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Gas-X

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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 2019
Label revision date
April 5, 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 2019
Label revision date
April 5, 2024
Manufacturer
Haleon US Holdings LLC
Registration number
M001
NDC root
0067-6283
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

Gas-X is a medication that helps relieve pressure, bloating, and discomfort caused by gas. It contains simethicone, which is a doctor-recommended ingredient known for its effectiveness in treating these symptoms. Available in Maximum Strength Softgels, Gas-X is designed to provide fast relief, working within minutes to help you feel more comfortable.

The softgels are concentrated, making them easy to swallow without a chalky taste, allowing you to manage gas-related discomfort conveniently. If you're experiencing bloating or pressure, Gas-X may be a helpful option to consider for quick relief.

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) or nonteratogenic effects associated with this medication. This makes it a safe option for those looking to alleviate gas-related discomfort.

Dosage and Administration

You can take this medication by swallowing 1 or 2 softgels with water after meals and at bedtime if you need it. This is suitable for adults and children aged 12 years and older.

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 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.

If you experience any unusual symptoms or side effects, stop using the medication and call your doctor right away. Additionally, if you have any concerns about your health or the effects of this medication, don’t hesitate to reach out to your healthcare provider for 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.

Pregnancy Use

When it comes to using GAS-X Maximum Strength Softgels during pregnancy, there is currently no information available about its safety, recommended dosage, or any special precautions you should take. This means that the effects of this medication on you and your developing baby are not well understood.

If you are pregnant or planning to become pregnant, it’s important to consult with your healthcare provider before taking any medication, including over-the-counter products like GAS-X. They can help you weigh the potential risks and benefits based on your individual situation.

Lactation Use

If you are breastfeeding and considering using Gas-X Maximum Strength Softgels, you can feel reassured that the drug insert does not mention any specific warnings or considerations for nursing mothers. This means that, based on the available information, there are no known risks associated with using this medication while breastfeeding.

However, it's always a good idea to consult with your healthcare provider before starting any new medication to ensure it’s safe for you and your baby.

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 dosage is to swallow 1 or 2 softgels with water after meals and at bedtime, but you should not exceed 2 softgels in a 24-hour period unless directed by a doctor.

If you have younger children, please consult with a healthcare professional before giving them this medication, as specific guidelines for younger age groups are not provided. Always prioritize safety and follow the advice of your healthcare provider.

Geriatric Use

While there is no specific information about the use of Gas-X Maximum Strength Softgels in older adults, it's always important to approach any medication with caution. Since the drug insert does not mention dosage adjustments or safety concerns for elderly patients, you should consult with a healthcare provider before starting this medication. They can help ensure that it is appropriate for your needs and discuss any potential interactions with other medications you may be taking.

Always prioritize your health and safety by seeking professional advice, especially when it comes to managing symptoms like gas and bloating.

Renal Impairment

If you have kidney 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 usual recommendations for monitoring or safety considerations related to renal impairment (kidney issues) are not provided.

Always consult your healthcare provider for personalized advice and to ensure that any medications you take are safe and appropriate for your kidney health. They can help you understand how your condition may affect your treatment plan.

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 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 at a controlled room temperature between 20-25°C (68-77°F). 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 in a clean environment to maintain its integrity. Following these guidelines will help you use the product safely and effectively.

Additional Information

You should take this medication orally by 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 Gas-X?

Gas-X is a #1 doctor recommended brand that contains 250 mg of simethicone, an antigas medicine, and is available in Maximum Strength Softgels.

How does Gas-X work?

Gas-X offers fast relief of pressure, bloating, and discomfort commonly referred to as gas by using simethicone, which helps break up gas bubbles.

How should I take Gas-X?

Adults and children 12 years and older should swallow 1 or 2 softgels with water as needed after meals and at bedtime, without exceeding 2 softgels in 24 hours unless advised by a physician.

Are there any contraindications for Gas-X?

There are no specific contraindications listed for Gas-X.

What should I do if the blister pack is damaged?

