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Simethicone 125 mg

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Active ingredient
Dimethicone 125 mg
Other brand names
Dosage form
Tablet, Chewable
Route
Oral
Prescription status
OTC (over the counter)
Marketed in the U.S.
Since 2018
Label revision date
January 15, 2025
Active ingredient
Dimethicone 125 mg
Other brand names
Dosage form
Tablet, Chewable
Route
Oral
Prescription status
OTC (over the counter)
CSA schedule
Not a scheduled drug
Marketed in the U.S.
Since 2018
Label revision date
January 15, 2025
Manufacturer
Reliable 1 Laboratires LLC
Registration number
M002
NDC root
69618-032

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Drug Overview

Simethicone is an antiflatulent medication that comes in 125 mg chewable tablets, typically available in a bottle of 60 tablets. It is designed to relieve bloating, pressure, and fullness that are commonly associated with gas in the digestive system. By breaking up gas bubbles, simethicone helps you feel more comfortable after meals.

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.

Additionally, there are no concerns regarding teratogenic effects (which means it doesn't cause birth defects) or nonteratogenic effects, so you can use it with confidence.

Dosage and Administration

You should chew 1 to 2 tablets thoroughly whenever you need relief, especially after meals and at bedtime. It's important to remember not to exceed a total of 4 tablets in one day. This way, you can manage your symptoms effectively while staying within the recommended limits. Always follow these guidelines to ensure safe and effective use of the medication.

What to Avoid

There are no specific contraindications, controlled substance classifications, or concerns regarding abuse, misuse, or dependence associated with this medication. Additionally, there are no explicit instructions indicating that you should not take or use this medication. Always consult with your healthcare provider for personalized advice and to ensure this medication is appropriate for you.

Side Effects

It's important to keep this medication out of reach of children to prevent any accidental ingestion. While there are no specific side effects or adverse reactions listed, always consult with your healthcare provider if you have any concerns or experience unusual symptoms after taking the medication. Your safety is a priority, so be sure to follow any guidance provided by your doctor or pharmacist.

Warnings and Precautions

It's important to keep this medication out of reach of children to prevent accidental ingestion, which can be dangerous. Always store it in a safe place where children cannot access it.

If you have any concerns or experience unusual symptoms while using this medication, stop using it and call your doctor for advice. Your health and safety are the top priority, so don’t hesitate to seek help 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

There is currently no specific information available regarding the use of Simethicone 125 mg 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's important to consult with your healthcare provider before taking any medication, including Simethicone. They can help you weigh the potential benefits and risks based on your individual health needs.

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. Additionally, there is no information indicating that Simethicone is excreted in breast milk or that it poses any risk to your infant. This means you can use it without concern for affecting your milk production or your baby's health.

Pediatric Use

It's important to keep this medication out of reach of children to ensure their safety. If your child needs to take it, they should thoroughly chew 1-2 tablets after meals and at bedtime, but make sure they do not exceed 4 tablets in a single day. Always monitor their intake to prevent any potential issues.

Geriatric Use

While there is no specific information about the use of Simethicone 125 mg in older adults, it's always important to approach any medication with caution, especially if you or your loved ones are elderly. Since the drug insert does not mention dosage adjustments or safety concerns for this age group, it’s advisable to consult with a healthcare provider before starting this medication. They can help ensure that it’s appropriate for your individual health needs and circumstances.

Always keep in mind that older adults may have different responses to medications, so discussing any potential risks or benefits with a doctor is a wise step.

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 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 reported 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, and helps avoid any potential issues.

Always keep your healthcare provider informed about any changes in your health or medications. They can provide personalized advice and monitor your treatment to ensure the best outcomes for your health.

Storage and Handling

To ensure the best performance of your product, store it at room temperature, ideally between 15° and 30°C (59° and 86°F). 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

You should take this medication orally by thoroughly chewing 1-2 tablets as needed after meals and at bedtime. It's important not to exceed 4 tablets in a single day to ensure your safety and effectiveness of the treatment. If you have any questions or concerns about how to use this medication, be sure to consult with your healthcare provider.

FAQ

What is Simethicone?

