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Extra Strength Gas Relief

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Active ingredient
Dimethicone 125 mg
Other brand names
Dosage form
Capsule
Route
Oral
Prescription status
OTC (over the counter)
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Marketed in the U.S.
Since 2023
Label revision date
February 11, 2025
Drug Information (PDF)
Prescribing information, PDF file
Active ingredient
Dimethicone 125 mg
Other brand names
Dosage form
Capsule
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 2023
Label revision date
February 11, 2025
Manufacturer
KROGER COMPANY
Registration number
M001
NDC root
41226-722
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 a medication available in 125mg capsules that helps relieve discomfort caused by gas in your digestive system. It works by breaking up gas bubbles in the stomach and intestines, which can help reduce feelings of pressure, bloating, and fullness. If you're experiencing these symptoms, simethicone may provide you with the relief you need.

Uses

You can use this medication to help relieve the discomfort of pressure, bloating, and fullness that is often caused by gas. It’s designed to make you feel more comfortable when you experience these common digestive issues.

Rest assured, there are no known teratogenic effects (which means it doesn’t cause birth defects) associated with this medication, making it a safer option for those who may be concerned about such risks.

Dosage and Administration

You can take this medication by swallowing 1 or 2 softgels with water after meals and at bedtime if you need it. This is suitable for adults and children aged 12 years and older.

It's important not to exceed 4 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

It's important to keep this medication out of reach of children to ensure their safety. There are no specific contraindications, controlled substance classifications, or concerns regarding abuse, misuse, or dependence associated with this medication. Always follow the guidance provided by your healthcare professional and use the medication responsibly.

Side Effects

It's important to be aware of potential side effects when taking this medication. Some serious side effects may occur, which could require immediate medical attention. Common adverse reactions include symptoms that many people experience, but they can vary in severity.

In addition to these, there are other reactions that you should be mindful of. If you notice anything unusual or concerning while using this medication, it's best to consult your healthcare provider for guidance.

Warnings and Precautions

It’s important to be aware of potential warnings associated with your medication. If you experience any unusual symptoms or reactions, please seek medical attention promptly.

While there are no specific general precautions or laboratory tests mentioned, it’s always a good idea to discuss any concerns with your healthcare provider. If you have questions about your treatment or notice anything concerning, don’t hesitate to reach out to your doctor for guidance.

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, or if you are unsure, 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 about the use of EXTRA STRENGTH GAS RELIEF (simethicone capsule) 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 is always best to consult with your healthcare provider before taking any medication, including over-the-counter products like simethicone. They can provide personalized advice based on your health needs and circumstances.

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 simethicone without concern for its effects on 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. For adults and children aged 12 years and older, the recommended dosage is to swallow 1 or 2 softgels with water after meals and at bedtime. However, you should not exceed 4 softgels in a 24-hour period unless directed by a doctor. Always consult with a healthcare professional if you have any questions or concerns about using this medication for yourself or your child.

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 to using this medication safely and effectively, taking into account any unique health needs or conditions that may be present. Always prioritize open communication with your healthcare team to ensure the best outcomes.

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 monitor your liver function and determine the best approach for your treatment.

Make sure to keep your doctor informed about your liver health, as they may need 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 you are taking, even if there are no specific drug interactions or laboratory test interactions noted for your treatment. This ensures that your healthcare team can monitor your health effectively and make informed decisions about your care.

Always feel free to ask questions and share all the medications and supplements you are using. This way, you can work together to ensure your treatment is safe and effective.

Storage and Handling

To ensure the best performance of your product, store it at room temperature. 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.

Additional Information

No further information is available.

FAQ

What is Simethicone used for?

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

What is the recommended dosage for adults and children 12 years and older?

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 teratogenic effects associated with Simethicone?

No teratogenic effects are mentioned for Simethicone.

Is there any specific information regarding the use of Simethicone during pregnancy?

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

What precautions should I take when using Simethicone?

