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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 2022
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 2022
Label revision date
December 13, 2024
Manufacturer
Spirit Pharmaceuticals LLC
Registration number
M002
NDC root
68210-4232
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 that comes in a 125 mg dosage and is commonly used to relieve discomfort caused by pressure, bloating, and fullness in the stomach, which are often associated with gas. 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 symptoms related to gas, simethicone can help provide relief and improve your comfort. It's a widely used option for those looking to ease the discomfort of digestive issues related to gas buildup.

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 you experience these common digestive issues.

Rest assured, this medication does not have any known teratogenic effects, meaning it does not cause harm to a developing fetus.

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 not to exceed 4 softgels in a 24-hour period unless your doctor advises you otherwise.

Make sure to take the softgels orally, which means you should swallow them with water. This method allows the medication to work effectively when you need it. Remember to follow the recommended dosage to ensure your safety and well-being.

What to Avoid

You can feel reassured that 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 your body becomes reliant on a substance) or any particular instructions advising against its use. Always consult with your healthcare provider if you have any questions or concerns about your treatment.

Side Effects

You may not experience any specific side effects while using this medication, as there are no listed adverse reactions or warnings associated with it. It's always a good idea to monitor how you feel and consult your healthcare provider if you have any concerns or unusual symptoms.

Warnings and Precautions

It's important to be aware of any potential issues when using this medication. While there are no specific warnings or precautions listed, it's always a good idea to stay informed about how you feel while taking any medication.

If you experience any unusual symptoms or have concerns, you should stop taking the medication and reach out to your doctor for guidance. Regular check-ins with your healthcare provider can help ensure that the medication is working effectively for you. Always prioritize your health and safety by communicating openly with your doctor about any changes you notice.

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 it comes to using this medication during pregnancy, there is no specific information available about its safety, recommended dosage adjustments, or any special precautions you should take. This means that if you are pregnant or planning to become pregnant, it’s important to consult with your healthcare provider before starting or continuing this medication. They can help you weigh the potential risks and benefits based on your individual situation. Always prioritize open communication with your doctor regarding 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 the use of this product while nursing. Additionally, there are no statements about whether this product is excreted in breast milk or any potential risks to your infant. This means that, based on the available information, you can use this product without concern for its effects on your milk production or your baby.

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 if you or a loved one is an older adult considering this medication, it’s important to consult with a healthcare provider. They can help determine the best approach based on individual health needs and any other medications being taken. Always prioritize open communication with your healthcare team to ensure safe and effective treatment.

Renal Impairment

If you have kidney problems, it's important to know that you may need a lower dose of this medication. Your doctor will determine the right dosage based on your creatinine clearance levels, which is a test that measures how well your kidneys are filtering waste from your blood.

To ensure your kidneys remain healthy while taking this medication, regular renal function tests are recommended. If you have severe kidney impairment, special monitoring is essential to prevent any potential toxicity from the medication. Always discuss your kidney health with your healthcare provider to ensure safe and effective treatment.

Hepatic Impairment

If you have liver problems, it's important to know that the drug insert does not provide specific information about dosage adjustments, special monitoring, or precautions for your condition. This means that there are no tailored guidelines for how this medication may affect you if you have hepatic impairment (liver issues).

Always consult your healthcare provider for personalized advice and to discuss any concerns regarding your liver health and medication use. They can help ensure that you receive the safest and most effective treatment based on your individual needs.

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 this medication is generally considered safe to use alongside other treatments and tests. However, every individual is different, and your healthcare provider can help ensure that your overall treatment plan is safe and effective for you. Always feel free to ask questions or express any concerns you may have regarding your medications or tests.

Storage and Handling

To ensure the best performance of your product, store it at a controlled room temperature between 20-25°C (68-77°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 safe and responsible disposal. By following these guidelines, you can help ensure the product remains safe and effective for your use.

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?

Adults should swallow 1 or 2 softgels with water as needed after meals and at bedtime, not exceeding 4 softgels in 24 hours unless advised by a physician.

How should Simethicone be taken?

Simethicone should be taken orally, swallowed with water, in the form of softgels.

Are there any contraindications for Simethicone?

No specific contraindications are listed for Simethicone.

Is Simethicone safe to use during pregnancy?