Simethicone is an antiflatulent medication that comes in 125 mg chewable tablets, designed to relieve bloating, pressure, and fullness commonly referred to as gas.

How should I take Simethicone?

You should thoroughly chew 1-2 tablets as needed after meals and at bedtime, but do not take more than 4 tablets per day.

Are there any contraindications for using Simethicone?

There are no contraindications listed for Simethicone in the provided information.

Is Simethicone safe to use during pregnancy?

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

Can nursing mothers use Simethicone?

There are no specific warnings or recommendations regarding the use of Simethicone in nursing mothers mentioned in the insert.

What should I do if I have children at home?

Keep Simethicone out of reach of children to ensure their safety.

What is the storage requirement for Simethicone?

Store Simethicone at room temperature between 15°-30°C (59°-86°F).

Are there any known drug interactions with Simethicone?

No drug interactions are listed in the provided information for Simethicone.

Packaging Info

Below are the non-prescription pack sizes of Simethicone 125 mg (simethicone). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Simethicone 125 mg.
Details

Drug Information (PDF)

This file contains official product information for Simethicone 125 mg, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)

Description

Simethicone, an antiflatulent, is formulated at a strength of 125 mg per chewable tablet. Each bottle contains 60 chewable tablets. This product is identified by the National Drug Code (NDC) 69618-032-06 and is comparable to the active ingredient found in Mylanta® Gas Maximum Strength.

Uses and Indications

This drug is indicated for the relief of bloating, pressure, and fullness commonly associated with gas.

There are no teratogenic or nonteratogenic effects reported for this medication.

Dosage and Administration

Healthcare professionals should instruct patients to thoroughly chew 1 to 2 tablets as needed after meals and at bedtime. The total daily dosage should not exceed 4 tablets. It is important to ensure that patients adhere to this dosing regimen to avoid potential overdose.

Contraindications

There are no contraindications listed for the use of this product. It is important to evaluate each patient's individual circumstances and medical history when considering treatment options.

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 the importance of proper storage and handling of the medication. This precaution is essential to safeguard against potential adverse effects that may arise from unintentional exposure in pediatric populations.

In addition, healthcare providers are encouraged to discuss the risks associated with improper use and to provide guidance on safe storage practices. Regular reminders about the importance of keeping medications secured can further enhance patient safety.

Side Effects

Patients should be advised to keep this medication out of reach of children. This warning is critical to prevent accidental ingestion or misuse, which could lead to serious consequences. No specific adverse reactions have been reported in clinical trials or postmarketing experiences beyond this precaution.

Drug Interactions

There are no known 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 125 mg (simethicone). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Simethicone 125 mg.
Details

Pediatric Use

Pediatric patients should be advised to keep this medication out of reach of children. For those who are able to safely use the tablets, the recommended dosage is to thoroughly chew 1-2 tablets as needed after meals and at bedtime, with a maximum of 4 tablets per day. Care should be taken to ensure that the dosage does not exceed the recommended limits.

Geriatric Use

There is no specific information regarding the use of Simethicone 125 mg 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 efficacy and potential adverse effects is advisable in this population, given the lack of targeted clinical findings for geriatric use.

Pregnancy

There is no specific information regarding the use of Simethicone 125 mg 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 are no specific warnings or recommendations regarding the use of Simethicone in lactating mothers. Additionally, there is no information available about the potential for excretion of Simethicone in breast milk or any associated risks to breastfed infants.

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 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 data, 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, consultation with a poison control center may provide valuable guidance in the management of potential overdosage cases.

Continued vigilance and patient assessment are crucial in ensuring safety and effective management in instances of 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 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 various package configurations, with specific NDC numbers available for identification. It should be stored at room temperature, within the range of 15° to 30°C (59° to 86°F). Care should be taken to ensure that the product is kept in a suitable container to maintain its integrity. Special handling requirements should be observed to prevent exposure to extreme temperatures or conditions that may compromise the product's quality.

Additional Clinical Information

The medication is administered orally, with patients advised to thoroughly chew 1-2 tablets as needed after meals and at bedtime. It is important for patients not to exceed a total of 4 tablets per day. 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 125 mg, 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 125 mg, 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.