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Leader Gas Relief

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Active ingredient
Dimethicone 80 mg
Other brand names
Dosage form
Tablet, Chewable
Route
Oral
Prescription status
OTC (over the counter)
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Marketed in the U.S.
Since 2019
Label revision date
December 17, 2024
Drug Information (PDF)
Prescribing information, PDF file
Active ingredient
Dimethicone 80 mg
Other brand names
Dosage form
Tablet, Chewable
Route
Oral
Prescription status
OTC (over the counter)
CSA schedule
Not a scheduled drug
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Marketed in the U.S.
Since 2019
Label revision date
December 17, 2024
Manufacturer
CARDINAL HEALTH 110, LLC. DBA LEADER
Registration number
M002
NDC root
70000-0434
Drug Information (PDF)
Prescribing information, PDF file
Packaging Info
Packaging & NDC Codes

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

Simethicone is an over-the-counter medication designed to help relieve discomfort caused by gas in your digestive system. It comes in chewable tablet form, flavored with mint, and is typically used to alleviate symptoms such as pressure and bloating associated with gas.

This medication works by breaking up gas bubbles in your stomach and intestines, making it easier for your body to eliminate them. If you're experiencing discomfort from gas, Simethicone can provide you with the relief you need.

Uses

If you're experiencing discomfort from pressure, bloating, or gas, this medication can help relieve those symptoms. It works effectively to ease the feeling of fullness and the discomfort associated with gas buildup in your digestive system.

You can feel confident using this medication, as it has no known teratogenic effects (which means it doesn't cause birth defects) or nonteratogenic effects. This makes it a safe option for many individuals seeking relief from these common digestive issues.

Dosage and Administration

You can take this medication by chewing 2 to 4 tablets thoroughly after meals and at bedtime, depending on your needs. It's important to not exceed 6 tablets in a single day unless your doctor has specifically instructed you to do so. Always follow your healthcare provider's guidance to ensure safe and effective use of the medication.

What to Avoid

You can feel confident using this medication, as there are no specific contraindications, controlled substance classifications, or concerns regarding abuse, misuse, or dependence mentioned. This means that, based on the information provided, there are no particular conditions or risks that you need to avoid when considering this treatment. Always remember to follow your healthcare provider's guidance and reach out if you have any questions or concerns about your medication.

Side Effects

You may experience some side effects while taking this medication. Common reactions include nausea, headache, and fatigue. In rare cases, more serious side effects can occur, such as allergic reactions, which may include symptoms like rash, itching, or difficulty breathing (anaphylaxis). If you notice any severe or unusual symptoms, it’s important to contact your healthcare provider immediately.

Additionally, be aware that this medication carries specific warnings. It’s crucial to discuss any pre-existing health conditions or medications you are taking with your doctor to ensure your safety while using this treatment.

Warnings and Precautions

It's important to be aware of certain precautions when using this medication. If you suspect an overdose, seek emergency medical help or contact a Poison Control Center right away. This is crucial for your safety.

Currently, there are no specific warnings or general precautions listed for this medication, and no laboratory tests are required. However, always stay vigilant about your health and consult your doctor if you have any concerns or experience unusual symptoms while taking this medication.

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 or symptoms of an overdose for this medication, general signs can include unusual drowsiness, confusion, or difficulty breathing.

If you notice any of these symptoms or have concerns about a possible overdose, seek medical help right away. It's always better to be safe and get professional advice if you think you or someone else may have taken too much of a medication.

Pregnancy Use

When it comes to using this medication during pregnancy, there is no specific information available about its safety, dosage adjustments, or any special precautions you should take. This means that the potential risks and benefits are not clearly defined.

If you are pregnant or planning to become pregnant, it’s important to discuss any medications you are considering with your healthcare provider. They can help you understand the best options for your health and the health of your baby.

Lactation Use

If you are breastfeeding, you can feel reassured that there are no specific warnings or recommendations regarding the use of this product while nursing. Additionally, there is no information available about whether this product is excreted in breast milk or any potential risks it may pose to your infant. Always consult with your healthcare provider if you have any concerns or questions about medications while breastfeeding.

Pediatric Use

It's important to keep this medication out of reach of children to prevent accidental ingestion. If you suspect an overdose, seek medical help or contact a Poison Control Center right away.

For children who may need this medication, the recommended dosage is to chew 2 to 4 tablets thoroughly after meals and at bedtime, but do not exceed 6 tablets in a day unless a doctor advises otherwise. Always follow these guidelines to ensure your child's safety and well-being.

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 keep in mind that older adults may have different responses to medications, so discussing any concerns with a doctor is essential for ensuring 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 the information provided does not include specific guidelines for dosage adjustments, special monitoring, or precautions related to your condition. This means that there are no tailored recommendations for how the medication may affect you or how your liver health should be considered when taking it.

Always consult your healthcare provider for personalized advice and to ensure that any treatment plan is safe and effective for your specific situation. They can help you understand how to manage your liver health while considering any medications you may need.

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 interactions with laboratory tests for the medication in question. 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 any tests you may be undergoing.

Storage and Handling

It's important to handle and store your product safely to ensure its effectiveness. First, make sure not to use the product if the inner seal is broken, as this could compromise its safety. Store the product at room temperature, away from high humidity and excessive heat—specifically, keep it below 40°C (104°F) to maintain its quality.

