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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 2017
Label revision date
July 13, 2017
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 2017
Label revision date
July 13, 2017
Manufacturer
RELIABLE 1 LABORATORIES LLC
Registration number
part332
NDC root
69618-045
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 is a medication that contains simethicone, which is designed to help relieve bloating, pressure, or fullness commonly associated with gas. Each softgel contains 180 mg of simethicone, making it effective for alleviating discomfort caused by excess gas in the digestive system.

This product is comparable to the active ingredient found in PHAZYME® Ultra Strength, providing you with a reliable option for managing gas-related symptoms. If you're experiencing discomfort from gas, Ultra Strength Gas Relief may be a suitable choice to help you feel more comfortable.

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. Whether it's after a meal or due to certain foods, this treatment aims to ease that uncomfortable sensation and help you feel more at ease.

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 be aware of certain guidelines when using this medication. If your condition does not improve or continues to persist, you should stop using the medication and consult your doctor for further advice. This ensures that you receive the appropriate care and support for your health needs.

Currently, there are no specific contraindications, risks of abuse or misuse, or concerns regarding dependence associated with this medication. 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 ensures that any underlying issues can be properly addressed. Always prioritize your health and seek professional advice if you have concerns about your condition.

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 mentioned, always prioritize your health and seek medical advice if you have any concerns or experience unusual symptoms. Your well-being is the most important factor in your treatment.

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, you may be wondering about the safety of using Ultra Strength Gas Relief, which contains simethicone. The information available does not include specific warnings, precautions, or dosage changes for pregnant individuals. Additionally, there is no indication that simethicone is contraindicated (not recommended) during pregnancy, nor are there any stated risks to the fetus.

Since there are no safety concerns mentioned regarding the use of simethicone while pregnant, it appears to be considered safe. However, it's always a good idea to consult with your healthcare provider before using any medication during pregnancy to ensure it’s appropriate for 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 if it poses any risk 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 well-being of your baby are important, and your provider can offer personalized advice.

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 healthcare providers may not have tailored guidelines for elderly patients.

If you or a loved one is an older adult considering this medication, it’s important to discuss any potential risks and benefits with your healthcare provider. They can help determine the best approach based on individual health needs and conditions. Always prioritize open communication with your doctor 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 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 recommendations apply, and there are no special monitoring requirements or precautions outlined for patients with liver impairment.

However, it's always best to discuss your individual health situation with your healthcare provider, as they can offer personalized advice and ensure that any medications you take are safe for your liver health.

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 feel free to ask questions or express any concerns you may have regarding your medications or tests.

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 180 mg of simethicone, 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?

The provided text does not specify any contraindications for Ultra Strength Gas Relief.

What should I do if my condition persists?

You should stop use and ask a doctor if your condition persists.

Is Ultra Strength Gas Relief safe to use during pregnancy?

The insert does not provide 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 is the proper storage condition for Ultra Strength Gas Relief?

Store Ultra Strength Gas Relief 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 in the provided text.

Is there any information about the use of Ultra Strength Gas Relief in elderly patients?

The insert does not provide specific information regarding the use of Ultra Strength Gas Relief in elderly patients.

What should I do if I accidentally take more than the recommended dose?

You should seek medical advice if you exceed the recommended dosage.

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 alleviate gas-related discomfort. Each bottle contains 180 softgels, and the product is identified by the National Drug Code (NDC) 69618-045-18. This product 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 associated with 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 supervision.

Contraindications

There are no specific contraindications identified for this product. However, it is advised to discontinue use and consult a healthcare professional if the condition persists.

Warnings and Precautions

Healthcare professionals should be aware of the following 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 physician. This precaution is essential to ensure that any underlying issues are appropriately addressed and managed.

While no specific warnings or laboratory tests have been outlined, it remains critical for healthcare providers to monitor the patient's response to treatment and to remain vigilant for any changes in their condition. Regular assessments may be necessary to ensure the safe and effective use of the medication.

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 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 product out of reach of children. The recommended dosage for pediatric patients should not exceed two softgels per day, unless directed by a physician. Careful supervision is advised to ensure safety and appropriate use.

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 are no specific warnings, precautions, or dosage modifications regarding the use of Ultra Strength Gas Relief (simethicone) during pregnancy. The prescribing information does not indicate whether the product is contraindicated in pregnant patients or if there are any associated risks to the fetus. Additionally, there is no available data concerning safety concerns related to the use of simethicone during pregnancy. Healthcare professionals should consider the lack of information when advising women of childbearing potential and weigh the benefits against any potential risks.

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 when administering the medication. It is essential to monitor patients closely for any signs of adverse effects or symptoms that may arise from excessive dosing.

In the event of suspected overdosage, immediate medical attention should be sought. Healthcare providers should implement supportive measures as necessary, which may include symptomatic treatment and monitoring of vital signs.

Due to the lack of detailed overdosage information, it is recommended that healthcare professionals refer to established clinical guidelines and protocols for managing overdose situations relevant to the specific medication in question. Additionally, contacting a poison control center may provide further guidance on appropriate management strategies.

Continued vigilance and patient assessment are crucial in mitigating potential risks associated with overdosage.

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. It is important for patients to understand that if their condition persists despite using the medication, they should stop use and consult a doctor for further evaluation and guidance.

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

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.