Aspirin 81 mg

Description

Aspirin is identified by the National Drug Code (NDC) 83813-001-01. It is a nonsteroidal anti-inflammatory drug (NSAID) commonly used for its analgesic, antipyretic, and anti-inflammatory properties. Aspirin is available in various dosage forms, including tablets and powders, and is characterized by its white crystalline appearance. The chemical formula for aspirin is C9H8O4, with a molecular weight of 180.16 g/mol.

Uses and Indications

This drug is indicated for the relief of pain.

There are no teratogenic effects associated with this drug. Additionally, no nonteratogenic effects have been reported.

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

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.

Healthcare professionals should advise patients to seek medical guidance before using this product if they have a history of stomach problems, such as heartburn, or if any of the following conditions apply: high blood pressure, heart disease, liver cirrhosis, kidney disease, or if they are currently taking a diuretic. Additionally, caution is warranted for individuals with asthma, those who have not been adequately hydrating, or those who have experienced significant fluid loss due to vomiting or diarrhea.

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 consult a healthcare provider if they experience any signs of an allergic reaction, such as difficulty breathing or swelling of the face, lips, or throat. Furthermore, they should seek medical attention if they notice any symptoms indicative of stomach bleeding, including feeling faint, passing bloody or black stools, vomiting blood, or experiencing persistent stomach pain. If pain worsens or lasts longer than 10 days, if redness or swelling occurs, if new symptoms arise, or if there is ringing in the ears or loss of hearing, patients should also contact their doctor, as these may be signs of a serious condition.

Side Effects

Patients using this product should be aware of several potential adverse reactions, which can range from serious to common.

A significant warning associated with this product is the risk of Reye's syndrome, particularly 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 healthcare professional immediately, as these may be early signs of this rare but serious illness.

Patients are advised to stop using the product and seek medical attention if they experience an allergic reaction or any signs indicative of stomach bleeding. Symptoms of stomach bleeding include feeling faint, having bloody or black stools, vomiting blood, or experiencing persistent stomach pain. Additionally, if pain worsens or lasts longer than 10 days, if there is noticeable redness or swelling, if new symptoms arise, or if patients experience ringing in the ears or a loss of hearing, they should contact a doctor, as these could signal a serious condition.

Before using this product, patients should consult a healthcare provider if they have a history of stomach problems such as heartburn, or if they have conditions such as high blood pressure, heart disease, liver cirrhosis, or kidney disease. Those taking a diuretic, individuals with asthma, or patients who have not been adequately hydrating or have lost significant fluids due to vomiting or diarrhea should also seek medical advice prior to use.

Drug Interactions

The concomitant use of anticoagulants or steroid medications may elevate the risk of severe 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 both prescription and over-the-counter options such as aspirin, ibuprofen, and naproxen, can further increase the risk of severe stomach bleeding. It is advisable for patients to avoid the concurrent use of these medications unless specifically directed by a healthcare provider.

Patients who are on prescription medications for diabetes, gout, or arthritis are encouraged to consult with their healthcare provider or pharmacist prior to initiating treatment with this drug to ensure safety and efficacy.

No specific interactions with laboratory tests have been identified in the available data.

Packaging & NDC

Below are the non-prescription pack sizes of Aspirin 81 mg (aspirin enteric coated tablets 81 mg). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients under 12 years of age should consult a healthcare professional before using this product. It is contraindicated in children and teenagers who have or are recovering from chickenpox or flu-like symptoms due to the risk of Reye's syndrome.

Healthcare providers should be vigilant for changes in behavior accompanied by nausea and vomiting in pediatric patients using this product, as these symptoms may indicate the onset of Reye's syndrome, a rare but serious condition.

Geriatric Use

Elderly patients, particularly those aged 60 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 of gastrointestinal bleeding is recommended, and dosage adjustments may be necessary based on the individual patient's health status and concurrent medications. Careful assessment of the risks versus benefits should be conducted to ensure the safety of elderly patients receiving this treatment.

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 before 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

There is no information available regarding dosage adjustments, special monitoring, or safety considerations for patients with renal impairment. Healthcare professionals should exercise caution and consider the lack of specific guidance when prescribing to patients with reduced kidney function.

Hepatic Impairment

There is no information available regarding the use of this medication in patients with hepatic impairment. Consequently, there are no dosage adjustments, special monitoring requirements, or precautions specified for individuals with compromised liver function. Healthcare professionals should exercise clinical judgment when considering the use of this medication in patients with liver problems, as the absence of data does not preclude the need for careful evaluation and monitoring based on individual patient circumstances.

Overdosage

In the absence of specific information regarding overdosage, healthcare professionals are advised to exercise caution and adhere to general principles of management in cases of suspected overdose.

It is essential to monitor the patient closely for any potential symptoms that may arise from an overdose. Symptoms can vary widely depending on the substance involved and the individual patient's response.

In the event of an overdose, the following management procedures are recommended:

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 as necessary, which may include airway management, oxygen supplementation, and intravenous fluids.

3. Consultation: Engage with a poison control center or a medical toxicologist for guidance on specific interventions and treatments that may be appropriate based on the substance involved.

4. Documentation: Document all findings, interventions, and the patient's response to treatment meticulously.

Healthcare professionals should remain vigilant and prepared to implement these general management strategies in the event of an overdose, even in the absence of specific overdosage information.

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 associated with the use of the product. Reports of gastrointestinal bleeding have been noted, particularly in patients with risk factors such as advanced age, a history of ulcers, and concurrent use of anticoagulants or other nonsteroidal anti-inflammatory drugs (NSAIDs).

Additionally, allergic reactions have been reported, including hives, facial swelling, shock, and asthma symptoms such as wheezing. Furthermore, cases of Reye's syndrome have been documented in children and teenagers recovering from chickenpox or flu-like symptoms who used aspirin. These events were reported voluntarily or through surveillance programs.

Patient Counseling

Patients should be advised to keep this medication out of reach of children. In the event of an overdose, they should seek medical help or contact a Poison Control Center immediately.

It is important to inform patients not to use this medication if they are allergic to aspirin or any other pain reliever or fever reducer. Patients should be instructed to stop use and consult a doctor if they experience any signs of an allergic reaction, such as difficulty breathing or swelling of the face or throat, and to seek medical help right away. They should also be made aware of the signs of stomach bleeding, which include feeling faint, having bloody or black stools, vomiting blood, or experiencing stomach pain that does not improve. Patients should discontinue use and consult a healthcare professional if their pain worsens or lasts more than 10 days, if redness or swelling occurs, if new symptoms arise, or if they experience ringing in the ears or a loss of hearing, as these may indicate a serious condition.

Patients should be encouraged to ask a doctor before use if any of the following apply: they have a history of stomach problems, such as heartburn; they have high blood pressure, heart disease, liver cirrhosis, or kidney disease; they are taking a diuretic; they have asthma; they have not been drinking fluids; or they have lost a significant amount of fluid due to vomiting or diarrhea.

Additionally, patients should be advised to consult a doctor or pharmacist before use if they are taking a prescription drug for diabetes, gout, or arthritis, if they are taking any other medications, or if they are under a doctor's care for any serious condition.

Storage and Handling

The product is supplied in various package configurations, with specific NDC numbers available for identification. Currently, there are no specified storage or handling conditions outlined in the provided information. Therefore, healthcare professionals are advised to refer to the product's official labeling or consult the manufacturer for any additional details regarding storage and handling requirements.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

This file contains official product information for Aspirin 81 mg, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)