Aspirin

Description

The drug is identified by the SPL code 34089-3. It is presented as a white to off-white, round, biconvex tablet, which is debossed with "XYZ" on one side and "123" on the opposite side. Each tablet contains 500 mg of the active ingredient. The formulation includes several inactive ingredients: microcrystalline cellulose, croscarmellose sodium, magnesium stearate, hydroxypropyl methylcellulose, titanium dioxide, iron oxide (red), and iron oxide (yellow).

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 release action, this product is not intended for the fast relief of headaches or other symptoms requiring immediate alleviation.

Limitations of Use: 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.

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 individuals with a known allergy to aspirin or any other pain reliever or fever reducer.

Patients should discontinue use and consult a healthcare professional if they experience signs of stomach bleeding, including feeling faint, vomiting blood, having bloody or black stools, or persistent stomach pain. Additionally, an allergic reaction necessitates immediate medical attention. The product should not be used if pain worsens or persists beyond 10 days, if redness or swelling occurs, if new symptoms arise, or if there is ringing in the ears or loss of hearing.

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 with a known allergy to aspirin or any other pain reliever or fever reducer should avoid using this product.

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 taking anticoagulants or steroid medications

• Are using 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

Emergency Medical Help In the event of an overdose, immediate medical assistance should be sought, or the Poison Control Center should be contacted without delay.

When to Stop Taking the Product and Contact a Doctor Patients should discontinue use and seek medical attention if they experience any of the following:

• Signs of stomach bleeding, including feeling faint, vomiting blood, passing bloody or black stools, or experiencing persistent stomach pain

• Any signs of an allergic reaction

• Worsening pain or pain that persists for more 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 adequately informed of these warnings and precautions to promote safe use of the product.

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, the product carries a significant allergy alert. Aspirin may induce 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 assistance promptly.

The product also 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 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 the 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. Furthermore, if an allergic reaction occurs, medical help should be sought immediately. Patients should also seek medical advice if pain worsens or lasts longer than 10 days, if redness or swelling is observed, 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), high blood pressure, heart disease, liver cirrhosis, or kidney disease, are taking diuretics, or have asthma, as these conditions may increase the risk of adverse reactions.

Drug Interactions

The concomitant use of anticoagulants or steroid medications with this drug may significantly increase the risk of severe gastrointestinal bleeding. Healthcare professionals should exercise caution when prescribing these agents together and consider monitoring for signs of gastrointestinal complications.

Additionally, the concurrent administration of this drug with other nonsteroidal anti-inflammatory drugs (NSAIDs), including but not limited to aspirin, ibuprofen, and naproxen, also elevates the risk of severe stomach bleeding. It is advisable to evaluate the necessity of NSAID therapy in patients receiving this drug and to monitor for any gastrointestinal 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. 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, it is important to consult a doctor, as these may be early signs of Reye's syndrome.

For dosage and administration, adults and children aged 12 years and over may take 4 to 8 tablets every 4 hours, not exceeding 48 tablets in a 24-hour period unless directed by a doctor. For children under 12 years, 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. This heightened risk necessitates careful consideration when prescribing medications that may exacerbate this condition.

Healthcare providers should exercise caution and consult with patients regarding their medical history, especially if they have a history of stomach problems, such as heartburn, or chronic conditions including high blood pressure, heart disease, liver cirrhosis, or kidney disease. These conditions are more prevalent in geriatric patients and may influence the safety and efficacy of treatment options.

Monitoring and potential dose adjustments may be warranted in this population to mitigate risks and ensure optimal therapeutic outcomes.

Pregnancy

Use of aspirin during the last trimester of pregnancy is contraindicated unless specifically directed by a healthcare provider. Administration of aspirin in this period may pose risks to the unborn child and can lead to complications during delivery. Healthcare professionals should counsel pregnant patients regarding these potential risks and consider alternative therapies when appropriate. It is essential to weigh the benefits against the potential fetal impacts before prescribing aspirin to women in the later stages of pregnancy.

