Aspirin

Description

NDC 36800-545-60. This product contains Aspirin 81 mg, classified as a nonsteroidal anti-inflammatory drug (NSAID) and is designed as a low dose regimen. It is presented in the form of 180 enteric-coated tablets, which are safety coated to enhance gastrointestinal tolerability. The product is distributed by Topco Associates LLC, Itasca, IL 60143, and is comparable to the active ingredient in St. Joseph® Low Dose Aspirin. This product is not manufactured or distributed by Foundation Consumer Healthcare, LLC, the owner of the registered trademark St. Joseph® Low Dose Aspirin. The product is laboratory tested to ensure the highest quality, and a tamper-evident seal is provided; do not use if the imprinted safety seal under the cap is broken or missing.

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

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, the use of this medication is not recommended unless specifically directed by a physician.

Contraindications

Use is contraindicated in individuals with a history of allergic reactions to any other pain reliever or fever reducer. This precaution is necessary to prevent potential severe allergic responses.

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 increases under certain conditions, including prolonged use beyond the recommended duration, concurrent use of anticoagulants or steroid medications, a history of stomach ulcers or bleeding disorders, consumption of three or more alcoholic beverages daily while using this product, being aged 60 or older, or taking other medications that contain NSAIDs (such as aspirin, ibuprofen, or naproxen).

Healthcare professionals should advise patients to consult a doctor prior to use if they are currently taking diuretics, have a history of stomach issues (such as heartburn), or have conditions such as high blood pressure, heart disease, liver cirrhosis, kidney disease, or asthma. Additionally, patients should be encouraged to seek guidance from a doctor or pharmacist if they are on prescription 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 should be instructed to discontinue use and contact their healthcare provider if they experience any signs of an allergic reaction, such as hives or swelling. They should also seek medical attention if they notice symptoms indicative of stomach bleeding, including vomiting blood, passing bloody or black stools, feeling faint, or experiencing persistent stomach pain. Other concerning symptoms that warrant immediate medical consultation include 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.

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. It is crucial for these individuals to avoid using 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.

Aspirin, the active ingredient in this product, may cause severe allergic reactions. Symptoms of such reactions can include hives, facial swelling, shock, and asthma (wheezing). Patients should seek immediate medical attention if they experience any signs of an allergic reaction.

This product contains a nonsteroidal anti-inflammatory drug (NSAID), which carries a risk of severe stomach bleeding. The likelihood of this adverse reaction increases under certain conditions, including prolonged use beyond the directed dosage, concurrent use of blood thinners or steroid medications, a history of stomach ulcers or bleeding problems, consumption of three or more alcoholic drinks daily while using the product, being aged 60 or older, or taking other medications containing NSAIDs such as aspirin, ibuprofen, or naproxen.

Patients are advised to discontinue use and consult a doctor if they experience any signs of stomach bleeding, which may manifest as vomiting blood, having bloody or black stools, feeling faint, or experiencing persistent stomach pain. Additionally, if patients notice ringing in the ears, a loss of hearing, worsening pain lasting more than 10 days, a fever that worsens or lasts more than three days, redness or swelling, or any new symptoms, they should seek medical advice.

Before using this product, patients should consult a doctor if they are taking diuretics, have a history of stomach problems such as heartburn, or have conditions such as high blood pressure, heart disease, liver cirrhosis, or kidney disease. Patients with asthma should also seek medical advice prior to use. Furthermore, it is recommended that patients consult a doctor or pharmacist if they are taking prescription medications for gout, diabetes, or arthritis.

Drug Interactions

Aspirin has the potential to cause severe gastrointestinal bleeding, particularly when co-administered with anticoagulants or steroid medications. Healthcare professionals should exercise caution and consider monitoring patients for signs of bleeding when these drugs are used concurrently.

In patients taking diuretics, it is advisable to consult a healthcare provider prior to the use of aspirin to ensure safety and appropriate management.

Additionally, individuals on prescription medications for gout, diabetes, or arthritis should seek guidance from a healthcare professional or pharmacist before initiating aspirin therapy. This precaution is essential to avoid potential interactions and to ensure optimal therapeutic outcomes.

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. If any changes in behavior accompanied by nausea and vomiting occur while using this product, it is essential to consult a doctor, as these symptoms may indicate the onset of Reye's syndrome, a rare but serious condition.

For pediatric patients under 12 years of age, the use of this product is not recommended unless directed by a healthcare professional. In contrast, for adults and children aged 12 years and older, the recommended dosage is 4 to 8 tablets every 4 hours, with a maximum limit of 48 tablets in a 24-hour period unless otherwise directed by a doctor.

Geriatric Use

Elderly patients, particularly those aged 60 and older, are at an increased risk for severe stomach bleeding. It is essential for healthcare providers to exercise caution when prescribing medications that may exacerbate this risk in this population.

Monitoring for signs of gastrointestinal bleeding is advised, and dosage adjustments may be necessary based on the individual patient's health status and concurrent medications. Careful assessment of the benefits and risks of treatment in geriatric patients is crucial to ensure their safety and well-being.

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 outcomes or complications during delivery. Therefore, it is crucial that pregnant patients only use aspirin under the guidance of a qualified healthcare provider 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 the use of this medication during lactation.

Renal Impairment

Patients with renal impairment should consult a healthcare professional prior to use, particularly if they have comorbid conditions such as 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 degree 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 for these patients to receive appropriate evaluation and monitoring of their liver function to ensure safe and effective use of the medication. Adjustments to dosage may be necessary based on the severity of hepatic impairment, and ongoing assessment of liver function is recommended throughout the treatment period.

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 interventions may be employed to counteract the effects of the overdose.

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 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 help 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 ever experienced an allergic reaction to any other pain reliever or fever reducer.

Patients should be instructed to stop using the medication 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 seek medical attention if they notice any signs of stomach bleeding, which may include vomiting blood, having bloody or black stools, feeling faint, or experiencing stomach pain that does not improve. Additionally, patients should be made aware that they need to stop use and consult a healthcare professional 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, redness or swelling, or any new symptoms.

Healthcare providers should encourage patients to ask a doctor before using this medication if they are currently taking a diuretic, if the warning regarding stomach bleeding applies to them, or if they have a history of stomach problems such as heartburn. Patients with high blood pressure, heart disease, liver cirrhosis, or kidney disease, as well as those with asthma, should also consult a doctor prior to use.

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

Storage and Handling

The product is supplied in configurations that include specific NDC numbers, which can be found on the packaging. It should be stored at a controlled room temperature of 25ºC (77ºF), with permissible excursions between 15ºC and 30ºC (59ºF to 86ºF).

Healthcare professionals are advised to check the end flap of the packaging for the expiration date and lot number to ensure proper tracking and usage.

Additional Clinical Information

The route of administration for the medication is oral. Clinicians should advise patients who are pregnant or breastfeeding to consult a health professional prior to use. It is particularly crucial to avoid the use of aspirin at 20 weeks of gestation or later 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, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)