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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 2020
Label revision date
June 26, 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 2020
Label revision date
June 26, 2024
Manufacturer
Walgreens
Registration number
M002
NDC root
0363-8730
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 designed to provide fast relief from bloating, pressure, and fullness that you may experience due to gas. Each softgel contains 180 mg of simethicone, which works by breaking up gas bubbles in your stomach and intestines, making it easier for your body to eliminate them. This ultra-strength formula is comparable to the active ingredient found in Phazyme® Ultra Strength, offering effective support for your digestive comfort.

Uses

If you're experiencing discomfort from bloating, pressure, or fullness often caused by gas, this medication can help provide quick relief. It’s designed to alleviate those uncomfortable feelings, allowing you to feel more at ease.

You can count on this treatment for fast relief from the pressure and fullness that can accompany digestive issues. It’s a straightforward solution to help you get back to feeling your best.

Dosage and Administration

You can take one or two softgels when you start to feel symptoms. 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 this guideline to ensure your safety and the effectiveness 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 about abuse, misuse, or dependence (which means relying on a substance in a harmful way), you should stop using the medication and consult your doctor if your condition does not improve. 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. 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. Always prioritize safety and seek guidance if you have any concerns.

Warnings and Precautions

If you are using this medication and your condition does not improve, it’s important to stop taking it and consult your doctor. This will help ensure you receive the appropriate care and guidance.

If you are pregnant or breastfeeding, please talk to 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

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 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, it’s important to consult with a healthcare provider before starting the medication. 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 the information provided does not include specific guidelines for dosage adjustments, special monitoring, or safety considerations related to renal impairment (kidney issues). This means that there are no tailored recommendations for how your treatment may need to change based on your kidney function.

Always consult your healthcare provider for personalized advice and to ensure that your treatment plan is safe and effective for your specific situation. They can help you understand any necessary precautions or adjustments based on your kidney health.

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 (issues with liver function).

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 you understand how to manage your treatment effectively.

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 laboratory test interactions associated with the medication. However, every individual is different, and your healthcare provider can help ensure that your treatment is safe and effective for you. Always feel free to ask questions and share your complete list of medications and any tests you may be undergoing.

Storage and Handling

To ensure the best performance of your product, store it in a cool, dry place at a temperature between 15-30ºC (59-86ºF). 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. Following these guidelines will help you use the product safely and effectively.

Additional Information

You can take this medication orally by swallowing one or two softgels when you experience symptoms. 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 should I take SIMETHICONE?

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

Are there any contraindications for SIMETHICONE?

No contraindications are listed for SIMETHICONE.

Can I use SIMETHICONE if I am pregnant or breastfeeding?

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

What should I do if my symptoms persist?

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

How should I store SIMETHICONE?

Store SIMETHICONE between 15-30ºC (59-86ºF) and protect it from heat and moisture.

Is there a risk of dependence or abuse with SIMETHICONE?

There are no listed risks of dependence or abuse with SIMETHICONE.

What should I do if the blister unit is damaged?

Do not use SIMETHICONE if the blister unit is torn, broken, or shows any signs of tampering.

Who distributes SIMETHICONE?

SIMETHICONE is distributed by Walgreen Co., located at 200 Wilmot Rd., Deerfield, IL 60015.

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

Simethicone, at a dosage of 180 mg, is formulated as an ultra-strength softgel intended for the rapid relief of pressure, bloating, and fullness associated with gas. The softgels are designed to be tamper-evident; users should not utilize the product if the blister unit is torn, broken, or exhibits any signs of tampering. For comprehensive warnings and product information, it is advised to retain the outer carton.

Uses and Indications

This drug is indicated for the relief of bloating, pressure, or fullness commonly associated with gas. It provides fast relief of these symptoms, addressing discomfort related to gastrointestinal gas accumulation.

Limitations of Use: There are no known teratogenic or nonteratogenic effects associated with this drug.

Dosage and Administration

Patients are advised to swallow one or two softgels as symptoms occur. The maximum recommended dosage is two softgels within a 24-hour period, unless otherwise directed by a physician. It is essential that patients do not exceed this dosage without medical supervision to ensure safety and efficacy.

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

Patients should discontinue use and consult a healthcare professional if the condition persists. This precaution is essential to ensure appropriate management and to rule out any underlying issues that may require further evaluation.

In addition, it is crucial for individuals who are pregnant or breastfeeding to seek advice from a healthcare professional prior to using this product. This step is necessary to assess potential risks and benefits associated with use during these sensitive periods.

No specific laboratory tests are recommended for monitoring in conjunction with this product. However, healthcare providers should remain vigilant and consider individual patient circumstances when determining the need for any additional assessments.

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 their safety.

Drug Interactions

There are no reported drug interactions associated with the use of this medication. Additionally, no interactions with laboratory tests have been identified. Therefore, no dosage adjustments or monitoring recommendations are necessary based on drug interactions.

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. Safety and efficacy in pediatric populations have not been established, and specific dosing recommendations for children are not provided. Caution is advised when administering this medication to ensure it is not accessible to young children.

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. 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 regarding the excretion of this medication 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 clinical trials for this medication. Consequently, there is no available information regarding 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 warranted based on clinical judgment.

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 information is available regarding teratogenic or non-teratogenic effects. Additionally, there is no data provided concerning nonclinical toxicology, animal pharmacology, or toxicology.

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. It is important for patients to understand that if their condition persists despite using the medication, they should stop use and consult a doctor for further evaluation and guidance.

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 15-30ºC (59-86ºF) to ensure optimal stability and efficacy. Additionally, the product must be protected from heat and moisture to maintain its integrity. Proper handling and storage conditions are essential for preserving the quality of the product.

Additional Clinical Information

The medication is administered orally, with patients instructed to swallow one or two softgels as symptoms occur. It is important for patients not to exceed a maximum of two softgels 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.

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.