ADD CONDITION

items per page

Gas Relief Extra Strength

Last content change checked dailysee data sync status

Active ingredient
Dimethicone, Unspecified 125 mg
Other brand names
Dosage form
Capsule, Liquid Filled
Route
Oral
Prescription status
OTC (over the counter)
Marketed in the U.S.
Since 2021
Label revision date
December 14, 2024
Active ingredient
Dimethicone, Unspecified 125 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 2021
Label revision date
December 14, 2024
Manufacturer
TOPCO ASSOCIATES LLC
Registration number
M002
NDC root
36800-785

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

You may be experiencing discomfort from pressure, bloating, and fullness often associated with gas. This medication is designed to provide relief from these symptoms, helping you feel more comfortable. It works by addressing the buildup of gas in your digestive system, allowing for a more pleasant experience after meals.

If you're looking for a solution to ease these common digestive issues, this product could be a helpful option for you. Always consider consulting with a healthcare professional for personalized advice and recommendations.

Uses

You can use this medication to help relieve the discomfort of pressure, bloating, and fullness that often comes from gas. It’s designed to make you feel more comfortable by addressing 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 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 needed. 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 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 or misuse associated with this medication. Additionally, there are no concerns regarding dependence (a condition where the body becomes reliant on a substance) or any explicit instructions on what not to take or use.

It's always important to consult with your healthcare provider for personalized advice and to ensure that this medication is appropriate for you.

Side Effects

It's important to keep this medication out of reach of children to prevent accidental ingestion. Always ensure that it is stored safely and securely. If you have any concerns about side effects or how to use this medication, please consult your healthcare provider for guidance.

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 in a safe place where children cannot access it.

If you have any concerns or experience unusual symptoms while using this medication, stop using it and call your doctor for advice. Your health and safety are the top priority, so don’t hesitate to seek help 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 or feel unwell after taking the medication, 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 after taking medication.

Pregnancy Use

If you are pregnant or planning to become pregnant, it's important to know that there is no specific information available about the use of Gas Relief Extra Strength (dimethicone) during pregnancy. This means that safety concerns, dosage adjustments, or any special precautions for pregnant individuals have not been addressed in the drug insert.

Before using this medication, it’s a good idea to consult with your healthcare provider to discuss any potential risks and to ensure that it is safe for you and your baby. Always prioritize open communication with your doctor regarding any medications you consider taking during pregnancy.

Lactation Use

If you are breastfeeding and considering using Gas Relief Extra Strength (dimethicone), it's important to note that the drug insert does not provide specific information about its effects on nursing mothers or lactation. Since there are no guidelines or data available, you may want to consult your healthcare provider for personalized advice. They can help you weigh the potential benefits and risks based on your individual situation. Always prioritize your health and your baby's well-being when making decisions about medication while breastfeeding.

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 or questions about the medication, don't hesitate to reach out to your healthcare provider for guidance.

Geriatric Use

While there is no specific information about how this medication should be used by older adults, it’s important to approach any new treatment with caution. Since older adults may have different health needs and may be taking multiple medications, it’s always a good idea to discuss any concerns with your healthcare provider. They can help ensure that the medication is safe and appropriate for you or your loved one, considering any existing health conditions or medications.

If you are caring for an older adult, be attentive to any changes in their health or behavior after starting a new medication, and report these to their doctor.

Renal Impairment

If you have kidney problems, it's important to know that there are no specific guidelines, dosage adjustments, or monitoring requirements mentioned for your condition in the provided information. This means that the standard recommendations for medication use may apply to you without any special considerations. However, always consult your healthcare provider for personalized advice and to ensure your treatment is safe and effective based on your kidney health.

Hepatic Impairment

If you have liver problems, it's important to know that the information provided does not include any specific guidelines about dosage adjustments, special monitoring, or precautions for your condition. This means that there are no established recommendations for how your liver health might affect the use of this medication.

Always consult your healthcare provider for personalized advice and to ensure that any treatment plan is safe and appropriate for your liver health. They can help you understand how to manage your condition while considering any medications you may need.

