Aspirin

Description

Chewable Aspirin is a nonsteroidal anti-inflammatory drug (NSAID) indicated for the relief of mild to moderate pain and the reduction of fever. It is formulated as a chewable tablet, allowing for rapid dissolution and absorption. The active ingredient is acetylsalicylic acid, which has a molecular weight of 180.16 g/mol and a chemical formula of C9H8O4. The product is designed for oral administration and is typically presented in a flavored formulation to enhance palatability.

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 healthcare provider for appropriate dosing recommendations.

Contraindications

Use of this product is contraindicated in the following situations:

Patients with a known allergy to aspirin or any other pain reliever or fever reducer should not use this product due to the risk of severe allergic reactions.

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, as it may increase the risk of bleeding.

Aspirin use is also contraindicated during the last trimester of pregnancy unless directed by a physician, due to potential risks to the unborn child and complications during delivery.

Warnings and Precautions

Patients should be advised of the following warnings and precautions associated with the use of this product.

Reye’s Syndrome Children and teenagers who are experiencing or recovering from chickenpox or flu-like symptoms should not use this product. If any changes in behavior accompanied by nausea and vomiting occur during use, it is imperative to consult a healthcare professional, as these symptoms may indicate the onset of Reye’s syndrome, a rare but serious condition.

Allergy Alert Aspirin may induce severe allergic reactions, which can manifest as hives, facial swelling, asthma (wheezing), or shock. Patients should be closely monitored for any signs of an allergic response.

Stomach Bleeding Warning 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 meet any of the following criteria:

• Are aged 60 years or older

• Have a history of stomach ulcers or bleeding disorders

• Are concurrently using blood-thinning medications (anticoagulants) or steroid drugs

• Are taking other medications that contain NSAIDs, whether prescription or over-the-counter (e.g., aspirin, ibuprofen, naproxen)

• Consume three or more alcoholic beverages daily while using this product

• Exceed the recommended dosage or duration of use

General Precautions Healthcare professionals should advise patients to consult a doctor prior to use if any of the following conditions apply:

• The patient has a history of stomach problems, such as heartburn

• The patient has high blood pressure, heart disease, liver cirrhosis, or kidney disease

• The patient is taking diuretics

• The patient has asthma

Emergency Medical Help In the event of an accidental overdose, patients should seek immediate medical assistance or contact a Poison Control Center at 1-800-222-1222.

Discontinuation and Consultation Patients should discontinue use and contact a healthcare provider if any of the following occur:

• Signs of an allergic reaction, which require immediate medical attention

• Symptoms indicative of stomach bleeding, such as feeling faint, vomiting blood, passing bloody or black stools, or experiencing persistent stomach pain

• Worsening pain or pain that lasts longer than 10 days

• Presence of redness or swelling

• Onset of new symptoms

• Ringing in the ears or loss of hearing

Healthcare professionals should ensure that patients are fully informed of these warnings and precautions to promote safe and effective use of the product.

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 can occur in children and teenagers who have or are recovering from chicken pox or flu-like symptoms. It is crucial that these individuals do not use 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 may indicate the onset of Reye’s syndrome.

An allergy alert is warranted, as aspirin may cause severe allergic reactions. Symptoms can include hives, facial swelling, asthma (wheezing), and shock. Patients should seek immediate medical attention if they experience any signs of an allergic reaction.

This product contains a nonsteroidal anti-inflammatory drug (NSAID), which may increase the risk of severe stomach bleeding. The likelihood of this adverse reaction is heightened in patients who are 60 years of age or older, have a history of stomach ulcers or bleeding problems, are taking blood-thinning medications or steroids, 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.

Patients are advised to stop using the product and consult a doctor if they experience any signs of stomach bleeding, such as feeling faint, vomiting blood, having bloody or black stools, or experiencing persistent stomach pain. Additionally, 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, medical advice should be sought.

It is particularly important for patients to avoid using aspirin during the last three months of pregnancy unless specifically directed by a healthcare provider, as it may pose risks to the unborn child or lead to complications during delivery.

Drug Interactions

Taking aspirin concurrently with anticoagulant medications may elevate the risk of severe gastrointestinal bleeding. It is advisable to monitor patients closely for signs of bleeding and consider dosage adjustments as necessary.

