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Ultra Strength 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)
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Marketed in the U.S.
Since 2018
Label revision date
March 27, 2018
Drug Information (PDF)
Prescribing information, PDF file
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
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Marketed in the U.S.
Since 2018
Label revision date
March 27, 2018
Manufacturer
PURACAP PHARMACEUTICAL LLC
Registration number
part332
NDC root
51013-431
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

Ultra Strength Gas Relief contains simethicone, a medication designed to help relieve pressure and bloating commonly associated with gas. Each softgel contains 180 mg of simethicone, which works by breaking up gas bubbles in your stomach and intestines, making it easier for your body to eliminate them.

This product is often compared to the active ingredient found in Gas-X® Ultra Strength, providing a familiar option for those seeking relief from uncomfortable gas-related symptoms. If you're experiencing discomfort due to gas, Ultra Strength Gas Relief may be a helpful choice for you.

Uses

If you're experiencing discomfort from pressure and bloating, often caused by gas, this medication can help provide relief. It's designed specifically to ease those uncomfortable feelings, allowing you to feel more at ease.

Rest assured, there are no known risks of teratogenic effects (which can cause developmental issues in a fetus) associated with this medication, making it a safer option for those who may be concerned.

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 2 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 mentioned. Always follow these guidelines to use the medication safely and effectively.

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, 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 advice. 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 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 know that there is no specific information available about the use of Ultra Strength Gas Relief (simethicone) during pregnancy. This means that safety concerns, dosage adjustments, or special precautions for pregnant individuals have not been addressed in the drug insert.

Before using this medication, you should consult with your healthcare provider to discuss any potential risks and to ensure that it is safe for you and your baby. Always prioritize open communication with your doctor regarding any medications you consider taking 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 is no information available about whether this product is excreted in breast milk or any potential risks to your infant. Always consult with your healthcare provider if you have any concerns or questions about medications while breastfeeding.

Pediatric Use

It's important to keep this medication out of reach of children to ensure their safety. If you are an adult taking this medication, the recommended dosage is to swallow 1 or 2 softgels with water after meals and at bedtime. However, you should not exceed 2 softgels in a 24-hour period unless directed by a doctor. Always consult with a healthcare professional before giving any medication to children, as their needs and dosages can differ significantly from adults.

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

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

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.

However, it's always a good idea to discuss your liver health with your healthcare provider before starting any new medication. They can provide personalized advice and ensure that your treatment is safe and effective for you.

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 the medication may not have known conflicts with other drugs or tests. However, every individual is different, and your healthcare provider can help ensure that your treatment is safe and effective based on your unique health situation.

Always discuss any new medications or tests with your healthcare provider to avoid potential issues and to get the best care possible. Your health and safety should always come first.

Storage and Handling

To ensure the best performance of your product, store it at a controlled room temperature between 15º - 30ºC (59º - 86ºF). It's important to keep it away from heat and moisture, as these can affect its quality and effectiveness.

When handling the product, always do so with clean hands and in a clean environment to maintain its integrity. Following these guidelines will help you use the product safely and effectively.

Additional Information

You should take this medication orally, swallowing 1 or 2 softgels with water after meals and at bedtime as needed. It's important not to exceed 2 softgels in a 24-hour period unless directed by your doctor. Always follow your physician's advice for safe use.

FAQ

What is Ultra Strength Gas Relief used for?

Ultra Strength Gas Relief is used for the relief of pressure and bloating commonly referred to as gas.

How should I take Ultra Strength Gas Relief?

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

Are there any contraindications for using Ultra Strength Gas Relief?

No contraindications are listed for Ultra Strength Gas Relief.

Is Ultra Strength Gas Relief safe to use during pregnancy?

There is no specific information regarding the safety of Ultra Strength Gas Relief during pregnancy.

Can nursing mothers use Ultra 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 Ultra Strength Gas Relief out of reach of children.

What is the active ingredient in Ultra Strength Gas Relief?

The active ingredient in Ultra Strength Gas Relief is simethicone, with a dosage of 180 mg.

How should I store Ultra Strength Gas Relief?

Store Ultra Strength Gas Relief at a controlled room temperature of 15º - 30ºC (59º - 86ºF) and protect it from heat and moisture.

Packaging Info

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

Packaging configurations for Ultra Strength Gas Relief.
Details

Drug Information (PDF)

This file contains official product information for Ultra Strength 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 simethicone as its active ingredient, with a dosage of 180 mg per softgel. This formulation is designed to provide effective relief from gas-related discomfort. The product is available in a package containing 50 softgels. The National Drug Code (NDC) for this product is 51013-431-09. This formulation is comparable to the active ingredient found in Gas-X® Ultra Strength.

Uses and Indications

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

There are no teratogenic or nonteratogenic effects mentioned associated with the use of this drug.

Dosage and Administration

Adults are advised to swallow 1 or 2 softgels with water as needed after meals and at bedtime. The maximum recommended dosage is 2 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 of this product is contraindicated in individuals who are unable to keep it out of reach of children. This precaution is necessary to prevent accidental ingestion or misuse by minors. No other contraindications have been identified in the available data.

Warnings and Precautions

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

Healthcare professionals should ensure that patients are aware of the importance of proper storage and handling of the medication. This precaution is essential to safeguard against potential adverse effects that may arise from unintentional exposure in pediatric populations.

In addition, healthcare providers are encouraged to educate caregivers about the signs of overdose or adverse reactions, emphasizing the need for immediate medical attention should such events occur. Regular follow-up and monitoring of patients may also be warranted to ensure safe and effective use of the medication.

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 detailed; however, the importance of safeguarding the medication from children is emphasized to mitigate potential risks.

Drug Interactions

No specific drug interactions have been identified in the available data. Additionally, there are no reported interactions between the drug 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 Ultra Strength Gas Relief (simethicone). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Ultra Strength Gas Relief.
Details

Pediatric Use

Pediatric patients should be advised to keep this medication out of reach of children. The dosing instructions provided are intended for adults, who are directed to swallow 1 or 2 softgels with water as needed after meals and at bedtime, without exceeding 2 softgels in a 24-hour period unless under the advice and supervision of a physician. There is no specific dosing information or study outcomes available for pediatric populations. Therefore, caution is advised when considering this medication for use in children.

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 Ultra Strength Gas Relief (simethicone) during pregnancy. The drug insert does not provide safety concerns, dosage modifications, or special precautions for pregnant patients. Therefore, healthcare professionals should consider the lack of data when advising women of childbearing potential and weigh the potential benefits against any unknown risks when recommending this medication during pregnancy.

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 data 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 potential risks and benefits.

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 use of the compound in question. Further studies may be necessary to elucidate these aspects of nonclinical toxicology.

Postmarketing Experience

No postmarketing experience details are available in the insert.

Patient Counseling

Healthcare providers should advise patients to keep this 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 individuals.

Storage and Handling

The product is supplied in various package configurations, with specific NDC numbers available upon request. It should be stored at a controlled room temperature ranging from 15º to 30ºC (59º to 86ºF). It is essential to protect the product from heat and moisture to maintain its integrity and efficacy. Proper handling and storage conditions are crucial to ensure the product remains within the specified temperature range and is shielded from environmental factors that could compromise its quality.

Additional Clinical Information

The medication is administered orally, with adults advised to swallow 1 or 2 softgels with water after meals and at bedtime. Patients should not exceed a total of 2 softgels within a 24-hour period unless directed by a physician. There are no additional details available regarding laboratory tests, abuse information, patient counseling, or postmarketing experience.

Drug Information (PDF)

This file contains official product information for Ultra Strength 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 Ultra Strength 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.