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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)
Marketed in the U.S.
Since 2019
Label revision date
November 19, 2025
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
Marketed in the U.S.
Since 2019
Label revision date
November 19, 2025
Manufacturer
Cardinal Health (Leader) 70000
Registration number
M002
NDC root
70000-0529

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

Drug Overview

Simethicone is an extra strength medication designed to provide fast relief from the discomfort associated with gas, including pressure, bloating, and fullness. Each softgel contains 125 mg of simethicone, which works as an anti-gas agent to help alleviate these common digestive issues.

If you're experiencing discomfort due to gas, simethicone can help you feel more comfortable and at ease. It's important to note that this product is comparable to Gas-X® Extra Strength, but it is not manufactured by the same company.

Uses

If you're experiencing discomfort from gas, such as pressure, bloating, or a feeling of fullness, this medication can help provide fast relief. It targets those uncomfortable sensations, allowing you to feel more at ease.

You can trust that this medication does not have any teratogenic effects, meaning it does not cause developmental issues in a fetus. So, if you're looking for a solution to alleviate gas-related discomfort, this option is designed to help you feel better quickly.

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 to ensure safe and effective use 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 make the drug unsafe for you) or controlled substance concerns associated with it. Additionally, there are no known risks of abuse, misuse, or dependence (a condition where your body becomes reliant on a substance) linked to this medication.

Since there are no "do not take" or "do not use" instructions provided, you can proceed with its use as directed by your healthcare provider. Always remember to consult with them if you have any questions or concerns about your treatment.

Side Effects

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

Warnings and Precautions

If you are pregnant or breastfeeding, it’s important to consult with a healthcare professional before using this medication. Your health and the health of your baby are paramount, and a professional can provide guidance tailored to your situation.

Additionally, make sure to keep this medication out of reach of children to prevent accidental ingestion. Always prioritize safety in your home. If you have any concerns or experience unusual symptoms, don’t hesitate to stop using the medication and contact your doctor for advice.

Overdose

It appears that there is no specific information available regarding overdosage for this medication. However, if you suspect that you or someone else may have taken too much of a medication, it’s important to be aware of potential signs of an overdose. These can include unusual drowsiness, confusion, or difficulty breathing.

If you notice any of these symptoms, or if you are unsure whether an overdose has occurred, seek immediate medical help. You can contact your local emergency services or go to the nearest hospital. Always keep medications out of reach and follow the prescribed dosage to prevent any risks associated with overdosage.

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 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 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 there are no specific guidelines, dosage adjustments, or monitoring requirements mentioned for your condition in the provided information. This means that the standard recommendations for medication use may apply to you without any special considerations. However, always consult your healthcare provider for personalized advice and to ensure your treatment is safe and effective 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 provided information. This means that the standard recommendations apply, and there are no special monitoring or precautions outlined for patients with liver impairment.

Always consult your healthcare provider for personalized advice and to ensure that any medications you take are safe for your liver health. They can provide guidance based on your individual situation and any other health considerations you may have.

Drug Interactions

It's important to have open conversations with your healthcare provider about any medications you are taking, as well as any lab tests you may undergo. While there are no specific drug interactions or laboratory test interactions noted for this medication, your healthcare provider can help ensure that your overall treatment plan is safe and effective. Always feel free to ask questions and share your complete list of medications and supplements to avoid any potential issues.

Storage and Handling

To ensure the best performance of your product, store it in a cool, dry place at a temperature between 20-25°C (68-77°F). It's important not to refrigerate the product, as this can affect its effectiveness. Additionally, make sure to protect it from light, heat, and moisture, as these elements can also compromise its quality.

When handling the product, always do so with clean hands and in a clean environment to maintain its integrity. Following these guidelines will help ensure that the product remains safe and effective for your use.

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

How does Simethicone work?

Simethicone acts as an anti-gas agent, providing fast relief from pressure, bloating, and discomfort.

What is the recommended dosage for adults and children 12 years and older?

You 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 warnings for using Simethicone?

If you are pregnant or breastfeeding, you should ask a health professional before use. Additionally, keep this product out of reach of children.

What should I do if the blister unit is damaged?

