Meijer Effervescent Pain Relief

Description

Meijer Pain 36 is a pharmaceutical formulation designed for the management of pain. The product is presented in a dosage form suitable for oral administration. The specific chemical composition and molecular weight are not detailed in the provided information. The formulation is characterized by its efficacy in alleviating discomfort associated with various conditions. Further details regarding the inactive ingredients and structural formula are not specified.

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. It is essential to completely dissolve the tablets 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.

Healthcare professionals should instruct patients that they do not need to consume any residue that may remain at the bottom of the glass, as the active ingredients are fully dissolved in the water. It is crucial 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 components. Exceeding the recommended dosage while using this product is also contraindicated.

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 may provoke severe allergic reactions in some individuals. Symptoms of such reactions can include hives, facial swelling, asthma (wheezing), and shock. Immediate medical attention should be sought if an allergic reaction occurs.

Stomach Bleeding Warning 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 aged 60 years or older

• Have a history of stomach ulcers or bleeding disorders

• Are concurrently using anticoagulants or steroid medications

• Are taking other 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, passing bloody or black stools, or experiencing persistent stomach pain. If any of these symptoms occur, patients should be advised to discontinue use and seek medical attention.

Additional Precautions Patients should be instructed to stop using this product and consult a healthcare provider if:

• Pain persists for more than 10 days or worsens

• Fever worsens or lasts longer than three days

• New symptoms develop

• Redness or swelling is observed

• Tinnitus or hearing loss occurs

In cases of an allergic reaction, immediate medical assistance is essential.

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, they should consult a doctor immediately, as these may be early signs of Reye’s syndrome.

Additionally, the product 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 carries a risk of severe stomach bleeding. The likelihood of this adverse reaction is increased 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 while using the product, or exceed the recommended dosage or duration of use.

Patients should discontinue use 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. Furthermore, 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 there is ringing in the ears or loss of hearing, medical advice should be sought.

Before using this product, patients should consult a doctor 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. Additionally, patients taking diuretics, those with asthma, or those on a sodium-restricted diet should seek medical advice prior to use. It is also advisable for patients taking prescription medications for diabetes, gout, or arthritis to consult a doctor or pharmacist before using this product.

Drug Interactions

Patients should consult a healthcare professional prior to using this medication if they are concurrently taking prescription drugs for diabetes, gout, or arthritis.

In terms of pharmacodynamic interactions, the risk of gastrointestinal bleeding may be increased when this medication is used in conjunction with anticoagulants, steroids, or other nonsteroidal anti-inflammatory drugs (NSAIDs), including both prescription and over-the-counter options such as aspirin, ibuprofen, and naproxen. It is advisable to monitor for signs of gastrointestinal bleeding in patients receiving these combinations.

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

Packaging & NDC

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

Pediatric Use

Pediatric patients, particularly 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. Healthcare professionals should advise caregivers to seek medical attention if pediatric patients exhibit changes in behavior accompanied by nausea and vomiting, as these may be early signs of this rare but serious condition.

For dosing, adults and children aged 12 years and older may 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 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 qualified healthcare provider, who can assess the benefits and risks in their specific situation.

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 its use 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 recommended for individuals with compromised liver function. It is advisable for healthcare providers to exercise caution and consider the overall clinical context when prescribing this medication to patients with hepatic impairment.

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 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 assess the patient for any signs of toxicity or distress.

Management of an overdose should be guided by established protocols, which may include supportive care and symptomatic treatment as necessary. Continuous evaluation of the patient's condition is recommended to ensure appropriate interventions are implemented in a timely manner.

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

No postmarketing experience details are available in the insert text.

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 previously 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 may occur, and if this happens, they should seek medical help immediately. Patients should also be advised to consult a doctor if their pain lasts for more than 10 days or worsens, if their 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 should be cautioned not to exceed the recommended dosage. It is important for patients 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 seek medical advice before using the product. Furthermore, patients taking a diuretic, those with asthma, or those on a sodium-restricted diet should consult a doctor prior to use. Lastly, patients should be encouraged to ask a doctor or pharmacist before using this product if they are taking a prescription drug 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 storage conditions are essential to maintain the product's efficacy and safety.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

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

View product document (PDF)