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Topcare Extra Strength Gas Relief

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Active ingredient
Dimethicone, Unspecified 125 mg
Other brand names
Dosage form
Tablet, Chewable
Route
Oral
Prescription status
OTC (over the counter)
Marketed in the U.S.
Since 2019
Label revision date
November 10, 2025
Active ingredient
Dimethicone, Unspecified 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 2019
Label revision date
November 10, 2025
Manufacturer
TOPCO ASSOCIATES LLC
Registration number
M002
NDC root
36800-488

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If you are a consumer or patient please visit this version.

Drug Overview

TopCare Extra Strength Simethicone is a chewable medication that contains 125 mg of simethicone, which is designed to help relieve the discomfort associated with gas. If you experience pressure, bloating, or fullness due to gas, this product can provide fast relief. It comes in a pleasant cherry crème flavor and is available in a pack of 48 chewable tablets, making it easy to take when you need it.

Uses

If you're experiencing discomfort from gas, such as pressure, bloating, or a feeling of fullness, this medication can help provide relief. It's designed to quickly ease those uncomfortable sensations associated with gas, allowing you to feel more at ease.

You can trust that this medication does not have any known harmful effects on developing babies (teratogenic effects), making it a safer option for those who may be pregnant.

Dosage and Administration

You can take this medication by chewing 1 to 2 tablets after meals and at bedtime, depending on your needs. It's important to remember not to exceed 4 tablets in a 24-hour period unless your doctor has advised you otherwise. Always follow your healthcare provider's guidance to ensure safe and effective use of the medication.

What to Avoid

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, there are no particular situations or conditions under which you should avoid using it. Always consult with your healthcare provider for personalized advice and to ensure that this medication is appropriate for your individual health needs.

Side Effects

It's important to be aware of potential side effects when using this medication. While specific adverse reactions are not detailed here, you should always consult your healthcare provider for a comprehensive understanding of what to expect.

Additionally, please remember to keep this medication out of reach of children to ensure their safety. If you have any concerns or experience unusual symptoms, contact your doctor promptly.

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 safely and ensure that children cannot access it.

If you have any concerns or experience unusual symptoms while using this medication, stop use immediately and contact your doctor for guidance. Your health and safety are the top priority, so don’t hesitate to seek help if needed.

Overdose

It appears that there is no specific information available regarding overdosage for this medication. However, it's important to be aware of the general signs of an overdose, which can include symptoms like extreme drowsiness, confusion, or difficulty breathing. If you suspect an overdose, it is crucial to seek immediate medical help.

In case of an emergency, call your local emergency number or go to the nearest hospital. Always keep medications out of reach of children and follow the prescribed dosage to prevent any potential risks. If you have any concerns or questions about your medication, don’t hesitate to reach out to your healthcare provider for guidance.

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 to ensure the best care for you and 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. Currently, there is no information available about whether this product is excreted in breast milk or if it poses any risk to your infant.

As always, it's a good idea to consult with your healthcare provider if you have any concerns or questions about using any medication while breastfeeding. Your health and the health of your baby are important, and your provider can help you make informed decisions.

Pediatric Use

It's important to keep this medication out of reach of children to ensure their safety. For adults, the recommended dosage is to chew 1 to 2 tablets as needed after meals and at bedtime, but you should not exceed 4 tablets in a 24-hour period unless directed by a doctor.

If you have any questions about using this medication for children or if you think your child may need it, please consult with a healthcare professional for guidance.

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, it’s important to consult with a healthcare provider for personalized advice. 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 issues, 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 for the medication do not include special monitoring or safety considerations tailored for patients with renal impairment (kidney problems).

Always consult your healthcare provider for personalized advice and to ensure that any treatment plan is safe and effective for your specific health needs. They can provide guidance based on your kidney function and overall health.

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 if you have hepatic impairment (liver issues).

Always consult your healthcare provider for personalized advice and to discuss any concerns regarding your liver health and how it may relate to your treatment. They can help ensure that you receive the safest and most effective care.

Drug Interactions

It's important to have open conversations with your healthcare provider about any medications or tests you may be taking. While there are no specific drug interactions or laboratory test interactions noted for this medication, your healthcare provider can help ensure that everything you are taking works well together and is safe for you.

Always feel free to ask questions and share your complete list of medications and any lab tests you may be undergoing. This way, you can receive the best possible care tailored to your needs.

Storage and Handling

To ensure the best performance of your product, store it at room temperature. It's important to keep it away from excessive heat and moisture, as these conditions can affect its quality and safety.

When handling the product, always do so with clean hands and in a clean environment to maintain its integrity. If you have any specific disposal instructions, be sure to follow them carefully to ensure safe and responsible disposal.

Additional Information

You can take this medication orally by chewing 1 to 2 tablets as needed after meals and at bedtime. However, be sure not to exceed 4 tablets in a 24-hour period unless your doctor advises otherwise. Always follow your healthcare provider's guidance for safe use.

FAQ

What is TopCare Extra Strength Simethicone used for?

