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Gas Relief

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Active ingredient
Dimethicone 125 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
August 30, 2024
Drug Information (PDF)
Prescribing information, PDF file
Active ingredient
Dimethicone 125 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
August 30, 2024
Manufacturer
Advanced Rx LLC
Registration number
M002
NDC root
80513-111
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 provide extra strength gas relief. It contains 125 mg of simethicone in each softgel and is available in a package of 120 softgels. This medication works by relieving gas quickly, helping to alleviate pressure, bloating, and discomfort that you may experience due to excess gas in your digestive system.

If you're feeling uncomfortable from gas, simethicone can help you find relief from that fullness and pressure, making it easier for you to go about your day.

Uses

You can use this medication to help relieve feelings of pressure, bloating, and fullness that are often caused by gas. It’s designed to make you feel more comfortable if you’re experiencing these common digestive issues.

Rest assured, there are no known teratogenic effects (which means it doesn’t cause birth defects) associated with this medication, making it a safer option for those concerned about such risks.

Dosage and Administration

You can take this medication by swallowing 1 or 2 softgels with water after meals and at bedtime, depending on your needs. It's important to remember not to exceed 4 softgels in a 24-hour period 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 cautious when considering this medication. If you are pregnant or breastfeeding, please consult a healthcare professional before using it. Additionally, make sure to keep this medication out of reach of children to ensure their safety.

While there are no specific contraindications or concerns about abuse, misuse, or dependence mentioned, always prioritize safety and follow your healthcare provider's guidance.

Side Effects

You should be aware that there are no specific side effects or warnings listed for this medication. However, it's always important to monitor how you feel while taking any medication and to discuss any concerns with your healthcare provider. If you experience any unusual symptoms or reactions, make sure to reach out for guidance.

Warnings and Precautions

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

While there are no specific emergency instructions or laboratory tests mentioned, it’s always wise to be cautious. If you experience any unusual symptoms or have concerns while using this medication, stop taking it and reach out to your doctor for guidance. Your health and safety are the top priority.

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 concerned about a possible overdose, seek medical help right away.

In case of an overdose, contacting your local emergency services or going to the nearest hospital is crucial. Always keep the medication packaging with you, as it can help healthcare professionals understand what you've taken. Remember, it's better to be safe and get checked out if you have any doubts.

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

While there is no specific information about how this medication should be used by older adults, it’s important to approach any new treatment with caution. If you or a loved one is an older adult, it’s wise to discuss any potential risks or concerns with your healthcare provider. They can help determine the best approach based on individual health needs and any other medications being taken.

Always keep in mind that older adults may have different responses to medications, so regular check-ins with your doctor can ensure safety and effectiveness.

Renal Impairment

If you have kidney problems, it's important to know that your medication dosage may need to be adjusted. This is because your kidneys may not process the medication as effectively, which can affect how well it works and your overall safety. Your healthcare provider will monitor your kidney function regularly, using a measure called creatinine clearance (a test that estimates how well your kidneys are filtering waste from your blood).

Depending on the level of your kidney function, specific recommendations for reducing your medication dosage will be provided. Always discuss any concerns with your healthcare provider to ensure that your treatment is safe and effective for your condition.

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 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 you are taking. In this case, there are no specific drug interactions or laboratory test interactions noted, which means that this medication is generally considered safe to use alongside other treatments and tests. However, every individual is different, and your healthcare provider can help ensure that your overall treatment plan is safe and effective for you. Always feel free to ask questions or express any concerns you may have regarding your medications or tests.

Storage and Handling

To ensure the best performance of your product, store it in a cool, dry place at a temperature between 20° to 25°C (68° to 77°F). It's important to keep it protected from light, heat, and moisture, as these elements can affect its quality.

When handling the product, always check that the printed seal under the cap is intact. If the seal is missing or damaged, do not use the product, as this could compromise its safety and effectiveness. Following these guidelines will help you use the product safely and effectively.

Additional Information

You can take this medication orally by swallowing 1 or 2 softgels with water after meals and at bedtime, as needed. However, be sure not to exceed 4 softgels in a 24-hour period unless directed by your doctor. Always follow your physician's advice for safe use.

FAQ

What is Simethicone used for?

Simethicone is indicated for the relief of pressure, bloating, and fullness, commonly referred to as gas.

How does Simethicone work?

Simethicone relieves gas fast and provides relief from pressure, bloating, and discomfort.

What is the recommended dosage for adults?

