Symptom checker
Select audience type

Switch between content for healthcare professionals (PRO) and general audience (GEN).

ADD CONDITION

items per page

Phazyme

Last content change checked dailysee data sync status

This product has been discontinued

Active ingredients
  • Dimethicone 250 mg/24 1
  • Calcium Carbonate 750 mg/24 1
Other brand names
Dosage form
Tablet, Chewable
Route
Oral
Prescription status
OTC (over the counter)
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Marketed in the U.S.
Since 2016
Label revision date
February 4, 2025
Drug Information (PDF)
Prescribing information, PDF file
Active ingredients
  • Dimethicone 250 mg/24 1
  • Calcium Carbonate 750 mg/24 1
Other brand names
Dosage form
Tablet, Chewable
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 2016
Label revision date
February 4, 2025
Manufacturer
C. B. Fleet Company, Inc.
Registration number
M002
NDC root
0132-0507
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 chewable medication that comes in a cherry flavor and is designed to help relieve various digestive discomforts. You can use PHAZYME to alleviate pressure and bloating commonly associated with gas, as well as to ease symptoms of acid indigestion, heartburn, sour stomach, and upset stomach.

This medication works by addressing these uncomfortable symptoms, providing you with relief when you need it most. With PHAZYME, you can find comfort from the discomforts of digestion, allowing you to feel better throughout your day.

Uses

If you're experiencing discomfort from pressure and bloating, often called gas, this medication can help relieve those symptoms. It’s also effective for managing acid indigestion, heartburn, and a sour stomach. If you have an upset stomach related to these issues, this medication may provide the relief you need.

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 concerned about such risks.

Dosage and Administration

If you are an adult or a child aged 12 years and older, you can take this medication by chewing and swallowing 1 to 2 chews whenever you experience symptoms, or as your doctor advises. It's important to follow your doctor's instructions for the best results. Make sure to only take the amount recommended to manage your symptoms effectively.

What to Avoid

It's important to use this product safely to avoid any potential issues. You should not take more than 2 chews in a 24-hour period. Additionally, if you find that you need to use the maximum dosage, do so for no longer than 2 weeks unless your doctor advises otherwise. Following these guidelines will help ensure your safety and well-being while using this product.

Side Effects

It's important to be aware of some key warnings and considerations when using this product. You should not take more than 2 chews in a 24-hour period, and it's advised not to use the maximum dosage for more than 2 weeks unless directed by a doctor. If you are currently taking any prescription medications, consult with your doctor or pharmacist first, as antacids can interact with certain drugs.

If you are pregnant or breastfeeding, please seek advice from a healthcare professional before using this product. Additionally, keep it out of reach of children to ensure their safety.

Warnings and Precautions

It's important to use this product safely. You should not take more than 2 chews in a 24-hour period, and if you need to use the maximum dosage, do so for no longer than 2 weeks unless your doctor advises otherwise.

Before using this product, consult with your doctor or pharmacist, especially if you are currently taking any prescription medications, as antacids can interact with them. If you are pregnant or breastfeeding, it's also essential to seek medical advice before use. Always keep this product out of reach of children to ensure their safety.

Overdose

Taking more than 2 chews in a 24-hour period can lead to an overdose, which may cause serious health issues. It's important to follow the recommended dosage and not use the maximum amount of this product for more than 2 weeks unless your doctor advises you to do so.

If you suspect an overdose, look for signs such as unusual drowsiness, confusion, or difficulty breathing (respiratory depression). If you notice any of these symptoms, seek immediate medical help. Always prioritize your safety and consult with a healthcare professional if you have any concerns about your medication use.

Pregnancy Use

If you are pregnant or breastfeeding, it’s important to consult your doctor before using this medication. Your healthcare provider can help you understand any potential risks and ensure that you make the safest choices for you and your baby. Always prioritize open communication with your doctor regarding any medications you may be considering during this time.

Lactation Use

If you are pregnant or breastfeeding, it’s important to consult your doctor before using any medication. This ensures that you understand any potential risks and can make informed decisions about your health and the health of your baby. Always prioritize open communication with your healthcare provider regarding your breastfeeding journey.

