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Phazyme

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Active ingredient
Dimethicone 250 mg
Other brand names
Dosage form
Capsule, Gelatin Coated
Route
Oral
Prescription status
OTC (over the counter)
Marketed in the U.S.
Since 2014
Label revision date
October 23, 2025
Active ingredient
Dimethicone 250 mg
Other brand names
Dosage form
Capsule, Gelatin Coated
Route
Oral
Prescription status
OTC (over the counter)
CSA schedule
Not a scheduled drug
Marketed in the U.S.
Since 2014
Label revision date
October 23, 2025
Manufacturer
C. B. Fleet Company, Inc.
Registration number
M002
NDC root
0132-0211

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Drug Overview

PHAZYME® is a medication that contains simethicone, specifically formulated to relieve bloating, pressure, or fullness that is commonly associated with gas. With a maximum strength of 250 mg, it works by breaking up gas bubbles in your stomach and intestines, making it easier for your body to eliminate them.

This product comes in a package containing 12 fast gels, providing a convenient option for those seeking quick relief from uncomfortable gas symptoms. If you're experiencing discomfort due to gas, PHAZYME® may help you feel more at ease.

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 by addressing 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

When you experience symptoms, you can take one or two fast gels to help manage them. It's important to remember that you should not take more than two fast gels in a 24-hour period unless your doctor advises you to do so. Always follow your healthcare provider's guidance to ensure your safety and the effectiveness of the treatment.

What to Avoid

It's important to be aware of certain guidelines when using this medication. While there are no specific contraindications or concerns regarding abuse, misuse, or dependence, you should stop using the medication and consult your doctor if your condition does not improve. This ensures that you receive the appropriate care and support for your health needs. Always prioritize your well-being and seek professional advice when necessary.

Side Effects

If you experience any persistent symptoms while using this medication, it's important to stop using it and consult your doctor. Additionally, please ensure that this medication is kept out of reach of children to prevent accidental ingestion.

Warnings and Precautions

It's important to be aware of your health while using this medication. If your condition does not improve or continues to persist, you should stop taking the medication and consult your doctor for further guidance.

Currently, there are no specific warnings, precautions, or laboratory tests associated with this medication. However, always stay informed and proactive about your health, and don't hesitate to reach out to your healthcare provider if you have any concerns.

Overdose

It appears that there is no specific information available regarding overdosage for this medication. However, it’s always important to be aware of the signs of an overdose, which can include unusual drowsiness, confusion, or difficulty breathing. If you suspect that you or someone else may have taken too much of a medication, it’s crucial to seek immediate medical help.

In case of an overdose, contact your local emergency services or go to the nearest hospital. Having the medication packaging or information on hand can help medical professionals provide the best care. Always remember that when in doubt, it’s better to err on the side of caution and seek assistance.

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 Phazyme (simethicone) during pregnancy. This means that safety concerns, dosage adjustments, or special precautions related to its use in pregnant individuals have not been clearly established.

As always, it's best to consult with your healthcare provider before taking any medication while pregnant to ensure the safety of both you and your baby. They can provide personalized advice based on your health needs and circumstances.

Lactation Use

If you are breastfeeding, you can feel reassured that there are no specific warnings or recommendations regarding the use of Phazyme (simethicone) while nursing. The information available does not indicate any particular considerations or precautions you need to take when using this medication during lactation. 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 reach of children to ensure their safety. If your child's condition does not improve or continues to persist, you should stop using the medication and consult a doctor for further guidance. Always prioritize your child's health and well-being by following these precautions.

Geriatric Use

While there is no specific information about how this medication should be used by older adults, it's important to approach any new treatment with caution. If you or a loved one is an older adult, always consult with a healthcare provider before starting a new medication. They can help determine the best approach based on individual health needs and any other medications being taken.

Since there are no dosage adjustments or special precautions mentioned for elderly patients, your healthcare provider will be the best resource for ensuring safety and effectiveness. They can monitor for any potential side effects and make recommendations tailored to your situation.

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. While there are no specific drug interactions or laboratory test interactions noted for this medication, your healthcare provider can help ensure that everything you are taking works well together and is safe for you. Always share your full list of medications and any health conditions you have to receive the best care possible.

Storage and Handling

To ensure the best performance of your product, store it at room temperature, ideally between 59ºF and 86ºF (15ºC to 30ºC). This temperature range helps maintain the product's effectiveness and safety.

When handling the product, make sure to do so in a clean environment to avoid contamination. Always follow any specific instructions provided with the product for safe use and disposal. Keeping these guidelines in mind will help you use the product safely and effectively.

Additional Information

No further information is available.

FAQ

What is PHAZYME®?

PHAZYME® is an anti-gas medication containing 250 mg of simethicone, which relieves bloating, pressure, or fullness commonly referred to as gas.

