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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)
Marketed in the U.S.
Since 2018
Label revision date
March 27, 2018
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 2018
Label revision date
March 27, 2018
Manufacturer
PURACAP PHARMACEUTICAL LLC
Registration number
part332
NDC root
51013-436

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Drug Overview

Ultra Strength Gas Relief is a medication that contains simethicone, which is used 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.

If you're experiencing symptoms of gas, this product may provide you with the relief you need to feel more comfortable. It's important to compare it to similar products, such as PHAZYME® Ultra Strength, to find the option that works best 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. 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, controlled substance classifications, or concerns regarding abuse, misuse, or 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. Additionally, please ensure that this product is kept out of reach of children to prevent any accidental ingestion or misuse.

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 safety. If you experience any unusual symptoms or have concerns about your treatment, don't hesitate to reach out to your healthcare provider for advice.

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 feel unwell after taking the medication, seek help right away.

In case of an overdose, contact your healthcare provider or local poison control center immediately. If you or someone else is experiencing severe symptoms, such as trouble breathing or loss of consciousness, call emergency services right away. Always prioritize safety and don't hesitate to reach out for 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 Ultra Strength 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.

Given this lack of information, it's advisable to consult with your healthcare provider before using this medication. They can help you weigh the potential benefits and risks based on your individual situation. Always prioritize open communication with your doctor regarding any medications you consider 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 are no statements indicating that this product is excreted in breast milk or that it poses any risk to your infant. This means you can use it without concern for affecting your milk production or your baby's health.

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

There are no specific guidelines, dosage adjustments, or monitoring requirements mentioned for patients with kidney problems in the provided information. If you have renal impairment (kidney issues), it's important to consult your healthcare provider for personalized advice and to ensure your treatment is safe and effective. Always keep your doctor informed about your kidney health, as they can provide the best recommendations tailored to your needs.

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 and monitoring practices apply, but you should always consult your healthcare provider for personalized advice. They can help ensure that any medications you take are safe and effective for your liver health.

Make sure to keep your doctor informed about your liver condition, as they may want to monitor your liver function regularly to ensure everything is working well. Your health and safety are the top 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, even if there are no known drug interactions or laboratory test interactions associated with them. This ensures that your treatment plan is safe and effective for your individual health needs.

Always keep your healthcare team informed about all the medications and supplements you use, as well as any lab tests you may undergo. This way, they can provide the best care tailored to you.

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 to ensure safety and effectiveness. If you have any questions about disposal or further handling, please refer to the guidelines provided with your product.

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 this medication?

No specific contraindications are mentioned 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 there any information about using this medication during pregnancy?

There is no information regarding the use of Ultra Strength Gas Relief during pregnancy or any associated safety concerns.

Can nursing mothers use Ultra Strength Gas Relief?

There are no specific warnings or recommendations regarding the use of this product in nursing mothers.

How should I store Ultra Strength Gas Relief?

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

What should I do if I have kidney or liver problems?

The provided information does not include any specific guidance for patients with kidney or liver problems.

Is Ultra Strength Gas Relief a controlled substance?

No, there are no details indicating that Ultra Strength Gas Relief is a controlled substance.

What should I keep in mind regarding children?

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

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 180 mg of simethicone per softgel, formulated to provide effective anti-gas relief. Each bottle contains 60 softgels. The product is identified by the National Drug Code (NDC) 51013-436-22. 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 are advised to 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 monitor patients for adherence to this dosage limit to ensure safety and efficacy.

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 safe use of the 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.

Currently, there are no specific warnings or general precautions outlined for this medication. Additionally, no laboratory tests have been specified for monitoring during treatment. It is advisable for healthcare providers to remain vigilant and assess the patient's response to therapy regularly.

Side Effects

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

Drug Interactions

There are no specific drug interactions identified for this medication. Additionally, no laboratory test interactions have been reported. 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 medication out of reach of children. The recommended dosage for pediatric patients is not to exceed two softgels per day, unless directed otherwise 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 is currently no information available 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. As such, healthcare professionals should exercise caution when considering the use of this medication in women of childbearing potential and weigh the potential benefits against any unknown risks to fetal outcomes. Further studies may be necessary to establish the safety profile of simethicone in pregnant patients.

Lactation

There are no specific warnings or recommendations regarding the use of this product in nursing mothers. Additionally, there are no statements concerning 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 consider the potential risks associated with excessive administration of the medication.

Recommended Actions

In the event of suspected overdosage, it is imperative to seek immediate medical attention. Healthcare providers should monitor the patient closely for any adverse effects and initiate supportive care as necessary.

Potential Symptoms

While specific symptoms of overdosage are not detailed, practitioners should remain vigilant for any unusual or severe reactions that may arise from excessive dosing.

Management Procedures

Management of overdosage should be tailored to the individual patient, taking into account their clinical presentation and any underlying health conditions. Supportive measures, including symptomatic treatment and monitoring of vital signs, are essential in the management of overdosage cases.

Healthcare professionals are encouraged to report any cases of overdosage to the appropriate regulatory authorities to enhance the understanding of the medication's safety profile.

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 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. This ensures that patients are aware of the need for professional medical advice in the event of ongoing symptoms.

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

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.

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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.