Good Sense 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.

For adults and children aged 12 years and older, the recommended dosage is 4 to 8 chewable tablets every 4 hours. The total daily intake 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, administration is contraindicated for at least 7 days following 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 avoid the use of this product due to the risk of Reye’s syndrome. This rare but serious condition may present with changes in behavior accompanied by nausea and vomiting. If such symptoms occur, it is imperative to consult a healthcare professional promptly.

Aspirin has the potential to induce severe allergic reactions. Healthcare professionals should be vigilant for signs of an allergic response, which may manifest as hives, facial swelling, asthma (wheezing), or shock. Immediate medical attention is warranted if any of these symptoms arise.

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 concurrently using anticoagulants or steroid medications, are taking other NSAIDs (including aspirin, ibuprofen, or naproxen), consume three or more alcoholic beverages daily while using this product, or exceed the recommended dosage or duration of use.

Patients should be advised to discontinue use and seek medical advice if any of the following occur: signs of an allergic reaction, symptoms indicative of stomach bleeding (such as feeling faint, vomiting blood, passing bloody or black stools, or experiencing persistent stomach pain), worsening pain lasting more than 10 days, fever that worsens or persists beyond three days, presence of redness or swelling, emergence of new symptoms, or any ringing in the ears or hearing loss.

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

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 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.

Patients are advised to discontinue use 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. 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 Good Sense Aspirin (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, a rare but serious illness. If 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.

For dosing, adults and children aged 12 years and over are directed to take 4 to 8 chewable 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, consultation with a doctor is advised before use.

Geriatric Use

Elderly patients, particularly those aged 60 and older, may have an increased risk of severe stomach bleeding associated with the use of this product, which contains a nonsteroidal anti-inflammatory drug (NSAID). It is crucial for healthcare providers to assess the individual risk factors for stomach bleeding in geriatric patients prior to prescribing this medication.

Healthcare providers should advise elderly patients to consult with a physician before using this product if they have a history of stomach problems, such as heartburn, or if they have comorbid conditions including high blood pressure, heart disease, liver cirrhosis, or kidney disease. Close monitoring and careful consideration of the patient's overall health status are recommended to mitigate potential risks associated with NSAID use in this population.

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 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 a history of kidney disease. It is essential to assess renal function and consider potential dosing adjustments or monitoring requirements based on the severity of renal impairment. Additionally, patients with concurrent conditions such as high blood pressure or heart disease may require further evaluation to ensure safe and effective use of the medication.

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 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. Healthcare professionals are advised to call the Poison Control Center at 1-800-222-1222 for guidance on managing the situation effectively.

Prompt intervention is crucial in mitigating potential adverse effects associated with an overdose. Symptoms may vary depending on the substance involved, and healthcare providers should be prepared to assess and manage these symptoms accordingly.

Management procedures may include supportive care and symptomatic treatment, tailored to the specific clinical presentation of the patient. Continuous monitoring and evaluation are essential to ensure patient safety and to address any complications that may arise during the course of treatment.

Nonclinical Toxicology

It is especially important to avoid the use of aspirin at 20 weeks or later in pregnancy 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 specified in the available data. Additionally, there are no details provided regarding nonclinical toxicology or animal pharmacology and toxicology.

Postmarketing Experience

Postmarketing experience has revealed reports of various adverse reactions associated with the use of this product. Notable allergic reactions include hives, facial swelling, asthma (wheezing), and shock. Additionally, instances of stomach bleeding have been reported, particularly among individuals aged 60 years or older, those with a history of stomach ulcers or bleeding problems, patients taking blood-thinning (anticoagulant) or steroid medications, users of other nonsteroidal anti-inflammatory drugs (NSAIDs), individuals consuming three or more alcoholic drinks daily, or those exceeding the recommended dosage.

Furthermore, cases of Reye’s syndrome have been documented in children and teenagers who have or are recovering from chickenpox or flu-like symptoms following the use of this product.

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 essential 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. They should be instructed to stop use and consult a doctor if they experience any signs of an allergic reaction, and to seek medical help immediately in such cases.

Healthcare providers should emphasize the importance of discontinuing use and consulting a doctor if patients notice 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 stop use and seek medical advice if their pain worsens or persists for more than 10 days, if their fever worsens or lasts more than 3 days, if redness or swelling occurs, or if new symptoms arise. They should also be informed to stop use and consult a doctor if they experience ringing in the ears or a loss of hearing, as these could indicate a serious condition.

Patients should be encouraged to ask a doctor before use if they have a history of stomach problems, such as heartburn, or if the stomach bleeding warning applies to them. It is also important for patients to consult a healthcare professional before using this medication 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 seek medical advice prior to use. Lastly, patients should be advised to consult a doctor or pharmacist if they are 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 any degradation of the product.

Additional Clinical Information

The product is administered orally. Clinicians should advise patients to consult with their doctor or healthcare provider prior to using this product for heart-related conditions. No further information is available regarding laboratory tests, abuse potential, or postmarketing experiences.

Drug Information (PDF)

This file contains official product information for Good Sense Aspirin, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)