Aspirin

Description

Aspirin is a nonsteroidal anti-inflammatory drug (NSAID) utilized for its analgesic and antipyretic properties. Each tablet contains 325 mg of aspirin, with a total of 100 tablets per bottle. The product is packaged with a tamper-evident safety seal; it should not be used if the seal under the cap is broken or missing. This product is distributed by Drug Mart-Food Fair, located at 211 Commerce Drive, Medina, OH 44256. It is important to note that this product is not manufactured or distributed by Bayer AG, the owner of the registered trademark Genuine Bayer® Aspirin. For more information, visit www.discount-drugmart.com.

Uses and Indications

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

There are no teratogenic or nonteratogenic effects reported for 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 hydration and absorption.

For adults and children aged 12 years and older, the recommended dosage is as follows: 1 or 2 tablets may be taken every 4 hours, or alternatively, 3 tablets may be taken every 6 hours. The total daily dosage must not exceed 12 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, a rare but serious illness. If any changes in behavior accompanied by nausea and vomiting occur while using this product, it is imperative to consult a healthcare professional immediately, as these may be early indicators of Reye's syndrome.

Aspirin may provoke severe allergic reactions in some individuals. Symptoms of such reactions can include facial swelling, shock, hives, 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 is increased in patients who are 60 years of age or older, those taking anticoagulants or steroid medications, individuals consuming three or more alcoholic drinks daily while using this product, and patients with a history of stomach ulcers or bleeding disorders. Additionally, the risk is heightened for those who exceed the recommended dosage or duration of use, or who are concurrently taking other NSAIDs, including aspirin, ibuprofen, or naproxen.

Healthcare professionals should advise patients to consult a doctor prior to use if they are currently taking diuretics, have a history of stomach issues such as heartburn, or have conditions such as high blood pressure, heart disease, liver cirrhosis, or kidney disease. Patients with asthma should also seek medical advice before using this product. Furthermore, it is recommended that patients consult a doctor or pharmacist if they are 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 should be instructed to discontinue use and contact their healthcare provider if they experience any signs of an allergic reaction, such as difficulty breathing or swelling. Additionally, they should seek medical attention if they notice any symptoms indicative of stomach bleeding, including feeling faint, vomiting blood, passing bloody or black stools, or experiencing persistent stomach pain. Other concerning symptoms that warrant immediate medical consultation include ringing in the ears or hearing loss, worsening pain lasting more than 10 days, fever that worsens or persists beyond three days, visible redness or swelling, or the emergence of new symptoms, as these may indicate 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 a significant risk of severe allergic reactions to aspirin, which may manifest as facial swelling, shock, hives, or asthma (wheezing). Patients experiencing any signs of an allergic reaction should seek medical assistance promptly.

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, those taking blood-thinning (anticoagulant) or steroid medications, individuals consuming three or more alcoholic drinks daily while using this product, and patients with a history of stomach ulcers or bleeding problems. Furthermore, the risk is heightened if patients take more of the product or use it for a longer duration than directed, or if they are concurrently using other medications containing prescription or nonprescription NSAIDs, such as aspirin, ibuprofen, or naproxen.

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, which may include feeling faint, vomiting blood, having bloody or black stools, or experiencing persistent stomach pain. Other concerning symptoms warranting medical attention include ringing in the ears or loss of hearing, worsening pain lasting more than 10 days, fever that worsens or lasts more than 3 days, redness or swelling, or the emergence of new symptoms. These could be indicative of a serious condition requiring immediate medical evaluation.

Drug Interactions

Aspirin has several notable interactions with various drug classes, which may lead to increased risks of adverse effects, particularly gastrointestinal bleeding.

Anticoagulants and Antiplatelet Agents Aspirin may enhance the effects of blood-thinning medications, increasing the risk of severe stomach bleeding. It is advisable for patients on anticoagulants to consult their healthcare provider before initiating aspirin therapy.

Corticosteroids The concomitant use of aspirin with steroid medications may also elevate the risk of severe stomach bleeding. Patients should seek medical advice prior to combining these therapies.

Diuretics Aspirin may interact with diuretics, potentially affecting their efficacy. Patients are encouraged to consult their healthcare provider before using aspirin if they are on diuretic therapy.

Gout Medications Prescription medications for gout may interact with aspirin. It is recommended that patients discuss their gout treatment with a healthcare professional prior to using aspirin.

