Symptom checker
Select audience type

Switch between content for healthcare professionals (PRO) and general audience (GEN).

ADD CONDITION

items per page

Gas Relief

Last content change checked dailysee data sync status

Active ingredient
Dimethicone 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 2021
Label revision date
July 10, 2025
Drug Information (PDF)
Prescribing information, PDF file
Active ingredient
Dimethicone 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 2021
Label revision date
July 10, 2025
Manufacturer
Rite Aid Corporation
Registration number
M002
NDC root
11822-6080
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 help relieve pressure, bloating, and fullness that you may experience due to gas. It is available in an Extra Strength formulation and comes in the form of chewable tablets with a cherry flavor. The active ingredient, simethicone, works by breaking up gas bubbles in your stomach and intestines, making it easier for your body to eliminate them.

This product is similar to the active ingredient found in Gas-X® Extra Strength, providing you with an effective option for managing gas discomfort. If you're looking for relief from the uncomfortable symptoms of gas, simethicone may be a suitable choice for you.

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 you feel 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

It's important to follow the dosage instructions carefully to ensure your safety and the effectiveness of the medication. You should not take more than the recommended amount. If you're using chewable tablets, make sure to chew or crush them completely before swallowing; do not swallow them whole.

For adults and children aged 12 years and older, you can take 1 or 2 chewable tablets as needed after meals and at bedtime. However, be cautious not to exceed 4 chewable tablets in a 24-hour period unless your doctor has advised you otherwise. If the patient is a child under 12 years old, it's best to consult a doctor before giving them this 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).

Since there are no explicit "do not take" or "do not use" instructions, it is important to follow your healthcare provider's guidance and use the medication as directed. Always consult with your doctor if you have any questions or concerns about your treatment.

Side Effects

It's important to keep this medication out of reach of children to prevent accidental ingestion. If you have any concerns about side effects or how to use this medication safely, 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, 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

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, or if you are unsure, 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 be safe and get checked by a healthcare professional if you have any concerns about your health.

Pregnancy Use

While the information provided does not specify any particular safety concerns or precautions for use during pregnancy, it is important to approach any medication with care. There are no dosage modifications recommended for pregnant individuals, which suggests that the standard dosing may be considered safe. However, always consult with your healthcare provider before starting or continuing any medication during pregnancy to ensure it is appropriate for your specific situation. Your health and the health of your baby are the top priority, so open communication with your doctor is essential.

Lactation Use

If you are breastfeeding or planning to breastfeed, it's important to consult your doctor before using this product. There is a possibility that it may be excreted in breast milk, which means it could potentially affect your baby. The safety of this product during lactation has not been fully established, so exercising caution is advised when considering its use while nursing. Always prioritize your health and your baby's well-being by discussing any concerns with your healthcare provider.

Pediatric Use

It's important to keep this medication out of reach of children. If your child is under 12 years old, you should consult a doctor before giving it to them. For those aged 12 and older, the recommended dosage is 1 or 2 chewable tablets as needed after meals and at bedtime. However, be sure not to exceed 4 chewable tablets in a 24-hour period unless directed by a doctor. Always prioritize safety and follow these guidelines to ensure proper use.

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. If you or a loved one is an older adult, it’s always a good idea to discuss any medications with a healthcare provider. They can help determine the best approach, considering any unique health needs or conditions.

Since there are no dosage adjustments or special precautions mentioned for elderly patients, your healthcare provider will guide you on the appropriate use of this medication based on individual health status. Always keep them informed about any other medications being taken or health changes that occur.

Renal Impairment

There are no specific guidelines, dosage adjustments, or monitoring requirements mentioned for patients with kidney problems in the provided information. If you have renal impairment (kidney issues), it's important to consult your healthcare provider for personalized advice regarding your medications and treatment plan. They can help ensure your safety and effectiveness of any treatments you may be receiving.

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 dosing and monitoring practices apply, but you should always consult your healthcare provider for personalized advice. They can help ensure that any medications you take are safe and effective for your liver health.

Make sure to keep your doctor informed about your liver condition, as they may need to monitor your liver function regularly to ensure your treatment is appropriate.

Drug Interactions

It's important to have open conversations with your healthcare provider about any medications you are taking, even if there are no specific drug interactions or laboratory test interactions noted for your treatment. This ensures that your healthcare team can monitor your health effectively and make informed decisions about your care.

Always feel free to ask questions and share any other medications or supplements you may be using. Your safety and well-being are the top priority, and discussing all aspects of your treatment helps to achieve the best outcomes.

Storage and Handling

To ensure the best quality and safety of your product, store it at room temperature, ideally around 25°C (77°F). It’s acceptable for the temperature to vary between 15°-30°C (59°-86°F), but make sure to keep it away from moisture. Always check the outer package before use; if it’s opened or if the blister is torn or broken, do not use the product. Additionally, remember to look at the end flap for important information like the expiration date and lot number, which are crucial for your safety.

Additional Information

You can take this medication orally, with the recommended dosage for adults and children aged 12 and over being 1 or 2 chewable tablets as needed after meals and at bedtime. However, you should not exceed 4 chewable tablets in a 24-hour period unless directed by your doctor. If the patient is under 12 years old, it's important to consult a doctor for appropriate guidance.

FAQ

What is Simethicone used for?

Simethicone is used to relieve pressure, bloating, and fullness commonly referred to as gas.