Lactation

Lactating mothers are advised to consult a health professional prior to 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 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 while breastfeeding.

Renal Impairment

There is no specific information regarding dosage adjustments, special monitoring, or safety considerations for patients with renal impairment. Healthcare professionals should exercise caution when prescribing to patients with reduced kidney function, as the absence of detailed guidance necessitates careful clinical judgment. Regular monitoring of renal function may be advisable in this patient population.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in relation to the use of this medication. Consequently, there are no established dosage adjustments, special monitoring requirements, or precautions outlined for individuals with compromised liver function. It is recommended that healthcare providers exercise caution when prescribing this medication to patients with hepatic impairment, given the lack of data on its safety and efficacy in this population. Regular monitoring of liver function may be prudent in these cases, although specific parameters are not defined in the available information.

Overdosage

In the absence of specific information regarding overdosage, healthcare professionals are advised to exercise caution and adhere to general principles of management in cases of suspected overdose.

It is essential to monitor the patient closely for any potential symptoms that may arise, as the clinical presentation can vary depending on the substance involved and the individual patient's response. Common symptoms of overdose may include, but are not limited to, altered mental status, cardiovascular instability, respiratory distress, and gastrointestinal disturbances.

In the event of an overdose, immediate medical attention should be sought. Healthcare providers should initiate supportive care, which may include maintaining airway patency, providing supplemental oxygen, and monitoring vital signs. The use of activated charcoal may be considered if the patient presents within a suitable timeframe and if the ingestion was recent.

Additionally, specific antidotes or treatments may be indicated based on the substance involved in the overdose. Consultation with a poison control center or a medical toxicologist is recommended to guide the management of the patient and to determine the most appropriate interventions.

Overall, vigilance and prompt action are critical in managing cases of suspected overdose, even in the absence of detailed information regarding specific overdosage effects.

Nonclinical Toxicology

It is especially important not to use aspirin during the last three months of pregnancy unless specifically directed by a healthcare professional, as it may lead to complications for the unborn child or 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 current information.

Postmarketing Experience

Postmarketing experience has identified several adverse reactions reported voluntarily or through surveillance programs. These include gastrointestinal bleeding, allergic reactions such as anaphylaxis, and Reye's syndrome in children and teenagers recovering from chickenpox or flu-like symptoms. Additionally, asthma exacerbation, tinnitus, and hearing loss have been noted. Reports of stomach ulcers and bleeding problems have also been documented. Furthermore, other unspecified adverse reactions have been reported.

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 to inquire whether patients have a known allergy to aspirin or any other pain reliever or fever reducer prior to recommending use.

Patients should be instructed to discontinue use and consult a doctor if they experience any signs of stomach bleeding, which may include feeling faint, vomiting blood, having bloody or black stools, or experiencing persistent stomach pain. Additionally, patients should seek medical help immediately if they notice any allergic reactions, if their 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.

Healthcare providers should also encourage patients to consult a doctor before use if they have a history of stomach problems, such as heartburn, or if the stomach bleeding warning applies to them. It is essential to discuss any existing conditions, including high blood pressure, heart disease, liver cirrhosis, or kidney disease, as well as the use of diuretics or a history of asthma.

Furthermore, patients should be advised to speak with their doctor or pharmacist before using this medication if they are currently taking prescription drugs for gout, diabetes, or arthritis.

Storage and Handling

The product is supplied in packaging that includes specific NDC numbers. It should be stored at a temperature range of 15° to 30°C (59° to 86°F) to maintain its integrity and efficacy. Healthcare professionals are advised to inspect the carton seal prior to use; the product should not be utilized if the seal is missing or damaged, as this may compromise the product's safety and effectiveness.

Additional Clinical Information

The medication is administered orally. Clinicians should counsel patients on the importance of avoiding 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. No additional information is available regarding laboratory tests, abuse potential, or postmarketing experience.

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)