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Premier Value

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Active ingredient
Dimethicone, Unspecified 125 mg
Other brand names
Dosage form
Tablet, Chewable
Route
Oral
Prescription status
OTC (over the counter)
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Marketed in the U.S.
Since 2019
Label revision date
October 28, 2024
Drug Information (PDF)
Prescribing information, PDF file
Active ingredient
Dimethicone, Unspecified 125 mg
Other brand names
Dosage form
Tablet, Chewable
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 2019
Label revision date
October 28, 2024
Manufacturer
PHARMACY VALUE ALLIANCE, LLC
Registration number
M002
NDC root
68016-811
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

Premier Value Extra Strength Simethicone is an over-the-counter medication that contains 125 mg of simethicone, which is designed to relieve pressure, bloating, and discomfort commonly associated with gas. This product comes in a cherry crème flavor and is available in a pack of 18 chewable tablets, making it easy to take when you need relief from gas-related discomfort.

Simethicone works by breaking up gas bubbles in the stomach and intestines, helping to alleviate the feeling of fullness and discomfort. If you're experiencing bloating or pressure due to gas, this product may provide the relief you need.

Uses

If you're experiencing discomfort from gas, such as pressure, bloating, or a feeling of fullness, this medication can help provide relief. It targets those uncomfortable sensations, making it easier for you to go about your day without the distraction of digestive issues.

Rest assured, this medication does not have any known teratogenic effects, meaning it does not cause developmental problems in a fetus. You can use it with confidence, knowing it is designed to alleviate your discomfort effectively.

Dosage and Administration

You can take this medication by chewing 1 to 2 tablets after meals and at bedtime, depending on your needs. It's important not to exceed 4 tablets 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 risks of abuse, misuse, or dependence associated with this medication. This means that, based on the available information, there are no particular situations or conditions under which you should avoid using it. 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. Always ensure that it is stored safely and securely.

While there are no specific general precautions or laboratory tests mentioned, it’s essential to stay informed about any potential side effects or interactions with other medications. If you have any concerns or experience unusual symptoms, 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, 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 this medication during pregnancy. This means that safety concerns, dosage adjustments, or any special precautions for pregnant individuals have not been addressed.

Given this lack of information, it is crucial to consult with your healthcare provider before using this medication. They can help you weigh the potential risks and benefits based on your individual circumstances. Always prioritize open communication with your doctor regarding any medications you may be considering 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 it may pose 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 notice that any individual blister is broken or open, do not use the medication, as this could compromise its effectiveness and safety.

For adults, the recommended dosage is to chew 1 to 2 tablets as needed after meals and at bedtime, but it's crucial not to exceed 4 tablets 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

While there is no specific information available about the use of this medication in older adults, it’s important to approach any new treatment with caution. Since older adults may have different health needs and responses to medications, you should always consult with a healthcare provider before starting any new medication. They can help determine the right dosage and monitor for any potential side effects, ensuring that the treatment is safe and effective for you or your loved one.

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 usual recommendations for monitoring or safety considerations related to renal impairment (kidney issues) are not provided.

Always consult your healthcare provider for personalized advice and to ensure that any medications you take are safe and appropriate for your kidney health. They can help you understand how your condition may affect your treatment plan.

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 for the medication do not change based on liver impairment. However, it’s always a good idea to discuss your liver health with your healthcare provider, as they can offer personalized advice and monitor your condition effectively.

Make sure to keep your doctor informed about any liver issues you may have, as they can help ensure that your treatment is safe and appropriate for you.

Drug Interactions

It's important to have open conversations with your healthcare provider about any medications you are taking. In this case, there are no specific drug interactions or laboratory test interactions noted, which means that the medication is generally considered safe to use with other drugs and tests. However, every individual is different, and your healthcare provider can help ensure that your treatment plan is safe and effective for you.

Always discuss any new medications or tests with your healthcare provider to avoid potential issues and to get the best care tailored to your needs.

Storage and Handling

To ensure the best performance of your product, store it at room temperature. It's important to keep it away from excessive heat and moisture, as these conditions can affect its quality and safety.

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 carefully to ensure safe and responsible disposal.

Additional Information

No further information is available.

FAQ

What is Premier Value Extra Strength Simethicone used for?

It is used for the relief of pressure, bloating, and discomfort commonly referred to as gas.

How should I take Premier Value Extra Strength Simethicone?

Adults should chew 1 to 2 tablets as needed after meals and at bedtime, not exceeding 4 tablets in 24 hours unless advised by a physician.

What flavor does this medication have?

It comes in a Cherry Creme flavor, which is naturally and artificially flavored.

Are there any contraindications for this medication?

No contraindications are listed for Premier Value Extra Strength Simethicone.

Is this medication safe to use during pregnancy?

There is no specific information regarding safety concerns or dosage modifications for use during pregnancy.

What should I do if a blister is broken or open?

