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Assured Gas Relief Extra Strength

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This product has been discontinued

Active ingredient
Dimethicone 125 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 2012
Label revision date
January 14, 2013
Drug Information (PDF)
Prescribing information, PDF file
Active ingredient
Dimethicone 125 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 2012
Label revision date
January 14, 2013
Manufacturer
Greenbrier International, Inc.
Registration number
part332
NDC root
33992-0113
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

Assured Extra Strength Gas Relief is a medication that contains simethicone (125 mg), which is designed to help relieve symptoms of bloating, pressure, fullness, and gas in your digestive system. It works by breaking up gas bubbles in the stomach and intestines, making it easier for your body to eliminate them.

This product comes in the form of softgels, and its active ingredient is similar to that found in Extra Strength Gas-X®. If you're experiencing discomfort from gas, Assured Extra Strength Gas Relief may provide the relief you need.

Uses

If you're experiencing discomfort from pressure, bloating, or a feeling of fullness often associated with gas, this medication can help provide relief. It's designed specifically to address these common digestive issues, making your day-to-day life more comfortable.

Rest assured, there are no known teratogenic effects (which means it doesn't cause birth defects) or nonteratogenic effects associated with this medication. This makes it a safe option for those looking to alleviate gas-related discomfort.

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 not to exceed 4 softgels in a 24-hour period unless your doctor advises otherwise.

Before using the medication, make sure that none of the individual blister units are broken or missing, as this could affect the safety and effectiveness of the product. Always follow these guidelines to ensure you use the medication safely and effectively.

What to Avoid

You can feel confident using this medication, as there are no specific contraindications, controlled substance classifications, or concerns regarding abuse, misuse, or dependence associated with it. This means that, based on the available information, there are no known reasons to avoid taking this medication. Always remember to follow your healthcare provider's guidance and reach out if you have any questions or concerns about your treatment.

Side Effects

You may experience some side effects while taking this medication. Allergic reactions can occur, which may include symptoms like rash, itching, or swelling. It's important to seek medical attention if you notice any severe reactions.

Cardiovascular issues, such as changes in heart rate or blood pressure, may also arise. Neurological effects can include headaches or dizziness. Additionally, there may be other adverse reactions that are important to monitor. Always consult your healthcare provider if you have concerns about these side effects or if you experience any unusual symptoms.

Warnings and Precautions

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.

Currently, there are no specific general precautions or laboratory tests associated with this medication mentioned. If you have any concerns or experience unusual symptoms, it's best to consult with 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 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

When considering the use of Assured Gas Relief Extra Strength (simethicone) during pregnancy, it's important to note that there is no specific information available 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 clearly studied or established.

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 individual health needs.

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 the product is excreted in breast milk or that it poses any risk to your infant. This means you can use the product without concern for its effects on 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. For adults, the recommended dosage is to swallow 1 or 2 softgels with water after meals and at bedtime, but you should not exceed 4 softgels in a 24-hour period unless directed by a doctor.

If you have any questions about using this medication for children or specific concerns, it's best to consult with a healthcare professional for guidance.

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 there are no specific guidelines or dosage adjustments mentioned for your condition in the available information. This means that the standard recommendations for the medication do not include special monitoring or safety considerations tailored for patients with renal impairment (kidney issues).

Always consult your healthcare provider for personalized advice and to ensure that any medication you take is safe and appropriate for your kidney health. They can provide guidance based on your individual situation and any other health factors you may have.

Hepatic Impairment

If you have liver problems, it's important to know that there are no specific guidelines, dosage adjustments, or special monitoring requirements mentioned for your condition in the provided information. This means that the standard recommendations apply, but you should always consult your healthcare provider for personalized advice. They can help ensure that any medications you take are safe and appropriate for your liver health.

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, tailored specifically to your health needs.

Always keep your healthcare provider informed about any changes in your medication or health status. Open communication helps prevent any potential issues and supports your overall well-being.

Storage and Handling

To ensure the best performance of your product, store it at a controlled room temperature between 20° and 25°C (68° to 77°F). It's important to keep it away from light, heat, and moisture, as these elements can affect its quality and effectiveness.

When handling the product, make sure to do so in a clean environment to maintain its integrity. Always follow any specific disposal instructions provided to ensure safety and compliance. By taking these precautions, you can help ensure that the product remains safe and effective for use.

Additional Information

No further information is available.

FAQ

What is Assured Extra Strength Gas Relief?

Assured Extra Strength Gas Relief contains Simethicone 125 mg and is used to relieve bloating, pressure, fullness, and gas.

How should I take Assured Extra Strength Gas Relief?

