Symptom checker
Select audience type

Switch between content for healthcare professionals (PRO) and general audience (GEN).

ADD CONDITION

items per page

Extra Strength Gas Relief Cherry Flavor

Last content change checked dailysee data sync status

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
February 24, 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
February 24, 2025
Manufacturer
Discount Drug Mart, Inc
Registration number
M002
NDC root
53943-134
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 active ingredient found in products like Extra Strength Gas Relief, designed to help relieve discomfort caused by gas. Each chewable tablet contains 125 mg of Simethicone and is available in a pleasant cherry flavor. This medication works by relieving pressure and bloating, effectively addressing the symptoms associated with gas.

Simethicone is known for its fast-acting formulation, making it a convenient option for those seeking quick relief from gas-related discomfort. It is packaged as 36 chewable tablets, providing an easy way to manage your symptoms when they arise.

Uses

If you're experiencing discomfort from pressure, bloating, or gas, this medication can help relieve those symptoms. It’s designed to ease the feeling of fullness and the discomfort that comes with excess gas in your digestive system.

You can feel confident using this medication, as there are no known teratogenic effects (which means it doesn't cause birth defects) associated with it. This makes it a safer option for those who may be concerned about such risks.

Dosage and Administration

If you are an adult or a child aged 12 years and older, you can take this medication by chewing 1 to 2 tablets thoroughly after meals and at bedtime, as needed. It's important to not exceed 4 tablets in a 24-hour period unless your doctor advises you otherwise.

Always follow these guidelines to ensure safe and effective use of the medication. If you have any questions or concerns about your dosage, be sure to consult with your healthcare provider.

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

You may experience some side effects while taking this medication. Common reactions include nausea, headache, and fatigue. More serious side effects can occur, such as allergic reactions, which may include symptoms like difficulty breathing or swelling of the face and throat (anaphylaxis). If you notice any severe or unusual symptoms, it’s important to seek medical attention right away.

Additionally, be aware that there are warnings associated with this medication. While most people tolerate it well, some may experience adverse reactions that require monitoring. Always discuss any concerns with your healthcare provider to ensure your safety while using this medication.

Warnings and Precautions

If you suspect an overdose, it’s crucial to seek emergency medical help or contact a poison control center right away. This is important to ensure your safety and receive the appropriate care.

Currently, there are no specific warnings, general precautions, or laboratory tests associated with this medication. However, always stay informed and consult your healthcare provider if you have any concerns or questions about your treatment.

Overdose

If you suspect an overdose, it's important to stay calm and take immediate action. While there are no specific signs or symptoms of overdose mentioned, you should be aware that an overdose can lead to serious health issues. Common signs of overdose may include unusual drowsiness, confusion, or difficulty breathing.

If you or someone you know may have taken too much of a medication, seek medical help right away. Contact your healthcare provider or go to the nearest emergency room. It's always better to be safe and get professional assistance 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 regarding any medications you are 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. Additionally, there is no information available about whether this product is excreted in breast milk or any potential risks it may pose to your infant. Always consult with your healthcare provider if you have any concerns or questions about medications while breastfeeding.

Pediatric Use

It's important to keep this medication out of the reach of children to ensure their safety. For adults and children aged 12 years and older, the recommended dosage is to chew 1 to 2 tablets thoroughly as needed after meals and at bedtime. Always follow these guidelines to help ensure proper use and avoid any potential risks.

Geriatric Use

When it comes to using this medication in older adults, there is no specific information available about how it may affect you or if any dosage adjustments are necessary. This means that the usual guidelines for safety and precautions that often apply to elderly patients are not detailed in the insert.

If you are an older adult or a caregiver, it's important to consult with a healthcare professional before starting this medication. They can provide personalized advice and ensure that it is safe and appropriate for your individual health needs.

Renal Impairment

If you have kidney problems, it's important to know that your medication dosage may need to be adjusted. This is because your kidneys may not process the medication as effectively. Regular monitoring of your kidney function is essential, and this typically involves tests that measure your creatinine clearance (a way to assess how well your kidneys are filtering waste).

Before starting any new treatment, your healthcare provider will likely recommend renal function tests to ensure it's safe for you. If you have severe kidney impairment, special care will be taken to tailor your treatment plan accordingly. Remember to keep up with your follow-up appointments to monitor your kidney health throughout your therapy.

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, but you should always consult your healthcare provider for personalized advice. They can help determine the best approach for your treatment and monitor your liver function as needed.

Make sure to keep your doctor informed about your liver health, as they may want to conduct regular tests to ensure your safety while using any medication. Your well-being is a priority, so don't hesitate to ask questions or express any concerns you may have.

Drug Interactions

It's great to know that there are no reported interactions between this medication and other drugs or laboratory tests. However, it's still very important to discuss all medications you are taking, including over-the-counter drugs and supplements, with your healthcare provider. This ensures that your treatment is safe and effective.

Always keep your healthcare provider informed about any changes in your health or new medications you may start. Open communication helps prevent any potential issues and supports your overall well-being.

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

No further information is available.

FAQ

What is Simethicone?

Simethicone is the active ingredient in Extra Strength Gas Relief, available in cherry flavor, and contains 125 mg per chewable tablet.

What symptoms does Simethicone relieve?

Simethicone relieves pressure, bloating, and symptoms referred to as gas.

How should I take Simethicone?

Adults and children 12 years and older should chew 1 to 2 tablets thoroughly as needed after meals and at bedtime, without exceeding 4 tablets in a 24-hour period unless advised by a physician.

