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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
February 8, 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
February 8, 2018
Manufacturer
PuraCap Pharmaceutical LLC
Registration number
part332
NDC root
51013-428
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 used to help relieve pressure and bloating 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 Gas-X® 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

You can use this medication to help relieve the discomfort of pressure and bloating that is 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 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 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 associated with this medication. Always follow the guidance provided to use it safely and effectively.

Side Effects

It's important to keep this medication out of reach of children to prevent accidental ingestion. Always ensure that it is stored safely and securely. If you have any concerns about side effects or how to use this medication, please consult your healthcare provider for guidance.

Warnings and Precautions

It's important to keep this medication out of reach of children to ensure their safety. While there are no specific general precautions or laboratory tests mentioned, always be mindful of how you store and handle your medications.

If you have any concerns or experience unusual symptoms while using this medication, it's best to consult your doctor for guidance. Your health and safety are paramount, so don't hesitate to reach out for professional advice 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 signs of overdose for this medication, general symptoms can include unusual drowsiness, confusion, or difficulty breathing. If you notice any of these signs, 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 err on the side of caution when it comes to your health. Remember, timely intervention can make a significant difference.

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.

Before taking any medication, including over-the-counter products like simethicone, you should consult with your healthcare provider to discuss potential risks and benefits tailored to your situation. Your health and the health of your baby are the top priority, so always seek professional advice when considering medication 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. For adults, the recommended use is to swallow 1 or 2 softgels with water after meals and at bedtime, but you should not exceed 2 softgels in a 24-hour period unless directed by a doctor.

If you have any questions about using this medication for children or if you think your child may have ingested it, please consult a healthcare professional for guidance. Always prioritize safety and follow the recommended guidelines.

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 circumstances. Always prioritize open communication about any concerns you may have regarding medication use.

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 recommendations apply, but you should always consult your healthcare provider for personalized advice. They can help monitor your liver function and determine the best approach 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, and your healthcare team is there to support you.

Drug Interactions

It's great to know that there are no reported drug interactions or interactions with laboratory tests for this medication. However, it's still very important to discuss all medications you are taking, including over-the-counter drugs and supplements, with your healthcare provider. This ensures that your treatment is safe and effective, and helps avoid any potential issues.

Always keep your healthcare provider informed about any changes in your health or new medications you start. Open communication is key to managing your health effectively.

Storage and Handling

To ensure the best performance and safety 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 effectiveness.

When handling the product, always do so with clean hands and in a clean environment to maintain its integrity. If you have any specific disposal instructions, be sure to follow them to ensure safe and responsible disposal.

Additional Information

No further information is available.

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.

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 per softgel.

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?

There are no contraindications listed for Ultra Strength Gas Relief.

Is Ultra Strength Gas Relief safe to use during pregnancy?

There is no specific information regarding the use 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 precautions should I take when using Ultra Strength Gas Relief?

Keep Ultra Strength Gas Relief out of reach of children and store it at a controlled room temperature of 15º - 30ºC (59º - 86ºF), protecting 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. Each bottle contains 50 softgels. The product is identified by the National Drug Code (NDC) 51013-428-09. 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 effects associated with this drug. Additionally, no nonteratogenic effects have been reported.

Dosage and Administration

Adults should 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 dosage limit to ensure safety and efficacy.

Contraindications

Use of this product is contraindicated in children due to the risk of accidental ingestion. It is essential to keep the product out of reach of children to prevent potential harm. No other contraindications have been identified.

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 and caregivers are aware of this critical safety measure.

Currently, there are no specific general precautions or laboratory tests associated with the use of this medication. However, healthcare providers should remain vigilant and monitor patients for any potential adverse effects or interactions that may arise during treatment.

In the absence of detailed emergency medical help instructions or specific guidance on when to discontinue use and contact a physician, it is advisable for healthcare professionals to educate patients on the importance of reporting any unusual symptoms or concerns promptly.

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.

No additional adverse reactions, including serious or common events, have been specified in the provided data. It is essential for healthcare providers to monitor patients for any unexpected effects and to report any adverse reactions that may arise during treatment.

Drug Interactions

There are no documented drug interactions associated with the use of this medication. Additionally, there are no reported interactions between this drug and laboratory tests. 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 this medication out of reach of children. The recommended directions for adult use involve swallowing 1 or 2 softgels with water after meals and at bedtime, with a maximum of 2 softgels in a 24-hour period unless otherwise directed by a physician. There is no specific dosing information provided for pediatric patients, and the use of this medication in children should be approached with caution, ensuring that it is only administered under the advice and supervision of a healthcare professional.

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, given the lack of targeted data.

Pregnancy

There is currently no information available regarding the use of Ultra Strength Gas Relief (simethicone) during pregnancy, including safety concerns, dosage modifications, or any special precautions that should be taken. Healthcare professionals should consider this lack of data when advising pregnant patients or women of childbearing potential. It is recommended that the potential benefits and risks be carefully weighed before prescribing this medication to pregnant individuals.

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 dosage adjustments, special monitoring requirements, or precautions recommended for individuals with compromised liver function. It is advised that healthcare professionals 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 considered as part of standard clinical practice.

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.

It is essential to monitor patients closely for any signs or symptoms that may arise from an overdose. Symptoms may vary depending on the medication's pharmacological profile and the individual patient's response.

In the event of suspected overdosage, immediate medical intervention is recommended. Healthcare providers should initiate supportive care and symptomatic treatment as necessary. It is advisable to consult local poison control centers or relevant medical authorities for guidance on management protocols specific to the medication in question.

Documentation of the incident, including the amount ingested and the time of exposure, is crucial for effective management and follow-up care. Continuous monitoring of the patient's vital signs and clinical status is also recommended to ensure timely intervention if complications arise.

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 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

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.