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Maximum Strength Gas Relief

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This product has been discontinued

Active ingredient
Dimethicone 250 mg
Other brand names
Dosage form
Capsule, Liquid Filled
Route
Oral
Prescription status
OTC (over the counter)
Marketed in the U.S.
Since 2016
Label revision date
July 28, 2016
Active ingredient
Dimethicone 250 mg
Other brand names
Dosage form
Capsule, Liquid Filled
Route
Oral
Prescription status
OTC (over the counter)
CSA schedule
Not a scheduled drug
Marketed in the U.S.
Since 2016
Label revision date
July 28, 2016
Manufacturer
PuraCap Pharmaceutical LLC
Registration number
part332
NDC root
51013-177

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Drug Overview

MB MAXIMUM STRENGTH Gas Relief is a medication designed to help relieve bloating, pressure, or fullness that is commonly associated with gas. It contains simethicone (a medication that helps break up gas bubbles in the stomach and intestines) in a strength of 250 mg, making it effective for alleviating discomfort caused by excess gas.

This product comes in a convenient formulation of 24 softgels, allowing you to easily manage gas-related symptoms when they arise. If you're experiencing discomfort from gas, MB MAXIMUM STRENGTH Gas Relief may provide the relief you need.

Uses

You can use this medication to help relieve feelings of bloating, pressure, or fullness that are often caused by gas. It’s designed to make you feel more comfortable by addressing these common digestive issues.

Rest assured, there are no known teratogenic effects (which means it doesn’t cause birth defects) associated with this medication, making it a safer option for those concerned about such risks.

Dosage and Administration

You should take one or two softgels after a meal. It's important not to exceed two softgels in a 24-hour period unless your doctor advises you otherwise. Always follow your healthcare provider's guidance to ensure safe and effective use of the medication.

What to Avoid

It's important to be aware of certain guidelines when using this medication. If your condition does not improve or continues to persist, you should stop using the medication and consult your doctor for further advice. This ensures that you receive the appropriate care and support for your health needs.

Currently, there are no specific contraindications, controlled substance classifications, or concerns regarding abuse, misuse, or dependence associated with this medication. Always prioritize your health and safety by following these instructions closely.

Side Effects

If you experience any persistent symptoms while using this medication, it's important to stop using it and consult your doctor. Additionally, be sure to keep this medication out of reach of children to ensure their safety.

While specific side effects are not detailed here, always be aware of how your body responds to any medication and communicate any concerns with your healthcare provider.

Warnings and Precautions

It's important to be aware of how to use this medication safely. If your condition does not improve or continues to persist, you should stop taking the medication and contact your doctor for further guidance.

While there are no specific warnings or precautions listed, always stay informed about your health and consult with your healthcare provider if you have any concerns or questions regarding your treatment.

Overdose

If you suspect an overdose, it's important to stay calm and take immediate action. While there are no specific signs or symptoms listed for an overdose, you should be aware of general warning signs such as extreme drowsiness, confusion, or difficulty breathing. If you notice any of these symptoms or feel something is wrong, seek medical help right away.

In case of an overdose, contact your local emergency services or go to the nearest hospital. It's always better to be safe and get checked by a healthcare professional if you have any concerns about your health.

Pregnancy Use

If you are pregnant or planning to become pregnant, it's important to know that there is currently no information available about the use of MAXIMUM STRENGTH GAS RELIEF (simethicone) during pregnancy. This means that safety concerns, dosage adjustments, or any special precautions related to its use in pregnant individuals have not been established.

Before taking any medication, including over-the-counter products like simethicone, you should consult with your healthcare provider to discuss potential risks and benefits specific to your situation. Your health and the health of your baby are the top priority, so it's always best to seek professional advice.

Lactation Use

If you are breastfeeding, you can feel reassured that there are no specific warnings or recommendations regarding the use of this product while nursing. Additionally, there are no statements indicating that the product is excreted in breast milk or that it poses any risk to your infant. This means you can use the product without concern for its effects on your milk production or your baby's health.

Pediatric Use

It's important to keep this medication out of reach of children to ensure their safety. If your child needs to take this medication, be aware that they should not exceed two softgels in a 24-hour period unless a doctor has specifically advised otherwise. Always consult with a healthcare professional if you have any questions or concerns about the appropriate use and dosage for your child.

Geriatric Use

When it comes to using this medication in older adults, there is no specific information available about dosage adjustments, safety concerns, or special precautions. This means that if you or a loved one is an older adult considering this medication, it’s important to consult with a healthcare provider. They can help determine the best approach based on individual health needs and any other medications being taken. Always prioritize open communication with your healthcare team to ensure safe and effective treatment.