Keep Simethicone out of reach of children and store it at room temperature, protected from light, heat, and moisture.

Are there any known drug interactions with Simethicone?

No specific drug interactions are mentioned for Simethicone.

Can nursing mothers use Simethicone?

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

Packaging Info

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

Packaging configurations for Extra Strength Gas Relief.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

722T_Kroger_Simethicone capsules contain 125 mg of simethicone as the active ingredient. These capsules are formulated to alleviate symptoms associated with excess gas in the gastrointestinal tract. The product is presented in a capsule dosage form, designed for oral administration.

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 and children 12 years and older may take 1 or 2 softgels as needed after meals and at bedtime. The softgels should be swallowed with water. It is important not to exceed a total of 4 softgels within a 24-hour period, unless directed otherwise by a physician.

Contraindications

Use of this product is contraindicated in children due to the risk of accidental ingestion. It should be kept out of reach of children to prevent potential harm. No other contraindications have been identified.

Warnings and Precautions

Warning: Healthcare professionals should be aware of the potential risks associated with the use of this medication. It is imperative to evaluate the patient's medical history and current health status prior to prescribing.

General precautions should be considered, although specific guidelines are not provided in the current documentation. Clinicians are encouraged to exercise clinical judgment and consider individual patient factors when determining the appropriateness of this treatment.

No laboratory tests or monitoring parameters have been specified in the available information. However, healthcare providers should remain vigilant and consider appropriate assessments based on the patient's condition and response to therapy.

In the absence of specific instructions regarding emergency medical help or directives to discontinue use, healthcare professionals should maintain open communication with patients, ensuring they are informed about any concerning symptoms that may arise during treatment.

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 overall well-being of participants. These reactions are typically mild to moderate in severity and may resolve with continued treatment or upon discontinuation of the medication.

In addition to the common and serious adverse reactions, there are additional adverse reactions or important notes that healthcare providers should be aware of. These may arise from postmarketing experiences and should be considered when evaluating the risk-benefit profile of the medication for individual patients.

Healthcare professionals are encouraged to report any adverse reactions to ensure ongoing safety monitoring and to contribute to the understanding of the medication's profile in diverse patient populations.

Drug Interactions

There are no specific drug interactions or laboratory test interactions identified in the available data. Therefore, no dosage adjustments or monitoring recommendations are necessary at this time.

Packaging & NDC

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

Packaging configurations for Extra Strength Gas Relief.
Details

Pediatric Use

Pediatric patients should be kept out of reach of children. For adolescents aged 12 years and older, the recommended dosage is 1 or 2 softgels taken with water after meals and at bedtime, not to exceed 4 softgels in a 24-hour period unless directed by a physician. Caution is advised to ensure that the dosage does not exceed the recommended limits without medical supervision.

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 is no specific information regarding the use of EXTRA STRENGTH GAS RELIEF (simethicone capsule) during pregnancy. The prescribing information does not provide safety concerns, dosage modifications, or special precautions for pregnant patients. Therefore, healthcare professionals should exercise caution when considering the use of this medication in pregnant women, as the absence of data does not imply safety. It is advisable to weigh the potential benefits against any unknown risks to fetal outcomes. Women of childbearing potential should be informed of the lack of established safety data when discussing treatment options.

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 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 information is available regarding teratogenic or non-teratogenic effects. Additionally, there is no data provided concerning nonclinical toxicology, animal pharmacology, or toxicology.

Postmarketing Experience

No postmarketing experience details are available in the insert text.

Patient Counseling

Healthcare providers should advise patients to keep the 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 children.

Storage and Handling

The product is supplied in various package configurations, with specific NDC numbers available for identification. It is essential to store the product at room temperature to maintain its integrity. Additionally, the product must be protected from light, heat, and moisture to ensure optimal stability and efficacy. Proper handling and storage conditions are crucial for preserving the quality of the product throughout its shelf life.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

This file contains official product information for 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 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

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.