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Gas-X

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Active ingredient
Dimethicone, Unspecified 500 mg
Other brand names
Dosage form
Capsule, Liquid Filled
Route
Oral
Prescription status
OTC (over the counter)
Marketed in the U.S.
Since 2025
Label revision date
May 20, 2025
Active ingredient
Dimethicone, Unspecified 500 mg
Other brand names
Dosage form
Capsule, Liquid Filled
Route
Oral
Prescription status
OTC (over the counter)
CSA schedule
Not a scheduled drug
Marketed in the U.S.
Since 2025
Label revision date
May 20, 2025
Manufacturer
Haleon US Holdings LLC
Registration number
M002
NDC root
0067-8075

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If you are a consumer or patient please visit this version.

Drug Overview

Gas-X is a medication that contains simethicone, which is designed to provide fast relief from gas-related discomfort. It works quickly, often within minutes, to alleviate feelings of pressure, bloating, and fullness that are commonly associated with gas. As the #1 doctor-recommended brand, Gas-X is known for its effectiveness, being twice as strong as some other over-the-counter gas relief options.

Available in a maximum strength formula, Gas-X comes in softgel form, making it easy to take when you need relief from gas symptoms.

Uses

If you're experiencing discomfort from pressure, bloating, or a feeling of fullness often associated with gas, this medication can help provide relief. It's designed specifically to address these common digestive issues, making your day-to-day life more comfortable.

Rest assured, there are no known teratogenic effects (which means it doesn't cause birth defects) associated with this medication, so it is considered safe in that regard.

Dosage and Administration

When taking this medication, you should swallow one softgel with water after meals or at bedtime. This is suitable for adults and children aged 12 years and older. It's important to remember that you should not take more than one softgel 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

There are no specific contraindications, controlled substance classifications, or risks of abuse, misuse, or dependence associated with this medication. This means that, based on the available information, there are no particular situations or conditions under which you should avoid using it. Always consult with your healthcare provider for personalized advice and to ensure that this medication is appropriate for your individual health needs.

Side Effects

It's important to keep this medication out of reach of children to prevent accidental ingestion. If you have any concerns about side effects or how to safely store the medication, please consult your healthcare provider for guidance.

Warnings and Precautions

It's important to keep this medication out of reach of children to prevent accidental ingestion, which can be dangerous. Always store it in a safe place where children cannot access it.

If you have any concerns or experience unusual symptoms while using this medication, stop using it and call your doctor for advice. Your health and safety are the top priority, so don’t hesitate to seek help if 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 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 planning to become pregnant, it's important to know that there is no specific information available about the use of Gas-X Ultimate Strength Softgels during pregnancy. This means that safety concerns, dosage adjustments, or any special precautions for pregnant individuals have not been addressed in the drug insert.

Before taking any medication, including over-the-counter products like Gas-X, you should consult with your healthcare provider to discuss potential risks and benefits tailored to your situation. Your health and the health of your baby are the top priority, so always seek professional advice when considering medication during pregnancy.

Lactation Use

If you are breastfeeding, you can feel reassured that there are no specific warnings or recommendations regarding the use of Gas-X Ultimate Strength Softgels for nursing mothers. The information available does not indicate any particular considerations or precautions you need to take while using this product during lactation (the period of breastfeeding).

Always consult with your healthcare provider if you have any concerns about medications while breastfeeding, but based on the current information, you can use Gas-X without specific worries related to your nursing status.

Pediatric Use

It's important to keep this medication out of reach of children to ensure their safety. For adults and children aged 12 years and older, the recommended way to take it is to swallow one softgel with water after meals or at bedtime. You should not exceed one softgel in a 24-hour period unless a doctor advises otherwise. Always consult with a healthcare professional if you have any questions or concerns about its use in children.

Geriatric Use

When considering Gas-X Ultimate Strength Softgels, it's important to note that there is no specific information available regarding its use in older adults. This means that the drug insert does not provide details on dosage adjustments, safety concerns, or special precautions that might be necessary for elderly patients.

If you are an older adult or a caregiver, it’s always a good idea to consult with a healthcare professional before starting any new medication. They can help ensure that the treatment is safe and appropriate for your individual health needs.

Renal Impairment

It appears that there is no specific information regarding renal impairment (kidney problems) in the provided text. Therefore, there are no dosage adjustments, special monitoring, or safety considerations to discuss for patients with kidney issues. If you have concerns about how your kidney health may affect your treatment, it's important to consult your healthcare provider for personalized advice and 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 available information. This means that the standard recommendations apply, but you should always consult your healthcare provider for personalized advice. They can help determine the best approach for your treatment and monitor your liver function as needed.

Make sure to keep your doctor informed about your liver health, as they may want to conduct regular liver function tests (which check how well your liver is working) to ensure your safety while using any medication.

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, based on the available information, this medication is not known to interfere with other drugs or lab tests. However, every individual is different, and your healthcare provider can help ensure that your treatment is safe and effective for you.

Always discuss any new medications or tests with your healthcare provider to avoid potential issues and to get personalized advice tailored to your health needs.

Storage and Handling

To ensure the best performance of your product, store it at a controlled room temperature between 20-25ºC (68-77ºF). It's important to keep it away from light, heat, and moisture, as these elements 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. If you have any specific disposal instructions, be sure to follow them carefully to ensure safety.

Additional Information

You should take this medication orally by swallowing one softgel with water after meals or at bedtime if you are an adult or a child aged 12 years and older. It's important not to exceed one softgel in a 24-hour period unless your doctor advises otherwise.

