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

This product has been discontinued

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 2015
Label revision date
January 12, 2022
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 2015
Label revision date
January 12, 2022
Manufacturer
Safeway
Registration number
part332
NDC root
21130-134
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 an extra strength gas relief medication that contains 125 mg of simethicone as its active ingredient. It is designed to help relieve discomfort caused by gas, including symptoms such as pressure and bloating. By breaking up gas bubbles in the stomach and intestines, simethicone can provide you with quick relief from the uncomfortable sensations associated with gas.

This medication is available in a chewable tablet form, often enjoyed in a cherry creme flavor, making it a convenient option for those seeking relief from gas-related discomfort.

Uses

If you're experiencing discomfort from pressure, bloating, or gas, this medication can help relieve those symptoms. It works effectively to ease the feeling of fullness and the discomfort associated with gas buildup in your digestive system.

You can feel confident using this medication, as it has no known teratogenic effects (which means it does not cause birth defects) or nonteratogenic effects. This makes it a safe option for those looking to alleviate these common digestive issues.

Dosage and Administration

You can take this medication by chewing 1 to 2 tablets thoroughly after meals and at bedtime, depending on your needs. It's important to remember not to exceed 4 tablets in a 24-hour period unless your doctor has advised you otherwise. Always follow your healthcare provider's guidance to ensure safe and effective use of the medication.

What to Avoid

There are no specific contraindications, controlled substance classifications, or risks of 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 for personalized advice and to ensure that this medication is appropriate for your individual health needs.

Side Effects

It's important to keep this medication out of the reach of children. If an overdose occurs, seek medical help or contact a poison control center right away.

While specific side effects are not detailed here, always be aware of how your body responds to any medication. If you experience unusual symptoms or reactions, consult your healthcare provider for guidance.

Warnings and Precautions

It's important to keep this medication out of the reach of children. If you suspect an overdose, seek medical help or contact a poison control center right away.

Always be cautious and monitor for any unusual symptoms. If you experience any concerning side effects or reactions, stop using the medication and call your doctor for guidance. Your safety is a priority, so don’t hesitate to reach out for help if needed.

Overdose

If you suspect an overdose, it’s crucial to seek medical help right away or contact a poison control center. Signs of an overdose can vary, but they may include unusual drowsiness, confusion, or difficulty breathing.

Don’t wait for symptoms to worsen; getting prompt assistance can be vital. Always prioritize your safety and the safety of others by acting quickly in these situations.

Pregnancy Use

When it comes to using this medication during pregnancy, there is no specific information available about its safety, recommended dosage adjustments, or any special precautions you should take. This means that if you are pregnant or planning to become pregnant, it’s important to consult with your healthcare provider before starting or continuing this medication. They can help you weigh the potential risks and benefits based on your individual situation. Always prioritize open communication with your doctor to ensure the best care for you and your baby.

Lactation Use

If you are breastfeeding, you can feel reassured that there are no specific warnings or recommendations regarding the use of this product while nursing. Additionally, there are no particular considerations or precautions mentioned for lactation. This means that, based on the available information, you can use this product without special concerns related to breastfeeding. Always consult with your healthcare provider if you have any questions or need personalized advice.

Pediatric Use

It's important to keep this medication out of the reach of children to prevent accidental ingestion. If you suspect your child has taken too much, seek medical help or contact a poison control center right away.

For children who may need this medication, the recommended dosage is to chew 1 to 2 tablets thoroughly after meals and at bedtime. However, do not exceed 4 tablets in a 24-hour period unless directed by a doctor. Always follow your healthcare provider's advice to ensure your child's safety.

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 before starting the medication. 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 be adjusted 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 condition. They can help monitor your kidney health and make any necessary changes to your medications.

Hepatic Impairment

If you have liver problems, it's important to know that the drug insert does not provide specific information about dosage adjustments, special monitoring, or precautions for your condition. This means that there are no tailored guidelines for how this medication may affect you differently due to your liver health.

Always consult your healthcare provider for personalized advice and to discuss any concerns you may have regarding your liver function and how it relates to your treatment. They can help ensure that your medication is safe and effective for you.

Drug Interactions

It's important to have open conversations with your healthcare provider about any medications or tests you may be taking. In this case, there are no known drug interactions or laboratory test interactions associated with the medication. However, every individual is different, and your healthcare provider can help ensure that your treatment is safe and effective for you. Always feel free to ask questions and share your complete list of medications and any tests you may be undergoing.

Storage and Handling

To ensure the safety and effectiveness of your product, it’s important to store it properly. Keep it at room temperature, away from high humidity and excessive heat—specifically, temperatures above 40°C (104°F). This will help maintain its quality and performance.

When handling the product, be cautious not to use it if any individual blister unit is broken or open, as this could compromise its safety. Following these guidelines will help you use the product effectively and safely.

Additional Information

You should take this medication orally by chewing 1 to 2 tablets thoroughly as needed after meals and at bedtime. It's important not to exceed 4 tablets in a 24-hour period unless directed by your doctor. Always follow your healthcare provider's advice regarding the use of this medication.

