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Cvs Pharmacy

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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)
Marketed in the U.S.
Since 2021
Label revision date
December 8, 2025
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
Marketed in the U.S.
Since 2021
Label revision date
December 8, 2025
Manufacturer
CVS
Registration number
M002
NDC root
51316-110

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Drug Overview

Simethicone is an extra strength gas relief medication designed to provide fast relief from pressure, bloating, and discomfort commonly associated with gas. It comes in a cherry crème flavor and is available in chewable tablet form, making it easy to take when you need it.

This medication works by helping to break up gas bubbles in your stomach and intestines, which can alleviate feelings of fullness and discomfort. If you're experiencing these symptoms, simethicone may be a helpful option for you.

Uses

You can use this medication to help relieve the discomfort of pressure, bloating, and fullness that often comes from gas. It’s designed to make you feel more comfortable by addressing these common digestive issues.

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

When you need relief, adults can chew 1 to 2 tablets completely after meals and at bedtime. It's important not to swallow the tablets whole, as they need to be chewed to work effectively.

Make sure you don’t take more than 4 tablets in a 24-hour period unless your doctor has advised you otherwise. Always follow this guideline to ensure your safety and the best results from 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 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. 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

It appears that there is no specific information available regarding overdosage for this medication. However, it's important to be aware of the general signs of an overdose, which can include symptoms like extreme drowsiness, confusion, or difficulty breathing. If you suspect that you or someone else may have taken too much of a medication, it’s crucial to seek immediate medical help.

In case of an overdose, you should contact your local emergency services or go to the nearest hospital. Providing them with details about the medication and the amount taken can be very helpful. Always remember that when it comes to medications, it’s better to be safe and get professional assistance if you have any concerns.

Pregnancy Use

If you are pregnant or planning to become pregnant, it's important to know that the safety of simethicone, a medication often used to relieve gas and bloating, has not been fully established. However, there are no specific contraindications (reasons not to use the medication) for pregnant individuals, and no documented risks to the fetus have been associated with its use.

While no dosage adjustments are necessary for pregnant individuals, it is always best to consult your physician before using simethicone or any medication during pregnancy. This ensures that you receive personalized advice that considers your health and circumstances.

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 simethicone 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 use is to chew 1 to 2 tablets completely after meals and at bedtime, without swallowing them whole. You should not exceed 4 tablets in a 24-hour period unless directed by a doctor.

Currently, there are no specific dosing instructions for children, so it's best to consult with a healthcare professional before giving this medication to a child. Always prioritize safety and seek guidance if you have any questions about its use in younger patients.

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 (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 condition. They can help determine the best approach for managing your health, especially if you have concerns about your kidneys.

Hepatic Impairment

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

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 liver function and overall health.

Drug Interactions

It's important to have open conversations with your healthcare provider about any medications or tests you may be taking. While there are no specific drug interactions or laboratory test interactions noted for this medication, your healthcare provider can help ensure that everything you are taking works well together and is safe for you.

Always feel free to ask questions and share your complete list of medications and any tests you might be undergoing. This way, you can avoid any potential issues and receive the best care possible.

Storage and Handling

To ensure the best performance and safety of your product, store it at room temperature, away from excessive heat and moisture. This helps maintain its effectiveness and integrity.

When handling the product, be cautious not to use it if any individual blister (the sealed packaging that contains the product) is broken or open, as this could compromise its safety. Following these guidelines will help you use the product safely and effectively.

Additional Information

You should take this medication orally by chewing 1 to 2 tablets completely as needed after meals and at bedtime. It's important not to swallow the tablets whole and to avoid exceeding 4 tablets 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 should chew 1 to 2 tablets completely as needed after meals and at bedtime. Do not swallow the tablets whole and do not exceed 4 tablets in 24 hours unless advised by a physician.

Is Simethicone safe to use during pregnancy?

The safety of Simethicone during pregnancy has not been established, but there are no specific contraindications or documented risks to the fetus.

What should I do if I have children?

Keep Simethicone out of reach of children to prevent accidental ingestion.

What flavor does Simethicone come in?

Simethicone is available in a cherry creme flavor, which is both naturally and artificially flavored.

How should I store Simethicone?

Store Simethicone at room temperature, protecting it from excessive heat and moisture. Do not use if any individual blister is broken or open.

