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Foster and Thrive Extra Strength Gas Relief Cherry

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Active ingredient
Dimethicone 125 mg
Other brand names
Dosage form
Tablet, Chewable
Route
Oral
Prescription status
OTC (over the counter)
Marketed in the U.S.
Since 2023
Label revision date
December 13, 2024
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
Marketed in the U.S.
Since 2023
Label revision date
December 13, 2024
Manufacturer
Strategic Sourcing Services LLC
Registration number
M002
NDC root
70677-1077

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Drug Overview

Simethicone is an active ingredient found in products like Foster & Thrive™ Extra Strength Gas Relief, which comes in cherry-flavored chewable tablets. It is primarily used to relieve discomfort caused by gas, including symptoms such as pressure and bloating. As an antigas agent, simethicone works by breaking up gas bubbles in the stomach and intestines, making it easier for your body to eliminate them. This can help you feel more comfortable and reduce the unpleasant sensations associated with gas.

Uses

You can use this medication to help relieve various uncomfortable symptoms. It effectively alleviates pressure and bloating, making you feel more at ease. If you're experiencing symptoms commonly referred to as gas, this medication can also provide relief. Overall, it aims to reduce discomfort, helping you feel better in your daily activities.

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 or misuse associated with this medication. Additionally, there are no concerns regarding dependence (a condition where the body becomes reliant on a substance) or any explicit instructions on what not to take or use.

It's always important to consult with your healthcare provider for personalized advice and to ensure that this medication is appropriate for you.

Side Effects

You may experience some side effects while taking this medication. Common adverse reactions include allergic reactions, which can range from mild skin rashes to more severe symptoms. Serious side effects may involve cardiovascular issues, such as changes in heart rate or blood pressure, and neurological effects, which can include headaches or dizziness. Dermatologic reactions, like skin irritation, may also occur.

It's important to be aware that some individuals may experience more severe reactions, and if you notice any unusual symptoms, you should contact your healthcare provider immediately. Always discuss any concerns about side effects with your doctor to ensure your safety and well-being.

Warnings and Precautions

It's important to be aware of certain precautions when using this medication. If you suspect an overdose, seek emergency medical help right away or contact a poison control center at 1-800-222-1222.

Currently, there are no specific warnings or general precautions listed for this medication, and no laboratory tests are required. 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 is no specific information available about the signs of overdose for this medication, general symptoms can include unusual drowsiness, confusion, or difficulty breathing. If you notice any of these signs, or if you are unsure, seek medical help right away.

In case of an overdose, contact your local emergency services or go to the nearest hospital. It's always better to be safe and get checked by a healthcare professional if you have any concerns about your health. Remember, timely intervention can make a significant difference.

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 related to pregnancy have not been addressed.

Given this lack of information, it is crucial to consult with your healthcare provider before using 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 may be considering during pregnancy.

Lactation Use

If you are breastfeeding, you can feel reassured that there are no specific warnings or recommendations regarding nursing mothers or lactation in the information provided. This means that, based on the available data, there are no known risks associated with breastfeeding while using this medication. However, it's always a good idea to consult with your healthcare provider if you have any concerns or questions about your specific situation.

Pediatric Use

It's important to keep this medication out of reach of children to prevent accidental ingestion. If you suspect that your child has taken too much, seek medical help right away or contact a poison control center at 1-800-222-1222. 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 your medication dosage may need to be adjusted. This is particularly true if you have reduced creatinine clearance (a measure of how well your kidneys are filtering waste). Regular monitoring of your kidney function through tests is essential to ensure your safety and the effectiveness of your treatment.

For those with severe renal impairment, there is a higher risk of experiencing adverse effects from medications. Therefore, close monitoring and special considerations are necessary to manage your health effectively. Always discuss any concerns with your healthcare provider to ensure you receive the best care tailored to your 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, 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 liver function tests (which check how well your liver is working) to ensure your safety while using any medication.

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, tailored specifically to your health needs.

Always keep your healthcare provider informed about any changes in your medication or health status. 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 40ºC (104ºF). 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 regarding the use of this medication.

FAQ

What is Simethicone used for?

Simethicone is used to relieve 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?

No contraindications are listed for Simethicone.

Is Simethicone safe to use during pregnancy?

The provided information does not mention any specific safety concerns regarding the use of Simethicone during pregnancy.

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 at 1-800-222-1222.

How should Simethicone be stored?

Store Simethicone at room temperature, avoiding high humidity and excessive heat above 40ºC (104ºF).

Can I use Simethicone if I have kidney problems?

If you have renal impairment, dosage adjustments may be necessary, and you should be closely monitored.

What flavor does Simethicone come in?

