Aspirin

Description

Aspirin is presented in a dosage form of 81 mg, featuring an orange flavor. This formulation is designed for specific therapeutic applications, leveraging the pharmacological properties of aspirin.

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 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 of this product is contraindicated in patients with a known allergy to aspirin or any other pain reliever or fever reducer. Additionally, the product should not be used for at least 7 days following a tonsillectomy or oral surgery, unless specifically directed by a healthcare professional.

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 Reye’s syndrome, a rare but serious condition.

Aspirin may provoke severe allergic reactions, which can manifest as hives, facial swelling, asthma (wheezing), or shock. 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 individuals who are 60 years of age or older, have a history of stomach ulcers or bleeding disorders, are taking anticoagulants or steroid medications, are using other NSAIDs (including aspirin, ibuprofen, or naproxen), consume three or more alcoholic beverages daily, or exceed the recommended dosage or duration of use.

Healthcare providers should advise patients to consult a physician prior to using this product if they have a history of stomach issues, such as heartburn, or if they have conditions such as high blood pressure, heart disease, liver cirrhosis, or kidney disease. Additionally, patients taking diuretics or those with asthma should seek medical advice before use.

In the event of an accidental overdose, it is crucial to obtain emergency medical assistance or contact a Poison Control Center at 1-800-222-1222 immediately.

Patients should discontinue use and contact their healthcare provider if they experience any signs of an allergic reaction, such as difficulty breathing or swelling, or if they notice symptoms indicative of stomach bleeding, including feeling faint, vomiting blood, passing bloody or black stools, or experiencing persistent stomach pain. Furthermore, 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 seek medical attention promptly.

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 chicken pox 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 may also cause severe allergic reactions, which can manifest as hives, facial swelling, asthma (wheezing), or shock. Patients experiencing any signs of an allergic reaction should seek medical help right away.

The product contains a nonsteroidal anti-inflammatory drug (NSAID), which carries a risk of severe stomach bleeding. The likelihood of this adverse reaction is increased in patients who are 60 years of age or older, have a history of stomach ulcers or bleeding problems, are taking blood thinners or steroid medications, consume three or more alcoholic drinks daily while using the product, or take other medications containing NSAIDs. Patients should be vigilant for signs of stomach bleeding, such as feeling faint, vomiting blood, having bloody or black stools, or experiencing persistent stomach pain. If any of these symptoms occur, patients should stop using the product and consult a doctor.

Patients are advised to stop use and seek medical attention if pain worsens or lasts longer than 10 days, if redness or swelling is present, if new symptoms arise, or if they experience ringing in the ears or loss of hearing.

Before using this product, patients should consult a doctor if they have a history of stomach problems, such as heartburn, or if they have high blood pressure, heart disease, liver cirrhosis, or kidney disease. Additionally, patients taking diuretics or prescription medications for gout, diabetes, or arthritis should seek advice from a healthcare professional prior to use.

For pregnant or breastfeeding patients, it is essential to consult a health professional before using this product. Aspirin should be avoided during the last three months of pregnancy unless specifically directed by a doctor, as it may pose risks to the unborn child or lead to complications during delivery.

Drug Interactions

The concomitant use of this product with anticoagulants or steroid medications may elevate the risk of gastrointestinal bleeding. Healthcare professionals should exercise caution when prescribing this product alongside these drug classes.

Additionally, the use of this product in conjunction with other 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 their healthcare provider if they are currently taking any prescription medications for conditions such as gout, diabetes, or arthritis to ensure safe and effective use.

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

Packaging & NDC

Below are the non-prescription pack sizes of Aspirin 81mg. 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, it is important to consult a doctor, as these may be early signs of Reye’s syndrome.

For dosing, adults and children aged 12 years and older may take 4 to 8 tablets every 4 hours, with a maximum of 48 tablets in a 24-hour period unless otherwise directed by a doctor. For children under 12 years of age, consultation with a doctor is advised before use.

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 this medication to geriatric patients, especially if they have a history of stomach problems, high blood pressure, heart disease, liver cirrhosis, or kidney disease.

Before initiating treatment, healthcare providers should inquire about the presence of any conditions that may heighten the risk of stomach bleeding. Close monitoring of these patients is recommended to ensure safety and to manage any potential adverse effects effectively.

Pregnancy

Pregnant patients should consult a healthcare professional before using this medication. The use of aspirin during the last trimester of pregnancy is particularly cautioned against, as it may lead to adverse effects on fetal development and complications during delivery. Therefore, it is essential that pregnant women only use aspirin in this period if specifically directed by a physician. Additionally, breastfeeding patients should also seek advice from a healthcare provider prior to use.

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 doctor, 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 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 conditions such as liver cirrhosis. It is essential for these patients to receive appropriate evaluation and monitoring of their liver function to ensure safe 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 accidental overdose, it is imperative to seek immediate medical assistance. Healthcare professionals should advise patients or caregivers to contact a Poison Control Center at 1-800-222-1222 without delay.

Prompt intervention is crucial in managing potential overdose situations. Symptoms of overdose may vary depending on the specific substance involved; therefore, a thorough assessment and appropriate management strategies should be implemented based on clinical presentation and available resources.

Healthcare providers are encouraged to monitor the patient closely and provide supportive care as necessary. This may include symptomatic treatment and, if indicated, specific antidotes or interventions based on the substance involved in the overdose.

Nonclinical Toxicology

It is especially important not to use aspirin during the last three months of pregnancy unless specifically 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 provided regarding nonclinical toxicology or animal pharmacology and toxicology.

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 (1-800-222-1222) in the event of an accidental overdose.

Patients should be informed that if they have a known allergy to aspirin or any other pain reliever or fever reducer, they should refrain from using this product for at least 7 days following a tonsillectomy or oral surgery, unless specifically directed by a physician.

It is important for healthcare providers to instruct patients 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. Patients should also be made aware of the signs of stomach bleeding, which include feeling faint, vomiting blood, having bloody or black stools, or experiencing persistent stomach pain. Additionally, patients should be advised to seek medical attention if their pain worsens or lasts longer than 10 days, if they notice redness or swelling, if new symptoms arise, or if they experience ringing in the ears or loss of hearing.

Healthcare providers should encourage patients to consult with a doctor before using this product 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 seek medical advice prior to use. Furthermore, it is recommended that patients taking a diuretic or those with asthma discuss their situation with a healthcare professional before using this product.

Lastly, patients should be advised to consult a doctor or pharmacist if they are currently taking prescription medications for gout, diabetes, or arthritis, to ensure safe and effective use of this product.

Storage and Handling

The product is supplied in a configuration that includes an imprinted safety seal under the cap. It is essential to store the product at room temperature to maintain its integrity and effectiveness. Healthcare professionals should ensure that the product is not used if the safety seal is broken or missing, as this may indicate potential tampering or contamination.

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 administration.

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 81mg, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)