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Dimethicone

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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 2016
Label revision date
November 25, 2024
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 2016
Label revision date
November 25, 2024
Manufacturer
Humanwell PuraCap Pharmaceutical (Wuhan) Co. , Ltd
Registration number
M002
NDC root
53345-036

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Drug Overview

Simethicone Capsules, 180 mg, are designed to help relieve bloating, pressure, or fullness that is 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 may provide you with the relief you need.

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 a sense of comfort and ease. You can expect to feel more at ease and less burdened by these uncomfortable sensations.

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

It's important to be aware of certain guidelines when using this medication. While there are no specific contraindications or concerns about abuse, misuse, or dependence (which means relying on a substance in a harmful way), you should stop using the medication and consult your doctor if your condition does not improve. Always prioritize your health and safety by following these instructions closely.

Side Effects

If your condition does not improve, it's important to stop using the medication and consult your doctor. Additionally, please ensure that this medication is kept out of reach of children to prevent any accidental ingestion.

Warnings and Precautions

It's important to keep this medication out of reach of children to ensure their safety. If your condition does not improve or continues to persist, please stop using the medication and consult your doctor for further advice.

While there are no specific emergency instructions or laboratory tests required for this medication, always prioritize your health and seek medical attention if you have any concerns.

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 consult with your healthcare provider before starting or continuing this medication. They can help you weigh the potential risks and benefits based on your individual situation. Always prioritize open communication with your doctor regarding any medications you are considering during pregnancy.

Lactation Use

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

As always, it's a good idea to consult with your healthcare provider before taking any medication while breastfeeding to ensure the safety and well-being of both you and your baby.

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

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 since older individuals may have different health needs and responses to treatments.

Since there are no dosage adjustments or special precautions mentioned for elderly patients, your healthcare provider can help determine the best approach based on individual health conditions and any other medications being taken. Always prioritize open communication with your healthcare team to ensure safe and effective care.

Renal Impairment

If you have kidney problems, it's important to know that the information provided does not include specific guidelines for dosage adjustments, special monitoring, or safety considerations related to renal impairment (kidney issues). This means that there are no tailored recommendations for how your treatment may need to change based on your kidney function.

Always consult your healthcare provider for personalized advice and to ensure that your treatment is safe and effective for your specific condition. They can help determine the best approach for managing your health, especially if you have concerns about your kidneys.

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 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 room temperature, ideally between 59ºF and 86ºF (15ºC and 30ºC). This temperature range helps maintain the integrity and effectiveness of the device.

When handling the product, make sure to do so in a clean environment to avoid contamination. Always follow any specific instructions provided for use to ensure safety and effectiveness. If you have any questions about disposal or further handling, please refer to the guidelines provided with your product.

Additional Information

No further information is available.

FAQ

What is Simethicone Capsules used for?

Simethicone Capsules relieve bloating, pressure, or fullness commonly referred to as gas.

How should I take Simethicone Capsules?

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.

What should I do if my condition persists?

You should stop use and ask a doctor if your condition persists.

How should I store Simethicone Capsules?

Store the capsules at room temperature between 15-30°C (59-86°F) and protect them from heat, humidity, and light. Do not refrigerate.

Are there any contraindications for Simethicone Capsules?

No specific contraindications are listed for Simethicone Capsules.

Is Simethicone a controlled substance?

No, Simethicone is not classified as a controlled substance.

What precautions should I take regarding children?

Keep Simethicone Capsules out of reach of children.

Is there any information about using Simethicone during pregnancy or while nursing?

The insert does not provide specific information regarding the use of Simethicone during pregnancy or lactation.

Are there any known drug interactions with Simethicone?

No drug interactions are mentioned in the provided text.

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 Capsules contain 180 mg of simethicone per capsule. Each bottle contains a total of 25,000 capsules. The product is identified by the National Drug Code (NDC) 53345-036-01. Simethicone is an anti-foaming agent used to relieve symptoms of excess gas in the gastrointestinal tract.

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 listed for this product. However, it is advised to discontinue use and consult a healthcare professional if the condition persists.

Warnings and Precautions

Healthcare professionals should be aware of the following warnings and precautions associated with the use of this product.

It is imperative to discontinue use and consult a physician if the condition persists. This precaution is essential to ensure that any underlying issues are appropriately addressed.

Additionally, the product should be kept out of reach of children to prevent accidental ingestion or misuse. This measure is crucial for safeguarding pediatric populations.

Currently, there are no specific laboratory tests recommended for monitoring the use of this product. However, healthcare providers should remain vigilant and assess the patient's condition as necessary.

In the absence of specific emergency medical instructions, practitioners should use their clinical judgment in the event of adverse reactions or complications.

Side Effects

Patients should be advised to stop use and consult a doctor if their condition persists. It is important to keep this product out of reach of children to prevent accidental ingestion or misuse.

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. 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. 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

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 available regarding the use of this medication during pregnancy, including safety concerns, dosage modifications, or special precautions that should be taken. Healthcare professionals should consider the lack of data when prescribing this medication to pregnant patients and weigh the potential risks and benefits. Women of childbearing potential should be counseled on the absence of established safety data and the importance of discussing any potential pregnancy with their healthcare provider.

Lactation

There is no specific information regarding the use of Simethicone Capsules 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 safety and efficacy in this population.

Renal Impairment

Patients with renal impairment have not been specifically addressed in the available prescribing information. There are no dosage adjustments, special monitoring requirements, or safety considerations outlined for individuals with reduced kidney function. Healthcare professionals should exercise caution and consider the lack of data when prescribing to 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 relevant toxicology resources for guidance on specific management protocols and antidotes, if applicable.

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 in these areas limits the understanding of the compound's safety profile in nonclinical settings.

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. It is important for patients to understand that if their condition persists despite using the medication, they should stop use and consult a doctor for further evaluation and guidance.

Storage and Handling

The product is supplied in various package configurations, with specific NDC numbers available for identification. It should be stored at room temperature, within the range of 59º to 86ºF (15º to 30ºC). Proper storage conditions are essential to maintain the integrity 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.

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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.