There are no specific safety concerns or recommendations regarding the use of Simethicone during pregnancy.

Can nursing mothers use Simethicone?

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

What should patients with renal impairment know about Simethicone?

Patients with renal impairment may require a reduced dose of Simethicone, and regular renal function tests are recommended to monitor kidney health.

How should Simethicone be stored?

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

Are there any known drug interactions with Simethicone?

No specific drug interactions are mentioned for Simethicone.

What should I do if I have questions about using Simethicone?

If you have questions or concerns about using Simethicone, consult your healthcare provider for personalized advice.

Packaging Info

Below are the non-prescription pack sizes of Gas Relief (simethicone). 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

Simethicone is presented in a pouch containing 125 mg of the active ingredient. The formulation is designed for oral administration. The product is characterized by its appearance, which is consistent with standard pharmaceutical practices for simethicone formulations.

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 are instructed to swallow 1 or 2 softgels with water as needed after meals and at bedtime. The total daily dosage should not exceed 4 softgels within a 24-hour period, unless directed and supervised by a physician.

The route of administration is oral, and the softgels should be taken with water to ensure proper swallowing and absorption.

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 precautions associated with the use of this medication. Healthcare professionals are advised to remain vigilant and monitor patients for any potential adverse effects or unusual reactions during treatment.

In the absence of defined laboratory tests or emergency instructions, it is essential for healthcare providers to maintain open communication with patients regarding their treatment and to encourage them to report any concerning symptoms or side effects promptly.

Should any new information regarding warnings, precautions, or necessary laboratory tests become available, it is imperative that healthcare professionals stay informed and adjust their clinical practices accordingly.

Side Effects

No specific adverse reactions have been identified in clinical trials or postmarketing experiences. There are no warnings or additional notes regarding side effects associated with the use of this product. As such, healthcare professionals should continue to monitor patients for any unexpected reactions during treatment.

Drug Interactions

There are no specific drug interactions identified for this medication. Additionally, no laboratory test interactions have been reported. Therefore, no dosage adjustments or monitoring recommendations are necessary based on drug or laboratory test interactions.

Packaging & NDC

Below are the non-prescription pack sizes of Gas Relief (simethicone). 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. It is essential to ensure that the medication is stored safely to prevent accidental ingestion or misuse.

Geriatric Use

Elderly patients may not have specific information regarding the use of this medication, including dosage adjustments, safety concerns, or special precautions. Therefore, healthcare providers should exercise caution when prescribing this medication to geriatric patients. It is advisable to monitor these patients closely for any adverse effects or changes in therapeutic response, given the lack of targeted data for this population.

Pregnancy

There is no specific information regarding the use of this drug during pregnancy, including safety concerns, dosage modifications, or special precautions. Healthcare professionals should consider the lack of data when prescribing this medication to pregnant patients. It is advisable to weigh the potential benefits against any unknown risks to fetal outcomes. Women of childbearing potential should be counseled on the absence of established safety data and the importance of discussing any potential pregnancy with their healthcare provider.

Lactation

There are no specific warnings or recommendations regarding the use of this product by lactating mothers. Additionally, there are no statements concerning the potential for excretion in breast milk or any associated risks to breastfed infants.

Renal Impairment

Patients with renal impairment may require a reduced dose of the medication. Dosage adjustments should be based on creatinine clearance levels to ensure appropriate therapeutic levels while minimizing the risk of adverse effects. Regular renal function tests are recommended to monitor kidney health in patients receiving this medication. Additionally, special monitoring is necessary for patients with severe renal impairment to avoid potential toxicity.

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 consider 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, specific antidotes or treatments should be administered according to established protocols. Additionally, healthcare professionals should consult local poison control centers or relevant clinical guidelines for further management recommendations tailored to the specific circumstances of the overdose.

Documentation of the incident, including the substance involved, estimated dose, time of exposure, and any symptoms observed, is crucial for ongoing management and treatment decisions.

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 a configuration that includes specific NDC numbers, which are essential for identification and inventory management. It is crucial to store the product at a controlled room temperature ranging from 20 to 25°C (68 to 77°F).

To ensure the integrity of the product, it must be protected from light, heat, and moisture during storage. Proper handling and storage conditions are vital to maintain the product's efficacy and safety.

Additional Clinical Information

No further data are available.

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.