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 2021
Label revision date
December 11, 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 2021
Label revision date
December 11, 2024
Manufacturer
Spirit Pharmaceuticals LLC
Registration number
M002
NDC root
68210-4154

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

You may be looking for a medication that comes in the form of softgels, which you can take with water. This medication is typically used by adults as needed after meals and at bedtime. It is important to follow the recommended dosage and not exceed two softgels in a 24-hour period unless directed by a physician.

If you have any specific questions about how this medication works or its intended use, please consult a healthcare professional for more detailed information.

Uses

You can use this medication to help manage your symptoms. For adults, the recommended way to take it is 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.

Rest assured, there are no known teratogenic effects (which means it doesn't cause birth defects) or nonteratogenic effects associated with this medication. Always consult with your healthcare provider if you have any questions or concerns about its use.

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

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

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 taking this medication, it’s best to stop using 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, 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

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 in pregnant individuals 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.

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 in nursing mothers or any considerations related to lactation (the process of producing milk). This means that there is no clear guidance on how Simethicone may affect your milk production or your nursing infant.

As always, it's best to consult with your healthcare provider before taking any medication while breastfeeding. They can help you weigh the benefits and risks based on your individual situation.

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 healthcare providers may not have tailored guidelines for elderly patients.

If you or a loved one is an older adult considering this medication, it’s important to discuss any potential risks and benefits with your healthcare provider. They can help determine the best approach based on individual health needs and circumstances. Always prioritize open communication about any concerns you may have regarding medication use.

Renal Impairment

It appears that there is no specific information regarding renal impairment (kidney problems) in the drug insert. This means that there are no dosage adjustments, special monitoring, or safety considerations outlined for patients like you who may have kidney issues.

If you have concerns about how this medication may affect your kidneys or if you have any existing kidney conditions, it’s important to discuss this with your healthcare provider. They can provide personalized advice and ensure that your treatment is safe and effective.

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 differently due to your liver health.

Always consult your healthcare provider for personalized advice and to discuss any concerns you may have regarding your liver function and how it relates to your treatment. They can help ensure that your medication is safe and effective for you.

Drug Interactions

It's great to know that there are no known interactions between this medication and other drugs or laboratory tests. However, it's still very important to discuss all medications you are taking, including over-the-counter drugs and supplements, with your healthcare provider. This ensures that your treatment is safe and effective.

Always keep your healthcare provider informed about any changes in your health or new medications you start. Open communication helps prevent any potential issues and supports your overall well-being.

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 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

How should I take this medication?

You should swallow 1 or 2 softgels with water as needed after meals and at bedtime.

What is the maximum dosage I can take in a day?

Do not exceed 2 softgels in 24 hours unless advised and supervised by a physician.

What is this medication used for?

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

Are there any teratogenic effects associated with this medication?

No teratogenic effects are mentioned.

What precautions should I take regarding children?

Keep this medication out of reach of children.

What is the recommended storage condition for this medication?

Store at controlled room temperature between 20-25°C (68-77°F) and protect 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

The product is identified by the SPL code 34089-3. No specific description details are provided in the text.

Uses and Indications

This drug is indicated for use in adults for the relief of symptoms as needed after meals and at bedtime. The recommended dosage is 1 or 2 softgels swallowed with water. It is important not to exceed 2 softgels within a 24-hour period unless directed by a physician.

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

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 minors. No other contraindications have been identified in the provided data.

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 and caregivers are aware of this critical safety measure to mitigate the risk of pediatric exposure.

Currently, there are no additional general precautions or specific laboratory tests associated with the use of this medication. However, healthcare providers should remain vigilant and monitor patients for any adverse effects or unusual symptoms that may arise during treatment.

In the event of an emergency or severe reaction, immediate medical assistance should be sought. Patients should be instructed to stop taking the medication and contact their healthcare provider if they experience any concerning symptoms or side effects.

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 beyond the noted warning. It is essential for healthcare providers to monitor patients for any unexpected effects and to educate them on the importance of safeguarding the medication from children.

Drug Interactions

No drug interactions or drug and laboratory test interactions have been identified for this product. Therefore, no specific recommendations for dosage adjustments or monitoring are necessary.

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. It is essential to ensure that the medication is stored safely to prevent accidental ingestion or misuse by pediatric populations.

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, given the lack of targeted data.

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 prescribing this medication to 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 is no specific information regarding the use of Simethicone in lactating mothers or any lactation considerations provided in the drug insert. Therefore, healthcare professionals should exercise caution and consider the lack of data when advising lactating mothers about the use of this medication. The effects on breastfed infants have not been established, and further research may be necessary to determine the safety and efficacy of Simethicone during lactation.

Renal Impairment

There is no information available regarding dosage adjustments, special monitoring, or safety considerations for patients with renal impairment. Healthcare professionals should exercise caution and consider the lack of specific guidance when prescribing to patients with reduced kidney function.

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 relevant toxicology resources for guidance on specific management protocols and antidotes, if applicable.

Documentation of the incident, including the amount and timing of the substance taken, is crucial for effective treatment 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 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 during storage and handling. It should be stored at a controlled room temperature of 20-25°C (68-77°F). It is essential to protect the product from heat and moisture to maintain its efficacy and safety.

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.