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Gas Relief

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This product has been discontinued

Active ingredient
Dimethicone 180 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 15, 2016
Active ingredient
Dimethicone 180 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 15, 2016
Manufacturer
PuraCap Pharmaceutical LLC
Registration number
part332
NDC root
51013-115

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If you are a consumer or patient please visit this version.

Drug Overview

ULTRA STRENGTH Gas Relief contains simethicone, a medication designed to help relieve bloating, pressure, or fullness that is commonly associated with gas. By breaking up gas bubbles in the stomach and intestines, simethicone helps you feel more comfortable and reduces the discomfort caused by excess gas.

This product is particularly useful if you experience occasional gas-related discomfort and are looking for a solution to alleviate those symptoms effectively.

Uses

You can use this medication to help relieve feelings of bloating, pressure, or fullness that are often caused by 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 one or two softgels after a meal, depending on your needs. It's important to remember not to exceed two softgels in a single day unless your doctor has specifically advised you to do so. Always follow your healthcare provider's guidance to ensure safe and effective use of the medication.

What to Avoid

It's important to be aware of certain guidelines when using this medication. While there are no specific contraindications or concerns about abuse, misuse, or dependence associated with it, you should stop using the medication and consult your doctor if your condition does not improve. Always prioritize your health and safety by following these instructions closely.

Side Effects

If you experience any persistent symptoms while using this medication, it’s important to stop using it and consult your doctor. This is a precaution to ensure your safety and well-being. Always pay attention to how your body responds, and don’t hesitate to seek medical advice if needed.

Warnings and Precautions

It's important to be aware of certain precautions when using this medication. If your condition does not improve or continues to persist, you should stop taking the medication and consult your doctor for further guidance.

While there are no specific warnings or laboratory tests associated with this medication, always prioritize your health and communicate openly with your healthcare provider about any concerns or unusual symptoms you may experience.

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, contacting your healthcare provider or local poison control center is crucial. They can provide guidance on what steps to take next. Always err on the side of caution—if you feel something is wrong, don’t hesitate to get help.

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 any special precautions related to its use in pregnant individuals have not been established.

Before taking any medication, including over-the-counter products like Gas Relief, you should consult with your healthcare provider to discuss your options and 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 nursing mothers or lactation in the information provided. This means that, based on the available data, there are no known risks associated with breastfeeding while using this medication. However, it's always a good idea to consult with your healthcare provider if you have any concerns or questions about your specific situation.

Pediatric Use

It's important to keep this medication out of reach of children to ensure their safety. If your child needs to take this medication, be aware that they should not exceed two softgels per day unless a doctor has specifically advised otherwise. Always consult with a healthcare professional if you have any questions or concerns about the appropriate dosage for your child.

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 there are no specific guidelines, dosage adjustments, or monitoring recommendations provided for your condition in the available information. This means that the standard instructions for the medication do not include special considerations for those with renal impairment (kidney issues).

Always consult your healthcare provider for personalized advice and to ensure that any medication you take is safe and appropriate for your kidney health. They can provide guidance tailored to your specific situation.

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 course of action 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 important to have open conversations with your healthcare provider about any medications you are taking. In this case, there are no specific drug interactions or laboratory test interactions noted, which means that this medication is generally considered safe to use alongside other treatments and tests. However, every individual is different, and your healthcare provider can help ensure that your overall treatment plan is safe and effective for you.

Always remember that discussing your full list of medications and any lab tests with your healthcare provider is crucial. This way, you can avoid any potential issues and receive the best care tailored to your needs.

Storage and Handling

To ensure the best performance of your product, store it at room temperature, ideally between 59ºF and 86ºF (15ºC and 30ºC). This temperature range helps maintain the integrity and effectiveness of the device.

When handling the product, make sure to do so in a clean environment to avoid contamination. Always follow any specific instructions provided for use and disposal to ensure safety and effectiveness.

Additional Information

You can take this medication orally by swallowing one or two softgels after a meal, as needed. It's important not to exceed two softgels in a day unless your doctor advises otherwise. Always follow your physician's guidance for safe use.

FAQ

What is ULTRA STRENGTH Gas Relief?

ULTRA STRENGTH Gas Relief is a medication containing Simethicone 180 mg, designed to relieve bloating, pressure, or fullness commonly referred to as gas.

How should I take ULTRA STRENGTH Gas Relief?

