Adult Low Dose Aspirin

Description

No description information is available for the specified drug.

Uses and Indications

This drug is indicated for the temporary relief of minor aches and pains as recommended by a healthcare professional. Due to its delayed release action, this product is not intended for the fast relief of headaches or 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 as needed for symptom relief. It is imperative that patients do not exceed a total of 48 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.

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, shock, facial swelling, or asthma (wheezing). Healthcare professionals should monitor patients for these symptoms and advise them to seek immediate medical attention if they occur.

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 increases 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, including aspirin, ibuprofen, or naproxen

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

• Exceed the recommended dosage or duration of use

Patients should be instructed to discontinue use and contact their healthcare provider 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, they should seek medical attention if they experience an allergic reaction, ringing in the ears, worsening pain lasting more than 10 days, fever persisting beyond three days, redness or swelling in the affected area, or the emergence of new symptoms that may indicate a serious condition.

Emergency Medical Help In the event of an overdose, it is crucial to seek immediate medical assistance or contact a Poison Control Center (1-800-222-1222). Prompt medical intervention is essential for both adults and children, even if no signs or symptoms are initially apparent.

No specific laboratory tests are recommended for monitoring the use of this 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 an allergy alert, as aspirin may induce severe allergic reactions. Symptoms of such reactions can include hives, shock, facial swelling, and asthma (wheezing).

The product 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, consume three or more alcoholic drinks daily while using the product, or exceed the recommended dosage or duration of use.

Patients should 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. Other concerning symptoms that warrant immediate medical consultation include any allergic reactions, ringing in the ears or loss of hearing, worsening pain lasting more than 10 days, fever persisting beyond three days, redness or swelling in the painful area, or the emergence of new symptoms that could indicate a serious condition.

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

Drug Interactions

There are currently no documented drug interactions associated with this medication. Additionally, there is no information available regarding interactions with laboratory tests. As such, no specific recommendations for dosage adjustments or monitoring are warranted at this time.

Packaging & NDC

Below are the non-prescription pack sizes of Adult Low Dose Aspirin (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 dosing, adults and children aged 12 years and older are directed to take 4 to 8 tablets every 4 hours while symptoms persist, with a maximum of 48 tablets in a 24-hour period unless otherwise directed by a doctor. For children under 12 years of age, it is advised to consult a doctor before use.

Geriatric Use

Elderly patients, particularly those aged 60 and older, may have an elevated risk of severe stomach bleeding. It is advisable for these patients to consult a healthcare provider if they have a history of gastrointestinal issues, such as heartburn, or if they fall under the aforementioned stomach bleeding warning.

Additionally, geriatric patients may exhibit increased sensitivity to side effects associated with the medication. Therefore, careful monitoring and consideration of dose adjustments may be necessary to ensure safety and efficacy in this population.

Pregnancy

Pregnant patients and those who are breastfeeding should consult a healthcare professional before using this medication. Aspirin use during the last trimester of pregnancy is particularly cautioned against, as it may lead to adverse effects on fetal development and 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 doctor, 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 no specific information regarding dosage adjustments, special monitoring, or safety considerations provided in the text. Therefore, healthcare professionals should exercise caution and consider individual patient factors when prescribing to this population. Regular monitoring of renal function may be warranted in patients with reduced kidney function to ensure safety and efficacy.

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 overdosage information, it is essential for healthcare professionals to remain vigilant regarding the potential for overdose with this medication. In cases where an overdose is suspected, immediate medical attention should be sought.

Healthcare providers are advised to monitor patients closely for any signs or symptoms that may indicate an overdose. These may include, but are not limited to, increased severity of known side effects, unusual behavioral changes, or any other atypical clinical manifestations.

Management of an overdose should be guided by the clinical presentation of the patient. Supportive care is paramount, and symptomatic treatment should be initiated as necessary. It is recommended that healthcare professionals consult local poison control centers or relevant toxicology resources for specific guidance on the management of overdose cases.

In summary, while no specific overdosage information is provided, healthcare professionals should exercise caution, remain alert to potential overdose symptoms, and implement appropriate management strategies as needed.

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 indicated that aspirin may lead to severe allergic reactions, which can manifest as hives, shock, facial swelling, and asthma (wheezing). Additionally, there have been reports of stomach bleeding associated with aspirin use, particularly in specific populations. These populations include patients aged 60 years or older, individuals with a history of stomach ulcers or bleeding problems, those taking anticoagulant or steroid medications, users of other prescription or nonprescription NSAIDs, individuals consuming three or more alcoholic drinks daily while using aspirin, and patients who take the medication for longer durations or in higher doses than recommended.

Patient Counseling

Healthcare providers should advise patients to seek immediate medical assistance or contact a Poison Control Center (1-800-222-1222) in the event of an overdose, as prompt medical attention is crucial for both adults and children, even if no signs or symptoms are apparent.

Patients should be informed not to use the medication if they have a known allergy to aspirin or any other pain reliever or fever reducer. It is important to instruct 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. Additionally, patients should seek medical help if they notice an allergic reaction, experience ringing in the ears or loss of hearing, if their pain worsens or lasts longer than 10 days, if their fever worsens or lasts more than 3 days, if redness or swelling occurs in the painful area, or if new symptoms arise, as these may indicate a serious condition.

Patients should be encouraged to consult a doctor before using the medication if they have asthma or if the stomach bleeding warning is applicable to them. It is also advisable for patients with a history of stomach problems, such as heartburn, or those with high blood pressure, heart disease, liver cirrhosis, or kidney disease to seek medical advice prior to use. Furthermore, patients taking a diuretic or any prescription medication for diabetes, gout, or arthritis should consult a doctor or pharmacist before using this medication. Lastly, patients under a doctor's care for any serious condition should also seek guidance before use, as well as those taking any other medications.

Storage and Handling

The product is supplied in a configuration that includes an imprinted safety seal under the cap. It is essential to ensure that this seal is intact before use, as the product should not be utilized if the seal is broken or missing.

For optimal storage, the product must be kept at room temperature, specifically within the range of 15-30°C (59-86°F). Proper handling and storage conditions are crucial to maintain the integrity and efficacy of the product.

Additional Clinical Information

The route of administration for the medication is oral. Clinicians should advise patients who are pregnant or breastfeeding to consult a health professional prior to use. It is particularly crucial to avoid aspirin during the last trimester of pregnancy 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 Adult Low Dose Aspirin, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)