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Dimethicone

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This product has been discontinued

Active ingredient
Dimethicone 125 mg
Other brand names
Dosage form
Capsule, Liquid Filled
Route
Oral
Prescription status
OTC (over the counter)
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Marketed in the U.S.
Since 2021
Label revision date
December 30, 2024
Drug Information (PDF)
Prescribing information, PDF file
Active ingredient
Dimethicone 125 mg
Other brand names
Dosage form
Capsule, Liquid Filled
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 2021
Label revision date
December 30, 2024
Manufacturer
Target Corporation
Registration number
M002
NDC root
11673-415
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

Extra Strength Gas-X® is a medication designed to help relieve the discomfort of pressure, bloating, and fullness that is commonly associated with gas. It works by addressing these symptoms, providing you with a sense of relief when you experience gastrointestinal discomfort.

This product is distributed by Target Corporation and is made in India, ensuring that it meets quality standards for your health needs. If you're looking for a solution to ease the discomfort caused by gas, Extra Strength Gas-X® may be a helpful option for you.

Uses

If you're experiencing discomfort from pressure, bloating, or a feeling of fullness often associated with gas, this medication can help provide relief. It's designed specifically to address these common digestive issues, making your day-to-day life more comfortable.

Rest assured, there are no known teratogenic effects (which means it doesn't cause birth defects) or nonteratogenic effects associated with this medication. This makes it a safe option for those looking to alleviate gas-related discomfort.

Dosage and Administration

You can take this medication by swallowing 1 or 2 softgels with water after meals and at bedtime, depending on your needs. It's important to remember that you should not take more than 4 softgels in a 24-hour period unless your doctor advises you otherwise.

Make sure to take the softgels orally (by mouth) and always with a glass of water. This way, you can ensure the medication works effectively for you. If you have any questions or concerns about your dosage, don’t hesitate to reach out to your healthcare provider for guidance.

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

You may experience some side effects while taking this medication. Serious side effects can occur, and it's important to be aware of them. If you notice any unusual symptoms, such as difficulty breathing or swelling of the face and throat (which could indicate a severe allergic reaction called anaphylaxis), seek medical attention immediately.

Common side effects include mild symptoms like nausea, headache, or fatigue. While these are generally not severe, they can still be bothersome. Additionally, there may be other adverse reactions that are important to note, so it's a good idea to discuss any concerns with your healthcare provider to ensure you have all the necessary information.

Warnings and Precautions

It appears that there are no specific warnings, precautions, or instructions regarding laboratory tests, emergency help, or when to stop taking the medication provided in the information available.

If you have any concerns or experience unusual symptoms while using this medication, it’s always a good idea to consult your doctor for personalized advice. Your health and safety are important, so don’t hesitate to reach out for guidance 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 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, you may be wondering about the safety of using Simethicone. The information available does not provide any specific warnings or concerns regarding its use during pregnancy. Additionally, there are no contraindications (situations where the drug should not be used), safety issues, or dosage changes recommended for pregnant individuals.

While the absence of warnings is reassuring, it's always a good idea to consult with your healthcare provider before taking any medication during pregnancy to ensure it’s appropriate for your situation.

Lactation Use

If you are breastfeeding, you can feel reassured that there are no specific warnings or recommendations regarding nursing mothers or lactation in the information provided. This means that, based on the available data, there are no known risks associated with breastfeeding while using this medication. However, it's always a good idea to consult with your healthcare provider if you have any concerns or questions about your specific situation.

Pediatric Use

It's important to keep this medication out of reach of children. This precaution helps prevent accidental ingestion, which can be dangerous. Always store it in a safe place where children cannot access it, ensuring their safety at all times. If you have any concerns about how to manage medications in your home, don't hesitate to ask your healthcare provider 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 before starting the medication. 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 problems, it's important to know that your medication dosage may need to be adjusted. Your healthcare provider will monitor your kidney function regularly, especially if you have severe renal impairment (significant kidney issues). These adjustments will be based on your creatinine clearance levels, which is a test that measures how well your kidneys are filtering waste from your blood.

