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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 2024
Label revision date
January 12, 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 2024
Label revision date
January 12, 2024
Manufacturer
AmerisourceBergen (Good Neighbor Pharmacy) 46122
Registration number
M002
NDC root
46122-769
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 ultra-strength anti-gas medication designed to provide fast relief from bloating, pressure, discomfort, and fullness commonly associated with gas. Each softgel contains 180 mg of simethicone, which works by breaking up gas bubbles in the stomach and intestines, making it easier for your body to eliminate them. If you're experiencing uncomfortable gas-related symptoms, simethicone may help you feel more at ease.

Uses

If you're experiencing bloating, pressure, or a feeling of fullness often associated with gas, this medication can help provide fast relief. It effectively addresses discomfort caused by these symptoms, allowing you to feel more comfortable in your daily activities.

You can expect quick alleviation of bloating, pressure, discomfort, and gas, making it a useful option for managing these common digestive issues.

Dosage and Administration

You can take this medication by swallowing one or two softgels when you start to feel symptoms. It's important to remember that you should not 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 (which means relying on a substance in a harmful way), you should always prioritize your health and safety.

If your condition does not improve or continues to persist, please stop using the medication and consult your doctor for further advice. Your well-being is the most important consideration, and your healthcare provider can help determine the best course of action for you.

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 about how to manage medications in your home, don't hesitate to ask 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

It appears that there is no specific information regarding renal impairment (kidney problems) in the provided text. This means there are no dosage adjustments, special monitoring, or safety considerations outlined for patients with kidney issues. If you have concerns about how your kidney health may affect your treatment, it's important to discuss this with your healthcare provider for personalized guidance.

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 provided information. This means that the medication may not have been studied in patients with liver impairment, and there are no special monitoring requirements or precautions outlined for you.

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 your liver condition may affect your treatment.

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.

Always keep your healthcare provider informed about any changes in your health or new medications you start. They can help you understand how different treatments may work together and monitor your health appropriately.

Storage and Handling

To ensure the best performance of your product, store it in a cool, dry place at a temperature between 15-30º C (59-86º F). 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

No further information is available.

FAQ

What is simethicone?

Simethicone is an ultra strength anti-gas and antiflatulent medication that comes in 180 mg softgels.

What does simethicone relieve?

Simethicone relieves bloating, pressure, discomfort, and 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.

What should I do if my condition persists?

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

Is simethicone safe to use during pregnancy or breastfeeding?

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

How should I store simethicone?

Store simethicone between 15-30º C (59-86º F) and protect it from heat and moisture.

What should I do if the safety seal 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 AmerisourceBergen, located at 1 West First Avenue, Conshohocken, PA 19428.

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 presented in a dosage form of softgels, with each softgel containing 180 mg of simethicone.

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 bloating, pressure, discomfort, and gas.

There are no 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 dosage should not exceed two softgels within a 24-hour period, unless directed otherwise by a physician. It is essential for healthcare professionals to monitor patients for adherence to this dosing regimen to ensure safety and efficacy.

Contraindications

There are no contraindications listed for this product. It is important to monitor the patient's condition; if symptoms persist, discontinue use and consult a healthcare professional.

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 have been identified for monitoring in relation to the use of this product. However, healthcare providers should remain vigilant and consider appropriate clinical assessments based on individual patient circumstances.

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

No drug interactions have been identified in the available data. Additionally, there are no reported interactions between drugs and laboratory tests. Therefore, no dosage adjustments or monitoring recommendations are necessary based on the current information.

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. There are no specific age ranges, dosage differences, or study outcomes provided for pediatric use in the available data. Caution is advised when administering this medication to ensure safety in the pediatric population.

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

There is no information available regarding dosage adjustments, special monitoring, or safety considerations for patients with renal impairment. Healthcare professionals should exercise caution and consider the lack of specific guidance when prescribing to patients with reduced kidney function.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in relation to the use of this medication. Consequently, there is no information available 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.

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, the following management procedures should be considered:

  1. Assessment: Conduct a thorough assessment of the patient's clinical status, including vital signs and level of consciousness.

  2. Supportive Care: Provide supportive care as needed, which may include airway management, oxygen supplementation, and intravenous fluids.

  3. Consultation: Engage with a poison control center or toxicology expert for guidance on specific interventions and antidotes, if applicable.

  4. Documentation: Document all findings, interventions, and the patient's response to treatment meticulously.

Healthcare professionals should remain vigilant and prepared to implement appropriate measures in the event of an overdose, even in the absence of specific overdosage data.

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 question.

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. It is important for patients to understand that if their condition persists, they should stop using the medication 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 for identification. It is essential to store the product at a temperature range of 15-30º C (59-86º F) to maintain its efficacy. Additionally, the product must be protected from heat and moisture to ensure its integrity and stability throughout its shelf life. Proper handling and storage conditions are crucial for optimal performance.

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.

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.