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Gas Relief

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Active ingredient
Dimethicone, Unspecified 500 mg
Other brand names
Dosage form
Capsule, Liquid Filled
Route
Oral
Prescription status
OTC (over the counter)
Marketed in the U.S.
Since 2026
Label revision date
February 1, 2026
Active ingredient
Dimethicone, Unspecified 500 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 2026
Label revision date
February 1, 2026
Manufacturer
Advanced Rx LLC
Registration number
M002
NDC root
80513-119

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

Drug Overview

You may be experiencing discomfort from pressure, bloating, and fullness, often caused by gas in your digestive system. This medication is designed to provide relief from these symptoms, helping you feel more comfortable. It works by targeting the underlying issues related to gas, allowing you to return to your daily activities with ease.

Uses

If you're experiencing discomfort from pressure, bloating, or a feeling of fullness due to gas, this medication can help provide relief. It's designed specifically to address these common digestive issues, making you feel more comfortable.

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

If you are an adult or a child aged 12 years and older, you can take this medication by swallowing one softgel with water. It’s best to do this after meals or at bedtime when you need it. However, it’s important not to take more than one softgel in a 24-hour period unless your doctor advises you to do so. Always follow your healthcare provider's guidance to ensure safe use.

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 are using this medication, it's important to be aware of some key warnings. You should stop using it and consult a doctor if your condition does not improve. If you are pregnant or breastfeeding, please talk to a healthcare professional before using this product to ensure it is safe for you and your baby. Additionally, make sure to keep this medication out of reach of children to prevent any accidental ingestion.

Warnings and Precautions

If you are using this medication, it's important to be aware of a few key warnings and precautions. If your condition does not improve or continues to persist, you should stop using the medication and consult your doctor for further advice.

If you are pregnant or breastfeeding, please speak with a healthcare professional before using this medication. Additionally, make sure to keep this product out of reach of children to ensure their safety.

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 more than the recommended dose. If you suspect an overdose, look for signs such as unusual drowsiness, confusion, or difficulty breathing.

In the event of an overdose, it is crucial to seek immediate medical help. You can contact your local emergency services or go to the nearest hospital. Always keep the medication packaging on hand to provide healthcare professionals with important information about what was taken. Remember, when in doubt, it’s better to be safe and get help right away.

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 to ensure their safety. For adults and children aged 12 years and older, the recommended dosage is to swallow one softgel with water as needed after meals or at bedtime. However, you should not exceed one softgel in a 24-hour period unless directed by a doctor. Always consult with a healthcare professional if you have any questions or concerns about its use in children.

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, it’s important to consult with a healthcare provider for personalized advice. 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 there are no special monitoring requirements or safety considerations outlined for patients like you with renal impairment (kidney issues).

Always consult your healthcare provider for personalized advice and to ensure that any medications you take are safe and appropriate for your situation. They can provide guidance tailored to your health needs.

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 should be used if you have hepatic impairment (liver issues).

Always consult your healthcare provider for personalized advice and to ensure that any medication you take is safe and appropriate for your liver health. They can help determine the best course of action based on your individual situation.

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 in a cool, dry place at a temperature between 20º to 25ºC (68º to 77ºF). 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

You should take this medication orally by swallowing one softgel with water, either after meals or at bedtime. It's important not to exceed one softgel in a 24-hour period unless your doctor advises otherwise. This guidance applies to both adults and children aged 12 years and older. Always follow your healthcare provider's instructions for safe use.

FAQ

What is the drug used for?

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

What should I do if my condition persists?

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

Can I use this drug if I am pregnant or breastfeeding?

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

What is the recommended dosage for adults and children 12 years and older?

Adults and children 12 years and older should swallow 1 softgel with water as needed after meals or at bedtime, not exceeding 1 softgel in 24 hours unless advised by a physician.

Are there any contraindications for this drug?

There are no contraindications listed for this drug.

How should I store this drug?

Store the drug at 20º to 25ºC (68º to 77ºF) and protect it from light, heat, and moisture.

Is there any risk of dependence or abuse with this drug?

There are no risks of dependence or abuse mentioned for this drug.

What should I do if I accidentally take more than the recommended dosage?

You should consult a doctor if you exceed the recommended dosage.

Is there any specific information for elderly patients?

No specific information regarding geriatric use or safety concerns for elderly patients is provided.

What should I keep in mind regarding children and this drug?

Keep this drug out of reach of children.

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

Dosage and Administration

Adults and children 12 years and older are instructed to swallow 1 softgel with water as needed after meals or at bedtime. It is essential that the dosage does not exceed 1 softgel within a 24-hour period, unless directed and supervised by a physician.

Contraindications

There are no contraindications listed 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 warnings and precautions associated with the use of this product.

Patients are advised to discontinue use and consult a healthcare provider if their condition persists. This is a critical step to ensure appropriate management and evaluation of the underlying issue.

In terms of general precautions, it is essential to advise patients who are pregnant or breastfeeding to seek guidance from a healthcare professional prior to using this product. This precaution helps to mitigate any potential risks to the mother or child.

Additionally, the product should be stored out of reach of children to prevent accidental ingestion or misuse. This is a standard safety measure to protect vulnerable populations.

No specific laboratory tests are recommended for monitoring in conjunction with the use of this product. However, healthcare providers should remain vigilant and assess the patient's overall health status as needed.

Side Effects

Patients should be advised to stop use and consult a healthcare professional 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 kept out of reach of children. For adolescents aged 12 years and older, the recommended dosage is 1 softgel taken with water as needed after meals or at bedtime. It is important not to exceed 1 softgel in a 24-hour period unless advised and supervised by a physician.

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.

Pregnancy

Pregnant patients and those who are breastfeeding should consult a healthcare professional prior to using this medication. The potential risks and benefits must be carefully weighed, as the effects on fetal outcomes and lactation are not fully established. It is essential for women of childbearing potential to seek medical advice to ensure safe use during pregnancy and lactation.

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 prescribing information. There are no dosage adjustments, special monitoring requirements, or safety considerations outlined for individuals with reduced kidney function. Healthcare professionals should exercise caution and consider the lack of data when prescribing to 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 and consider the overall clinical context when prescribing this medication to patients with hepatic impairment, as individual responses may vary.

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 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 packaging that ensures its integrity and stability. It should be stored at a temperature range of 20º to 25ºC (68º to 77ºF). It is essential to protect the product from light, heat, and moisture to maintain its efficacy and safety. Proper handling and storage conditions are critical to preserving the quality of the product throughout its shelf life.

Additional Clinical Information

The medication is administered orally, with a recommended dosage of one softgel for adults and children aged 12 years and older, to be taken with water as needed after meals or at bedtime. Patients should not exceed one softgel within a 24-hour period unless advised and supervised by a physician.

No additional information is available regarding laboratory tests, abuse potential, patient counseling, or postmarketing experience.

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.