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Gas Relief Simethicone 250 mg Anti-Gas

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Active ingredient
Dimethicone 250 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 2022
Label revision date
February 6, 2025
Drug Information (PDF)
Prescribing information, PDF file
Active ingredient
Dimethicone 250 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 2022
Label revision date
February 6, 2025
Manufacturer
CVS Pharmacy, Inc.
Registration number
M002
NDC root
51316-702
Drug Information (PDF)
Prescribing information, PDF file
Packaging Info (2 NDCs)
Packaging & NDC Codes (2)

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

Simethicone is a medication designed to provide relief from gas-related discomfort, such as pressure, bloating, and fullness. It works quickly to alleviate these symptoms, helping you feel more comfortable. This product is available in a formulation of 250 mg and comes in the form of 30 soft chewables with a pleasant mixed berry flavor, making it easy to take when you need it.

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

If you are an adult or a child aged 12 years and older, you can take 1 or 2 chewable tablets as needed after meals and at bedtime. It's important to remember not to exceed 2 chewables 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

It's important to be aware of certain precautions when using this medication. While there are no specific contraindications or concerns about abuse, misuse, or dependence (which means relying on a substance in a harmful way), you should be cautious.

If you suspect an accidental overdose, it’s crucial to seek professional help or contact a poison control center right away. Your safety is the top priority, so don’t hesitate to reach out for assistance if needed.

Side Effects

It's important to be aware of potential side effects when taking this medication. In the event of an accidental overdose, you should seek professional help or contact a poison control center right away.

While specific side effects are not detailed here, always monitor how you feel and report any unusual symptoms to your healthcare provider. Your safety is a priority, so don't hesitate to reach out if you have concerns.

Warnings and Precautions

If you accidentally take too much of this medication, it’s important to get help right away. Contact a healthcare professional or call a poison control center immediately for assistance.

Always be cautious and monitor your health while using this medication. If you experience any unusual symptoms or side effects, stop using the medication and reach out to your doctor for guidance. Your safety is the top priority, so don’t hesitate to seek help if you need it.

Overdose

If you suspect an accidental overdose, it’s important to act quickly. Seek professional assistance or contact a poison control center right away. Signs of an overdose can vary, but they may include unusual drowsiness, confusion, or difficulty breathing.

Remember, if you notice any severe symptoms or if you are unsure about the situation, don’t hesitate to seek immediate medical help. Your safety is the top priority, so getting prompt care is essential.

Pregnancy Use

When it comes to using Gas Relief Simethicone 250 mg during pregnancy, there is currently no specific information available about its safety, dosage adjustments, or any special precautions you should take. This means that the effects of this medication on pregnant individuals and their developing babies are not well-studied or documented.

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 Simethicone for nursing mothers. Additionally, there is no information indicating that Simethicone is excreted in breast milk or that it poses any risk to your infant. This means you can use it without concern for affecting your milk production or your baby's health.

Pediatric Use

It's important to keep this medication out of reach of children to prevent accidental ingestion. If you suspect an overdose, seek professional help or contact a poison control center right away.

For children aged 12 years and older, the recommended dosage is 1 or 2 chewable tablets as needed after meals and at bedtime. However, do not exceed 2 chewables in a 24-hour period unless directed by a doctor. Always follow these guidelines to ensure your child's safety and well-being.

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 plan is safe and effective for your specific situation. They can help monitor your kidney health and make any necessary adjustments to your medications.

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 if you have hepatic impairment (issues with liver function).

Always consult your healthcare provider for personalized advice and to discuss any concerns regarding your liver health and how it may relate to your treatment. They can help ensure that you receive the safest and most effective care.

Drug Interactions

It's important to have open conversations with your healthcare provider about any medications you are taking, even if there are no known drug interactions or laboratory test interactions associated with them. This ensures that your treatment plan is safe and effective for your individual health needs.

Always keep your healthcare team informed about all the medications and supplements you use, as well as any lab tests you may undergo. This way, they can provide the best care tailored to you.

Storage and Handling

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

When handling the product, make sure to use the Child Resistant Container provided. Do not use the product if the printed seal under the cap is broken or missing, as this could indicate that the product is no longer safe to use. Following these guidelines will help you maintain the product's integrity and ensure your safety.

Additional Information

You can take this medication orally, with the recommended dosage for adults and children aged 12 years and older being 1 or 2 chewable tablets as needed after meals and at bedtime. However, it's important not to exceed 2 chewables in a 24-hour period unless directed by your doctor. Always follow your healthcare provider's advice regarding your medication use.

FAQ

What is Simethicone used for?

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

How should I take Simethicone?

Adults and children 12 years and older should take 1 or 2 chewables as needed after meals and at bedtime, but do not exceed 2 chewables in 24 hours unless advised by a physician.

Are there any contraindications for using Simethicone?

No specific contraindications are listed for Simethicone.

What should I do in case of an accidental overdose?

In case of accidental overdose, seek professional assistance or contact a poison control center immediately.

