Regular Strength Aspirin

Description

No relevant information is available for SPL code 34089-3.

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 for optimal efficacy. It is important to swallow the tablets whole; they should not be chewed or crushed to ensure proper release of the active ingredients.

For adults and children aged 12 years and older, the recommended dosage is 1 to 2 tablets every 4 hours as needed. The total daily dosage should not exceed 12 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 doctor for appropriate dosing recommendations. Adherence to the recommended dosage is crucial to avoid exceeding the maximum allowable intake.

Contraindications

There are no specific contraindications listed for this product. However, it is essential to keep the product out of reach of children to prevent accidental ingestion. In the event of an overdose, immediate medical assistance should be sought, or the Poison Control Center (1-800-222-1222) should be contacted.

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, a rare but serious illness. 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 may be early signs of Reye's syndrome.

Aspirin may induce severe allergic reactions, which can manifest as hives, facial swelling, asthma (wheezing), or shock. Individuals with known allergies to aspirin or other pain relievers/fever reducers should refrain from using this product.

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

Healthcare professionals should advise patients to consult a doctor prior to use if any of the following conditions apply: the stomach bleeding warning is relevant, the patient is taking a diuretic, has a history of stomach issues such as heartburn, or has conditions such as high blood pressure, heart disease, liver cirrhosis, kidney disease, or asthma. Additionally, patients should seek guidance from a doctor or pharmacist if they are currently taking prescription medications for diabetes, gout, or arthritis.

Patients are advised to discontinue use and consult a healthcare professional if they experience any signs of stomach bleeding, such as feeling faint, vomiting blood, passing bloody or black stools, or experiencing persistent stomach pain. Immediate medical attention should be sought in the event of an allergic reaction. Other reasons to stop use include worsening pain lasting more than 10 days, the presence of redness or swelling, a fever that worsens or persists beyond three days, the emergence of new symptoms, or symptoms such as ringing in the ears or loss of hearing, which may indicate a serious condition.

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

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 cause severe allergic reactions in some patients, which can manifest as hives, facial swelling, asthma (wheezing), or shock. Patients with a known allergy to aspirin or any other pain reliever or fever reducer should not use this product.

This 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 anticoagulants or steroid medications, consume three or more alcoholic drinks daily, or use other NSAIDs concurrently. Patients should be advised to seek medical attention if they experience any signs of stomach bleeding, such as feeling faint, vomiting blood, having bloody or black stools, or experiencing persistent stomach pain.

Patients are also cautioned to consult a doctor before using this product if they have a history of stomach problems (such as heartburn), high blood pressure, heart disease, liver cirrhosis, kidney disease, or asthma, or if they are taking diuretics or prescription medications for diabetes, gout, or arthritis.

Patients should discontinue use and seek medical advice if they experience worsening pain that lasts more than 10 days, redness or swelling, fever that worsens or lasts more than three days, any new symptoms, or symptoms such as ringing in the ears or loss of hearing, which may indicate a serious condition.

Drug Interactions

Co-administration of aspirin with anticoagulants or steroid medications may elevate the risk of gastrointestinal bleeding. Healthcare professionals should exercise caution and consider monitoring patients for signs of bleeding when these medications are used concurrently.

The concomitant use of aspirin with other nonsteroidal anti-inflammatory drugs (NSAIDs), including ibuprofen and naproxen, is also associated with an increased risk of stomach bleeding. It is advisable to avoid the simultaneous use of multiple NSAIDs to mitigate this risk.

Patients taking diuretics should consult their healthcare provider prior to using aspirin to ensure safe and effective use. Additionally, individuals on prescription medications for diabetes, gout, or arthritis are encouraged to seek guidance from a healthcare professional or pharmacist before initiating aspirin therapy to prevent potential interactions.

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

Packaging & NDC

Below are the non-prescription pack sizes of Regular Strength Aspirin (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, 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 1-2 tablets every 4 hours as needed, with a maximum of 12 tablets in 24 hours, or as directed by a healthcare professional. For children under 12 years of age, it is advised to consult a doctor before use.

This product should be kept out of reach of children. In the event of an overdose, immediate medical assistance should be sought, or contact a Poison Control Center at 1-800-222-1222.

Geriatric Use

Elderly patients, particularly those aged 60 years and older, are at an increased risk for severe stomach bleeding. It is essential for healthcare providers to advise these patients to consult a physician before using this medication if they have concerns related to the stomach bleeding warning.

For geriatric patients, the recommended dosage is consistent with that for adults and children aged 12 years and older. Patients should take 1-2 tablets every 4 hours as needed, with a maximum limit of 12 tablets in a 24-hour period, unless otherwise directed by a healthcare professional.

Given the heightened risk of adverse effects in this population, careful monitoring and consideration of individual patient factors are crucial when prescribing this medication to elderly 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 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 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 a history of kidney disease. It is essential to assess renal function and consider potential dosing adjustments or monitoring requirements based on the degree of impairment.

Hepatic Impairment

Patients with hepatic impairment, particularly those with liver cirrhosis, should consult a healthcare professional prior to use. It is essential to assess liver function and consider potential adjustments in dosage or treatment plans based on the severity of hepatic impairment. 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. Healthcare professionals are advised to contact a Poison Control Center at 1-800-222-1222 for guidance on managing the situation effectively.

Prompt intervention is crucial, as the symptoms of an overdose may vary depending on the substance involved. Therefore, a thorough assessment and appropriate management strategies should be implemented based on the specific clinical scenario presented.

Healthcare providers should ensure that they are prepared to provide comprehensive care, which may include supportive measures and symptomatic treatment as necessary. Continuous monitoring of the patient’s condition is essential to address any complications that may arise during the management of an overdose.

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 keep this medication out of reach of children to prevent accidental ingestion. It is crucial to emphasize the importance of safety in the home environment, particularly for households with young children.

In the event of an overdose, healthcare providers should instruct patients to seek medical help immediately or contact a Poison Control Center at 1-800-222-1222. Patients should be made aware of the potential seriousness of an overdose and the importance of prompt action.

Storage and Handling

The product is supplied in various package configurations, with specific NDC numbers available upon request. It should be stored at room temperature, within the range of 15°C to 30°C (59°F to 86°F). Proper storage conditions are essential to maintain the integrity of the product.

Additional Clinical Information

The medication is administered orally. 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 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 Regular Strength Aspirin, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)