Aspirin

Description

No description information is available for the specified drug.

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 and administration guidelines. It is imperative not to exceed the directed dosage.

For adults and children aged 12 years and older, the recommended dosage is 4 to 8 chewable tablets every 4 hours. The total daily intake must not exceed 48 chewable tablets within a 24-hour period unless otherwise directed by a healthcare professional.

Patients are advised to drink a full glass of water with each dose to ensure proper hydration and facilitate the medication's effectiveness. Chewable tablets must be completely chewed or crushed before swallowing; they should not be swallowed whole.

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

Contraindications

Use of this product is contraindicated in the following situations:

• Patients with a known allergy to aspirin or any other pain reliever/fever reducer.

• Individuals who have a history of allergic reactions to this product or any of its ingredients.

• Patients who have undergone tonsillectomy or oral surgery within the past 7 days, unless directed by a healthcare professional.

In the event of an allergic reaction, immediate medical attention is required. Additionally, discontinue use and consult a physician if any of the following occur: signs of stomach bleeding (such as vomiting blood, bloody or black stools, faintness, or persistent stomach pain), tinnitus or hearing loss, worsening pain lasting more than 10 days, fever persisting beyond 3 days, presence of redness or swelling, or the emergence of new symptoms.

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 immediately.

Aspirin may induce severe allergic reactions, which can manifest as hives, facial swelling, shock, or asthma symptoms such as 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 but not limited to the concurrent use of blood thinners (anticoagulants) or steroid medications, the use of other NSAIDs (prescription or nonprescription), consumption of three or more alcoholic beverages daily while using this product, being aged 60 or older, exceeding the recommended dosage or duration of use, or having a history of stomach ulcers or bleeding disorders.

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, high blood pressure, heart disease, liver cirrhosis, kidney disease, asthma, or if they are taking diuretics. Additionally, patients should seek guidance from a doctor or pharmacist if they are currently prescribed 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 are advised to discontinue use and contact a healthcare provider if they experience any signs of an allergic reaction, symptoms indicative of stomach bleeding (such as vomiting blood, bloody or black stools, faintness, or persistent stomach pain), ringing in the ears or hearing loss, worsening pain lasting more than 10 days, fever that worsens or persists beyond three days, redness or swelling, or the emergence of new symptoms. These may indicate a serious condition requiring prompt medical evaluation.

Side Effects

Patients using this product should be aware of several serious adverse reactions associated with its use. Notably, Reye’s syndrome is a rare but serious illness that can 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 may be early signs of Reye's syndrome.

Additionally, there is a significant risk of severe allergic reactions to aspirin, which may manifest as hives, facial swelling, shock, or 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 taking blood thinners (anticoagulants) or steroid medications, those who consume three or more alcoholic drinks daily while using the product, individuals aged 60 or older, and those who take the medication for longer than directed or have a history of stomach ulcers or bleeding problems.

Patients are advised to stop using the product and consult a doctor if they experience any signs of stomach bleeding, which may include vomiting blood, having bloody or black stools, feeling faint, or experiencing persistent stomach pain. 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. These could indicate a serious condition requiring prompt evaluation.

Drug Interactions

There are currently no documented drug interactions associated with this medication. Additionally, there are no known interactions with laboratory tests. As such, no specific recommendations for dosage adjustments or monitoring are warranted at this time.

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 important to consult a doctor, 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. In contrast, adults and children aged 12 years and older may take 4 to 8 chewable tablets every 4 hours, with a maximum of 48 chewable tablets in a 24-hour period, unless otherwise directed by a healthcare professional.

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 of these conditions in elderly patients, as they may necessitate closer monitoring or alternative therapeutic strategies. The potential for adverse effects, such as gastrointestinal bleeding, should be carefully weighed against the benefits of treatment in this population.

Pregnancy

Pregnant patients and those who are breastfeeding should consult a healthcare professional prior to use. The use of aspirin is particularly cautioned against after 20 weeks of pregnancy unless explicitly directed by a physician, as it may pose risks to the developing fetus and lead to complications during delivery. Healthcare providers should carefully evaluate the benefits and risks of aspirin use in this population to ensure maternal and fetal safety.

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, 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 its use during lactation.

Renal Impairment

Patients with renal impairment should consult a healthcare professional prior to use, particularly if they have 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 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 vigilant for symptoms that may arise from an overdose, although specific symptoms are not detailed in the provided information. The management of an overdose typically involves supportive care and symptomatic treatment, tailored to the individual patient's needs.

It is essential for healthcare providers to remain alert to the signs of overdose and to act swiftly to ensure patient safety and optimal outcomes.

Nonclinical Toxicology

It is especially important to avoid the use of aspirin at 20 weeks or later in pregnancy unless specifically directed by a healthcare professional, as it may lead to complications for the unborn child or during delivery. No non-teratogenic effects have been provided in the available data. Additionally, there is no information regarding nonclinical toxicology or animal pharmacology and toxicology in the insert.

Postmarketing Experience

Postmarketing experience has revealed that aspirin may lead to severe allergic reactions, which can manifest as hives, facial swelling, shock, and asthma (wheezing). Additionally, there have been indications that aspirin can cause severe stomach bleeding, particularly in individuals who are concurrently using blood thinning (anticoagulant) or steroid medications, taking other drugs that contain prescription or nonprescription NSAIDs, consuming three or more alcoholic drinks daily while using this product, are aged 60 or older, exceed the recommended dosage or duration of use, or have a history of stomach ulcers or bleeding disorders. Furthermore, reports of Reye’s syndrome have been documented in children and teenagers who have or are recovering from chickenpox or flu-like symptoms following the use of aspirin.

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 important for patients to understand the seriousness of an overdose and the necessity of prompt action to ensure their safety.

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 25°C (77°F), with permissible excursions between 15°C and 30°C (59°F to 86°F).

Healthcare professionals are advised to check the end flap of the packaging for the expiration date and lot number to ensure proper inventory management and product 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)