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Simethicone

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This product has been discontinued

Active ingredient
Dimethicone 180 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 2009
Label revision date
December 2, 2009
Drug Information (PDF)
Prescribing information, PDF file
Active ingredient
Dimethicone 180 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 2009
Label revision date
December 2, 2009
Manufacturer
SPIRIT PHARMACEUTICALS, LLC
Registration number
part310.545
NDC root
68210-1902
Drug Information (PDF)
Prescribing information, PDF file
Packaging Info (5 NDCs)
Packaging & NDC Codes (5)

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 Capsules USP 180mg contain simethicone (a medication that helps relieve gas) and are specifically designed to alleviate pressure and bloating commonly associated with gas. 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 from gas, simethicone can provide relief and help you feel more comfortable. Always consult with a healthcare professional if you have any questions or concerns about using this medication.

Uses

If you're experiencing discomfort from pressure and bloating, often caused by gas, this medication can help provide relief. It's designed specifically to ease these uncomfortable sensations, allowing you to feel more at ease.

Rest assured, there are no known teratogenic effects (which means it doesn't cause birth defects) associated with this medication, making it a safer option for those concerned about such risks.

Dosage and Administration

You can take this medication by swallowing 1 or 2 softgels with water after meals and at bedtime, depending on your needs. It's important to remember not to exceed 2 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

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 accidental ingestion. If you have any concerns about side effects or how to use this medication safely, please consult your healthcare provider for guidance.

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 are no specific signs or symptoms of overdose mentioned, you should be aware that an overdose can lead to serious health issues. Common signs of overdose may include unusual drowsiness, confusion, or difficulty breathing.

If you or someone you know may have taken too much of a medication, seek medical help right away. Contact your healthcare provider or go to the nearest emergency room. It's always better to be safe and get professional assistance in these situations.

Pregnancy Use

When considering the use of Simethicone during pregnancy, it's important to note that there is no specific information available regarding its safety, dosage adjustments, or any special precautions for pregnant individuals. This means that the effects of Simethicone on pregnancy have not been clearly studied or established.

If you are pregnant or planning to become pregnant, it's always best to consult with your healthcare provider before taking any medication, including over-the-counter products like Simethicone. They can provide personalized advice based on your health needs and circumstances.

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 there are no specific guidelines or dosage adjustments mentioned for your condition in the available information. This means that the usual recommendations for monitoring or safety considerations related to renal impairment (kidney issues) are not provided.

Always consult your healthcare provider for personalized advice and to ensure that any medications you take are safe and appropriate for your kidney health. They can help you understand how your condition may affect your treatment plan.

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 for the medication do not change based on liver impairment. However, it’s always a good idea to discuss your liver health with your healthcare provider before starting any new medication. They can help ensure that your treatment is safe and effective for you.

Drug Interactions

It's important to have open conversations with your healthcare provider about any medications or tests you may be taking. In this case, there are no known drug interactions or laboratory test interactions associated with the medication. However, every individual is different, and your healthcare provider can help ensure that your treatment is safe and effective for you. Always feel free to ask questions and share your complete list of medications and tests during your appointments.

Storage and Handling

To ensure the best performance of your product, store it at a controlled room temperature between 20-25°C (68-77°F). It's important to keep it away from heat and moisture, as these can affect its quality and effectiveness.

When handling the product, make sure to maintain a clean environment to avoid contamination. Always follow any specific instructions provided with the product for safe use and disposal. By taking these precautions, you can help ensure the product remains safe and effective for your needs.

Additional Information

You can take this medication orally by swallowing 1 or 2 softgels with water after meals and at bedtime, as needed. However, it's important not to exceed 2 softgels in a 24-hour period unless your doctor advises otherwise. Always follow your healthcare provider's guidance for safe use.

FAQ

What is Simethicone used for?

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

What is the recommended dosage for adults?

Adults should swallow 1 or 2 softgels with water as needed after meals and at bedtime, not exceeding 2 softgels in 24 hours unless advised by a physician.

What should I do if I have children at home?

Keep Simethicone out of reach of children to prevent accidental ingestion.

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.

Can nursing mothers use Simethicone?

There are no specific warnings or recommendations regarding the use of Simethicone in nursing mothers.

How should I store Simethicone?

Store Simethicone at a controlled room temperature of 59° - 86°F (15° - 30°C), protecting it from light, moisture, and freezing.

What is the NDC number for Simethicone?

The NDC number for Simethicone is 68210-1902.

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 Capsules USP contain 180 mg of simethicone per softgel. These capsules are formulated to provide relief from symptoms of excess gas in the gastrointestinal tract. The active ingredient, simethicone, is a silicone-based compound known for its anti-foaming properties, which help reduce bloating and discomfort associated with gas. The softgel dosage form facilitates easy administration and absorption.

Uses and Indications

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

There are no teratogenic or nonteratogenic effects associated with this drug.

Dosage and Administration

Adults should swallow 1 or 2 softgels with water as needed after meals and at bedtime. The maximum recommended dosage is 2 softgels within a 24-hour period, unless otherwise directed by a physician. It is important to adhere to this dosage limit to ensure safety and efficacy.

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 ensure that patients are aware of the importance of proper storage and handling of the medication. This precaution is essential to safeguard against potential adverse effects that may arise from unintentional exposure in pediatric populations.

In addition, healthcare providers are encouraged to discuss the risks associated with improper use and the necessity of adhering to prescribed dosages and administration guidelines. Regular patient education on the safe storage of medications can further mitigate risks associated with pediatric access.

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 adverse reactions.

In clinical trials and postmarketing experiences, no specific adverse reactions were reported; however, the importance of safeguarding the medication from children remains a priority to ensure patient safety.

Drug Interactions

There are no reported drug interactions associated with the use of this medication. Additionally, no interactions with laboratory tests have been identified. Therefore, no dosage adjustments or monitoring recommendations are necessary based on drug 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. There are no specific age ranges, dosage differences, or study outcomes provided for pediatric use in the available data. Caution is advised when administering this medication to ensure safety in the pediatric population.

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 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

There is no specific information regarding dosage adjustments, special monitoring, or safety considerations for patients with renal impairment. Healthcare professionals should exercise caution when prescribing to patients with reduced kidney function, as the absence of detailed guidance necessitates careful clinical judgment. Regular monitoring of renal function may be advisable in this patient population.

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 information regarding overdosage, healthcare professionals are advised to exercise caution when administering the medication. It is essential to monitor patients closely for any signs of adverse effects or symptoms that may arise from excessive dosing.

In the event of suspected overdosage, immediate medical attention should be sought. Healthcare providers should implement supportive measures as necessary, which may include symptomatic treatment and monitoring of vital signs.

Due to the lack of detailed overdosage information, it is recommended that healthcare professionals refer to established clinical guidelines and protocols for managing overdose situations relevant to the specific medication in question. Additionally, contacting a poison control center may provide valuable assistance in managing potential overdosage cases.

Continued vigilance and adherence to dosing recommendations are crucial to minimize the risk of overdosage and ensure patient safety.

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 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 a configuration that includes specific NDC numbers, which are essential for identification and inventory management. It is crucial to store the product at a controlled room temperature ranging from 20 to 25°C (68 to 77°F). Additionally, the product must be protected from heat and moisture to maintain its integrity and efficacy. Proper handling and storage conditions are vital to ensure the product remains within its specified parameters.

Additional Clinical Information

The medication is administered orally, with adults advised to swallow 1 or 2 softgels with water after meals and at bedtime. Patients should not exceed a total of 2 softgels within a 24-hour period unless directed by a physician. There is no additional information available regarding laboratory tests, abuse potential, 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.