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Gas Relief

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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 2018
Label revision date
November 21, 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 2018
Label revision date
November 21, 2024
Manufacturer
Walgreen Co.
Registration number
M002
NDC root
0363-9938
Drug Information (PDF)
Prescribing information, PDF file
Packaging Info (3 NDCs)
Packaging & NDC Codes (3)

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

EXTRA STRENGTH GAS RELIEF is a medication that contains simethicone (125 mg), which is designed to help relieve discomfort caused by pressure, bloating, and fullness commonly associated with gas. This product comes in the form of softgels and is intended to provide you with quick relief from these uncomfortable symptoms.

If you're experiencing gas-related issues, EXTRA STRENGTH GAS RELIEF may be a suitable option to help ease your discomfort and improve your overall well-being.

Uses

You can use this medication to help relieve the discomfort of pressure, bloating, and fullness that often comes from gas. It’s designed to make you feel more comfortable by addressing these common digestive issues.

Rest assured, there are no known teratogenic effects (which means it doesn’t cause birth defects) associated with this medication, making it a safer option for those concerned about such risks.

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

It's important to keep this medication out of reach of children to ensure their safety. There are no specific contraindications, controlled substance classifications, or concerns regarding abuse, misuse, or dependence associated with this medication. Always follow safety guidelines to use it responsibly.

Side Effects

It's important to keep this medication out of reach of children to prevent accidental ingestion. If you have any concerns about side effects or how to use this medication safely, please consult your healthcare provider for guidance.

Warnings and Precautions

It's important to keep this medication out of reach of children to prevent accidental ingestion. Always ensure that it is stored safely and securely.

While there are no specific general precautions or laboratory tests mentioned, it's essential to stay informed about any potential side effects or interactions with other medications. If you have any concerns or experience unusual symptoms, don't hesitate to reach out to your healthcare provider for guidance.

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 or symptoms of an overdose for this medication, general signs may include unusual drowsiness, confusion, or difficulty breathing.

If you notice any of these symptoms or have concerns about a possible overdose, seek medical help right away. It's always better to err on the side of caution when it comes to your health. Remember, if you are ever in doubt, contacting a healthcare professional is the best course of action.

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 Gas Relief (simethicone) during pregnancy. This means that safety concerns, dosage adjustments, or special precautions related to its use in pregnant individuals have not been clearly established.

Before taking any medication, including over-the-counter products like Gas Relief, you should consult with your healthcare provider to discuss your specific situation and any potential risks. Your health and the health of your baby are the top priority, so it's always best to seek professional advice.

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. Currently, there is also no information available about whether this product is excreted in breast milk or any potential risks to your infant.

As always, it's a good idea to consult with your healthcare provider if you have any concerns or questions about using this product while breastfeeding. Your health and the health of your baby are important, and your provider can help you make informed decisions.

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, 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

There are no specific guidelines, dosage adjustments, or monitoring requirements mentioned for patients with kidney problems in the provided information. If you have renal impairment (kidney issues), it's important to consult your healthcare provider for personalized advice regarding your treatment and any necessary adjustments. Always keep them informed about your kidney health to ensure safe and effective 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, and there are no special monitoring requirements or precautions outlined for patients with liver impairment.

Always consult your healthcare provider for personalized advice and to ensure that any medications you take are safe for your liver health. They can provide guidance tailored to your specific situation.

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.

Always keep your healthcare provider informed about any changes in your health or new medications you may 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 room temperature, ideally between 15°-30°C (59°-86°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 can take this medication orally by swallowing 1 or 2 softgels with water after meals and at bedtime, as needed. However, be sure not to exceed 4 softgels in a 24-hour period unless directed by your doctor. Always follow your healthcare provider's advice for safe use.

FAQ

What is EXTRA STRENGTH GAS RELIEF used for?

EXTRA STRENGTH GAS RELIEF is used for the relief of pressure, bloating, and fullness commonly referred to as gas.

What is the active ingredient in EXTRA STRENGTH GAS RELIEF?

The active ingredient is SIMETHICONE, which is present at a dosage of 125 mg per softgel.

How should I take EXTRA STRENGTH GAS RELIEF?

