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.

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

Dosage and Administration

Patients should adhere strictly to the recommended dosage. For adults and children aged 12 years and older, the dosage is 4 to 8 tablets every 4 hours, with a maximum limit of 48 tablets within a 24-hour period, unless otherwise directed by a physician.

It is essential to consume a full glass of water with each dose to ensure proper administration.

For children under 12 years of age, the use of this medication is not advised unless specifically directed by a healthcare professional.

Contraindications

Use is contraindicated in individuals with a history of allergic reactions to any other pain reliever or fever reducer. This precaution is necessary to prevent potential severe allergic reactions.

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 signs of Reye's syndrome.

Aspirin may induce severe allergic reactions, which can manifest as hives, facial swelling, shock, or asthma (wheezing). Healthcare professionals should be vigilant for these symptoms 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 increases under certain conditions, including but not limited to: concurrent use of blood thinners (anticoagulants) or steroid medications, being aged 60 years or older, consuming three or more alcoholic beverages daily while using this product, having a history of stomach ulcers or bleeding disorders, exceeding the recommended dosage or duration of use, or taking other medications that contain NSAIDs (such as aspirin, ibuprofen, or naproxen).

Healthcare professionals should advise patients to consult a doctor prior to use if any of the following conditions apply: a history of stomach problems (e.g., heartburn), high blood pressure, heart disease, liver cirrhosis, kidney disease, or if they are taking diuretics or have asthma. Additionally, patients should seek guidance from a doctor or pharmacist if they are currently taking prescription medications for gout, diabetes, or arthritis.

In the event of an overdose, it is crucial to seek emergency medical assistance or contact a Poison Control Center immediately.

Patients should discontinue use and contact their healthcare provider if they experience any signs of an allergic reaction, such as hives or swelling. They should also seek medical attention if they notice any symptoms indicative of stomach bleeding, including vomiting blood, passing bloody or black stools, feeling faint, 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 any new symptoms.

Side Effects

Patients using this product should be aware of several serious and common 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 chicken pox or flu-like symptoms. It is crucial for these individuals to avoid using this product. 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.

Aspirin, the active ingredient in this product, may cause severe allergic reactions in some patients. Symptoms of such reactions can include hives, facial swelling, shock, and asthma (wheezing). Patients experiencing any signs of an allergic reaction should seek medical help right away.

This product contains a nonsteroidal anti-inflammatory drug (NSAID), which carries a risk of severe stomach bleeding. The likelihood of this adverse reaction increases in patients who are taking blood thinners or steroid medications, are aged 60 or older, consume three or more alcoholic drinks daily while using the product, have a history of stomach ulcers or bleeding problems, exceed the recommended dosage, or use other medications containing NSAIDs such as aspirin, ibuprofen, or naproxen.

Patients should discontinue use and consult a doctor if they experience any signs of stomach bleeding, which may include vomiting blood, having bloody or black stools, feeling faint, or experiencing persistent stomach pain. Other symptoms warranting medical consultation include ringing in the ears, loss of hearing, worsening pain lasting more than 10 days, fever lasting more than 3 days, redness or swelling, or the appearance of any new symptoms.

Before using this product, patients should seek medical advice 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. Additionally, patients taking diuretics or those with asthma should consult a doctor prior to use.

Patients taking prescription medications for gout, diabetes, or arthritis should also consult a doctor or pharmacist before using this product.

In the event of an overdose, patients should seek medical help or contact a Poison Control Center immediately.

Drug Interactions

There are currently no documented drug interactions associated with the use of 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. For children under 12 years of age, the product should not be used unless directed by a doctor.

Healthcare professionals should be vigilant for changes in behavior accompanied by nausea and vomiting in pediatric patients using this product, as these symptoms may indicate the onset of Reye's syndrome, a rare but serious condition.

Geriatric Use

Elderly patients, particularly those aged 60 years and older, may have an increased risk of severe stomach bleeding. Healthcare providers should exercise caution when prescribing this medication to geriatric patients, considering the potential for heightened adverse effects.

It is advisable to closely monitor these patients for any signs of gastrointestinal bleeding and to evaluate the necessity of dosage adjustments based on individual patient factors. Careful assessment of the risk-benefit ratio is essential in this population to ensure safe and effective treatment.

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 the unborn child and complications during delivery. Therefore, it is crucial that pregnant patients only use aspirin under the guidance of a healthcare provider, particularly in the later stages of pregnancy.

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 the use of this medication 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 specific symptoms of an overdose may vary depending on the 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. Continuous monitoring of the patient's vital signs and clinical status is recommended. In cases where the specific substance is known, targeted therapies may be employed as indicated.

It is essential for healthcare providers to remain vigilant and act swiftly in the management of overdose situations to ensure optimal patient outcomes.

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 specific postmarketing experience details have been provided in the insert text. As such, there are no additional adverse events or rare case reports to summarize at this time.

Patient Counseling

Healthcare providers should advise patients to seek immediate medical help or contact a Poison Control Center in the event of an overdose. It is crucial to inform patients that they should not use this medication if they have ever experienced an allergic reaction to any other pain reliever or fever reducer.

Patients should be instructed to stop using the medication and consult a doctor if they experience any signs of an allergic reaction, such as difficulty breathing or swelling of the face, lips, or throat. They should also be made aware of the signs of stomach bleeding, which include vomiting blood, having bloody or black stools, feeling faint, or experiencing stomach pain that does not improve. Additionally, patients should be informed to seek medical attention if they experience ringing in the ears, a loss of hearing, worsening pain that lasts more than 10 days, a fever that worsens or lasts more than 3 days, any redness or swelling, or the appearance of any new symptoms.

Healthcare providers should encourage patients to consult a doctor before using the medication if they have a history of stomach problems, such as heartburn, or if the stomach bleeding warning applies to them. Patients with 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 or those with asthma should be encouraged to discuss their conditions with a healthcare professional before starting the medication.

Lastly, patients should be advised to consult a doctor or pharmacist before use if they are currently taking prescription medications for gout, diabetes, or arthritis.

Storage and Handling

The product is supplied in configurations that include specific NDC numbers, which can be found on the packaging. It should be stored at a controlled room temperature of 25°C (77°F), with permissible excursions between 15°C and 30°C (59°F to 86°F).

Healthcare professionals are advised to check the end flap of the packaging for the expiration date and lot number to ensure proper inventory management and product 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 crucial to avoid the use of aspirin after 20 weeks 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 Low Dose Aspirin, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)