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Dimethicone

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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)
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Marketed in the U.S.
Since 2025
Label revision date
January 24, 2026
Drug Information (PDF)
Prescribing information, PDF file
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
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Marketed in the U.S.
Since 2025
Label revision date
January 24, 2026
Manufacturer
Softgel Healthcare Pvt Ltd
Registration number
M002
NDC root
35916-1938
Drug Information (PDF)
Prescribing information, PDF file
Packaging Info (3 NDCs)
Packaging & NDC Codes (3)

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 a medication available in capsule form, specifically as Simethicone Capsules USP, 125 mg. It is designed to provide quick relief from gas-related discomfort, including pressure and bloating. This medication works by breaking up gas bubbles in the stomach and intestines, making it easier for your body to eliminate them.

If you're experiencing discomfort due to gas, simethicone can help alleviate those symptoms effectively. It is often compared to other over-the-counter products like Gas-X®, and is available in softgel form for easy consumption.

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 teratogenic effects (which means it doesn't cause birth defects) associated with this medication, so it is considered safe in that regard.

Dosage and Administration

You can take this medication by swallowing 1 or 2 softgels with water after meals and at bedtime if you need it. This is suitable for adults and children aged 12 years and older.

It's important to remember not to exceed 4 softgels in a 24-hour period unless your doctor advises you otherwise. Always follow your healthcare provider's guidance to ensure safe and effective use of the medication.

What to Avoid

You can feel reassured that there are no specific contraindications, risks of abuse or misuse, or concerns about dependence associated with this medication. Additionally, there are no particular instructions indicating that you should avoid taking or using it. Always consult with your healthcare provider if you have any questions or concerns about your treatment.

Side Effects

You should be aware that there are no specific side effects or adverse reactions listed for this medication. However, it's important to stay informed and consult your healthcare provider if you experience any unusual symptoms or have concerns while using it. Always prioritize your health and safety by discussing any potential risks with your doctor.

Warnings and Precautions

It's important to be aware of the potential risks associated with this medication. If you experience any unusual symptoms or reactions, please seek medical attention immediately.

While there are no specific general precautions or laboratory tests mentioned, it's always a good idea to discuss your health history and any concerns with your healthcare provider before starting any new medication. If you have any questions or experience side effects, don't hesitate to reach out to your doctor for guidance.

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’s 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 planning to become pregnant, it's important to know that there is no specific information available about the use of Simethicone during pregnancy. This means that safety concerns, dosage adjustments, or any special precautions related to its use while pregnant have not been clearly established.

As always, it's best to consult with your healthcare provider before taking any medication during pregnancy to ensure the safety of both you and your baby. They can provide personalized advice based on your individual health needs.

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 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

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 healthcare providers may not have tailored guidelines for elderly patients, which can be important given the unique health considerations that often come with aging.

If you or a caregiver are considering this medication for an older adult, it’s essential to consult with a healthcare professional. They can provide personalized advice and monitor for any potential side effects or interactions with other medications that may be more relevant for older individuals. 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 therapy, your healthcare provider will likely perform these renal function tests and continue to check your kidney health periodically. If you have severe renal impairment, special care will be taken to ensure your treatment is safe and effective. Always discuss any concerns with your healthcare provider to ensure you receive the best care tailored to your needs.

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 you might need a lower dose of the drug to ensure it's safe and effective for you. Regular monitoring of your liver function tests (which check how well your liver is working) is also necessary to keep track of your health while using this medication.

When taking this drug, special precautions should be taken to protect your liver. Always discuss your liver health with your healthcare provider to ensure you receive the best care tailored to your needs.

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 receive the best possible care tailored to your needs.

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.

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 4 softgels in 24 hours unless advised by a physician.

Are there any contraindications for 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, and no teratogenic effects are mentioned.

Can Simethicone be used by nursing mothers?

There are no 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, dosage adjustments may be necessary, and your renal function should be monitored regularly.

What precautions should be taken for patients with hepatic impairment?

Patients with hepatic impairment may require a reduced dose, and liver function tests should be 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.

Are there any known side effects of Simethicone?

No specific side effects or adverse reactions are provided in the text.

What should I do if I experience a warning while taking Simethicone?

If you experience any warnings while taking Simethicone, consult your healthcare provider.

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 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 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 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 not classified as a controlled substance, and there are no identified risks of abuse, misuse, or dependence.

Warnings and Precautions

Warning: Healthcare professionals should be aware of the potential risks associated with the use of this medication. It is imperative to evaluate the patient's medical history and current health status prior to prescribing.

General precautions should be considered, although no specific precautions are outlined in the available information. Clinicians are encouraged to maintain vigilance and exercise clinical judgment when monitoring patients.

Currently, there are no laboratory tests specified for the safe use of this medication. However, healthcare providers should remain attentive to any emerging guidelines or recommendations regarding monitoring parameters that may be relevant to patient safety.

In the absence of specific instructions for emergency medical help or directives for discontinuation of the medication, healthcare professionals should rely on their clinical expertise and established protocols to manage any adverse events or complications that may arise during treatment.

Side Effects

Patients should be aware of the potential for adverse reactions associated with the use of this medication. A warning has been issued regarding the use of this product, although no specific side effects or adverse reactions have been detailed in the available data.

Healthcare professionals are encouraged to monitor patients for any unexpected reactions during treatment, as individual responses may vary. It is important to report any adverse events to ensure comprehensive safety data collection.

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 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 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 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. It is advisable to monitor these patients closely for any adverse effects or changes in efficacy, given the lack of targeted data for this population.

Pregnancy

There is no specific information available regarding the use of Simethicone during pregnancy, including safety concerns, dosage modifications, or special precautions. Healthcare professionals should consider the lack of data when advising pregnant patients. As with any medication, the potential benefits must be weighed 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

Renal impairment may necessitate dosage adjustments for patients with reduced kidney function. It is essential for healthcare professionals to monitor renal function regularly in these patients. Dosage adjustments should be based on creatinine clearance levels, with special consideration given to those with severe renal impairment. Renal function tests are recommended prior to initiating therapy and should be performed periodically thereafter to ensure appropriate management of the patient's condition.

Hepatic Impairment

Patients with hepatic impairment may experience altered metabolism of the drug, necessitating careful consideration during treatment. It is recommended that these patients receive a reduced dose to mitigate potential risks associated with compromised liver function.

Additionally, liver function tests should be routinely monitored in this population to ensure safety and efficacy. Special precautions are advised when administering the drug to patients with liver problems, emphasizing the need for vigilant oversight throughout the treatment process.

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.

Healthcare providers should be aware that symptoms of overdose may vary depending on the drug's pharmacological properties and the patient's individual response. Common signs of overdose may include, but are not limited to, severe drowsiness, confusion, respiratory depression, or other significant alterations in mental status.

In the event of suspected overdosage, immediate medical attention is warranted. Recommended actions include contacting a poison control center or seeking emergency medical assistance. Supportive care should be initiated as necessary, which may involve monitoring vital signs, providing respiratory support, and administering specific antidotes if applicable.

It is crucial for healthcare professionals to familiarize themselves with the management protocols for overdose associated with this medication, including any specific interventions that may be required based on the clinical presentation of the patient.

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 compound in these areas.

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.

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.