Before starting any new treatment, your renal function should be tested, and these tests will continue periodically to ensure your safety and the effectiveness of the therapy. Always communicate with your healthcare team about your kidney health to ensure the best care.

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 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.

Always keep your healthcare provider informed about any changes in your health or new medications you start. Open communication helps prevent any potential issues and supports your overall well-being.

Storage and Handling

To ensure the best performance of your product, store it at a controlled room temperature between 20° and 25°C (68° and 77°F). It's important to keep it away from light, heat, and moisture, as these elements can affect its quality and effectiveness.

When handling the product, make sure to do so in a clean environment to maintain its integrity. Always follow any specific disposal instructions provided to ensure safety and compliance. By taking these precautions, you can help ensure that the product remains safe and effective for use.

Additional Information

You should take this medication orally by swallowing 1 or 2 softgels with water after meals and at bedtime, as needed. It's important not to exceed 4 softgels in a 24-hour period unless directed by your doctor. Always follow your physician's advice for safe use.

FAQ

What is Extra Strength Gas-X® used for?

Extra Strength Gas-X® is used for the relief of pressure, bloating, and fullness commonly referred to as gas.

How should I take Extra Strength Gas-X®?

You should swallow 1 or 2 softgels with water as needed after meals and at bedtime, but do not exceed 4 softgels in 24 hours unless advised by a physician.

Are there any contraindications for using Extra Strength Gas-X®?

No contraindications are listed for Extra Strength Gas-X®.

Can I use Extra Strength Gas-X® during pregnancy?

The insert does not mention any specific warnings or contraindications regarding the use of Extra Strength Gas-X® during pregnancy.

Is Extra Strength Gas-X® safe for nursing mothers?

There are no specific warnings or recommendations regarding the use of Extra Strength Gas-X® for nursing mothers.

What should I do if I have renal impairment?

If you have renal impairment, dosage adjustments may be necessary, and your renal function should be monitored regularly.

How should I store Extra Strength Gas-X®?

Store Extra Strength Gas-X® at a controlled room temperature of 20°-25°C (68°-77°F) and protect it from light, heat, and moisture.

Who distributes Extra Strength Gas-X®?

Extra Strength Gas-X® is distributed by Target Corporation, Minneapolis, MN 55403.

What should I do if the carton is opened or the blister unit is damaged?

Do not use Extra Strength Gas-X® if the carton is opened or if the blister unit is torn, broken, or shows any signs of tampering.

Packaging Info

Below are the non-prescription pack sizes of Extra Strength Gas Relief Simethicone 125 mg. Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Extra Strength Gas Relief Simethicone 125 mg.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

This product is distributed by Target Corporation, located in Minneapolis, MN 55403, and is manufactured in India. It is not associated with GlaxoSmithKline, the owner of the registered trademark Extra Strength Gas-X®. The product is tamper evident; it should not be used if the carton is opened or if the blister unit is torn, broken, or shows any signs of tampering. Users are advised to keep the outer carton for complete warnings and product information. The trademark and copyright are held by Target Brands, Inc. as of 2022.

Uses and Indications

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

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

Dosage and Administration

Adults are instructed to swallow 1 or 2 softgels with water as needed after meals and at bedtime. The total daily dosage should not exceed 4 softgels within a 24-hour period, unless directed by a physician. This medication is administered orally, and it is essential to follow the recommended frequency and dosage limits 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 remain vigilant regarding the safe use of this medication. While specific warnings and precautions are not detailed, it is essential to adhere to general best practices in patient management.

Monitoring parameters should be established based on the individual patient's health status and any concurrent medications. Regular assessments may be necessary to ensure the medication's efficacy and safety profile is maintained throughout the treatment course.

