Aspirin

Description

The product is Aspirin, with a strength of 325 mg. It is identified by the SPL Code 34089-3 and is available in multiple packaging options, including bulk and bottle labels.

Uses and Indications

This drug is indicated for the temporary relief of minor aches and pains associated with various conditions, including headache, colds, menstrual pain, muscle pain, toothache, and minor pain of arthritis. It may also be used as directed by a healthcare professional.

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

Dosage and Administration

Patients should drink a full glass of water with each dose to ensure proper administration and absorption.

For adults and children aged 12 years and older, the recommended dosage is 1 to 2 tablets every 4 hours as needed while symptoms persist. It is important not to exceed 12 tablets within a 24-hour period unless directed by a healthcare professional.

For children under 12 years of age, it is advised to consult a doctor for appropriate dosing recommendations.

Contraindications

Use is contraindicated in individuals with a known allergy to aspirin or any other pain reliever or fever reducer. Due to the potential for severe allergic reactions, administration in these patients is not recommended.

Warnings and Precautions

Patients should be informed 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 avoid using 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 has the potential to cause severe allergic reactions. Symptoms may include hives, facial swelling, shock, and asthma (wheezing). Patients with a known allergy to aspirin or other NSAIDs should not use this product.

Stomach Bleeding Warning This product contains a nonsteroidal anti-inflammatory drug (NSAID), which may increase the risk of severe stomach bleeding. The likelihood of this adverse effect is heightened 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

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

• Exceed the recommended dosage or duration of use

• Are using other medications that contain NSAIDs, including aspirin, ibuprofen, or naproxen

Monitoring Parameters Patients should be advised to discontinue use and seek medical attention if they experience any signs of stomach bleeding, which may include feeling faint, having bloody or black stools, vomiting blood, or experiencing persistent stomach pain. Additionally, if pain worsens or lasts longer than 10 days, if fever intensifies or persists beyond three days, if redness or swelling occurs in the affected area, or if any new symptoms arise, medical consultation is recommended. Patients should also report any occurrences of ringing in the ears or hearing loss.

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

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, aspirin may provoke severe allergic reactions in some individuals. Symptoms of such reactions can include hives, facial swelling, shock, and asthma characterized by wheezing.

This product contains a nonsteroidal anti-inflammatory drug (NSAID), which carries a risk of severe stomach bleeding. The likelihood of this adverse reaction is increased 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, consume three or more alcoholic drinks daily while using the product, exceed the recommended dosage or duration of use, or are concurrently using other NSAIDs such as aspirin, ibuprofen, or naproxen.

Patients are advised to discontinue use and seek medical attention if they experience any signs of stomach bleeding, which may manifest as feeling faint, having bloody or black stools, vomiting blood, or experiencing persistent stomach pain. Furthermore, if pain worsens or lasts longer than 10 days, if fever intensifies or persists beyond three days, if redness or swelling occurs in the painful area, if any new symptoms arise, or if there is ringing in the ears or loss of hearing, patients should consult a healthcare professional.

Before using this product, patients should seek medical advice if any of the following conditions apply: a history of stomach problems such as heartburn, asthma, high blood pressure, heart disease, liver cirrhosis, or kidney disease; if they are taking diuretics; if they have not been adequately hydrated; or if they have experienced significant fluid loss due to vomiting or diarrhea. Additionally, patients should consult a doctor or pharmacist if they are taking prescription medications for diabetes, gout, or arthritis, any other drugs, or if they are under medical care for any serious condition.

Drug Interactions

Aspirin may interact with various classes of medications, leading to increased risks of adverse effects.

Anticoagulants and Steroids Aspirin has the potential to enhance the effects of blood-thinning agents (anticoagulants) and steroid medications, which may significantly elevate the risk of gastrointestinal bleeding. It is advisable for patients to undergo careful monitoring if these medications are used concurrently.

Nonsteroidal Anti-Inflammatory Drugs (NSAIDs) Aspirin should not be co-administered with other NSAIDs, whether prescription or nonprescription, such as ibuprofen or naproxen. The concomitant use of these agents may increase the likelihood of adverse effects, including gastrointestinal complications.

Diabetes, Gout, and Arthritis Medications Patients taking prescription medications for diabetes, gout, or arthritis are advised to consult their healthcare provider prior to initiating aspirin therapy, as potential interactions may occur that could affect treatment outcomes.

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 chickenpox or flu-like symptoms should not use this product due to the risk of Reye's syndrome, a rare but serious illness. If pediatric patients experience changes in behavior accompanied by nausea and vomiting while using this product, it is important to consult a healthcare professional, as these may be early signs of Reye's syndrome.

