Aspirin

Description

Chewable Aspirin is formulated as an orange-flavored tablet, each containing 81 mg of aspirin. This nonsteroidal anti-inflammatory drug (NSAID) serves as a pain reliever and is intended for use in a low dose aspirin regimen. The product is packaged in a bottle containing 36 tablets.

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.

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 doctor for appropriate dosing recommendations.

Contraindications

Use is contraindicated in patients with a history of allergic reactions to any pain reliever or fever reducer. Additionally, the product should not be administered 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, 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, as these may be early signs of Reye’s syndrome.

Aspirin may induce severe allergic reactions, which can manifest as hives, facial swelling, asthma (wheezing), or shock. Healthcare professionals should be vigilant for these symptoms 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 individuals 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 while using this product, or exceed the recommended dosage or duration of use.

Healthcare providers 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 diuretics or have asthma. Additionally, patients should be encouraged to discuss their use of prescription medications for gout, diabetes, or arthritis with their healthcare provider or pharmacist before using this product.

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 be instructed to discontinue use and contact their doctor if they experience any signs of an allergic reaction, such as hives or swelling, or if they exhibit symptoms indicative of stomach bleeding, including feeling faint, vomiting blood, having bloody or black stools, experiencing persistent stomach pain, or if pain worsens or lasts longer than 10 days. Additionally, if fever persists or worsens beyond three days, if redness or swelling occurs, if new symptoms arise, or if there is ringing in the ears or loss of hearing, medical advice should be sought promptly.

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 associated with this product. Aspirin may cause severe allergic reactions, which can manifest as hives, facial swelling, asthma (wheezing), or shock. 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 stomach pain that does not improve. Additional symptoms warranting medical attention include worsening pain lasting more than 10 days, fever that worsens or lasts more than three days, the presence of redness or swelling, the emergence of new symptoms, or ringing in the ears or loss of hearing. These symptoms could indicate a serious condition requiring prompt medical evaluation.

Drug Interactions

Patients taking anticoagulants or steroid medications may experience significant drug interactions. The concurrent use of these agents can increase the risk of bleeding or other adverse effects. It is advisable for healthcare providers to closely monitor patients for signs of bleeding and to consider dosage adjustments as necessary based on the clinical scenario.

Additionally, the use of nonsteroidal anti-inflammatory drugs (NSAIDs), including both prescription and nonprescription options such as aspirin, ibuprofen, and naproxen, may also lead to interactions. The combination of these NSAIDs with other medications can heighten the risk of gastrointestinal complications and renal impairment. Monitoring for adverse effects is recommended, and dosage adjustments may be warranted depending on the patient's overall health status and concurrent therapies.

No specific laboratory test interactions have been identified in the available data.

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 those under 12 years of age, should consult a doctor before using this product. For children and teenagers who have or are recovering from chicken pox or flu-like symptoms, the use of this product is contraindicated 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 essential to seek medical advice, as these may be early signs of Reye’s syndrome.

For adolescents 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.

Geriatric Use

Elderly patients, particularly those aged 60 and older, may have an increased risk of severe stomach bleeding. It is essential for healthcare providers to exercise caution when prescribing this medication to geriatric patients.

Monitoring for signs and symptoms of gastrointestinal bleeding is recommended in this population. Additionally, healthcare providers should consider the overall health status and concurrent medications of elderly patients, as these factors may further influence the risk of adverse effects.

Dose adjustments may be necessary based on individual patient assessments, and careful evaluation of the benefits versus risks should guide treatment decisions in geriatric patients.

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 to the unborn child and may lead to complications during delivery. Therefore, it is crucial that pregnant patients only use aspirin under the guidance of a physician 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 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 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 the individual’s health status. Therefore, a thorough assessment and monitoring of the patient are essential.

Management procedures may include supportive care and symptomatic treatment, tailored to the specific symptoms presented. It is recommended that healthcare providers remain vigilant and prepared to implement appropriate interventions based on the clinical presentation of the patient.

Nonclinical Toxicology

It is especially important to avoid the use of aspirin at 20 weeks of gestation or later unless specifically directed by a healthcare professional, as it may lead to complications for the unborn child or during delivery. No non-teratogenic effects have been reported in the available data. Additionally, there are no findings related to animal pharmacology and toxicology provided in the current dataset.

Postmarketing Experience

No specific postmarketing experience details are available in the extracted data. As such, there are no additional adverse events or rare case reports to summarize.

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 instructed to refrain from using the medication for at least 7 days following a tonsillectomy or oral surgery unless specifically directed by a healthcare professional. They must be made aware that they should stop using the medication and consult a doctor if any signs of an allergic reaction occur, and to seek medical help immediately in such cases.

Healthcare providers should also inform patients to discontinue use and consult a doctor if they experience any symptoms indicative of stomach bleeding, which 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 fever intensifies or lasts more than 3 days, if redness or swelling occurs, if new symptoms arise, or if they experience ringing in the ears or a loss of hearing.

Patients should be encouraged to consult a doctor before using the medication if the warning regarding stomach bleeding applies to them. It is also important to discuss their medical history, particularly if they have a history of stomach problems such as heartburn, high blood pressure, heart disease, liver cirrhosis, or kidney disease. Furthermore, patients taking diuretics or those with asthma should be advised to seek medical guidance prior to use. Lastly, patients should be encouraged to consult a doctor or pharmacist if they are currently taking prescription medications 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 exposure to extreme temperatures, which may compromise the product's quality.

Additional Clinical Information

The medication is administered orally, with specific dosing guidelines for different age groups. Adults and children aged 12 years and older are advised to take 4 to 8 chewable tablets every 4 hours, not exceeding 48 tablets in a 24-hour period unless directed by a physician. For children under 12 years, consultation with a doctor is recommended 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)