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Maximum Strength Gas Relief Softgel

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Active ingredient
Dimethicone, Unspecified 250 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 2022
Label revision date
December 30, 2024
Drug Information (PDF)
Prescribing information, PDF file
Active ingredient
Dimethicone, Unspecified 250 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 2022
Label revision date
December 30, 2024
Manufacturer
CVS PHARMACY, INC
Registration number
M002
NDC root
51316-813
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

You may find relief from bloating, pressure, or fullness commonly referred to as gas with this medication. It is designed to help alleviate these uncomfortable sensations, making it easier for you to feel more at ease in your daily activities. If you're experiencing these symptoms, this drug could be a helpful option for you.

Uses

You can use this medication to help relieve feelings of bloating, pressure, or fullness that are often caused by gas. It’s designed to make you feel more comfortable if you’re experiencing these common digestive issues.

Rest assured, there are no known teratogenic effects (which means it doesn’t cause birth defects) associated with this medication, making it a safer option for those who may be concerned about such risks.

Dosage and Administration

You can take this medication by swallowing one or two softgels when you start to feel symptoms. It's important to remember not to take more than two softgels in a 24-hour period unless your doctor advises you to do so. Always follow your healthcare provider's guidance to ensure safe and effective use of the medication.

What to Avoid

It's important to keep this medication out of reach of children to ensure their safety. There are no specific contraindications, controlled substance classifications, or noted risks of abuse, misuse, or dependence associated with this medication. Always follow the guidance provided by your healthcare professional and use the medication responsibly.

Side Effects

If you experience any persistent symptoms while using this medication, it's important to stop using it and consult your doctor. Additionally, if you are pregnant or breastfeeding, please speak with a healthcare professional before using this product to ensure it is safe for you and your baby.

Warnings and Precautions

If your condition does not improve, it's important to stop using this medication and consult your doctor. Additionally, if you are pregnant or breastfeeding, please speak with a healthcare professional before using this product to ensure it is safe for you and your baby.

Always keep this medication out of reach of children to prevent accidental ingestion. If you experience any concerning symptoms or have questions about your health while using this medication, do not hesitate to reach out to your healthcare provider for guidance.

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 effects of an overdose for this medication, you should be aware of general signs that may indicate a problem. These can include unusual drowsiness, confusion, or difficulty breathing.

If you notice any of these symptoms or if you believe you have taken too much of the 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 checked out if you have any concerns about your health.

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.

Pediatric Use

It's important to keep this medication out of reach of children. This precaution helps prevent accidental ingestion, which can be dangerous. Always store it in a safe place where children cannot access it, ensuring their safety at all times. If you have any concerns or questions about the medication, don't hesitate to reach out to your healthcare provider for guidance.

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 considering this medication, it’s important to consult with a healthcare provider. 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 there are no specific guidelines or dosage adjustments mentioned for your condition in the available information. This means that the usual recommendations for monitoring or safety considerations related to renal impairment (kidney issues) are not provided.

Always consult your healthcare provider for personalized advice and to ensure that any medications you take are safe and appropriate for your kidney health. They can help you understand how your condition may affect your treatment plan.

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 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 best performance of your product, store it at room temperature, ideally between 20-25°C (68-77°F). It's important to keep it away from light, heat, and moisture, as these elements can affect its quality and effectiveness.

When handling the product, make sure to do so in a clean environment to maintain its integrity. Always follow any specific disposal instructions provided to ensure safe and responsible disposal. By taking these precautions, you can help ensure that the product remains safe and effective for your use.

Additional Information

You will take this medication orally. There are no additional details available regarding laboratory tests, abuse potential, patient counseling, or postmarketing experiences. If you have any questions or concerns about your treatment, be sure to discuss them with your healthcare provider.

FAQ

What is the primary use of this drug?

This drug relieves bloating, pressure, or fullness commonly referred to as gas.

How should I take this medication?

You should swallow one or two softgels as symptoms occur, but do not exceed 2 softgels per 24 hours unless advised by a physician.

Are there any contraindications for this drug?

No contraindications are listed for this drug.

What should I do if my condition persists?

You should stop use and ask a doctor if your condition persists.

Is this drug safe to use during pregnancy or breastfeeding?

