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Phazyme

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Active ingredient
Dimethicone 180 mg
Other brand names
Dosage form
Capsule, Gelatin Coated
Route
Oral
Prescription status
OTC (over the counter)
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Marketed in the U.S.
Since 2012
Label revision date
October 23, 2025
Drug Information (PDF)
Prescribing information, PDF file
Active ingredient
Dimethicone 180 mg
Other brand names
Dosage form
Capsule, Gelatin Coated
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 2012
Label revision date
October 23, 2025
Manufacturer
C. B. Fleet Company, Inc.
Registration number
M002
NDC root
0132-0208
Drug Information (PDF)
Prescribing information, PDF file
Packaging Info (3 NDCs)
Packaging & NDC Codes (3)

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

PHAZYME® ULTRA STRENGTH is an anti-gas medication that contains simethicone (a substance that helps reduce gas in the digestive tract). It is designed to relieve bloating, pressure, or fullness that you may experience due to gas. Each package contains 12 fast-acting gel capsules, making it convenient for quick relief when you need it.

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 due to certain foods, this treatment aims to ease that uncomfortable sensation and help you feel more at ease.

Dosage and Administration

When you start to 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 safe and effective use of the medication.

What to Avoid

It's important to be aware of certain guidelines when using this medication. If your condition does not improve or continues to persist, you should stop using the medication and consult your doctor for further advice. This ensures that you receive the appropriate care and support for your health needs.

Currently, there are no specific contraindications, risks of abuse or misuse, or concerns about dependence associated with this medication. Always prioritize your health and safety by following these instructions closely.

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

If your condition does not improve, it's important to stop using this medication and consult your doctor for further advice. Always keep this medication out of reach of children to ensure their safety.

If you experience any unusual symptoms or have concerns while using this medication, don't hesitate to reach out to your healthcare provider for guidance. Your health and safety are the top priority.

Overdose

It appears that there is no specific information available regarding overdosage for this medication. However, if you suspect an overdose, it is important to be aware of potential signs, which may include unusual drowsiness, confusion, or difficulty breathing.

If you notice any of these symptoms or have concerns about an overdose, seek immediate medical help. It’s always better to err on the side of caution when it comes to your health. Remember, if you are ever in doubt, contacting a healthcare professional is the best course of action.

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 established.

Before taking any medication, including over-the-counter products like Phazyme, you should consult with your healthcare provider to discuss potential risks and benefits tailored to your situation. Your health and the health of your baby are the top priority, so always seek professional advice when considering medication during pregnancy.

Lactation Use

If you are breastfeeding, you can feel reassured that there are no specific warnings or recommendations regarding the use of Phazyme while nursing. The information available does not indicate any particular considerations or precautions you need to take while using this product during lactation (the period of breastfeeding).

As always, if you have any concerns about medications and their effects on your milk production or your baby, it's a good idea to consult with your healthcare provider for personalized advice.

Pediatric Use

It's important to keep this medication out of reach of children to ensure their safety. If your child needs to use fast gels, remember that they should not exceed two gels in a 24-hour period unless a doctor has specifically advised otherwise. Always consult with a healthcare professional if you have any questions or concerns about using this medication for your child.

Geriatric Use

When it comes to using Phazyme (simethicone) for older adults, there is no specific information available about dosage adjustments or safety concerns. This means that the standard dosage may be appropriate, but it’s always wise to consult with a healthcare provider before starting any new medication.

As you consider using Phazyme, keep in mind that older adults may have different health needs. If you or a loved one are experiencing symptoms like gas or bloating, discussing these with a doctor can help ensure that the treatment is safe and effective for 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 standard recommendations for the medication do not include special monitoring or safety considerations tailored for patients with renal impairment (kidney issues).

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 function. However, it’s always a good idea to discuss your liver health with your healthcare provider before starting any new medication. They can help ensure that your treatment is safe and effective for you.

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 discuss your full list of medications, including over-the-counter drugs and supplements, as well as any upcoming lab tests. This way, you can avoid any potential issues and receive the best care possible.

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, make sure to do so in a clean environment to avoid contamination. Always follow any specific disposal instructions provided to ensure safety and compliance with local regulations. By taking these precautions, you can help ensure the product remains safe and effective for use.

