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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)
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Marketed in the U.S.
Since 2025
Label revision date
October 7, 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 2025
Label revision date
October 7, 2025
Manufacturer
Chain Drug Marketing Association, Inc.
Registration number
M002
NDC root
83324-325
Drug Information (PDF)
Prescribing information, PDF file
Packaging Info
Packaging & NDC Codes

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 an extra strength gas relief medication available in chewable tablet form, with each tablet containing 125 mg of the active ingredient. It is cherry flavored for a more pleasant taste. Simethicone works by relieving pressure, bloating, and discomfort that are commonly associated with gas in the digestive system, helping you feel more comfortable after meals.

Uses

You can use this medication to help relieve the discomfort of pressure, bloating, and fullness that is 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 concerned about such risks.

Dosage and Administration

When using this medication, it's important to follow the instructions carefully. 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 advises 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 confident using this medication, as there are no specific contraindications, controlled substance classifications, or concerns regarding abuse, misuse, or dependence associated with it. This means that, based on the available information, there are no known reasons that would prevent you from taking this medication safely. Always remember to follow your healthcare provider's guidance and reach out if you have any questions or concerns about your treatment.

Side Effects

You can feel reassured that there are no specific side effects or adverse reactions associated with this medication as noted in the provided information. This means that, based on the available data, you are unlikely to experience any adverse effects while using it. Always consult with your healthcare provider if you have any concerns or experience unusual symptoms.

Warnings and Precautions

It’s important to keep this medication out of reach of children to prevent accidental ingestion, which can be dangerous. Always store it safely and ensure that children cannot access it.

If you experience any unusual symptoms or side effects, stop using the medication and call your doctor immediately. Additionally, if you have any concerns about how this medication may affect your health, consult your healthcare provider for guidance.

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 potential risks associated with taking any medication. If you suspect that you or someone else may have taken too much of a medication, look out for unusual symptoms such as extreme drowsiness, confusion, or difficulty breathing.

In the event of an overdose, it is crucial to seek immediate medical help. You can do this by calling your local emergency number or going to the nearest hospital. Always keep the medication packaging on hand to provide healthcare professionals with important information. Remember, it's better to be safe and get checked out if you have any concerns about an overdose.

Pregnancy Use

When it comes to using this medication during pregnancy, there are no specific guidelines or safety concerns mentioned. This means that there is no detailed information available about how the medication may affect you or your baby during this time. Additionally, there are no recommended changes to the dosage for pregnant individuals, nor are there any special precautions outlined for use while pregnant.

If you are pregnant or planning to become pregnant, it's always best to consult with your healthcare provider before starting any new medication. They can provide personalized advice and help you weigh the potential risks and benefits.

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. For adults and children aged 12 years and older, the recommended dosage is 1 or 2 chewable tablets taken as needed after meals and at bedtime. However, you should not exceed 4 chewable tablets in a 24-hour period unless your doctor advises otherwise.

If your child is under 12 years old, it's essential to consult a doctor before giving them this medication. Always prioritize safety and follow the guidance of a healthcare professional when it comes to treating children.

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 standard recommendations for the medication do not include special monitoring or safety considerations tailored for patients with renal impairment (kidney issues).

Always consult your healthcare provider for personalized advice and to ensure that your treatment plan is safe and effective for your specific health needs. They can provide guidance based on your kidney function and overall health.

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 monitor your liver function and make any necessary adjustments to your care.

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 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 the expiration date and lot number to ensure you are using a safe and effective item.

Additional Information

You should take this medication orally. It's important to chew or crush the tablets completely before swallowing them; do not swallow them whole. There are no additional details regarding laboratory tests, abuse potential, or postmarketing experiences related to this medication.

FAQ

What is Simethicone used for?

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

What is the recommended dosage for adults and children over 12?

Adults and children 12 years and over should take 1 or 2 chewable tablets as needed after meals and at bedtime, not exceeding 4 tablets in 24 hours unless directed by a doctor.

