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Maximum Strength Gas Relief

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This product has been discontinued

Active ingredient
Dimethicone 250 mg
Other brand names
Dosage form
Capsule, Liquid Filled
Route
Oral
Prescription status
OTC (over the counter)
Marketed in the U.S.
Since 2022
Label revision date
December 13, 2024
Active ingredient
Dimethicone 250 mg
Other brand names
Dosage form
Capsule, Liquid Filled
Route
Oral
Prescription status
OTC (over the counter)
CSA schedule
Not a scheduled drug
Marketed in the U.S.
Since 2022
Label revision date
December 13, 2024
Manufacturer
Spirit Pharmaceuticals LLC
Registration number
M002
NDC root
68210-4233

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Drug Overview

Simethicone is a medication that helps relieve bloating, pressure, or fullness that is commonly associated with gas. If you experience discomfort from gas buildup in your stomach or intestines, simethicone can provide relief by helping to break up gas bubbles, making it easier for your body to eliminate them. This can lead to a more comfortable feeling in your digestive system.

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.

You can use this medication without worrying about any harmful effects on pregnancy, as there are no teratogenic effects (which means it won't cause birth defects) associated with it. Overall, it’s a straightforward option for managing gas-related discomfort.

Dosage and Administration

You should take one or two softgels after a meal. It's important not to exceed this amount, so make sure you don’t take more than two softgels in a 24-hour period unless your doctor advises 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 (conditions that would prevent you from taking it) or concerns about abuse, misuse, or dependence (a condition where your body becomes reliant on a substance). Additionally, there are no particular instructions advising against its use. Always remember to follow your healthcare provider's guidance and reach out if you have any questions or concerns about your treatment.

Side Effects

If you experience any persistent symptoms while using this medication, it’s important to stop using it and consult your doctor. This is a precaution to ensure your safety and well-being. Always pay attention to how your body responds, and don’t hesitate to seek medical advice if needed.

Warnings and Precautions

If your condition does not improve or continues to persist while using this medication, it is important to stop using it and consult your doctor. This ensures that you receive the appropriate care and guidance for your health needs. Always prioritize your well-being and seek professional advice when necessary.

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 concerned about a possible overdose, seek medical help right away.

In case of an overdose, contacting your local emergency services or going to the nearest hospital is crucial. Always keep the medication packaging with you, as it can help healthcare professionals understand what you've taken. Remember, it's better to be safe and get checked out if you have any doubts.

Pregnancy Use

When considering the use of Maximum Strength Gas Relief (simethicone) during pregnancy, it's important to note that there is no specific information available regarding its safety, dosage adjustments, or any special precautions for pregnant individuals. This means that the effects of this medication on pregnancy have not been clearly studied or established.

If you are pregnant or planning to become pregnant, it's always best to consult with your healthcare provider before taking any medication, including over-the-counter products like simethicone. They can help you weigh the potential benefits and risks based on your individual health needs.

Lactation Use

If you are breastfeeding or planning to breastfeed, it's important to know that there is no specific information available about the use of MAXIMUM STRENGTH GAS RELIEF (simethicone) for nursing mothers. This means that the effects of this medication on breast milk and nursing infants have not been studied or documented.

As always, it's best to consult with your healthcare provider before taking any medication while breastfeeding to ensure the safety of both you and your baby. They can provide personalized advice based on your situation.

Pediatric Use

It's important to keep this medication out of reach of children to ensure their safety. If your child needs to take this medication, be aware that they should not exceed two softgels in a 24-hour period unless a doctor has specifically advised and supervised this dosage. Always consult with a healthcare professional if you have any questions or concerns about using this medication for 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 the drug insert does not provide guidelines tailored for elderly patients.

If you are caring for an older adult, it's important to consult with a healthcare professional for personalized advice. They can help determine the best approach to using this medication safely and effectively, considering any unique health needs or conditions.

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 medication you take is safe and appropriate for your kidney health. They can provide guidance based on your individual situation.

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

Make sure to keep your doctor informed about your liver health, as they may want to conduct regular liver function tests (which check how well your liver is working) to ensure your safety while using any medication.

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 provide the best care tailored to your needs.

Always feel free to ask questions and share all the medications and supplements you are using. This helps your provider monitor your health effectively and make informed decisions about your treatment.