Renal Impairment

If you have kidney problems, it's important to know that there are no specific guidelines or dosage adjustments mentioned for your condition in the available information. This means that the usual recommendations for monitoring or safety considerations related to renal impairment (kidney issues) are not provided.

Always consult your healthcare provider for personalized advice and to ensure that any medications you take are safe and appropriate for your kidney health. They can help you understand how your condition may affect your treatment and what steps to take for your safety.

Hepatic Impairment

If you have liver problems, it's important to know that the drug insert does not provide specific information about dosage adjustments, special monitoring, or precautions for your condition. This means that there are no tailored guidelines for how this medication may affect you if you have hepatic impairment (liver issues).

Before starting any new medication, including this one, you should discuss your liver health with your healthcare provider. They can help determine the best approach for your treatment and ensure your safety.

Drug Interactions

It's important to have open conversations with your healthcare provider about any medications you are taking. In this case, there are no specific drug interactions or laboratory test interactions noted, which means that this medication is generally considered safe to use alongside other treatments and tests. However, every individual is different, and your healthcare provider can help ensure that your overall treatment plan is safe and effective for you. Always feel free to ask questions or express any concerns you may have regarding your medications or tests.

Storage and Handling

To ensure the best performance of your product, store it at room temperature, ideally between 59°F and 86°F (15°C and 30°C). This temperature range helps maintain the product's effectiveness and safety.

When handling the product, make sure to do so in a clean environment to avoid contamination. Always follow any specific instructions provided with the product for safe use and disposal. Keeping these guidelines in mind will help you use the product safely and effectively.

Additional Information

No further information is available.

FAQ

What is MB MAXIMUM STRENGTH Gas Relief used for?

MB MAXIMUM STRENGTH Gas Relief is used to relieve bloating, pressure, or fullness commonly referred to as gas.

What is the active ingredient in MB MAXIMUM STRENGTH Gas Relief?

The active ingredient in MB MAXIMUM STRENGTH Gas Relief is SIMETHICONE, with a dosage of 250 mg.

How should I take MB MAXIMUM STRENGTH Gas Relief?

You should swallow one or two softgels after a meal, but do not exceed two softgels per 24 hours unless advised by a physician.

Are there any contraindications for using MB MAXIMUM STRENGTH Gas Relief?

No specific contraindications are mentioned for MB MAXIMUM STRENGTH Gas Relief.

What should I do if my condition persists while using this product?

You should stop use and ask a doctor if your condition persists.

Is MB MAXIMUM STRENGTH Gas Relief safe to use during pregnancy?

There is no specific information regarding the use of MB MAXIMUM STRENGTH Gas Relief during pregnancy.

Can nursing mothers use MB MAXIMUM STRENGTH Gas Relief?

There are no specific warnings or recommendations regarding the use of this product in nursing mothers.

How should I store MB MAXIMUM STRENGTH Gas Relief?

You should store MB MAXIMUM STRENGTH Gas Relief at room temperature between 59°-86°F (15°-30°C).

What should I keep in mind regarding children and MB MAXIMUM STRENGTH Gas Relief?

Keep MB MAXIMUM STRENGTH Gas Relief out of reach of children.

Packaging Info

Below are the non-prescription pack sizes of Maximum Strength Gas Relief (simethicone). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Maximum Strength Gas Relief.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

MB MAXIMUM STRENGTH Gas Relief contains simethicone as its active ingredient, with a concentration of 250 mg per softgel. This product is available in a package containing 24 softgels. The National Drug Code (NDC) for this formulation is 51013-177-04. It is formulated to provide maximum strength gas relief and is comparable to the active ingredient found in PHAZYME® Maximum Strength.

Uses and Indications

This drug is indicated for the relief of bloating, pressure, or fullness commonly referred to as gas.

There are no teratogenic effects associated with this drug. Additionally, no nonteratogenic effects have been reported.

Dosage and Administration

Patients should swallow one or two softgels after a meal. The maximum recommended dosage is two softgels within a 24-hour period, unless otherwise directed by a physician. It is important for healthcare professionals to advise patients not to exceed this dosage without appropriate medical supervision.

Contraindications

There are no specific contraindications identified for this product. However, it is advised to discontinue use and consult a healthcare professional if the condition persists.

Warnings and Precautions

Healthcare professionals should be aware of the following considerations regarding the safe use of the medication.

In the event that the patient's condition does not improve or persists, it is imperative to discontinue use and consult a physician. This action is crucial to ensure appropriate management and to rule out any underlying issues that may require further intervention.

No specific warnings, general precautions, or laboratory tests have been identified in the current documentation. Therefore, ongoing vigilance and clinical judgment are essential in monitoring the patient's response to treatment and addressing any emerging concerns.

