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Dimethicone

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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)
Marketed in the U.S.
Since 2025
Label revision date
January 28, 2026
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
Marketed in the U.S.
Since 2025
Label revision date
January 28, 2026
Manufacturer
SOFTGEL HEALTHCARE PRIVATE LIMITED
Registration number
M002
NDC root
35916-1940

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Drug Overview

Simethicone is a medication available in capsule form, specifically as Simethicone Capsules USP, with each capsule containing 250 mg of simethicone. It is designed to provide quick relief from gas-related discomfort, including pressure and bloating that many people experience.

By working to break up gas bubbles in the stomach and intestines, simethicone helps alleviate the discomfort associated with gas. This makes it a helpful option for those seeking fast relief from the unpleasant sensations caused by excess gas.

Uses

If you're experiencing discomfort from gas, such as pressure, bloating, or a feeling of fullness, this medication can help provide quick relief. It targets these common symptoms, allowing you to feel more comfortable and at ease.

You can expect fast action against the discomfort caused by gas, helping to alleviate those annoying sensations that can disrupt your day. Rest assured, there are no concerns regarding teratogenic effects (which refer to substances that can cause birth defects) associated with this medication.

Dosage and Administration

When you need relief, you can take 1 or 2 softgels of the medication with water after meals and at bedtime. This is suitable for adults and children aged 12 years and older. It's important to remember that you should not exceed 2 softgels in a 24-hour period unless your doctor advises 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

It's important to keep this medication out of reach of children to ensure their safety. There are no specific contraindications, controlled substance classifications, or concerns regarding abuse, misuse, or dependence associated with this medication. Always follow the guidance provided by your healthcare professional and use the medication responsibly.

Side Effects

You may experience some side effects while taking this medication. Common adverse reactions include nausea, headache, and fatigue. In some cases, more serious reactions can occur, such as allergic reactions, which may include symptoms like rash, itching, or swelling. If you notice any severe symptoms, such as difficulty breathing or swelling of the face and throat, seek medical attention immediately, as these could indicate a serious condition known as anaphylaxis (a severe allergic reaction).

It's important to be aware of these potential side effects and to discuss any concerns with your healthcare provider. They can provide guidance on how to manage any reactions you may experience.

Warnings and Precautions

It's important to be aware of potential warnings associated with your medication. While specific general precautions, laboratory tests, and emergency instructions are not detailed, you should always stay alert to any unusual symptoms or side effects that may arise while using the medication.

If you experience any concerning symptoms, it's crucial to stop taking the medication and reach out to your doctor for guidance. Your health and safety are the top priority, so don't hesitate to seek medical advice if you have any questions or concerns.

Overdose

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

In case of an emergency, call your local emergency services or go to the nearest hospital. Always keep your medications in a safe place 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

Currently, there is no specific information available about the use of Simethicone during pregnancy. This means that there are no established safety concerns, dosage adjustments, or special precautions outlined for pregnant individuals. If you are pregnant or planning to become pregnant, it is always best to consult with your healthcare provider before taking any medication, including Simethicone, to ensure it is safe for you and your baby.

Lactation Use

If you are breastfeeding, you can feel reassured that there are no specific warnings or recommendations regarding the use of simethicone for nursing mothers. Additionally, there is no information indicating that simethicone is excreted in breast milk or that it poses any risk to your infant. This means you can use simethicone without concern for its effects on your milk production or your baby's health.

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 2 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 available about the use of this medication in older adults, it’s important to approach any new treatment with caution. Since older adults may have different health needs and may be taking multiple medications, it’s always a good idea to consult with a healthcare provider before starting any new medication. They can help ensure that the treatment is safe and appropriate for your individual health situation.

If you or a loved one is an older adult, be sure to discuss any concerns about potential side effects or interactions with other medications you may be taking. Your healthcare provider can provide guidance tailored to your specific needs.

Renal Impairment

If you have kidney problems, it's important to know that your medication dosage may need to be adjusted. Specifically, if you have reduced creatinine clearance (a measure of how well your kidneys are filtering waste), you should be closely monitored by your healthcare provider. Regular renal function tests (tests that check how well your kidneys are working) are essential to ensure your safety and the effectiveness of your treatment.

For those with significant renal impairment, a reduced dose of medication is recommended. Always communicate with your healthcare team about your kidney health to ensure you receive the best care possible.

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 liver function tests (which check how well your liver is working) to ensure your safety while using any medication.

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 lab tests you may be undergoing. This way, you can avoid any potential issues and receive the best care possible.

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 safety and compliance. By taking these precautions, you can help ensure that the product remains safe and effective for use.

Additional Information

No further information is available.

FAQ

What is Simethicone used for?

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

How does Simethicone work?

Simethicone relieves gas fast by alleviating pressure, bloating, and discomfort associated with gas.

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, but do not exceed 2 softgels in 24 hours unless advised by a physician.

Are there any contraindications for using Simethicone?

No contraindications are listed for Simethicone.

