Aspirin

Description

Aspirin, at a dosage of 81 mg, is formulated as an enteric safety coated tablet. This nonsteroidal anti-inflammatory drug (NSAID) serves as a pain reliever and is intended for use in a low dose aspirin regimen. The product is packaged in a container containing 300 coated tablets. It is important to note that the packaging includes a tamper-evident feature; the product should not be used 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, as well as for use as recommended by a healthcare professional. Due to its delayed action, this product is not suitable for the immediate relief of headaches or other symptoms requiring prompt alleviation.

Limitations of Use: 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.

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 specifically directed by a healthcare professional.

It is essential for patients to consume a full glass of water with each dose to ensure proper hydration and facilitate the medication's effectiveness.

For children under 12 years of age, the use of this medication is not recommended unless directed by a healthcare provider.

Contraindications

Use of this product is contraindicated in individuals with a known allergy to aspirin or any other pain reliever or fever reducer. Additionally, it should not be administered to patients who have a history of allergic reactions to this product or any of its components.

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 illness.

Aspirin may provoke severe allergic reactions in some individuals. Symptoms of such reactions can include hives, facial swelling, shock, and asthma (wheezing). Immediate medical attention should be sought if any of these symptoms 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 individuals who are 60 years of age or older, those taking other medications that contain NSAIDs (including aspirin, ibuprofen, or naproxen), individuals with a history of stomach ulcers or bleeding problems, those consuming three or more alcoholic drinks daily while using this product, and patients who exceed the recommended dosage or duration of use. Additionally, individuals taking anticoagulants or steroid medications should exercise caution.

Healthcare professionals should advise patients to consult a doctor prior to use if any of the following conditions apply: a history of stomach problems (such as heartburn), current use of diuretics, high blood pressure, heart disease, liver cirrhosis, kidney disease, or asthma.

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

Patients should discontinue use and contact a healthcare provider if they experience any signs of an allergic reaction, such as hives or swelling. Additionally, they should seek medical attention if they notice any symptoms indicative of stomach bleeding, including vomiting blood, feeling faint, passing bloody or black stools, or experiencing persistent stomach pain. Other concerning symptoms that warrant 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 new symptoms, as these may signal a serious underlying condition.

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. 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 may also cause severe allergic reactions in some patients. Symptoms of such reactions can include hives, facial swelling, shock, and asthma (wheezing). Patients experiencing any signs of an allergic reaction should seek medical help right away.

This product contains a nonsteroidal anti-inflammatory drug (NSAID), which may lead to severe stomach bleeding. The risk of this adverse reaction is heightened in patients who are 60 years of age or older, those taking other NSAIDs (either prescription or nonprescription), individuals with a history of stomach ulcers or bleeding problems, patients consuming three or more alcoholic drinks daily while using this product, and those who take the medication for longer than directed or in higher doses. Additionally, patients on blood thinners (anticoagulants) or steroid drugs are at increased risk.

Patients should stop using the product and consult a doctor if they experience any signs of stomach bleeding, which may include vomiting blood, feeling faint, having bloody or black stools, or experiencing stomach pain that does not improve. Other concerning symptoms that warrant medical attention include 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 the emergence of new symptoms, as these could indicate a serious condition.

Before using this product, patients should consult a doctor if any of the following apply: they have a history of stomach problems such as heartburn, are taking a diuretic, have high blood pressure, heart disease, liver cirrhosis, or kidney disease, or have asthma. Furthermore, patients should seek advice from a doctor or pharmacist if they are taking prescription medications for gout, diabetes, or arthritis.

Drug Interactions

Aspirin may interact with several classes of medications, leading to increased risks of adverse effects, particularly gastrointestinal bleeding.

Nonsteroidal Anti-Inflammatory Drugs (NSAIDs) The concomitant use of aspirin with other NSAIDs, including both prescription and nonprescription agents such as ibuprofen and naproxen, may significantly elevate the risk of severe stomach bleeding. It is advisable to avoid the simultaneous use of these medications unless directed by a healthcare professional.

Anticoagulants and Antiplatelet Agents The risk of gastrointestinal bleeding is further heightened when aspirin is taken alongside blood-thinning medications (anticoagulants) or steroid drugs. Close monitoring is recommended for patients on these therapies, and dosage adjustments may be necessary based on clinical judgment.

