless explicitly directed by a physician, 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 Regimen, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)