Aspirin Low Dose

Description

The product is identified by the SPL Code 34089-3 and is packaged in a blister containing 30 tablets.

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 healthcare professional 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 Reye’s syndrome, a rare but serious condition.

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 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.

Healthcare providers should advise patients to consult a physician prior to using this product if they have a history of stomach problems, such as heartburn, or if they have conditions such as high blood pressure, heart disease, liver cirrhosis, or kidney disease. Additionally, patients taking diuretics or prescription medications for diabetes, gout, or arthritis should seek guidance from a healthcare professional before use.

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, having 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 chickenpox 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.

An allergy alert is warranted, as aspirin may cause severe allergic reactions. Symptoms of such reactions can include hives, facial swelling, asthma (wheezing), and shock. Patients with known allergies to aspirin or other NSAIDs should avoid this product.

The 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 blood-thinning medications or steroids, 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 should discontinue use and seek medical attention 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. Additional symptoms warranting medical consultation include worsening pain lasting more than 10 days, the presence of redness or swelling, the appearance of any new symptoms, or ringing in the ears or loss of hearing.

Furthermore, an overdose of this product can lead to liver damage. Patients are advised to seek immediate medical help or contact a Poison Control Center if they suspect an overdose, as prompt medical attention is critical for both adults and children, even in the absence of noticeable signs or symptoms.

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 for signs of gastrointestinal bleeding 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. If any 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, a rare but serious condition.

This 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 older 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, may have an increased risk of severe stomach bleeding when using this medication. It is essential for healthcare providers to exercise caution when prescribing to this population.

Before initiating treatment, it is advisable for healthcare providers to assess the patient's medical history, especially in those with pre-existing conditions such as high blood pressure, heart disease, liver cirrhosis, or kidney disease. Consultation with a physician is recommended to evaluate the appropriateness of the medication in these cases, as underlying health issues may necessitate dosage adjustments or alternative therapeutic strategies.

Ongoing monitoring of elderly patients is crucial to ensure safety and efficacy, given the heightened risk of adverse effects in this demographic.

Pregnancy

Pregnant patients should consult a healthcare professional before using this medication. It is particularly important to avoid the use of aspirin during the last trimester of pregnancy unless specifically directed by a physician, as it may pose risks to the unborn child and lead to complications during delivery. The potential fetal impacts and associated risks necessitate careful consideration and professional guidance for women of childbearing potential.

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, 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 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 and monitoring. It is essential to recognize that individuals with liver cirrhosis or other significant liver conditions may be at increased risk for adverse effects, particularly in the context of overdose.

Taking more than the recommended dose can lead to liver damage; therefore, it is crucial for patients to adhere strictly to prescribed dosages. 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.

Monitoring of liver function may be warranted in patients with compromised liver function to ensure safety and efficacy of the treatment. Regular assessment of liver enzymes and other relevant parameters should be considered to mitigate potential risks associated with hepatic impairment.

Overdosage

Taking more than the recommended dose of this medication may lead to significant liver damage. It is crucial for healthcare professionals to recognize the seriousness of an overdose and the potential for severe health 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, utilizing the national hotline at 1-800-222-1222. Prompt intervention is essential, as quick medical attention can be critical 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 risks associated with overdose 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 additional non-teratogenic effects or specific nonclinical toxicology details have been identified in the available data. Furthermore, there are no specific findings related to animal pharmacology and toxicology.

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 inquire about the patient's 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 advised to consult a doctor before using the medication if they are taking a diuretic or if they are on prescription medications 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 in a suitable container that protects it from environmental factors. Special handling requirements should be followed to prevent any compromise to the product's quality.

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 Aspirin Low Dose, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

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