Aspirin Low Dose

Description

SPL Code 34089-3 corresponds to a blister pack containing 30 tablets. The product is designed for oral administration and is presented in a blister format to ensure stability and ease of use.

Uses and Indications

This drug is indicated for the temporary relief of minor aches and pains, or as recommended by a healthcare professional. Due to its delayed action, this product may not provide immediate relief for headaches or other symptoms requiring prompt alleviation.

Healthcare professionals are encouraged to inquire about additional uses for this product based on individual patient needs.

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

Dosage and Administration

Adults and children aged 12 years and older are instructed to take 4 to 8 tablets orally every 4 hours, with a maximum limit of 48 tablets within a 24-hour period unless otherwise directed by a physician. For children under 12 years of age, consultation with a doctor is recommended prior to administration.

Each dose should be accompanied by a full glass of water to ensure proper swallowing and absorption. It is imperative that the recommended dosage is not exceeded to avoid potential adverse effects.

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

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 this rare but serious illness.

Aspirin may provoke severe allergic reactions in some individuals. Symptoms of such reactions can include hives, facial swelling, asthma (wheezing), and shock. Healthcare professionals should be vigilant for these signs when prescribing or recommending this product.

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

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

In the event of an overdose, immediate medical assistance should be sought, or the Poison Control Center should be contacted at 1-800-222-1222. Prompt medical attention is crucial for both adults and children, even if no signs or symptoms are initially apparent.

Patients should discontinue use and contact a healthcare provider if they experience any signs of stomach bleeding, which may include feeling faint, vomiting blood, passing bloody or black stools, experiencing persistent stomach pain, or if pain worsens or lasts longer than 10 days. Additional symptoms warranting medical consultation include the presence of redness or swelling, the emergence of any new symptoms, or occurrences of ringing in the ears or loss of hearing.

Side Effects

Patients using this product should be aware of several serious adverse reactions and warnings associated with its use.

Reye’s syndrome is a rare but serious illness that can occur in children and teenagers who have or are recovering from chicken pox or flu-like symptoms. It is crucial that these individuals do not use 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 may indicate the onset of Reye’s syndrome.

Aspirin may also cause severe allergic reactions in some patients, which can manifest as hives, facial swelling, asthma (wheezing), or shock. Patients with known allergies to aspirin or other pain relievers/fever reducers should not use this product.

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, or exceed the recommended dosage or duration of use. Patients should be advised to stop using the product and seek medical attention if they experience any signs of stomach bleeding, such as feeling faint, vomiting blood, having bloody or black stools, or experiencing persistent stomach pain.

Patients are also cautioned to consult a doctor before using this product if they have a history of stomach problems, high blood pressure, heart disease, liver cirrhosis, or kidney disease, or if they are taking diuretics. Furthermore, it is advisable to seek guidance from a healthcare professional if taking prescription medications for diabetes, gout, or arthritis.

In the event of an overdose, which may lead to liver damage, patients should seek medical help or contact a Poison Control Center immediately. Prompt medical attention is essential for both adults and children, even if no signs or symptoms are initially apparent.

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. Clinicians should exercise caution and consider monitoring patients closely for signs of gastrointestinal complications when these medications are used concurrently.

Additionally, it is advisable for patients to consult a healthcare professional prior to using aspirin if they are currently prescribed medications for diabetes, gout, or arthritis. This precaution is essential to ensure safe and effective use of aspirin in conjunction with these therapeutic agents.

Packaging & NDC

Below are the non-prescription pack sizes of Aspirin Low Dose (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.

The product should be kept out of reach of children. In the event of an overdose, quick medical attention is critical for both adults and children, even if no signs or symptoms are immediately apparent.

For dosing, adults and children aged 12 years and over are directed to take 4 to 8 tablets every 4 hours, not exceeding 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, are at an increased risk for severe stomach bleeding. It is essential for healthcare providers to exercise caution when prescribing this medication to geriatric patients, especially if they have a history of stomach problems, high blood pressure, heart disease, liver cirrhosis, or kidney disease.

