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Gas Relief

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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 2023
Label revision date
December 13, 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 2023
Label revision date
December 13, 2024
Manufacturer
Spirit Pharmaceuticals LLC
Registration number
M002
NDC root
68210-5026
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

You can use this medication to help relieve feelings of pressure, bloating, and fullness that are commonly associated with gas. It is designed to provide comfort when you experience these uncomfortable symptoms. If you're dealing with gas-related discomfort, this medication may be a helpful option for you.

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 associated with this medication. This makes it a safe option for managing your symptoms without additional concerns.

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 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

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, you can use it without concerns about these particular issues. However, 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 not experience any specific side effects or adverse reactions while using this medication, as there are no listed concerns in these areas. It's always a good idea to monitor how you feel and discuss any unusual symptoms with your healthcare provider.

Warnings and Precautions

While there are no specific warnings or precautions listed for this medication, it's always important to stay informed about your health. If you experience any unusual symptoms or reactions while taking this medication, it’s advisable to stop using it and consult your doctor for guidance.

Additionally, if you ever feel that you need immediate medical assistance, don’t hesitate to seek emergency help. Always prioritize your health and well-being by keeping open communication with your healthcare provider.

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

When considering the use of simethicone 125 mg capsules 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 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 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, the information provided does not mention any particular considerations or precautions related to lactation. This means that, based on the available data, simethicone is generally considered safe for you 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

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 and benefits with your healthcare provider. They can help determine the best approach based on individual health needs and circumstances.

Renal Impairment

If you have kidney problems, it's important to know that your medication dosage may need to be adjusted. This is because your renal function, which is how well your kidneys are working, can affect how your body processes certain medications. Your healthcare provider will monitor your renal function regularly, especially by checking your creatinine clearance levels (a test that measures how well your kidneys filter waste).

Before starting any new treatment, your renal function should be tested, and these tests will continue periodically to ensure your safety. If you have moderate to severe renal impairment, you may require a reduced dose of your medication to avoid potential complications. 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 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 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 great to know that there are no known 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 your use.

Additional Information

You should take this medication orally, 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 this drug used for?

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

How should I take this medication?

Adults should swallow 1 or 2 softgels with water as needed after meals and at bedtime. 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 renal impairment?

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

Is this drug safe to use during pregnancy?

No specific information regarding safety during pregnancy is provided in the drug insert.

Can nursing mothers use this medication?

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

How should I store this medication?

Store at controlled room temperature between 20°-25°C (68°-77°F) and protect from light, heat, and moisture.

Are there any side effects associated with this drug?

No specific side effects or adverse reactions are listed for this drug.

What should I do if I accidentally take too much?

If you exceed the recommended dosage, seek advice from a physician.

Is there any information on drug interactions?

No drug interactions information is provided for this medication.

Packaging Info

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

Packaging configurations for Gas Relief.
Details

Drug Information (PDF)

This file contains official product information for Gas Relief, 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 should swallow 1 or 2 softgels with water as needed after meals and at bedtime. The maximum recommended dosage is 4 softgels within a 24-hour period, unless otherwise directed by a physician. It is important to adhere to this guideline to ensure safe and effective use of the medication.

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

There are currently no specific warnings or general precautions associated with the use of this medication. Healthcare professionals are advised to remain vigilant and monitor patients for any adverse effects or unusual symptoms that may arise during treatment.

In the absence of specified laboratory tests, it is recommended that healthcare providers consider routine monitoring based on the clinical context and individual patient needs. This may include assessments relevant to the patient's overall health status and any concurrent medications.

In the event of an emergency, healthcare professionals should ensure that patients are aware of the importance of seeking immediate medical assistance if they experience severe or concerning symptoms. Additionally, patients should be instructed to discontinue use of the medication and consult their healthcare provider if they encounter any unexpected reactions or side effects.

Ongoing communication between healthcare providers and patients is essential to ensure safe and effective use of the medication.

Side Effects

There are no specific side effects or adverse reactions reported in clinical trials or postmarketing experiences for this product. Additionally, no warnings regarding adverse reactions have been identified. Therefore, healthcare professionals should be aware that the absence of documented adverse reactions does not preclude the possibility of individual patient experiences. Monitoring for any unexpected effects is recommended during treatment.

Drug Interactions

No drug interactions or drug and laboratory test interactions have been identified for this product. 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 (simethicone 125 mg). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Gas Relief.
Details

Pediatric Use

Pediatric patients should be advised to keep this medication out of reach of children. Safety and efficacy have not been established in pediatric populations, 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 is no specific information regarding the use of simethicone 125 mg capsule, liquid filled, in pregnant patients. The prescribing information does not provide safety concerns, dosage modifications, or special precautions for use during pregnancy. Healthcare professionals should consider the lack of data when prescribing this medication to women of childbearing potential and weigh the potential benefits against any unknown risks to fetal outcomes.

Lactation

There are no specific warnings or recommendations regarding the use of simethicone in lactating mothers. Additionally, there are no specific considerations or precautions related to lactation mentioned in the provided text. Therefore, healthcare professionals may consider the use of simethicone in nursing mothers without specific concerns.

Renal Impairment

Patients with renal impairment may necessitate dosage adjustments based on their renal function. It is essential for healthcare professionals to monitor renal function regularly in these patients. Dosage adjustments should be guided by creatinine clearance levels, with reduced doses potentially required for those with moderate to severe renal impairment. Renal function tests should be performed prior to initiating therapy and periodically thereafter to ensure appropriate dosing and to mitigate the risk of adverse effects.

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 toxicology experts for guidance on specific management protocols and interventions tailored to the substance involved.

Documentation of the incident, including the amount ingested and the time of exposure, 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 storing the medication in a secure location, away from the sight and reach of young children. This precaution helps ensure the safety of pediatric patients and minimizes the risk of potential harm.

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 instructed 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 advised and supervised 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 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 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.