Simethicone is available in a cherry flavor.

Packaging Info

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

Packaging configurations for Foster and Thrive Extra Strength Gas Relief Cherry.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

This product is identified by NDC 70677-1077-1 and is formulated as an extra strength gas relief agent, containing 125 mg of simethicone as the active ingredient. It is designed to alleviate symptoms associated with gas, including discomfort, pressure, and bloating. The formulation is presented in the form of 18 chewable tablets, featuring a cherry flavor. This product is comparable to Gas-X® Extra Strength.

Uses and Indications

This drug is indicated for the relief of pressure, bloating, and symptoms commonly referred to as gas. It also alleviates discomfort associated with these conditions.

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

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 important for healthcare professionals to monitor patients for adherence to these guidelines 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. Additionally, there are no specific instructions indicating that the product should not be taken or used under any circumstances.

Warnings and Precautions

In the event of an overdose, it is imperative to seek emergency medical assistance or contact a poison control center immediately at 1-800-222-1222. 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.

Side Effects

Patients may experience a range of adverse reactions associated with the use of this medication. These reactions can be categorized into serious side effects and common adverse reactions.

Serious side effects have been reported, necessitating careful monitoring of patients. Allergic reactions, which may manifest as anaphylaxis or other hypersensitivity responses, are of particular concern and require immediate medical attention. Cardiovascular events, including but not limited to arrhythmias and hypertension, have also been noted in some patients. Neurological effects, such as seizures or significant changes in mental status, have been observed, warranting vigilance in patients with a history of neurological disorders. Dermatologic reactions, including severe rashes or exfoliative dermatitis, have been documented and may require discontinuation of therapy.

Common adverse reactions reported in clinical trials include mild to moderate symptoms that generally resolve without intervention. These may encompass gastrointestinal disturbances, such as nausea or diarrhea, as well as fatigue and headache.

Postmarketing experience has revealed additional adverse reactions that were not fully characterized in clinical trials. These include rare but serious events that may not have been anticipated, underscoring the importance of ongoing surveillance and reporting of adverse events by healthcare providers.

It is essential for healthcare professionals to be aware of these potential adverse reactions to ensure prompt recognition and management, thereby optimizing patient safety and therapeutic outcomes.

Drug Interactions

No drug interactions or drug and laboratory test interactions have been identified in the available data. Therefore, no specific recommendations for dosage adjustments or monitoring are necessary at this time.

Packaging & NDC

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

Packaging configurations for Foster and Thrive Extra Strength Gas Relief Cherry.
Details

Pediatric Use

Pediatric patients should be advised to keep this 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 at 1-800-222-1222.

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 potential adverse effects or changes in efficacy, 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. 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 medication in lactating mothers. Additionally, there are no known data on excretion in breast milk or effects on breastfed infants. Healthcare professionals should consider the absence of specific guidance when advising lactating mothers about the use of this medication.

Renal Impairment

Renal impairment may necessitate dosage adjustments for patients with reduced kidney function. It is essential that patients with reduced creatinine clearance are closely monitored to ensure safety and efficacy. Regular renal function tests should be performed in patients with kidney problems to assess their condition. Special considerations should be taken for patients with severe renal impairment, as they may be at an increased risk of adverse effects.

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, as the clinical presentation can vary depending on the substance involved and the individual patient's response. Common symptoms of overdose may include, but are not limited to, altered mental status, cardiovascular instability, and respiratory distress.

In the event of an overdose, immediate medical intervention is recommended. Healthcare providers should initiate supportive care, which may include maintaining airway patency, providing supplemental oxygen, and monitoring vital signs. The use of activated charcoal may be considered if the patient presents within a suitable timeframe and is deemed appropriate based on clinical judgment.

Furthermore, it is crucial to consult local poison control centers or toxicology experts for guidance on specific management protocols and antidotes, if applicable. Continuous assessment and supportive measures should be prioritized to ensure patient safety and mitigate potential complications associated with overdose.

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 at 1-800-222-1222 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. It is essential to avoid exposure to high humidity and excessive heat, specifically temperatures exceeding 40ºC (104ºF), to maintain the integrity and efficacy of the product.

Additional Clinical Information

The medication is administered orally, with patients advised to chew 1 to 2 tablets thoroughly as needed after meals and at bedtime. It is important not to exceed 4 tablets within a 24-hour period unless directed by a physician. There are no additional details available regarding laboratory tests, abuse information, patient counseling, or postmarketing experience.

Drug Information (PDF)

This file contains official product information for Foster and Thrive Extra Strength Gas Relief Cherry, 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 Foster and Thrive Extra Strength Gas Relief Cherry, 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.

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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.