Good Sense Effervescent Pain Relief

Description

Good Sense Pain 36 is a pharmaceutical formulation designed for the management of pain. The product is characterized by its specific active ingredients and dosage form, which contribute to its therapeutic efficacy. The formulation is presented in a suitable dosage form that facilitates administration. The appearance of Good Sense Pain 36 is consistent with standard pharmaceutical products, ensuring ease of identification and use in clinical settings. Further details regarding its chemical composition, including molecular weight and structural formula, are available in the complete product specifications.

Uses and Indications

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

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

Dosage and Administration

Adults and children aged 12 years and older are advised to take 2 tablets every 4 hours, as needed, not to exceed 8 tablets within a 24-hour period. For individuals aged 60 years and older, the recommended dosage is also 2 tablets every 4 hours, but the total should not exceed 4 tablets in a 24-hour period.

For children under 12 years of age, it is essential to consult a healthcare professional for appropriate dosing recommendations.

To prepare the medication, place 2 tablets in 4 ounces of water and ensure that the tablets are completely dissolved before ingestion. The product can be taken at any time of day—morning, noon, or night—when relief from headaches, backaches, body aches, or muscle pain is needed.

It is important to note that any residue remaining at the bottom of the glass does not need to be consumed, as the active ingredients are fully dissolved in the water. Adherence to the recommended dosages is crucial to avoid serious injury.

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 ingredients.

Warnings and Precautions

Use of this product is associated with several important warnings and precautions that healthcare professionals should be aware of to ensure patient safety.

Reye’s Syndrome Children and teenagers who are experiencing or recovering from chickenpox or flu-like symptoms should not use this product. If patients exhibit changes in behavior accompanied by nausea and vomiting while using this product, it is imperative to consult a physician, as these symptoms may indicate the onset of Reye’s syndrome, a rare but serious condition.

Allergy Alert Aspirin has the potential to induce severe allergic reactions. Symptoms may include hives, facial swelling, asthma (wheezing), and shock. Immediate medical attention should be sought if any signs of an allergic reaction occur.

Stomach Bleeding Warning This product contains a nonsteroidal anti-inflammatory drug (NSAID), which may lead to severe stomach bleeding. The risk is heightened in patients who:

• Are aged 60 years or older

• Have a history of stomach ulcers or bleeding disorders

• Are concurrently using blood thinners (anticoagulants) or steroid medications

• Are taking other medications that contain NSAIDs (including aspirin, ibuprofen, or naproxen)

• Consume three or more alcoholic beverages daily while using this product

• Exceed the recommended dosage or duration of use

Monitoring Parameters Healthcare professionals should monitor patients for signs of stomach bleeding, which may include feeling faint, vomiting blood, having bloody or black stools, or experiencing persistent stomach pain.

Discontinuation of Use Patients should be advised to stop using this product and consult a healthcare provider if they experience any of the following:

• Signs of stomach bleeding

• An allergic reaction

• Pain that persists for more than 10 days or worsens

• Fever that worsens or lasts longer than three days

• The emergence of new symptoms

• Redness or swelling

• Ringing in the ears or hearing loss

Emergency Medical Help In the event of an allergic reaction, immediate medical assistance is essential.

These warnings and precautions are critical for the safe use of this product and should be communicated effectively to patients.

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 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.

The product contains a nonsteroidal anti-inflammatory drug (NSAID), which may increase the risk of severe stomach bleeding. This risk is heightened in patients who are 60 years of age or older, have a history of stomach ulcers or bleeding problems, are taking blood thinners or steroid medications, consume three or more alcoholic drinks daily, or use other NSAIDs concurrently. Patients should be advised to stop use and consult a doctor if they experience symptoms indicative of stomach bleeding, such as feeling faint, vomiting blood, having bloody or black stools, or experiencing persistent stomach pain.

Common adverse reactions may include prolonged pain lasting more than 10 days, worsening fever lasting more than three days, the emergence of new symptoms, redness or swelling, and auditory disturbances such as ringing in the ears or loss of hearing. Patients are encouraged to seek medical advice if any of these symptoms occur.

Before using this product, patients should consult a doctor if they have a history of stomach problems, high blood pressure, heart disease, liver cirrhosis, or kidney disease, or if they are taking diuretics, have asthma, or are on a sodium-restricted diet. Furthermore, patients taking prescription medications for diabetes, gout, or arthritis should also seek guidance from a healthcare professional prior to use.

Drug Interactions

Taking this product may lead to an increased risk of gastrointestinal bleeding when used concurrently with anticoagulants or steroid medications. Healthcare professionals should exercise caution and consider monitoring for signs of bleeding in patients receiving these combinations.

Additionally, the concomitant use of this product with other nonsteroidal anti-inflammatory drugs (NSAIDs), including both prescription and over-the-counter options such as aspirin, ibuprofen, and naproxen, may also elevate the risk of stomach bleeding. It is advisable to assess the necessity of dosage adjustments or alternative therapies in patients who require both this product and NSAIDs.