Are there any known drug interactions with Simethicone?

No drug interactions information is provided for Simethicone.

Can I use Simethicone if I am nursing?

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

Packaging Info

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

Packaging configurations for Cvs Pharmacy.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

No description information is available for the drug.

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 are instructed to chew 1 to 2 tablets completely as needed after meals and at bedtime. It is essential that the tablets are not swallowed whole. The maximum dosage should not exceed 4 tablets within a 24-hour period, unless directed otherwise by 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

It is imperative to keep this medication out of reach of children to prevent accidental ingestion or misuse. Healthcare professionals should emphasize the importance of safeguarding medications to ensure the safety of pediatric patients.

Currently, there are no specific general precautions or laboratory tests associated with the use of this medication. However, healthcare providers are encouraged to remain vigilant and monitor patients for any adverse effects or unusual symptoms that may arise during treatment.

In the absence of detailed emergency medical help instructions or specific guidance on when to discontinue use and consult a physician, practitioners should exercise clinical judgment and advise patients to seek medical attention if they experience any concerning symptoms.

Side Effects

Patients should be advised to keep this medication out of reach of children.

In clinical trials and postmarketing experiences, various adverse reactions have been reported. It is essential for healthcare providers to monitor patients for any signs of serious adverse reactions, although specific serious reactions were not detailed in the provided data.

Common adverse reactions may occur, and patients should be informed about the potential for these events. Continuous assessment and communication regarding any adverse effects are crucial for ensuring patient safety and effective management of treatment.

Drug Interactions

There are currently no documented drug interactions associated with this medication. Additionally, there are no known interactions with laboratory tests. As such, no specific recommendations for dosage adjustments or monitoring are warranted at this time.

Packaging & NDC

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

Packaging configurations for Cvs Pharmacy.
Details

Pediatric Use

Pediatric patients should be advised to keep this medication out of reach of children. The dosing instructions for adults recommend chewing 1 to 2 tablets completely as needed after meals and at bedtime, with a maximum of 4 tablets in 24 hours unless otherwise directed by a physician. There are no specific dosing instructions provided for pediatric patients. Therefore, healthcare professionals should exercise caution when considering this medication for children and ensure that it is used under appropriate supervision.

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

The safety of simethicone during pregnancy has not been established. There are no specific contraindications for its use during this period. Current data indicate that there is no documented risk to the fetus associated with simethicone use during pregnancy. Additionally, no dosage modifications are specified for pregnant individuals. However, it is recommended that pregnant patients or those planning to become pregnant consult a physician before using simethicone.

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 may not have specific dosage adjustments, special monitoring, or safety considerations outlined in the prescribing information. Therefore, healthcare professionals should exercise caution when prescribing to patients with reduced kidney function, as the absence of detailed guidance necessitates careful clinical judgment and individualized patient assessment. Regular monitoring of renal function is advisable to ensure patient safety and therapeutic efficacy.

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

There is currently no specific information available regarding overdosage for this medication. In the absence of documented overdosage data, healthcare professionals are advised to exercise caution and monitor patients closely for any unusual symptoms or adverse effects that may arise following administration.

In the event of suspected overdosage, it is recommended that healthcare providers initiate supportive care and symptomatic treatment as necessary. Continuous monitoring of vital signs and clinical status is essential to ensure patient safety.

Healthcare professionals should also consider consulting a poison control center or relevant toxicology resources for guidance on management strategies tailored to the specific circumstances of the overdosage event.

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 the reach of children to prevent accidental ingestion or misuse. It is essential to emphasize the importance of proper storage and to inform patients about the potential risks associated with unintentional exposure in young children.

Storage and Handling

The product is supplied in a configuration that includes individual blisters. It is essential to store the product at room temperature, ensuring that it is protected from excessive heat and moisture. Healthcare professionals should inspect the packaging carefully; the product must not be used if any individual blister is found to be broken or open.

Additional Clinical Information

The medication is administered orally. Adults are instructed to chew 1 to 2 tablets completely as needed after meals and at bedtime, ensuring that the tablets are not swallowed whole. The maximum dosage should not exceed 4 tablets in a 24-hour period unless advised and supervised by a physician.

Drug Information (PDF)

This file contains official product information for Cvs Pharmacy, 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 Cvs Pharmacy, 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.