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.

There are no teratogenic effects associated with this drug. Additionally, no nonteratogenic effects have been reported.

Dosage and Administration

Patients should take a full glass of water with each dose to ensure proper administration and absorption of the medication.

For adults and children aged 12 years and older, the recommended dosage is 4 to 8 chewable tablets every 4 hours. The total daily dosage 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 advised to consult a healthcare provider for appropriate dosing recommendations.

Contraindications

Use is contraindicated in patients with a history of allergic reactions to 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 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 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 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.

In the event of an overdose, it is crucial to seek emergency medical assistance or contact a Poison Control Center immediately at 1-800-222-1222.

Patients should discontinue use and consult a healthcare provider if any of the following occur: an allergic reaction, signs of stomach bleeding (such as feeling faint, vomiting blood, having bloody or black stools, or experiencing persistent stomach pain), worsening pain lasting more than 10 days, fever that worsens or persists beyond 3 days, presence of redness or swelling, emergence of new symptoms, or symptoms such as ringing in the ears or hearing loss. These may indicate serious underlying conditions that require prompt medical evaluation.

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 seek immediate medical attention if any signs of an allergic reaction occur.

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 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 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 persistent stomach pain. Furthermore, if pain worsens or lasts longer than 10 days, if fever intensifies or persists beyond three days, if redness or swelling occurs, if new symptoms arise, or if there is ringing in the ears or loss of hearing, patients should seek medical evaluation, 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 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 symptoms may indicate the onset of Reye’s syndrome, a rare but serious condition.

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 consideration of alternative therapies. The potential for adverse effects, particularly related to gastrointestinal bleeding, underscores the importance of individualized assessment and management in this population.

Pregnancy

Pregnant patients and women 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 outcomes or complications during delivery. Therefore, it is crucial that pregnant patients only use aspirin under the guidance of a qualified 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 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 degree 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. The national Poison Control Center can be reached at 1-800-222-1222.

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 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 relevant information is available regarding non-teratogenic effects. Additionally, there is no relevant information provided concerning nonclinical toxicology or animal pharmacology and toxicology.

Postmarketing Experience

Postmarketing experience has identified several adverse reactions associated with the use of aspirin. Severe allergic reactions have been reported, which may include symptoms such as hives, facial swelling, asthma (wheezing), and shock. Additionally, instances of stomach bleeding have been noted, particularly in individuals aged 60 or older, those with a history of stomach ulcers or bleeding problems, patients taking blood-thinning (anticoagulant) or steroid medications, individuals using other nonsteroidal anti-inflammatory drugs (NSAIDs), those consuming three or more alcoholic drinks daily while using aspirin, or patients exceeding the recommended dosage.

Reports of serious conditions have also been documented, including signs indicative of stomach bleeding, such as feeling faint, vomiting blood, having bloody or black stools, and experiencing persistent stomach pain. Furthermore, new symptoms have been observed, including worsening pain lasting more than 10 days, worsening fever lasting more than 3 days, and symptoms such as ringing in the ears or loss of hearing.

Patient Counseling

Healthcare providers should advise patients to seek immediate medical assistance or contact a Poison Control Center at 1-800-222-1222 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 cautioned against using this medication for at least 7 days following a tonsillectomy or oral surgery unless specifically directed by a healthcare professional. Providers should instruct patients to discontinue use and consult a doctor if they experience any signs of an allergic reaction, emphasizing the importance of seeking medical help promptly.

Healthcare providers should also inform patients to stop using the medication and seek medical advice 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, patients should be advised to consult a doctor if their pain worsens or lasts longer than 10 days, if their fever intensifies or persists beyond 3 days, if they observe any redness or swelling, or if new symptoms arise. Patients should also be made aware that they should stop use and consult a doctor if they experience ringing in the ears or a loss of hearing.

Providers should encourage patients to consult a doctor before using this medication if they have a history of stomach problems, such as heartburn, or if the stomach bleeding warning applies to them. It is also important to advise patients to seek medical guidance before use if they have high blood pressure, heart disease, liver cirrhosis, or kidney disease, or if they are taking a diuretic. Furthermore, patients with asthma should be advised to consult a doctor prior to use. Lastly, healthcare providers should recommend that patients speak with a doctor or pharmacist before using this medication if they are currently taking a prescription drug for gout, diabetes, 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 20-25°C (68-77°F) to maintain its integrity and efficacy. Proper storage conditions should be ensured to prevent any degradation of the product.

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 chewable tablets every 4 hours, with a maximum of 48 tablets in a 24-hour period unless otherwise directed by a healthcare professional. For children under 12 years, it is advised to consult a doctor prior to use.

Clinicians should counsel patients to discuss any heart-related concerns with their healthcare provider before using this product. No additional information is available regarding laboratory tests, abuse potential, or postmarketing experiences.

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)