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Gas Relief

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Active ingredient
Dimethicone 125 mg
Other brand names
Dosage form
Capsule
Route
Oral
Prescription status
OTC (over the counter)
Marketed in the U.S.
Since 2026
Label revision date
December 24, 2025
Active ingredient
Dimethicone 125 mg
Other brand names
Dosage form
Capsule
Route
Oral
Prescription status
OTC (over the counter)
CSA schedule
Not a scheduled drug
Marketed in the U.S.
Since 2026
Label revision date
December 24, 2025
Manufacturer
H-E-B
Registration number
M001
NDC root
37808-744

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

Drug Overview

Simethicone is a medication commonly used to relieve discomfort caused by pressure, bloating, and fullness in the stomach, often associated with gas. It works by breaking up gas bubbles in the digestive tract, making it easier for your body to eliminate them.

Available in softgel form, Simethicone is designed to provide quick relief from these uncomfortable symptoms, helping you feel more at ease after meals or during times of digestive distress.

Uses

You can use this medication to help relieve feelings of pressure, bloating, and fullness that are often caused by gas. It’s designed to make you feel more comfortable when these symptoms arise.

Rest assured, there are no known teratogenic effects (which means it doesn’t cause birth defects) associated with this medication, so it is considered safe in that regard.

Dosage and Administration

You can take this medication by swallowing 1 or 2 softgels with water after meals and at bedtime if you need it. This is suitable for adults and children aged 12 years and older.

It's important not to exceed 4 softgels in a 24-hour period unless your doctor advises you to do so. Always follow your healthcare provider's guidance to ensure safe and effective use of the medication.

What to Avoid

It's important to keep this medication out of reach of children to ensure their safety. There are no specific contraindications, controlled substance classifications, or concerns regarding abuse, misuse, or dependence associated with this medication. Always follow safety guidelines to use it responsibly.

Side Effects

It appears that there are no specific side effects or adverse reactions listed for this medication. However, it's important to be aware that all medications can potentially cause side effects, and you should discuss any concerns with your healthcare provider. If you experience any unusual symptoms after taking this medication, please seek medical advice promptly.

Warnings and Precautions

It’s important to be aware of the potential risks associated with this medication. If you experience any unusual symptoms or reactions, please seek medical attention immediately.

While there are no specific general precautions or laboratory tests mentioned, it’s always a good idea to discuss your health history and any concerns with your doctor before starting a new medication. If you have any questions or experience side effects, don’t hesitate to reach out to your healthcare provider for guidance.

Overdose

It appears that there is no specific information available regarding overdosage for this medication. However, it's important to be aware of the general signs of an overdose, which can include symptoms like extreme drowsiness, confusion, or difficulty breathing. If you suspect an overdose, it is crucial to seek immediate medical help.

In case of an emergency, you should call your local emergency services or go to the nearest hospital. Always keep your medications in their original packaging and follow the prescribed dosage to minimize the risk of an overdose. If you have any concerns or questions about your medication, don’t hesitate to reach out to your healthcare provider for guidance.

Pregnancy Use

If you are pregnant or planning to become pregnant, it's important to be aware that there is no specific information available about the use of this medication during pregnancy. This means that safety concerns, dosage adjustments, or any special precautions have not been established.

Before taking this medication, you should consult with your healthcare provider to discuss any potential risks and to ensure that you are making informed decisions for your health and the health of your baby. Always prioritize open communication with your doctor regarding any medications you may be considering during pregnancy.

Lactation Use

If you are breastfeeding, you can feel reassured that there are no specific warnings or recommendations regarding the use of simethicone for nursing mothers. The information available does not indicate any particular considerations or precautions you need to take while breastfeeding. This means that simethicone is generally considered safe for use during lactation, allowing you to manage any discomfort without added concerns.

