Aspirin

Description

Aspirin is a nonsteroidal anti-inflammatory drug (NSAID) indicated for pain relief. This formulation is a low-dose version, containing 81 mg of aspirin per tablet. The tablets are enteric coated and safety coated to enhance gastrointestinal tolerability and ensure product integrity. Each bottle contains 1000 tablets. The product features a tamper-evident seal; it 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.

There are no teratogenic or nonteratogenic effects associated with this drug.

Dosage and Administration

Patients should adhere strictly to the recommended dosage. Each dose should be taken with a full glass of water to ensure proper administration.

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, the use of this medication is not recommended unless specifically directed by a physician.

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 used in 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). 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: exceeding the recommended dosage or duration of use, concurrent use of other NSAIDs (such as aspirin, ibuprofen, or naproxen), a history of stomach ulcers or bleeding disorders, consumption of three or more alcoholic beverages daily while using this product, concurrent use of anticoagulants or steroid medications, and in patients aged 60 years or older.

Healthcare professionals should advise patients to consult a doctor prior to use if any of the following conditions apply: a history of stomach bleeding, asthma, previous stomach issues (such as heartburn), current use of diuretics, or the presence of high blood pressure, heart disease, liver cirrhosis, or kidney disease. Additionally, patients should seek guidance from a doctor or pharmacist if they are currently taking prescription 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 consult a healthcare professional if they experience any signs of an allergic reaction, such as hives or swelling, or if they observe any symptoms indicative of stomach bleeding, including vomiting blood, passing bloody or black stools, feeling faint, or experiencing persistent stomach pain. Other concerning symptoms that warrant immediate medical attention include ringing in the ears, loss of hearing, the emergence of new symptoms, worsening pain lasting more than 10 days, fever persisting beyond 3 days, or the presence of redness or swelling, as these may signal a serious underlying condition.

Side Effects

Patients using this product should be aware of several serious 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.

Additionally, there is an allergy alert associated with this product. Aspirin may cause severe allergic reactions, which can manifest as hives, facial swelling, shock, or asthma symptoms such as wheezing. Patients experiencing any signs of an allergic reaction should seek medical attention promptly.

This product contains a nonsteroidal anti-inflammatory drug (NSAID), which carries a warning for the potential risk of severe stomach bleeding. The likelihood of this adverse reaction increases under certain conditions, including prolonged use beyond the directed dosage, concurrent use of other NSAIDs (such as aspirin, ibuprofen, or naproxen), a history of stomach ulcers or bleeding problems, consumption of three or more alcoholic drinks daily while using the product, use of blood-thinning (anticoagulant) or steroid medications, and in patients aged 60 years or older.

Patients are advised to stop using the product and consult a doctor if they experience any signs of an allergic reaction or symptoms indicative of stomach bleeding, such as vomiting blood, having bloody or black stools, feeling faint, or experiencing persistent stomach pain. Other concerning symptoms that warrant medical consultation include ringing in the ears, loss of hearing, the emergence of new symptoms, worsening pain lasting more than 10 days, or a fever that worsens or persists beyond three days, as well as any redness or swelling. These symptoms could signify a serious condition requiring immediate medical evaluation.

Drug Interactions

Aspirin may interact with various medications, leading to significant clinical effects that warrant careful consideration.

Nonsteroidal Anti-Inflammatory Drugs (NSAIDs) Aspirin may interact with other drugs containing prescription or nonprescription NSAIDs, such as ibuprofen and naproxen. Co-administration of these agents can increase the risk of adverse effects, particularly gastrointestinal complications.

Anticoagulants and Steroids The concomitant use of aspirin with blood-thinning agents (anticoagulants) or steroid medications may elevate the risk of stomach bleeding. It is advisable to monitor patients closely for signs of gastrointestinal bleeding and consider dosage adjustments as necessary.

Diuretics Patients taking diuretics should consult a healthcare provider prior to initiating aspirin therapy, as there may be potential interactions that could affect the efficacy of the diuretic or increase the risk of adverse effects.

Other Prescription Medications Aspirin may also interact with prescription drugs used for conditions such as gout, diabetes, or arthritis. Healthcare professionals should evaluate the potential for interactions and adjust treatment regimens accordingly to ensure patient safety.

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, a rare but serious illness. If changes in behavior accompanied by nausea and vomiting occur while using this product, a healthcare professional should be consulted, as these may be early signs of Reye's syndrome.

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 tablets every 4 hours, with a maximum of 48 tablets in a 24-hour period, unless otherwise directed by a healthcare professional.

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 advised, 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 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 developing fetus and lead to complications during delivery.

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 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 or specific monitoring parameters may be necessary based on the severity of hepatic impairment. Therefore, healthcare providers should assess the patient's overall health status, including any comorbidities such as high blood pressure or heart disease, before initiating treatment.

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 assess the patient for any signs of toxicity or distress.

Management of an overdose should be guided by the severity of the symptoms and the clinical judgment of the healthcare provider. Supportive care and symptomatic treatment may be necessary, and the involvement of poison control experts can provide additional guidance on the appropriate management strategies.

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 provided regarding nonclinical toxicology or animal pharmacology and toxicology.

Postmarketing Experience

Postmarketing experience has revealed reports of serious adverse reactions, including gastrointestinal bleeding, allergic reactions, and Reye's syndrome. Cases of gastrointestinal bleeding have been documented, particularly in patients with a history of ulcers or those concurrently using other nonsteroidal anti-inflammatory drugs (NSAIDs). Allergic reactions, such as hives, facial swelling, and shock, have also been noted in postmarketing reports. Additionally, instances of Reye's syndrome have been reported in children and teenagers who used aspirin during viral infections, especially in cases of chickenpox or flu-like symptoms.

Patient Counseling

Patients should be advised to keep this medication out of reach of children to prevent accidental ingestion. In the event of an overdose, it is crucial to seek medical assistance or contact a Poison Control Center immediately.

Patients must be informed not to use this product if they have a known allergy to aspirin or any other pain reliever or fever reducer. Additionally, they should refrain from using it if they have previously experienced an allergic reaction to this product or any of its ingredients. If an allergic reaction occurs, patients should stop using the medication and seek medical help right away.

Healthcare providers should instruct patients to discontinue use 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. Patients should also be advised to stop use and seek medical attention if they notice ringing in the ears, a loss of hearing, or if new symptoms arise. Furthermore, if pain worsens or lasts more than 10 days, or if fever intensifies or persists for more than 3 days, patients should consult a healthcare professional. Redness or swelling should also prompt a discussion with a doctor, as these could indicate a serious condition.

Patients should be encouraged to ask a doctor before using this medication if they have a history of stomach bleeding, asthma, or stomach problems such as heartburn. It is also important for patients to consult a healthcare provider if they are taking a diuretic, have high blood pressure, heart disease, liver cirrhosis, or kidney disease. Additionally, patients should seek advice from a doctor or pharmacist if they are currently taking prescription medications for gout, diabetes, or arthritis.

Storage and Handling

The product is supplied with an expiration date clearly indicated on the package. It should be stored at a controlled room temperature of 25°C (77°F). Temporary excursions are permissible within the range of 15° to 30°C (59° to 86°F). Proper storage conditions are essential to maintain the integrity and efficacy of the product.

Additional Clinical Information

The medication is administered orally. Clinicians should advise patients who are pregnant or breastfeeding to consult a healthcare 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 Aspirin, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

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