TopCare Extra Strength Simethicone is used for the relief of pressure, bloating, and fullness commonly referred to as gas.

How should I take TopCare Extra Strength Simethicone?

Adults should chew 1 to 2 tablets as needed after meals and at bedtime, but do not exceed 4 tablets in 24 hours unless advised by a physician.

Are there any contraindications for using this product?

No contraindications are listed for TopCare Extra Strength Simethicone.

Is this product safe to use during pregnancy or while nursing?

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

What should I do if the inner seal is broken or missing?

Do not use the product if the printed inner seal is broken or missing.

How should I store TopCare Extra Strength Simethicone?

Store the product at room temperature and protect it from excessive heat and moisture.

What flavor does TopCare Extra Strength Simethicone come in?

It comes in a cherry creme flavor, which is both naturally and artificially flavored.

Who distributes TopCare Extra Strength Simethicone?

It is distributed by Topco Associates LLC, located in Elk Grove Village, IL.

What should I do if I have questions about this product?

You can call 1-888-423-0139 or email topcare@topco.com for any questions.

Is there a comparison to other products?

Yes, TopCare Extra Strength Simethicone can be compared to GAS-X®.

Packaging Info

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

Packaging configurations for Topcare Extra Strength Gas Relief.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

No description information is available.

Uses and Indications

This drug is indicated for the relief of pressure, bloating, and fullness commonly referred to as gas. It provides fast relief of bloating, pressure, and discomfort associated with gas.

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

Dosage and Administration

Adults are advised to chew 1 to 2 tablets as needed after meals and at bedtime. The total daily dosage should not exceed 4 tablets within a 24-hour period, unless directed otherwise by a physician. It is essential for healthcare professionals to monitor patients for adherence to these guidelines to ensure safe and effective use of the medication.

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

It is imperative to keep this medication out of reach of children to prevent accidental ingestion or misuse. Healthcare professionals should emphasize the importance of secure storage and educate caregivers on the potential risks associated with unauthorized access to the medication.

No additional warnings, general precautions, or recommended laboratory tests have been provided; therefore, it is essential for healthcare providers to remain vigilant and ensure that patients are informed about the safe handling and storage of this medication.

Side Effects

Patients should be aware of the potential adverse reactions associated with the use of this medication. It is important to note that specific warnings are in place to ensure safe usage.

In addition, it is crucial to keep this medication out of reach of children to prevent accidental ingestion or misuse.

Healthcare providers should monitor patients for any adverse effects and provide guidance on the safe handling and storage of the medication.

Drug Interactions

There are currently no documented drug interactions or interactions with laboratory tests associated with this medication. As such, no specific recommendations for dosage adjustments or monitoring are necessary at this time. Healthcare professionals should continue to assess individual patient circumstances and consider any potential interactions based on the patient's overall medication regimen.

Packaging & NDC

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

Packaging configurations for Topcare Extra Strength Gas Relief.
Details

Pediatric Use

Pediatric patients should be advised to keep this medication out of reach of children. The recommended directions for adult use involve chewing 1 to 2 tablets as needed after meals and at bedtime, with a maximum of 4 tablets in 24 hours unless otherwise directed by a physician. There are no specific dosage recommendations provided for pediatric patients, and caution should be exercised when considering use in this population.

Geriatric Use

There is no specific information available 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.

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 the absence of established safety profiles. Women of childbearing potential should be counseled on the importance of effective contraception while using this medication.

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 data regarding dosage adjustments, special monitoring, or safety considerations. Therefore, healthcare professionals should exercise caution when prescribing to patients with reduced kidney function, as the lack of specific guidance necessitates careful clinical judgment and monitoring of these patients.

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 overdosage information, it is essential for healthcare professionals to remain vigilant regarding the potential risks associated with excessive dosing of the medication.

Healthcare providers are advised to monitor patients closely for any signs of adverse reactions or symptoms that may arise from an overdose. In the event of suspected overdosage, immediate medical intervention is recommended.

Management procedures should include supportive care tailored to the patient's clinical presentation. This may involve symptomatic treatment and monitoring of vital signs. Additionally, healthcare professionals should consult local poison control centers or relevant toxicology resources for guidance on specific management strategies based on the medication involved.

It is crucial to educate patients about the importance of adhering to prescribed dosages and to provide clear instructions on what to do in case of a missed dose or accidental 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 use of the compound in these contexts.

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, ensuring that it is protected from excessive heat and moisture to maintain its integrity and efficacy. Proper storage conditions are essential for optimal product performance.

Additional Clinical Information

The medication is administered orally, with adults advised to chew 1 to 2 tablets as needed after meals and at bedtime. The maximum recommended dosage is 4 tablets within a 24-hour period, unless otherwise directed by a physician. There is no additional information available regarding laboratory tests, abuse potential, patient counseling, or postmarketing experience.

Drug Information (PDF)

This file contains official product information for Topcare Extra Strength 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 Topcare Extra Strength 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

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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.