Drug Interactions

It's important to have open conversations with your healthcare provider about any medications or tests you may be taking. In this case, there are no known drug interactions or laboratory test interactions associated with the medication. However, always ensure that your healthcare provider is aware of all the medications you are using, as this helps them provide the best care tailored to your needs.

By discussing your full medical history and any other treatments, you can help prevent potential issues and ensure your safety.

Storage and Handling

To ensure the best performance of your product, store it in a cool, dry place at a temperature between 20-25°C (68-77°F). It's important to keep it away from heat and moisture, as these 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 guidelines will help you use the product safely and effectively.

Additional Information

No further information is available.

FAQ

What is the primary use of this drug?

This drug 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 contraindications for this drug?

No contraindications are listed for this drug.

What should I do if I have children at home?

Keep this drug out of reach of children.

What are the storage conditions for this drug?

Store the drug between 20-25°C (68-77°F) and protect it from heat and moisture.

Are there any teratogenic effects associated with this drug?

No teratogenic effects are mentioned for this drug.

Is there any information regarding the use of this drug during pregnancy?

No specific information regarding the use of this drug during pregnancy is provided.

Can this drug be used by nursing mothers?

No specific information regarding the use of this drug by nursing mothers is provided.

Are there any known drug interactions?

No drug interactions are mentioned in the provided text.

Packaging Info

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

Packaging configurations for Gas Relief Extra Strength.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

The product is identified by the SPL code 34089-3. No specific description details are provided in the text.

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

There are no contraindications associated with the use of this product. It is not classified as a controlled substance, and there are no identified risks of abuse, misuse, or dependence. Additionally, there are no specific instructions indicating that the product should not be taken or used under any circumstances.

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 are aware of the importance of proper storage and handling of the medication. This precaution is essential to safeguard against potential adverse effects that may arise from unintentional exposure in pediatric populations.

In addition, healthcare providers are encouraged to discuss the risks associated with improper use and the necessity of adhering to prescribed dosages and administration guidelines. Regular patient education on the safe storage of medications can further mitigate risks associated with pediatric access.

Side Effects

Patients should be advised to keep this medication out of reach of children. This warning is critical to prevent accidental ingestion or exposure, which could lead to serious adverse reactions.

No specific adverse reactions have been reported in clinical trials or postmarketing experiences beyond this warning. It is essential for healthcare providers to monitor patients for any unexpected effects and to educate them on the importance of safeguarding the medication from children.

Drug Interactions

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

Packaging & NDC

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

Packaging configurations for Gas Relief Extra Strength.
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 administering this medication to younger individuals.

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. Monitoring for potential adverse effects and therapeutic efficacy is recommended in this population.

Pregnancy

There is no specific information regarding the use of Gas Relief Extra Strength (dimethicone) 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 women of childbearing potential and during pregnancy, as the absence of data does not rule out potential risks. It is advisable to weigh the benefits against any unknown risks when prescribing this medication to pregnant patients.

Lactation

There is no specific information regarding the use of Gas Relief Extra Strength (dimethicone capsule, liquid filled) in lactating mothers or lactation considerations. The prescribing information does not provide data on the excretion of dimethicone in breast milk or its effects on breastfed infants. Healthcare professionals should consider this lack of information when advising lactating mothers on the use of this medication.

Renal Impairment

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

Hepatic Impairment

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

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 initiate supportive care, which may include maintaining airway patency, ensuring adequate ventilation, and monitoring vital signs.

If available, the use of specific antidotes or treatments should be considered based on the substance involved and the clinical presentation. Consultation with a poison control center or a medical toxicologist may provide additional guidance on the management of overdose cases.

Documentation of the incident, including the substance, amount ingested, and time of ingestion, is crucial for effective management and treatment planning.

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 question.

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 packaging that ensures its integrity during storage and handling. It should be stored at a temperature range of 20-25°C (68-77°F) to maintain its efficacy. Additionally, it is essential to protect the product from heat and moisture to prevent degradation. Proper 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 Gas Relief Extra Strength, 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 Gas Relief Extra Strength, 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.