Quality Choice Effervescent Pain Relief

Description

Quality Choice Pain 36 is a pharmaceutical product formulated for pain management. The specific composition and dosage form are not detailed in the provided information. Further specifications regarding the molecular weight, chemical formula, and inactive ingredients are also not available. The product is designed to meet quality standards for efficacy and safety in its intended use.

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, or as directed by a healthcare professional. The maximum dosage should not 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, with a maximum limit of 4 tablets in a 24-hour period.

For children under 12 years of age, consultation with a healthcare professional is required prior to administration.

To ensure safety and efficacy, tablets must be completely dissolved in 4 ounces of water before ingestion. The preparation involves placing two tablets in the specified amount of water and allowing them to dissolve fully. 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 contained within the dissolved solution.

This product can be taken at any time of day—morning, noon, or night—when relief from headache, backaches, body aches, or muscle pain is needed. It is imperative to adhere to the recommended dosages 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. Healthcare providers should be vigilant in assessing patients for any signs of an allergic response.

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, whether prescription or over-the-counter (e.g., aspirin, ibuprofen, 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 seek medical attention if any of the following occur:

• Signs of stomach bleeding as previously mentioned

• Any allergic reaction, which requires immediate medical assistance

• Pain that persists for more than 10 days or worsens

• Fever that worsens or lasts longer than three days

• The emergence of new symptoms

• Presence of redness or swelling

• Ringing in the ears or loss of hearing

Healthcare professionals should ensure that patients are fully informed of these warnings and precautions to promote safe and effective use of the product.

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. Furthermore, medical attention should be sought if an allergic reaction occurs, if pain persists for more than 10 days or worsens, if fever worsens or lasts more than three days, if new symptoms arise, if redness or swelling is present, or if there is ringing in the ears or a loss of hearing.

Drug Interactions

The presence of a nonsteroidal anti-inflammatory drug (NSAID) in this product may increase the risk of severe gastrointestinal bleeding, particularly in patients concurrently using anticoagulants or steroid medications. It is advisable for patients to consult with a healthcare professional prior to using this product if they are currently prescribed medications for diabetes, gout, or arthritis, as these conditions may influence the safety and efficacy of the NSAID.

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

Packaging & NDC

Below are the non-prescription pack sizes of Quality Choice 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, consultation with a doctor is advised before 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 medications that may contribute to gastrointestinal complications.

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 monitor these patients closely for any signs of gastrointestinal bleeding and to adjust dosages as necessary to mitigate potential risks.

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, 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 prescribing information. There are no dosage adjustments, special monitoring requirements, or safety considerations outlined for individuals with reduced kidney function. Healthcare professionals should exercise caution and consider the lack of data when prescribing to this patient population.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in clinical trials for this medication. Consequently, there is no available information regarding dosage adjustments, special monitoring requirements, or precautions 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 warranted based on clinical judgment.

Overdosage

In the event of an overdose, it is imperative to seek immediate medical assistance or contact the Poison Control Center without delay. Prompt intervention is crucial to mitigate potential adverse effects associated with the overdose.

Healthcare professionals should be vigilant in monitoring for symptoms that may arise from an overdose. While specific symptoms are not detailed in the provided information, it is essential to be aware that they can vary based on the substance involved and the individual’s health status.

Management of an overdose typically involves supportive care and symptomatic treatment. Healthcare providers should ensure that the patient is stabilized and closely monitored throughout the treatment process. It is advisable to follow established protocols for overdose management, which may include administering activated charcoal if appropriate and ensuring the patient receives the necessary medical interventions based on their clinical presentation.

In summary, immediate action is critical in the case of an overdose, and healthcare professionals should be prepared to implement appropriate management strategies to ensure patient safety and recovery.

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 or additional nonclinical toxicology details are available in the provided data. Furthermore, there are no specific findings related to 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. Furthermore, new symptoms have been reported, including redness or swelling, ringing in the ears, or loss of hearing.

Patients are advised to seek immediate medical assistance 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 arise.

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, or if they have ever experienced an allergic reaction to this product or any of its ingredients.

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 stomach pain that does not improve. Additionally, they should be made aware that an allergic reaction requires immediate medical help. Patients should also be cautioned to discontinue use if pain persists for more than 10 days or worsens, if fever worsens or lasts more than 3 days, if new symptoms arise, if redness or swelling occurs, or if they experience ringing in the ears or a loss of hearing.

It is important to emphasize that patients should not exceed the recommended dosage while using this product. Healthcare providers should encourage patients to consult a doctor before use if they have a history of stomach problems, such as heartburn, or if they have 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 Quality Choice Effervescent Pain Relief, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)