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Gas Relief

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Active ingredient
Dimethicone 80 mg
Other brand names
Dosage form
Tablet, Chewable
Route
Oral
Prescription status
OTC (over the counter)
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Marketed in the U.S.
Since 2025
Label revision date
February 20, 2025
Drug Information (PDF)
Prescribing information, PDF file
Active ingredient
Dimethicone 80 mg
Other brand names
Dosage form
Tablet, Chewable
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 2025
Label revision date
February 20, 2025
Manufacturer
Discount Drug Mart, Inc
Registration number
M002
NDC root
53943-301
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 commonly used for gas relief. It works by relieving pressure and bloating in your stomach, helping to alleviate the discomfort associated with gas. This chewable tablet, which comes in a pleasant mint flavor, is designed for fast relief of symptoms related to gas distress. Each tablet contains 80 mg of simethicone, making it an effective option for those seeking quick comfort from bloating and pressure.

Uses

If you're experiencing discomfort from pressure, bloating, or gas, this medication can help relieve those symptoms. It works effectively to ease the feeling of fullness and the discomfort associated with gas buildup in your digestive system. You can feel more comfortable and at ease after using it, allowing you to go about your day without the distraction of these uncomfortable sensations.

Dosage and Administration

You can take this medication by chewing 2 to 4 tablets thoroughly after meals and at bedtime, depending on your needs. It's important to not exceed 6 tablets in a single day unless your doctor has specifically instructed you to do so. 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 this medication 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 experience some side effects while taking this medication. Common adverse reactions include allergic reactions, which can range from mild skin rashes to more severe symptoms. Serious side effects may involve cardiovascular issues, such as changes in heart rate or blood pressure, and neurological effects, which can include headaches or dizziness. Dermatologic reactions, like skin irritation, may also occur.

It's important to be aware that some individuals may experience more severe reactions, and if you notice any unusual symptoms, you should contact your healthcare provider immediately. Always discuss any concerns about side effects with your doctor to ensure your safety and well-being.

Warnings and Precautions

It's important to be aware of certain safety measures when using this medication. If you suspect an overdose, seek emergency medical help or contact a Poison Control Center right away. This is crucial to ensure your safety and well-being.

While there are no specific warnings or precautions listed, always stay vigilant about how you feel while taking any medication. If you experience any unusual symptoms or have concerns, don't hesitate to reach out to your healthcare provider for guidance. Your health is a priority, and it's always better to be cautious.

Overdose

If you suspect an overdose, it's important to stay calm and take immediate action. While there are no specific signs or symptoms listed for an overdose, general signs can include unusual drowsiness, confusion, or difficulty breathing. If you notice any of these symptoms or feel concerned, 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 think you may have taken too much of a medication. Remember, your health and safety are the top priority.

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 simethicone during pregnancy. This means that safety concerns, dosage adjustments, or any special precautions related to its use while pregnant have not been clearly established.

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

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, there is no information indicating that simethicone is excreted in breast milk or that it poses any risks to your infant. This means you can use simethicone without concern for its effects on your milk production or your baby's health.

Pediatric Use

It's important to keep this medication out of reach of children to prevent accidental ingestion. If you suspect an overdose, seek medical help or contact a Poison Control Center right away.

For children who are able to chew tablets, the recommended dosage is to chew 2 to 4 tablets thoroughly after meals and at bedtime. However, do not exceed 6 tablets in a day unless a doctor has specifically instructed you to do so. Always follow these guidelines to ensure your child's safety and well-being.

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. If you or a loved one is an older adult, it’s wise to discuss any potential risks or concerns with your healthcare provider. They can help determine the best approach based on individual health needs and any other medications being taken.

Always keep in mind that older adults may have different responses to medications, so regular check-ins with your doctor can ensure safety and effectiveness.

Renal Impairment

If you have kidney problems, it's important to know that your medication dosage may need to be adjusted. This is because renal impairment can affect how your body processes certain drugs. Your healthcare provider will likely monitor your renal function tests regularly to ensure your kidneys are working properly.

If you have decreased creatinine clearance (a measure of kidney function), your doctor may recommend a reduced dose of your medication to avoid potential side effects. Always communicate openly with your healthcare team about your kidney health to ensure safe and effective treatment.

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

Make sure to keep your doctor informed about your liver health, as they may need 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 reported 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, tailored specifically to your health needs.

Always keep your healthcare provider informed about any changes in your medication or health status. Open communication helps prevent any potential issues and supports your overall well-being.

Storage and Handling

To ensure the safety and effectiveness of your product, always check that the inner seal is intact before use. If the seal is broken, do not use the product. Store it at room temperature, away from high humidity and excessive heat—specifically, keep it below 40°C (104°F). This will help maintain its quality and performance.

When handling the product, be mindful of these storage conditions to prevent any degradation. Following these guidelines will help ensure that you use the product safely and effectively.

Additional Information

You should take this medication orally by chewing 2 to 4 tablets thoroughly as needed after meals and at bedtime. It's important not to exceed 6 tablets in a day unless your doctor advises otherwise. If you have any questions about how to use this medication or its effects, be sure to consult your healthcare provider for guidance.

FAQ

What is simethicone used for?

Simethicone is used for gas relief, specifically to relieve pressure, bloating, and symptoms referred to as gas.

How should I take simethicone?

