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Phazyme Ultimate

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Active ingredient
Dimethicone 500 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 2024
Label revision date
October 23, 2025
Drug Information (PDF)
Prescribing information, PDF file
Active ingredient
Dimethicone 500 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 2024
Label revision date
October 23, 2025
Manufacturer
C. B. Fleet Company, Inc.
Registration number
M002
NDC root
0132-0222
Drug Information (PDF)
Prescribing information, PDF file
Packaging Info (2 NDCs)
Packaging & NDC Codes (2)

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If you are a consumer or patient please visit this version.

Drug Overview

PHAZYME® is a medication that contains simethicone, which is used to relieve bloating, pressure, or fullness that is commonly associated with gas. It works by breaking up gas bubbles in the stomach and intestines, making it easier for your body to eliminate them.

If you're experiencing discomfort from gas, PHAZYME® can help provide relief and improve your overall comfort. It's a simple solution for those occasional moments when gas becomes bothersome.

Uses

If you're experiencing discomfort from bloating, pressure, or a feeling of fullness often associated with gas, this medication can help relieve those symptoms. It works by targeting the underlying causes of gas, providing you with the comfort you need. Whether it's after a meal or during a stressful day, this treatment aims to ease that uncomfortable sensation and help you feel more at ease.

Dosage and Administration

When you start experiencing symptoms, you can take one Fast Gel by swallowing it. It's important to remember that you should not take more than one Fast Gel 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 risks of abuse, misuse, or dependence associated with it, 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. This ensures that any ongoing issues can be properly addressed. Always prioritize your health and seek professional advice if you have concerns.

Warnings and Precautions

It's important to be aware of your health while using this medication. If your condition continues or does not improve, 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 vigilant about your health and seek medical advice if you have any concerns.

Overdose

It appears that there is no specific information available regarding overdosage for this medication. However, it's important to be aware of the general signs of an overdose, which can include symptoms like extreme drowsiness, confusion, or difficulty breathing. If you suspect an overdose, it’s crucial to seek immediate medical help.

In case of an emergency, call your local emergency number or go to the nearest hospital. Always keep medications out of reach of children and follow the prescribed dosage to prevent any potential risks. If you have any concerns or questions about your medication, don’t hesitate to reach out to your healthcare provider for guidance.

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

Before taking any medication, including Phazyme Ultimate, you should consult with your healthcare provider to discuss potential risks and benefits, ensuring that you make informed decisions for your health and the health of your baby.

Lactation Use

If you are breastfeeding, you can use Phazyme Ultimate (simethicone) without specific warnings or recommendations against it. The information available does not indicate any concerns about the medication being present in breast milk or any risks to your nursing infant.

As always, it's a good idea to consult with your healthcare provider if you have any questions or concerns about medications while breastfeeding.

Pediatric Use

It's important to keep this product out of reach of children to ensure their safety. If your child needs to use Fast Gel, remember that they should not use more than one application in a 24-hour period unless a doctor has specifically advised you to do so. Always consult with a healthcare professional if you have any questions or concerns about its use in children.

Geriatric Use

When considering the use of Phazyme Ultimate (simethicone) for older adults, it's important to note that the drug insert does not provide specific information about dosage adjustments, safety concerns, or special precautions for elderly patients. This means that while there are no explicit guidelines, you should still approach its use with care.

If you are an older adult or a caregiver, it's always a good idea to consult with a healthcare professional before starting any new medication. They can help ensure that it is safe and appropriate for your individual health needs.

Renal Impairment

If you have kidney issues, 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 for the medication do not include special monitoring or safety considerations tailored for patients with renal impairment (kidney problems).

Always consult your healthcare provider for personalized advice and to ensure that any medication you take is safe and appropriate for your kidney health. They can provide guidance based on your individual situation.

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 for the medication do not change based on liver impairment. However, it’s always best to discuss your individual health situation with your healthcare provider, as they can offer personalized advice 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 this medication.

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 complete list of medications and any recent lab tests to avoid any potential issues. Your health and safety should always come first.

Storage and Handling

To ensure the best performance of your product, store it at room temperature, ideally between 59°F and 86°F (15°C and 30°C). This temperature range helps maintain the integrity and effectiveness of the device.

When handling the product, be sure to do so with clean hands and in a safe environment to avoid contamination. Always follow any specific disposal instructions provided to ensure safety and compliance.

Additional Information

No further information is available.

FAQ

What is PHAZYME®?

PHAZYME® is an anti-gas medication containing 500 mg of simethicone, which relieves bloating, pressure, or fullness commonly referred to as gas.

How should I use PHAZYME®?

You should swallow one Fast Gel as symptoms occur, but do not exceed one Fast Gel per 24 hours unless advised by a physician.

