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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)
Marketed in the U.S.
Since 2016
Label revision date
July 26, 2016
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
Marketed in the U.S.
Since 2016
Label revision date
July 26, 2016
Manufacturer
PuraCap Pharmaceutical LLC
Registration number
part332
NDC root
51013-132

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, which is designed to help relieve discomfort caused by gas in your digestive system. It works by breaking up gas bubbles in your stomach and intestines, making it easier for your body to eliminate them. This can help alleviate feelings of pressure, bloating, and fullness that are often associated with gas.

You can find this product in softgel form, with each softgel containing 125 mg of simethicone. It is comparable to the active ingredient found in Gas-X® Extra Strength Softgels, providing a similar relief from gas-related discomfort.

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 when you experience 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 who may be 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

There are no specific contraindications, controlled substance classifications, or concerns regarding abuse, misuse, or dependence associated with this medication. Additionally, there are no explicit instructions indicating that you should not take or use this medication. Always consult with your healthcare provider for personalized advice and to ensure this medication is appropriate for you.

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 safely store the medication, 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, which can be dangerous. Always store it in a safe place where children cannot access it.

If you have any concerns or experience unusual symptoms while using this medication, stop using it and call your doctor for guidance. Your health and safety are the top priority, so don’t hesitate to seek help if needed.

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

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 the safety of this medication for pregnant individuals has not been clearly established, and there are no guidelines on dosage adjustments or special precautions to take while using it.

As always, it's best to consult with your healthcare provider before taking any medication during pregnancy. They can help you weigh the potential benefits and risks based on your individual situation.

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 to ensure their safety. For adults, the recommended way to take the medication is to swallow 1 or 2 softgels with water after meals and at bedtime, but you should not exceed 4 softgels in a 24-hour period unless directed by a doctor.

If you have any questions about using this medication for children or specific age-related guidelines, it's best to consult with a healthcare professional for personalized advice.

Geriatric Use

When it comes to using Gas Relief (simethicone) for older adults, there is no specific information available about dosage adjustments or safety concerns. This means that the standard dosage may be appropriate, but it’s always wise to consult with a healthcare provider before starting any new medication.

As you consider using this product, keep in mind that older adults may have unique health needs. If you or a loved one are experiencing gas discomfort, discussing this with a doctor can help ensure that the treatment is safe and effective for your specific situation.

Renal Impairment

It appears that there is no specific information regarding renal impairment (kidney problems) in the provided text. Therefore, there are no guidelines, dosage adjustments, or monitoring instructions to share for patients with kidney issues. If you have concerns about how your kidney health may affect your treatment, it's important to discuss this with your healthcare provider for personalized advice and recommendations.

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 dosing may apply to you, but it’s always best to consult with your healthcare provider for personalized advice. They can help monitor your liver function and ensure that any medications you take are safe and effective for you. Always keep them informed about your liver health to receive the best care possible.

Drug Interactions

It's great to know that there are no reported interactions between this medication and other drugs or laboratory tests. This means you can feel more confident about using it alongside your current treatments or tests. However, it's still very important to discuss all medications and tests with your healthcare provider. They can help ensure that everything works well together and monitor your health effectively. Always keep an open line of communication with your doctor about any changes in your medications or health status.

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 safe and responsible disposal. By taking these precautions, you can help ensure the product remains safe and effective for your use.

Additional Information

No further information is available.

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, with 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, not exceeding 4 softgels in 24 hours unless advised by a physician.

Are there any contraindications for using EXTRA STRENGTH GAS RELIEF?

No contraindications are listed for this product.

Is EXTRA STRENGTH GAS RELIEF safe to use during pregnancy?

There are no specific warnings or safety concerns regarding the use of this product 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.

What should I do if I have children at home?

Keep EXTRA STRENGTH GAS RELIEF out of reach of children.

How should I store EXTRA STRENGTH GAS RELIEF?

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

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

This formulation contains Simethicone, an antiflatulent agent, at a strength of 125 mg per softgel. The product is presented in a dosage form of softgels, with a total of 30 softgels per package. The National Drug Code (NDC) for this product is 51013-132-10. This formulation is comparable to the active ingredient found in Gas-X® Extra Strength Softgels, providing effective relief from gas-related discomfort.

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 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

There are no contraindications listed for the use of this product. It is important to evaluate each patient's individual circumstances and medical history to ensure safe and appropriate use.

Warnings and Precautions

It is imperative to keep this medication out of reach of children to prevent accidental ingestion or misuse. Healthcare professionals should counsel patients and caregivers on the importance of secure storage to ensure the safety of pediatric populations.

In addition, it is essential to monitor patients for any adverse reactions or side effects associated with the use of this medication. Regular follow-up appointments may be necessary to assess the patient's response to treatment and to make any necessary adjustments to the therapeutic regimen.

Healthcare providers are encouraged to educate patients about the signs and symptoms of potential complications, ensuring they understand when to seek immediate medical attention.

Side Effects

Patients should be advised to keep this medication out of reach of children to prevent accidental ingestion or exposure.

In clinical trials and postmarketing experiences, no specific adverse reactions were reported. However, it is essential for healthcare providers to monitor patients for any unexpected effects and to report them as necessary.

Drug Interactions

No drug interactions have been identified in the available data. Additionally, there are no reported interactions between drugs and laboratory tests. Therefore, no dosage adjustments or monitoring recommendations are necessary based on the current information.

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. The recommended directions for adult use involve swallowing 1 or 2 softgels with water after meals and at bedtime, with a maximum of 4 softgels in a 24-hour period unless otherwise directed by a physician. There are no specific dosage recommendations or study outcomes provided for pediatric populations, and caution should be exercised when considering use in children.

Geriatric Use

There is no specific information regarding the use of Gas Relief (simethicone) in geriatric patients, including dosage adjustments, safety concerns, or special precautions. Healthcare providers should exercise clinical judgment when prescribing this medication to elderly patients, as individual responses may vary. Monitoring for efficacy and potential adverse effects is recommended, given the lack of targeted data for this population.

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

There is no information available regarding the use of this medication in patients with hepatic impairment. Consequently, there are no dosage adjustments, special monitoring requirements, or precautions specified for individuals with compromised liver function. Healthcare professionals should exercise clinical judgment when considering the use of this medication in patients with liver problems, as the absence of specific guidance necessitates careful evaluation of the patient's overall health status and liver function.

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.

If available, specific antidotes or treatments should be administered as per established protocols. Additionally, contacting a poison control center can provide valuable guidance on the management of overdose cases.

Documentation of the incident, including the substance involved, the amount taken, and the time of ingestion, is crucial for effective treatment 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 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 various package configurations, with specific NDC numbers available upon request. It should be stored at room temperature, within the range of 15° to 30°C (59° to 86°F). Care must be taken to protect the product from light, heat, and moisture to ensure its integrity and efficacy.

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.

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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.