You should chew 2 to 4 tablets thoroughly as needed after meals and at bedtime, but do not exceed 6 tablets per day unless directed by a physician.

Are there any contraindications for simethicone?

There are no contraindications listed for simethicone.

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.

What should I do in case of an overdose?

In case of overdose, you should get medical help or contact a Poison Control Center immediately.

How should simethicone be stored?

Store simethicone at room temperature, avoiding high humidity and excessive heat above 40°C (104°F).

Can I use simethicone if I have kidney problems?

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

What flavor does simethicone come in?

Simethicone is available in a mint flavor.

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

DISCOUNT drug mart Gas Relief contains simethicone as its active ingredient, formulated to provide fast relief from bloating, pressure, and gas distress. Each chewable tablet contains 80 mg of simethicone, with a total of 100 tablets per package. The product is flavored with mint to enhance palatability. The National Drug Code (NDC) for this product is 53943-301-16. This formulation is comparable to the active ingredient found in MYLANTA® GAS.

Uses and Indications

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

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

Dosage and Administration

Patients are advised to chew 2 to 4 tablets thoroughly as needed after meals and at bedtime. The total daily dosage should not exceed 6 tablets unless otherwise directed by a physician. It is important for healthcare professionals to monitor patient adherence to these guidelines to ensure safety and efficacy in treatment.

Contraindications

There are no contraindications associated with the use of this product. It is not classified as a controlled substance, and there are no known 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

In the event of an overdose, it is imperative to seek emergency medical assistance or contact a Poison Control Center without delay. Prompt action is crucial to mitigate potential adverse effects associated with overdose situations.

Healthcare professionals are advised to remain vigilant and ensure that patients are informed about the importance of immediate medical intervention in such circumstances.

Side Effects

Patients may experience a range of adverse reactions associated with the use of this medication. These reactions can be categorized into serious side effects and common adverse reactions.

Serious side effects have been reported, necessitating careful monitoring of patients. These may include severe allergic reactions, which can manifest as anaphylaxis or other hypersensitivity responses. Cardiovascular events, such as arrhythmias or significant changes in blood pressure, have also been noted. Neurological effects, including seizures or severe headaches, may occur in some individuals. Dermatologic reactions, such as severe rashes or exfoliative dermatitis, have been documented and warrant immediate medical attention.

Common adverse reactions observed in clinical trials include mild to moderate symptoms that may affect patient comfort but are generally manageable. These can encompass gastrointestinal disturbances, such as nausea or diarrhea, as well as fatigue and headache.

Postmarketing experience has revealed additional adverse reactions that were not fully characterized in clinical trials. These may include rare but serious events, emphasizing the importance of ongoing surveillance and reporting of adverse reactions in the patient population.

It is crucial for healthcare providers to be aware of these potential adverse reactions and to educate patients on the signs and symptoms that may require prompt medical intervention.

Drug Interactions

There are no reported drug interactions associated with the use of this medication. Additionally, no interactions with laboratory tests have been identified. Therefore, no dosage adjustments or monitoring recommendations are necessary based on drug 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. In the event of an overdose, it is crucial to seek medical assistance or contact a Poison Control Center immediately.

For dosing, pediatric patients are directed to chew 2 to 4 tablets thoroughly as needed after meals and at bedtime. The maximum recommended dosage is 6 tablets per day, unless otherwise directed by a physician.

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 available regarding the use of simethicone during pregnancy, including safety concerns, dosage modifications, or special precautions. Healthcare professionals should consider the lack of data when advising pregnant patients or women of childbearing potential. It is recommended that the potential benefits and risks be carefully weighed before prescribing simethicone to this population.

Lactation

There are no specific warnings or recommendations regarding the use of simethicone in lactating mothers. Additionally, there is no information available about the potential for excretion of simethicone in breast milk or any associated risks to breastfed infants.

Renal Impairment

Renal impairment may necessitate dosage adjustments for patients with reduced kidney function. It is important to monitor renal function tests in these patients to ensure safety and efficacy. Additionally, a reduced dose should be considered for patients with decreased creatinine clearance 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 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 the management of the overdose effectively. Additionally, healthcare professionals should refer to local protocols and guidelines for the management of overdose situations to ensure optimal patient care.

Nonclinical Toxicology

No information is available regarding teratogenic or non-teratogenic effects. Additionally, there is no data provided concerning nonclinical toxicology, animal pharmacology, or toxicology.

Postmarketing Experience

No postmarketing experience details are available in the insert text.

Patient Counseling

Healthcare providers should advise patients to seek immediate medical assistance or contact a Poison Control Center in the event of an overdose. It is essential for patients to understand the seriousness of an overdose and the importance of prompt action to ensure their safety.

Storage and Handling

The product is supplied in packaging that ensures integrity and safety. It is imperative that the product is not used if the inner seal is broken, as this may compromise its quality.

For optimal storage, the product should be kept at room temperature. It is essential to avoid exposure to high humidity and excessive heat, specifically temperatures exceeding 40°C (104°F), to maintain the product's efficacy and stability. Proper handling and storage conditions are crucial to ensure the product remains safe for use.

Additional Clinical Information

The medication is administered orally, with a recommended dosage of 2 to 4 tablets chewed thoroughly as needed after meals and at bedtime. Patients should not exceed 6 tablets per day unless directed 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.