ADD CONDITION

items per page

Simethicone

Last content change checked dailysee data sync status

This product has been discontinued

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 2012
Label revision date
June 29, 2012
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 2012
Label revision date
June 29, 2012
Manufacturer
Softech Pharma Pvt. Ltd
Registration number
part332
NDC root
48769-113

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, typically at a strength of 125 mg. It is primarily used to relieve pressure and bloating that is commonly associated with gas in the digestive system. By helping to break up gas bubbles, simethicone can provide you with comfort and ease any discomfort caused by excess gas.

Uses

If you're experiencing discomfort from pressure and bloating, often caused by gas, this medication can help relieve those symptoms. It works by targeting the buildup of gas in your digestive system, providing you with much-needed comfort. You can expect to feel a reduction in that uncomfortable feeling, allowing you to go about your day more easily.

Dosage and Administration

When taking this medication, you should not exceed 4 softgels in a 24-hour period. For adults, the recommended way to take the softgels is to swallow them with water, either 1 or 2 softgels as needed. It's best to take them after meals and at bedtime to help manage your symptoms effectively. Always remember to follow these guidelines 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

It's important to keep this medication out of reach of children to prevent any accidental ingestion. While there are no specific side effects or adverse reactions listed, always be cautious and consult with a healthcare professional if you have any concerns or questions about its use.

Warnings and Precautions

It's important to keep this medication out of reach of children to prevent accidental ingestion, which can be dangerous. Always store it in a safe place where children cannot access it.

If you have any concerns or experience unusual symptoms while using this medication, stop using it and call your doctor for advice. Your health and safety are the top priority, so don’t hesitate to seek help if needed.

Overdose

If you suspect an overdose, it's important to stay calm and take immediate action. While there is no specific information available about the signs of overdose for this medication, general symptoms can include unusual drowsiness, confusion, or difficulty breathing. If you notice any of these signs, or if you are unsure, seek medical help right away.

In case of an overdose, contact your local emergency services or go to the nearest hospital. It's always better to be safe and get checked by a healthcare professional if you have any concerns about your health. Remember, timely intervention can make a significant difference.

Pregnancy Use

When it comes to using this medication during pregnancy, there is no specific information available about its safety, dosage adjustments, or any special precautions you should take. This means that the potential risks and benefits have not been clearly established for pregnant individuals.

If you are pregnant or planning to become pregnant, it’s important to discuss any medications you are considering with your healthcare provider. They can help you understand the best options for your health and the health of 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 it without concern for affecting your milk production or your baby's health.

Pediatric Use

It's important to keep this medication out of reach of children. This precaution helps prevent accidental ingestion, which can be dangerous. Always store it in a safe place where children cannot access it, ensuring their safety at all times. If you have any concerns or questions about the medication, don't hesitate to reach out to your healthcare provider for guidance.

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 considering this medication, it’s important to consult with a healthcare provider. 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 particularly true if you have decreased creatinine clearance (a measure of how well your kidneys are filtering waste). Regular monitoring of your renal function tests is essential to ensure your kidneys are working properly and to help guide any necessary changes to your treatment.

Always discuss your kidney health with your healthcare provider, as they can determine the best approach for your specific situation and make any needed adjustments to your medication.

Hepatic Impairment

If you have liver problems, it's important to know that the drug insert does not provide specific information about dosage adjustments, special monitoring, or precautions for your condition. This means that there are no tailored guidelines for how this medication may affect you if you have hepatic impairment (liver issues).

Always consult your healthcare provider for personalized advice and to discuss any concerns you may have regarding your liver health and medication use. They can help ensure that you receive the safest and most effective treatment based on your individual needs.

Drug Interactions

It's important to have open conversations with your healthcare provider about any medications you are taking. In this case, there are no specific drug interactions or laboratory test interactions noted, which means that this medication is generally considered safe to use alongside other treatments and tests. However, every individual is different, and your healthcare provider can help ensure that your overall treatment plan is safe and effective for you. Always feel free to ask questions and share any concerns you may have regarding your medications or tests.

Storage and Handling

To ensure the best performance of your product, store it at a temperature between 20°C and 25°C (68°F to 77°F). This temperature range helps maintain the integrity and effectiveness of the device.

When handling the product, be sure to do so with care to avoid any damage. Always follow any specific instructions provided for use to ensure safety and effectiveness. If you have any questions about disposal or further handling, please consult the guidelines provided with your product.

Additional Information

You can take this medication orally by swallowing 1 or 2 softgels with water, as needed after meals and at bedtime. It's important to follow this method of administration to ensure the best results. If you have any questions about how to use this medication, feel free to ask your healthcare provider for more information.

FAQ

What is simethicone?

Simethicone is a medication available in 125 mg capsules that relieves pressure and bloating commonly referred to as gas.

How should I take simethicone?