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

Are there any contraindications for using EXTRA STRENGTH GAS RELIEF?

There are no contraindications listed for using EXTRA STRENGTH GAS RELIEF.

Is EXTRA STRENGTH GAS RELIEF safe to use during pregnancy?

There is no specific information regarding the use of EXTRA STRENGTH GAS RELIEF during pregnancy.

Can nursing mothers use EXTRA STRENGTH GAS RELIEF?

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

How should I store EXTRA STRENGTH GAS RELIEF?

Store EXTRA STRENGTH GAS RELIEF at room temperature between 15°-30°C (59°-86°F) and protect it from light, heat, and moisture.

What should I do if I accidentally take too much EXTRA STRENGTH GAS RELIEF?

Do not exceed the recommended dosage of 4 softgels in 24 hours unless under the advice of a physician.

What are the warnings associated with EXTRA STRENGTH GAS RELIEF?

Keep EXTRA STRENGTH GAS RELIEF out of reach of children.

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, an active ingredient in this formulation, is present at a strength of 125 mg per softgel. This product is designed for extra strength gas relief and is available in a package containing 20 softgels. The National Drug Code (NDC) for this product is 0363-9938-08. This formulation is comparable to the active ingredient found in Gas-X® Extra Strength Softgels.

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 essential to adhere to this guideline to ensure safe and effective use of the medication.

Contraindications

Use is contraindicated in individuals who are unable to keep the product out of reach of children. This precaution is necessary to prevent accidental ingestion or misuse by pediatric patients. No other contraindications have been identified.

Warnings and Precautions

It is imperative to keep this medication out of reach of children to prevent accidental ingestion or misuse.

No specific general precautions or laboratory tests have been identified for this medication. Healthcare professionals are advised to remain vigilant and monitor for any potential adverse effects or interactions that may arise during treatment.

Side Effects

Patients should be advised to keep this medication out of reach of children. This warning is critical to prevent accidental ingestion or exposure, which could lead to serious adverse reactions.

In clinical trials and postmarketing experiences, no specific adverse reactions were reported; however, the importance of safeguarding the medication from children cannot be overstated. It is essential for patients to understand the potential risks associated with improper access to the medication.

Drug Interactions

No drug interactions or drug and laboratory test interactions have been identified in the available data. 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). 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. There are no specific age ranges, dosage differences, or study outcomes provided for pediatric use in the available data. Caution is advised when administering this medication to ensure safety in the pediatric population.

Geriatric Use

There is no specific information available 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. It is advisable to monitor these patients closely for any adverse effects or changes in efficacy.

Pregnancy

There is no specific information regarding the use of 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 this product in nursing mothers. Additionally, there is no information available about the potential for excretion in breast milk or any associated risks to breastfed infants.

Renal Impairment

There is no information available regarding dosage adjustments, special monitoring, or safety considerations for patients with renal impairment. Healthcare professionals should exercise caution and consider the lack of specific guidance when prescribing to patients with reduced kidney function.

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 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, as the clinical presentation can vary depending on the substance involved and the individual patient's response. Common symptoms of overdose may include, but are not limited to, altered mental status, cardiovascular instability, respiratory distress, and gastrointestinal disturbances.

In the event of an overdose, immediate medical attention should be sought. Healthcare providers should initiate supportive care, which may include maintaining airway patency, providing supplemental oxygen, and ensuring adequate circulation. The use of activated charcoal may be considered if the patient presents within a suitable timeframe and if the ingestion was recent.

Furthermore, specific antidotes or treatments may be indicated based on the substance involved in the overdose. It is crucial for healthcare professionals to consult relevant clinical guidelines and toxicology resources to determine the most appropriate management strategies.

In summary, while no specific overdosage information is provided, vigilance and prompt intervention are paramount in managing potential overdose situations.

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 in these areas limits the understanding of the compound's potential effects in nonclinical settings.

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 packaging that ensures its integrity during storage and handling. It should be stored at room temperature, specifically within the range of 15° to 30°C (59° to 86°F). It is essential to protect the product from light, heat, and moisture to maintain its efficacy and safety. Proper storage conditions are crucial for 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 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.