Are there any contraindications for PHAZYME®?

There are no contraindications listed for PHAZYME®.

What should I do if my condition persists?

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

Is PHAZYME® safe for children?

You should keep PHAZYME® out of reach of children.

Can I use PHAZYME® during pregnancy or while nursing?

There is no specific information regarding the use of PHAZYME® during pregnancy or nursing mothers.

What are the storage conditions for PHAZYME®?

Store PHAZYME® at room temperature between 59°- 86°F (15°-30°C).

Packaging Info

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

Packaging configurations for Phazyme Ultimate.
Details

Drug Information (PDF)

This file contains official product information for Phazyme Ultimate, 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.

Uses and Indications

This drug is indicated for the relief of bloating, pressure, or fullness commonly associated with gas. It is intended for use in patients experiencing these gastrointestinal symptoms.

Dosage and Administration

Patients should swallow one Fast Gel as symptoms occur. It is important not to exceed one Fast Gel within a 24-hour period unless directed by a physician. Healthcare professionals are advised to monitor patients for adherence to this dosing regimen and to provide guidance on the appropriate use of the product.

Contraindications

There are no contraindications listed for this product. It is important to monitor the patient's condition, and if symptoms persist, the patient should discontinue use and consult a healthcare professional for further evaluation.

Warnings and Precautions

Healthcare professionals should be aware of the following considerations regarding the safe use of the medication.

In the event that the patient's condition persists, it is imperative to discontinue use of the medication and consult a healthcare provider for further evaluation and management. Continuous monitoring of the patient's symptoms is essential to ensure appropriate therapeutic outcomes and to identify any potential complications that may arise during treatment.

No specific laboratory tests or additional warnings have been identified; however, practitioners should remain vigilant and responsive to any changes in the patient's condition throughout the course of therapy.

Side Effects

Patients should be advised to discontinue use and consult a healthcare professional if their condition persists. This warning is critical to ensure that any underlying issues are appropriately addressed and managed.

In clinical practice, monitoring for adverse reactions is essential to ensure patient safety and treatment efficacy. It is important for healthcare providers to remain vigilant and responsive to any changes in a patient's condition during the course of treatment.

Drug Interactions

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

Packaging & NDC

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

Packaging configurations for Phazyme Ultimate.
Details

Pediatric Use

Pediatric patients should be advised to keep this product out of reach of children. It is important to note that the recommended maximum dosage is one Fast Gel per 24 hours, unless otherwise directed by a physician. Caregivers should ensure that this guidance is strictly followed to prevent potential misuse or adverse effects.

Geriatric Use

There is no specific information regarding the use of Phazyme Ultimate (simethicone) in geriatric patients, including dosage adjustments, safety concerns, or special precautions. Healthcare providers should exercise clinical judgment when prescribing this medication to elderly patients, as individual responses may vary. Monitoring for efficacy and potential adverse effects is recommended, given the lack of targeted studies in this population.

Pregnancy

There is no specific information regarding the use of Phazyme Ultimate (simethicone) 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. As with any medication, the potential benefits must be weighed against any unknown risks to fetal outcomes. Women of childbearing potential should be counseled accordingly.

Lactation

There are no specific warnings or recommendations regarding the use of Phazyme Ultimate (simethicone) in lactating mothers. Additionally, there is no information available about the potential for excretion of simethicone in breast milk or any associated risks to 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 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 overdosage information, it is essential for healthcare professionals to remain vigilant and prepared for potential scenarios involving overdose.

Healthcare providers should be aware that the clinical presentation of an overdose may vary depending on the substance involved and the individual patient’s characteristics. Symptoms of overdose can range from mild to severe and may include altered mental status, cardiovascular instability, respiratory distress, and gastrointestinal disturbances.

In the event of suspected overdosage, immediate medical evaluation is recommended. Healthcare professionals should assess the patient's vital signs and conduct a thorough clinical examination. Supportive care should be initiated as necessary, including airway management, oxygen supplementation, and intravenous fluids.

If the specific agent involved in the overdose is known, appropriate antidotes or treatments should be administered as per established guidelines. Continuous monitoring of the patient’s condition is crucial, and further interventions may be required based on the evolving clinical picture.

It is advisable for healthcare professionals to consult local poison control centers or toxicology experts for guidance on managing specific overdose cases. Documentation of the incident and any interventions performed is also critical for ongoing patient care and legal considerations.

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. It is important to inform patients that if their condition persists despite using the medication, they should stop use 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 for identification. It is essential to store the product at room temperature, maintaining a range of 59°F to 86°F (15°C to 30°C). 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 Ultimate, 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 Ultimate, 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.