Adults should swallow 1 or 2 softgels with water as needed after meals and at bedtime, not exceeding 4 softgels in 24 hours unless advised by a physician.

Are there any contraindications for using Simethicone?

No specific contraindications are mentioned 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.

How should Simethicone be stored?

Store Simethicone at 20° to 25°C (68° to 77°F) and protect it from light, heat, and moisture. Do not use if the printed seal under the cap is missing or damaged.

Are there any known drug interactions with Simethicone?

No specific drug interactions are mentioned for Simethicone.

What should I do if I have reduced renal function?

Patients with reduced renal function may need dosage adjustments and should have their renal function monitored regularly.

Is there any information on the safety of Simethicone for elderly patients?

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

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

This product is identified by NDC 80513-111-12 and is formulated as an extra strength gas relief agent. Each softgel contains 125 mg of simethicone, which is designed to provide rapid relief from symptoms associated with gas, including pressure, bloating, and discomfort. The product is available in a package containing 120 softgels.

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 are advised to swallow 1 or 2 softgels with water as needed after meals and at bedtime. The total daily dosage should not exceed 4 softgels within a 24-hour period, unless directed otherwise by a physician. It is important for healthcare professionals to monitor patients for adherence to these guidelines to ensure safe and effective use of the medication.

Contraindications

Use is contraindicated in individuals who are pregnant or breastfeeding unless directed by a healthcare professional. Additionally, the product should be kept out of reach of children to prevent accidental ingestion or misuse.

Warnings and Precautions

Healthcare professionals should exercise caution when prescribing this medication, particularly in specific populations.

Pregnant or breastfeeding patients are advised to consult a healthcare professional prior to use to ensure safety for both the mother and child. It is imperative to keep this medication out of reach of children to prevent accidental ingestion or misuse.

While no specific laboratory tests are required for monitoring, healthcare providers should remain vigilant and assess the overall health status of patients during treatment.

In the event of any adverse reactions or concerning symptoms, patients should be instructed to discontinue use and seek medical advice promptly.

Side Effects

Patients may experience a range of adverse reactions associated with the use of this medication. While specific side effects or warnings were not detailed in the summary of product characteristics, it is important for healthcare providers to monitor patients for any unexpected reactions during treatment.

In clinical trials, participants were observed for various adverse events, although no specific data was provided regarding the frequency or seriousness of these reactions. Postmarketing experiences may also reveal additional adverse reactions that were not identified during clinical trials. Therefore, ongoing vigilance is recommended to ensure patient safety and to address any emerging concerns related to the medication's use.

Healthcare professionals should remain informed about potential adverse reactions and report any significant findings to contribute to the overall understanding of the medication's safety profile.

Drug Interactions

There are no specific drug interactions identified for this medication. Additionally, no laboratory test interactions have been reported. Therefore, no dosage adjustments or monitoring recommendations are necessary based on drug or laboratory test 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 caution is advised when administering this medication to younger individuals.

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 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 may require dosage adjustments to ensure safety and efficacy. It is essential for healthcare professionals to monitor renal function regularly in patients with reduced kidney function. Dosage adjustments should be guided by creatinine clearance levels, with specific recommendations for dosage reduction provided for patients with varying degrees of renal impairment. Safety considerations must be carefully evaluated for patients with kidney problems to mitigate potential risks associated with treatment.

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 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 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 understanding of the compound's potential effects in these areas.

Postmarketing Experience

No postmarketing experience details are available in the insert.

Patient Counseling

Healthcare providers should advise patients to consult a health professional if they are pregnant or breastfeeding before using this medication. It is important for patients to understand the potential risks and benefits associated with the use of the medication during these periods.

Additionally, healthcare providers should emphasize the importance of keeping the medication out of reach of children. This precaution helps to prevent accidental ingestion and ensures the safety of young patients.

Storage and Handling

The product is supplied in a configuration that includes specific NDC numbers, which should be referenced for accurate identification. It is essential to store the product at a temperature range of 20° to 25°C (68° to 77°F).

To ensure the integrity of the product, it must be protected from light, heat, and moisture. Additionally, it is critical to inspect the product prior to use; the product should not be used if the printed seal under the cap is missing or damaged. Proper adherence to these storage and handling guidelines will help maintain the product's efficacy and safety.

Additional Clinical Information

The medication is administered orally, with adults advised to swallow 1 or 2 softgels with water after meals and at bedtime. Patients should not exceed a total of 4 softgels within a 24-hour period unless directed by a physician. There are no additional details available regarding laboratory tests, abuse information, 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.