If you are pregnant or breastfeeding, you should ask a health professional before use.

How should I store this medication?

Store at room temperature between 20-25°C (68-77°F) and protect from light, heat, and moisture.

What precautions should I take with this drug?

Keep this drug out of reach of children.

Packaging Info

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

Packaging configurations for Maximum Strength Gas Relief Softgel.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

SPL Code 34089-3 corresponds to the compound CVS-813. This substance is characterized by its specific molecular structure and properties, which are essential for its intended use in medical applications. Further details regarding its chemical composition and formulation may be provided in additional sections of the labeling.

Uses and Indications

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

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

Dosage and Administration

Patients should swallow one or two softgels as symptoms occur. The maximum recommended dosage is two softgels within a 24-hour period. This limit should not be exceeded unless directed by a physician. It is important for healthcare professionals to advise patients to adhere to this dosage guideline to ensure safety and efficacy.

Contraindications

Use is contraindicated in children due to the risk of accidental ingestion. Ensure that the product is kept out of reach of children to prevent potential harm. No other contraindications have been identified.

Warnings and Precautions

It is imperative that healthcare professionals advise patients to discontinue use and consult a physician if the condition persists. This precaution is essential to ensure that any underlying issues are appropriately addressed.

For patients who are pregnant or breastfeeding, it is crucial to seek guidance from a healthcare professional prior to use. This recommendation is vital to safeguard both maternal and infant health.

General precautions should be emphasized, particularly the importance of keeping the product out of reach of children. This measure is necessary to prevent accidental ingestion or misuse.

Currently, there are no specific laboratory tests or emergency medical help protocols provided in the insert. However, healthcare professionals should remain vigilant and prepared to address any potential complications that may arise during treatment.

Side Effects

Patients should be advised to discontinue use and consult a healthcare professional if their condition persists. Additionally, it is recommended that individuals who are pregnant or breastfeeding seek guidance from a health professional prior to using the product.

Drug Interactions

There are no documented drug interactions associated with the use of this medication. Additionally, there are no reported interactions between this medication and laboratory tests. Therefore, no specific dosage adjustments or monitoring recommendations are necessary based on drug interactions.

Packaging & NDC

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

Packaging configurations for Maximum Strength Gas Relief Softgel.
Details

Pediatric Use

Pediatric patients should be advised to keep this medication out of reach of children. This precaution is essential to ensure safety and prevent accidental ingestion.

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. Monitoring for potential adverse effects and therapeutic efficacy is recommended in this population, given the lack of targeted data.

Pregnancy

Pregnant patients and those who are breastfeeding should consult a healthcare professional prior to using this medication. It is important to assess the potential risks and benefits, as well as any available data regarding fetal outcomes and lactation. Healthcare providers can offer guidance tailored to individual circumstances, ensuring the safety of both the patient and the developing fetus or nursing infant.

Lactation

Lactating mothers are advised to consult a health professional prior to using this medication. There is no specific data available regarding the excretion of this medication in breast milk or its effects on breastfed infants. Therefore, caution is recommended when administering this medication to lactating individuals.

Renal Impairment

Patients with renal impairment have no specific information regarding dosage adjustments, special monitoring, or safety considerations provided in the text. Therefore, healthcare professionals should exercise caution and consider individual patient factors when prescribing to this population. Regular monitoring of renal function may be warranted in patients with reduced kidney function to ensure safety and efficacy.

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, respiratory depression, altered mental status, cardiovascular instability, and gastrointestinal disturbances.

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 if the ingestion was recent.

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 until the patient stabilizes or further treatment is determined.

In summary, while specific overdosage information is not available, healthcare professionals should remain vigilant and prepared to implement standard overdose management strategies in any suspected cases.

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 proper storage to ensure the safety of young individuals.

Storage and Handling

The product is supplied in packaging that ensures its integrity and stability. It should be stored at room temperature, specifically within the range of 20-25°C (68-77°F). Care must be taken to protect the product from light, heat, and moisture to maintain its efficacy and safety. Proper handling and storage conditions are essential to preserve the quality of the product throughout its shelf life.

Additional Clinical Information

The medication is administered orally. 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 Maximum Strength Gas Relief Softgel, 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 Maximum Strength Gas Relief Softgel, 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.