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Gas Relief

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Active ingredient
Dimethicone 125 mg
Other brand names
Dosage form
Tablet, Chewable
Route
Oral
Prescription status
OTC (over the counter)
Marketed in the U.S.
Since 2020
Label revision date
November 15, 2025
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
Marketed in the U.S.
Since 2020
Label revision date
November 15, 2025
Manufacturer
Meijer Distribution, Inc.
Registration number
M002
NDC root
79481-0608

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Drug Overview

Simethicone is a medication designed to provide relief from gas-related discomfort, such as pressure and bloating. It comes in extra strength chewable tablets with a pleasant cherry flavor, making it easy to take. The active ingredient, simethicone, works by breaking up gas bubbles in your stomach and intestines, helping to alleviate the discomfort associated with gas.

This product is available in packages containing 18 tablets, and it is important to chew or crush the tablets completely before swallowing for the best effect. If you're experiencing discomfort from gas, simethicone may be a helpful option to consider.

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

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 an adult or a child aged 12 years and older, you can take 1 or 2 chewable tablets after meals and at bedtime as needed. Make sure to chew or crush the tablets completely before swallowing; do not swallow them whole.

Be mindful not to exceed 4 chewable tablets in a 24-hour period unless your doctor advises otherwise. If the person taking the medication is under 12 years old, it's best to consult a doctor for guidance on the appropriate dosage. Always prioritize your health by following these instructions closely.

What to Avoid

You can feel reassured that there are no specific contraindications, risks of abuse or misuse, or concerns about dependence associated with this medication. Additionally, there are no particular instructions indicating that you should avoid taking or using it under certain circumstances. Always consult with your healthcare provider 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

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

In case of an emergency, call your local emergency services or go to the nearest hospital. Always keep medications out of reach of children and follow the prescribed dosage to prevent any potential risks. If you have any concerns or questions about your medication, don’t hesitate to reach out to your healthcare provider for guidance.

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 simethicone chewable tablets during pregnancy. This means that safety concerns, dosage adjustments, or any special precautions related to pregnancy have not been clearly established.

Before taking simethicone or any medication while pregnant, you should consult with your healthcare provider to discuss potential risks and benefits. Your doctor can help you make informed decisions based on your individual health needs.

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. Since the effects on nursing infants have not been thoroughly studied, it's best to exercise caution. 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 to ensure their safety. If your child is under 12 years old, you should consult a doctor before giving them this medication. For those aged 12 and older, the recommended dosage is 1 or 2 chewable tablets after meals and at bedtime, but be careful not to exceed 4 chewable tablets in a 24-hour period unless a doctor advises otherwise. Always prioritize your child's health by following these guidelines closely.

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 for personalized advice. 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 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 for patients with 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 apply, and there are no special monitoring or precautions outlined for patients like you.

Always consult your healthcare provider for personalized advice and to ensure that any medications you take are safe and appropriate for your liver health. They can provide guidance based on your individual situation.

Drug Interactions

It's important to have open conversations with your healthcare provider about any medications or tests you may be taking. Currently, there are no known interactions between this medication and other drugs or laboratory tests. However, your healthcare provider can help ensure that your treatment plan is safe and effective, taking into account your unique health situation. Always feel free to ask questions or express any concerns you may have regarding your medications or tests.

Storage and Handling

To ensure the best performance 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 packaging before use; if the package is opened or if the blister is torn or broken, do not use the product. Additionally, be sure to look at the end flap for important information like the expiration date and lot number, which are essential for safety and tracking.

Additional Information

You will take this medication orally. There are no additional details available regarding laboratory tests, abuse potential, patient counseling, or postmarketing experiences. If you have any questions or concerns about your treatment, be sure to discuss them with your healthcare provider.

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?

You should chew or crush the tablets completely before swallowing. Adults and children 12 years and over can take 1 or 2 chewable tablets as needed after meals and at bedtime, but do not exceed 4 tablets in 24 hours unless directed by a doctor.

