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Extra Strength Gas Relief

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Active ingredient
Dimethicone, Unspecified 125 mg
Other brand names
Dosage form
Tablet, Chewable
Route
Oral
Prescription status
OTC (over the counter)
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Marketed in the U.S.
Since 2020
Label revision date
October 29, 2025
Drug Information (PDF)
Prescribing information, PDF file
Active ingredient
Dimethicone, Unspecified 125 mg
Other brand names
Dosage form
Tablet, Chewable
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 2020
Label revision date
October 29, 2025
Manufacturer
SAFEWAY
Registration number
M002
NDC root
21130-441
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 an extra strength gas relief medication designed to provide fast relief from pressure, bloating, and discomfort commonly associated with gas. Each chewable tablet contains 125 mg of simethicone, which works by breaking up gas bubbles in the stomach and intestines, making it easier for your body to eliminate them. This product is available in a pleasant peppermint flavor, making it a more enjoyable option for those seeking relief from gas-related discomfort.

Uses

If you're experiencing discomfort from pressure, bloating, or a feeling of fullness often associated with gas, this medication can help relieve those symptoms. It's designed to ease the discomfort that can come from excess gas in your digestive system.

You can feel confident using this medication, as there are no known teratogenic effects (which means it doesn't cause birth defects) or other nonteratogenic effects associated with it.

Dosage and Administration

If you are an adult or a child aged 12 years and older, you can take this medication by chewing 1 to 2 tablets thoroughly after meals and at bedtime, as needed. It's important to not exceed 4 tablets in a 24-hour period unless your doctor has advised you to do so. Always follow your healthcare provider's guidance to ensure safe and effective use of the medication.

What to Avoid

It's important to be aware of certain precautions when using this medication. While there are no specific contraindications or risks of abuse, misuse, or dependence associated with it, you should take care to avoid any potential overdose. If you suspect an overdose, seek medical help or contact a poison control center immediately. Your safety is a priority, so always use medications as directed and consult with your healthcare provider if you have any concerns.

Side Effects

You may experience some side effects while taking this medication. Common reactions include nausea, headache, and fatigue. It's important to be aware that serious side effects can occur, such as severe allergic reactions (anaphylaxis), which may require immediate medical attention.

Additionally, there are specific warnings associated with this medication, including a boxed warning that highlights the potential for serious adverse reactions. Always consult your healthcare provider if you notice any unusual symptoms or if you have concerns about the side effects you may experience.

Warnings and Precautions

If you suspect an overdose, it’s crucial to seek emergency medical help or contact a poison control center right away. This is important to ensure your safety and receive the appropriate care.

Currently, there are no specific warnings, general precautions, or laboratory tests associated with this medication. However, always stay informed and consult your healthcare provider if you have any concerns or questions about your treatment.

Overdose

It appears that there is no specific information available regarding overdosage for this medication. However, if you suspect an overdose, it is important to be aware of potential signs, which may include unusual drowsiness, confusion, or difficulty breathing.

If you notice any of these symptoms or have concerns about an overdose, seek immediate medical help. It’s always better to err on the side of caution when it comes to your health. Remember, if you are ever in doubt, contacting a healthcare professional or poison control can provide you with the guidance you need.

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 Extra Strength Gas Relief (simethicone) during pregnancy. This means that safety concerns, dosage adjustments, or special precautions related to its use in pregnant individuals have not been established.

As always, it's best to consult with your healthcare provider before taking any medication while pregnant to ensure the safety of both you and your baby.

Lactation Use

If you are breastfeeding or planning to breastfeed, it's important to consult your physician before using this product. There is a possibility that it may be excreted in breast milk, which means it could potentially affect your nursing infant. Additionally, the safety of this product during lactation has not been established, so discussing your options with a healthcare professional is crucial to ensure the well-being of both you and your baby.

Pediatric Use

It's important to keep this medication out of reach of children to prevent accidental ingestion. If you suspect an overdose, seek medical help or contact a poison control center right away.

For children aged 12 years and older, the recommended dosage is to chew 1 to 2 tablets thoroughly as needed after meals and at bedtime. However, do not exceed 4 tablets in a 24-hour period unless directed by a doctor. Always follow these guidelines to ensure your child's safety and well-being.

