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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
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 2009
Label revision date
August 28, 2014
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 2009
Label revision date
August 28, 2014
Manufacturer
Select Brand
Registration number
part332
NDC root
15127-157
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 medication designed to provide relief from gas, pressure, bloating, and discomfort in your digestive system. Each chewable tablet contains 125 mg of simethicone and is available in a pleasant Cherry Creme flavor, making it easy to take.

This medication works by breaking up gas bubbles in the stomach and intestines, helping you feel more comfortable after meals or during times of digestive distress. Simethicone is comparable to the active ingredient found in Gas-X Extra strength, making it a reliable option for managing gas-related issues.

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 more comfortable and at ease after using it, allowing you to go about your day without the distraction of these uncomfortable sensations.

Dosage and Administration

You can take this medication by chewing 1 to 2 tablets thoroughly whenever you need relief, especially after meals and at bedtime. 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

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

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 to prevent accidental ingestion. If you suspect an overdose, seek medical help or contact a poison control center right away.

Always be cautious and monitor your health while using this medication. If you experience any unusual symptoms or side effects, 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 symptoms that are more severe than what you would typically experience with the medication.

Don’t wait to see if symptoms improve; getting prompt assistance can be vital. Always prioritize your health and safety by reaching out for help if you think you or someone else may have taken too much of a medication.

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 this medication during pregnancy. This means that safety concerns, dosage adjustments, or any special precautions have not been clearly outlined.

Given this lack of information, it is advisable to consult with your healthcare provider before using this medication. They can help you weigh the potential risks and benefits based on your individual circumstances. Always prioritize open communication with your doctor regarding any medications you may be considering during pregnancy.

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. Currently, there is no information available about whether this product is excreted in breast milk or if it poses any risk to your infant.

As always, it's a good idea to consult with your healthcare provider if you have any concerns or questions about using any medication while breastfeeding. Your health and the well-being of your baby are important, and your provider can help guide you in making the best choices.

Pediatric Use

It's important to keep this medication out of the reach of children. If you suspect that a child has taken too much, seek medical help or contact a poison control center right away. Being aware of these precautions can help 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 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 is safe and effective for your specific condition. They can help you understand any necessary precautions or adjustments based on your kidney health.

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 if you have hepatic impairment (issues with liver function).

Always consult your healthcare provider for personalized advice and to discuss any concerns regarding your liver health and how it may relate to your treatment. They can help ensure that you receive the safest and most effective care.

Drug Interactions

It's important to communicate openly with your healthcare provider about any medications you are taking. In this case, there are no reported interactions between this medication and other drugs or laboratory tests. This means that, as of now, you can feel confident that this medication should work well alongside others you may be using.

However, always keep in mind that individual responses can vary, and new information may emerge over time. Therefore, discussing your complete medication list and any lab tests with your healthcare provider is essential to ensure your safety and the effectiveness of your treatment.

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 physician's advice for safe use.

FAQ

What is Simethicone used for?

Simethicone is used to relieve gas, pressure, bloating, and discomfort associated with gas.

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 contraindications for using Simethicone?

There are no contraindications listed for Simethicone.

Is Simethicone safe to use during pregnancy?

The insert does not provide specific information regarding the use of Simethicone during pregnancy.

Can nursing mothers use Simethicone?

There are no specific warnings or recommendations regarding the use of Simethicone in nursing mothers.

What should I do in case of an overdose?

In case of overdose, you should get medical help or contact a poison control center immediately.

How should Simethicone be stored?

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

What flavor is Simethicone available in?

Simethicone is available in Cherry Creme flavor.

What is the strength of each Simethicone tablet?

Each Simethicone tablet contains 125 mg of the active ingredient.

Is there any information about drug interactions with Simethicone?

No drug interactions have been reported 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

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 and is packaged in a container containing 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 should 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 for healthcare professionals to monitor patients for adherence to this dosing regimen to ensure safety and efficacy.

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.

Warnings and Precautions

It is imperative to keep this medication out of the reach of children to prevent accidental ingestion and potential harm.

In the event of an overdose, immediate medical assistance should be sought. Healthcare professionals are advised to contact a poison control center without delay to ensure appropriate management and intervention.

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

No drug interactions have been reported for this medication. Additionally, there are no interactions identified between this drug and laboratory tests. 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 the medication out of reach of children. In the event of an overdose, it is crucial to seek medical assistance or contact a poison control center immediately.

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

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 in nursing mothers. Additionally, there is no information available about the potential for excretion in breast milk or any associated risks to breastfed infants.

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 intervention is crucial to mitigate potential adverse effects associated with the overdose.

Healthcare professionals should be aware that the symptoms of overdose may vary depending on the specific substance involved. Therefore, a thorough assessment of the patient's condition is essential to determine the appropriate course of action.

Management of an overdose typically involves supportive care and symptomatic treatment. This may include monitoring vital signs, providing respiratory support, and administering activated charcoal if indicated and within the appropriate time frame.

It is essential for healthcare providers to remain vigilant and prepared to implement emergency protocols as necessary, ensuring the safety and well-being of the patient.

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 question.

Postmarketing Experience

No postmarketing experience details are available in the insert text.

Patient Counseling

Healthcare providers should advise patients to keep this medication out of the 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 children. Providers should emphasize the necessity of storing the medication in a secure location, away from children's sight and reach, to ensure safety.

Storage and Handling

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

For optimal storage, the product should be kept at room temperature, ensuring that it is protected from high humidity and excessive heat. Temperatures should not exceed 40°C (104°F) to maintain the integrity of the product.

Additional Clinical Information

The medication is administered orally, with the recommended direction for patients 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.