Furthermore, patients taking prescription medications for diabetes, gout, or arthritis should consult with a healthcare provider or pharmacist prior to using this product to ensure safe and effective use, as potential interactions may necessitate closer monitoring or adjustments in therapy.

Packaging & NDC

Below are the non-prescription pack sizes of Good Sense Effervescent Pain Relief (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 2 tablets every 4 hours, not to exceed 8 tablets in a 24-hour period. For children under 12 years of age, consultation with a doctor is recommended prior to use.

Geriatric Use

Elderly patients, particularly those aged 60 years and older, are at an increased risk for severe stomach bleeding. This heightened risk necessitates careful consideration when prescribing and monitoring treatment in this population.

For geriatric patients, the recommended dosage is 2 tablets every 4 hours, or as directed by a healthcare provider, with a maximum limit of 4 tablets within a 24-hour period. It is essential for healthcare providers to ensure that elderly patients adhere to this dosage guideline to mitigate potential adverse effects, particularly the risk of gastrointestinal complications. Regular monitoring for signs of stomach bleeding is advised in this demographic to ensure patient safety.

Pregnancy

Pregnant patients and those who are breastfeeding should consult a healthcare professional prior to use. The use of aspirin during pregnancy, particularly at 20 weeks gestation or later, is associated with potential risks. Specifically, aspirin may lead to adverse fetal outcomes or complications during delivery if not used under medical supervision. Therefore, it is crucial for healthcare providers to evaluate the necessity and safety of aspirin use in pregnant patients on a case-by-case basis.

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 have not been specifically addressed in the available data regarding dosage adjustments, special monitoring, or safety considerations. Therefore, healthcare professionals should exercise caution when prescribing this medication to patients with reduced kidney function, as the lack of information necessitates careful clinical judgment and monitoring of these patients.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in relation to the use of this medication. Consequently, there are no established dosage adjustments, special monitoring requirements, or precautions outlined for individuals with compromised liver function. It is recommended that healthcare providers exercise caution when prescribing this medication to patients with hepatic impairment, given the lack of data on its safety and efficacy in this population. Regular monitoring of liver function may be prudent in these cases, although specific parameters are not defined in the available information.

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.

Management of an overdose typically involves supportive care and symptomatic treatment. Continuous monitoring of the patient's vital signs and clinical status is recommended. Depending on the severity of the overdose and the substance involved, additional interventions may be necessary.

It is critical for healthcare providers to remain vigilant and prepared to implement appropriate treatment protocols based on the clinical presentation and the substance implicated in the overdose.

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 provided regarding nonclinical toxicology or animal pharmacology and toxicology.

Postmarketing Experience

Postmarketing experience has identified several adverse reactions reported voluntarily or through surveillance programs. These include allergic reactions such as hives, facial swelling, asthma (wheezing), and shock. Additionally, cases of stomach bleeding have been noted, particularly in patients aged 60 or older, those with a history of stomach ulcers or bleeding problems, individuals taking anticoagulant or steroid medications, users of other NSAIDs, and those consuming three or more alcoholic drinks daily while using this product or exceeding the recommended dosage. Symptoms indicative of stomach bleeding may include feeling faint, vomiting blood, having bloody or black stools, and experiencing persistent stomach pain.

New symptoms may arise, and signs such as redness or swelling have been reported. Instances of tinnitus (ringing in the ears) or hearing loss have also been documented. It is recommended that medical assistance be sought immediately if an allergic reaction occurs, if pain persists for more than 10 days, if fever worsens or lasts more than three days, or if new symptoms develop.

Patient Counseling

Healthcare providers should advise patients to keep this product out of reach of children to prevent accidental ingestion. Patients should be informed not to use the product if they have a known allergy to aspirin or any other pain reliever or fever reducer. It is essential to emphasize that individuals who have previously experienced an allergic reaction to this product or any of its ingredients should also refrain from use.

Patients should be instructed to stop using the product and seek medical attention 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. Additionally, they should be made aware that an allergic reaction may occur, and they should seek immediate medical help if pain lasts for more than 10 days, if fever worsens or lasts more than 3 days, if new symptoms arise, if redness or swelling is present, or if they experience ringing in the ears or a loss of hearing.

When using this product, patients must not exceed the recommended dosage. Healthcare providers should encourage patients to consult a doctor before use if the warning regarding stomach bleeding applies to them, if they have a history of stomach problems such as heartburn, or if they have conditions such as high blood pressure, heart disease, liver cirrhosis, or kidney disease. Patients taking diuretics, those with asthma, or individuals on a sodium-restricted diet should also seek medical advice prior to use.

Furthermore, patients should be advised to consult a doctor or pharmacist before using this product if they are currently taking prescription medications for diabetes, gout, 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 room temperature, maintaining a range of 59ºF to 86ºF. Care should be taken to avoid exposure to excessive heat, as this may compromise the integrity of the product. Proper storage conditions are crucial to ensure the product remains effective and safe for use.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

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

View product document (PDF)