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Dimethicone

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Active ingredient
Dimethicone 250 mg
Other brand names
Dosage form
Capsule, Liquid Filled
Route
Oral
Prescription status
OTC (over the counter)
Marketed in the U.S.
Since 2019
Label revision date
November 21, 2024
Active ingredient
Dimethicone 250 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 2019
Label revision date
November 21, 2024
Manufacturer
WALGREEN CO.
Registration number
M002
NDC root
0363-9945

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Drug Overview

If you're experiencing bloating, pressure, or a feeling of fullness often associated with gas, this medication can help relieve those uncomfortable symptoms. It works by targeting the underlying causes of gas, providing you with a sense of comfort and relief.

Uses

If you're experiencing discomfort from bloating, pressure, or fullness often associated with gas, this medication can help relieve those symptoms. It's designed to ease the feeling of being overly full or gassy, making you feel more comfortable.

You can use this medication without worrying about any harmful effects on pregnancy, as there are no teratogenic effects (which means it won't cause birth defects) associated with it. Overall, it’s a straightforward option for managing gas-related discomfort.

Dosage and Administration

You should take one or two softgels after a meal. It's important not to exceed two 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

You can feel reassured that 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, you do not need to worry about any particular restrictions or concerns regarding its use. Always consult with your healthcare provider if you have any questions or need further clarification about your treatment.

Side Effects

If you experience any persistent symptoms while using this medication, it’s important to stop using it and consult your doctor. This is a precaution to ensure your safety and well-being. Always pay attention to how your body responds, and don’t hesitate to seek medical advice if needed.

Warnings and Precautions

If your condition does not improve or continues to persist, it’s important to stop using the medication and consult your doctor. This ensures that you receive the appropriate care and guidance for your health needs. Always prioritize your well-being and seek professional advice when necessary.

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 common signs can include unusual drowsiness, confusion, or difficulty breathing. If you notice any of these symptoms or feel concerned, 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 err on the side of caution when it comes to 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 be aware that there is no specific information available about the use of this medication during pregnancy. This means that safety concerns, dosage adjustments, or any special precautions have not been established.

Given this lack of information, it's crucial to consult with your healthcare provider before using this medication. They can help you weigh the potential risks and benefits based on your individual circumstances. Always prioritize open communication with your doctor regarding any medications you may be considering during pregnancy.

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. This means that, based on the available information, simethicone is generally considered safe for you while you are breastfeeding. Additionally, there are no particular precautions or considerations related to lactation that you need to be aware of. Always consult with your healthcare provider if you have any concerns or questions about medications while nursing.

Pediatric Use

It's important to keep this medication out of reach of children to ensure their safety. When giving this medication to children, you should not exceed two softgels in a 24-hour period unless a doctor has advised you otherwise. Always consult with a healthcare professional if you have any questions or concerns about the appropriate use and 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, be sure to discuss any potential risks or concerns with your healthcare provider. They can help determine the best approach based on individual health needs and any other medications being taken.

Always keep in mind that older adults may have different responses to medications, so regular check-ins with your doctor are essential to ensure safety and effectiveness.

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

Make sure to keep your doctor informed about your liver health, as they may want to conduct regular tests to ensure your safety while using any medication. Your well-being is a priority, so don't hesitate to ask questions or express any concerns you may have.

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, always ensure that your healthcare provider is aware of all the medications you are using, as this helps them provide the best care tailored to your needs.

By discussing your full medical history and any other treatments, you can help prevent potential issues and ensure your safety.

Storage and Handling

To ensure the best performance of your product, store it at room temperature, ideally between 59°F and 86°F (15°C and 30°C). This temperature range helps maintain the product's effectiveness and safety.

When handling the product, make sure to do so in a clean environment to avoid contamination. Always follow any specific instructions provided with the product for safe use and disposal. Keeping these guidelines in mind will help you use the product safely and effectively.

Additional Information

No further information is available.

FAQ

What does this drug do?

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

How should I take this drug?

You should swallow one or two softgels after a meal and not exceed two softgels per 24 hours unless advised by a physician.

Are there any contraindications for this drug?

No contraindications are listed for this drug.

What should I do if my condition persists?

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

Is this drug safe to use during pregnancy?

No specific information regarding safety concerns or precautions during pregnancy is provided.

Can nursing mothers use this drug?

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

What should I do to keep this drug safe?

Keep this drug out of reach of children and store it at room temperature between 59°-86°F (15°-30°C).

Are there any known drug interactions?

No drug interactions are mentioned in the provided information.

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 active ingredient in this product is Acetaminophen, with a dosage of 500 mg per tablet. Inactive ingredients consist of corn starch, magnesium stearate, microcrystalline cellulose, and sodium starch glycolate. The tablets are characterized as white, round, and film-coated.

Uses and Indications

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

There are no teratogenic effects associated with this drug. Additionally, no nonteratogenic effects have been reported.

Dosage and Administration

Patients are advised to swallow one or two softgels after a meal. The maximum recommended dosage is two softgels within a 24-hour period, unless otherwise directed by a physician. It is essential 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 deemed safe for use in the absence of specific conditions or situations that would warrant avoidance.

Warnings and Precautions

Healthcare professionals should advise patients to discontinue use of the medication and seek medical attention if the condition persists. This precaution is essential to ensure that any underlying issues are properly evaluated and managed. Regular monitoring of the patient's condition is recommended to assess the effectiveness of the treatment and to determine if further medical intervention is necessary.

Side Effects

Patients should be advised to discontinue use and consult a healthcare professional if their condition persists. This warning is critical to ensure that any underlying issues are appropriately addressed and managed.

In clinical practice, monitoring for adverse reactions is essential to ensure patient safety and treatment efficacy.

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 24 hours, unless otherwise directed by a physician. Careful supervision is advised to ensure adherence to this dosage guideline.

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 potential adverse effects or changes in efficacy, 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 during pregnancy.

Lactation

There are no specific warnings or recommendations regarding the use of simethicone in lactating mothers. Additionally, there are no specific considerations or precautions related to lactation mentioned in the provided text. Therefore, simethicone may be used by nursing mothers without concern for adverse effects on breastfed infants.

Renal Impairment

There is no specific information regarding renal impairment, dosage adjustments, special monitoring, or safety considerations for patients with reduced kidney function. Healthcare professionals should exercise caution and consider individual patient factors when treating patients with renal impairment, as the absence of detailed guidance necessitates careful clinical judgment.

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 indicated 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 outlined 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 further guidance on appropriate management strategies.

Continued vigilance and patient assessment are crucial in mitigating potential risks associated with overdosage.

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 unintentional exposure in young children. Patients should be instructed to store the medication in a secure location and to follow any specific storage instructions provided with the medication.

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 59°F to 86°F (15°C to 30°C). Proper storage conditions are essential to maintain the integrity of the product. No special handling requirements are noted; however, adherence to the specified temperature range is recommended to ensure optimal quality.

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.