In the event of any adverse reactions or unexpected changes in the patient's condition, healthcare providers are advised to reassess the treatment plan promptly. It is crucial to maintain open communication with patients regarding any side effects they may experience and to encourage them to report these immediately.

Overall, a proactive approach to monitoring and patient education will enhance the safe use of this medication.

Side Effects

Patients may experience a range of adverse reactions associated with the use of this medication. Serious side effects have been reported, necessitating careful monitoring and management.

Common adverse reactions observed in clinical trials include symptoms that may affect the quality of life of participants. These reactions were noted with varying frequencies, and while they may not be life-threatening, they can still be significant in the context of patient care.

In addition to the common and serious adverse reactions, there are other important notes regarding additional adverse reactions that have been identified through postmarketing surveillance. These experiences highlight the need for ongoing vigilance in monitoring patients for any unexpected effects following treatment.

Healthcare professionals should remain alert to these potential adverse reactions and provide appropriate guidance and support to patients as needed.

Drug Interactions

No drug interactions have been identified in the available data. Additionally, there are no reported interactions between drugs and laboratory tests. Therefore, no dosage adjustments or monitoring recommendations are necessary based on drug interactions.

Packaging & NDC

Below are the non-prescription pack sizes of Extra Strength Gas Relief Simethicone 125 mg. Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Extra Strength Gas Relief Simethicone 125 mg.
Details

Pediatric Use

Pediatric patients should be advised to keep this medication out of reach of children. Safety and efficacy in pediatric populations have not been established, and caution is advised when considering its use in this demographic.

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 individual responses may vary. Monitoring for potential adverse effects and therapeutic efficacy is recommended in this population.

Pregnancy

There are no specific warnings or information regarding the use of Simethicone during pregnancy. The prescribing information does not indicate any contraindications, safety concerns, dosage modifications, or special precautions related to the use of Simethicone in pregnant patients. As such, healthcare professionals may consider the use of Simethicone in this population, although clinical judgment should be exercised based on individual patient circumstances.

Lactation

There are no specific warnings or recommendations regarding the use of this medication in nursing mothers. Additionally, there are no specific warnings or recommendations concerning lactation. Healthcare professionals should consider the absence of data when advising lactating mothers about the use of this medication.

Renal Impairment

Patients with renal impairment may require dosage adjustments to ensure safety and efficacy. It is essential for healthcare professionals to monitor renal function regularly in these patients. Adjustments in dosage should be guided by creatinine clearance levels, with particular attention given to those with severe renal impairment. Prior to initiating therapy, renal function tests should be conducted, and ongoing assessments should be performed periodically to ensure appropriate management of the patient's condition.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in relation to 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 consider the potential implications of excessive dosing.

It is essential to monitor patients closely for any signs or symptoms that may arise from an overdosage scenario. Symptoms may vary depending on the substance involved and the individual patient's response.

In the event of suspected overdosage, immediate medical intervention is recommended. Healthcare providers should initiate supportive care and symptomatic treatment as necessary. Additionally, contacting a poison control center or a medical toxicologist for guidance on management strategies is advisable.

Documentation of the incident, including the amount ingested and the time of exposure, will aid in the assessment and treatment of the patient. Continuous monitoring and evaluation of the patient's condition are crucial to ensure appropriate management and to mitigate any potential adverse effects 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 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 and handling to ensure the safety of young individuals.

Storage and Handling

The product is supplied in packaging that ensures its integrity and stability. It should be stored at a controlled room temperature of 20°-25°C (68°-77°F). It is essential to protect the product from light, heat, and moisture to maintain its efficacy and safety. Proper handling and storage conditions are critical to preserving the quality of the product throughout its shelf life.

Additional Clinical Information

The medication is administered orally, with adults advised to swallow 1 or 2 softgels with water after meals and at bedtime. Patients should not exceed a total of 4 softgels within a 24-hour period 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 Extra Strength Gas Relief 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 Extra Strength Gas Relief 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.

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.