Do not use Simethicone if the blister unit is torn, broken, or shows any signs of tampering.

How should Simethicone be stored?

Store Simethicone between 20-25°C (68-77°F), do not refrigerate, and protect it from light, heat, and moisture.

Is there any information on drug interactions with Simethicone?

No drug interactions information is provided for Simethicone.

Who distributes Simethicone?

Simethicone is distributed by Cardinal Health, Dublin, Ohio 43017.

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

No description information is available for the drug.

Uses and Indications

This drug is indicated for the relief of pressure, bloating, and fullness commonly referred to as gas. It provides fast relief of symptoms including pressure, bloating, and discomfort associated with gastrointestinal distress.

Limitations of Use: There are no teratogenic or nonteratogenic effects associated with this drug.

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 within a 24-hour period, unless directed otherwise by a physician.

Contraindications

There are no contraindications associated with the use of this product. It is deemed safe for use in the absence of specific conditions or situations that would warrant avoidance.

Warnings and Precautions

Healthcare professionals are advised to exercise caution when prescribing this medication to pregnant or breastfeeding patients. It is imperative that patients consult with a healthcare professional prior to use in these circumstances to ensure safety and appropriateness of treatment.

Additionally, this medication should be stored securely and kept out of reach of children to prevent accidental ingestion or misuse. Proper storage practices are essential to maintain the integrity of the medication and safeguard against potential harm to pediatric populations.

Side Effects

Patients should be advised to consult a health professional if they are pregnant or breastfeeding before using this product. It is important to keep this medication out of reach of children to prevent accidental ingestion or misuse.

No specific adverse reactions have been reported in clinical trials or postmarketing experiences; however, the aforementioned warnings highlight the need for caution in vulnerable populations.

Drug Interactions

There are currently no documented drug interactions associated with this medication. Additionally, there are no known interactions with laboratory tests. As such, no specific recommendations for dosage adjustments or monitoring are necessary at this time.

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 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 4 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

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 maternal and fetal safety.

Lactation

Lactating mothers are advised to consult a health professional prior to using this medication. There is currently no available data on the excretion of this drug in human breast milk or its effects on breastfed infants. Therefore, caution is recommended when administering this medication to lactating individuals.

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

There is no information available regarding the use of this medication in patients with hepatic impairment. Consequently, there are no dosage adjustments, special monitoring requirements, or precautions specified for individuals with compromised liver function. Healthcare professionals should exercise caution and consider the overall clinical context when prescribing this medication to patients with liver problems, as the absence of specific guidance necessitates careful evaluation of potential risks and benefits.

Overdosage

In the absence of specific overdosage information, it is essential for healthcare professionals to remain vigilant regarding the potential for overdose with this medication. In cases where an overdose is suspected, immediate medical attention should be sought.

Healthcare providers are advised to monitor patients closely for any signs or symptoms that may indicate an overdose. These may include, but are not limited to, increased severity of known side effects, unusual behavioral changes, or any other atypical clinical manifestations.

Management of an overdose should be guided by the clinical presentation of the patient. Supportive care is paramount, and symptomatic treatment should be initiated as necessary. It is recommended that healthcare professionals consult local poison control centers or relevant toxicology resources for specific guidance on the management of overdose cases.

In summary, while specific overdosage information is not available, healthcare professionals should exercise caution, remain observant for potential overdose symptoms, and implement appropriate management strategies as needed.

Nonclinical Toxicology

If pregnant or breastfeeding, it is advised to consult a health professional prior to use. No specific non-teratogenic effects have been identified. Additionally, there are no detailed findings related to nonclinical toxicology or animal pharmacology and toxicology available.

Postmarketing Experience

No postmarketing experience details are available in the insert.

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 children.

Storage and Handling

The product is supplied in packaging that ensures its integrity and stability. It should be stored at a temperature range of 20-25°C (68-77°F). It is essential to avoid refrigeration, as this may compromise the product's quality. Additionally, the product must be protected from light, heat, and moisture to maintain its efficacy and safety. Proper handling and storage conditions are crucial for preserving the product's intended use.

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. Patients should not exceed a total of 4 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.