You should swallow one or two softgels as needed after a meal, but do not exceed two softgels per day unless advised by a physician.

Are there any contraindications for using this medication?

No contraindications are listed for ULTRA STRENGTH Gas Relief.

What should I do if my condition persists?

You should stop using the medication and ask a doctor if your condition persists.

Is ULTRA STRENGTH Gas Relief safe to use during pregnancy?

The provided information does not mention any specific safety concerns or dosage modifications for use during pregnancy.

Can nursing mothers use ULTRA STRENGTH Gas Relief?

There are no specific warnings or recommendations regarding the use of this medication by nursing mothers.

How should I store ULTRA STRENGTH Gas Relief?

Store the medication at room temperature between 59º - 86ºF (15º - 30ºC).

Are there any known drug interactions with ULTRA STRENGTH Gas Relief?

No specific drug interactions are mentioned for this medication.

Is there any information regarding the use of ULTRA STRENGTH Gas Relief in elderly patients?

The drug insert does not provide specific information regarding geriatric use or safety concerns for elderly patients.

What is the mechanism of action of Simethicone?

Simethicone works by relieving bloating, pressure, or fullness commonly referred to as gas.

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

ULTRA STRENGTH Gas Relief contains 180 mg of simethicone, an effective antiflatulent agent. The product is identified by the National Drug Code (NDC) 51013-115-01. This formulation is comparable to the active ingredient found in PHAZYME® Ultra Strength.

Uses and Indications

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

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

Dosage and Administration

Patients are advised to swallow one or two softgels as needed after a meal. The maximum recommended dosage is two softgels per day, unless otherwise directed by a physician. It is important for healthcare professionals to monitor patients for adherence to this dosage limit to ensure safety and efficacy.

Contraindications

There are no contraindications listed for this product. It is important to monitor the patient's condition; if symptoms persist, discontinue use and consult a healthcare professional.

Warnings and Precautions

Healthcare professionals should be aware of the following considerations regarding the safe use of this medication.

In the event that the patient's condition does not improve or persists, it is imperative to discontinue use and consult a healthcare provider for further evaluation and management. Continuous monitoring of the patient's response to treatment is essential to ensure safety and efficacy.

No specific laboratory tests or emergency medical instructions are provided; however, practitioners should remain vigilant and assess the patient's overall health status regularly.

Side Effects

Patients should be advised to discontinue use and consult a healthcare professional if their condition persists. This warning is crucial for ensuring patient safety and appropriate management of their health concerns.

Drug Interactions

No specific drug interactions have been identified for this medication. Additionally, there are no reported interactions with laboratory tests. Therefore, no dosage adjustments or monitoring recommendations are necessary based on drug or laboratory test 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. The recommended dosage for pediatric patients is limited to a maximum of two softgels per day, unless otherwise directed by a physician. Careful supervision is advised to ensure safety and adherence to dosing guidelines.

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. Monitoring for potential adverse effects and therapeutic efficacy is recommended in 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. As such, healthcare professionals should exercise caution when recommending this medication to pregnant patients. The absence of data does not imply safety; therefore, the potential risks and benefits should be carefully considered in the context of each individual patient's circumstances. Women of childbearing potential should be informed of the lack of available information and encouraged to discuss any concerns with their healthcare provider.

Lactation

There are no specific warnings or recommendations regarding the use of this medication in lactating mothers. Additionally, there are no known data on excretion in breast milk or effects on breastfed infants. Healthcare professionals should consider the absence of specific guidance when advising lactating mothers about the use of this medication.

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 excessive dosing. Symptoms of overdosage 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 further management and intervention strategies.

Documentation of the incident, including the amount ingested and the time of exposure, 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. It is important for patients to understand that if their condition persists, they should stop using the medication and consult a doctor for further evaluation and guidance. This ensures that patients are aware of the necessary steps to take should their symptoms not improve, promoting safe and effective use of the medication.

Storage and Handling

The product is supplied in various package configurations, with specific NDC numbers available upon request. It is essential to store the product at room temperature, maintaining a temperature range of 59º - 86ºF (15º - 30ºC). Proper storage conditions are crucial to ensure the integrity and efficacy of the product.

Additional Clinical Information

The product is administered orally, with patients advised to swallow one or two softgels as needed after a meal. It is important for patients not to exceed a total of two softgels per day unless directed by a physician. No additional information is 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.

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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.