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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 6, 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 6, 2025
Manufacturer
Guardian Drug Company
Registration number
M002
NDC root
53041-103
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

GUARDIAN is a chewable tablet that provides fast relief from pressure, bloating, and gas distress. Each tablet contains 80 mg of simethicone, an anti-gas medication that helps break up gas bubbles in your stomach and intestines, making it easier for your body to eliminate them. Available in a refreshing mint flavor, GUARDIAN comes in a package of 100 tablets, making it a convenient option for managing uncomfortable gas symptoms.

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 confident using this medication, as it has no known teratogenic effects (which means it doesn't cause birth defects) or nonteratogenic effects. This makes it a safe option for many individuals seeking relief from these common digestive issues.

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, there are no particular situations or conditions under which you should avoid using it. 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 nausea, headache, and fatigue. In rare cases, more serious reactions can occur, such as severe allergic reactions (anaphylaxis), which may require immediate medical attention.

It's important to be aware of these potential side effects and to discuss any concerns with your healthcare provider. If you notice any unusual or severe symptoms, please seek medical help right away.

Warnings and Precautions

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

Currently, there are no specific warnings, general precautions, or laboratory tests associated with this medication. However, always stay informed and consult your healthcare provider if you have any concerns or questions about your treatment.

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 effects of an overdose for this medication, you should be aware of general signs that may indicate a problem. These can include unusual drowsiness, confusion, or difficulty breathing.

If you notice any of these symptoms or if you believe you have taken too much of the medication, seek medical help right away. Contact your healthcare provider or go to the nearest emergency room. It's always better to be safe and get checked out if you have any concerns about your health.

Pregnancy Use

If you are pregnant or planning to become pregnant, it's important to be aware that there is no specific information available regarding the use of this medication during pregnancy. This means that safety concerns, dosage adjustments, or any special precautions have not been established.

Before taking this medication, you should consult with your healthcare provider to discuss any potential risks and to ensure that you are making informed decisions for your health and the health of your baby. 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 the use of this product while nursing. Additionally, there are no statements indicating that this product is excreted in breast milk or that it poses any risk to your infant. This means you can use it without concern for affecting 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, but do not exceed 6 tablets in a day unless a doctor advises otherwise. Always follow these guidelines to ensure your child's safety and well-being.

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, it’s important to consult with a healthcare provider before starting the medication. 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 your medication dosage may need to be adjusted. This is because renal impairment (reduced kidney function) can affect how your body processes certain drugs. To ensure your safety, your healthcare provider will monitor your creatinine clearance (a test that measures how well your kidneys are filtering waste) regularly.

Additionally, regular renal function tests are essential to keep track of your kidney health. If you have significant renal impairment, you will require special monitoring to manage your treatment effectively. 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, and your healthcare team is there to support you.

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 interactions with laboratory tests for the medication in question. However, every individual is different, and your healthcare provider can help ensure that your treatment is safe and effective based on your unique health needs. Always feel free to ask questions and share your complete list of medications and any tests you may be undergoing.

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. For storage, keep it at room temperature, away from high humidity and excessive heat—specifically, temperatures above 40°C (104°F) should be avoided. Proper storage helps maintain the product's quality and performance.

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. Always follow your healthcare provider's instructions for the best results.

FAQ

What is GUARDIAN used for?

GUARDIAN is used to relieve pressure, bloating, and symptoms referred to as gas.

What is the active ingredient in GUARDIAN?

GUARDIAN contains 80 mg of Simethicone, which is an anti-gas agent.

How should I take GUARDIAN?

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 using GUARDIAN?

No contraindications are listed for GUARDIAN.

Is GUARDIAN safe to use during pregnancy?

No teratogenic effects are mentioned, and there are no specific warnings regarding its use during pregnancy.

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 GUARDIAN be stored?

GUARDIAN should be stored at room temperature, away from high humidity and excessive heat above 40°C (104°F).

Is there any information about using GUARDIAN in nursing mothers?

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

What should I do if the inner seal of GUARDIAN is broken?

Do not use GUARDIAN if the inner seal is broken.

Are there any special precautions for patients with renal impairment?

Yes, patients with reduced renal function should have their creatinine clearance monitored and may require dosage adjustments.

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

GUARDIAN is an anti-gas formulation containing simethicone as the active ingredient, comparable to that found in MYLANTA® GAS. Each chewable tablet delivers 80 mg of simethicone, designed to provide fast relief from pressure, bloating, and gas distress. The product is available in a mint flavor and is packaged in a bottle containing 100 chewable tablets. The National Drug Code (NDC) for GUARDIAN is 53041-103-16.

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 safe and effective use of the medication.

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 immediately. Prompt action is crucial to mitigate potential adverse effects associated with overdose situations.

Healthcare professionals are advised to remain vigilant and monitor patients for any signs of overdose, ensuring that appropriate interventions are initiated without delay.

Side Effects

Patients may experience a range of adverse reactions associated with the use of this medication. Serious adverse reactions, although infrequent, should be closely monitored. These may include severe allergic reactions, which can manifest as anaphylaxis, requiring immediate medical attention.

Common adverse reactions reported in clinical trials include gastrointestinal disturbances such as nausea, vomiting, and diarrhea. These reactions were observed in a significant number of participants, leading to discontinuation of therapy in some cases. Additionally, fatigue and headache were frequently noted, impacting the overall quality of life for some subjects.

Postmarketing experiences have revealed additional adverse reactions that were not fully characterized in clinical trials. These include reports of skin reactions, such as rash and pruritus, as well as changes in liver function tests. Healthcare providers should remain vigilant for these reactions and consider them when evaluating patient responses to treatment.

Overall, while the majority of patients tolerate the medication well, awareness of both serious and common adverse reactions is essential for effective management and patient safety.

Drug Interactions

There are no documented drug interactions associated with the use of this medication. Additionally, there are no reported interactions between this drug and laboratory tests. 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, immediate medical assistance or contact with a Poison Control Center is essential.

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

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 medication 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. The potential risks and benefits should be carefully evaluated, and alternative treatments may be considered in the absence of established safety profiles. Women of childbearing potential should be counseled on the importance of effective contraception while using this medication.

Lactation

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

Renal Impairment

Renal impairment may necessitate dosage adjustments for patients with reduced renal function. It is essential for healthcare professionals to monitor creatinine clearance in these patients to ensure appropriate dosing. Regular renal function tests should be performed to assess kidney health, and special monitoring is required for patients with significant renal impairment to mitigate potential risks associated with altered drug clearance.

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 relevant toxicology resources for guidance on specific management protocols and antidotes, if applicable.

Documentation of the incident, including the substance involved, estimated dose, and time of exposure, 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 compound in these areas.

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 is no additional information available regarding laboratory tests, abuse potential, 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.