Adults should swallow 1 or 2 softgels with water as needed after meals and at bedtime, but do not exceed 4 softgels in 24 hours.

Are there any contraindications for simethicone?

There are no specific contraindications listed for simethicone.

What should I be cautious about when using simethicone?

Keep simethicone out of reach of children.

Are there any drug interactions with simethicone?

No specific drug interactions have been mentioned for simethicone.

Is simethicone safe to use during pregnancy or while nursing?

The insert does not provide specific information regarding the use of simethicone during pregnancy or in nursing mothers.

What should I know about using simethicone if I have kidney problems?

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

What is the recommended storage for simethicone?

Store simethicone at a temperature between 20°C to 25°C.

Packaging Info

Below are the non-prescription pack sizes of Simethicone (dimethicone). 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

Simethicone is presented in capsule form, with each capsule containing 125 mg of simethicone. The formulation is designed to alleviate symptoms of excess gas in the gastrointestinal tract. The capsules are typically opaque and may vary in color, depending on the specific product formulation.

Uses and Indications

This drug is indicated for the relief of pressure and bloating commonly associated with gas. It is intended for use in patients experiencing discomfort due to excessive gas accumulation in the gastrointestinal tract.

Dosage and Administration

Adults are advised to take 1 or 2 softgels as needed after meals and at bedtime. The softgels should be swallowed whole with water. It is important not to exceed a total of 4 softgels within a 24-hour period.

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

It is imperative to keep this medication out of reach of children to prevent accidental ingestion or misuse. Healthcare professionals should counsel patients and caregivers on the importance of secure storage to mitigate the risk of pediatric exposure.

In addition, ongoing monitoring of patients is essential to ensure safe and effective use of the medication. Regular assessments should be conducted to evaluate the patient's response to treatment and to identify any potential adverse effects. Specific laboratory tests may be recommended based on the individual patient's condition and treatment regimen, and healthcare providers should remain vigilant in reviewing these parameters to optimize patient safety.

Side Effects

Patients should be advised to keep this medication out of reach of children. This warning is critical to prevent accidental ingestion or misuse, which could lead to serious consequences. No specific adverse reactions have been reported in clinical trials or postmarketing experiences beyond this precaution.

Drug Interactions

There are no specific drug interactions identified for this medication. Additionally, no laboratory test interactions have been reported. Therefore, no dosage adjustments or monitoring recommendations are necessary based on drug or laboratory test interactions.

Packaging & NDC

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

Packaging configurations for Simethicone.
Details

Pediatric Use

Pediatric patients should be advised to keep this medication out of reach of children. Safety and efficacy have not been established in pediatric populations, and caution is advised when considering its use in this demographic.

Geriatric Use

Elderly patients may not have specific information regarding the use of this medication, including dosage adjustments, safety concerns, or special precautions. Therefore, healthcare providers should exercise caution when prescribing this medication to geriatric patients. It is advisable to monitor these patients closely for any potential 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 this medication during pregnancy, including safety concerns, dosage modifications, or special precautions. Healthcare professionals should consider the lack of data when prescribing this medication 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 on the importance of effective contraception during treatment.

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 require dosage adjustments to ensure safety and efficacy. It is essential to monitor renal function tests in individuals with kidney problems to assess their renal status. Additionally, a reduced dose should be considered for patients with decreased creatinine clearance to mitigate the risk of adverse effects associated with impaired renal function.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in relation to 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 information regarding overdosage, healthcare professionals are advised to exercise caution and adhere to general principles of management in cases of suspected overdose.

It is essential to monitor the patient closely for any potential symptoms that may arise from an overdose. Symptoms can vary widely depending on the substance involved and the individual patient's response.

In the event of an overdose, immediate medical attention should be sought. Healthcare providers should initiate supportive care, which may include monitoring vital signs, providing symptomatic treatment, and ensuring the patient's safety.

If available, consultation with a poison control center or a medical toxicologist is recommended to guide further management and treatment options.

Documentation of the incident, including the substance involved, the amount taken, and the time of ingestion, is crucial for effective management and follow-up care.

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 the reach of children to prevent accidental ingestion or misuse. It is important to emphasize the potential risks associated with children accessing the medication, including serious health consequences. Patients should be encouraged to store the medication in a secure location, such as a locked cabinet or high shelf, to ensure safety.

Storage and Handling

The product is supplied in various package configurations, with specific NDC numbers available upon request. It is essential to store the product at a controlled room temperature, specifically between 20°C to 25°C. Proper storage conditions must be maintained to ensure the integrity and efficacy of the product.

Additional Clinical Information

The medication is administered orally, with adults advised to swallow 1 or 2 softgels with water as needed after meals and at bedtime. There are no additional details available regarding laboratory tests, abuse information, patient counseling, or postmarketing experience.

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.