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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)
Marketed in the U.S.
Since 2012
Label revision date
June 29, 2012
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
Marketed in the U.S.
Since 2012
Label revision date
June 29, 2012
Manufacturer
Softech Pharma Pvt. Ltd.
Registration number
part332
NDC root
48769-112

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Drug Overview

If you're experiencing discomfort from bloating, pressure, or fullness often associated with gas, this medication can help relieve those symptoms. It is designed to ease the feeling of being overly full or gassy, providing you with comfort and relief.

While the specific details about how it works are not provided, its primary purpose is to address the common issues related to gas in the digestive system. If you're looking for a solution to these uncomfortable sensations, this medication may be a suitable option for you.

Uses

If you're experiencing discomfort from bloating, pressure, or a feeling of fullness often associated with gas, this medication can help relieve those symptoms. It works by targeting the underlying causes of gas, providing you with the comfort you need. Whether it's after a meal or during a stressful day, this treatment aims to ease that uncomfortable sensation and help you feel more at ease.

Dosage and Administration

You can take one or two softgels after a meal when you need them. It's important not to take more than two softgels in a single day unless your doctor has advised you to do so and is supervising your use of the medication. Always follow this guidance to ensure your safety and the effectiveness of the treatment.

What to Avoid

There are no specific contraindications, controlled substance classifications, or concerns regarding abuse, misuse, or dependence associated with this medication. This means that, based on the available information, there are no known reasons to avoid using it, and it does not fall under any controlled substance regulations.

However, it's always important to consult with your healthcare provider before starting any new medication to ensure it is appropriate for your individual health needs.

Side Effects

If you experience any ongoing issues while using this medication, it's important to stop using it and consult your doctor. Currently, there are no specific side effects or adverse reactions reported for this medication. However, always stay alert to how you feel and communicate any concerns with your healthcare provider.

Warnings and Precautions

If your condition does not improve, it’s important to stop using the medication and consult your doctor for further guidance. This ensures that you receive the appropriate care and adjustments to your treatment if necessary.

Always be attentive to how you feel while using this medication. If you experience any unusual symptoms or if your condition worsens, do not hesitate to reach out to your healthcare provider for advice. Your health and safety are the top priority.

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, recommended dosage adjustments, or any special precautions you should take. This means that if you are pregnant or planning to become pregnant, it’s important to discuss your options with your healthcare provider. They can help you weigh the potential risks and benefits based on your individual situation. Always prioritize open communication with your doctor to ensure the best care for you and your baby.

Lactation Use

If you are breastfeeding, you can use Simethicone without specific warnings or recommendations against it. The information available does not indicate whether Simethicone is passed into breast milk or if it poses any risk to your nursing infant. Always consult with your healthcare provider if you have concerns about medications while breastfeeding.

Pediatric Use

It's important to keep this medication out of reach of children to ensure their safety. If your child needs to take this medication, be aware that they should not exceed two softgels per day unless a doctor has specifically advised otherwise. Always consult with a healthcare professional if you have any questions or concerns about the appropriate dosage for 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 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 because your kidneys may not process the medication as effectively. Regular monitoring of your renal function tests is essential to ensure your kidneys are working properly. If you have decreased creatinine clearance (a measure of how well your kidneys filter waste), your healthcare provider may recommend a reduced dose of your medication to avoid potential complications. Always discuss any concerns with your doctor to ensure your treatment is safe and effective.

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 apply, but you should always consult your healthcare provider for personalized advice. They can help monitor your liver function and determine the best approach for your treatment.

Make sure to keep your doctor informed about your liver health, as they may need to conduct regular liver function tests (which check how well your liver is working) to ensure your safety while using any medication.

Drug Interactions

It's great to know that there are no reported drug interactions or laboratory test interactions with this medication. 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, and helps avoid any potential issues.

Always keep your healthcare provider informed about any changes in your health or new medications you start. Open communication is key to managing your health effectively.

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 proper handling or storage, don’t hesitate to reach out for guidance.

