Aspirin

Description

2023 Globe Aspirin Coated Tablets contain 325 mg of acetylsalicylic acid per tablet. The product is presented in a coated tablet dosage form, designed for oral administration. Each package contains 50 tablets. The expiration date for this product is August 2024, and it is regulated under the Center for Drug Evaluation and Research (CDER).

Uses and Indications

This drug is indicated for the temporary relief of various types of pain and discomfort, including headache, pain and fever associated with colds, toothache, menstrual pain, muscle pain, and minor pain related to arthritis.

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

Dosage and Administration

Adults and children aged 12 years and older are advised to take 1 or 2 tablets every 4 hours, or 3 tablets every 6 hours, with a maximum limit of 12 tablets in a 24-hour period unless otherwise directed by a physician.

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

Each dose should be taken with a full glass of water to ensure proper administration and absorption.

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, which can manifest as facial swelling, hives, shock, or asthma symptoms such as wheezing. Healthcare professionals should be vigilant for these signs and advise patients to seek immediate medical attention if an allergic reaction occurs.

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 have a history of stomach ulcers or bleeding disorders, those taking anticoagulants or steroid medications, individuals aged 60 years or older, and those who consume three or more alcoholic beverages daily while using this product. Additionally, the risk is heightened for patients taking other medications that contain NSAIDs, including aspirin, ibuprofen, or naproxen, especially if they exceed the recommended dosage or duration of use.

Patients should be advised to discontinue use and consult a healthcare provider if they experience any signs of stomach bleeding, such as feeling faint, vomiting blood, passing bloody stools, or experiencing persistent stomach pain. Other concerning symptoms that warrant medical consultation include ringing in the ears, loss of hearing, worsening pain lasting more than 10 days, fever that worsens or persists beyond three days, the emergence of new symptoms, or the presence of redness or swelling, as these may indicate a serious underlying condition.

In the event of an overdose, it is crucial to seek emergency medical assistance or contact a poison control center immediately.

Side Effects

Patients using this product should be aware of several serious adverse reactions and warnings 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.

Severe allergic reactions may also occur, characterized by symptoms such as facial swelling, hives, shock, and 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 increase the risk of severe stomach bleeding. The likelihood of this adverse reaction is heightened in patients with a history of stomach ulcers or bleeding problems, those taking blood-thinning medications or steroids, individuals aged 60 or older, and those consuming three or more alcoholic drinks daily while using this product. Patients should be vigilant for signs of stomach bleeding, including feeling faint, vomiting blood, having bloody stools, or experiencing persistent stomach pain, and should stop use and consult a doctor if these symptoms occur.

Additional warnings include the potential for ringing in the ears or loss of hearing, worsening pain lasting more than 10 days, or a fever that persists beyond three days. Patients should also be cautious of new symptoms, redness, or swelling, as these may indicate a serious condition.

Before using this product, patients should consult a doctor if they have a history of stomach problems, such as heartburn, asthma, high blood pressure, heart disease, liver cirrhosis, or kidney disease. It is also advisable to seek medical advice if they are taking diuretics or prescription medications for gout, diabetes, or arthritis.

Drug Interactions

Aspirin has the potential to induce severe allergic reactions, which may manifest as facial swelling, hives, shock, and asthma symptoms such as wheezing.

When considering concomitant use of aspirin with anticoagulants or steroid medications, it is important to note that the risk of severe gastrointestinal bleeding is significantly increased. Therefore, careful monitoring and assessment of the patient's overall risk factors for bleeding should be conducted.

Patients who are currently prescribed medications for gout, diabetes, or arthritis should consult with a healthcare professional, such as a doctor or pharmacist, prior to initiating aspirin therapy. This is essential to ensure safe and effective use, as potential interactions may necessitate dosage adjustments or enhanced monitoring.

Packaging & NDC

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

Pediatric Use

Pediatric patients, particularly those under 12 years of age, should not use this product unless directed by a healthcare professional. It is contraindicated in children and teenagers who have or are recovering from chickenpox or flu-like symptoms due to the risk of Reye's Syndrome, a rare but serious condition.

If pediatric patients experience changes in behavior accompanied by nausea and vomiting while using this product, it is essential to consult a doctor, as these symptoms may indicate the onset of Reye's Syndrome.

For adolescents aged 12 years and older, the recommended dosage is 1 or 2 tablets every 4 hours or 3 tablets every 6 hours, with a maximum of 12 tablets in a 24-hour period unless otherwise directed by a healthcare provider.

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 gastrointestinal issues, such as heartburn, or if they have comorbid conditions including high blood pressure, heart disease, liver cirrhosis, or kidney disease.

Before initiating treatment, healthcare providers should inquire about the presence of any of these risk factors in elderly patients. Close monitoring for signs of gastrointestinal bleeding is recommended in this population to ensure patient safety and to mitigate potential adverse effects.

Pregnancy

Pregnant patients 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 explicitly 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 have not been specifically addressed in the available prescribing information. There are no dosage adjustments, special monitoring requirements, or safety considerations outlined for individuals with reduced kidney function. Healthcare professionals should exercise caution and consider the lack of data when prescribing to 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 patients closely for any signs or symptoms that may arise following an overdose. Common symptoms may include, but are not limited to, alterations in consciousness, cardiovascular instability, and gastrointestinal disturbances.

In the event of an overdose, immediate medical attention should be sought. Supportive care is the cornerstone of management, which may include monitoring vital signs, providing symptomatic treatment, and ensuring the patient's safety.

Healthcare professionals should also consider contacting a poison control center for guidance on specific interventions and management strategies tailored to the substance involved in the 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 current information.

Postmarketing Experience

No postmarketing experience details are available in the insert text.

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 discuss any known allergies, particularly to aspirin or other pain relievers and fever reducers, as well as any previous allergic reactions to this product or its ingredients.

Patients should be informed to watch for signs of an allergic reaction, which necessitate prompt medical attention. Additionally, they should be made aware of symptoms indicative of stomach bleeding, such as feeling faint, vomiting blood, having bloody stools, or experiencing persistent stomach pain. If patients experience ringing in the ears, loss of hearing, worsening pain lasting more than 10 days, or a fever that worsens or lasts more than 3 days, they should be instructed to seek medical advice.

Healthcare providers should emphasize the importance of reporting any new symptoms, as well as any redness or swelling, as these may signal a serious condition. It is crucial to assess whether the stomach bleeding warning applies to the patient, especially if they have a history of stomach problems, such as heartburn, or if they have asthma.

Patients with high blood pressure, heart disease, liver cirrhosis, or kidney disease should be counseled on the potential risks associated with this product. Furthermore, those taking diuretics or prescription medications for gout, diabetes, or arthritis should be advised to discuss their current medications with their healthcare provider to ensure safe use.

Storage and Handling

The product is supplied in packaging that includes specific NDC numbers, which can be found on the label. It should be stored at a controlled room temperature of 25ºC (77ºF). Temporary excursions are permissible between 15ºC and 30ºC (59ºF to 86ºF).

For proper inventory management, users are advised to check the end flap of the packaging for the expiration date and lot number. It is essential to adhere to the use-by expiration date indicated on the package to ensure product efficacy. Additionally, the product must be kept out of reach of children to prevent accidental ingestion.

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 at 20 weeks of gestation or later 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)