Adults should swallow 1 or 2 softgels with water as needed after meals and at bedtime, but do not exceed 4 softgels in 24 hours unless advised by a physician.

Are there any contraindications for this medication?

No contraindications are listed for Assured Extra Strength Gas Relief.

Is it safe to use during pregnancy?

The drug insert does not provide specific information regarding the use of Assured Extra Strength Gas Relief during pregnancy.

Can nursing mothers use this product?

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

What should I do if a blister unit is broken or missing?

Do not use Assured Extra Strength Gas Relief if any individual blister unit is broken or missing.

How should I store this medication?

Store Assured Extra Strength Gas Relief at controlled room temperature between 20°-25°C (68-77°F) and protect it from light, heat, and moisture.

What are the warnings associated with this medication?

Keep Assured Extra Strength Gas Relief out of reach of children.

Packaging Info

Below are the non-prescription pack sizes of Assured Gas Relief Extra Strength (simethicone). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Assured Gas Relief Extra Strength.
Details

Drug Information (PDF)

This file contains official product information for Assured Gas Relief Extra Strength, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)

Description

Simethicone is a medication formulated to provide extra strength gas relief, containing 125 mg of simethicone per dosage unit. It is indicated for the alleviation of symptoms associated with excess gas in the gastrointestinal tract. The active ingredient, simethicone, is a silicone-based compound that acts by reducing surface tension, thereby facilitating the coalescence of gas bubbles, which can be expelled more easily. The product is presented in a dosage form suitable for oral administration.

Uses and Indications

This drug is indicated for the relief of pressure, bloating, and fullness commonly referred to as gas.

There are no teratogenic or nonteratogenic effects associated with this drug.

Dosage and Administration

Adults should swallow 1 or 2 softgels with water as needed after meals and at bedtime. The maximum recommended dosage is 4 softgels within a 24-hour period, unless otherwise directed by a physician. It is important to note that the product should not be used if any individual blister unit is broken or missing.

Contraindications

There are no contraindications associated with the use of this product. It is not classified as a controlled substance, and there are no known risks of abuse, misuse, or dependence.

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 may experience a range of adverse reactions associated with the use of this medication. Serious adverse reactions include allergic reactions, which can manifest as urticaria, angioedema, or anaphylaxis. These reactions require immediate medical attention.

Cardiovascular adverse reactions have been reported, although specific details regarding their frequency or severity were not provided. Neurological adverse reactions may also occur, potentially impacting the patient's overall health and well-being.

In addition to the aforementioned serious reactions, there are other adverse reactions that may be observed in patients. It is important for healthcare providers to monitor for these reactions and manage them appropriately.

Postmarketing experiences have further highlighted the need for vigilance regarding these adverse reactions, emphasizing the importance of patient education and awareness.

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 Assured Gas Relief Extra Strength (simethicone). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Assured Gas Relief Extra Strength.
Details

Pediatric Use

Pediatric patients should be advised to keep this medication out of reach of children. The recommended dosage for adults is to swallow 1 or 2 softgels with water after meals and at bedtime, with a maximum of 4 softgels in a 24-hour period unless directed otherwise by a physician. There is no specific pediatric dosing information provided, and caution should be exercised when considering 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 individual responses may vary. Monitoring for potential adverse effects and therapeutic efficacy is recommended in this population.

Pregnancy

There is no specific information regarding the use of Assured Gas Relief Extra Strength (simethicone) during pregnancy. The prescribing information does not provide safety concerns, dosage modifications, or special precautions for pregnant patients. Therefore, healthcare professionals should consider the lack of data when advising women of childbearing potential and weigh the potential benefits against any unknown risks when recommending this product during pregnancy.

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

Patients with renal impairment have not been specifically addressed in the available data regarding dosage adjustments, special monitoring, or safety considerations. Therefore, healthcare professionals should exercise caution when prescribing this medication to patients with reduced kidney function, as the lack of information necessitates careful clinical judgment and monitoring.

Hepatic Impairment

There is no available information 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 caution and consider the overall clinical context when prescribing this medication to patients with liver problems, as the absence of specific guidance necessitates careful evaluation of potential risks and benefits.

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 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 to emphasize the necessity of safeguarding medications to ensure the safety of young individuals.

Storage and Handling

The product is supplied in packaging that ensures its integrity during storage and handling. It should be stored at a controlled room temperature of 20°-25°C (68-77°F). It is essential to protect the product from light, heat, and moisture to maintain its efficacy and safety. Proper storage conditions are critical to preserving the quality of the product throughout its shelf life.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

This file contains official product information for Assured Gas Relief Extra Strength, 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 Assured Gas Relief Extra Strength, 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.