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Ultra Strength Gas Relief

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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
November 21, 2024
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
November 21, 2024
Manufacturer
Wal-Mart Stores Inc
Registration number
M002
NDC root
49035-585
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

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.

You can use this medication without concern for teratogenic effects (which are harmful effects on a developing fetus) or nonteratogenic effects, as none have been reported. This means it is considered safe in those respects.

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 that you should not exceed 2 softgels in a 24-hour period. Always follow the advice and supervision of your physician when using this medication to ensure it's safe and effective for you.

What to Avoid

There are no specific contraindications, controlled substance classifications, or risks of abuse, misuse, or dependence associated with this medication. This means that, based on the available information, you can use this medication without concerns about these particular issues. However, always consult with your healthcare provider for personalized advice and to ensure that this medication is appropriate for your individual health needs.

Side Effects

It's important to be aware of potential side effects when using this medication. While specific adverse reactions are not detailed here, you should always consult your healthcare provider for a comprehensive understanding of what to expect.

Additionally, please remember to keep this medication out of reach of children to ensure their safety. If you have any concerns or experience unusual symptoms, contact your doctor promptly.

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 safely and ensure that children cannot access it.

If you experience any unusual symptoms or side effects while using this medication, stop taking it immediately and contact your doctor for guidance. Additionally, if you have any concerns about your health or the effects of this medication, don't hesitate to seek medical advice. Your safety is the top priority.

Overdose

If you suspect an overdose, it's important to stay calm and take immediate action. While the specific signs of an overdose are not detailed, common symptoms can include unusual drowsiness, confusion, or difficulty breathing. If you notice any of these signs, or if you are unsure, seek medical help right away.

In case of an overdose, contact your local emergency services or go to the nearest hospital. It's crucial to provide them with as much information as possible about the substance taken and the amount, if known. Remember, acting quickly can make a significant difference in your health and safety.

Pregnancy Use

When considering the use of Ultra Strength Gas Relief (simethicone) during pregnancy, it's important to note that there is no available information about its safety, dosage adjustments, or any special precautions for pregnant individuals. This means that the effects of this medication on pregnancy have not been studied, and you should approach its use with caution.

If you are pregnant or planning to become pregnant, it's always best to consult with your healthcare provider before taking any medication, including over-the-counter products like simethicone. They can help you weigh the potential benefits and risks based on your specific 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. 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.

Currently, there are no specific dosing guidelines or age recommendations for children provided in the medication insert. Therefore, if you are considering this medication for a child, it's best to consult with a healthcare professional for advice.

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 the information provided does not include specific guidelines for dosage adjustments, special monitoring, or safety considerations related to renal impairment. This means that there are no tailored recommendations for how your kidney condition might affect the use of this medication.

Always consult your healthcare provider for personalized advice and to ensure that any treatment plan is safe and effective for your specific situation. They can help determine the best approach based on your kidney health.

Hepatic Impairment

If you have liver problems, it's important to know that the drug insert does not provide specific information about dosage adjustments, special monitoring, or precautions for your condition. This means that there are no tailored guidelines for how this medication may affect you differently due to your liver health.

Always consult your healthcare provider for personalized advice and to discuss any concerns you may have regarding your liver function and how it relates to your treatment. They can help ensure that your medication is safe and effective for you.

Drug Interactions

It's great to know that there are no reported interactions between this medication and other drugs or laboratory tests. 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 medications. They can provide personalized advice and monitor your treatment to ensure the best outcomes for your health.

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.

When handling the product, always check that the safety seal under the cap is intact. If the seal is broken or missing, do not use the product, as this could compromise its safety and effectiveness. Following these guidelines will help you use the product safely and effectively.

Additional Information

You should take this medication orally by swallowing 1 or 2 softgels with water after meals and at bedtime, as needed. However, it's important not to exceed 2 softgels in a 24-hour period, and you should do this under the advice and supervision of your physician.

FAQ

What is Ultra Strength Gas Relief?

Ultra Strength Gas Relief is a medication containing 180 mg of simethicone, designed to relieve pressure and bloating commonly referred to as gas.

How should I take Ultra Strength Gas Relief?

For adults, 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 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 should I do if the safety seal is broken or missing?

Do not use Ultra Strength Gas Relief if the imprinted safety seal under the cap is broken or missing.

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.

What are the warnings associated with Ultra Strength Gas Relief?

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 simethicone as its active ingredient, with a dosage of 180 mg per softgel. This formulation is designed to provide effective anti-gas relief. The product is available in a package containing 50 softgels. The National Drug Code (NDC) for this product is 49035-585-21. This formulation can be compared 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 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, and this should only be undertaken under the advice and supervision of a physician.

Contraindications

There are no contraindications associated with the use of this product. It is deemed safe for use in the absence of specific conditions or situations that would warrant avoidance.

Warnings and Precautions

Healthcare professionals are advised to ensure that the medication is stored securely and kept out of reach of children to prevent accidental ingestion or misuse.

In addition to this critical warning, it is essential to monitor patients for any adverse reactions or side effects associated with the use of this medication. Regular assessments and appropriate laboratory tests should be conducted as necessary to ensure patient safety and therapeutic efficacy.

Healthcare providers should remain vigilant and educate patients and caregivers about the importance of adhering to safety measures, including proper storage and handling of the medication.

Side Effects

Patients should be aware of the potential adverse reactions associated with the use of this medication. It is important to note that this product should be kept out of reach of children to prevent accidental ingestion or misuse.

While specific adverse reactions were not detailed in the provided information, healthcare professionals are encouraged to monitor patients for any unexpected effects during treatment. In the event of serious adverse reactions, appropriate medical attention should be sought immediately.

Patients and caregivers should be informed about the importance of adhering to safety guidelines, including the proper storage of the medication, to minimize risks associated with accidental exposure.

Drug Interactions

There are no known 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 kept out of reach of children. The product is intended for adult use, with directions indicating that adults may swallow 1 or 2 softgels with water as needed after meals and at bedtime, without exceeding 2 softgels in a 24-hour period under the advice and supervision of a physician. There are no specific dosing or age recommendations provided for pediatric patients in the prescribing information.

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 adverse effects or changes in efficacy, given the lack of targeted data for 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 who are pregnant or may become pregnant. It is advisable to weigh the potential benefits against any unknown risks to fetal outcomes. Further studies may be necessary to establish the safety profile of simethicone in this population.

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

Patients with renal impairment have not been specifically addressed in the available prescribing information. There are no dosage adjustments, special monitoring requirements, or safety considerations outlined for individuals with reduced kidney function. Healthcare professionals should exercise caution and consider the lack of data when prescribing to this patient population.

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 outlined 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 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 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 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 a configuration that includes an imprinted safety seal under the cap. It is essential to store the product at a controlled room temperature between 15ºC and 30ºC (59ºF and 86ºF). Care should be taken to protect the product from heat and moisture to maintain its integrity. Additionally, the product should not be used if the imprinted safety seal under the cap is broken or missing, as this may indicate compromised safety or efficacy.

Additional Clinical Information

The medication is administered orally, with adults advised to swallow 1 or 2 softgels with water after meals and at bedtime, ensuring not to exceed 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.