Diabetes Medications Aspirin may affect the pharmacodynamics of prescription drugs used for diabetes management. Patients should consult their doctor or pharmacist before using aspirin alongside diabetes medications.

Arthritis Medications The use of aspirin in conjunction with prescription drugs for arthritis may lead to interactions. Patients are advised to seek guidance from their healthcare provider before combining these treatments.

Nonsteroidal Anti-Inflammatory Drugs (NSAIDs) The concurrent use of aspirin with other NSAIDs, including ibuprofen and naproxen, may significantly increase the risk of stomach bleeding. Patients should be cautious and consult their healthcare provider if they are considering the use of multiple NSAIDs.

In all cases, careful monitoring and consultation with a healthcare professional are recommended to mitigate potential risks associated with these drug interactions.

Packaging & NDC

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

Pediatric Use

Pediatric patients under 12 years of age should not use this product unless directed by a healthcare professional. For adolescents and adults 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 physician.

Caution is advised for children and teenagers who have or are recovering from chickenpox or flu-like symptoms, as they are at risk for Reye’s syndrome. If any changes in behavior accompanied by nausea and vomiting occur while using this product, a healthcare provider should be consulted immediately, as these may be early signs of this rare but serious condition.

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 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, and careful evaluation of the benefits versus risks should guide treatment decisions in geriatric patients.

Pregnancy

Pregnant patients and those who are breastfeeding should consult a healthcare professional before using this medication. The use of aspirin during pregnancy, particularly at 20 weeks gestation or later, is associated with potential risks. Specifically, it may lead to adverse effects on fetal development and complications during delivery. Therefore, it is crucial that pregnant patients only use aspirin under the guidance of a qualified healthcare provider to mitigate these risks.

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 gestation or later, 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 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 may be necessary based on the severity of hepatic impairment, and ongoing assessment of liver function is recommended throughout the treatment period.

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 aware that the symptoms of overdose may vary depending on the specific substance involved. Therefore, a thorough assessment of the patient's condition is essential to determine the appropriate course of action.

Management of an overdose typically involves supportive care and symptomatic treatment. This may include monitoring vital signs, providing respiratory support, and administering activated charcoal if indicated and within the appropriate time frame. Specific antidotes or treatments may be required based on the substance involved, and healthcare providers should refer to established guidelines for the management of overdose cases.

In summary, immediate medical attention is critical in overdose situations, and healthcare professionals should be prepared to implement appropriate management strategies based on the clinical presentation and substance involved.

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 or additional nonclinical toxicology details are available in the provided data. Furthermore, there are no specific findings related to animal pharmacology and toxicology.

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. Patients should be instructed to discontinue use and consult a doctor if they experience any signs of an allergic reaction, emphasizing the importance of seeking medical help right away.

Patients should also be informed to stop use and consult a doctor if they notice any signs of stomach bleeding, which may include feeling faint, vomiting blood, having bloody or black stools, or experiencing stomach pain that does not improve. Additionally, they should be cautioned to stop use and seek medical advice if they experience ringing in the ears or a loss of hearing.

It is important for patients to be aware that they should stop use and consult a doctor if their pain worsens or persists for more than 10 days, if their fever intensifies or lasts longer than 3 days, or if they notice any redness or swelling. New symptoms should also prompt a consultation with a healthcare provider, as these could indicate a serious condition.

Patients should be encouraged to discuss their current medications with their healthcare provider before use, particularly if they are taking a diuretic, have a history of stomach problems such as heartburn, or have conditions such as high blood pressure, heart disease, liver cirrhosis, or kidney disease. Furthermore, patients with asthma should also consult their doctor prior to use.

Lastly, patients should be advised to speak with their doctor or pharmacist if they are taking prescription medications for gout, diabetes, or arthritis, to ensure safe and effective use of the product.

Storage and Handling

The product is supplied in packaging that includes specific NDC numbers. It should be stored at a controlled room temperature of 25°C (77°F). Temporary excursions are permitted within the range of 15° to 30°C (59° to 86°F). It is essential to adhere to the expiration date indicated on the package to ensure product efficacy and safety.

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 critical to avoid aspirin use 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. No further information is available regarding laboratory tests, abuse potential, or postmarketing experiences.

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)