Additional Information

You can take this medication orally by swallowing one or two softgels after a meal, as needed. It's important not to exceed two softgels in a day unless your doctor advises otherwise. Always follow your physician's guidance for safe use.

FAQ

What is the purpose of this drug?

This drug relieves bloating, pressure, or fullness commonly referred to as gas.

How should I take this medication?

You should swallow one or two softgels as needed after a meal, but do not exceed two softgels per day unless advised by a physician.

Are there any warnings I should be aware of?

Yes, you should stop use and ask your doctor if your condition persists.

Is there any information on drug interactions?

No drug interactions were listed for this medication.

What should I do if I have kidney problems?

If you have renal impairment, you may require dosage adjustments and should monitor renal function tests.

What is the storage requirement for this drug?

Store the medication at a temperature between 20°C and 25°C.

Is this drug safe for nursing mothers?

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

What should I do if I have questions about my dosage?

Consult your physician for advice, especially if you have any health conditions or concerns.

How should I keep this medication away from children?

Make sure to keep it out of reach of children.

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

The drug is presented in a carton labeled for 180 mg.

Uses and Indications

This drug is indicated for the relief of bloating, pressure, or fullness commonly referred to as gas. It is intended for use in patients experiencing these gastrointestinal symptoms.

Dosage and Administration

Patients are advised to swallow one or two softgels as needed after a meal. The maximum recommended dosage is two softgels per day, unless otherwise directed by a physician. It is important for healthcare professionals to monitor patients to ensure adherence to this dosage limit and to provide guidance as necessary.

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

Patients should discontinue use and consult a healthcare professional if the condition persists. This precaution is essential to ensure appropriate management and to rule out any underlying issues that may require further evaluation or treatment.

No additional general precautions or laboratory tests have been specified. It is advisable for healthcare professionals to remain vigilant and assess the patient's overall health status during treatment.

Side Effects

Patients should be advised to stop use and consult a doctor if their condition persists. No specific side effects or adverse reactions have been reported in clinical trials or postmarketing experiences.

Drug Interactions

There are no documented drug interactions associated with the use of this medication. Additionally, there are no reported interactions between this drug and laboratory tests. As such, no specific 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 product out of reach of children. The recommended dosage for pediatric patients is limited to a maximum of two softgels per day, unless otherwise directed by a physician. Careful supervision is advised to ensure safety and adherence to dosing guidelines.

Geriatric Use

There is no specific information 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 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. The potential risks and benefits should be carefully evaluated, and alternative treatments may be considered in consultation with the patient. Women of childbearing potential should be advised to discuss their pregnancy status and any plans for pregnancy with their healthcare provider prior to initiating treatment.

Lactation

There are no specific warnings or recommendations regarding the use of Simethicone in lactating mothers. Additionally, there are no details provided 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 the use of this medication. Consequently, there are no established dosage adjustments, special monitoring requirements, or precautions 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, as the clinical presentation can vary depending on the substance involved and the individual patient's response. Common symptoms of overdose may include, but are not limited to, altered mental status, cardiovascular instability, and respiratory distress.

In the event of an overdose, immediate medical intervention is recommended. Healthcare providers should initiate supportive care, which may include maintaining airway patency, providing supplemental oxygen, and ensuring hemodynamic stability. The use of activated charcoal may be considered if the patient presents within a suitable timeframe and if the ingestion was recent.

Additionally, it is crucial to consult local poison control centers or toxicology experts for guidance on specific management protocols and antidotes, if applicable. Continuous monitoring and supportive care remain the cornerstones of effective management in overdose situations.

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 instructed 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 for identification. It is essential to store the product at a controlled temperature range of 20°C to 25°C. Proper storage conditions must be maintained to ensure the integrity and efficacy of the product.

Additional Clinical Information

The product is administered orally, with patients advised to swallow one or two softgels as needed after a meal. It is important for patients not to exceed a total of two softgels per day unless directed by a physician. No additional information is 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.

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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.