Geriatric Use

While there is no specific information available about the use of this medication in older adults, it’s important to approach any new treatment with caution. If you or a loved one is an older adult, it’s always wise to discuss any medications with a healthcare provider, especially considering factors like kidney function and changes in cognition (thinking and memory) that can occur with age.

Since there are no dosage adjustments or special precautions mentioned for elderly patients, your healthcare provider can help determine the best approach based on individual health needs and conditions. Always prioritize open communication with your doctor to ensure safe and effective use of any medication.

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 there are no special monitoring requirements or safety considerations outlined for patients like you with renal impairment (kidney issues).

Always consult your healthcare provider for personalized advice and to ensure that any medications you take are safe and appropriate for your situation. They can provide guidance tailored to your health needs.

Hepatic Impairment

If you have liver problems, it's important to know that your condition can affect how your body processes certain medications. This means that you may need to adjust your dosage to ensure the drug works effectively and safely for you.

For those with severe liver impairment, a lower dose may be necessary, or you might need to consider different treatment options altogether. Regular monitoring of your liver function tests (which check how well your liver is working) is also recommended to keep track of your health while on medication. Always consult your healthcare provider for personalized advice and adjustments based on your specific situation.

Drug Interactions

It's important to have open conversations with your healthcare provider about any medications or tests you may be taking. While there are no specific drug interactions or laboratory test interactions noted for this medication, your healthcare provider can help ensure that everything you are taking works well together and is safe for you. Always share your complete list of medications and any recent lab tests to avoid any potential issues. Your health and safety should always come first.

Storage and Handling

To ensure the best performance of your product, store it at room temperature, away from moisture. Keeping it dry is essential for maintaining its effectiveness and safety.

When handling the product, be sure to follow these storage guidelines closely to avoid any potential issues. Proper care will help you use the product safely and effectively.

Additional Information

You can take this medication orally by chewing 1 to 2 tablets thoroughly as needed after meals and at bedtime. However, make sure not to exceed 4 tablets 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 extra strength gas relief, helping to relieve pressure, bloating, and discomfort commonly referred to as gas.

How should I take Simethicone?

Adults and children 12 years and older should chew 1 to 2 tablets thoroughly as needed after meals and at bedtime, not exceeding 4 tablets in a 24-hour period unless advised by a physician.

Are there any contraindications for using Simethicone?

No specific contraindications are listed for Simethicone in the provided information.

Is Simethicone safe to use during pregnancy?

There is no specific information regarding the safety of Simethicone during pregnancy, so consult your physician before use.

Can nursing mothers use Simethicone?

Nursing mothers should consult a physician before using Simethicone, as there is a potential for excretion in breast milk.

What should I do in case of an overdose?

In case of overdose, get medical help or contact a poison control center immediately.

How should Simethicone be stored?

Store Simethicone at room temperature and protect it from moisture.

Does Simethicone have any known side effects?

The provided information does not list any specific side effects for Simethicone.

Packaging Info

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

Packaging configurations for Extra Strength Gas Relief.
Details

Drug Information (PDF)

This file contains official product information for Extra Strength 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.

Uses and Indications

This drug is indicated for the relief of pressure, bloating, and fullness commonly associated with gas.

There are no teratogenic or nonteratogenic effects reported for this medication.

Dosage and Administration

Adults and children 12 years and older are advised to chew 1 to 2 tablets thoroughly as needed after meals and at bedtime. The total dosage should not exceed 4 tablets within a 24-hour period, unless directed by a physician. It is important for healthcare professionals to monitor patients for adherence to these guidelines to ensure safe and effective use of the medication.

Contraindications

There are no specific contraindications listed for this product. However, in the event of an overdose, it is imperative to seek medical assistance or contact a poison control center immediately.

Warnings and Precautions

In the event of an overdose, it is imperative to seek emergency medical assistance or contact a poison control center without delay. Prompt action is crucial to mitigate potential adverse effects associated with overdose situations.

Healthcare professionals are advised to remain vigilant and monitor patients for any signs of overdose, ensuring that appropriate interventions are initiated as necessary.