Do not use Gas-X if the blister is broken or damaged, as it has a tamper evident feature.

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

The drug insert does not provide specific information regarding the use of Gas-X during pregnancy or lactation.

What are the storage instructions for Gas-X?

Store Gas-X at a controlled room temperature of 20-25°C (68-77°F) and protect it from light, heat, and moisture.

What should I keep in mind regarding children and Gas-X?

Keep Gas-X out of reach of children to prevent accidental ingestion.

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 is a brand name for a formulation containing the active ingredient simethicone at a concentration of 250 mg per softgel. This product is indicated for the relief of gas-related discomfort, including pressure and bloating. Gas-X is available in the form of softgels, which are designed to be small and easy to swallow, with a formulation that avoids a chalky taste. The maximum strength softgels are concentrated to deliver liquid gas-fighting medicine effectively. Gas-X Ultra Strength Softgels provide rapid relief from symptoms that antacids may not address, and simethicone is the most commonly recommended antigas medicine by healthcare professionals for alleviating gas-related discomfort. Each package contains 50 softgels, and the product features a tamper-evident design, ensuring that it should not be used if the blister is broken or damaged.

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

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. Additionally, there are no specific instructions indicating that the product should not be taken or used under any circumstances.

Warnings and Precautions

Healthcare professionals are advised to ensure that the medication is stored securely and kept out of reach of children to prevent accidental ingestion or misuse.

In addition to this critical warning, it is essential to monitor patients for any adverse reactions associated with the use of this medication. Regular assessments and appropriate laboratory tests should be conducted as necessary to ensure patient safety and therapeutic efficacy.

Healthcare providers should remain vigilant and educate patients about the importance of adhering to prescribed dosages and the potential risks associated with improper use.

Side Effects

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

In clinical trials and postmarketing experiences, no specific adverse reactions were reported; however, the importance of safeguarding the medication from children remains a priority to ensure patient safety.

Drug Interactions

There are no specific drug interactions identified for this medication. Additionally, no laboratory test interactions have been noted in the available data. 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-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 1 or 2 softgels taken with water after meals and at bedtime, not to exceed 2 softgels in a 24-hour period unless directed by a physician. Caution is advised to ensure that the dosage does not exceed the recommended limits without medical supervision.

Geriatric Use

Elderly patients may not have specific information regarding the use of Gas-X Maximum Strength Softgels, including dosage adjustments, safety concerns, or special precautions. As such, healthcare providers should exercise caution when prescribing this medication to geriatric patients.

Due to the absence of targeted clinical data for this population, it is advisable for healthcare providers to closely monitor elderly patients for any potential adverse effects or unusual responses to treatment. Individual patient factors, including comorbidities and concurrent medications, should be considered when determining the appropriateness of this medication for geriatric patients.

Pregnancy

There is no information available regarding the use of GAS-X Maximum Strength Softgels during pregnancy, including safety concerns, dosage modifications, or any special precautions. Healthcare professionals should exercise caution when considering the use of this product in pregnant patients due to the lack of data on potential risks or fetal outcomes. Women of childbearing potential should be advised to consult their healthcare provider before using this medication during pregnancy.

Lactation

There are no specific warnings or considerations regarding nursing mothers or lactation associated with Gas-X Maximum Strength Softgels. The available data does not indicate any known effects on breastfed infants or excretion in breast milk. Therefore, healthcare professionals may consider the use of this medication in lactating mothers without specific concerns related to breastfeeding.

Renal Impairment

Patients with renal impairment have not been specifically addressed in the available data regarding dosage adjustments, special monitoring, or safety considerations. Therefore, healthcare professionals should exercise caution when prescribing this medication to patients with reduced kidney function, as the lack of information necessitates careful clinical judgment and monitoring.

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 amount and timing of the substance taken, is crucial for effective treatment 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 keep this medication out of reach of children to prevent accidental ingestion or misuse. It is important to emphasize the necessity of proper storage and handling to ensure the safety of young individuals.

Storage and Handling

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

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 for patients 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-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.

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.