Side Effects

Patients should be advised to discontinue use and consult a healthcare professional if their condition persists. It is also important to keep the product out of reach of children to prevent accidental ingestion or misuse.

No specific adverse reactions were reported in clinical trials or postmarketing experiences; however, the aforementioned warnings highlight the necessity for caution in use.

Drug Interactions

There are no specific drug interactions identified for this medication. Additionally, no laboratory test interactions have been reported. Therefore, no dosage adjustments or monitoring recommendations are necessary based on drug or laboratory test interactions.

Packaging & NDC

Below are the non-prescription pack sizes of Maximum Strength Gas Relief (simethicone). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Maximum Strength Gas Relief.
Details

Pediatric Use

Pediatric patients should be advised to keep this medication out of reach of children. The recommended dosage for pediatric patients is limited to a maximum of two softgels per 24 hours, unless otherwise directed by a physician. Careful supervision is advised to ensure adherence to this dosage guideline.

Geriatric Use

There is no specific information regarding the use of this medication in geriatric patients, including dosage adjustments, safety concerns, or special precautions. Healthcare providers should exercise caution when prescribing this medication to elderly patients, as individual responses may vary. It is advisable to monitor these patients closely for any adverse effects or changes in efficacy, given the lack of targeted data for this population.

Pregnancy

There is currently no information available regarding the use of MAXIMUM STRENGTH GAS RELIEF (simethicone) during pregnancy. The prescribing information does not provide safety concerns, dosage modifications, or special precautions for pregnant patients. Healthcare professionals should consider this lack of data when advising women of childbearing potential and weigh the potential benefits against any unknown risks to fetal outcomes.

Lactation

There are no specific warnings or recommendations regarding the use of this product in nursing mothers. Additionally, there are no statements concerning the potential for excretion in breast milk or any associated risks to breastfed infants.

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 absence of specific information regarding overdosage, healthcare professionals are advised to exercise caution and adhere to general principles of management in cases of suspected overdose.

It is essential to monitor the patient closely for any potential symptoms that may arise from an overdose. Symptoms can vary widely depending on the substance involved and the individual patient's response.

In the event of an overdose, immediate medical attention should be sought. Healthcare providers should initiate supportive care, which may include maintaining airway patency, ensuring adequate ventilation, and monitoring vital signs.

If available, specific antidotes or treatments should be administered as per established protocols. Additionally, contacting a poison control center can provide valuable guidance on the management of overdose cases.

Documentation of the incident, including the substance involved, the amount ingested, and the time of ingestion, is crucial for effective treatment and follow-up care.

Nonclinical Toxicology

No teratogenic or non-teratogenic effects have been reported in the available nonclinical studies. Additionally, there is no information regarding animal pharmacology and toxicology. The absence of data limits the assessment of potential risks associated with the use of the compound in question. Further studies may be necessary to fully evaluate the nonclinical toxicology profile.

Postmarketing Experience

No postmarketing experience details are available in the insert text.

Patient Counseling

Healthcare providers should advise patients to keep the medication out of reach of children to prevent accidental ingestion or misuse. It is important for patients to understand the necessity of discontinuing use and consulting a doctor if their condition persists, as this may indicate the need for further evaluation or alternative treatment options.

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 59°F to 86°F (15°C to 30°C). Proper storage conditions are crucial to ensure the integrity and efficacy of the product.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

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

View product document (PDF)

Data Generation & Sources

This page was automatically generated and is maintained by the AllDrugs AI Data-Science Team. It was built from the FDA Structured Product Label (DailyMed) for Maximum Strength Gas Relief, retrieved by a validated AI data-extraction workflow.

All FDA-listed dosage forms and strengths are shown in the Packaging & NDC Codes section above. Regulatory status appears in the Summary Information panel above and was verified in the FDA National Drug Code directory and the NSDE NDC Directory daily file.

Note: an automated daemon monitors NSDE checksums; when the record for this NDC changes, the new file is pulled instantly and this page is refreshed.

No human clinician has reviewed this version.

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Primary FDA sources:

Orange Book data shown on this page are limited to Regulatory Status (Rx), Established Pharmacologic Class (EPC), and Mechanism of Action (MoA).

Regulatory data notice: Information on this page is reproduced verbatim from FDA public databases (NSDE, Orange Book, Purple Book, DailyMed SPL). NDA/ANDA drugs are FDA-approved, BLA biologics are FDA-licensed. Inclusion alone does not guarantee current market availability or imply FDA endorsement.

Medical disclaimer: This AI-generated content is provided for educational purposes only and does not constitute medical advice. Always consult a licensed healthcare professional for diagnosis or treatment decisions.