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Rugby Gas Relief

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Active ingredient
Dimethicone 125 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 2019
Label revision date
November 24, 2025
Drug Information (PDF)
Prescribing information, PDF file
Active ingredient
Dimethicone 125 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 2019
Label revision date
November 24, 2025
Manufacturer
Rugby Laboratories
Registration number
part332
NDC root
0536-1223
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 an active ingredient found in products like gas-x® Extra Strength, designed to help relieve discomfort caused by gas. It comes in a formulation of 125 mg per chewable tablet, available in a pleasant antigas mint flavor.

This medication works by alleviating gas pain, pressure, and bloating, providing you with relief from the uncomfortable symptoms associated with gas. If you're experiencing these issues, simethicone may be a helpful option to consider for easing your discomfort.

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 pain associated with gas, making you feel more comfortable.

You can trust that this medication does not have any teratogenic effects, meaning it does not cause developmental issues in a fetus. So, if you're looking for relief from these common digestive issues, this medication may be a suitable option for you.

Dosage and Administration

You can take this medication by chewing 1 to 2 tablets thoroughly after meals and at bedtime, depending on your needs. It's important to not exceed 4 tablets 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 concerns regarding 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 not experience any specific side effects while using this medication, as there are no known adverse reactions reported. It's important to stay informed and monitor how you feel while taking it. If you have any concerns or notice anything unusual, be sure to discuss it with your healthcare provider.

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. Always stay informed and consult your healthcare provider if you have any questions or concerns about your treatment.

Overdose

It appears that there is no specific information available regarding overdosage for this medication. However, it's always important to be aware of the signs of an overdose, which can include unusual drowsiness, confusion, or difficulty breathing. If you suspect that you or someone else may have taken too much of a medication, it’s crucial to seek immediate medical help.

In case of an overdose, contact your local emergency services or go to the nearest hospital. Having the medication packaging or information on hand can help medical professionals provide the best care. Always remember that when it comes to medications, it's better to be safe and get help if you have any concerns.

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 Rugby Gas Relief (simethicone) during pregnancy. This means that safety concerns, dosage adjustments, or any special precautions for pregnant individuals have not been addressed in the drug insert.

As always, it's best to consult with your healthcare provider before taking any medication while pregnant to ensure the safety of both you and your baby.

Lactation Use

If you are breastfeeding, you can feel reassured that there are no specific warnings or recommendations regarding the use of simethicone. The information available does not indicate any concerns about simethicone being passed into breast milk or posing any risk to your nursing infant.

As always, if you have any questions or concerns about medications while breastfeeding, it's a good idea to consult with your healthcare provider for personalized advice.

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 may need this medication, the recommended dosage is to chew 1 to 2 tablets thoroughly after meals and at bedtime. However, do not exceed 4 tablets in a 24-hour period unless directed by a doctor. Always follow your healthcare provider's advice to ensure safe use.

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 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 your condition can affect how your body processes certain medications. This means that you may need to adjust your dosage to ensure safety and effectiveness. For those with severe liver impairment, a lower dose may be necessary, or you might need to consider different treatment options altogether.

Additionally, regular monitoring of your liver function tests (which check how well your liver is working) is recommended. This helps your healthcare provider keep track of your liver health and make any necessary changes to your treatment plan. Always discuss your liver condition with your doctor to ensure you receive the best care.

Drug Interactions

It's important to have open conversations with your healthcare provider about any medications or tests you may be taking. While there are no specific drug interactions or laboratory test interactions noted for this medication, your healthcare provider can help ensure that everything you are taking works well together and is safe for you. Always share your complete list of medications and any recent lab tests to avoid any potential issues. Your health and safety should always come first.

Storage and Handling

To ensure the safety and effectiveness of your product, always check that the inner seal is intact before use; do not use it if the seal is broken. Store the product at room temperature, and be mindful to keep it away from high humidity and excessive heat, which can occur at temperatures above 40°C (104°F).

By following these simple storage and handling guidelines, you can help maintain the quality and safety of the product for your use.

Additional Information

You should take this medication orally by chewing 1 to 2 tablets thoroughly as needed after meals and at bedtime. It's important not to exceed 4 tablets in a 24-hour period unless directed by your doctor. Always follow your physician's advice regarding the use of this medication.

FAQ

What is Simethicone used for?