Pediatric Use

It's important to keep this medication out of reach of children to ensure their safety. For adults and children aged 12 years and older, the recommended dosage is to swallow 1 or 2 softgels with water after meals and at bedtime. However, you should not exceed 4 softgels in a 24-hour period unless directed by a doctor.

If you have younger children, please consult a healthcare professional for guidance, as this medication is not specifically recommended for them. Always prioritize safety and follow the advice of a physician when it comes to medication use in your family.

Geriatric Use

While there is no specific information available about the use of this medication in older adults, it’s important to approach any new treatment with caution. Since older adults may have different health needs and responses to medications, you should always consult with a healthcare provider before starting any new medication. They can help determine the right dosage and monitor for any potential side effects, ensuring that the treatment is safe and effective for you or your loved one.

Renal Impairment

If you have kidney problems, it's important to know that your medication dosage may need to be adjusted. This is because your kidneys may not process the medication as effectively. Regular monitoring of your renal function tests is essential to ensure your kidneys are working properly. If you have decreased creatinine clearance (a measure of how well your kidneys filter waste), your healthcare provider may recommend a reduced dose of your medication to avoid potential complications. Always discuss any concerns with your doctor to ensure your treatment is safe and effective.

Hepatic Impairment

If you have liver 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 standard recommendations apply, but you should always consult your healthcare provider for personalized advice. They can help determine the best approach for your treatment and monitor your liver function as needed.

Make sure to keep your doctor informed about your liver health, as they may want to conduct regular tests to ensure your safety while using any medication. Your well-being is a priority, so don't hesitate to ask questions or express any concerns you may have.

Drug Interactions

It's important to have open conversations with your healthcare provider about any medications or tests you may be taking. While there are no specific drug interactions or laboratory test interactions noted for this medication, your healthcare provider can help ensure that everything you are taking works well together and is safe for you.

Always feel free to ask questions and share your complete list of medications and any lab tests you may be undergoing. This way, you can receive the best possible care tailored to your needs.

Storage and Handling

To ensure the best performance of your product, store it at room temperature. It's important to keep it away from light, heat, and moisture, as these elements can affect its quality and effectiveness.

When handling the product, make sure to do so in a clean environment to maintain its integrity. Always follow any specific disposal instructions provided to ensure safety and compliance. By taking these precautions, you can help ensure that the product remains safe and effective for use.

Additional Information

No further information is available.

FAQ

What is Simethicone used for?

Simethicone is used for the relief of pressure, bloating, and fullness commonly referred to as gas.

What are the available forms of Simethicone?

Simethicone is available in 125mg softgels, with options for 30ct and 200ct packages.

How should I take Simethicone?

Adults and children 12 years and older should swallow 1 or 2 softgels with water as needed after meals and at bedtime, without exceeding 4 softgels in 24 hours unless advised by a physician.

Are there any contraindications for Simethicone?

There are no contraindications listed for Simethicone.

Is Simethicone safe to use during pregnancy?

The provided information does not mention any specific safety concerns or precautions regarding the use of Simethicone during pregnancy.

Can Simethicone be used by nursing mothers?

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

What should I do if I have kidney problems?

If you have renal impairment, dosage adjustments may be necessary, and renal function tests should be monitored.

How should Simethicone be stored?

Store Simethicone at room temperature, protecting it from light, heat, and moisture.

What should I keep in mind regarding children and Simethicone?

Keep Simethicone out of reach of children.

Are there any known side effects of Simethicone?

The provided text does not mention any specific side effects or adverse reactions associated with Simethicone.

Packaging Info

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

Packaging configurations for Gas Relief.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

No description information is available for the specified drug.

Uses and Indications

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

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

Dosage and Administration

Adults and children 12 years and older may take 1 or 2 softgels as needed after meals and at bedtime. The softgels should be swallowed with water. It is important not to exceed a total of 4 softgels within a 24-hour period, unless directed otherwise by a physician.

Contraindications

Use is contraindicated in children due to the risk of accidental ingestion. Ensure that the product is kept out of reach of children to prevent potential harm. No other contraindications have been identified.