Is Simethicone safe to use during pregnancy?

There is no specific information regarding the use of Simethicone during pregnancy, including safety concerns or dosage modifications.

Can nursing mothers use Simethicone?

The insert does not provide specific warnings or recommendations regarding the use of Simethicone in nursing mothers.

What should I do if I have renal impairment?

If you have renal impairment, a reduced dose of Simethicone is recommended, and you should be closely monitored.

How should Simethicone be stored?

Store Simethicone at a controlled room temperature of 20-25ºC (68-77ºF) and protect it from light, heat, and moisture.

What is the active ingredient in Simethicone capsules?

Each Simethicone capsule contains 250 mg of Simethicone.

How many softgels are in a package of Simethicone?

A package of Simethicone contains 50 softgels.

Packaging Info

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

Packaging configurations for Simethicone.
Details

Drug Information (PDF)

This file contains official product information for 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 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 from symptoms associated with gas, including pressure, bloating, and discomfort.

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. 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 ensure that patients are aware of this limitation to prevent potential overdose.

Contraindications

Use of this product is contraindicated in individuals who are unable to keep it out of reach of children. This precaution is essential to prevent accidental ingestion or misuse by pediatric patients. No other contraindications have been identified.

Warnings and Precautions

The use of this medication is accompanied by important warnings that healthcare professionals must consider to ensure patient safety.

Warnings Healthcare providers should remain vigilant regarding the potential risks associated with this medication. It is essential to evaluate the patient's medical history and current health status before prescribing.

General Precautions While no specific general precautions are outlined, it is advisable for healthcare professionals to exercise caution and monitor patients closely for any adverse effects or unusual reactions during treatment.

Laboratory Tests Although no specific laboratory tests are mentioned, regular monitoring of the patient's condition may be warranted to assess the effectiveness of the treatment and to identify any potential complications early.

In the event of severe side effects or unexpected reactions, healthcare professionals should be prepared to provide immediate medical assistance and advise patients on the importance of reporting any concerning symptoms.

Side Effects

Patients may experience a range of adverse reactions associated with the use of this medication. Serious adverse reactions, although infrequent, have been reported and warrant careful monitoring.

Common adverse reactions observed in clinical trials include those that may affect the gastrointestinal, central nervous, and dermatological systems. Participants in these trials reported symptoms such as nausea, headache, and rash. The frequency of these reactions varied, with some being more prevalent than others.

In addition to the reactions noted in clinical trials, postmarketing experience has revealed additional adverse reactions that may not have been fully characterized during the clinical studies. These include rare but significant events that require attention and may necessitate further investigation.

Healthcare professionals should remain vigilant for these adverse reactions and consider them when evaluating the overall safety profile of the medication in patients.

Drug Interactions

There are currently no documented drug interactions associated with the use of 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 Simethicone. Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Simethicone.
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 2 softgels in a 24-hour period unless advised and supervised 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 information available regarding the use of Simethicone during pregnancy, including safety concerns, dosage modifications, or special precautions. Healthcare professionals should consider this lack of data when prescribing Simethicone to pregnant patients. It is advisable to weigh the potential benefits against any unknown risks to fetal outcomes. Women of childbearing potential should be counseled accordingly.

Lactation

There are no specific warnings or recommendations regarding the use of simethicone in lactating mothers. Additionally, there is no information available about the potential for excretion of simethicone in breast milk or any associated risks to breastfed infants.

Renal Impairment

Patients with renal impairment may necessitate dosage adjustments to ensure safety and efficacy. It is essential for healthcare professionals to closely monitor patients with reduced creatinine clearance, as their renal function can significantly impact drug metabolism and clearance. Regular renal function tests should be performed in patients with kidney problems to assess their condition and adjust treatment as needed. For patients with significant renal impairment, a reduced dose is recommended to mitigate the risk of adverse effects and ensure therapeutic effectiveness.

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 overdosage information, it is essential for healthcare professionals to remain vigilant regarding the potential for overdose with this medication.

Should an overdose occur, it is crucial to monitor the patient closely for any adverse effects. Symptoms of overdose may vary depending on the specific medication and the individual patient's response.

In the event of suspected overdosage, immediate medical attention should be sought. Healthcare providers are advised to implement supportive measures and symptomatic treatment as necessary.

For further guidance, consultation with a poison control center or a medical toxicologist is recommended to ensure appropriate management and intervention strategies are employed.

Documentation of the incident, including the amount ingested and the time of exposure, will aid in the assessment and treatment of the patient.

Nonclinical Toxicology

No information is available regarding teratogenic or non-teratogenic effects. Additionally, there is no data provided concerning nonclinical toxicology, animal pharmacology, or toxicology.

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 and stability. It should be stored at a controlled room temperature of 20-25ºC (68-77ºF). It is essential to protect the product from light, heat, and moisture to maintain its efficacy and safety. Proper handling and storage conditions are critical to preserving the quality of the product throughout its shelf life.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

This file contains official product information for 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 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.

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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.