Simethicone is used to relieve gas pain, pressure, and bloating, as well as symptoms referred to as gas.

How should I take Simethicone?

You should chew 1 to 2 tablets thoroughly as needed after meals and at bedtime, but do not exceed 4 tablets in a 24-hour period unless advised by a physician.

Are there any side effects associated with Simethicone?

No specific side effects or warnings are listed for Simethicone.

Is Simethicone safe to use during pregnancy or while nursing?

The provided information does not mention any specific warnings or recommendations regarding the use of Simethicone during pregnancy or lactation.

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 I store Simethicone?

Store Simethicone at room temperature, away from high humidity and excessive heat above 40°C (104°F), and do not use if the inner seal is broken.

Are there any contraindications for using Simethicone?

There are no contraindications listed for Simethicone.

Can I use Simethicone if I have kidney or liver problems?

Yes, but dosage adjustments may be necessary for patients with renal or hepatic impairment, and monitoring of renal and liver function tests is recommended.

Packaging Info

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

Packaging configurations for Rugby Gas Relief.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

No description information is available for the drug.

Uses and Indications

This drug is indicated for the relief of pressure, bloating, and symptoms associated with gas, including gas pain.

There are no teratogenic or nonteratogenic effects associated with this drug.

Dosage and Administration

Patients are advised to chew 1 to 2 tablets thoroughly as needed after meals and at bedtime. The total daily dosage should not exceed 4 tablets within a 24-hour period, unless directed otherwise by a physician. It is essential that patients 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

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 monitor patients for any signs of overdose, ensuring that appropriate interventions are initiated as necessary.

Side Effects

No specific side effects have been identified in clinical trials or postmarketing experiences. Additionally, there are no additional adverse reactions or important notes to report.

Drug Interactions

There are currently no documented drug interactions associated with this medication. Additionally, there are no known interactions with laboratory tests. As such, no specific recommendations for dosage adjustments or monitoring are warranted at this time.

Packaging & NDC

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

Packaging configurations for Rugby 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 1 to 2 tablets thoroughly as needed after meals and at bedtime. The maximum recommended dosage is 4 tablets within a 24-hour period, 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 regarding the use of Rugby Gas Relief (simethicone) during pregnancy, including safety concerns, dosage modifications, or special precautions. Healthcare professionals should consider the lack of data when advising pregnant patients. As with any medication, the potential benefits must be weighed against any unknown risks to fetal outcomes. Women of childbearing potential should be counseled accordingly.

Lactation

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

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 may experience altered metabolism of the drug, necessitating dosage adjustments. It is recommended that these patients undergo special monitoring of liver function tests to assess their hepatic status and ensure safe administration of the medication.

For patients with severe hepatic impairment, a reduced dose may be required, or alternative therapy should be considered to mitigate potential risks associated with compromised liver function.

Overdosage

In the absence of specific overdosage information, it is essential for healthcare professionals to remain vigilant regarding the potential for overdose with this medication. In cases where an overdose is suspected, immediate medical attention should be sought.

Healthcare providers are advised to monitor patients closely for any signs or symptoms that may indicate an overdose. These may include, but are not limited to, increased severity of known side effects, unusual behavioral changes, or any other atypical clinical manifestations.

Management of an overdose should be guided by the clinical presentation of the patient. Supportive care is paramount, and symptomatic treatment should be initiated as necessary. It is recommended that healthcare professionals consult local poison control centers or relevant toxicology resources for specific guidance on the management of overdose cases.

In summary, while specific overdosage information is not available, healthcare professionals should exercise caution, monitor for symptoms, and provide appropriate management in the event of an overdose.

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 provided in the insert.

Patient Counseling

Healthcare providers should advise patients to keep this medication out of the reach of children to prevent accidental ingestion. It is crucial to emphasize the importance of safety in the home environment, particularly for households with young children.

In the event of an overdose, healthcare providers should instruct patients to seek medical help or contact a Poison Control Center immediately. Patients should be made aware of the signs of overdose and the urgency of obtaining assistance to ensure their safety and well-being.

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 and efficacy.

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

Additional Clinical Information

The medication is administered orally, with the recommended direction for patients to chew 1 to 2 tablets thoroughly as needed after meals and at bedtime. Patients should not exceed 4 tablets within a 24-hour period unless advised and supervised 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 Rugby 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 Rugby 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.