Is Simethicone safe to use during pregnancy?

There is no specific information regarding the safety of Simethicone during pregnancy.

Can nursing mothers use Simethicone?

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

How should Simethicone be stored?

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

What is the formulation of Simethicone?

Simethicone is formulated as 250 mg soft chewables with a mixed berry flavor.

Packaging Info

Below are the non-prescription pack sizes of Gas Relief Simethicone 250 mg Anti-Gas (simethicone). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Gas Relief Simethicone 250 mg Anti-Gas.
Details

Drug Information (PDF)

This file contains official product information for Gas Relief Simethicone 250 mg Anti-Gas, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)

Description

CVS Health Compare to the active ingredient in Gas-X®* contains simethicone as its active ingredient, with a concentration of 250 mg per dosage unit. This formulation is designed for gas relief, providing fast relief from symptoms such as bloating, pressure, and gas discomfort. The product is presented in the form of 30 soft chewables, featuring a mixed berry flavor. The National Drug Code (NDC) for this product is 51316-702-12.

Uses and Indications

This drug is indicated for the relief of pressure, bloating, and fullness 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 and children aged 12 years and older may take 1 or 2 chewable tablets as needed after meals and at bedtime. The maximum recommended dosage is 2 chewable tablets 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

There are no specific contraindications listed for this product. However, in the event of an accidental overdose, it is imperative to seek professional assistance or contact a poison control center immediately.

Warnings and Precautions

In the event of an accidental overdose, it is imperative to seek professional assistance or contact a poison control center without delay. Prompt action is essential to mitigate potential adverse effects associated with overdose. Healthcare professionals should ensure that patients are aware of this critical information and understand the importance of immediate intervention in such situations.

Side Effects

In the event of an accidental overdose, it is imperative that patients seek professional assistance or contact a poison control center immediately. This warning underscores the seriousness of potential overdose situations and the necessity for prompt medical intervention.

No additional adverse reactions have been specified in the provided data. Therefore, healthcare professionals should remain vigilant and monitor patients for any unexpected reactions during treatment, while also ensuring that patients are informed about the importance of adhering to prescribed dosages to mitigate the risk of overdose.

Drug Interactions

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

Packaging & NDC

Below are the non-prescription pack sizes of Gas Relief Simethicone 250 mg Anti-Gas (simethicone). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Gas Relief Simethicone 250 mg Anti-Gas.
Details

Pediatric Use

Pediatric patients should be kept out of reach of children to prevent accidental ingestion. In the event of an accidental overdose, it is crucial to seek professional assistance or contact a poison control center immediately.

For children aged 12 years and older, the recommended dosage is 1 or 2 chewable tablets as needed after meals and at bedtime. It is important not to exceed 2 chewable tablets in a 24-hour period unless advised and supervised by a physician.

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 therapeutic response, given the lack of targeted data for this population.

Pregnancy

There is no specific information available regarding the use of Gas Relief Simethicone 250 mg during pregnancy. As such, the safety of this medication in pregnant patients has not been established, and there are no known dosage modifications or special precautions recommended for use during pregnancy. Healthcare professionals should weigh the potential benefits against any unknown risks when considering the use of this medication in women of childbearing potential. It is advisable to discuss any concerns with patients who are pregnant or planning to become pregnant.

Lactation

There are no specific warnings or recommendations regarding the use of Simethicone in lactating mothers. Additionally, there is no information available about the potential for excretion of Simethicone 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 event of an accidental overdose, it is imperative to seek professional assistance or contact a poison control center without delay. Prompt action is crucial to ensure the safety and well-being of the patient.

Healthcare professionals should be aware that symptoms of overdose may vary depending on the specific substance involved. Monitoring for any adverse effects is essential, and appropriate management should be initiated based on the clinical presentation.

Management procedures may include supportive care and symptomatic treatment, tailored to the individual patient's needs. Continuous assessment and monitoring are recommended to address any complications that may arise during the course of treatment.

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.

Patient Counseling

Healthcare providers should advise patients to seek professional assistance or contact a poison control center immediately in the event of an accidental overdose. It is important for patients to understand the seriousness of an overdose and the necessity of prompt action to ensure their safety. Providers should encourage patients to keep emergency contact information readily available and to discuss any concerns regarding dosage or potential risks associated with their medication.

Storage and Handling

The product is supplied in a Child Resistant Container. It is essential to store the product at a controlled room temperature of 20-25°C (68-77°F). Care should be taken to protect the product from light, heat, and moisture to maintain its integrity. Additionally, the product should not be used if the printed seal under the cap is broken or missing, ensuring safety and efficacy.

Additional Clinical Information

The medication is administered orally. For adults and children aged 12 years and older, the recommended dosage is 1 or 2 chewable tablets as needed after meals and at bedtime, with a maximum limit of 2 chewables within a 24-hour period unless directed otherwise 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 Gas Relief Simethicone 250 mg Anti-Gas, 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 Gas Relief Simethicone 250 mg Anti-Gas, 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.