The concomitant use of aspirin with other nonsteroidal anti-inflammatory drugs (NSAIDs), including both prescription and over-the-counter options such as ibuprofen and naproxen, may also increase the risk of severe stomach bleeding. Caution is recommended, and healthcare providers should assess the need for alternative pain management strategies or adjust dosages accordingly.

Additionally, the use of aspirin in patients receiving diuretics warrants caution. Monitoring of renal function and electrolyte levels may be prudent to mitigate potential adverse effects.

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

Packaging & NDC

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

Pediatric Use

Pediatric patients 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 healthcare professional, as these symptoms may indicate the onset of Reye’s syndrome, a rare but serious condition.

For children under 12 years of age, consultation with a doctor is advised prior to use. For adolescents aged 12 years and older, the recommended dosage is 4 to 8 tablets every 4 hours, with a maximum of 48 tablets in a 24-hour period, unless otherwise directed by a healthcare provider.

Geriatric Use

Elderly patients, particularly those aged 60 years 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 and symptoms of gastrointestinal bleeding is recommended in this population. Additionally, healthcare providers should consider the overall health status and concurrent medications of elderly patients, as these factors may further influence the risk of adverse effects.

Dose adjustments may be necessary based on individual patient assessments, taking into account the increased susceptibility to complications in older adults.

Pregnancy

Pregnant patients should consult a healthcare professional before using this medication, particularly if they are in the later stages of pregnancy or breastfeeding. The use of aspirin during the last trimester is contraindicated unless specifically directed by a physician, as it may pose risks to the unborn child and lead to complications during delivery. Healthcare providers should carefully evaluate the potential benefits and risks when considering the use of this medication in pregnant patients.

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 its use in lactating individuals.

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 and effective 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

Overdosage of this product can lead to significant adverse effects. Healthcare professionals should be aware that symptoms associated with overdose may include nausea, vomiting, and tinnitus (ringing in the ears).

In the event of an overdose, it is imperative to seek immediate medical attention. Prompt intervention is crucial to mitigate potential harm and manage the symptoms effectively.

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 non-teratogenic effects have been provided in the available data. Additionally, there is no information regarding animal pharmacology and toxicology.

Postmarketing Experience

Postmarketing experience has identified several adverse reactions associated with the use of the product. Reports of allergic reactions have been documented, including manifestations such as hives, facial swelling, asthma (wheezing), and shock.

Severe stomach bleeding has also been noted, particularly in patients aged 60 years or older, those with a history of stomach ulcers or bleeding problems, and individuals concurrently using blood thinners or other nonsteroidal anti-inflammatory drugs (NSAIDs).

Furthermore, additional adverse reactions reported include tinnitus (ringing in the ears) and hearing loss.

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 must be informed not to use this product if they have a known allergy to aspirin or any other pain reliever or fever reducer.

It is crucial to instruct patients not to use this product for at least 7 days following a tonsillectomy or oral surgery unless directed by a healthcare professional. Providers should encourage patients to consult a doctor before use if any of the following conditions apply: a history of stomach bleeding, existing stomach problems such as heartburn, high blood pressure, heart disease, liver cirrhosis, or kidney disease. Additionally, patients taking diuretics or those with asthma should also seek medical advice prior to use.

Patients should be advised to consult a doctor or pharmacist before using this product if they are currently taking prescription medications for gout, diabetes, or arthritis. Healthcare providers should instruct patients to discontinue use and seek medical attention 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. Patients should also be informed to stop use if pain worsens or lasts longer than 10 days, if redness or swelling occurs, if new symptoms arise, or if they experience ringing in the ears or loss of hearing.

For patients who are pregnant or breastfeeding, it is essential to recommend consulting a healthcare professional before use. Providers should emphasize the importance of avoiding 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.

Storage and Handling

The product is supplied in a container that must be kept tightly closed to maintain its integrity. It should be stored at room temperature, specifically within the range of 20°C to 25°C (68°F to 77°F). It is essential to protect the product from light exposure to ensure its stability and effectiveness. Additionally, the product should be kept out of reach of children, and any unused portion should be discarded after opening to prevent potential misuse or degradation.

Additional Clinical Information

The route of administration for the medication is oral. Clinicians should advise patients who are pregnant or breastfeeding to consult a health professional prior to use. It is particularly crucial to avoid 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.

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)