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Gas Relief

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This product has been discontinued

Active ingredient
Dimethicone 125 mg
Other brand names
Dosage form
Capsule, Liquid Filled
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
November 19, 2025
Drug Information (PDF)
Prescribing information, PDF file
Active ingredient
Dimethicone 125 mg
Other brand names
Dosage form
Capsule, Liquid Filled
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
November 19, 2025
Manufacturer
Hy-Vee
Registration number
M002
NDC root
42507-789
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 that contains 125 mg of simethicone in each small, easy-to-swallow softgel. It is designed to help relieve pressure, bloating, and fullness that are commonly associated with gas. By acting as an antigas agent, simethicone works to alleviate discomfort caused by excess gas in the digestive system, providing you with relief when you need it most.

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 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 swallowing 1 or 2 softgels with water after meals and at bedtime if needed. This is suitable for adults and children aged 12 years and older. However, it's important not to exceed 4 softgels 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).

Since there are no explicit "do not take" or "do not use" instructions, it suggests that this medication is generally safe for use. However, always consult with your healthcare provider for personalized advice and to ensure it’s appropriate for your situation.

Side Effects

If you are pregnant or breastfeeding, it’s important to consult a healthcare professional before using this medication. Additionally, be sure to keep this medication out of reach of children to ensure their safety.

Warnings and Precautions

If you are pregnant or breastfeeding, it’s important to consult with a healthcare professional before using this medication. Your health and the health of your baby are paramount, and a professional can provide guidance tailored to your situation.

Make sure to keep this medication out of reach of children to prevent accidental ingestion. If you suspect that a child has taken this medication, seek emergency help immediately. Always prioritize safety and don’t hesitate to reach out to your doctor if you have any concerns or experience unusual symptoms while using this medication.

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 breastfeeding, it’s important to consult with a healthcare professional before using this medication. They can provide guidance on whether it’s safe for you and your baby. Always prioritize your health and the health of your child by seeking expert advice.

Lactation Use

If you are pregnant or breastfeeding, it’s important to consult with a healthcare professional before using any medication. This ensures that you understand any potential risks and can make informed decisions about your health and the health of your baby. Always prioritize open communication with your doctor regarding your breastfeeding journey.

Pediatric Use

It's important to keep this medication out of reach of children to ensure their safety. For adults and children aged 12 years and older, the recommended dosage is to swallow 1 or 2 softgels with water after meals and at bedtime. However, you should not exceed 4 softgels in a 24-hour period unless directed by a doctor.

If you have younger children, please consult with a healthcare professional before considering this medication for them, as specific guidelines for younger age groups are not provided. Always prioritize safety and follow the recommended dosages.

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 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 plan is safe and effective for your specific situation. They can help monitor your kidney health and make any necessary adjustments to your medications.

Hepatic Impairment

If you have liver problems, it's important to know that the information provided does not include specific guidelines about dosage adjustments, special monitoring, or precautions for your condition. This means that there are no detailed recommendations available for how your liver health might affect the use of this medication.

Always consult your healthcare provider for personalized advice and to ensure that any treatment plan is safe and appropriate for your liver condition. They can help you understand how to manage your health effectively while using this medication.

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 avoid any potential issues and receive the best care possible.

Storage and Handling

To ensure the best performance of your product, store it in a cool, dry place at a temperature between 20-25°C (68-77°F). It's important not to refrigerate the product, as this can affect its effectiveness. Additionally, keep it protected from light, heat, and moisture to maintain its quality.

When handling the product, always ensure that you are in a clean environment to avoid contamination. Following these storage and handling guidelines will help you use the product safely and effectively.

Additional Information

You should take this medication orally by swallowing 1 or 2 softgels with water after meals and at bedtime, if needed. It's important not to exceed 4 softgels in a 24-hour period unless your doctor advises otherwise. This guidance applies to both adults and children aged 12 years and older. Always follow your healthcare provider's instructions for safe use.

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 dosage for adults and children 12 years and older?

Adults and children 12 years and older should swallow 1 or 2 softgels with water as needed after meals and at bedtime, not exceeding 4 softgels in 24 hours unless advised by a physician.

Are there any warnings for using Simethicone?

If you are pregnant or breastfeeding, you should ask a health professional before use. Additionally, keep this product out of reach of children.