Are there any warnings for using Simethicone?

Yes, keep Simethicone out of reach of children. Children under 12 years should ask a doctor before use.

What should I do if the package is tampered with?

Do not use Simethicone if the package is opened or if the blister unit is torn, broken, or shows any signs of tampering.

Is Simethicone safe to use during pregnancy?

There is no specific information regarding the safety of Simethicone during pregnancy, so consult your doctor before use.

Can nursing mothers use Simethicone?

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

What is the active ingredient in Simethicone?

The active ingredient in Simethicone is 125 mg of Simethicone.

What flavor do the chewable tablets come in?

The chewable tablets of Simethicone come in a cherry flavor.

How should Simethicone be stored?

Store Simethicone at 25°C (77°F), with permitted excursions between 15°-30°C (59°-86°F), and protect it from moisture.

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

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 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 about the importance of adhering to prescribed dosages and the potential risks associated with improper 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 specific adverse reactions have been reported in clinical trials or postmarketing experiences. However, it is essential for healthcare providers to monitor patients for any unexpected effects and to report them as necessary.

Drug Interactions

There are currently no documented drug interactions associated with this medication. Additionally, there is no information available regarding 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 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, with a maximum of 4 chewable tablets in a 24-hour period unless otherwise 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 potential adverse effects or changes in efficacy, given the lack of targeted data for this population.

Pregnancy

There is no specific information available regarding the use of simethicone chewable tablets during pregnancy. As such, safety concerns, dosage modifications, or special precautions for pregnant patients have not been established. Healthcare professionals should consider the lack of data when advising women of childbearing potential and weigh the potential benefits against any unknown risks when prescribing this medication during pregnancy.

Lactation

Nursing mothers should consult a doctor before using this product. There is a potential for excretion in breast milk, and the effects on a nursing infant are not well studied; therefore, caution is advised.

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

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 data does not preclude the need for careful evaluation and monitoring based on individual patient circumstances.

Overdosage

In the absence of specific overdosage information, it is essential for healthcare professionals to remain vigilant regarding the potential risks associated with excessive administration of the medication.

In the event of suspected overdosage, it is recommended that healthcare providers assess the patient's clinical status and consider the following general management procedures:

  1. Assessment of Symptoms: Healthcare professionals should monitor for any unusual or severe symptoms that may arise, which could indicate an adverse reaction to the medication. Symptoms may vary depending on the drug's pharmacological profile and the patient's individual response.

  2. Supportive Care: Supportive measures should be initiated as necessary. This may include maintaining airway patency, providing supplemental oxygen, and ensuring adequate circulation.

  3. Consultation with Poison Control: In cases of suspected overdose, it is advisable to contact a poison control center or a medical toxicologist for guidance on specific management strategies tailored to the substance involved.

  4. Consideration of Antidotes: If applicable, the use of specific antidotes should be evaluated based on the medication's mechanism of action and the nature of the overdose.

  5. Monitoring and Follow-Up: Continuous monitoring of the patient's vital signs and clinical status is crucial. Follow-up care may be necessary to address any delayed effects of the overdose.

Healthcare professionals are encouraged to report any cases of overdosage to the appropriate regulatory authorities to contribute to the ongoing assessment of the medication's safety profile.

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 provided in the insert.

Patient Counseling

Healthcare providers should advise patients to keep this medication out of reach of children to prevent accidental ingestion or misuse. It is important to emphasize the necessity of proper storage and handling to ensure the safety of young individuals.

Storage and Handling

The product is supplied in a tamper-evident package. It should not be used if the outer package is opened or if the blister is torn or broken. The recommended storage temperature is 25°C (77°F), with permissible excursions between 15°-30°C (59°-86°F). It is essential to protect the product from moisture. For additional information, the expiration date and lot number can be found on the end flap of the packaging.

Additional Clinical Information

The medication is administered orally. There are no additional details available regarding laboratory tests, abuse information, patient counseling, or postmarketing experience.

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

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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.