FAQ

What is SIMETHICONE used for?

SIMETHICONE is used to relieve symptoms of gas discomfort, pressure, and bloating.

How should I take SIMETHICONE?

You should chew 1 to 2 tablets thoroughly as needed after meals and at bedtime, but do not exceed 4 tablets in a 24-hour period unless advised by a physician.

Are there any warnings associated with SIMETHICONE?

Yes, keep SIMETHICONE out of the reach of children. In case of overdose, seek medical help or contact a poison control center immediately.

Does SIMETHICONE have any contraindications?

No contraindications are listed for SIMETHICONE.

Can I use SIMETHICONE during pregnancy or while nursing?

The provided information does not mention any specific warnings or recommendations for use during pregnancy or lactation.

What is the active ingredient in SIMETHICONE?

The active ingredient in SIMETHICONE is SIMETHICONE 125 mg.

What flavor does SIMETHICONE come in?

SIMETHICONE is available in a cherry creme flavor.

How many tablets are in a package of SIMETHICONE?

Each package of SIMETHICONE contains 18 chewable tablets.

What should I do if a blister unit of SIMETHICONE is broken or open?

Do not use SIMETHICONE if any individual blister unit is broken or open.

How should I store SIMETHICONE?

Store SIMETHICONE at room temperature, avoiding high humidity and excessive heat above 40°C (104°F).

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

Simethicone is presented in a dosage form of chewable tablets, with each tablet containing 125 mg of simethicone. The product is formulated with a cherry crème flavor to enhance palatability. Each package contains a total of 18 chewable tablets.

Uses and Indications

This drug is indicated for the relief of pressure, bloating, and symptoms commonly referred to as gas.

There are no teratogenic effects associated with this drug, and no nonteratogenic effects have been reported.

Dosage and Administration

Patients are advised to chew 1 to 2 tablets thoroughly as needed after meals and at bedtime. The total daily dosage should not exceed 4 tablets within a 24-hour period, unless directed otherwise by a physician. It is essential that patients adhere to this guideline to ensure safe and effective use of the medication.

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 the reach of children. In the event of an overdose, immediate medical assistance should be sought, or contact with a poison control center is strongly advised.

Healthcare professionals should ensure that patients and caregivers are aware of the potential risks associated with accidental ingestion by children and the necessary steps to take in such situations.

Side Effects

Patients should be advised to keep the medication out of the reach of children. In the event of an overdose, it is crucial to seek medical assistance or contact a poison control center immediately. This warning underscores the importance of proper storage and handling to prevent accidental ingestion, particularly in pediatric populations.

Drug Interactions

There are no reported drug interactions associated with the use of this medication. Additionally, no interactions with laboratory tests have been identified. Therefore, no dosage adjustments or monitoring recommendations are necessary based on drug interactions.

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 advised to keep this medication out of reach of children. In the event of an overdose, immediate medical assistance or contact with a poison control center is essential.

For dosing, pediatric patients are directed to chew 1 to 2 tablets thoroughly as needed after meals and at bedtime. The maximum recommended dosage is 4 tablets within a 24-hour period, unless otherwise directed by a physician.

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

There is no specific information regarding the use of this medication during pregnancy, including safety concerns, dosage modifications, or special precautions. Healthcare professionals should consider the lack of data when prescribing this medication to pregnant patients. It is advisable to weigh the potential benefits against any unknown risks to fetal outcomes. Women of childbearing potential should be counseled on the importance of effective contraception during treatment.

Lactation

There are no specific warnings or recommendations regarding the use of this product by lactating mothers. Additionally, there are no specific considerations or precautions mentioned related to lactation. Therefore, healthcare professionals may consider the use of this product in nursing mothers without special precautions.

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 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 event of an overdose, it is imperative to seek medical assistance or contact a poison control center without delay. Prompt action is crucial to mitigate potential adverse effects associated with excessive intake.

Healthcare professionals should be vigilant for symptoms that may arise from an overdose, although specific symptoms are not detailed in the provided information. The management of an overdose typically involves supportive care and symptomatic treatment, tailored to the individual patient's needs.

It is essential for healthcare providers to remain informed about the appropriate protocols for managing overdose situations, ensuring that patients receive timely and effective 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 in these areas limits the understanding of the compound's potential effects in nonclinical settings.

Postmarketing Experience

No postmarketing experience details are available in the insert text.

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 safeguarding the medication to ensure the safety of young individuals.

Storage and Handling

The product is supplied in individual blister units. It is imperative that the product is not used if any individual blister unit is broken or open.

For optimal storage, the product should be kept at room temperature. It is essential to avoid exposure to high humidity and excessive heat, specifically temperatures exceeding 40°C (104°F), to maintain the integrity of the product.

Additional Clinical Information

The medication is administered orally, with the recommended directions for use being to chew 1 to 2 tablets thoroughly as needed after meals and at bedtime. Patients should not exceed 4 tablets within a 24-hour period unless advised and supervised by a physician. There is no additional information 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.