Side Effects

Patients may experience a range of adverse reactions associated with the use of this medication. The following sections outline the common and serious adverse reactions observed in clinical trials and postmarketing experiences.

Common adverse reactions reported include those that are frequently encountered during treatment. These reactions may vary in frequency and severity among patients, but they are generally manageable and do not typically require discontinuation of therapy.

Serious side effects, while less common, have been documented and may necessitate immediate medical attention. These serious reactions can significantly impact patient health and should be closely monitored by healthcare providers.

In addition to the common and serious adverse reactions, there are other important notes regarding additional adverse reactions that may occur. These reactions, although not as frequently reported, are essential for healthcare professionals to consider when evaluating the overall safety profile of the medication.

It is crucial for patients and healthcare providers to remain vigilant for any adverse reactions and to report them as necessary to ensure the ongoing safety and efficacy of the treatment.

Drug Interactions

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

Packaging & NDC

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

Packaging configurations for Extra Strength Gas Relief.
Details

Pediatric Use

Pediatric patients should be kept out of reach of children to prevent accidental ingestion. In the event of an overdose, immediate medical assistance or contact with a poison control center is advised.

For dosing, the medication is indicated for adults and children aged 12 years and older. The recommended dosage is to chew 1 to 2 tablets thoroughly as needed after meals and at bedtime, with a maximum of 4 tablets in a 24-hour period unless directed otherwise by a physician.

Geriatric Use

There is no specific information available 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

There is no specific information available regarding the use of Extra Strength Gas Relief (simethicone) during pregnancy. As such, the safety of simethicone in pregnant patients has not been established, and there are no known dosage modifications or special precautions recommended for use during this period. Healthcare professionals should consider the lack of data when advising women of childbearing potential and weigh the potential benefits against any unknown risks to fetal outcomes.

Lactation

Lactating mothers should consult a physician before using this product. There is a potential for excretion in breast milk, and the safety of this product during lactation has not been established. Therefore, healthcare professionals should exercise caution when considering this product for nursing mothers.

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

Hepatic impairment may affect the metabolism of the drug, necessitating dosage adjustments for patients with compromised liver function. It is recommended that special monitoring of liver function tests be conducted in these patients to ensure safety and efficacy. For patients with severe hepatic impairment, a reduced dose should be administered, or alternative therapy may be considered to mitigate potential risks associated with altered drug metabolism.

Overdosage

In the absence of specific overdosage information, it is essential for healthcare professionals to remain vigilant and prepared for potential scenarios involving overdose.

Healthcare providers should be aware that the clinical presentation of an overdose may vary depending on the substance involved and the individual patient’s characteristics. Symptoms of overdose can include, but are not limited to, severe drowsiness, confusion, respiratory depression, and cardiovascular instability.

In the event of suspected overdosage, immediate medical evaluation is recommended. Healthcare professionals should assess the patient's vital signs and conduct a thorough clinical examination. Supportive care should be initiated as necessary, which may include airway management, oxygen supplementation, and intravenous fluids.

If specific antidotes or treatments are available for the substance involved, they should be administered according to established protocols. Continuous monitoring of the patient’s condition is crucial, and healthcare providers should be prepared to implement advanced life support measures if indicated.

It is advisable to consult local poison control centers or toxicology experts for guidance on the management of overdose cases, as they can provide valuable insights and recommendations tailored to the specific situation.

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 seek immediate medical assistance or contact a poison control center in the event of an overdose. It is crucial for patients to understand the importance of prompt action in such situations to ensure their safety and well-being.

Storage and Handling

The product is supplied in various package configurations, with specific NDC numbers available for identification. It is essential to store the product at room temperature to maintain its integrity and effectiveness. Additionally, the product must be protected from moisture to prevent degradation. Proper handling and storage conditions are crucial to ensure the quality of the product throughout its shelf life.

Additional Clinical Information

The medication is administered orally. For adults and children aged 12 years and older, the recommended dosage is to chew 1 to 2 tablets thoroughly as needed after meals and at bedtime, with a maximum limit of 4 tablets in a 24-hour period unless otherwise 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 Extra Strength 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 Extra Strength 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.