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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 2018
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 2018
Label revision date
June 26, 2024
Manufacturer
Walgreens
Registration number
M002
NDC root
0363-0932
Drug Information (PDF)
Prescribing information, PDF file
Packaging Info (2 NDCs)
Packaging & NDC Codes (2)

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 comes in ultra strength softgel form, containing 180 mg of the active ingredient simethicone. It is designed to relieve bloating, pressure, and discomfort caused by gas in your digestive system. By breaking up gas bubbles, simethicone helps alleviate the feelings of fullness and pressure that can be uncomfortable.

If you're experiencing gas-related discomfort, simethicone may provide you with the relief you need to feel more comfortable. Always ensure that the product is sealed properly before use for your safety.

Uses

If you're experiencing bloating, pressure, or a feeling of fullness often associated with gas, this medication can help relieve those uncomfortable symptoms. It effectively addresses bloating, gas, and the discomfort that comes with these issues, allowing you to feel more at ease.

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 meals as needed. It's important not to exceed two softgels in a single day unless your doctor advises you otherwise. 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. 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. This is a precaution to ensure your safety and well-being. Always pay attention to how your body responds, and don’t hesitate to seek medical advice if needed.

Warnings and Precautions

If you are pregnant or breastfeeding, it’s important to consult with a healthcare professional before using this medication to ensure it’s safe for you and your baby.

If your condition does not improve or continues to persist, please stop taking the medication and reach out to your doctor for further guidance. Your health and safety are paramount, so don’t hesitate to seek help if you have any concerns.

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 or symptoms of an overdose for this medication, general signs can include unusual drowsiness, confusion, or difficulty breathing. If you notice any of these symptoms or feel unwell after taking the medication, 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 after taking medication.

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 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 monitor your kidney health and make any necessary adjustments to your medications.

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 great to know that there are no reported interactions between this medication and other drugs or laboratory tests. However, it's still very important to discuss all medications you are taking, including over-the-counter drugs and supplements, with your healthcare provider. This ensures that your treatment is safe and effective, tailored specifically to your health needs.

Always keep your healthcare provider informed about any changes in your medication or health status. Open communication helps prevent any potential issues and supports your overall well-being.

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 effectiveness and safety.

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 after meals, as needed. It's important not to exceed two softgels in a day unless your doctor advises otherwise. Always follow your healthcare provider's guidance for safe use.

FAQ

What is SIMETHICONE used for?

SIMETHICONE is an anti-gas medication that relieves bloating, pressure, and discomfort commonly referred to as gas.

How should I take SIMETHICONE?

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

Are there any warnings associated with SIMETHICONE?

You should stop use and ask a doctor if your condition persists. Additionally, keep out of reach of children.

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 the safety seal is broken or missing?

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

Where is SIMETHICONE distributed?

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

What is the storage condition for SIMETHICONE?

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

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 is an anti-gas agent formulated at a strength of 180 mg per softgel. The product is presented in an ultra strength dosage form, designed for effective relief from gas-related discomfort. The softgels are characterized by their easy-to-swallow formulation, facilitating patient compliance.

Uses and Indications

This drug is indicated for the relief of bloating, pressure, and fullness commonly associated with gas. It effectively alleviates symptoms of bloating, gas, pressure, 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 meals. The maximum recommended dosage is two softgels per day, 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 specified contraindications 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 precautions when considering the use of this medication.

General precautions must be taken for patients who are pregnant or breastfeeding. It is essential for these individuals to consult a healthcare professional prior to use to ensure safety and appropriateness of the treatment.

In the event that a patient's condition does not improve or persists, it is imperative to discontinue use of the medication and seek medical advice. This step is crucial to prevent potential complications and to explore alternative treatment options.

No specific laboratory tests or emergency medical help instructions are provided in the insert; however, healthcare professionals should remain vigilant and monitor patients for any adverse effects or lack of therapeutic response.

Side Effects

Patients should be advised to discontinue use and consult a healthcare professional if their condition persists. This warning is crucial for ensuring patient safety and appropriate management of their health concerns.

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. 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. 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 the safety of both the mother and the developing fetus.

Lactation

Lactating mothers are advised to consult a health professional prior to using this medication. There is no specific data available regarding the excretion of this medication in 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 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 when administering the medication. It is essential to monitor patients closely for any signs of adverse effects or symptoms that may arise from excessive dosing.

In the event of suspected overdosage, immediate medical attention should be sought. Healthcare providers should implement supportive measures as necessary, which may include symptomatic treatment and monitoring of vital signs.

Due to the lack of detailed overdosage data, it is recommended that healthcare professionals refer to established clinical guidelines and protocols for managing overdose situations relevant to the specific medication in question. Additionally, contacting a poison control center may provide further guidance on appropriate management strategies.

Continued vigilance and patient assessment are crucial in mitigating potential risks associated with overdosage.

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 provided in the insert.

Patient Counseling

Healthcare providers should advise patients to keep the medication out of reach of children to prevent accidental ingestion or misuse. 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. This ensures that patients are aware of the necessary steps to take should their symptoms not improve, promoting safe and effective use of the medication.

Storage and Handling

The product is supplied in various package configurations, with specific NDC numbers available upon request. It is essential to store the product at a temperature range of 15-30ºC (59-86ºF). Care should be taken to protect the product from heat and moisture to ensure its integrity and efficacy. Proper storage conditions are crucial for maintaining the quality of the product throughout its shelf life.

Additional Clinical Information

The medication is administered orally, with patients instructed to swallow one or two softgels as needed after meals. It is important for patients not to exceed a total of two softgels per day 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.