Storage and Handling

To ensure the best performance of your product, store it at room temperature, specifically between 59°F and 86°F (15°C and 30°C). This temperature range helps maintain the product's effectiveness and safety.

When handling the product, make sure to do so in a clean environment to avoid contamination. Always follow any specific instructions provided for use and disposal to ensure safety and effectiveness.

Additional Information

No further information is available.

FAQ

What is Simethicone used for?

Simethicone is used to relieve bloating, pressure, or fullness commonly referred to as gas.

How should I take Simethicone?

You should swallow one or two softgels after a meal and not exceed two softgels in 24 hours unless advised by a physician.

Are there any warnings associated with Simethicone?

You should stop using Simethicone and ask a doctor if your condition persists.

Is Simethicone safe to use during pregnancy?

There is no specific information regarding the use of Simethicone during pregnancy, but no teratogenic effects are mentioned.

Can children use Simethicone?

You should keep Simethicone out of reach of children.

What should I do if I experience side effects?

If you experience any side effects or if your condition persists, consult your doctor.

How should Simethicone be stored?

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

Packaging Info

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

Packaging configurations for Maximum Strength Gas Relief.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

Simethicone is presented in a pouch containing 250 mg of the active ingredient. The formulation is designed to alleviate symptoms of excess gas in the gastrointestinal tract. The pouch is designed for ease of use and portability, ensuring that the product can be conveniently administered as needed.

Uses and Indications

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

There are no teratogenic effects associated with this drug. Additionally, no nonteratogenic effects have been reported.

Dosage and Administration

Patients are advised to swallow one or two softgels after a meal. The maximum recommended dosage is two softgels within a 24-hour period, unless otherwise directed by a physician. It is essential that patients adhere to this guideline to ensure safe and effective use of the product.

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 before prescribing.

Warnings and Precautions

Healthcare professionals should advise patients to discontinue use and seek medical attention if the condition persists. This precaution is essential to ensure that any underlying issues are appropriately addressed and managed. Regular monitoring of the patient's condition is recommended to assess the effectiveness of the treatment and to identify any potential complications early.

Side Effects

Patients should be advised to discontinue use and consult a healthcare professional if their condition persists. This warning is crucial for ensuring patient safety and addressing any underlying issues that may not be resolved with the use of the product.

In clinical practice, it is important to monitor patients for any adverse reactions that may arise during treatment. While specific adverse reactions were not detailed in the provided data, the emphasis on seeking medical advice underscores the necessity for vigilance in patient management.

Drug Interactions

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

Packaging & NDC

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

Packaging configurations for Maximum Strength Gas Relief.
Details

Pediatric Use

Pediatric patients should be advised to keep this medication out of reach of children. The recommended dosage for pediatric patients is limited to a maximum of two softgels in a 24-hour period, unless otherwise directed by a physician. Careful supervision is advised to ensure adherence to this dosage guideline.

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 Maximum Strength Gas Relief (simethicone) during pregnancy. The prescribing information does not provide safety concerns, dosage modifications, or special precautions for pregnant patients. As such, healthcare professionals should consider the lack of data when advising women of childbearing potential and weigh the potential benefits against any unknown risks. It is recommended that pregnant patients consult their healthcare provider before using this medication.

Lactation

There is no specific information regarding nursing mothers or lactation considerations provided in the drug insert for MAXIMUM STRENGTH GAS RELIEF (simethicone). Therefore, healthcare professionals should exercise caution when recommending this medication to lactating mothers, as the effects on breastfed infants are not established.

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 this medication to patients with reduced kidney function, as the lack of information necessitates careful clinical judgment and monitoring.

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 and adhere to general principles of management in cases of suspected overdose.

It is essential to monitor the patient closely for any potential symptoms that may arise from an overdose. Symptoms can vary widely depending on the substance involved and the individual patient's response.

In the event of an overdose, immediate medical attention should be sought. Healthcare providers should implement supportive care measures, which may include maintaining airway patency, providing supplemental oxygen, and monitoring vital signs.

Additionally, it is recommended to consult local poison control centers or relevant toxicology resources for guidance on specific management protocols and antidotes, if applicable.

Documentation of the incident, including the substance involved, estimated dose, and time of ingestion, is crucial for effective treatment and follow-up care.

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 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, maintaining a range of 59-86°F (15-30°C). Proper storage conditions are crucial to ensure the integrity and efficacy of the product.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

This file contains official product information for Maximum 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 Maximum 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.

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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.