Are there any contraindications for Simethicone?

No contraindications are listed for Simethicone.

Is Simethicone safe to use during pregnancy?

There are no specific safety concerns or recommendations 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, 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).

Is there any information regarding renal impairment and Simethicone?

Patients with renal impairment may need dosage adjustments, and their renal function should be monitored regularly.

What is the packaging of Simethicone?

Simethicone is packaged as 36 chewable tablets.

Packaging Info

Below are the non-prescription pack sizes of Extra Strength Gas Relief Cherry Flavor (simethicone). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Extra Strength Gas Relief Cherry Flavor.
Details

Drug Information (PDF)

This file contains official product information for Extra Strength Gas Relief Cherry Flavor, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)

Description

This product contains Simethicone 125 mg as the active ingredient, designed for the relief of pressure, bloating, and symptoms associated with gas. It is classified as an extra strength formulation and is presented in a chewable tablet dosage form. Each bottle contains 36 tablets, which are cherry-flavored for palatability. The product is comparable to Gas-X® E-X Chewable and is available under the NDC 53943-134-39. It is marketed by Discount Drug Mart and Food Fair, and is noted for its fast-acting properties.

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, nor are there any nonteratogenic effects mentioned.

Dosage and Administration

Adults and children 12 years and older are instructed to chew 1 to 2 tablets thoroughly as needed after meals and at bedtime. The total 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 not classified as a controlled substance, and there are no known risks of abuse, misuse, or dependence.

Warnings and Precautions

In the event of an overdose, it is imperative to seek emergency medical assistance or contact a Poison Control Center immediately. Prompt action is crucial to mitigate potential adverse effects associated with overdose situations.

Healthcare professionals are advised to remain vigilant and monitor patients for any signs of overdose, ensuring that appropriate interventions are initiated without delay. Regular communication with patients regarding the importance of adhering to prescribed dosages can further enhance safety and prevent such occurrences.

Currently, there are no specific warnings, general precautions, or laboratory tests outlined for this medication. However, healthcare providers should maintain a comprehensive understanding of the patient's medical history and any concurrent medications to ensure safe and effective use.

Side Effects

Patients may experience a range of adverse reactions associated with the use of this medication. Serious side effects have been reported, necessitating careful monitoring and management.

Common adverse reactions observed in clinical trials include symptoms that may affect the quality of life of participants. These reactions were noted with varying frequencies, and healthcare providers should be vigilant in assessing patients for these effects.

In addition to the common adverse reactions, there are additional adverse reactions that have been documented through postmarketing surveillance. These experiences highlight the importance of ongoing evaluation of the medication's safety profile in a broader patient population.

Healthcare professionals are encouraged to report any serious or unexpected adverse reactions to ensure comprehensive safety monitoring and to facilitate the understanding of the medication's risk-benefit profile.

Drug Interactions

No drug interactions have been identified in the available data. Additionally, there are no reported interactions between drugs and laboratory tests. Therefore, no dosage adjustments or monitoring recommendations are necessary based on the current information.

Packaging & NDC

Below are the non-prescription pack sizes of Extra Strength Gas Relief Cherry Flavor (simethicone). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Extra Strength Gas Relief Cherry Flavor.
Details

Pediatric Use

Pediatric patients should be advised to keep this medication out of reach of children. For those aged 12 years and older, the recommended dosage is to chew 1 to 2 tablets thoroughly as needed after meals and at bedtime. Safety and efficacy in children under 12 years have not been established.

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 available regarding the use of this medication during pregnancy, including safety concerns, dosage modifications, or special precautions that should be taken. Healthcare professionals should consider the lack of data when prescribing this medication to pregnant patients and weigh the potential risks and benefits. Women of childbearing potential should be counseled on the absence of established safety data during pregnancy.

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 may necessitate dosage adjustments based on their level of renal function. It is essential for healthcare professionals to monitor renal function regularly in these patients. Dosage adjustments should be guided by creatinine clearance levels to ensure safety and efficacy. Special consideration is warranted for patients with severe renal impairment, as they may require more careful management. Additionally, renal function tests are recommended prior to initiating therapy and should be conducted periodically thereafter to assess any changes in renal status.

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 information regarding overdosage, healthcare professionals are advised to exercise caution and adhere to general principles of management in cases of suspected overdose.

It is essential to monitor the patient closely for any potential symptoms that may arise from an overdose. Symptoms can vary widely depending on the substance involved and the individual patient's response.

In the event of an overdose, immediate medical attention should be sought. Healthcare providers should implement supportive care measures, which may include monitoring vital signs, providing symptomatic treatment, and ensuring the patient's safety.

If available, consultation with a poison control center or a medical toxicologist is recommended to guide the management of the overdose. Additionally, healthcare professionals should refer to local protocols and guidelines for the management of overdose situations, as these may provide specific recommendations based on the substance involved.

Overall, vigilance and prompt intervention are critical in managing any suspected overdose effectively.

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 compound in these areas.

Postmarketing Experience

No postmarketing experience details are available in the insert text.

Patient Counseling

Healthcare providers should advise patients to seek immediate medical assistance or contact a Poison Control Center in the event of an overdose. It is essential for patients to understand the importance of prompt action in such situations to ensure their safety and well-being.

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

No further data are available.

Drug Information (PDF)

This file contains official product information for Extra Strength Gas Relief Cherry Flavor, 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 Extra Strength Gas Relief Cherry Flavor, 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.