For dosing, adults and children aged 12 years and older are directed to take 1 to 2 tablets every 4 hours while symptoms persist, with a maximum of 12 tablets in 24 hours unless otherwise directed by a physician. For children under 12 years of age, consultation with a doctor is recommended prior to use.

This product should be kept out of reach of children. In the event of an overdose, immediate medical assistance or contact with a Poison Control Center is advised.

Geriatric Use

Elderly patients, particularly those aged 60 and older, are at an increased risk of severe stomach bleeding when using this product, which contains a nonsteroidal anti-inflammatory drug (NSAID). This risk is further heightened in individuals with a history of stomach ulcers or bleeding problems, those who are concurrently using blood-thinning medications (anticoagulants) or steroid drugs, and patients who consume three or more alcoholic drinks daily while using this product.

It is essential for healthcare providers to closely monitor geriatric patients for signs of gastrointestinal bleeding, especially if they are taking this NSAID in conjunction with other medications that may increase the risk, such as prescription or nonprescription NSAIDs (e.g., aspirin, ibuprofen, naproxen). Additionally, dosage adjustments may be necessary for elderly patients to mitigate potential adverse effects. Careful consideration should be given to the duration of therapy and the total daily dose, ensuring that it does not exceed recommended limits.

Pregnancy

Pregnant patients and those who are breastfeeding should consult a healthcare professional before using this medication. The use of aspirin during the last trimester of pregnancy is particularly cautioned against, as it may lead to adverse effects on fetal outcomes or complications during delivery. Therefore, it is essential that pregnant patients only use aspirin in this period if explicitly directed by a healthcare provider.

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, 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 have not been specifically addressed in the available data regarding dosage adjustments, special monitoring, or safety considerations. Therefore, healthcare professionals should exercise caution when prescribing this medication to patients with reduced kidney function, as the lack of information necessitates careful clinical judgment and monitoring of these patients.

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 and consider the overall clinical context when prescribing this medication to patients with hepatic impairment, as individual responses may vary.

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, and respiratory distress.

In the event of an overdose, immediate medical intervention is recommended. 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 is deemed appropriate based on clinical judgment.

Additionally, it is crucial to consult local poison control centers or toxicology experts for guidance on specific management protocols and antidotes, if applicable. Continuous assessment and supportive measures should be prioritized to ensure patient safety and mitigate potential complications associated with overdose.

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 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 reports of various adverse reactions. These include allergic reactions such as hives, facial swelling, shock, and asthma (wheezing). Additionally, instances of stomach bleeding have been noted, particularly in individuals aged 60 or older, those with a history of stomach ulcers or bleeding problems, or patients concurrently using blood thinners or steroids. Furthermore, changes in behavior accompanied by nausea and vomiting have been reported, which may represent early signs of Reye's syndrome in children and teenagers recovering from chickenpox or flu-like symptoms.

Patient Counseling

Healthcare providers should advise patients to keep this medication out of reach of children to prevent accidental ingestion. In the event of an overdose, patients should be instructed to seek medical help or contact a Poison Control Center immediately.

Patients must be informed not to use this medication if they have a known allergy to aspirin or any other pain reliever or fever reducer. It is essential to counsel patients to stop using the medication and consult a doctor if they experience any signs of stomach bleeding, which may include feeling faint, having bloody or black stools, vomiting blood, or experiencing stomach pain that does not improve.

Patients should be made aware that if their pain worsens or persists for more than 10 days, or if their fever worsens or lasts more than 3 days, they should seek medical advice. Additionally, they should report any redness or swelling in the painful area, the appearance of new symptoms, or if they experience ringing in the ears or a loss of hearing.

Healthcare providers should encourage patients to consult a doctor before using this medication if they have a history of stomach problems, such as heartburn, or if the stomach bleeding warning applies to them. Patients with asthma, high blood pressure, heart disease, liver cirrhosis, or kidney disease should also be advised to seek medical guidance prior to use.

Furthermore, patients taking diuretics, those who have not been drinking fluids, or those who have lost a significant amount of fluid due to vomiting or diarrhea should consult a doctor before using this medication. It is also important for patients to discuss with their doctor or pharmacist if they are taking any prescription drugs for diabetes, gout, or arthritis, or if they are on any other medications. Lastly, patients under a doctor's care for any serious condition should be encouraged to seek advice before using this medication.

Storage and Handling

The product is supplied in various package configurations, with specific NDC numbers available for identification. 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).

Healthcare professionals are advised to adhere to the expiration date indicated on the package to ensure product efficacy and safety. Proper storage conditions are essential to maintain the integrity of the product throughout its shelf life.

Additional Clinical Information

No further data are available.

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)