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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 2016
Label revision date
July 28, 2016
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 2016
Label revision date
July 28, 2016
Manufacturer
Chain Drug Marketing Association Inc.
Registration number
part332
NDC root
63868-098
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 bloating, pressure, or fullness that is commonly associated with gas. Each softgel contains 180 mg of simethicone, which works by breaking up gas bubbles in the stomach and intestines, making it easier for your body to eliminate them.

This product is intended for those who experience discomfort due to gas, providing a simple and effective solution to help you feel more comfortable. If you're looking for relief from gas-related symptoms, Ultra Strength Gas Relief may be a helpful option for you.

Uses

If you're experiencing discomfort from bloating, pressure, or a feeling of fullness often associated with gas, this medication can help relieve those symptoms. It works by targeting the underlying causes of gas, providing you with the comfort you need.

Using this medication can make a significant difference in how you feel, allowing you to go about your day without the distraction of digestive discomfort.

Dosage and Administration

You can take this medication by swallowing 1 or 2 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 keep this medication out of reach of children to ensure their safety. If your condition does not improve or continues to persist, please stop using the medication and consult your doctor for further guidance. This will help ensure that you receive the appropriate care and support for your health needs.

Side Effects

If your condition does not improve, it's important to stop using the medication and consult your doctor. Additionally, please ensure that this medication is kept out of reach of children to prevent any accidental ingestion.

Warnings and Precautions

It's important to be aware of how to use this medication safely. If your condition continues or does not improve, you should stop taking the medication and contact your doctor for further guidance.

While there are no specific warnings or precautions listed, always stay informed about your health and any changes you may experience while using this medication. If you have any concerns or questions, don’t hesitate to reach out to your healthcare provider.

Overdose

If you suspect an overdose, it's important to stay calm and take immediate action. While there are no specific signs or symptoms listed for an overdose, you should be aware of general warning signs such as extreme drowsiness, confusion, or difficulty breathing. If you notice any of these symptoms or feel something is wrong, 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.

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 any 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 it may pose 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 your child's condition does not improve or continues to persist, you should stop using the medication and consult a doctor for further guidance. Always prioritize your child's health and well-being by following these precautions.

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 requirements mentioned for your condition in the provided information. This means that the standard recommendations for medication use may apply to you without any special considerations. However, always consult your healthcare provider for personalized advice and to ensure your treatment is safe and effective based on your kidney health.

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 liver function tests (which check how well your liver is working) to ensure your safety while using any medication.

Drug Interactions

It's important to have open conversations with your healthcare provider about any medications or tests you may be taking. In this case, there are no known drug interactions or laboratory test interactions associated with the medication. However, always ensure that your healthcare provider is aware of all the medications you are using, as this helps them provide the best care tailored to your needs.

By discussing your full medical history and any other treatments, you can help prevent potential issues and ensure your safety.

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

No further information is available.

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 1 or 2 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 Ultra Strength Gas Relief?

There are no contraindications listed for Ultra Strength Gas Relief.

What should I do if my condition persists?

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

Is Ultra Strength Gas Relief safe for children?

You should keep Ultra Strength Gas Relief out of reach of children.

Can I use Ultra Strength Gas Relief during pregnancy or while nursing?

There is no specific information regarding the use of Ultra Strength Gas Relief during pregnancy or nursing.

How should I store Ultra Strength Gas Relief?

Store Ultra Strength Gas Relief at room temperature between 59º - 86ºF (15º - 30ºC).

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. Each bottle contains 60 softgels. The product is identified by the National Drug Code (NDC) 63868-098-60. 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. It is intended for use in patients experiencing these gastrointestinal symptoms.

Dosage and Administration

Patients should swallow 1 or 2 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 advise patients not to exceed this dosage without appropriate medical guidance.

Contraindications

There are no specific contraindications listed for this product. However, it is advised to keep the product out of reach of children. Additionally, if symptoms persist, discontinue use and consult a healthcare professional.

Warnings and Precautions

Healthcare professionals should be aware of the following important considerations regarding the 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. This precaution is essential to ensure that any underlying issues are appropriately addressed and to prevent potential complications associated with prolonged use of the medication.

No specific warnings, general precautions, or laboratory tests have been identified for this medication; however, vigilance in monitoring the patient's response to treatment is advised. Regular assessment of the patient's condition will aid in determining the necessity for continued therapy or alternative interventions.

Side Effects

Patients should be advised to stop use and consult a doctor if their condition persists. It is also important to keep this product out of reach of children to prevent accidental ingestion or misuse.

Drug Interactions

There are no reported drug interactions associated with the use of this medication. Additionally, no interactions with laboratory tests have been identified. Therefore, no dosage adjustments or monitoring recommendations are necessary based on drug interactions.

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 the medication out of reach of children. In the event that the condition persists, caregivers are instructed to stop use and consult a healthcare professional for further guidance.

Geriatric Use

Elderly patients may not have specific information regarding the use of this medication, including dosage adjustments, safety concerns, or special precautions. Therefore, healthcare providers should exercise caution when prescribing this medication to geriatric patients. It is advisable to monitor these patients closely for any potential adverse effects or changes in therapeutic response, given the lack of targeted data for this population.

Pregnancy

There is no specific information regarding the use of Ultra Strength Gas Relief (simethicone) during pregnancy. The prescribing information 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 by lactating 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 renal impairment, dosage adjustments, special monitoring, or safety considerations for patients with reduced kidney function. Healthcare professionals should exercise caution and consider individual patient factors when treating patients with renal impairment, as specific guidelines or recommendations are not provided.

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 data does not preclude the need for careful evaluation and monitoring based on individual patient circumstances.

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, the use of activated charcoal may be considered if the patient presents within a suitable timeframe and if the ingestion was recent. Consultation with a poison control center or toxicology expert is recommended for guidance on specific management strategies tailored to the situation.

Overall, vigilance and prompt intervention are critical in managing any suspected overdose scenario.

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 compound in these areas.

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 for identification. It is essential to store the product at room temperature, maintaining a range of 59º - 86ºF (15º - 30ºC). Proper storage conditions are crucial to ensure the integrity and efficacy of the product.

Additional Clinical Information

No further data are available.

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

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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.