Aspirin

Uses and Indications

This drug is indicated for the temporary relief of various types of pain and discomfort, including headache, toothache, menstrual pain, muscle pain, and minor pain associated with arthritis. Additionally, it is effective in alleviating pain and fever associated with colds.

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 specifically directed by a healthcare professional.

For children under 12 years of age, the use of this medication is not recommended unless 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 used in patients who have a history of allergic reactions 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. 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, which can manifest as shock, facial swelling, hives, or asthma symptoms such as wheezing. Healthcare professionals should be vigilant for these signs and ensure that patients are aware of the potential for such reactions.

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 individuals who are 60 years of age or older, have a history of stomach ulcers or bleeding disorders, are concurrently using anticoagulants or steroid medications, are taking other NSAIDs (including aspirin, ibuprofen, or naproxen), consume three or more alcoholic beverages daily, or exceed the recommended dosage or duration of use.

Prior to use, patients should be advised to consult a healthcare provider if any of the following conditions apply: a history of stomach problems such as heartburn, asthma, high blood pressure, heart disease, liver cirrhosis, or kidney disease; or if they are taking diuretics. Additionally, it is recommended that patients seek guidance from a healthcare professional or pharmacist if they are currently prescribed medications for gout, diabetes, or arthritis.

In the event of an overdose, immediate medical assistance should be sought, or the Poison Control Center should be contacted without delay.

Patients should discontinue use and contact a healthcare provider if they experience any signs of an allergic reaction, such as difficulty breathing or swelling, or if they exhibit symptoms indicative of stomach bleeding, including feeling faint, vomiting blood, passing bloody or black stools, or experiencing persistent stomach pain. Other concerning symptoms warranting medical attention include ringing in the ears, loss of hearing, worsening pain lasting more than 10 days, fever persisting beyond 3 days, the emergence of new symptoms, or the presence of redness or swelling, as these may signal a serious underlying condition.

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 may 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 symptoms could indicate the onset of Reye's syndrome.

Additionally, there is an allergy alert for this product, as aspirin may cause severe allergic reactions. Symptoms of such reactions can include shock, facial swelling, hives, 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 may increase the risk of severe stomach bleeding. The likelihood 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 stop using the product 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. Other symptoms that warrant medical attention include ringing in the ears or loss of hearing, worsening pain lasting more than 10 days, fever that worsens or lasts more than three days, the emergence of new symptoms, or the presence of redness or swelling. These could be indicative of a serious condition requiring prompt medical evaluation.

Drug Interactions

Aspirin has the potential to cause severe gastrointestinal bleeding, particularly when used concurrently with certain medications.

Anticoagulants and Steroids The concomitant use of aspirin with blood-thinning agents (anticoagulants) or steroid medications may significantly increase the risk of gastrointestinal bleeding. It is advisable to monitor patients closely for signs of bleeding and consider dosage adjustments as necessary.

Nonsteroidal Anti-Inflammatory Drugs (NSAIDs) Aspirin should not be used in combination with other NSAIDs, whether prescription or nonprescription, such as ibuprofen or naproxen, due to the heightened risk of gastrointestinal complications. Caution is recommended, and alternative therapies should be considered.

Drug and Laboratory Test Interactions Patients should consult with a healthcare professional prior to using aspirin if they are currently taking medications for gout, diabetes, or arthritis. Additionally, individuals with a history of gastrointestinal issues, such as heartburn, or those with asthma, high blood pressure, heart disease, liver cirrhosis, or kidney disease should seek medical advice before initiating aspirin therapy. Special consideration should also be given to patients taking diuretics, as this may influence the safety and efficacy of aspirin.

Packaging & NDC

Below are the non-prescription pack sizes of Aspirin. Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients, particularly children and teenagers, should not use this product if they have or are recovering from chicken pox or flu-like symptoms due to the associated risk of Reye's syndrome. In the event that changes in behavior accompanied by nausea and vomiting occur during use, it is essential to consult a healthcare professional, as these symptoms may indicate the onset of Reye's syndrome.

For children under 12 years of age, the product should only be used if directed by a doctor.

Geriatric Use

Elderly patients, particularly those aged 60 and older, are at an increased risk of severe stomach bleeding when using this product, which contains a nonsteroidal anti-inflammatory drug (NSAID). This risk is further heightened in individuals with a history of stomach ulcers or bleeding problems, those who are concurrently using blood thinners (anticoagulants) or steroid medications, and patients taking other NSAIDs, whether prescription or over-the-counter, such as aspirin, ibuprofen, or naproxen.

Healthcare providers should exercise caution when prescribing this product to geriatric patients, especially if they consume three or more alcoholic drinks daily while using the medication. It is essential to monitor these patients closely for any signs of gastrointestinal bleeding and to consider dose adjustments or alternative therapies as necessary. Additionally, patients should be advised to adhere strictly to the recommended dosage and duration of use to minimize the risk of adverse effects.

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 the unborn child or complications during delivery. Therefore, it is crucial that aspirin is only used in these circumstances if explicitly directed by a physician.

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 pregnancy 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. Additionally, caution is advised for patients who are taking a diuretic, as this may further impact renal function and necessitate closer monitoring.

Hepatic Impairment

Patients with hepatic impairment should consult a healthcare professional prior to use, particularly if they have underlying conditions such as liver cirrhosis. It is essential for these patients to receive appropriate evaluation and monitoring of 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 substance is known, specific antidotes or treatments may be indicated, and healthcare providers should refer to established guidelines for the management of the particular overdose scenario.

It is essential for healthcare professionals to remain vigilant and act swiftly in the event of an overdose 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 non-teratogenic effects have been specified. Additionally, there are no details provided regarding nonclinical toxicology or animal pharmacology and toxicology.

Postmarketing Experience

No specific postmarketing experience details have been reported. As such, there are currently no additional adverse events or rare case reports available for review.

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 not to use the product if they have a known allergy to aspirin or any other pain reliever or fever reducer. Additionally, patients should be cautioned against using the product if they have previously experienced an allergic reaction to it or any of its ingredients.

Patients should be instructed to stop using the product and consult a doctor if they experience any signs of an allergic reaction, and to seek medical assistance right away. They should also be made aware of the signs of potential stomach bleeding, which include feeling faint, vomiting blood, having bloody or black stools, or experiencing stomach pain that does not improve. If any of these symptoms occur, patients should be advised to stop use and contact a healthcare professional.

Furthermore, patients should be informed to discontinue use and consult a doctor if they experience ringing in the ears or a loss of hearing, if their pain worsens or lasts longer than 10 days, if their fever worsens or persists for more than 3 days, or if new symptoms arise. The presence of redness or swelling should also prompt them to stop use and seek medical advice, as these could indicate a serious condition.

Healthcare providers should encourage patients to consult a doctor before using the product if they have a history of stomach problems, such as heartburn, or if the stomach bleeding warning applies to them. Patients with asthma, high blood pressure, heart disease, liver cirrhosis, or kidney disease should also be advised to seek medical guidance prior to use. Additionally, those taking a diuretic or prescription medications for gout, diabetes, or arthritis should be encouraged to discuss their current medications with a doctor or pharmacist before using the product.

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

Patients should be advised to consult a healthcare professional if they are pregnant or breastfeeding before using the medication. 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. In the event of an overdose, patients should seek immediate medical assistance or contact a Poison Control Center.

No further information is available regarding laboratory tests, abuse potential, or the route, method, and frequency of administration. Additionally, there are no updates from postmarketing experience.

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)