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Gas Relief

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Active ingredient
Dimethicone 250 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 250 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
80513-112
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 high-potency medication designed to provide fast relief from gas-related discomfort. It works by addressing symptoms such as pressure, bloating, and fullness, which are commonly associated with gas in the digestive system.

Each softgel contains 250 mg of Simethicone, making it an effective option for those seeking quick relief from uncomfortable gas symptoms. This product is similar to the active ingredient found in Maximum Strength Gas-X, although it is not manufactured or distributed by the owner of that trademark.

Uses

If you're experiencing discomfort from pressure, bloating, or a feeling of fullness—often caused by gas—this medication can help provide relief. It's designed specifically to ease these uncomfortable symptoms, allowing you to feel more at ease.

Rest assured, this medication does not have any known teratogenic effects, meaning it does not cause developmental issues in a fetus if taken during pregnancy.

Dosage and Administration

You can take this medication if you are an adult or a child aged 12 years and older. Simply swallow 1 or 2 softgels with water after meals and at bedtime, depending on your needs. However, it's important not to exceed 2 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.

What to Avoid

It's important to be cautious when using this medication. If you are pregnant or breastfeeding, please consult a healthcare professional before using it. Additionally, keep this medication out of reach of children to ensure their safety. If your condition does not improve or worsens, stop using the medication and seek advice from your doctor.

While there are no specific contraindications or concerns about abuse, misuse, or dependence associated with this medication, it's always best to use it responsibly and under the guidance of a healthcare provider.

Side Effects

It's important to be aware of potential side effects when using this medication. If your condition does not improve or worsens, you should stop using the medication and consult your doctor for further guidance.

Always keep an eye on how you feel while taking this medication, and don't hesitate to reach out to your healthcare provider if you have any concerns. Your health and safety are the top priority.

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.

If your condition does not improve or continues to persist, please stop using the medication and contact your doctor for further guidance.

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

When using this medication for children, it's important to note that it is intended for adults and children aged 12 years and older. If your child falls within this age range, they can take 1 or 2 softgels with water as needed after meals and at bedtime. Always ensure that the medication is kept out of reach of younger children to prevent accidental ingestion.

As a caregiver, please follow these guidelines closely to ensure the safety and well-being of your child. If you have any concerns or questions about the use of this medication, consult your healthcare provider for further advice.

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 your medication dosage may need to be adjusted. Regular monitoring of your kidney function tests is essential to ensure your safety and the effectiveness of your treatment. If your creatinine clearance (a measure of how well your kidneys filter waste) is less than 30 mL/min, you may require a lower dose of your medication. Additionally, if you have severe renal impairment, special considerations will be necessary to manage your treatment effectively. Always consult your healthcare provider for personalized advice and adjustments based on your kidney health.

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 available information. This means that the standard recommendations for the medication do not change based on liver function. However, it’s always a good idea to discuss your liver health with your healthcare provider before starting any new medication. They can help ensure that your treatment is safe and effective for you.

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 the medication is generally considered safe to use with other drugs and tests. However, every individual is different, and your healthcare provider can help ensure that your treatment plan is safe and effective for you.

Always discuss any changes in your medication or health status with your healthcare provider to avoid any potential issues and to get the best care possible.

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 should take this medication orally, swallowing 1 or 2 softgels with water after meals and at bedtime, if needed. It's important not to exceed 2 softgels in a 24-hour period unless directed by your doctor. This guidance applies to both adults and children aged 12 years and older. Always follow your healthcare provider's advice for safe use.

FAQ

What is Simethicone used for?

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

How should I take Simethicone?

Adults and children 12 years and older should swallow 1 or 2 softgels with water as needed after meals and at bedtime, not exceeding 2 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.

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 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.

Is there a risk of dependence or abuse with Simethicone?

There are no specified risks of dependence or abuse associated with Simethicone.

What should I do if I have renal impairment?

If you have renal impairment, dosage adjustments may be necessary, and you should monitor renal function tests regularly.

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 contains Simethicone, a high-potency active ingredient, at a concentration of 250 mg per softgel. It is formulated to provide rapid relief from gas-related symptoms, including pressure, bloating, and discomfort. The product is packaged in a bottle containing 100 softgels. The National Drug Code (NDC) for this product is 80513-112-01. It is important to note that this product is not manufactured or distributed by the owner of the registered trademark Maximum Strength Gas-X.

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 may take 1 or 2 softgels as needed after meals and at bedtime. It is important to swallow the softgels with water. The maximum recommended dosage is 2 softgels within a 24-hour period, unless otherwise directed by a physician. Healthcare professionals should advise patients to adhere to this dosage limit to ensure safety and efficacy.

Contraindications

Use is contraindicated in the following situations:

Pregnant or breastfeeding individuals should consult a healthcare professional prior to use.

The product must be kept out of reach of children to prevent accidental ingestion.

If symptoms persist, discontinue use and seek medical advice.

Warnings and Precautions

Healthcare professionals should be aware of the following precautions when considering the use of this product.

General precautions must be observed, particularly in special populations. It is advised that individuals who are pregnant or breastfeeding consult a healthcare professional prior to use to ensure safety for both the mother and child. Additionally, the product should be stored out of reach of children to prevent accidental ingestion or misuse.

In the event that symptoms persist despite use, it is imperative to discontinue the product and seek medical advice. This step is crucial to ensure that any underlying conditions are appropriately addressed.

Side Effects

Patients should be aware of the potential adverse reactions associated with the use of this medication. In the event that symptoms persist, it is advised to discontinue use and consult a healthcare professional.

While specific adverse reactions have not been detailed, the importance of monitoring for any ongoing or worsening conditions is emphasized. Patients are encouraged to report any unusual symptoms or concerns to their healthcare provider promptly.

Drug Interactions

No specific drug interactions have been identified in the available data. Additionally, there are no reported interactions between the drug 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 aged 12 years and older may take 1 or 2 softgels as needed after meals and at bedtime, to be swallowed with water. It is important to keep this medication out of reach of children to ensure safety.

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 considered in these populations to ensure the safety of both the mother and the fetus or infant.

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

Renal impairment may necessitate dosage adjustments for patients with reduced kidney function. It is essential to monitor renal function tests regularly in these patients to ensure appropriate management. For patients with a creatinine clearance of less than 30 mL/min, a reduced dose may be required. Additionally, special considerations should be taken for patients with severe renal impairment 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 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 assessment of potential risks associated with the use of the compound in these contexts.

Postmarketing Experience

No postmarketing experience details are available in the insert text.

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 packaging 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 is necessary to maintain product efficacy and safety.

Additional Clinical Information

The medication is administered orally, with adults and children aged 12 years and older advised to swallow 1 or 2 softgels with water as needed after meals and at bedtime. It is important not to exceed 2 softgels within a 24-hour period unless directed 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.