Additional Information

No further information is available.

FAQ

What is PHAZYME® ULTRA STRENGTH?

PHAZYME® ULTRA STRENGTH is an anti-gas medication containing simethicone 180 mg, designed to relieve bloating, pressure, or fullness commonly referred to as gas.

How should I use PHAZYME® ULTRA STRENGTH?

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® ULTRA STRENGTH?

There are no specific contraindications mentioned for PHAZYME® ULTRA STRENGTH.

What should I do if my condition persists?

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

Is PHAZYME® ULTRA STRENGTH safe for children?

You should keep PHAZYME® ULTRA STRENGTH out of reach of children.

Is there any information about using PHAZYME® ULTRA STRENGTH during pregnancy?

There is no specific information regarding the use of PHAZYME® ULTRA STRENGTH during pregnancy.

Can nursing mothers use PHAZYME® ULTRA STRENGTH?

The insert does not provide specific warnings or recommendations regarding the use of PHAZYME® ULTRA STRENGTH in nursing mothers.

What is the recommended storage condition for PHAZYME® ULTRA STRENGTH?

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

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.

Uses and Indications

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

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 specific contraindications identified 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 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.

It is crucial to keep this product out of reach of children to prevent accidental ingestion or misuse. Proper storage and handling should be emphasized to safeguard against potential harm.

Side Effects

Patients should be advised to stop use and consult a doctor if their condition persists. It is also 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 warranted 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 advised to keep this medication out of reach of children. It is important to note that the maximum recommended dosage is two fast gels per 24 hours, and this limit should not be exceeded unless under the advice and supervision of a physician.

Geriatric Use

Elderly patients may not have specific dosage adjustments, safety concerns, or special precautions outlined in the prescribing information for Phazyme (simethicone). As there is no available data regarding the use of this medication in geriatric populations, healthcare providers should exercise caution when prescribing Phazyme to elderly patients.

It is advisable to monitor these patients closely for any potential adverse effects, given the lack of targeted clinical findings in this demographic. Individual patient factors should be considered when determining the appropriateness of treatment with Phazyme in elderly patients.

Pregnancy

There is no specific information available regarding the use of Phazyme (simethicone) during pregnancy. The prescribing information does not provide safety concerns, dosage modifications, or special precautions for pregnant patients. As such, healthcare professionals should exercise caution when considering the use of this medication in pregnant women, weighing the potential benefits against any unknown risks. It is advisable to consult with a healthcare provider for individualized recommendations in this population.

Lactation

There are no specific warnings or recommendations regarding the use of Phazyme in lactating mothers. Additionally, there are no specific considerations or precautions related to lactation mentioned in the prescribing information. Therefore, healthcare professionals may consider the use of Phazyme in nursing mothers without specific concerns related to breastfeeding.

Renal Impairment

Patients with renal impairment have not been specifically addressed in the available prescribing information. There are no dosage adjustments, special monitoring requirements, or safety considerations outlined for individuals with reduced kidney function. Healthcare professionals should exercise caution and consider the lack of data when prescribing to 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 assessment of the patient’s condition is crucial. Recommended actions include:

  1. Assessment: Conduct a thorough evaluation of the patient, including vital signs and a detailed history of substance use.

  2. Supportive Care: Initiate supportive measures as necessary, which may include airway management, oxygen supplementation, and intravenous fluids.

  3. Toxicology Consultation: Consider consulting a poison control center or a toxicologist for guidance on specific management strategies tailored to the substance involved.

  4. Monitoring: Continuous monitoring of the patient’s vital signs and clinical status is essential to detect any deterioration promptly.

It is imperative for healthcare professionals to familiarize themselves with the specific antidotes or treatment protocols relevant to the substance in question, as these may significantly influence patient outcomes in cases of 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 question. Further studies may be necessary to elucidate these aspects of nonclinical toxicology.

Postmarketing Experience

No postmarketing experience details are available in the provided 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 for patients to understand that if their condition persists despite using the medication, they should stop use and consult a doctor for further evaluation and guidance. This ensures that patients are aware of the necessary steps to take should their symptoms not improve, promoting safe and effective use of the medication.

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, 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.

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.