Do not use the product if any individual blister is broken or open.

How should I store this medication?

Store at room temperature and protect from excessive heat and moisture.

What should I do if I have questions about this medication?

Keep the carton for future reference on full labeling and consult your physician if you have any questions.

Is there any information regarding nursing mothers?

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

What is the active ingredient in this medication compared to?

It compares to the active ingredient in Gas-X® Extra Strength.

Packaging Info

Below are the non-prescription pack sizes of Premier Value (simethicone). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Premier Value.
Details

Drug Information (PDF)

This file contains official product information for Premier Value, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)

Description

Premier Value Extra Strength Antigas contains simethicone as its active ingredient, providing gas relief through the alleviation of pressure, bloating, and discomfort. Each chewable tablet contains 125 mg of simethicone and is available in a cherry crème flavor, which is both naturally and artificially flavored. The product is packaged in a bottle containing 18 chewable tablets. It is classified as K Pareve and is distributed by Pharmacy Value Alliance, LLC, located at 407 East Lancaster Avenue, Wayne, PA 19087. The National Drug Code (NDC) for this product is 68016-811-18. This product is not manufactured or distributed by GSK Consumer Healthcare, Inc., the distributor of Gas-X® Extra Strength, but is comparable to its active ingredient.

Uses and Indications

This drug is indicated for the relief of pressure, bloating, and fullness commonly referred to as gas. It effectively alleviates symptoms of pressure, bloating, and discomfort associated with gastrointestinal distress.

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

Dosage and Administration

Adults are advised to chew 1 to 2 tablets as needed after meals and at bedtime. The total daily dosage should not exceed 4 tablets within a 24-hour period, unless directed by a physician. It is important for healthcare professionals to monitor patients for adherence to this dosing regimen to ensure safety and efficacy.

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

It is imperative to keep this medication out of reach of children to prevent accidental ingestion or misuse.

No specific general precautions or laboratory tests have been identified for this medication. Healthcare professionals are advised to remain vigilant and monitor for any potential adverse effects or interactions as part of standard patient care.

Side Effects

Patients should be aware of the potential adverse reactions associated with the use of this medication. It is important to note that specific warnings are in place to ensure safe usage.

In addition, it is crucial to keep this medication out of reach of children to prevent accidental ingestion or misuse.

Healthcare providers should monitor patients for any adverse effects and provide guidance on the safe handling and storage of the medication.

Drug Interactions

No specific drug interactions have been identified in the available data. Additionally, there are no reported interactions between the drug and laboratory tests. Therefore, no dosage adjustments or monitoring recommendations are necessary based on the current information.

Packaging & NDC

Below are the non-prescription pack sizes of Premier Value (simethicone). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Premier Value.
Details

Pediatric Use

Pediatric patients should be advised to keep this medication out of reach of children. It is important to note that the product should not be used if any individual blister is broken or open.

For adults, the recommended dosage is to chew 1 to 2 tablets as needed after meals and at bedtime, with a maximum of 4 tablets in a 24-hour period unless directed otherwise by a physician. Specific dosing recommendations for pediatric patients have not been provided, and caution should be exercised when considering use in this population.

Geriatric Use

There is no specific information available 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 this medication during pregnancy, including safety concerns, dosage modifications, or special precautions. Healthcare professionals should consider the lack of data when prescribing this medication to pregnant patients. It is advisable to weigh the potential benefits against any unknown risks to fetal outcomes. Women of childbearing potential should be counseled on the importance of effective contraception during treatment and the need to inform their healthcare provider if they become pregnant or plan to become pregnant while on 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 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

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 indicated 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, as the clinical presentation can vary depending on the substance involved and the individual patient's response. Common symptoms of overdose may include, but are not limited to, altered mental status, cardiovascular instability, respiratory distress, and gastrointestinal disturbances.

In the event of an overdose, immediate medical attention should be sought. Healthcare providers should initiate supportive care, which may include maintaining airway patency, providing supplemental oxygen, and ensuring adequate circulation. The use of activated charcoal may be considered if the patient presents within a suitable timeframe and is deemed appropriate based on clinical judgment.

Additionally, specific antidotes or treatments may be indicated depending on the substance involved in the overdose. Consultation with a poison control center or a medical toxicologist is recommended to guide management decisions and optimize patient outcomes.

Overall, vigilance and prompt intervention are critical in managing cases of suspected overdose, even in the absence of detailed information regarding specific overdosage effects.

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 storing the medication in a secure location, away from the sight and reach of young children. This precaution helps ensure the safety of pediatric patients and minimizes the risk of adverse events associated with unintentional exposure.

Storage and Handling

The product is supplied in various package configurations, with specific NDC numbers available for identification. It should be stored at room temperature, ensuring that it is protected from excessive heat and moisture to maintain its integrity and efficacy. Proper storage conditions are essential for optimal product performance.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

This file contains official product information for Premier Value, 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 Premier Value, 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.