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Phazyme

Last content change checked dailysee data sync status

This product has been discontinued

Active ingredient
Dimethicone 250 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 2014
Label revision date
September 1, 2017
Drug Information (PDF)
Prescribing information, PDF file
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
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Marketed in the U.S.
Since 2014
Label revision date
September 1, 2017
Manufacturer
C. B. Fleet Company, Inc.
Registration number
part332
NDC root
0132-0214
Drug Information (PDF)
Prescribing information, PDF file
Packaging Info
Packaging & NDC Codes

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 is a medication designed to help relieve bloating, pressure, or fullness that is commonly associated with gas. It contains 250 mg of active ingredients and has been effective since its introduction on September 1, 2017. If you experience discomfort from gas, Phazyme may provide the relief you need.

Uses

If you're experiencing discomfort from bloating, pressure, or fullness often associated with gas, this medication can help relieve those symptoms. It's designed to ease the feeling of being overly full or gassy, making you feel more comfortable.

Additionally, there are no concerns regarding teratogenic effects (which means it doesn't cause birth defects) or nonteratogenic effects, so you can use it with confidence.

Dosage and Administration

You should take one or two softgels after a meal. This helps your body absorb the medication more effectively. It's important not to exceed two softgels in a 24-hour period unless your doctor advises you otherwise. 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. While there are no specific contraindications or concerns about abuse, misuse, or dependence (which means relying on a substance in a harmful way), you should stop using the medication and consult your doctor if your condition does not improve. 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. This is a precaution to ensure your safety and well-being. Always pay attention to how your body responds, and don’t hesitate to seek medical advice if needed.

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 vigilant about any changes in your health and communicate openly with your healthcare provider.

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 action 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 PHAZYME (simethicone) during pregnancy. This means that safety concerns, dosage adjustments, or any 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 during pregnancy to ensure the safety of both you and your baby.

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 about any concerns you may have regarding your health and breastfeeding.

Pediatric Use

It's important to keep this medication out of reach of children to ensure their safety. If your child needs to take this medication, be aware that they should not exceed two softgels 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 the appropriate use and dosage for your child.

Geriatric Use

When it comes to using PHAZYME (simethicone) in older adults, there is no specific information available about dosage adjustments, safety concerns, or special precautions. This means that the drug insert does not highlight any unique considerations for elderly patients.

As always, it's important for you or your caregiver to consult with a healthcare professional before starting any new medication. They can provide personalized advice based on your health needs and any other medications you may be taking.

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 the drug insert does not provide specific information about dosage adjustments, special monitoring, or precautions for your condition. This means that there are no tailored guidelines for how this medication should be used if you have hepatic impairment (liver issues).

Always consult your healthcare provider for personalized advice and to ensure that any medication you take is safe for your liver health. They can help determine the best approach for your treatment based on your individual circumstances.

Drug Interactions

It's important to have open conversations with your healthcare provider about any medications you are taking, even if there are no specific drug interactions or laboratory test interactions noted for your treatment. This ensures that your healthcare team can provide the best care tailored to your needs.

Always feel free to ask questions about how different medications might work together or affect any tests you may need. Your health and safety are the top priority, and discussing these details can help prevent any potential issues.

Storage and Handling

To ensure the best performance of your product, store it at room temperature, ideally between 59ºF and 86ºF (15ºC and 30ºC). 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 instructions provided for use to ensure safety and effectiveness. If you have any questions about disposal or further handling, please refer to the guidelines provided with your product.

Additional Information

No further information is available.

FAQ

What is Phazyme used for?

Phazyme is used to relieve bloating, pressure, or fullness commonly referred to as gas.

How should I take Phazyme?

You should swallow one or two softgels after a meal, but do not exceed two softgels 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 while using Phazyme?

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

Is Phazyme safe to use during pregnancy or while nursing?

There is no specific information regarding the use of Phazyme during pregnancy or nursing in the provided text.

What are the storage instructions for Phazyme?

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

When was Phazyme effective from?

Phazyme has been effective since September 1, 2017.

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

Phazyme is presented in a carton containing 24 capsules, each containing 250 mg of the active ingredient. The formulation is designed for the relief of gas-related discomfort. The capsules are intended for oral administration.

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 are advised to swallow one or two softgels after a meal. The maximum recommended dosage is two softgels within a 24-hour period. Exceeding this dosage should only occur under the guidance and supervision of a physician.

Contraindications

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

Warnings and Precautions

Healthcare professionals should be aware that there are no specific warnings or general precautions associated with the use of this product. However, it is essential to monitor the patient's condition closely.

In the event that the patient's condition persists, it is imperative to discontinue use and consult a healthcare provider for further evaluation and management. Regular assessment of the patient's response to treatment is recommended to ensure safety and efficacy.

Side Effects

Patients should be advised to discontinue use and consult a healthcare professional if their condition persists. This warning is crucial for ensuring patient safety and appropriate management of their health concerns.

Drug Interactions

There are no specific drug interactions identified in the available data. Additionally, no laboratory test interactions have been reported. Therefore, no dosage adjustments or monitoring recommendations are necessary based on the current information.

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. The recommended dosage for pediatric patients is limited to a maximum of two softgels per 24 hours, unless otherwise directed by a physician. Careful supervision is advised to ensure adherence to this dosage guideline.

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 to elderly patients. It is advisable to monitor these patients closely for any potential adverse effects or changes in efficacy, given the lack of targeted clinical findings for this demographic.

Pregnancy

There is no specific information regarding the use of PHAZYME (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 this medication in nursing mothers. Additionally, there are no specific warnings or recommendations related to lactation. Healthcare professionals should consider the absence of data when advising lactating mothers about the use of this medication.

Renal Impairment

Patients with renal impairment have not been specifically addressed in the available data regarding dosage adjustments, special monitoring, or safety considerations. Therefore, healthcare professionals should exercise caution when prescribing this medication to patients with reduced kidney function, as the lack of information may necessitate individualized assessment and monitoring based on the patient's overall clinical status and renal function.

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 consider general principles of management in cases of suspected overdose.

It is essential to monitor the patient closely for any potential symptoms that may arise from an overdose. Symptoms can vary widely depending on the substance involved and the individual patient's response.

In the event of an overdose, immediate medical attention should be sought. Healthcare providers should initiate supportive care and symptomatic treatment as necessary. This may include monitoring vital signs, providing respiratory support, and administering intravenous fluids if indicated.

Additionally, healthcare professionals should consult local poison control centers or relevant toxicology resources for guidance on specific management protocols tailored to the substance involved.

Documentation of the incident, including the amount and timing of the substance taken, is crucial for effective management and follow-up care.

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 provided in the insert.

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 59º - 86ºF (15º - 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.

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.