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Gas Relief

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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 2019
Label revision date
March 10, 2026
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 2019
Label revision date
March 10, 2026
Manufacturer
Walgreens
Registration number
M002
NDC root
0363-8970
Drug Information (PDF)
Prescribing information, PDF file
Packaging Info (3 NDCs)
Packaging & NDC Codes (3)

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 provide relief from the discomfort of gas, including pressure, bloating, and fullness. It works quickly to alleviate these symptoms, making it a helpful option for those experiencing gas-related issues. You may recognize it as the active ingredient in products like Gas-X® Extra Strength Softgels, which are formulated to offer extra strength relief.

This medication is available in softgel form, making it easy to take. If you're dealing with uncomfortable gas, simethicone can help you feel more comfortable and at ease.

Uses

If you're experiencing discomfort from pressure, bloating, or fullness often associated with gas, this medication can help provide relief. It works quickly to alleviate these uncomfortable sensations, allowing you to feel more at ease.

You can trust that this medication does not have any teratogenic effects, meaning it does not cause harm to a developing fetus. This makes it a safer option for those who may be pregnant or planning to become pregnant.

Dosage and Administration

You can take this medication by swallowing 1 or 2 softgels with water after meals and at bedtime if you need it. This is suitable for adults and children aged 12 years and older.

It's important to remember 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 concerns regarding abuse, misuse, or dependence associated with this medication. This means that, based on the available information, there are no particular situations or conditions under which you should avoid using it. Always consult with your healthcare provider if you have any questions or concerns about your treatment.

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 product 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.

Additionally, make sure to keep this medication out of reach of children to prevent accidental ingestion. Always prioritize safety and seek immediate medical help if you suspect a child has taken 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 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, contact your local emergency services or go to the nearest hospital. Having the medication packaging or information on hand can help medical professionals provide the best care. Always remember to use medications as directed by your healthcare provider to minimize the risk of any adverse effects.

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 and any medications you may consider.

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. Always consult with a healthcare professional if you have any questions or concerns about using this medication for your child.

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

There are no specific guidelines, dosage adjustments, or monitoring requirements mentioned for patients with kidney problems in the provided information. If you have kidney issues, it's important to consult your healthcare provider for personalized advice regarding any medications you may be taking. They can help ensure your treatment is safe and effective based on your individual health needs.

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 requirements or precautions outlined for patients like you.

However, it's always a good idea to discuss your liver health with your healthcare provider before starting any new medication. They can provide personalized advice and ensure that your treatment is safe and effective based on your individual health 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 discuss your full list of medications, including over-the-counter drugs and supplements, as well as any lab tests you may need. 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 at room temperature, specifically between 20-25°C (68-77°F). It's important not to refrigerate it, as this can affect its effectiveness. Additionally, keep the product away from light, heat, and moisture to maintain its quality.

When handling the product, make sure to do so in a clean environment to avoid contamination. Following these storage and handling guidelines will help ensure that the product remains safe and effective for your use.

Additional Information

You can take this medication orally by swallowing 1 or 2 softgels with water after meals and at bedtime, but be sure not to exceed 4 softgels in a 24-hour period unless directed by your doctor. If you are pregnant or breastfeeding, it's important to consult a healthcare professional before using this product. Additionally, keep this medication out of reach of children to ensure their safety.

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?

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.

What is the storage requirement for Simethicone?

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

Is there any information on drug interactions with Simethicone?

No drug interactions information is provided for Simethicone.

Is Simethicone a controlled substance?

No, Simethicone is not classified as a controlled substance.

What is the active ingredient in Gas-X® Extra Strength Softgels?

The active ingredient in Gas-X® Extra Strength Softgels is similar to 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 specified drug.

Uses and Indications

This drug is indicated for the relief of pressure, bloating, and fullness commonly referred to as gas. It provides fast relief of these symptoms, enhancing patient comfort and well-being.

There are no teratogenic or nonteratogenic effects associated with this drug.

Dosage and Administration

Adults and children 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 otherwise by a physician.

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 exercise caution when prescribing this medication to pregnant or breastfeeding patients. It is imperative that patients consult with a healthcare professional prior to use in these circumstances to ensure safety for both the mother and child.

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 maintain the integrity of the medication and to safeguard against potential harm to pediatric patients.

Side Effects

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

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 to swallow 1 or 2 softgels with water as needed after meals and at bedtime. The maximum dosage should not exceed 4 softgels in a 24-hour period unless directed and supervised by a physician.

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. Monitoring for potential adverse effects and therapeutic efficacy is recommended in 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 on 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

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

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 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 based on clinical judgment.

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.

Should an overdosage occur, it is recommended that healthcare providers assess the patient's clinical status and initiate appropriate monitoring. Symptoms of overdosage may vary depending on the medication involved and the individual patient's response.

Management procedures should include supportive care tailored to the patient's needs, which may involve symptomatic treatment and monitoring of vital signs. In cases where the specific antidote or treatment protocol is known, it should be administered as per established guidelines.

Healthcare professionals are encouraged to consult relevant toxicology resources or poison control centers for guidance on managing suspected overdosage cases effectively.

Nonclinical Toxicology

If pregnant or breastfeeding, it is advised to consult a health professional prior to use. There are no specific non-teratogenic effects or nonclinical toxicology details available. Additionally, no specific information regarding animal pharmacology and toxicology has been provided.

Postmarketing Experience

No postmarketing experience details are available in the provided text.

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 packaging that ensures its integrity and efficacy. It should be stored at a temperature range of 20-25°C (68-77°F). Refrigeration is not recommended, as it may compromise the product's quality.

To maintain optimal conditions, the product must be protected from light, heat, and moisture. Proper handling and storage are essential to preserve the product's effectiveness and safety.

Additional Clinical Information

Patients aged 12 years and older are advised to take the medication orally, swallowing 1 or 2 softgels with water as needed after meals and at bedtime, without exceeding 4 softgels in a 24-hour period unless directed by a physician. Clinicians should counsel patients to consult a health professional if they are pregnant or breastfeeding and to keep the product out of reach of children.

No additional information is 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.