Before using the product, make sure to read all the information provided and keep the carton for future reference. Additionally, check the packaging for a tamper-evident feature; do not use the product if the blister is broken or damaged.

FAQ

What is Gas-X?

Gas-X is an antiflatulent medication containing Simethicone 500 mg, designed to relieve gas quickly.

How does Gas-X work?

Gas-X works by relieving pressure, bloating, and fullness caused by gas, going to work in minutes.

What is the recommended dosage for adults and children?

Adults and children 12 years and older should swallow 1 softgel with water after meals or at bedtime, not exceeding 1 softgel in 24 hours unless advised by a physician.

Are there any contraindications for using Gas-X?

No specific contraindications are listed for Gas-X.

Is Gas-X safe to use during pregnancy or while nursing?

The provided information does not mention any specific safety concerns or recommendations for use during pregnancy or lactation.

What should I do if I have children?

Keep Gas-X out of reach of children to ensure their safety.

How should I store Gas-X?

Store Gas-X at controlled room temperature between 20-25ºC (68-77ºF) and protect it from light, heat, and moisture.

What should I do if the blister pack is damaged?

Do not use Gas-X if the blister is broken or damaged, as it may indicate tampering.

Packaging Info

Below are the non-prescription pack sizes of Gas-X (simethicone). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Gas-X.
Details

Drug Information (PDF)

This file contains official product information for Gas-X, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)

Description

Gas-X contains the active ingredient simethicone at a strength of 500 mg, formulated as Ultimate Strength SoftGels. Each package contains 20 SoftGels. Manufactured by HALEON, Gas-X is indicated for the relief of gas-related discomfort, including pressure and bloating. This formulation is recognized as the #1 doctor-recommended brand and is designed to provide rapid relief, acting within minutes. Gas-X is noted for its effectiveness, being 2X stronger than the original Gas-X formulation, making it the strongest over-the-counter gas relief option available.

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 are instructed to swallow one softgel with water after meals or at bedtime. It is essential that the dosage does not exceed one softgel within a 24-hour period, unless otherwise directed by a physician.

Contraindications

There are no contraindications associated with the use of this product. It is not classified as a controlled substance, and there are no known risks of abuse, misuse, or dependence.

Warnings and Precautions

It is imperative to keep this medication out of reach of children to prevent accidental ingestion or misuse. Healthcare professionals should counsel patients and caregivers on the importance of secure storage practices to mitigate the risk of pediatric exposure.

In addition, ongoing monitoring of patients is essential to ensure safe and effective use of the medication. Regular assessments should be conducted to evaluate the patient's response to treatment and to identify any potential adverse effects. Specific laboratory tests may be recommended based on the individual patient's condition and treatment regimen, and healthcare providers should remain vigilant in reviewing these parameters to optimize patient safety.

Side Effects

Patients should be advised to keep the medication out of reach of children. This warning is critical to prevent accidental ingestion or misuse, which could lead to serious adverse reactions.

No specific adverse reactions have been reported in clinical trials or postmarketing experiences beyond the noted warning. It is essential for healthcare providers to monitor patients for any unexpected effects and to educate them on the importance of proper storage and handling of the medication.

Drug Interactions

There are no specific drug interactions identified in the available data. Additionally, no laboratory test interactions have been reported. 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-X (simethicone). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Gas-X.
Details

Pediatric Use

Pediatric patients should be kept out of reach of children. For adolescents aged 12 years and older, the recommended dosage is to swallow 1 softgel with water after meals or at bedtime. It is important not to exceed 1 softgel in a 24-hour period unless advised and supervised by a physician.

Geriatric Use

There is no specific information regarding the use of Gas-X Ultimate Strength Softgels 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 efficacy and potential adverse effects is recommended in this population, given the lack of targeted clinical data.

Pregnancy

There is no specific information regarding the use of Gas-X Ultimate Strength Softgels during pregnancy, including safety concerns, dosage modifications, or special precautions. Healthcare professionals should consider the lack of data when prescribing this medication to pregnant patients. It is advisable to weigh the potential benefits against any unknown risks to fetal outcomes. Women of childbearing potential should be counseled accordingly.

Lactation

There are no specific warnings or recommendations regarding the use of Gas-X Ultimate Strength Softgels in lactating mothers. Additionally, there are no specific considerations or precautions related to lactation mentioned in the provided text.

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 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 information, 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 available in the insert text.

Patient Counseling

Healthcare providers should advise patients to keep this medication out of reach of children to prevent accidental ingestion or misuse. It is important for patients to understand the potential risks associated with improper access to the medication by young individuals. Providers should emphasize the necessity of storing the medication in a secure location, away from children's sight and reach, to ensure safety.

Storage and Handling

The product is supplied in packaging that ensures its integrity and stability. It should be stored at a controlled room temperature of 20-25ºC (68-77ºF). It is essential to protect the product from light, heat, and moisture to maintain its efficacy and safety. Proper handling and storage conditions are critical to preserving the quality of the product throughout its shelf life.

Additional Clinical Information

Patients should be advised that the medication is administered orally, with the recommended dosage being one softgel taken with water after meals or at bedtime for adults and children aged 12 years and older. It is important not to exceed one softgel within a 24-hour period unless directed by a physician.

Clinicians should counsel patients to read all product information prior to use and to retain the carton for important information. Additionally, patients should be informed of the tamper-evident feature, indicating that the product should not be used if the blister is broken or damaged.

Drug Information (PDF)

This file contains official product information for Gas-X, 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-X, 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.

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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.