Market Basket Effervescent Pain Relief

Description

The product is identified by the SPL code 34089-3. No specific description details are provided in the text.

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

The recommended dosage for adults and children aged 12 years and older is two tablets every four hours, as needed, not to exceed eight tablets within a 24-hour period. For individuals aged 60 years and older, the dosage remains two tablets every four hours, but the total should not exceed four tablets in a 24-hour period.

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

To prepare the medication, place two tablets in 4 ounces of water and ensure that the tablets are completely dissolved before administration. 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 required.

It is important to note that the residue remaining at the bottom of the glass does not need to be consumed, as the active ingredients are fully dissolved in the water. Healthcare professionals should emphasize the importance of not exceeding the recommended dosage 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 components. Exceeding the recommended dosage is also contraindicated during use.

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 Reye’s syndrome, a rare but serious condition.

Aspirin may provoke severe allergic reactions, which can manifest as hives, facial swelling, asthma (wheezing), or shock. 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 taking anticoagulants or steroid medications, are using 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 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, if an allergic reaction occurs, immediate medical assistance is necessary.

Healthcare professionals should also instruct patients to stop using the product and consult a doctor if pain persists for more than 10 days or worsens, if fever intensifies or lasts longer than three days, if new symptoms arise, if redness or swelling is observed, or if there is ringing in the ears or a loss of hearing.

In cases of an allergic reaction, it is crucial to obtain emergency medical help without delay.

Side Effects

Patients using this product should be aware of several serious and common 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. It is crucial for these individuals to avoid using this product. 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.

Aspirin, the active ingredient in this product, may cause severe allergic reactions. Symptoms of such reactions can include hives, facial swelling, asthma (wheezing), and 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 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, are using other NSAIDs (including aspirin, ibuprofen, or naproxen), consume three or more alcoholic drinks daily, or exceed the recommended dosage or duration of use. Patients should stop using the product and consult a doctor if they experience any signs of stomach bleeding, such as feeling faint, vomiting blood, having bloody or black stools, or experiencing persistent stomach pain.

Additional adverse reactions may occur, and patients are advised to seek medical advice if pain lasts longer than 10 days or worsens, if fever persists or worsens beyond three days, if new symptoms arise, if redness or swelling is observed, or if they experience ringing in the ears or a loss of hearing.

Patients should consult a doctor before using this product if any of the following apply: they have a history of stomach problems (such as heartburn), high blood pressure, heart disease, liver cirrhosis, or kidney disease; they are taking diuretics; they have asthma; or they are on a sodium-restricted diet. Additionally, it is recommended that patients ask a doctor or pharmacist before use if they are taking prescription medications for diabetes, gout, or arthritis.

Drug Interactions

Taking this product may elevate the risk of gastrointestinal bleeding when used concurrently with anticoagulants or steroid medications. Clinicians 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 increase 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 professional prior to using this product to ensure safe and effective use. Monitoring and potential adjustments may be warranted based on the specific medications involved.

Packaging & NDC

Below are the non-prescription pack sizes of Market Basket Effervescent Pain Relief (aspirin). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients 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. If any changes in behavior accompanied by nausea and vomiting occur while using this product, it is essential to consult a healthcare professional, as these may be early signs of Reye’s syndrome, a rare but serious condition.

For children under 12 years of age, it is advised to consult a doctor 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. It is crucial that these patients do not exceed a total of 4 tablets within a 24-hour period to minimize the risk of adverse effects.

Healthcare providers should closely monitor elderly patients for any signs of gastrointestinal bleeding and adjust treatment plans accordingly to ensure safety and efficacy.

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 development and complications during delivery. Therefore, it is crucial that pregnant patients only use aspirin under the guidance of a healthcare provider if deemed necessary.

Lactation

Lactating mothers are advised to consult a health professional before using this medication while breastfeeding. It is particularly important to avoid the use of aspirin at 20 weeks of pregnancy or later unless specifically directed by a healthcare provider, 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 its use in lactating individuals.

Renal Impairment

There is no specific information regarding dosage adjustments, special monitoring, or safety considerations for patients with renal impairment. Healthcare professionals should exercise caution when prescribing to patients with reduced kidney function, as the absence of detailed guidance necessitates careful clinical judgment. Regular monitoring of renal function may be advisable in this patient population.

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 symptoms of 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 specific antidotes are available, their administration should be considered based on the clinical scenario and the substance involved.

It is essential for healthcare providers to remain vigilant and prepared to implement emergency protocols in the event of an overdose, ensuring the best possible outcomes for affected individuals.

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 regarding nonclinical toxicology or animal pharmacology and toxicology provided in the current information.

Postmarketing Experience

No specific postmarketing experience details are available in the insert text. As such, there are no additional adverse events or rare case reports to summarize at this time.

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 are allergic to aspirin or any other pain reliever or fever reducer, or if they have ever had 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, patients should be made aware that they should seek immediate medical help if an allergic reaction occurs, if pain lasts for more than 10 days or worsens, if fever worsens or lasts more than 3 days, if new symptoms develop, 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 be cautioned not to 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, high blood pressure, heart disease, liver cirrhosis, or kidney disease, if they are taking a diuretic, have asthma, or are on a sodium-restricted diet.

Furthermore, patients should be advised to consult a doctor or pharmacist before using this product if they are taking a prescription medication for diabetes, gout, or arthritis.

Storage and Handling

The product is supplied in various package configurations, with specific NDC numbers available for identification. It should be stored at room temperature, within the range of 59ºF to 86ºF (15ºC to 30ºC). Care should be taken to avoid exposure to excessive heat, as this may compromise the integrity of the product. Proper container requirements must be adhered to, ensuring that the product is kept in a suitable environment to maintain its efficacy. Special handling needs should be observed to ensure optimal storage conditions are met.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

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

View product document (PDF)