Warnings and Precautions

Warning: Healthcare professionals should be aware of the potential risks associated with the use of this medication. It is imperative to evaluate the patient's medical history and current health status before prescribing.

General precautions should be considered, although no specific precautions are outlined in the available information. Clinicians are encouraged to remain vigilant and exercise clinical judgment in the management of patients receiving this treatment.

Currently, there are no laboratory tests specified for monitoring the safety and efficacy of this medication. However, healthcare providers should consider appropriate clinical assessments based on individual patient needs and the therapeutic context.

In the absence of specific instructions regarding emergency medical help or when to discontinue use, healthcare professionals should maintain open communication with patients about any adverse effects or concerns that may arise during treatment. Regular follow-up and patient education are essential components of safe medication management.

Side Effects

Patients receiving the treatment should be aware of the potential for serious adverse reactions, as indicated in the warnings section. However, specific adverse reactions, including their frequency or severity, have not been detailed in the available data. It is essential for healthcare providers to monitor patients closely for any signs of adverse effects during treatment. Further information may be obtained from clinical trials or postmarketing experiences as they become available.

Drug Interactions

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

Packaging & NDC

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

Packaging configurations for Gas Relief.
Details

Pediatric Use

Pediatric patients should be kept out of reach of children. For adolescents aged 12 years and older, the recommended dosage is to swallow 1 or 2 softgels with water as needed after meals and at bedtime. It is important not to exceed 4 softgels in a 24-hour period unless advised and supervised by a physician.

Geriatric Use

Elderly patients may not have specific information regarding the use of this medication, including dosage adjustments, safety concerns, or special precautions. Therefore, healthcare providers should exercise caution when prescribing this medication to geriatric patients. It is advisable to monitor these patients closely for any potential adverse effects or changes in efficacy, given the lack of targeted data for this population.

Pregnancy

There is no specific information regarding the use of this medication during pregnancy, including safety concerns, dosage modifications, or special precautions. Healthcare professionals should consider the lack of data when prescribing this medication to pregnant patients. It is advisable to weigh the potential benefits against any unknown risks to fetal outcomes. Women of childbearing potential should be counseled on the importance of effective contraception during treatment and the need to inform their healthcare provider if they become pregnant or plan to become pregnant while on this medication.

Lactation

There are no specific warnings or recommendations regarding the use of simethicone in lactating mothers. Additionally, there are no specific considerations or precautions related to lactation mentioned in the provided text. Therefore, healthcare professionals may consider the use of simethicone in nursing mothers without special precautions.

Renal Impairment

Patients with renal impairment may require dosage adjustments to ensure safety and efficacy. It is essential to monitor renal function tests in these patients to assess their kidney status. Additionally, a reduced dose should be considered for patients with decreased creatinine clearance to mitigate the risk of adverse effects associated with impaired renal function.

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 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. In the absence of documented overdosage data, healthcare professionals are advised to exercise caution and monitor patients closely for any unusual symptoms or adverse effects that may arise following administration.

In the event of suspected overdosage, it is recommended that healthcare providers initiate supportive care and symptomatic treatment as necessary. Continuous monitoring of vital signs and clinical status is essential to ensure patient safety.

Healthcare professionals should also consider consulting a poison control center or relevant toxicology resources for guidance on management strategies tailored to the specific circumstances of the overdosage event.

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 provided in the insert.

Patient Counseling

Healthcare providers should advise patients to keep this medication out of reach of children to prevent accidental ingestion or misuse. It is important to emphasize the necessity of proper storage and handling to ensure the safety of young individuals.

Storage and Handling

The product is supplied in configurations that include specific NDC numbers, which should be referenced for accurate identification. It is essential to store the product at room temperature to maintain its integrity. Additionally, the product must be protected from light, heat, and moisture to ensure optimal stability and efficacy. Proper handling and storage conditions are crucial for preserving 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 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 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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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.