ADD CONDITION

items per page

Dimethicone

Last content change checked dailysee data sync status

This product has been discontinued

Active ingredient
Dimethicone 180 mg
Other brand names
Dosage form
Capsule, Gelatin Coated
Route
Oral
Prescription status
OTC (over the counter)
Marketed in the U.S.
Since 2020
Label revision date
December 12, 2024
Active ingredient
Dimethicone 180 mg
Other brand names
Dosage form
Capsule, Gelatin Coated
Route
Oral
Prescription status
OTC (over the counter)
CSA schedule
Not a scheduled drug
Marketed in the U.S.
Since 2020
Label revision date
December 12, 2024
Manufacturer
Spirit Pharmaceuticals LLC
Registration number
M002
NDC root
68210-0314

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 an anti-gas medication designed to provide fast relief from bloating, pressure, fullness, and gas. Each softgel contains 180 mg of Simethicone, which works by breaking up gas bubbles in your stomach and intestines, making it easier for your body to eliminate them.

This medication is available in a convenient softgel form, with a package containing 50 softgels. You can take 1 or 2 softgels with water as needed after meals and at bedtime to help alleviate discomfort caused by excess gas.

Uses

If you're experiencing discomfort from bloating, pressure, fullness, or gas, this medication can provide you with fast relief. It’s designed to help alleviate these common digestive issues, allowing you to feel more comfortable and at ease.

You can trust that this medication does not have any teratogenic effects, meaning it does not cause harm to a developing fetus. This makes it a safer option for those who may be pregnant or planning to become pregnant.

Dosage and Administration

If you're experiencing discomfort from pressure and bloating, often known as gas, this medication can help provide relief. It's designed specifically for this purpose, making it a suitable option for easing those uncomfortable feelings.

While the information provided does not specify how to take the medication—such as whether it should be taken orally or in another form—it's important to follow any additional instructions given by your healthcare provider or the product packaging. Always ensure you use the medication as directed to achieve the best results.

What to Avoid

You can feel confident using this medication, as there are no specific contraindications, controlled substance classifications, or concerns regarding abuse, misuse, or dependence associated with it. This means that, based on the available information, there are no known reasons to avoid taking this medication. Always remember to follow your healthcare provider's guidance and reach out if you have any questions or concerns about your treatment.

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 safely store the medication, 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 ensure that it is stored safely and securely.

If you have any concerns or experience unusual symptoms while using this medication, it’s best to stop taking it and consult your doctor for further guidance. Your health and safety are paramount, so don’t hesitate to seek medical advice 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, contacting your local poison control center or going to the nearest emergency room is crucial. They can provide the necessary guidance and treatment. Always remember that it's better to be safe and get checked if you have any concerns about your health.

Pregnancy Use

There is currently no specific information available regarding the use of Simethicone during pregnancy. This means that safety concerns, dosage adjustments, or any special precautions for pregnant individuals have not been addressed in the drug insert. If you are pregnant or planning to become pregnant, it is important to consult with your healthcare provider before using this medication to ensure it is safe for you and your baby.

Lactation Use

If you are breastfeeding or planning to breastfeed, it's important to know that the drug insert for Simethicone does not provide specific information about its use during nursing. This means there are no established guidelines or known effects on breast milk or your nursing infant.

As always, it's a good idea to consult with your healthcare provider before taking any medication while breastfeeding to ensure it is safe for you and your baby.

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

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. If you or a loved one is an older adult, it’s always wise to discuss any medications with a healthcare provider, especially considering factors like kidney function and changes in cognition (thinking and memory) that can occur with age.

Make sure to inform your doctor about any other medications being taken, as well as any health conditions, to ensure the safest and most effective treatment plan. Always prioritize open communication with your healthcare team to address any concerns or questions you may have.

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.

It's always best to discuss your individual situation with your healthcare provider, who can offer personalized advice and ensure that any medications you take are safe and effective for you.

Hepatic Impairment

If you have liver problems, it's important to know that the information provided does not include specific guidelines for dosage adjustments, special monitoring, or precautions related to your condition. This means that there are no tailored recommendations for how the medication may affect you differently due to your liver health.

Always consult your healthcare provider for personalized advice and to ensure that any treatment plan is safe and effective for your specific situation. They can help determine the best approach based on your liver function and overall health.

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, based on the available information, this medication does not have known conflicts with other drugs or tests. However, every individual is different, and your healthcare provider can help ensure that your treatment plan is safe and effective for you.

Always discuss any new medications or tests with your healthcare provider to avoid potential issues and to get personalized advice tailored to your health needs.

