Medique Medi-Seltzer Pain Relief

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 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 2 tablets every 4 hours, or as directed by a healthcare professional. It is imperative that the total daily dosage does not exceed 8 tablets within a 24-hour period.

For adults aged 60 years and older, the dosage remains at 2 tablets every 4 hours, or as directed by a healthcare professional; however, the maximum allowable dosage is limited to 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 ensure safety and efficacy, tablets must be completely dissolved in 4 ounces of water prior to administration. It is critical 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 administered to patients who have previously experienced an allergic reaction to this product or any of its components. Exceeding the recommended dosage is also contraindicated.

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 physician prior to using this product if they have a history of stomach issues such as heartburn, high blood pressure, heart disease, liver cirrhosis, or kidney disease. Additionally, patients taking diuretics, those with asthma, or individuals on a sodium-restricted diet should seek medical advice before use. It is also recommended that patients on prescription medications for diabetes, gout, or arthritis consult with their doctor or pharmacist prior to using this product.

In the event of an overdose, immediate medical assistance should be sought, or the Poison Control Center should be contacted without delay.

Patients should discontinue use and contact a healthcare professional if they experience any signs of stomach bleeding, such as feeling faint, vomiting blood, having bloody or black stools, or experiencing persistent stomach pain. Additionally, they should seek medical attention if they have an allergic reaction, 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 occurs, or if they experience ringing in the ears or hearing loss.

Side Effects

Patients using this product may experience a range of adverse reactions, some of which can be serious.

Serious Adverse Reactions 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. Patients should be advised not to use this product under these circumstances. If changes in behavior accompanied by nausea and vomiting occur, it is essential to consult a healthcare professional, as these symptoms could indicate the onset of Reye's syndrome.

Aspirin may also 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 immediate medical attention.

Additionally, 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, consume three or more alcoholic drinks daily, or use other NSAIDs concurrently.

Common Adverse Reactions Patients should discontinue use and consult a healthcare provider if they experience any signs of stomach bleeding, such as feeling faint, vomiting blood, having bloody or black stools, or experiencing persistent stomach pain. Other symptoms warranting medical consultation include an allergic reaction, pain lasting more than 10 days or worsening, fever that worsens or lasts more than three days, the appearance of new symptoms, redness or swelling, or ringing in the ears or loss of hearing.

Precautions Before using this product, patients should consult a healthcare professional 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, it is advisable for patients to consult a doctor or pharmacist if they are taking prescription medications for diabetes, gout, or arthritis.

Drug Interactions

There are currently no documented drug interactions associated with this medication. Additionally, there are no known interactions with laboratory tests. As such, no specific recommendations for dosage adjustments or monitoring are necessary at this time.

Packaging & NDC

Below are the non-prescription pack sizes of Medique Medi-Seltzer Pain Relief (aspifin). 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 pediatric patients experience changes in behavior accompanied by nausea and vomiting while using this product, a healthcare professional should be consulted, as these symptoms may indicate the onset of Reye's syndrome.

For children under 12 years of age, it is advised to consult a doctor before use. For adolescents aged 12 years and older, the recommended dosage is 2 tablets every 4 hours, or as directed by a healthcare professional, with a maximum of 8 tablets in a 24-hour period.

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 adults aged 60 years and over, 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 exercise caution and closely monitor elderly patients for any signs of gastrointestinal bleeding, especially when initiating therapy or adjusting dosages. Regular assessment of the patient's overall health status and medication regimen is advised to ensure safety and efficacy in this vulnerable population.

Pregnancy

Pregnant patients and those who are breastfeeding should consult a healthcare professional before using this medication. It is particularly important to avoid the use of aspirin after 20 weeks of pregnancy unless specifically directed by a physician, as it may pose risks to the developing fetus and could lead to complications during delivery. Healthcare providers should carefully evaluate the potential benefits and risks when considering the use of this medication in pregnant patients.

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, due to potential risks to the unborn child and 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 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

There is currently no specific information available regarding overdosage for this medication. Healthcare professionals are advised to monitor patients closely for any signs of adverse effects or symptoms that may arise from excessive dosing.

In the event of suspected overdosage, it is recommended that healthcare providers initiate supportive care and symptomatic treatment as necessary. Patients should be evaluated for potential complications, and appropriate interventions should be implemented based on clinical judgment.

For further guidance, healthcare professionals should refer to established protocols and consult relevant toxicology resources.

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 specific details regarding nonclinical toxicology or animal pharmacology and toxicology provided in the text.

Postmarketing Experience

Postmarketing experience has revealed reports of various adverse reactions associated with the use of the product. These include allergic reactions such as hives, facial swelling, asthma (wheezing), and shock. Additionally, cases of stomach bleeding have been reported, particularly among patients who are older, have a history of stomach ulcers or bleeding problems, or are concurrently using other NSAIDs or blood thinners.

Further adverse reactions reported include tinnitus (ringing in the ears) or loss of hearing, the emergence of new symptoms following use, and localized redness or swelling at the site of application. Notably, there have also been reports of Reye's syndrome in children and teenagers who have used aspirin during or after experiencing chickenpox or flu-like symptoms.

Patient Counseling

Healthcare providers should advise patients to keep this product out of reach of children. In the event of an overdose, patients should seek medical help or contact a Poison Control Center immediately.

Patients should be informed not to use this product if they are allergic to aspirin or any other pain reliever or fever reducer. Additionally, they should not use it if they have ever experienced an allergic reaction to this product or any of its ingredients.

Healthcare providers should instruct patients to 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 stomach pain that does not improve. Patients should also be advised to seek medical attention if they notice any allergic reactions, if pain persists for more than 10 days or worsens, if fever worsens or lasts more than 3 days, if new symptoms appear, if redness or swelling occurs, or if they experience ringing in the ears or a loss of hearing.

It is important for healthcare providers to remind patients not to exceed the recommended dosage while using this product. Patients should be encouraged to consult a doctor before use if they have a history of stomach problems, such as heartburn, or if the stomach bleeding warning applies to them.

Patients with high blood pressure, heart disease, liver cirrhosis, or kidney disease should also be advised to seek medical guidance before using this product. Furthermore, patients taking diuretics, those with asthma, or those on a sodium-restricted diet should consult a doctor prior to use. Lastly, patients should be encouraged to speak with a doctor or pharmacist if they are taking prescription medications for diabetes, gout, or arthritis.

Storage and Handling

The product is supplied in tamper-evident sealed packets, ensuring integrity and safety. It is essential to store the packets at room temperature, specifically within the range of 59º to 86º F (15º to 30º C). Care should be taken to avoid exposure to excessive heat, which may compromise the product's quality. Opened or torn packets should not be used, as they may not provide the intended efficacy or safety.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

This file contains official product information for Medique Medi-Seltzer Pain Relief, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)