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Extra Strength Simethicone

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Active ingredient
Dimethicone 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 2025
Label revision date
September 1, 2025
Drug Information (PDF)
Prescribing information, PDF file
Active ingredient
Dimethicone 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 2025
Label revision date
September 1, 2025
Manufacturer
Bi-Mart
Registration number
M002
NDC root
37835-233
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

You may be experiencing discomfort from pressure, bloating, and fullness, often caused by gas. This medication is designed to provide relief from these symptoms, helping you feel more comfortable. It works by addressing the underlying issues related to gas, allowing you to return to your daily activities with ease.

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 harmful effects on pregnancy (teratogenic effects) or other non-pregnancy-related issues (nonteratogenic effects) associated with this medication. You can use it with confidence to alleviate those uncomfortable symptoms.

Dosage and Administration

You can take this medication by chewing one or two tablets after meals and at bedtime, depending on your needs. It's important to remember not to exceed four tablets in a 24-hour period unless your doctor has specifically advised 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

You may experience some side effects while taking this medication. Serious side effects can occur, and it's important to be aware of them. If you notice any unusual symptoms, such as difficulty breathing or swelling of the face, seek medical attention immediately, as these could indicate a severe allergic reaction (anaphylaxis).

Common side effects include nausea, headache, and fatigue. While these are generally mild, they can still be bothersome. Additionally, there may be other adverse reactions that are less common but still important to monitor. Always discuss any concerns with your healthcare provider to ensure your safety and well-being.

Warnings and Precautions

If you accidentally take too much of this medication, it’s important to seek emergency medical help immediately. You can contact a Poison Control Center at 1-800-222-1222 for assistance.

Currently, there are no specific warnings, general precautions, or laboratory tests associated with this medication mentioned. However, always stay alert to how you feel while taking any medication, and if you notice anything unusual, don’t hesitate to reach out to your healthcare provider.

Overdose

It appears that there is no specific information available regarding overdosage for this medication. However, it's important to be aware of the general signs of an overdose, which can include symptoms like extreme drowsiness, confusion, or difficulty breathing. If you suspect an overdose, it is crucial to seek immediate medical help.

In case of an emergency, call your local emergency number or go to the nearest hospital. Always keep medications out of reach of children and follow the prescribed dosage to prevent any potential risks. If you have any concerns or questions about your medication, don’t hesitate to reach out to your healthcare provider for guidance.

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 prevent any accidental ingestion. If you suspect that your child has taken too much, seek medical help immediately or contact a Poison Control Center at 1-800-222-1222. Being aware of these precautions can help ensure your child's safety.

Geriatric Use

When it comes to using this medication in older adults, there is no specific information available about dosage adjustments, safety concerns, or special precautions. This means that if you or a loved one is an older adult, it’s important to consult with a healthcare provider for personalized advice. They can help determine the best approach based on individual health needs and any other medications being taken. Always prioritize open communication with your healthcare team to ensure safe and effective treatment.

Renal Impairment

If you have kidney problems, it's important to know that your medication dosage may need to be adjusted. This is because your renal function, which refers to how well your kidneys are working, can affect how your body processes certain medications. Regular monitoring of your renal function is essential, and this typically involves tests that measure creatinine clearance (a way to assess kidney function).

Before starting any new treatment, your healthcare provider will likely perform these renal function tests and continue to check your kidney health periodically. If you have moderate to severe renal impairment, a lower dose of the medication is usually recommended to ensure your safety and effectiveness of the treatment. Always discuss your kidney health with your doctor to ensure the best care.

Hepatic Impairment

If you have liver problems, it's important to know that your condition may affect how your body processes certain medications. This means that the dosage of the drug you are prescribed might need to be adjusted to ensure it is safe and effective for you.

Your healthcare provider will likely monitor your liver function tests (which are blood tests that check how well your liver is working) to keep an eye on your liver health while you are taking the medication. Special precautions will be taken when administering the drug to ensure your safety, so be sure to discuss any concerns with your doctor.

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 feel free to ask questions and share your complete list of medications and any tests you might be undergoing. This way, you can avoid any potential issues and ensure the best possible care for your health.

Storage and Handling

To ensure the best performance of your product, store it at room temperature, ideally around 25°C (77°F). It’s acceptable for the temperature to fluctuate between 15°-30°C (59°-86°F), but make sure to keep it away from moisture, as this can affect its quality.

When handling the product, be cautious and check the packaging carefully. Do not use the product if the seal around the tablet is broken or damaged, as this could compromise its safety and effectiveness. Following these guidelines will help you use the product safely and effectively.

Additional Information

You can take this medication orally by chewing one or two tablets as needed after meals and at bedtime. However, be sure not to exceed four tablets in a 24-hour period unless directed by your doctor. Always follow your physician's advice for safe use.

FAQ

What is the drug used for?

The drug is used for the relief of pressure, bloating, and fullness commonly referred to as gas.

How should I take this drug?

You should chew one or two tablets as needed after meals and at bedtime, but do not exceed 4 tablets in 24 hours unless advised by a physician.

Are there any contraindications for this drug?

No contraindications are listed for this drug.

What should I do in case of an accidental overdose?

In case of accidental overdose, get medical help or contact a Poison Control Center at 1-800-222-1222 immediately.

Is it safe to use this drug during pregnancy or breastfeeding?

If you are pregnant or breastfeeding, you should ask a health professional before using this drug.

