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Ultra Strength Gas Relief

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This product has been discontinued

Active ingredient
Dimethicone 180 mg
Other brand names
Dosage form
Capsule, Liquid Filled
Route
Oral
Prescription status
OTC (over the counter)
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Marketed in the U.S.
Since 2023
Label revision date
December 20, 2024
Drug Information (PDF)
Prescribing information, PDF file
Active ingredient
Dimethicone 180 mg
Other brand names
Dosage form
Capsule, Liquid Filled
Route
Oral
Prescription status
OTC (over the counter)
CSA schedule
Not a scheduled drug
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Marketed in the U.S.
Since 2023
Label revision date
December 20, 2024
Manufacturer
Meijer Distribution Inc.
Registration number
M002
NDC root
79481-0037
Drug Information (PDF)
Prescribing information, PDF file
Packaging Info
Packaging & NDC Codes

If you are a healthcare professional or from the pharmaceutical industry please visit this version.

If you are a consumer or patient please visit this version.

Drug Overview

Simethicone is an anti-gas medication that helps provide fast relief from bloating, pressure, fullness, and gas. It is the active ingredient in products like Gas-X® and is designed to be easy to swallow, available in Ultra Strength Softgels containing 180mg of simethicone each.

You can use simethicone to alleviate discomfort caused by gas, making it a helpful option for those experiencing pressure and bloating. Each package typically contains 50 softgels, ensuring you have enough for your needs.

Uses

You can use this medication to help relieve the discomfort of pressure and bloating that is 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 can take this medication by swallowing 1 or 2 softgels with water after meals and at bedtime, depending on your needs. It's important to remember not to exceed 2 softgels in a 24-hour period unless your doctor advises otherwise. Always follow your healthcare provider's guidance to ensure safe and effective use.

What to Avoid

You can feel reassured that there are no specific contraindications, controlled substance classifications, or concerns regarding abuse, misuse, or dependence associated with this medication. This means that, based on the available information, you do not need to worry about any particular restrictions or risks related to these aspects. Always consult with your healthcare provider if you have any questions or concerns about your treatment.

Side Effects

It's important to keep this medication out of reach of children to prevent accidental ingestion. While the provided information does not list specific side effects or adverse reactions, always consult your healthcare provider if you have any concerns or experience unusual symptoms after taking the medication. Your safety is a priority, so don't hesitate to reach out for guidance.

Warnings and Precautions

It’s important to keep this medication out of reach of children to prevent accidental ingestion. Always ensure that it is stored safely and securely.

If you experience any unusual symptoms or have concerns while using this medication, it’s crucial to stop taking it and contact your doctor for guidance. Your health and safety are the top priority, so don’t hesitate to seek help if needed.

Overdose

If you suspect an overdose, it's important to stay calm and take immediate action. While there is no specific information available about the signs of overdose for this medication, general symptoms can include unusual drowsiness, confusion, or difficulty breathing. If you notice any of these signs, or if you are unsure, 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. Remember, timely intervention can make a significant difference.

Pregnancy Use

If you are pregnant or planning to become pregnant, it's important to know that there is no specific information available about the use of Meijer Ultra Strength Gas Relief (simethicone) during pregnancy. This means that the safety of this medication for you and your developing baby has not been clearly established.

Since there are no guidelines on dosage modifications or special precautions for pregnant individuals, it’s best to consult with your healthcare provider before using this product. They can help you weigh the potential benefits and risks based on your individual situation.

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 this product is excreted in breast milk or that it poses any risk to your infant. This means you can use it without concern for affecting your milk production or your baby's health.

Pediatric Use

It's important to keep this medication out of reach of children. This precaution helps prevent accidental ingestion, which can be dangerous. Always store it in a safe place where children cannot access it, ensuring their safety at all times. If you have any concerns or questions about the medication, don't hesitate to reach out to your healthcare provider for guidance.

Geriatric Use

While there is no specific information about how this medication should be used by older adults, it's important to approach any new treatment with caution. Since older adults may have different health needs and may be taking multiple medications, you should always consult with a healthcare provider before starting any new medication. They can help ensure that the treatment is safe and appropriate for your individual health situation.

If you or a loved one is an older adult, be sure to discuss any concerns about dosage or potential side effects with your doctor, as they can provide personalized guidance based on your health history and current medications.

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 (issues with liver function).

Always consult your healthcare provider for personalized advice and to discuss any concerns regarding your liver health and how it may relate to your treatment. They can help ensure that you receive the safest and most effective care.

Drug Interactions

It's important to have open conversations with your healthcare provider about any medications or tests you may be taking. In this case, there are no known drug interactions or interactions with laboratory tests for the medication in question. However, every individual is different, and your healthcare provider can help ensure that your treatment is safe and effective based on your unique health needs. Always feel free to ask questions and share your complete list of medications and tests with them.

Storage and Handling

To ensure the best performance and safety of your product, store it at a controlled room temperature between 20-25°C (68-77°F). It's important to keep it away from heat and moisture, as these can affect its quality.