Pediatric Use

When it comes to using this medication for children, it's important to note that it is intended for adults and children aged 12 years and older. If your child is within this age range, they can chew and swallow 1 to 2 chews as needed for symptoms or as directed by a healthcare professional.

Always remember to keep this medication out of reach of younger children to ensure their safety. If you have any questions or concerns about its use, consult your child's doctor for guidance.

Geriatric Use

While there is no specific information available about the use of this medication in older adults, it’s important to approach any new treatment with caution. Since older adults may have different health needs and responses to medications, you should always consult with a healthcare provider before starting any new medication. They can help determine the best approach for you or your loved one, considering any existing health conditions or medications that may interact.

Remember, your safety and well-being are the top priority, so don’t hesitate to ask questions and discuss any concerns with your doctor or pharmacist.

Renal Impairment

If you have kidney problems, it's important to know that the information provided does not include specific guidelines for dosage adjustments, special monitoring, or safety considerations related to renal impairment (kidney issues). This means that there are no tailored recommendations for how your treatment may need to change based on your kidney function.

Always consult your healthcare provider for personalized advice and to ensure that your treatment is safe and effective for your specific condition. They can help determine the best approach for managing your health, especially if you have concerns about your kidneys.

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 be aware that antacids, which are commonly used to relieve heartburn and indigestion, can interact with some prescription medications. This means that taking antacids at the same time as certain drugs might affect how well those medications work.

To ensure your safety and the effectiveness of your treatment, always discuss any medications you are taking, including over-the-counter products like antacids, with your healthcare provider. They can help you understand potential interactions and adjust your treatment plan if necessary.

Storage and Handling

To ensure the best performance of your product, store it at room temperature, ideally between 59°F and 77°F (15°C to 25°C). This temperature range helps maintain the product's effectiveness and safety.

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

Additional Information

No further information is available.

FAQ

What is PHAZYME used for?

PHAZYME is used for the relief of pressure and bloating (gas), acid indigestion, heartburn, sour stomach, and upset stomach associated with these symptoms.

How should I take PHAZYME?

Adults and children 12 years and older should chew and swallow 1 to 2 chews as symptoms occur or as directed by a doctor.

What is the maximum dosage for PHAZYME?

Do not take more than 2 chews in a 24-hour period, and do not use the maximum dosage for more than 2 weeks without a doctor's advice.

Are there any warnings associated with PHAZYME?

Yes, do not exceed 2 chews in a 24-hour period and consult a doctor if you are taking prescription drugs, pregnant, or breastfeeding.

Is there any information on teratogenic effects?

No teratogenic effects are mentioned for PHAZYME.

What should I do if I have questions about using PHAZYME?

You should ask a doctor or pharmacist before using PHAZYME, especially if you are taking other prescription drugs.

How should I store PHAZYME?

Store PHAZYME at room temperature between 59°-77°F.

Is PHAZYME safe for children?

PHAZYME should be kept out of reach of children, and it is intended for use in adults and children 12 years and older.

Packaging Info

Below are the non-prescription pack sizes of Phazyme (simethicone and calcium carbonate). 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 a chewable formulation designed to alleviate symptoms associated with gas and acid. Each package contains 24 chewable tablets, which are flavored with cherry to enhance palatability.

Uses and Indications

This drug is indicated for the relief of pressure and bloating commonly referred to as gas, as well as for the management of acid indigestion, heartburn, sour stomach, and upset stomach associated with these symptoms.

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

Dosage and Administration

Adults and children 12 years and older are advised to chew and swallow 1 to 2 chews as symptoms occur or as directed by a healthcare professional. It is important to follow the recommended dosage and not exceed the advised amount unless specifically instructed by a physician.

Contraindications

Use of this product is contraindicated in patients who exceed the recommended dosage of more than 2 chews in a 24-hour period. Additionally, the maximum dosage should not be used for more than 2 weeks unless advised and supervised by a healthcare professional.