Before initiating treatment, healthcare providers should inquire about the presence of any of these conditions in elderly patients, as they may necessitate closer monitoring or alternative therapeutic strategies. The potential for adverse effects, such as gastrointestinal bleeding, should be carefully weighed against the benefits of treatment in this population.

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 concerning, as it may lead to adverse effects on fetal outcomes or complications during delivery. Therefore, it is crucial 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. 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. Therefore, caution is recommended when considering its use in lactating individuals.

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 may experience altered pharmacokinetics of the medication, necessitating careful consideration of dosage adjustments and monitoring. It is essential to evaluate liver function prior to initiating treatment and to monitor liver enzymes regularly throughout the course of therapy.

In patients with liver cirrhosis or significant liver dysfunction, the risk of adverse effects, including potential liver damage, may be heightened. Therefore, it is crucial to adhere to the recommended dosing guidelines and to avoid exceeding the prescribed dosage. An overdose, defined as taking more than the recommended dose, can lead to liver damage. In the event of an overdose, immediate medical assistance should be sought, and contacting a Poison Control Center is advised. Prompt medical attention is critical for both adults and children, even in the absence of noticeable signs or symptoms of overdose.

Healthcare providers should exercise caution when prescribing this medication to patients with compromised liver function and ensure that appropriate monitoring protocols are in place to mitigate risks associated with hepatic impairment.

Overdosage

Taking more than the recommended dose of this medication may lead to significant liver damage. It is imperative that healthcare professionals remain vigilant regarding the potential for overdose and its serious consequences.

In the event of an overdose, immediate medical assistance should be sought. Healthcare providers are advised to contact a Poison Control Center without delay; the national hotline can be reached at 1-800-222-1222. Prompt intervention is crucial, as quick medical attention is essential for both adults and children, even in the absence of noticeable signs or symptoms of overdose.

Monitoring and management of the patient should be initiated as soon as possible to mitigate the risk of severe liver injury and to ensure appropriate care is provided.

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

No postmarketing experience details are available in the insert text.

Patient Counseling

Healthcare providers should advise patients about the potential risks associated with overdose, emphasizing that taking more than the recommended dose may lead to liver damage. In the event of an overdose, patients should be instructed to seek medical help immediately or contact a Poison Control Center at 1-800-222-1222. It is crucial to stress that prompt medical attention is necessary 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. Healthcare providers should encourage patients to stop using the medication 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. Additionally, patients should be advised to seek medical attention if pain worsens or persists for more than 10 days, if redness or swelling occurs, if any new symptoms arise, or if they experience ringing in the ears or loss of hearing.

It is important for healthcare providers to ask patients about their medical history, particularly regarding any history of stomach problems such as heartburn, as well as conditions like high blood pressure, heart disease, liver cirrhosis, or kidney disease. Patients should also be encouraged to consult a doctor before using the medication if they are taking a diuretic or any prescription drugs for diabetes, gout, or arthritis.

Storage and Handling

The product is supplied in various package configurations, with specific NDC numbers available for identification. It is essential to store the product at a controlled temperature range of 20° to 25°C (68° to 77°F) to maintain its integrity and efficacy. Proper storage conditions must be adhered to, ensuring that the product is kept within the specified temperature limits to prevent degradation.

Additional Clinical Information

The route of administration for the medication is oral. For adults and children aged 12 years and older, the recommended dosage is 4 to 8 tablets every 4 hours, with a maximum of 48 tablets in a 24-hour period unless otherwise directed by a physician. For children under 12 years, it is advised to consult a doctor for appropriate dosing.

Clinicians should counsel patients regarding the use of this medication during pregnancy or breastfeeding, emphasizing the importance of consulting a healthcare professional before use. It is particularly critical to avoid aspirin during the last trimester of pregnancy unless specifically instructed by a doctor, 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 Aspirin Low Dose, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

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