How should I use PHAZYME®?

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

Are there any contraindications for PHAZYME®?

No contraindications are listed for PHAZYME®.

What should I do if my symptoms persist?

You should stop using PHAZYME® and ask a doctor if your condition persists.

Is PHAZYME® safe to use during pregnancy?

There is no specific information regarding the safety of PHAZYME® during pregnancy.

Can nursing mothers use PHAZYME®?

The provided text does not mention any specific warnings or recommendations for nursing mothers using PHAZYME®.

What is the storage requirement for PHAZYME®?

PHAZYME® should be stored at room temperature between 59º-86ºF (15º-30ºC).

What should I keep in mind regarding children and PHAZYME®?

You should keep PHAZYME® out of reach of children.

Packaging Info

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

Packaging configurations for Phazyme.
Details

Drug Information (PDF)

This file contains official product information for Phazyme, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)

Description

No description information is available for the specified drug.

Uses and Indications

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

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

Dosage and Administration

Patients should swallow one or two fast gels as symptoms occur. The maximum dosage should not exceed two fast gels within a 24-hour period, unless otherwise directed by a physician. It is essential for healthcare professionals to monitor patients for adherence to these guidelines to ensure safe and effective use of the product.

Contraindications

There are no contraindications listed for this product. However, it is advised to discontinue use and consult a healthcare professional if the condition persists.

Warnings and Precautions

Healthcare professionals should be aware that if a patient's condition persists, it is imperative to discontinue use and consult a physician for further evaluation and management. This precaution is essential to ensure patient safety and to address any underlying issues that may require medical attention.

Currently, there are no specific warnings, general precautions, or recommended laboratory tests associated with the use of this product. However, vigilance in monitoring the patient's condition is advised, and any changes should prompt immediate medical consultation.

Side Effects

Patients should be advised to stop use and consult a doctor if their condition persists. It is important to keep this product out of reach of children to prevent accidental ingestion or misuse.

Drug Interactions

There are currently no documented drug interactions associated with this medication. Additionally, there are no known interactions with laboratory tests. As such, no specific recommendations for dosage adjustments or monitoring are necessary at this time.

Packaging & NDC

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

Packaging configurations for Phazyme.
Details

Pediatric Use

Pediatric patients should be monitored closely, and the product should be kept out of reach of children to prevent accidental ingestion. If the condition persists, caregivers are advised to stop use and consult a healthcare professional for further evaluation and guidance.

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.

Pregnancy

There is no specific information available regarding the use of Phazyme (simethicone) during pregnancy, including safety concerns, dosage modifications, or special precautions. As such, healthcare professionals should exercise caution when prescribing this medication to pregnant patients. The absence of data does not imply safety; therefore, the potential risks and benefits should be carefully considered in women of childbearing potential. Further studies may be necessary to fully understand the implications of simethicone use during pregnancy and its effects on fetal outcomes.

Lactation

There are no specific warnings or recommendations regarding the use of Phazyme (simethicone) in lactating mothers. Additionally, there are no specific considerations or precautions related to lactation mentioned in the provided text. Therefore, healthcare professionals may consider the use of Phazyme in nursing mothers without specific concerns regarding excretion in breast milk or effects on breastfed infants.

Renal Impairment

There is no specific information regarding dosage adjustments, special monitoring, or safety considerations for patients with renal impairment. Healthcare professionals should exercise caution when prescribing to patients with reduced kidney function, as the absence of detailed guidance necessitates careful clinical judgment. Regular monitoring of renal function may be advisable in 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 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 overdosage information, it is essential for healthcare professionals to remain vigilant regarding the potential for overdose with this medication. In cases where an overdose is suspected, immediate medical attention should be sought.

Healthcare providers are advised to monitor patients closely for any signs or symptoms that may indicate an overdose. These may include, but are not limited to, increased severity of known side effects, unusual behavioral changes, or any other atypical clinical manifestations.

Management of an overdose should be guided by the clinical presentation of the patient. Supportive care is paramount, and symptomatic treatment should be initiated as necessary. It is recommended that healthcare professionals consult local poison control centers or relevant toxicology resources for specific guidance on the management of overdose cases.

In summary, while specific overdosage information is not available, healthcare professionals should exercise caution, remain observant for potential overdose symptoms, and implement appropriate management strategies in the event of an 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 use of the compound in these contexts.

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. It is important for patients to understand that if their condition persists, they should stop using the medication and consult a doctor for further evaluation and guidance.

Storage and Handling

The product is supplied in various package configurations, with specific NDC numbers available upon request. It is essential to store the product at room temperature, maintaining a temperature range of 59ºF to 86ºF (15ºC to 30ºC). Proper storage conditions are crucial to ensure the integrity and efficacy of the product.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

This file contains official product information for Phazyme, 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 Phazyme, 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.