Diuretics Patients taking diuretics should consult their healthcare provider prior to using aspirin, as there may be potential interactions that could affect the efficacy of either medication.

Pre-existing Conditions Individuals with high blood pressure, heart disease, liver cirrhosis, or kidney disease should seek medical advice before initiating aspirin therapy. These conditions may influence the safety profile of aspirin and necessitate careful consideration of its use.

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 changes in behavior accompanied by nausea and vomiting occur while using this product, a healthcare professional should be consulted, as these symptoms may indicate the onset of Reye's syndrome, a rare but serious condition.

For children under 12 years of age, the product should not be used unless directed by a doctor. It is essential to keep this product out of reach of children and it is not recommended for households with young children.

Geriatric Use

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

Monitoring for signs and symptoms of gastrointestinal bleeding is recommended in this population. Additionally, healthcare providers should consider the overall health status and concurrent medications of elderly patients, as these factors may further influence the risk of adverse effects.

Dose adjustments may be necessary based on individual patient assessments, taking into account the potential for altered pharmacokinetics and pharmacodynamics in older adults. Regular follow-up and reassessment of therapy are advised to ensure safety and efficacy in geriatric patients.

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 qualified healthcare provider, particularly in the later stages of pregnancy.

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 gestation 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 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 severity of renal impairment.

Hepatic Impairment

Patients with hepatic impairment should consult a healthcare professional prior to use, particularly if they have underlying conditions such as liver cirrhosis. It is essential for these patients to receive appropriate medical guidance to assess the potential risks and benefits associated with the use of this medication. Monitoring of liver function may be necessary to ensure safety and efficacy in this population. Adjustments to dosage or treatment regimens may be required based on the severity of hepatic impairment, and healthcare providers should evaluate each case individually.

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 response.

Management of an overdose typically involves supportive care and symptomatic treatment. The healthcare provider should assess the patient's condition and implement appropriate measures based on the severity of the overdose and the symptoms presented. Continuous monitoring and evaluation are recommended to ensure patient safety and effective management of the situation.

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 or additional nonclinical toxicology details are available in the provided data. Furthermore, there are no specific findings related to animal pharmacology and toxicology.

Postmarketing Experience

Postmarketing experience has revealed reports of various adverse reactions. These include allergic reactions such as hives, facial swelling, shock, and asthma (wheezing). Additionally, instances of stomach bleeding have been noted, particularly in patients taking NSAIDs, especially those over 60 years of age or with a history of stomach ulcers or bleeding problems. Furthermore, changes in behavior accompanied by nausea and vomiting have been reported, which may represent early signs of Reye's syndrome in children and teenagers recovering from chickenpox or flu-like symptoms.

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 product if they have a known allergy to aspirin or any other pain reliever or fever reducer. Additionally, patients should be cautioned against using the product if they have previously experienced an allergic reaction to it or any of its ingredients.

Patients must be instructed to discontinue use and consult a doctor if they experience any signs of an allergic reaction, and to seek medical help immediately in such cases. They should also be made aware of the signs of potential stomach bleeding, which include vomiting blood, feeling faint, having bloody or black stools, or experiencing stomach pain that does not improve. If any of these symptoms occur, patients should stop using the product and contact a healthcare professional.

Furthermore, patients should be advised to stop use and consult a doctor if they experience ringing in the ears, a loss of hearing, worsening pain that lasts more than 10 days, or a fever that worsens or lasts more than 3 days. They should also seek medical advice if they notice any redness or swelling or if new symptoms arise, as these may indicate a serious condition.

Healthcare providers should encourage patients to consult a doctor before using the product if they have a history of stomach problems, such as heartburn, or if the stomach bleeding warning applies to them. It is also important to advise patients to seek medical guidance if they are taking a diuretic, have high blood pressure, heart disease, liver cirrhosis, kidney disease, or asthma. Lastly, patients should be reminded to consult a doctor or pharmacist before use if they are currently taking prescription medications for gout, diabetes, or arthritis.

Storage and Handling

The product is supplied in packaging that includes specific NDC numbers. 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 and 86°F). It is essential to adhere to the expiration date indicated on the package to ensure product efficacy and safety.

Additional Clinical Information

The product is administered orally. Clinicians should advise patients to consult with their doctor or healthcare provider prior to using this product for heart-related conditions. No further information is available regarding laboratory tests, abuse potential, or postmarketing experiences.

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)