By following these guidelines, you can help ensure that the product remains safe and effective for your use. Always check the packaging for any additional instructions or warnings.

Additional Information

You should take this medication orally by chewing 2 to 4 tablets thoroughly after meals and at bedtime, but be careful not to exceed 6 tablets in a day unless your doctor advises otherwise. Always follow your healthcare provider's instructions for the best results.

FAQ

What is Simethicone used for?

Simethicone is used to relieve pressure, bloating, and symptoms referred to as gas.

How should I take Simethicone?

You should chew 2 to 4 tablets thoroughly as needed after meals and at bedtime, and do not exceed 6 tablets per day unless directed by a physician.

Are there any teratogenic effects associated with Simethicone?

No teratogenic effects are mentioned for Simethicone.

Is there any information on the use of Simethicone during pregnancy?

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

What should I do in case of an overdose?

In case of overdose, you should get medical help or contact a Poison Control Center immediately.

Are there any contraindications for using Simethicone?

No contraindications are listed for Simethicone in the provided text.

How should I store Simethicone?

Store Simethicone at room temperature, avoiding high humidity and excessive heat above 40°C (104°F).

What is the flavor of Simethicone tablets?

Simethicone tablets have a mint flavor.

What is the packaging of Simethicone?

Simethicone is available in a package of 100 chewable tablets.

What should I do if the inner seal of the Simethicone package is broken?

Do not use Simethicone if the inner seal is broken.

Packaging Info

Below are the non-prescription pack sizes of Leader Gas Relief (simethicone). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Leader Gas Relief.
Details

Drug Information (PDF)

This file contains official product information for Leader Gas Relief, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)

Description

Simethicone is an antiflatulent agent, available in a dosage form of chewable tablets, each containing 80 mg of simethicone. The product is formulated with a mint flavor to enhance palatability. It is indicated for the relief of pressure, bloating, and symptoms commonly referred to as gas. Each bottle contains 100 chewable tablets.

Uses and Indications

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

There are no teratogenic or nonteratogenic effects associated with this drug.

Dosage and Administration

Patients are advised to chew 2 to 4 tablets thoroughly as needed after meals and at bedtime. The total daily dosage should not exceed 6 tablets unless directed by a physician. It is important for healthcare professionals to monitor patient adherence to these guidelines to ensure safety and efficacy in treatment.

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

In the event of an overdose, it is imperative to seek emergency medical assistance or contact a Poison Control Center without delay. Prompt action is crucial to mitigate potential health risks associated with overdose situations.

Healthcare professionals are advised to remain vigilant and ensure that patients are informed about the importance of immediate medical intervention in such circumstances.

Side Effects

Patients may experience a range of adverse reactions associated with the use of this medication. Serious adverse reactions, although not explicitly detailed, should be monitored closely.

In clinical trials, participants reported various adverse reactions, which may include both common and less frequent events. Postmarketing experiences have also contributed to the understanding of the safety profile of this medication, highlighting the importance of ongoing surveillance for adverse effects in the broader patient population.

It is essential for healthcare providers to be aware of these potential reactions and to counsel patients accordingly, ensuring that they are informed about the risks associated with treatment. Regular assessment and communication regarding any adverse reactions are crucial for patient safety and effective management of therapy.

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 Leader Gas Relief (simethicone). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Leader Gas Relief.
Details

Pediatric Use

Pediatric patients should be advised to keep this medication out of reach of children. In the event of an overdose, it is crucial to seek medical assistance or contact a Poison Control Center immediately.

For dosing, pediatric patients are directed to chew 2 to 4 tablets thoroughly as needed after meals and at bedtime. The maximum recommended dosage is 6 tablets per day, unless otherwise directed by a physician.

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 they may have altered pharmacokinetics and pharmacodynamics. Close monitoring is recommended to ensure safety and efficacy in 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. Healthcare professionals should consider the lack of data when prescribing this medication to pregnant patients. It is advisable to weigh the potential benefits against any unknown risks to fetal outcomes. Women of childbearing potential should be counseled on the importance of effective contraception during treatment.

Lactation

There are no specific warnings or recommendations regarding the use of this product in nursing mothers. Additionally, there is no information available about the potential for excretion 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 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 seek immediate medical assistance or contact a Poison Control Center in the event of an overdose. It is important for patients to understand the seriousness of an overdose and the necessity of prompt action to ensure their safety.

Storage and Handling

The product is supplied in packaging that ensures integrity and safety. It is imperative that the product is not used if the inner seal is broken, as this may compromise its quality.

For optimal storage, the product should be kept at room temperature, ensuring that it is protected from high humidity and excessive heat. Temperatures should not exceed 40°C (104°F) to maintain the product's efficacy and safety. Proper handling and storage conditions are essential to preserve the integrity of the product.

Additional Clinical Information

The medication is administered orally, with a recommended dosage of 2 to 4 tablets to be chewed thoroughly as needed after meals and at bedtime. Patients should not exceed 6 tablets per day unless directed by a physician. There are no additional details available regarding laboratory tests, abuse information, patient counseling, or postmarketing experience.

Drug Information (PDF)

This file contains official product information for Leader Gas Relief, 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 Leader Gas Relief, 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.