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Extra Strength Gas Relief

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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 2020
Label revision date
October 29, 2025
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 2020
Label revision date
October 29, 2025
Manufacturer
SAFEWAY
Registration number
M002
NDC root
21130-110
Drug Information (PDF)
Prescribing information, PDF file
Packaging Info (2 NDCs)
Packaging & NDC Codes (2)

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If you are a consumer or patient please visit this version.

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 works by breaking up gas bubbles in the stomach and intestines, making it easier for your body to eliminate them. This product comes in a cherry crème flavor and is available in chewable tablet form, making it a convenient option for those seeking quick relief from gas-related discomfort.

Uses

You can use this medication to help relieve feelings of pressure, bloating, and fullness that are often caused by gas. It’s designed to make you feel more comfortable when you experience 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 who may be concerned about such risks.

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 to remember 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

You can feel reassured that there are no specific contraindications, controlled substance classifications, or risks of abuse or misuse associated with this medication. Additionally, there are no concerns regarding dependence (a condition where the body becomes reliant on a substance) or any explicit instructions advising against its use. Always consult with your healthcare provider if you have any questions or concerns about your treatment.

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, which can be dangerous.

If you experience any unusual symptoms or side effects, stop using the medication and call your doctor immediately. Always consult your healthcare provider if you have any concerns or questions about your treatment.

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 right away. Always keep the medication packaging on hand, as it can provide important information to healthcare professionals. Remember, when in doubt, it’s better to err on the side of caution and get help.

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 special precautions have not been clearly outlined.

Before taking any medication, including this one, you should consult with your healthcare provider to discuss potential risks and benefits. They can help you make informed decisions that prioritize your health and the health of 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. This precaution helps prevent accidental ingestion, which can be dangerous. Always store it in a safe place where children cannot access it, ensuring their safety at all times. If you have any concerns or questions about the medication, don't hesitate to reach out to your healthcare provider for guidance.

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 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 (liver issues).

Always consult your healthcare provider for personalized advice and to discuss any concerns you may have regarding your liver health and medication use. They can help ensure that you receive the safest and most effective treatment based on your individual needs.

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 lab tests you may be undergoing. This way, you can receive the best possible 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. Following these simple guidelines will help you use the product safely and effectively.

Additional Information

You can take this medication orally by chewing 1 to 2 tablets as needed after meals and at bedtime. However, be sure not to exceed 4 tablets in a 24-hour period unless your doctor advises otherwise. Always follow your healthcare provider's guidance for safe use.

FAQ

What is Simethicone used for?

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

How should I take Simethicone?

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

What flavor does Simethicone come in?

Simethicone is available in a Cherry Creme flavor and is both naturally and artificially flavored.

Are there any contraindications for using Simethicone?

No contraindications are listed for Simethicone.

Is Simethicone safe to use during pregnancy?

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

Can nursing mothers use Simethicone?

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

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

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

How should I store Simethicone?

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

What should I keep in mind regarding children and Simethicone?

Keep Simethicone out of reach of children.

Packaging Info

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

Packaging configurations for Extra Strength Gas Relief.
Details

Drug Information (PDF)

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

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 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 otherwise 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

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 about the importance of adhering to prescribed dosages and the potential risks associated with improper use.

Side Effects

Patients should be aware of the potential adverse reactions associated with the use of this medication. It is important to note that this product should be kept out of reach of children to prevent accidental ingestion or misuse.

While specific adverse reactions were not detailed in the provided information, healthcare professionals are encouraged to monitor patients for any unexpected effects during treatment. In the event of serious adverse reactions, appropriate medical attention should be sought immediately.

Patients and caregivers should be informed about the importance of adhering to safety guidelines, including the storage of the medication, to minimize risks associated with accidental exposure.

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 necessary at this time.

Packaging & NDC

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

Packaging configurations for Extra Strength Gas Relief.
Details

Pediatric Use

Pediatric patients should be advised to keep this medication out of reach of children. Safety and efficacy in pediatric populations have not been established, and caution is advised when administering this medication to younger individuals.

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. It is advisable to monitor these patients closely for any adverse effects or changes in efficacy, given the lack of targeted data for 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. The potential risks and benefits should be carefully evaluated, and alternative treatments may be considered in the absence of established safety information. Women of childbearing potential should be counseled on the importance of effective contraception during treatment.

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

There is no specific information available regarding dosage adjustments, special monitoring, or safety considerations for patients with renal impairment. Healthcare professionals should exercise caution when prescribing to patients with reduced kidney function, as the absence of detailed guidance necessitates careful clinical judgment. Regular monitoring of renal function may be advisable in these patients to ensure safety and 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

In the absence of specific overdosage information, it is essential for healthcare professionals to remain vigilant regarding the potential for overdose with this medication. In cases where an overdose is suspected, immediate medical attention should be sought.

Healthcare providers are advised to monitor patients closely for any signs or symptoms that may arise from an overdose. These may include, but are not limited to, increased severity of known side effects, altered mental status, or any unusual physiological responses.

Management of an overdose should be guided by the clinical presentation of the patient. Supportive care is paramount, and symptomatic treatment should be initiated as necessary. It is recommended that healthcare professionals consult local poison control centers or relevant toxicology resources for specific guidance on the management of overdose cases.

In summary, while specific overdosage information is not available, healthcare professionals should exercise caution, monitor for symptoms, and provide appropriate supportive care in the event of an overdose.

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 compound in these areas.

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 proper storage to ensure the safety of young children.

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

The medication is administered orally, with adults advised to chew 1 to 2 tablets as needed after meals and at bedtime. The maximum dosage should not exceed 4 tablets within a 24-hour period unless directed by a physician. No further information is available regarding laboratory tests, abuse potential, patient counseling, or postmarketing experiences.

Drug Information (PDF)

This file contains official product information for Extra 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 Extra 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.