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Phazyme

Last content change checked dailysee data sync status

This product has been discontinued

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 1998
Label revision date
March 16, 2016
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 1998
Label revision date
March 16, 2016
Manufacturer
C. B. Fleet Company, Inc.
NDC root
0132-0210
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

This medication is designed to help relieve bloating, pressure, or fullness that you may experience due to gas. It works by addressing the discomfort associated with these symptoms, providing you with a sense of relief and comfort. If you're feeling uneasy from gas, this drug may be a helpful option for you.

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

You should take one or two softgels after a meal. It's important not to exceed this amount, so make sure you don’t take more than two softgels in a day 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. 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 will help ensure your safety and address any ongoing health concerns. Always prioritize your well-being and seek professional advice if needed.

Warnings and Precautions

It's important to be aware of certain precautions when 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.

While there are no specific warnings or laboratory tests associated with this medication, always prioritize your health and communicate openly with your healthcare provider about any concerns or unusual symptoms you may experience.

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, 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 intervention can make a significant difference.

Pregnancy Use

When it comes to using this medication during pregnancy, there is no specific information available about its safety, dosage adjustments, or any special precautions you should take. This means that the potential risks and benefits are not clearly defined.

If you are pregnant or planning to become pregnant, it’s important to discuss any medications you are considering with your healthcare provider. They can help you understand the best options for your health and the health of your baby.

Lactation Use

If you are breastfeeding, you can feel reassured that there are no specific warnings or recommendations regarding the use of this product while nursing. Additionally, there is no information available about whether this product is excreted in breast milk or any potential risks to your infant. 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. 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, it’s important to consult with a healthcare provider before starting the medication. 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 your medication dosage may need to be adjusted. Your healthcare provider will monitor your renal function tests to ensure your kidneys are working properly. If your creatinine clearance (a measure of kidney function) falls below a certain level, a reduced dose may be necessary to avoid potential complications. Additionally, if you have severe renal impairment, special monitoring will be required to keep track of your health and medication effects. Always discuss any concerns with your healthcare provider to ensure your treatment is safe and effective.

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 may affect you if you have hepatic impairment (liver issues).

Always consult your healthcare provider for personalized advice and to discuss any concerns regarding your liver health and how it may relate to your treatment. They can help ensure that you receive the safest and most effective care.

Drug Interactions

It's important to have open conversations with your healthcare provider about any medications you are taking. In this case, there are no specific drug interactions or laboratory test interactions noted, which means that the medication is generally considered safe to use with other drugs and tests. However, every individual is different, and your healthcare provider can help ensure that your treatment plan is safe and effective for you.

Always remember that discussing your full list of medications and any lab tests with your healthcare provider is crucial. This way, you can avoid any potential issues and receive the best care tailored to your needs.

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 and disposal to ensure safety and effectiveness.

Additional Information

You should take this medication orally by swallowing one or two softgels after a meal. It's important not to exceed two softgels per day unless your doctor advises otherwise. Always follow your healthcare provider's guidance to ensure safe and effective use.

FAQ

What does this drug do?

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

How should I take this drug?

You should swallow one or two softgels after a meal and not exceed two softgels per day unless advised by a physician.

What should I do if my condition persists?

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

Are there any contraindications for this drug?

No contraindications are listed for this drug.

Is this drug safe for children?

You should keep this drug out of reach of children.

Can I use this drug during pregnancy?

No specific information regarding the use of this drug during pregnancy is provided.

Is this drug safe for nursing mothers?

There are no specific warnings or recommendations regarding the use of this product in nursing mothers.

What should I know about renal impairment?

Renal impairment may necessitate dosage adjustments, and renal function tests should be monitored in affected patients.

How should I store this drug?

You should store this drug at room temperature between 59º - 86ºF (15º - 30ºC).

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

The drug is presented in the package label featuring a principal display panel. The effective date of the insert is March 16, 2016. An accompanying image description is available, referencing an image file named "carton.jpg."

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 are advised to swallow one or two softgels after a meal. The maximum recommended dosage is two softgels per day, unless otherwise directed by a physician. It is important for healthcare professionals to monitor patients to ensure adherence to this dosage guideline and to provide supervision if higher doses are deemed necessary.

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.

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 and consult a healthcare provider for further evaluation and management. Continuous monitoring of the patient's response to treatment is essential to ensure optimal therapeutic outcomes and to identify any potential complications early.

No specific laboratory tests or additional warnings have been identified; however, practitioners should remain vigilant and exercise clinical judgment in the management of patients receiving this medication. Regular follow-up and assessment of the patient's condition are recommended to ensure safety and efficacy.

Side Effects

Patients should be monitored for adverse reactions during treatment. In the event that a condition persists, it is advised to stop use and consult a healthcare professional.

No specific adverse reactions have been detailed in the available data; however, the importance of vigilance in monitoring for any unexpected effects is emphasized. It is crucial for patients to communicate any ongoing symptoms to their healthcare provider to ensure appropriate management and care.

Drug Interactions

No specific drug interactions have been identified in the available data. Additionally, there are no reported interactions with laboratory tests. 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. Safety and efficacy in pediatric populations have not been established, and specific dosing recommendations for children are not provided. Caution is advised when administering this medication to ensure it is not accessible to young children.

Geriatric Use

Elderly patients may not have specific information regarding the use of this medication, including dosage adjustments, safety concerns, or special precautions. Therefore, healthcare providers should exercise caution when prescribing this medication to geriatric patients. It is advisable to monitor these patients closely for any adverse effects or changes in therapeutic response, given the lack of targeted data for this population.

Pregnancy

There is no specific information available regarding the use of this medication 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. It is advisable to weigh the potential benefits against any unknown risks to fetal outcomes. Women of childbearing potential should be counseled on the importance of effective contraception during treatment.

Lactation

There are no specific warnings or recommendations regarding the use of this product in nursing mothers. Additionally, there is no information provided regarding the potential for excretion in breast milk or any associated risk to breastfed infants.

Renal Impairment

Renal impairment may necessitate dosage adjustments for patients with reduced kidney function. It is essential to monitor renal function tests in these patients to ensure safety and efficacy. For patients with a creatinine clearance below a specified threshold, a reduced dose should be considered. Additionally, special monitoring is required for patients with severe renal impairment to manage potential risks effectively.

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, it is recommended to consult local poison control centers or toxicology experts for guidance on specific management strategies tailored to the situation.

Overall, while specific overdosage information is not available, vigilance and prompt intervention remain critical in managing potential overdose scenarios.

Nonclinical Toxicology

No information is available regarding teratogenic or non-teratogenic effects. Additionally, there is no data provided concerning nonclinical toxicology, animal pharmacology, or toxicology.

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 they should discontinue use and consult a doctor if their condition persists, ensuring they understand the significance of seeking professional guidance in such cases.

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

The medication is administered orally, with patients advised to swallow one or two softgels after a meal. It is important for patients not to exceed a dosage of two softgels per day unless directed by a physician. No additional information is available regarding laboratory tests, abuse potential, patient counseling, or postmarketing experiences.

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.