What precautions should I take if I have renal impairment?

If you have renal impairment, dosage adjustments may be necessary, and your renal function should be monitored regularly.

What should I know about storing this drug?

Store the drug at 25°C (77°F), with excursions permitted between 15°-30°C (59°-86°F), and protect it from moisture. Do not use if the seal around the tablet is broken or damaged.

Packaging Info

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

Packaging configurations for Extra Strength Simethicone.
Details

Drug Information (PDF)

This file contains official product information for Extra Strength Simethicone, 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 specified drug.

Uses and Indications

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

There are no teratogenic or nonteratogenic effects mentioned associated with the use of this drug.

Dosage and Administration

Adults are advised to chew one or two tablets as needed after meals and at bedtime. The maximum recommended dosage is four tablets within a 24-hour period, unless otherwise directed by a physician. It is essential that patients adhere to this guideline to avoid potential adverse effects.

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

In the event of an accidental overdose, it is imperative to seek emergency medical assistance immediately. Healthcare professionals should advise patients to contact a medical professional or a Poison Control Center at 1-800-222-1222 without delay.

While specific warnings and general precautions are not detailed, it is essential for healthcare providers to remain vigilant and monitor patients for any adverse effects or unusual symptoms that may arise during treatment. Regular assessment and communication with patients regarding their health status can facilitate early detection of potential issues.

Healthcare professionals are encouraged to maintain a high index of suspicion and to provide clear instructions to patients regarding the importance of adhering to prescribed dosages to mitigate the risk of overdose.

Side Effects

Patients may experience a range of adverse reactions associated with the use of this medication. Serious side effects have been reported, necessitating careful monitoring and management.

Common adverse reactions observed in clinical trials include symptoms that may affect the overall well-being of participants. These reactions were noted with varying frequencies, and while most were manageable, they warrant attention during treatment.

In addition to the aforementioned reactions, there are other adverse reactions that have been reported in postmarketing experiences. These reactions may not have been fully characterized in clinical trials but are important for healthcare providers to consider when prescribing this medication.

Healthcare professionals should remain vigilant for both serious and common adverse reactions, ensuring that patients are adequately informed and monitored throughout their treatment regimen.

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 Simethicone (simethicone). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Extra Strength Simethicone.
Details

Pediatric Use

Pediatric patients should be monitored closely, and this medication must be kept out of reach of children to prevent accidental ingestion. In the event of an accidental overdose, immediate medical assistance should be sought, or contact a Poison Control Center at 1-800-222-1222.

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 they may have altered pharmacokinetics and pharmacodynamics. Close monitoring is recommended to ensure safety and efficacy in this population.

Pregnancy

Pregnant patients and those who are breastfeeding should consult a healthcare professional prior to using this medication. It is important to assess the potential risks and benefits associated with its use during pregnancy and lactation. The safety of this medication in pregnant women has not been established, and caution is advised to ensure the well-being of both the mother and the fetus.

Lactation

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

Renal Impairment

Patients with renal impairment may require dosage adjustments to ensure safety and efficacy. It is essential that renal function is monitored regularly in these patients. Dosage adjustments should be based on creatinine clearance levels, with a reduced dose recommended for those with moderate to severe renal impairment. Prior to initiating therapy, renal function tests should be performed, and these tests should be conducted periodically thereafter to assess ongoing renal status in patients with renal impairment.

Hepatic Impairment

Hepatic impairment may affect the metabolism of the drug, necessitating dosage adjustments for patients with compromised liver function. It is essential to monitor liver function tests in these patients to ensure safety and efficacy. Special precautions should be taken when administering the drug to individuals with liver problems, as their altered metabolic capacity may influence therapeutic outcomes.

Overdosage

In the absence of specific overdosage information, it is essential for healthcare professionals to remain vigilant regarding the potential risks associated with excessive administration of the medication.

Healthcare providers are advised to monitor patients closely for any signs of adverse effects that may arise from overdosage. Symptoms may vary depending on the medication's pharmacological profile and the individual patient's response.

In the event of suspected overdosage, immediate medical intervention is recommended. Healthcare professionals should initiate supportive care and consider symptomatic treatment as necessary. It is also advisable to consult local poison control centers or relevant toxicology resources for guidance on management protocols specific to the medication in question.

Documentation of the incident, including the amount ingested and the time of exposure, is crucial for effective management and follow-up care. Continuous assessment of the patient's clinical status is necessary to ensure appropriate interventions are implemented.

In summary, while specific overdosage information is not provided, healthcare professionals should exercise caution, remain alert to potential symptoms, and be prepared to take appropriate action in the event of an overdose.

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 seek immediate medical assistance or contact a Poison Control Center at 1-800-222-1222 in the event of an accidental 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 a configuration that includes specific NDC numbers, which should be referenced for accurate identification. It is essential to store the product at a controlled room temperature of 25°C (77°F), with permissible excursions between 15°C and 30°C (59°F and 86°F).

To ensure the integrity of the product, it must be protected from moisture. Additionally, healthcare professionals should be advised that the product should not be used if the seal around the tablet is broken or damaged, as this may compromise its safety and efficacy.

Additional Clinical Information

The medication is administered orally. For adults, the recommended dosage is to chew one or two tablets as needed after meals and at bedtime, with a maximum limit of 4 tablets in a 24-hour period unless directed otherwise 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 Simethicone, 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 Simethicone, 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.