Warnings and Precautions

Patients should adhere strictly to the recommended dosage guidelines. It is imperative not to exceed 2 chews within a 24-hour period. Additionally, the maximum dosage should not be utilized for more than 2 weeks unless directed and monitored by a healthcare professional.

Before initiating treatment, it is advisable for patients to consult with a physician or pharmacist, particularly if they are currently taking any prescription medications. This precaution is essential as antacids may interact with certain prescription drugs, potentially leading to adverse effects.

For individuals who are pregnant or breastfeeding, consultation with a healthcare provider is recommended prior to use to ensure safety for both the mother and child. Furthermore, this product should be stored out of reach of children to prevent accidental ingestion.

No specific laboratory tests are required for monitoring during the use of this product. However, healthcare professionals should remain vigilant for any potential interactions or side effects that may arise during treatment.

Side Effects

Patients should be aware of the following warnings and precautions associated with the use of this product. It is advised that no more than 2 chews be taken within a 24-hour period. Additionally, the maximum dosage should not be used for more than 2 weeks unless under the advice and supervision of a healthcare professional.

Before using this product, patients are encouraged to consult with a doctor or pharmacist, particularly if they are currently taking a prescription medication, as antacids may interact with certain prescription drugs.

For pregnant or breastfeeding individuals, it is recommended to seek medical advice prior to use. Furthermore, this product should be kept out of reach of children to prevent accidental ingestion.

Drug Interactions

Antacids may interact with various prescription medications, potentially affecting their absorption and efficacy. It is advisable to monitor the timing of antacid administration in relation to other medications to minimize these interactions. Specifically, antacids should be taken at least 2 hours apart from other drugs to ensure optimal therapeutic effects and to avoid diminished efficacy of the prescribed treatments.

Packaging & NDC

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

Packaging configurations for Phazyme.
Details

Pediatric Use

Pediatric patients aged 12 years and older may chew and swallow 1 to 2 chews as symptoms occur or as directed by a healthcare professional. It is important to keep this medication out of reach of children to prevent accidental ingestion.

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 potential adverse effects or changes in therapeutic response, given the lack of targeted data for this population.

Pregnancy

Pregnant patients and those who are breastfeeding should consult a healthcare professional prior to using this medication. It is important to evaluate the potential risks and benefits associated with the use of this drug during pregnancy and lactation. Healthcare providers should consider the available data and individual patient circumstances when advising on the use of this medication in these populations.

Lactation

Lactating mothers are advised to consult a healthcare professional prior to using this medication. There is no specific data available regarding the excretion of this drug in human breast milk or its effects on breastfed infants. Therefore, caution is recommended when administering this medication to lactating individuals.

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 event of overdosage, it is critical to adhere to the recommended dosage guidelines to prevent adverse effects. The maximum allowable intake is limited to two chews within a 24-hour period. Exceeding this dosage may lead to potential complications that require careful management.

Healthcare professionals should advise patients against using the maximum dosage of this product for longer than two weeks unless specifically directed by a physician. Prolonged use at maximum dosage without medical supervision may increase the risk of serious side effects.

In cases of suspected overdosage, it is essential to monitor the patient for any symptoms that may arise and to initiate appropriate management procedures. Immediate consultation with a healthcare provider is recommended to assess the situation and determine the necessary interventions.

Nonclinical Toxicology

No teratogenic effects were reported in the studies conducted. Additionally, there was no increase in fetal malformations observed, indicating a lack of non-teratogenic effects. Information regarding nonclinical toxicology and animal pharmacology and toxicology was not provided in the insert.

Postmarketing Experience

No postmarketing experience details are available in the insert text.

Patient Counseling

Healthcare providers should advise patients not to exceed a maximum of 2 chews within a 24-hour period. It is important to emphasize that the maximum dosage of this product should not be used for more than 2 weeks unless directed and supervised by a healthcare professional.

Additionally, patients should be informed about the potential interactions between antacids and certain prescription medications. Healthcare providers are encouraged to discuss any current prescription drugs the patient is taking to ensure safe and effective use of the product.

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 temperature range between 59°F and 77°F. 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.