What should I do if the blister unit is damaged?

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

How should Simethicone be stored?

Store Simethicone between 20-25°C (68-77°F), do not refrigerate, and protect it from light, heat, and moisture.

Is there any information on drug interactions?

No drug interactions information is provided for Simethicone.

What is the active ingredient in Simethicone?

The active ingredient in Simethicone is Simethicone, with a dosage of 125 mg per softgel.

Is there any information regarding contraindications?

No contraindications are listed for Simethicone.

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

Adults and children aged 12 years and older may take 1 or 2 softgels as needed after meals and at bedtime. The softgels should be swallowed with water. It is important not to exceed a total of 4 softgels within a 24-hour period, unless directed by a physician.

Contraindications

There are no contraindications associated with the use of this product. It is not classified as a controlled substance, and there are no known risks of abuse, misuse, or dependence. Therefore, no specific instructions regarding avoidance or non-use are necessary.

Warnings and Precautions

Healthcare professionals are advised to exercise caution when prescribing this medication to pregnant or breastfeeding patients. It is imperative that individuals in these categories consult with a healthcare professional prior to use to ensure safety and appropriateness of treatment.

Additionally, this medication should be stored securely and kept out of reach of children to prevent accidental ingestion or misuse. Proper storage practices are essential to safeguard against potential risks associated with pediatric exposure.

Side Effects

Patients should be advised to consult a health professional if they are pregnant or breastfeeding before using this medication. It is important to keep this product out of reach of children to prevent accidental ingestion or misuse.

No specific adverse reactions have been reported in clinical trials or postmarketing experiences; however, the aforementioned warnings highlight the need for caution in vulnerable populations.

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 adolescents aged 12 years and older, the recommended dosage is 1 or 2 softgels taken with water after meals and at bedtime, not to exceed 4 softgels in a 24-hour period unless directed by a physician. Caution is advised to ensure that the dosage does not exceed the recommended limits.

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 and those who are breastfeeding should consult a healthcare professional prior to using this medication. The potential risks and benefits must be carefully considered in these populations to ensure the safety of both the mother and the fetus or infant.

Lactation

Lactating mothers are advised to consult a health professional prior to using this medication. There is currently no available data regarding the excretion of this medication in human breast milk or its effects on breastfed infants. Therefore, caution is recommended when administering this medication to lactating individuals.

Renal Impairment

Patients with renal impairment have not been specifically addressed in the available prescribing information. There are no dosage adjustments, special monitoring requirements, or safety considerations outlined for individuals with reduced kidney function. Healthcare professionals should exercise caution and consider the lack of data when prescribing to this patient population.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in clinical trials for this medication. Consequently, there is no information available regarding dosage adjustments, special monitoring, or precautions 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 warranted in these patients, 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. Common symptoms may include, but are not limited to, severe drowsiness, confusion, respiratory distress, or any other unusual clinical manifestations.

Management of an overdose should be tailored to the individual patient and may involve supportive care, including monitoring vital signs and providing symptomatic treatment as necessary. In cases of significant overdose, consultation with a poison control center or toxicology specialist is recommended to determine the most appropriate course of action.

It is crucial for healthcare professionals to educate patients about the importance of adhering to prescribed dosages and to provide guidance on what to do in the event of a suspected overdose.

Nonclinical Toxicology

If pregnant or breastfeeding, it is advised to consult a health professional prior to use. No specific non-teratogenic effects have been identified. Additionally, there is no available information regarding nonclinical toxicology or animal pharmacology and toxicology.

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 for patients to understand the potential risks associated with improper access to the medication by young individuals.

Storage and Handling

The product is supplied in packaging that ensures its integrity and efficacy. It should be stored at a temperature range of 20-25°C (68-77°F). It is imperative that the product is not refrigerated, as this may compromise its quality. Additionally, the product must be protected from light, heat, and moisture to maintain its stability and effectiveness. Proper handling and storage conditions are essential to ensure the product remains within its specified parameters.

Additional Clinical Information

The medication is administered orally, with adults and children aged 12 years and older advised to swallow 1 or 2 softgels with water after meals and at bedtime. Patients should not exceed a total of 4 softgels within a 24-hour period unless directed by a physician.

No additional information is available regarding laboratory tests, abuse potential, 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

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.