How should I take Simethicone tablets?

You should chew or crush the tablets completely before swallowing; do not swallow them whole.

Are there any warnings associated with Simethicone?

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 provided information does not mention any specific safety concerns regarding the use of Simethicone during pregnancy.

What should I do if I have questions about Simethicone?

You can call customer service at 800-935-2362 for any questions regarding Simethicone.

How should I store Simethicone?

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

What flavor do Simethicone chewable tablets come in?

Simethicone chewable tablets are cherry flavored.

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 the age of 12, 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

It is imperative to keep this medication out of reach of children to prevent accidental ingestion or misuse.

Healthcare professionals should exercise caution when prescribing this medication, ensuring that patients are informed about the potential risks associated with its use. Regular monitoring of patients may be necessary to assess for any adverse effects or complications that could arise during treatment.

In addition, healthcare providers should consider implementing appropriate laboratory tests to evaluate the patient's response to therapy and to monitor for any potential side effects. This proactive approach will help ensure the safe and effective use of the medication in clinical practice.

Side Effects

There are no specific side effects or adverse reactions associated with the use of the product as indicated in the provided information. Therefore, healthcare professionals should monitor patients for any unexpected reactions during treatment, as no adverse reactions have been documented in clinical trials or postmarketing experiences.

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 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 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 healthcare professional.

For children under 12 years of age, it is advised to consult a doctor before use.

Geriatric Use

There is no specific information 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

The available data regarding the use of this medication during pregnancy is limited. There are no specific safety concerns identified for pregnant patients, nor are there any dosage modifications recommended for this population. Additionally, no special precautions have been outlined for the use of this medication in pregnant individuals. Healthcare professionals should weigh the potential benefits against any unknown risks when considering this medication for women of childbearing potential. Further studies may be necessary to fully understand the implications of this medication on fetal outcomes.

Lactation

There are no specific warnings or recommendations regarding the use of simethicone in lactating mothers. Additionally, there is no information available concerning the potential for excretion of simethicone in breast milk or any associated risks to breastfed infants.

Renal Impairment

Patients with renal impairment have no specific information regarding dosage adjustments, special monitoring, or safety considerations provided in the insert text. Therefore, healthcare professionals should exercise caution when prescribing this medication to patients with reduced kidney function, as the lack of data 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 and prepared for potential scenarios involving overdose.

Healthcare providers should be aware that the clinical presentation of an overdose may vary depending on the substance involved and the individual patient’s characteristics. Symptoms may include, but are not limited to, altered mental status, cardiovascular instability, respiratory distress, and gastrointestinal disturbances.

In the event of suspected overdosage, immediate assessment of the patient's condition is crucial. Recommended actions include:

  1. Assessment and Monitoring: Continuous monitoring of vital signs and neurological status is imperative. Establishing intravenous access may be necessary for fluid resuscitation or medication administration.

  2. Supportive Care: Provide supportive care tailored to the symptoms presented. This may involve oxygen supplementation, airway management, and intravenous fluids.

  3. Decontamination: If the overdose is recent and the patient is alert, activated charcoal may be administered to limit further absorption of the substance. However, this should be avoided in cases of altered consciousness or risk of aspiration.

  4. Specific Antidotes: If applicable, the use of specific antidotes should be considered based on the substance involved in the overdose.

  5. Consultation: Engaging with a poison control center or toxicology expert can provide additional guidance on management strategies and potential interventions.

In all cases, timely intervention and a thorough understanding of the clinical implications of an overdose are critical to optimizing patient outcomes.

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 understanding of potential risks associated with the compound in nonclinical settings.

Postmarketing Experience

No postmarketing experience details are available 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 to ensure the safety of young individuals.

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. Patients are advised not to swallow the tablets whole; instead, they should chew or crush the tablets completely before swallowing. There is no additional information available regarding laboratory tests, abuse potential, 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

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.