Aspirin

Description

No description information is available for the drug.

Uses and Indications

This drug is indicated for the temporary relief of pain and fever associated with various conditions, including colds, toothache, menstrual pain, muscle pain, headache, and minor pain of arthritis.

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

Dosage and Administration

Patients should adhere strictly to the recommended dosage. Each dose should be taken with a full glass of water to ensure proper administration.

For adults and children aged 12 years and older, the recommended dosage is as follows: 1 or 2 tablets may be taken every 4 hours, or alternatively, 3 tablets may be taken every 6 hours. The total daily dosage must not exceed 12 tablets within a 24-hour period unless otherwise directed by a healthcare professional.

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

Contraindications

Use of this product is contraindicated in individuals with a known allergy to aspirin or any other pain reliever or fever reducer. Additionally, it should not be administered to patients who have previously experienced an allergic reaction to this product or any of its components.

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.

Aspirin may induce severe allergic reactions, which can manifest as hives, shock, facial swelling, or asthma symptoms such as wheezing. Healthcare professionals should be vigilant for these signs 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 the concurrent use of blood thinners or steroid medications, a history of stomach ulcers or bleeding disorders, prolonged use beyond the recommended duration, the use of other NSAIDs (including prescription and nonprescription options such as aspirin, ibuprofen, or naproxen), consumption of three or more alcoholic beverages daily while using this product, and in individuals aged 60 years or older.

Healthcare professionals should advise patients to consult a doctor prior to use if any of the following conditions apply: a history of stomach bleeding, asthma, previous stomach issues such as heartburn, current use of diuretics, or the presence of high blood pressure, heart disease, liver cirrhosis, or kidney disease. Additionally, patients taking prescription medications for gout, diabetes, or arthritis should seek guidance from a healthcare provider or pharmacist before using this product.

In the event of an overdose, immediate medical assistance should be sought, or contact with a Poison Control Center is recommended.

Patients should be instructed to discontinue use and contact their doctor if they experience any signs of an allergic reaction, symptoms indicative of stomach bleeding (such as feeling faint, vomiting blood, having bloody or black stools, or persistent stomach pain), ringing in the ears or hearing loss, worsening pain lasting more than 10 days, the emergence of new symptoms, fever that worsens or persists beyond three days, or any redness or swelling. These symptoms may indicate a serious condition requiring prompt medical evaluation.

Side Effects

Patients using this product should be aware of several serious adverse reactions 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. 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, shock, facial swelling, or asthma (wheezing). Patients experiencing any signs of an allergic reaction should seek medical attention promptly.

This 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 taking blood thinners or steroid medications, have a history of stomach ulcers or bleeding problems, exceed the recommended dosage or duration of use, consume other NSAIDs (including aspirin, ibuprofen, or naproxen), consume three or more alcoholic drinks daily while using this product, or are aged 60 years or older.

Patients are advised to stop using the product and consult a doctor if they experience any signs of an allergic reaction or symptoms indicative of stomach bleeding, such as feeling faint, vomiting blood, having bloody or black stools, or experiencing persistent stomach pain. Other concerning symptoms that warrant medical consultation include ringing in the ears or loss of hearing, worsening pain lasting more than 10 days, the emergence of new symptoms, or a fever that worsens or lasts more than three days, along with any redness or swelling. These symptoms could indicate a serious condition requiring immediate medical attention.

Drug Interactions

There are currently no documented drug interactions associated with this medication. Additionally, there are no known 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 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 changes in behavior accompanied by nausea and vomiting occur while using this product, it is important to consult a doctor, as these symptoms may indicate the onset of Reye's syndrome, a rare but serious condition.

For pediatric patients under 12 years of age, the product should not be used unless directed by a healthcare professional. For those aged 12 years and older, the recommended dosage is 1 or 2 tablets every 4 hours or 3 tablets every 6 hours, with a maximum of 12 tablets in a 24-hour period unless otherwise directed by a doctor.

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 medications that may exacerbate this risk in this population. It is advisable to closely monitor these patients for any signs of gastrointestinal bleeding and to consider appropriate dose adjustments or alternative therapies as necessary to ensure their safety.

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 fetal development and complications during delivery. Therefore, it is crucial that pregnant patients only use aspirin under the guidance of a healthcare provider if deemed necessary.

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 unless specifically 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 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 underlying 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. It is essential to assess liver function prior to initiating treatment. In patients with significant liver conditions such as cirrhosis, dosage adjustments may be necessary to avoid potential toxicity.

Monitoring of liver function tests is recommended throughout the treatment course to ensure safety and efficacy. Patients with hepatic impairment should be closely observed for any signs of adverse reactions, particularly those related to liver function.

Due to the potential for increased risk of complications, it is advised that healthcare providers exercise caution when prescribing this medication to patients with compromised liver function, including those with liver cirrhosis.

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 vigilant for symptoms that may arise from an overdose, although specific symptoms are not detailed in the provided information. The management of an overdose typically involves supportive care and symptomatic treatment, tailored to the individual patient's needs.

It is essential for healthcare providers to remain informed about the appropriate protocols for managing overdose situations, ensuring that patients receive timely and effective care.

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 have been identified in the available data. Additionally, there are no details regarding nonclinical toxicology or animal pharmacology and toxicology provided in the text.

Postmarketing Experience

No postmarketing experience details are available in the insert text.

Patient Counseling

Healthcare providers should advise patients to seek immediate medical assistance or contact a Poison Control Center in the event of an overdose. It is important to instruct patients to discontinue use and consult a doctor if they experience any signs of an allergic reaction, and to seek medical help without delay.

Patients should be informed to stop using the medication and consult a healthcare professional if they notice any symptoms indicative of stomach bleeding, such as feeling faint, vomiting blood, having bloody or black stools, or experiencing persistent stomach pain. Additionally, they should be advised to seek medical attention if they experience ringing in the ears or a loss of hearing.

Healthcare providers should counsel patients to stop use and consult a doctor if their pain worsens or persists for more than 10 days, if new symptoms arise, or if a fever intensifies or lasts longer than 3 days. Patients should also be made aware that redness or swelling may indicate a serious condition, warranting immediate medical consultation.

Before initiating treatment, healthcare providers should encourage patients to discuss their medical history, particularly if they have a history of stomach problems such as heartburn, asthma, or if they are taking a diuretic. It is also essential to advise patients to consult a doctor if they have high blood pressure, heart disease, liver cirrhosis, or kidney disease. Furthermore, patients should be instructed to speak with 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 packaging that includes specific NDC numbers. It should be stored at a controlled room temperature of 25ºC (77ºF), with permissible excursions between 15ºC and 30ºC (59ºF to 86ºF). It is essential to adhere to the expiration date indicated on the package to ensure product efficacy and 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 at 20 weeks of gestation or later unless explicitly 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, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)