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Gas Relief

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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
October 7, 2025
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
October 7, 2025
Manufacturer
United Natural Foods, Inc. dba UNFI
Registration number
M002
NDC root
83455-152
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 a medication designed to relieve discomfort caused by gas in your digestive system. Each softgel contains 180 mg of simethicone, which works by breaking up gas bubbles in your stomach and intestines, helping to alleviate bloating, pressure, and fullness. If you're experiencing these uncomfortable symptoms, simethicone can provide fast relief, making it easier for you to feel more comfortable.

Uses

If you're experiencing discomfort from gas, such as bloating, pressure, or a feeling of fullness, this medication can help provide fast relief. It specifically targets symptoms like gas, pressure, bloating, and general discomfort, making it easier for you to feel more comfortable.

You can trust that this medication does not have any teratogenic effects, meaning it does not cause harm to a developing fetus. This makes it a safer option for those who may be pregnant or planning to become pregnant.

Dosage and Administration

You can take one or two softgels after a meal when you need them. It's important not to take more than two 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 be aware of certain guidelines when using this medication. While there are no specific contraindications or concerns regarding abuse, misuse, or dependence, you should stop using the medication and consult your doctor if your condition does not improve. This ensures that you receive the appropriate care and support for your health needs. Always prioritize your well-being and seek professional advice when necessary.

Side Effects

If you experience any persistent symptoms while using this medication, it's important to stop using it and consult your doctor. If you are pregnant or breastfeeding, please speak with a healthcare professional before using this product to ensure it is safe for you. Additionally, keep this medication out of reach of children to prevent accidental ingestion.

Warnings and Precautions

If your condition continues despite treatment, it’s important to stop using the medication and call your doctor for further guidance. This ensures that you receive the appropriate care and adjustments to your treatment plan.

If you are pregnant or breastfeeding, please consult a healthcare professional before using this medication to ensure it is safe for you and your baby. Always prioritize your health and well-being by seeking advice when needed.

Overdose

It appears that there is no specific information available regarding overdosage for this medication. However, it's always important to be aware of the potential risks associated with taking any medication. If you suspect that you or someone else may have taken too much of a medication, look out for unusual symptoms such as extreme drowsiness, confusion, or difficulty breathing.

In the event of an overdose, it is crucial to seek immediate medical help. You can do this by calling your local emergency number or going to the nearest hospital. Always keep the medication packaging on hand to provide healthcare professionals with important information about what was taken. Remember, it's better to be safe and get checked out if you have any concerns.

Pregnancy Use

If you are pregnant or breastfeeding, it’s important to consult with a healthcare professional before using this medication. They can provide guidance on whether it’s safe for you and your baby. Always prioritize your health and the health of your child by seeking expert advice.

Lactation Use

If you are pregnant or breastfeeding, it’s important to consult with a healthcare professional before using any medication. This ensures that you understand any potential risks and can make informed decisions about your health and the health of your baby. Always prioritize open communication with your doctor regarding your breastfeeding journey.

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

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 plan.

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 differently due to your liver health.

Always consult your healthcare provider for personalized advice and to discuss any concerns you may have regarding your liver function and how it relates to your treatment. They can help ensure that your medication is safe and effective for you.

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 tests you are 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 in a cool, dry place at a temperature between 15º-30ºC (59º-86ºF). It's important to keep it away from heat and moisture, as these can affect its quality and effectiveness.

When handling the product, always do so with clean hands and in a clean environment to maintain its integrity. If you have any specific disposal instructions, be sure to follow them to ensure safe and responsible disposal.

Additional Information

You can take this medication orally by swallowing one or two softgels after a meal. It's important not to exceed two softgels in a 24-hour period unless your doctor advises otherwise. Always follow your healthcare provider's guidance for safe use.

FAQ

What is Simethicone used for?

Simethicone is used to relieve bloating, pressure, or fullness commonly referred to as gas.

How does Simethicone work?

Simethicone works by providing fast relief from gas, pressure, bloating, and discomfort.

What is the recommended dosage for Simethicone?

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

Are there any contraindications for using Simethicone?

No contraindications are listed for Simethicone.

What should I do if my condition persists while using Simethicone?

If your condition persists, stop using Simethicone and ask a doctor for advice.

Is Simethicone safe to use during pregnancy or breastfeeding?

