Regular Strength Aspirin Ec

Description

The product is identified by SPL Code 34089-3 and is presented as a white to off-white, round, biconvex, film-coated tablet. Each tablet is debossed with "325" on one side and is plain on the reverse side. The formulation contains 325 mg of aspirin per tablet. Inactive ingredients include carnauba wax, microcrystalline cellulose, corn starch, dibasic calcium phosphate, hypromellose, iron oxide, magnesium stearate, polyethylene glycol, polysorbate 80, pregelatinized starch, talc, and titanium dioxide.

Uses and Indications

This drug is indicated for the temporary relief of minor aches and pains associated with various conditions, including headache, colds, muscle pain, menstrual 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 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 1 to 2 tablets every 4 hours as needed for symptom relief. It is important not to exceed 12 tablets within a 24-hour period unless specifically 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 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 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 or 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). Healthcare professionals should monitor patients for these signs and advise them to seek immediate medical attention if they occur.

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 patients 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

Monitoring for Stomach Bleeding Patients should be instructed to discontinue use and seek medical advice 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, patients should consult a healthcare provider.

Hearing Changes Patients should also be aware that ringing in the ears or loss of hearing may occur, and they should report these symptoms to their healthcare provider.

Emergency Medical Help In the event of an overdose, it is crucial to seek emergency medical assistance or contact a Poison Control Center immediately at 1-800-222-1222.

Side Effects

Patients using this product may experience a range of adverse reactions, some of which can be serious.

Serious Adverse Reactions 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. Patients should be advised to discontinue use and consult a doctor if they experience changes in behavior accompanied by nausea or vomiting, as these may be early signs of Reye's syndrome.

Aspirin may also cause severe allergic reactions, which can manifest as hives, facial swelling, shock, or asthma (wheezing). Patients should seek immediate medical attention if they experience any of these symptoms.

Additionally, 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, or exceed the recommended dosage or duration of use.

Common Adverse Reactions Patients should be instructed to stop use and consult a doctor if they experience signs of stomach bleeding, which may include feeling faint, having bloody or black stools, vomiting blood, or experiencing persistent stomach pain. Other reasons to seek medical advice include worsening pain lasting more than 10 days, a fever that worsens or lasts more than three days, the presence of redness or swelling in the painful area, the emergence of new symptoms, or symptoms such as ringing in the ears or loss of hearing.

Precautions Before using this product, patients should consult a doctor if they have a history of stomach problems, such as heartburn, or if they have high blood pressure, heart disease, liver cirrhosis, or kidney disease. Patients taking diuretics, those with asthma, or those who have not been adequately hydrating should also seek medical advice prior to use. Furthermore, patients taking prescription medications for diabetes, gout, or arthritis, or any other drugs, should consult a doctor or pharmacist before using this product, especially if they are under medical care for any serious condition.

Drug Interactions

Aspirin has the potential to cause severe gastrointestinal bleeding, particularly when co-administered with anticoagulants or other nonsteroidal anti-inflammatory drugs (NSAIDs) such as ibuprofen or naproxen. The risk of such bleeding is significantly increased when multiple NSAIDs are used concurrently, whether they are prescription or nonprescription.

Patients are advised to consult a healthcare professional prior to using aspirin if they are currently taking prescription medications for diabetes, gout, or arthritis. This precaution is essential to ensure safe and effective use of aspirin in conjunction with these therapies. Monitoring for signs of gastrointestinal bleeding is recommended in patients receiving aspirin alongside other blood-thinning agents or NSAIDs.

Packaging & NDC

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

Pediatric Use

Pediatric patients, particularly those under 12 years of age, should consult a doctor before using this product. For adolescents aged 12 years and older, the recommended dosage is 1 to 2 tablets every 4 hours as needed, with a maximum of 12 tablets in a 24-hour period unless otherwise directed by a healthcare professional.

It is important to note that 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. If any changes in behavior accompanied by nausea or vomiting occur while using this product, a doctor should be consulted immediately, as these may be early signs of this rare but serious illness.

Geriatric Use

Elderly patients, particularly those aged 60 and older, may experience an increased risk of severe stomach bleeding. This risk is further heightened in individuals with a history of stomach ulcers or bleeding problems. Therefore, it is imperative that healthcare providers consult with patients regarding the stomach bleeding warning, especially for those within this age group.

Additionally, geriatric patients may exhibit increased sensitivity to side effects associated with the medication. This necessitates careful monitoring and consideration of potential dose adjustments to mitigate adverse effects. Healthcare providers should remain vigilant in assessing the overall health status and medication tolerance of elderly patients to ensure safe and effective treatment.

Pregnancy

Pregnant patients and those who are breastfeeding should consult a healthcare professional prior to use. 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 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

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 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 from an overdose. Symptoms can vary widely depending on the substance involved and the individual patient's response.

In the event of an overdose, immediate medical attention should be sought. Healthcare providers should implement supportive care measures, which may include monitoring vital signs, providing symptomatic treatment, and ensuring the patient's safety.

If available, consultation with a poison control center or a medical toxicologist is recommended to guide the management of the overdose effectively. Additionally, healthcare professionals should refer to local protocols and guidelines for the management of overdose situations, as these may provide specific recommendations based on the substance involved.

Overall, vigilance and prompt intervention are critical in managing any suspected overdose scenario.

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 detailed findings regarding nonclinical toxicology or animal pharmacology and toxicology provided in the current information.

Postmarketing Experience

Adverse events have been reported voluntarily and through surveillance programs. Healthcare professionals and patients are encouraged to report any adverse drug events to the designated contact number, (800) 616-2471. This information contributes to the ongoing monitoring of the drug's safety profile.

Patient Counseling

Healthcare providers should advise patients to keep the 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 at 1-800-222-1222.

Patients must be cautioned against using the medication if they have a known allergy to aspirin or any other pain reliever or fever reducer. It is important to inform patients to discontinue use 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 persistent stomach pain.

Healthcare providers should emphasize that if pain worsens or lasts more than 10 days, or if fever worsens or lasts more than 3 days, patients should seek medical advice. Additionally, patients should be made aware that the presence of redness or swelling in the painful area, the appearance of any new symptoms, or the occurrence of ringing in the ears or loss of hearing warrants consultation with a healthcare professional.

Patients should be encouraged to ask a doctor before use if they have a history of stomach problems, such as heartburn, or if they have high blood pressure, heart disease, liver cirrhosis, or kidney disease. Those taking diuretics or who have asthma should also consult a healthcare provider prior to use. Furthermore, patients should be advised to seek guidance if they have not been drinking fluids adequately.

It is essential for patients to consult a doctor or pharmacist before using the medication if they are taking 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 discuss their use of this medication with their healthcare provider.

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. For adults and children aged 12 years and older, the recommended dosage is 1 to 2 tablets every 4 hours as needed, with a maximum of 12 tablets in a 24-hour period unless otherwise directed by a healthcare professional. For children under 12 years, consultation with a doctor is advised prior to use.

Clinicians should counsel patients regarding the use of this medication during pregnancy and breastfeeding. It is particularly important to avoid aspirin in the last trimester 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 Information (PDF)

This file contains official product information for Regular Strength Aspirin Ec, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

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