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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
June 7, 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
June 7, 2018
Manufacturer
CVS PHARMACY, INC.
Registration number
part332
NDC root
69842-166

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.

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 you otherwise. Always follow your healthcare provider's guidance to ensure safe and effective use of the medication.

What to Avoid

There are no specific contraindications, controlled substance classifications, or concerns regarding abuse, misuse, or dependence associated with this medication. Additionally, there are no explicit instructions indicating that you should not take or use this medication. Always consult with your healthcare provider for personalized advice and to ensure this medication is appropriate for you.

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 prevent accidental ingestion, which can be dangerous.

If you experience any unusual symptoms or side effects, stop using the medication and call your doctor right away. Additionally, if you have any concerns about your health or the effects of this medication, don’t hesitate to reach out to your healthcare provider for guidance.

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 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 always better to be safe and get checked by a healthcare professional if you have any concerns about your health. Remember, timely intervention can make a significant difference.

Pregnancy Use

Currently, there is no 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 established. If you are pregnant or planning to become pregnant, it is important to consult with your healthcare provider before using this medication to ensure it is safe for you and your baby.

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. If you are an adult taking this medication, the recommended dosage is to swallow 1 or 2 softgels with water after meals and at bedtime. However, you should not exceed 2 softgels in a 24-hour period unless directed by a doctor. Always consult with a healthcare professional before giving any medication to children, as their needs and dosages can differ significantly from adults.

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, it’s important to consult with a healthcare provider before starting the medication. 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 (kidney issues). This means that there are no tailored recommendations for how your treatment may need to change based on your kidney function.

Always consult your healthcare provider for personalized advice and to ensure that your treatment is safe and effective for your specific situation. They can help you understand how your kidney health may affect your medications and what steps to take for your well-being.

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 tests to ensure your safety while using any medication. Your well-being is a 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 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 and safety of your product, store it at a controlled room temperature between 15º and 30ºC (59º and 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

You should take this medication orally by swallowing 1 or 2 softgels with water after meals and at bedtime, as needed. It's important not to exceed 2 softgels in a 24-hour period unless directed by your doctor. Always follow your physician's advice for safe use.

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?

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 I have children at home?

Keep Ultra Strength Gas Relief out of reach of children.

What is the storage requirement for 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.

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, providing a convenient dosage form for the relief of gas-related discomfort. The product is identified by the National Drug Code (NDC) 69842-166-09. 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 are instructed to swallow 1 or 2 softgels with water as needed after meals and at bedtime. The maximum dosage should not exceed 2 softgels within a 24-hour period, unless otherwise directed by a physician. It is essential that patients adhere to this guideline to ensure safe and effective use of the medication.

Contraindications

There are no contraindications listed for the use of this product. It is important to evaluate each patient's individual circumstances and medical history when considering treatment options.

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 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, particularly regarding the storage and handling of the medication.

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 specific adverse reactions have been reported in clinical trials or postmarketing experiences beyond the noted warning. It is essential for healthcare providers to monitor patients for any unexpected effects and to educate them on the importance of proper storage and handling of the medication.

Drug Interactions

No drug interactions or drug and laboratory test interactions have been identified in the available data. Therefore, no specific recommendations for dosage adjustments or monitoring are necessary at this time.

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 dosing instructions provided are intended for adults, who are directed to swallow 1 or 2 softgels with water as needed after meals and at bedtime, without exceeding 2 softgels in a 24-hour period unless under the advice and supervision of a physician. There is no specific dosing information or study outcomes available for pediatric populations. Therefore, caution is advised when considering this medication for use in children.

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 they may have different pharmacokinetic and pharmacodynamic responses compared to younger populations. Monitoring for potential adverse effects and therapeutic efficacy is recommended in this demographic.

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. Healthcare professionals should consider this lack of data when advising women of childbearing potential and weigh the potential benefits against any unknown risks. It is recommended that pregnant patients consult their healthcare provider before using this medication.

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 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 initiate supportive care, which may include monitoring vital signs, providing symptomatic treatment, and ensuring the patient's safety.

If available, consultation with a poison control center or a medical toxicologist is recommended to guide further management and treatment options.

Documentation of the incident, including the amount and timing of the substance taken, 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 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

The medication is administered orally, with adults advised to swallow 1 or 2 softgels with water after meals and at bedtime. Patients should not exceed a total of 2 softgels within a 24-hour period unless directed by a physician. There is no additional information available regarding laboratory tests, abuse potential, 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.

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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.