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 do so in a clean environment to maintain its integrity. Always follow any specific instructions provided for safe use and disposal to ensure your safety and the product's effectiveness.

Additional Information

No further information is available.

FAQ

What is Simethicone used for?

Simethicone is an anti-gas medication used for fast relief of bloating, pressure, fullness, and gas.

What is the recommended dosage for adults?

Adults should swallow 1 or 2 softgels with water as needed after meals and at bedtime, without exceeding 2 softgels in 24 hours unless advised by a physician.

How many softgels are in a package of Simethicone?

Each package contains 50 softgels.

Are there any teratogenic effects associated with Simethicone?

No teratogenic effects are mentioned for Simethicone.

What precautions should I take when using Simethicone?

Keep Simethicone out of reach of children.

What should I do if I experience side effects?

The insert does not provide specific instructions for side effects, but you should consult your doctor if you have concerns.

What is the storage recommendation for Simethicone?

Store Simethicone at controlled room temperature between 20-25°C (68-77°F) and protect it from heat and moisture.

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

Simethicone is an anti-gas agent formulated to provide fast relief from symptoms associated with bloating, pressure, fullness, and gas. Each softgel contains 180 mg of simethicone. The product is presented in a dosage form of softgels, with a total of 50 softgels per container.

Uses and Indications

This drug is indicated for the fast relief of symptoms associated with gastrointestinal discomfort, including bloating, pressure, fullness, and gas.

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

Dosage and Administration

For the relief of pressure and bloating commonly referred to as gas, the healthcare professional should consider the appropriate dosage based on the patient's individual needs and response to treatment.

As no specific route, method, or frequency of administration is provided, it is recommended that healthcare professionals assess the patient's condition and determine the most suitable administration approach. Monitoring the patient's response to therapy is essential to ensure optimal relief of symptoms.

Contraindications

There are no contraindications associated with the use of this product. It is deemed safe for use in the absence of specific conditions or situations that would warrant avoidance.

Warnings and Precautions

It is imperative to keep this medication out of reach of children to prevent accidental ingestion or misuse.

Healthcare professionals should remain vigilant regarding the safety and proper use of this medication. While no specific general precautions or laboratory tests are outlined, it is essential to monitor patients for any adverse effects or unusual symptoms that may arise during treatment.

In the event of an emergency, immediate medical assistance should be sought. Additionally, patients should be advised to discontinue use and contact their healthcare provider if they experience any concerning side effects or reactions.

Side Effects

Patients should be advised to keep this medication out of reach of children. This warning is critical to prevent accidental ingestion or exposure, which could lead to serious adverse reactions.

No specific adverse reactions have been reported in clinical trials or postmarketing experiences. However, it is essential for healthcare providers to monitor patients for any unexpected effects and to report them as necessary.

Drug Interactions

No specific drug interactions have been identified in the available data. Additionally, there are no reported interactions between the drug and laboratory tests. Therefore, no dosage adjustments or monitoring recommendations are necessary based on the current information.

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 advised to keep this medication out of reach of children. This precaution is essential to ensure safety and prevent accidental ingestion.

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 adverse effects or changes in therapeutic response, given the lack of targeted data for this population.

Pregnancy

There is no specific information regarding the use of Simethicone during pregnancy, including safety concerns, dosage modifications, or special precautions. As such, healthcare professionals should exercise caution when prescribing this medication to pregnant patients. The absence of data necessitates a careful assessment of the potential benefits and risks when considering Simethicone for women of childbearing potential. Further studies may be warranted to elucidate any potential fetal impacts associated with its use during pregnancy.

Lactation

There is no specific information regarding nursing mothers or lactation considerations provided in the drug insert for Simethicone. Therefore, the effects on breastfed infants and the excretion of Simethicone in breast milk are not established. Healthcare professionals should consider this lack of data when advising lactating mothers on the use of this medication.

Renal Impairment

There is no specific information available 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 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 implement supportive care measures, which may include maintaining airway patency, providing supplemental oxygen, and monitoring vital signs.

Additionally, it is recommended to consult local poison control centers or toxicology experts for guidance on specific management protocols and interventions tailored to the situation.

Documentation of the incident, including the substance involved, estimated dose, and time of exposure, 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 the 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 children.

Storage and Handling

The product is supplied in various package configurations, with specific NDC numbers available for identification. It should be stored at a controlled room temperature of 20-25°C (68-77°F) to maintain its efficacy. Additionally, it is essential to protect the product from heat and moisture to ensure its integrity and stability throughout its shelf life. Proper handling and storage conditions are crucial for preserving the quality of the product.

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.