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Maximum Strength Gas Relief

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Active ingredient
Dimethicone 250 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 2023
Label revision date
May 13, 2024
Drug Information (PDF)
Prescribing information, PDF file
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
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Marketed in the U.S.
Since 2023
Label revision date
May 13, 2024
Manufacturer
TARGET CORPORATION
Registration number
M002
NDC root
11673-827
Drug Information (PDF)
Prescribing information, PDF file
Packaging Info (2 NDCs)
Packaging & NDC Codes (2)

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 that helps relieve pressure, bloating, and fullness caused by gas in your digestive system. It works by breaking up gas bubbles in the stomach and intestines, making it easier for your body to eliminate them. If you're experiencing discomfort from gas, simethicone may provide you with the relief you need.

Uses

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

Rest assured, there are no known teratogenic effects (which means it doesn’t cause birth defects) or nonteratogenic effects (which refers to other types of harmful effects) associated with this medication.

Dosage and Administration

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

It's important to remember not to exceed 2 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 to use it safely and effectively.

Side Effects

It's important to keep this medication out of reach of children to prevent accidental ingestion. If you have any concerns about side effects or how to safely store the medication, please consult your healthcare provider for guidance.

Warnings and Precautions

It's important to keep this medication out of reach of children to ensure their safety. While there are no specific general precautions or laboratory tests mentioned, you should always be mindful of how you use any medication.

If you experience any unusual symptoms or have concerns while taking this medication, it's best to stop using it and consult your doctor for guidance. Your health and safety are paramount, so don't hesitate to seek professional advice 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 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

When it comes to using MAXIMUM STRENGTH GAS RELIEF (simethicone) during pregnancy, there is no specific information available regarding its safety, dosage adjustments, or any special precautions you should take. This means that the drug insert does not provide guidance on how this medication may affect you or your developing baby.

If you are pregnant or planning to become pregnant, it's important to consult with your healthcare provider before using this medication. They can help you weigh the potential benefits and risks based on your individual situation. Always prioritize open communication with your doctor about any medications you are considering during pregnancy.

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 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 2 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 healthcare providers may not have tailored guidelines for elderly patients.

If you or a loved one is an older adult considering this medication, it's important to discuss any potential risks or concerns with your healthcare provider. They can help determine the best approach based on individual health needs and circumstances. Always prioritize open communication with your doctor to ensure safe and effective treatment.

Renal Impairment

It appears that there is no specific information regarding renal impairment (kidney problems) in the provided text. Therefore, there are no guidelines, dosage adjustments, or monitoring instructions to share for patients with kidney issues. If you have concerns about how your kidney health may affect your treatment, it's important to discuss this with your healthcare provider for personalized advice and recommendations.

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 differently due to your liver health.

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 determine the best approach based on your liver function and overall health.

Drug Interactions

It's important to have open conversations with your healthcare provider about any medications you are taking. In this case, there are no specific drug interactions or laboratory test interactions noted, which means that the medication is generally considered safe to use with other drugs and tests. However, every individual is different, and your healthcare provider can help ensure that your treatment plan is safe and effective for you.

Always discuss any changes in your medication or health status with your healthcare provider to avoid any potential issues and to get the best care possible.

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. Following these simple storage and handling guidelines will help you use the product safely and effectively.

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.

How should I take Simethicone?

Adults and children 12 years and older should swallow 1 or 2 softgels with water as needed after meals and at bedtime.

What is the maximum dosage of Simethicone I can take?

Do not exceed 2 softgels in 24 hours unless advised and supervised by a physician.

Are there any contraindications for using Simethicone?

No contraindications are listed for Simethicone.

What precautions should I take when using Simethicone?

Keep Simethicone out of reach of children.

Is Simethicone safe to use during pregnancy or while nursing?

The provided text does not mention specific warnings or recommendations regarding the use of Simethicone during pregnancy or nursing.

How should I store Simethicone?

Store Simethicone at room temperature and protect it from light, heat, and moisture.

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 250 mg serves as the active ingredient in this formulation. The product is presented in a dosage form of softgels, with each package containing a total of 50 softgels.

Uses and Indications

This drug is indicated for the relief of pressure, bloating, and 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

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 2 softgels within a 24-hour period, unless directed otherwise by a physician.

Contraindications

Use of this product is contraindicated in individuals who are unable to keep it out of reach of children. This precaution is essential to prevent accidental ingestion or misuse by pediatric patients. No other contraindications have been identified.

Warnings and Precautions

It is imperative to keep this medication out of reach of children to prevent accidental ingestion or misuse. Healthcare professionals should ensure that patients and caregivers are aware of this critical safety measure to mitigate the risk of pediatric exposure.

Currently, there are no specific general precautions or laboratory tests associated with the use of this medication. Healthcare providers should remain vigilant and monitor for any emerging safety information or guidelines that may be issued in the future.

In the absence of detailed emergency medical help instructions or specific recommendations for discontinuation and consultation with a physician, it is advisable for healthcare professionals to maintain open lines of communication with patients regarding any concerns or adverse effects that may arise during treatment.

Side Effects

Patients should be advised to keep this medication out of reach of children. This warning is critical to prevent accidental ingestion and potential harm to pediatric populations.

No additional adverse reactions, including serious or common events, have been specified in the provided data. It is essential for healthcare providers to monitor patients for any unexpected reactions and report them as necessary.

Drug Interactions

No specific drug interactions have been identified in the available data. Additionally, there are no reported interactions between the drug and 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 kept out of reach of children. For adolescents aged 12 years and older, the recommended dosage is to swallow 1 or 2 softgels with water as needed after meals and at bedtime. It is important not to exceed 2 softgels in a 24-hour period unless advised and supervised by a physician.

Geriatric Use

Elderly patients may not have specific dosage adjustments, safety concerns, or special precautions outlined in the drug insert. As such, healthcare providers should exercise caution when prescribing this medication to geriatric patients, considering the general principles of pharmacotherapy in this population.

Due to the lack of specific data, it is advisable for healthcare providers to closely monitor elderly patients for any potential adverse effects or changes in therapeutic response. Individual patient factors, including comorbidities and concurrent medications, should be taken into account when determining the appropriateness of this medication for geriatric patients.

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. Therefore, healthcare professionals should consider the lack of data when advising women of childbearing potential and weigh the potential benefits against any unknown risks to fetal outcomes. It is recommended that healthcare providers exercise caution and discuss any concerns with their patients.

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 related to lactation. Healthcare professionals should consider the absence of data when advising lactating mothers about the use of this medication.

Renal Impairment

There is no information available regarding renal impairment, including dosage adjustments, special monitoring, or safety considerations for patients with reduced kidney function. Healthcare professionals should exercise caution and consider the lack of specific guidance when treating patients with renal impairment.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in clinical trials for this medication. Consequently, there is no available information regarding 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 warranted based on clinical judgment.

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 monitoring vital signs, providing symptomatic treatment, and ensuring the patient's safety.

If available, consultation with a poison control center or a medical toxicologist is recommended to guide further management and treatment options.

Documentation of the incident, including the substance involved, the amount taken, and the time of ingestion, is crucial for effective management 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 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 configurations that include specific NDC numbers. It should be stored at room temperature, ensuring that it is protected from light, heat, and moisture to maintain its integrity and efficacy. Proper handling is essential to prevent exposure to conditions that may compromise the product's quality.

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.

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.