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, or as recommended by a healthcare professional. Healthcare providers may also consider other potential uses for Chewable Aspirin 81 mg based on individual patient needs.

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

Dosage and Administration

Patients are advised to 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. The total daily intake should not exceed 48 tablets within a 24-hour period unless otherwise directed by a healthcare professional.

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

Contraindications

Use of this product is contraindicated in patients with a known allergy to aspirin or any other pain reliever or fever reducer. Additionally, the product should not be used for at least 7 days following a tonsillectomy or oral surgery, unless specifically directed by a healthcare professional.

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 Reye's syndrome, a rare but serious condition.

Aspirin may provoke severe allergic reactions, which can manifest as hives, facial swelling, asthma (wheezing), or shock. Healthcare professionals should be vigilant for these signs and ensure that patients are aware of the potential for such reactions.

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 are 60 years of age or older, have a history of stomach ulcers or bleeding disorders, are taking anticoagulants or steroid medications, are using other NSAIDs (including aspirin, ibuprofen, or naproxen), consume three or more alcoholic beverages daily, or exceed the recommended dosage or duration of use.

Before initiating treatment, it is advisable for patients to consult a healthcare provider if any of the following conditions apply: a history of stomach problems such as heartburn, high blood pressure, heart disease, liver cirrhosis, kidney disease, asthma, or if they are currently taking a diuretic. Additionally, patients should seek guidance from a healthcare professional or pharmacist if they are on prescription medications for gout, diabetes, or arthritis.

In the event of an overdose, immediate medical assistance should be sought, or contact a Poison Control Center at 800-222-1222.

Patients should discontinue use and contact a healthcare provider if they experience any signs of stomach bleeding, such as feeling faint, vomiting blood, passing bloody or black stools, or experiencing persistent stomach pain. Immediate medical attention is also warranted for any allergic reactions, worsening pain lasting more than 10 days, fever that persists beyond 3 days, the presence of redness or swelling, the emergence of new symptoms, or symptoms such as ringing in the ears or loss of hearing.

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, there is a significant risk of severe allergic reactions to aspirin, which may manifest as hives, facial swelling, asthma (wheezing), or shock. Patients should be vigilant for these symptoms and seek immediate medical attention if they occur.

The product contains a nonsteroidal anti-inflammatory drug (NSAID), which carries a warning for potential 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, are using other NSAIDs (including aspirin, ibuprofen, or naproxen), consume three or more alcoholic drinks daily while using this product, or exceed the recommended dosage or duration of use.

Patients are advised to discontinue use and consult a doctor if they experience 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. Furthermore, any occurrence of an allergic reaction warrants immediate medical assistance. Patients should also seek medical advice if pain worsens or persists beyond 10 days, if fever intensifies or lasts more than three days, if redness or swelling is observed, if new symptoms arise, or if there is ringing in the ears or loss of hearing, as these could indicate serious conditions.

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 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 over may take 4 to 8 tablets every 4 hours, with a maximum of 48 tablets in 24 hours unless otherwise directed by a doctor. For children under 12 years of age, consultation with a doctor is advised prior to use.

Geriatric Use

Elderly patients, particularly those aged 60 and older, are at an increased risk for severe stomach bleeding. Healthcare providers should exercise caution when prescribing this medication to geriatric patients, as the likelihood of adverse gastrointestinal events may be heightened in this population.

It is advisable to closely monitor elderly patients for any signs of gastrointestinal bleeding and to consider appropriate dose adjustments or alternative therapies based on individual patient assessments. Regular evaluation of the patient's overall health status and concurrent medications is essential to mitigate potential risks associated with treatment in this age group.

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 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 prior to using this medication if they are pregnant or breastfeeding. It is particularly important to avoid the use of aspirin during the last three months of pregnancy unless explicitly 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.

Renal Impairment

Patients with renal impairment should consult a healthcare professional prior to use, particularly if they have comorbid 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 medical guidance to assess the potential risks and benefits associated with the use of this medication. Monitoring of liver function may be necessary to ensure safety and efficacy in this population. Adjustments to dosage or treatment regimens may be required based on the severity of hepatic impairment and the patient's overall health status.

Overdosage

In the event of an overdose, it is imperative to seek immediate medical assistance or contact a Poison Control Center without delay. The national Poison Control Center can be reached at 800-222-1222.

Healthcare professionals should be aware that timely intervention is crucial in managing overdose situations. Symptoms of overdose may vary depending on the substance involved, and it is essential to monitor the patient closely for any signs of adverse reactions.

Management of an overdose typically involves supportive care and symptomatic treatment. Healthcare providers should ensure that the patient is stabilized and may need to implement specific protocols based on the substance taken. Continuous assessment and monitoring of vital signs are recommended to guide further treatment decisions.

In summary, prompt action and appropriate medical intervention are vital in the management of overdose cases to mitigate potential complications and ensure patient safety.

Nonclinical Toxicology

It is especially important not to use aspirin during the last three months of 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 specific details regarding nonclinical toxicology or animal pharmacology and toxicology provided in the current information.

Postmarketing Experience

Postmarketing experience has identified several adverse reactions associated with the use of the product. Notably, gastrointestinal bleeding has been reported, particularly in patients with risk factors such as advanced age, a history of ulcers, and concurrent use of anticoagulants or other nonsteroidal anti-inflammatory drugs (NSAIDs). Additionally, allergic reactions, including cases of anaphylaxis, have been documented. Other serious conditions related to aspirin use have also been reported, highlighting the need for caution and monitoring in patients with pre-existing health issues.

Patient Counseling

Healthcare providers should advise patients to seek immediate medical assistance or contact a Poison Control Center at 800-222-1222 in the event of an overdose. It is crucial to inform patients that this product should not be used if they have a known allergy to aspirin or any other pain reliever or fever reducer.

Patients should be instructed not to use this product for at least 7 days following a tonsillectomy or oral surgery unless specifically directed by a healthcare professional. Providers should emphasize the importance of discontinuing use and consulting a doctor if patients experience any signs of stomach bleeding, which may include feeling faint, vomiting blood, having bloody or black stools, or experiencing persistent stomach pain.

Additionally, patients should be informed to stop using the product and seek medical advice if they experience an allergic reaction, if their pain worsens or persists beyond 10 days, if their fever worsens or lasts more than 3 days, or if they notice any redness or swelling. They should also be advised to consult a doctor if any new symptoms arise, or if they experience ringing in the ears or loss of hearing, as these could indicate a serious condition.

Healthcare providers should encourage patients to consult with a doctor before using this product if the warning regarding stomach bleeding applies to them, particularly if they have a history of stomach issues such as heartburn. It is also important to discuss the need for medical advice prior to use if patients have high blood pressure, heart disease, liver cirrhosis, kidney disease, or asthma. Furthermore, patients taking diuretics or prescription medications for gout, diabetes, or arthritis should be advised to consult with a doctor or pharmacist before using this product.

Storage and Handling

The product is supplied in a tamper-evident container. It should not be used if the safety seal under the cap is broken or missing.

For optimal storage, the product must be kept at room temperature, specifically between 20°-25°C (68°-77°F). Temporary excursions in temperature are permissible, provided they remain within the range of 15-30°C (59-86°F).

Additional Clinical Information

The product is administered orally. Clinicians should advise patients to consult with their doctor or healthcare provider prior to using this product for heart-related conditions. No further information is available regarding laboratory tests, abuse potential, or postmarketing experiences.

Drug Information (PDF)

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

View product document (PDF)