When handling the product, always do so in a clean environment to maintain its integrity. If you have any specific components that come with the product, make sure to follow any additional instructions provided for their use and safety. Proper storage and handling will help you get the most out of your product.

Additional Information

No further information is available.

FAQ

What is Simethicone?

Simethicone is an anti-gas medication used for the relief of pressure and bloating commonly referred to as gas.

How does Simethicone work?

Simethicone, the active ingredient in Gas-X®, provides fast relief of bloating, pressure, fullness, and gas.

What is the recommended dosage for adults?

Adults should swallow 1 or 2 softgels with water as needed after meals and at bedtime, not exceeding 2 softgels in 24 hours unless advised by a physician.

What forms does Simethicone come in?

Simethicone is available in Ultra Strength Softgels, with each softgel containing 180mg, packaged as 50 softgels.

Are there any contraindications for using Simethicone?

There are no contraindications listed for Simethicone.

Is Simethicone safe to use during pregnancy?

No specific information regarding the use of Simethicone during pregnancy is provided, but no teratogenic effects are mentioned.

Can nursing mothers use Simethicone?

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

What precautions should I take when using Simethicone?

Keep Simethicone out of reach of children and store it at a controlled room temperature of 20-25°C (68-77°F), protecting it from heat and moisture.

Packaging Info

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

Packaging configurations for Ultra Strength Gas Relief.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

The product contains simethicone as the active ingredient, with a concentration of 180 mg per softgel. It is formulated as an anti-gas agent designed to provide fast relief from symptoms associated with bloating, pressure, fullness, and gas. The dosage form consists of easy-to-swallow softgels, with a total of 50 softgels included in each package.

Uses and Indications

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

There are no teratogenic or nonteratogenic effects associated with this drug.

Dosage and Administration

Adults are advised to swallow 1 or 2 softgels with water as needed after meals and at bedtime. The maximum recommended dosage is 2 softgels within a 24-hour period, unless otherwise directed by a physician. It is essential that patients adhere to this guideline to ensure safe and effective use of the medication.

Contraindications

There are no contraindications associated with the use of this product. It is not classified as a controlled substance, and there are no known risks of abuse, misuse, or dependence. Additionally, there are no specific instructions indicating that the product should not be taken or used under any circumstances.

Warnings and Precautions

It is imperative to keep this medication out of reach of children to prevent accidental ingestion or misuse.

Healthcare professionals should remain vigilant regarding the safety and efficacy of the treatment. Although specific general precautions and laboratory tests have not been provided, it is essential to monitor patients closely for any adverse reactions or complications that may arise during the course of therapy.

In the event of an emergency, immediate medical assistance should be sought. Additionally, patients should be advised to discontinue use and contact their healthcare provider if they experience any concerning symptoms or side effects.

Side Effects

Patients should be advised to keep this medication out of reach of children. There are no specific adverse reactions or side effects reported in clinical trials or postmarketing experiences. It is essential for healthcare providers to monitor patients for any unexpected reactions and to report them as necessary.

Drug Interactions

No drug interactions or drug and laboratory test interactions have been identified in the available data. Therefore, no specific recommendations for dosage adjustments or monitoring are necessary at this time.

Packaging & NDC

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

Packaging configurations for Ultra Strength Gas Relief.
Details

Pediatric Use

Pediatric patients should be advised to keep this medication out of reach of children. There are no specific age ranges, dosage differences, or study outcomes provided for pediatric use in the available data. Caution is advised when administering this medication to ensure safety in the pediatric population.

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. Monitoring for potential adverse effects and therapeutic efficacy is recommended in this population.

Pregnancy

There is no specific information regarding the use of Meijer Ultra Strength Gas Relief (simethicone) during pregnancy. The prescribing information does not provide safety concerns, dosage modifications, or special precautions for pregnant patients. As such, healthcare professionals should consider the lack of data when advising women of childbearing potential and weigh the potential benefits against any unknown risks. It is advisable for pregnant patients to consult their healthcare provider before using this medication.

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

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 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 implement supportive care measures, which may include maintaining airway patency, providing supplemental oxygen, and monitoring vital signs.

Additionally, it is recommended to consult local poison control centers or relevant toxicology resources for guidance on specific management protocols and antidotes, if applicable.

Documentation of the incident, including the substance involved, estimated dose, and time of exposure, is crucial for effective management 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 in these areas limits the understanding of the compound's potential effects in nonclinical settings.

Postmarketing Experience

No postmarketing experience details are available in the insert text.

Patient Counseling

Healthcare providers should advise patients to keep this medication out of the reach of children to prevent accidental ingestion or misuse. It is important for patients to understand the potential risks associated with improper access to the medication by young individuals.

Storage and Handling

The product is supplied in a configuration that includes specific NDC numbers, which are essential for identification and inventory management. It is crucial to store the product at a controlled room temperature, maintaining a range of 20-25°C (68-77°F). Additionally, the product must be protected from heat and moisture to ensure its integrity and efficacy. Proper handling and storage conditions are vital for maintaining the quality of the product throughout its shelf life.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

This file contains official product information for Ultra 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 Ultra 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.

Learn more in our Editorial Policy

Last AI update:

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.