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Gas-X

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Active ingredient
Dimethicone, Unspecified 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 2011
Label revision date
March 14, 2025
Drug Information (PDF)
Prescribing information, PDF file
Active ingredient
Dimethicone, Unspecified 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 2011
Label revision date
March 14, 2025
Manufacturer
Haleon US Holdings LLC
Registration number
M001
NDC root
0067-6275
Drug Information (PDF)
Prescribing information, PDF file
Packaging Info (7 NDCs)
Packaging & NDC Codes (7)

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 an over-the-counter medication that contains simethicone, which is designed to relieve gas quickly. It works by breaking up gas bubbles in your stomach and intestines, helping to alleviate pressure, bloating, and the discomfort often associated with gas.

As the #1 doctor-recommended brand for gas relief, Gas-X is available in an extra strength formula, providing effective support when you need it most. Each bottle contains 120 softgels, making it a convenient option for managing gas-related symptoms.

Uses

You can use this medication to help relieve the discomfort of pressure, bloating, and fullness that often comes from gas. It’s designed to make you feel more comfortable by addressing 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 who may be 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 if needed. It's important to remember that you should not exceed 4 softgels in a 24-hour period unless your doctor advises you otherwise.

Make sure to follow these guidelines closely to ensure your safety and the effectiveness of the medication. If you have any questions or concerns about your dosage, don’t hesitate to reach out to your healthcare provider for guidance.

What to Avoid

You can feel confident using this medication, as there are no specific contraindications (conditions that would prevent you from taking it) or concerns about abuse, misuse, or dependence (a condition where your body becomes reliant on a substance). Additionally, there are no particular instructions indicating that you should avoid taking or using this medication under certain circumstances. Always consult with your healthcare provider if you have any questions or concerns about your treatment.

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 use this medication safely, 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 for medical advice. Always prioritize your safety and well-being.

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 or symptoms of an overdose for this medication, general signs can include unusual drowsiness, confusion, or difficulty breathing.

If you notice any of these symptoms or have concerns about a possible overdose, seek medical help right away. It's always better to be safe and get professional advice if you think you or someone else may have taken too much of a medication.

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 Extra Strength Softgels (which contain simethicone) during pregnancy. This means that safety concerns, dosage adjustments, or special precautions for pregnant individuals have not been clearly established.

Before taking any medication, including over-the-counter products like Gas-X, you should consult with your healthcare provider to discuss your specific situation and any potential risks. Your health and the health of your baby are the top priority, so it's always best to seek professional advice.

Lactation Use

If you are breastfeeding or planning to breastfeed, it's important to know that there is no specific information available about the use of Gas-X Extra Strength Softgels during nursing. This means that the effects on breast milk and nursing infants have not been studied or documented.

As always, it's a good idea to consult with your healthcare provider before taking any medication while breastfeeding to ensure the safety of both 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. However, you should not exceed 4 softgels in a 24-hour period unless directed by a doctor. Always consult with a healthcare professional if you have any questions or concerns about using this medication for yourself or your child.

Geriatric Use

While there is no specific information about the use of Gas-X Extra 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 and what steps to take for your safety.

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 tests to ensure your safety while using any medication. Your well-being is a priority, so don't hesitate to ask questions or express any concerns you may have.

Drug Interactions

It's important to have open conversations with your healthcare provider about any medications or tests you may be taking. In this case, there are no known drug interactions or interactions with laboratory tests for the medication in question. However, every individual is different, and your healthcare provider can help ensure that your treatment is safe and effective based on your unique health needs. Always feel free to ask questions and share your complete list of medications and any tests you may be undergoing.

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, make sure to do so in a clean environment to maintain its integrity. Always follow any specific disposal instructions provided to ensure safe and responsible disposal. By following these guidelines, you can help ensure the product remains safe and effective for use.

Additional Information

You should take this medication orally, swallowing 1 or 2 softgels with water after meals and at bedtime if needed. Make sure not to exceed 4 softgels in a 24-hour period unless directed by your doctor.

Before using the product, it's important to read all the information provided. Keep the carton for future reference, and do not use the product if the blister packaging is broken or damaged, as this indicates it may have been tampered with.

FAQ

What is Gas-X?

Gas-X is an extra strength antiflatulent containing simethicone 125 mg, designed to relieve gas quickly.

What symptoms does Gas-X relieve?

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

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.

What is the maximum dosage of Gas-X?

Do not exceed 4 softgels in 24 hours unless advised by a physician.

Are there any contraindications for Gas-X?

No contraindications are listed for Gas-X in the provided information.

Is Gas-X safe to use during pregnancy?

There is no specific information regarding the use of Gas-X during pregnancy.

What should I do if I have children?

Keep Gas-X out of reach of children.

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.

Is there any information on drug interactions with Gas-X?

No drug interactions are 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.

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 concentration of 125 mg per softgel. This formulation is classified as extra strength and is indicated for the relief of gas-related symptoms, including pressure, bloating, and discomfort. Each package contains 120 softgels, designed for rapid relief of gas.

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. The softgels should be swallowed with water. It is important not to exceed a total of 4 softgels in a 24-hour period, unless directed by a physician.

Contraindications

There are no contraindications listed for this product. It is important to evaluate each patient's individual circumstances and medical history when considering its use.

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 and caregivers about the importance of adhering to safety measures, including proper storage and handling of the medication.

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.

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 report any adverse reactions that may arise during treatment.

Drug Interactions

There are no documented drug interactions associated with the use of this medication. Additionally, there are no reported interactions between this drug and laboratory tests. Therefore, no dosage adjustments or monitoring recommendations are necessary based on drug 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 to swallow 1 or 2 softgels with water as needed after meals and at bedtime. It is important not to exceed 4 softgels 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 Extra 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 the absence of data necessitates careful consideration of individual patient factors and potential risks. Monitoring for efficacy and adverse effects is recommended in this population, given the lack of established guidelines for geriatric use.

Pregnancy

There is no specific information available regarding the use of Gas-X Extra Strength Softgels (simethicone) during pregnancy. The prescribing information does not provide safety concerns, dosage modifications, or special precautions for pregnant patients. As such, healthcare professionals should exercise caution when considering the use of this medication in women of childbearing potential and during pregnancy, given the absence of data on potential fetal impacts. It is advisable to weigh the benefits against any potential risks when recommending this product to pregnant patients.

Lactation

There is no specific information regarding the use of Gas-X Extra Strength Softgels in lactating mothers or its effects on breastfed infants. Healthcare professionals should consider the lack of data when advising lactating mothers on the use of this medication.

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

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 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 20-25ºC (68-77ºF). Care must be taken to protect the product from light, heat, and moisture to maintain its efficacy and safety.

Additional Clinical Information

Patients aged 12 years and older are advised to take the medication orally, swallowing 1 or 2 softgels with water after meals and at bedtime, without exceeding 4 softgels in 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 details. Additionally, patients should be informed of the tamper-evident feature, advising them not to use the product if the blister is broken or damaged. No further information is available regarding laboratory tests, abuse potential, or postmarketing experiences.

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.