If you are pregnant or breastfeeding, you should ask a health professional before using Simethicone.

How should I store Simethicone?

Store Simethicone at 15º-30ºC (59º-86ºF) and protect it from heat and moisture.

What should I do if the safety seal under the cap is broken or missing?

Do not use Simethicone if the printed safety seal under the cap is broken or missing.

Who distributes Simethicone?

Simethicone is distributed by UNFI, Providence, RI 02908.

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 drug.

Uses and Indications

This drug is indicated for the relief of bloating, pressure, and fullness commonly associated with gas. It provides fast relief from symptoms including gas, pressure, bloating, and discomfort.

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

Dosage and Administration

Patients should swallow one or two softgels as needed 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 contraindications listed for this product. It is important to note that if symptoms persist, patients should discontinue use and consult a healthcare professional for further evaluation.

Warnings and Precautions

Healthcare professionals should be aware of the following warnings and precautions associated with the use of this medication.

Warnings Patients are advised to seek medical attention if their condition persists. Continuous symptoms may indicate the need for reevaluation of the treatment plan.

General Precautions It is essential for individuals who are pregnant or breastfeeding to consult a healthcare professional prior to using this medication. This precaution ensures that both maternal and fetal health are considered in the treatment decision.

Monitoring Parameters Currently, there are no specific laboratory tests recommended for monitoring the use of this medication. However, healthcare providers should remain vigilant in assessing the patient's condition and response to treatment.

In summary, healthcare professionals should emphasize the importance of monitoring symptoms and consulting with a physician if the condition does not improve.

Side Effects

Patients should be advised to stop use and consult a doctor if their condition persists. It is important for individuals who are pregnant or breastfeeding to seek guidance from a health professional prior to using this product. Additionally, the product should be kept out of reach of children to ensure safety.

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 advised to keep this medication out of reach of children. It is essential to ensure that children do not have access to the medication to prevent accidental ingestion or misuse.

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

Pregnant patients and those who are breastfeeding should consult a healthcare professional prior to using this medication. It is important to assess the potential risks and benefits, as well as any available data regarding fetal outcomes and lactation. Healthcare providers should consider individual circumstances and the specific health needs of the patient when making recommendations.

Lactation

Lactating mothers are advised to consult a health professional prior to using this medication. There is currently no available data on the excretion of this drug in human breast milk or its effects on breastfed infants. Therefore, caution is recommended when administering this medication to lactating individuals.

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 overdosage information, it is essential for healthcare professionals to remain vigilant and prepared for potential scenarios involving overdose.

Healthcare providers should be aware that the clinical presentation of an overdose may vary significantly depending on the substance involved and the individual patient’s characteristics. Symptoms of overdose can range from mild to severe and may include altered mental status, cardiovascular instability, respiratory distress, and gastrointestinal disturbances.

In the event of suspected overdosage, immediate medical evaluation is recommended. Healthcare professionals should assess the patient's vital signs and conduct a thorough clinical examination. Supportive care should be initiated as necessary, including airway management, oxygen supplementation, and intravenous fluids.

If the specific agent involved in the overdose is known, appropriate antidotes or specific treatments should be administered as indicated. Continuous monitoring of the patient’s condition is crucial, and healthcare providers should be prepared to manage complications that may arise.

In all cases of suspected overdose, it is advisable to contact a poison control center or consult relevant clinical guidelines for further management recommendations.

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 these contexts.

Postmarketing Experience

No postmarketing experience details are available in the insert.

Patient Counseling

Healthcare providers should advise patients to keep the medication out of reach of children to prevent accidental ingestion. It is important to inform patients that they should discontinue use and consult a doctor if their condition persists, ensuring they understand the significance of seeking further medical advice in such cases.

Storage and Handling

The product is supplied in various package configurations, with specific NDC numbers available upon request. It should be stored at a temperature range of 15º to 30ºC (59º to 86ºF). Care must be taken to protect the product from heat and moisture to ensure its integrity and efficacy.

Additional Clinical Information

The medication is administered orally, with patients instructed to swallow one or two softgels as needed after a meal. It is important not to exceed a total of two softgels within a 24-hour period unless advised and supervised by a physician. No further information is available regarding laboratory tests, abuse potential, patient counseling, or postmarketing experiences.

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.

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.