What is the active ingredient in Simethicone?

The active ingredient in Simethicone is 125 mg of Simethicone.

How should I take Simethicone?

Adults and children 12 years and over should take 1 or 2 chewable tablets as needed after meals and at bedtime, without exceeding 4 tablets in 24 hours unless directed by a doctor.

Can children under 12 take Simethicone?

Children under 12 years should ask a doctor before using Simethicone.

Are there any warnings for using Simethicone?

Yes, keep Simethicone out of reach of children and do not use if the package is opened or if the blister unit is torn or broken.

Is Simethicone safe to use during pregnancy?

The safety of Simethicone during pregnancy has not been specifically mentioned, and no special precautions are provided.

What should nursing mothers know about Simethicone?

Nursing mothers should consult a doctor before using Simethicone, as there is a potential for excretion in breast milk.

How should Simethicone be stored?

Store Simethicone at 25°C (77°F), protecting it from moisture, and do not use if the outer package is opened or the blister is torn or broken.

What flavor does Simethicone come in?

Simethicone is available in a cherry flavor.

Who distributes Simethicone?

Simethicone is distributed by Rite Aid, located at 200 Newberry Commons, Etters, PA 17319.

Packaging Info

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

Packaging configurations for Gas Relief.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

NDC 11822-6080-4. This product contains simethicone, an active ingredient comparable to that found in Gas-X® Extra Strength, at a concentration of 125 mg per chewable tablet. The formulation is designed for gas relief, specifically targeting symptoms such as pressure, bloating, and fullness. Each package contains 18 chewable tablets, which are cherry-flavored. The tablets should be chewed or crushed completely before swallowing. The product is tamper-evident; do not use if the package is opened or if the blister unit is torn, broken, or shows any signs of tampering. This product is not manufactured or distributed by GSK Consumer Healthcare S.A., the owner of the registered trademark Gas-X® Extra Strength.

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

Patients should adhere strictly to the recommended dosage and administration guidelines. For adults and children aged 12 years and older, the recommended dose is 1 to 2 chewable tablets taken as needed after meals and at bedtime. It is imperative that the tablets are chewed or crushed completely before swallowing; they should not be swallowed whole.

The maximum allowable dosage for this population is 4 chewable tablets within a 24-hour period, unless otherwise directed by a healthcare professional. For children under 12 years of age, it is advised to consult a doctor before administration.

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 and caregivers about the importance of adhering to these precautions to mitigate risks associated with the medication's use.

Side Effects

Patients should be advised to keep this medication out of reach of children. This warning is critical to prevent accidental ingestion or exposure, which could lead to serious adverse reactions.

No additional adverse reactions have been reported in clinical trials or postmarketing experiences. It is essential for healthcare providers to monitor patients for any unexpected effects and to report them as necessary.

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). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Gas Relief.
Details

Pediatric Use

Pediatric patients should be kept out of reach of children. For children under 12 years of age, it is advised to consult a doctor before use. For adolescents 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 4 chewable tablets in a 24-hour period unless directed by a healthcare professional.

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

Pregnant patients should be aware that there are no specific safety concerns or dosage modifications related to the use of this medication during pregnancy as detailed in the prescribing information. Additionally, there are no special precautions indicated for the use of this medication in pregnant individuals. Healthcare professionals should consider the overall clinical context when prescribing this medication to women of childbearing potential. As always, the benefits and risks should be carefully weighed in the context of individual patient circumstances.

Lactation

Nursing mothers should consult a doctor before using this product. There is a potential for excretion in breast milk, and the safety of this product during lactation has not been established. Caution is advised when administering this product to nursing mothers.

Renal Impairment

There is no information available regarding renal impairment, including dosage adjustments, special monitoring, or safety considerations for patients with reduced kidney function. Healthcare professionals should exercise caution and consider the lack of data when prescribing to patients with renal impairment.

Hepatic Impairment

There is no information available 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 clinical judgment when considering the use of this medication in patients with liver problems, as the absence of specific guidance necessitates careful evaluation of the potential risks and benefits.

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 from excessive dosing. Symptoms of overdosage can vary widely depending on the substance involved and the individual patient's response.

In the event of an overdose, immediate medical attention should be sought. Healthcare providers should implement supportive care measures, which may include monitoring vital signs, providing symptomatic treatment, and ensuring the patient's safety.

If available, consultation with a poison control center or a medical toxicologist is recommended to guide the management of the overdose. Additionally, healthcare professionals should refer to local protocols and guidelines for the management of overdose situations, as these may provide specific recommendations based on the substance involved.

Documentation of the incident, including the amount ingested and the time of exposure, is crucial for effective management and follow-up care.

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.

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 a tamper-evident package. Healthcare professionals should ensure that the outer package remains unopened and that the blister is intact; do not use if the package is opened or the blister is torn or broken.

Storage conditions require the product to be maintained at a temperature of 25°C (77°F), with permissible excursions between 15°-30°C (59°-86°F). It is essential to protect the product from moisture. For reference, the expiration date and lot number can be found on the end flap of the packaging.

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 of 4 chewable tablets in a 24-hour period unless otherwise directed by a physician. For children under 12 years of age, it is advised to consult a doctor for appropriate dosing guidance.

No additional information is available regarding laboratory tests, abuse potential, patient counseling, or postmarketing experiences.

Drug Information (PDF)

This file contains official product information for 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 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.

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.