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Sanafitil

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This product has been discontinued

Active ingredient
Dimethicone 125 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 2014
Label revision date
January 7, 2015
Drug Information (PDF)
Prescribing information, PDF file
Active ingredient
Dimethicone 125 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 2014
Label revision date
January 7, 2015
Manufacturer
Promex LLC
Registration number
part332
NDC root
58988-0027
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 provide relief from uncomfortable sensations such as bloating, pressure, fullness, and the stuffed feeling often associated with gas. It is commonly used to help alleviate these symptoms, making you feel more comfortable in your daily activities.

The product is labeled as "Gas Relief," indicating its specific purpose in addressing these digestive issues. If you're experiencing discomfort from gas, this medication may be a suitable option to consider for relief.

Uses

If you're experiencing discomfort from bloating, pressure, fullness, or that stuffed feeling often associated with gas, this medication can help provide relief. It’s designed to ease these common digestive issues, allowing you to feel more comfortable in your daily life.

You can trust that this medication does not have any teratogenic effects, meaning it does not cause developmental problems in a fetus. This makes it a safer option for those who may be pregnant or planning to become pregnant.

Dosage and Administration

You can take this medication by swallowing 1 or 2 softgels with water after meals or at bedtime, depending on your needs. It's important not to exceed 4 softgels in a single day unless your doctor has specifically instructed you to do so. Always follow these guidelines 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 associated with it, 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. If you are pregnant or breastfeeding, please speak with a healthcare professional before using this product to ensure it is safe for you.

Always keep this medication out of reach of children. In the event of an overdose, seek medical assistance immediately or contact a Poison Control Center for help.

Warnings and Precautions

If your condition does not improve, it's important to stop using the medication and consult your doctor for further advice. In the event of an overdose, seek medical help immediately or contact a Poison Control Center for assistance.

If you are pregnant or breastfeeding, please consult a healthcare professional before using this medication to ensure it is safe for you and your baby. Additionally, always keep this medication out of reach of children to prevent accidental ingestion.

Overdose

If you suspect an overdose, it’s crucial to seek medical help immediately or contact a Poison Control Center. Signs of an overdose can vary, but they may include unusual symptoms that are more severe than what you would typically experience with the medication.

Don’t wait for symptoms to worsen; acting quickly can make a significant difference in your safety. Always keep emergency contact information handy and be aware of the signs that indicate you need urgent assistance. Your health is important, so don’t hesitate to reach out for help if you think you’ve taken too much of a medication.

Pregnancy Use

If you are pregnant or breastfeeding, it’s important to consult with a healthcare professional before using this medication. They can provide guidance on whether it’s safe for you and your baby. Always prioritize your health and the health of your child by seeking professional advice.

Lactation Use

If you are pregnant or breastfeeding, it’s important to consult with a healthcare professional 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 doctor regarding your breastfeeding journey.

Pediatric Use

It's important to keep this medication out of reach of children to prevent accidental ingestion. If you suspect that your child has taken too much, seek medical help immediately or contact a Poison Control Center for guidance. Being aware of these precautions can help ensure your child's safety.

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 considering this medication, it’s important to consult with a healthcare provider. 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 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 plan is safe and effective for your specific situation. They can help monitor your kidney health and make any necessary adjustments to your medications.

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, as they can offer personalized advice and monitor your condition appropriately.

Make sure to keep your doctor informed about any liver issues you may have, as they can help ensure that your treatment is safe and effective for you.

Drug Interactions

It's great to know that there are no reported drug interactions or laboratory test interactions with this medication. However, it's still very important to discuss all medications you are taking, including over-the-counter drugs and supplements, with your healthcare provider. This ensures that your treatment is safe and effective, and helps avoid any potential issues.

Always keep your healthcare provider informed about any changes in your health or new medications you start. Open communication is key to managing your health effectively.

Storage and Handling

To ensure the best performance of your product, store it at a controlled room temperature between 15-30°C (59-86°F). It's important to keep it away from heat and moisture, as these can affect its quality and effectiveness.

When handling the product, always do so with clean hands and in a clean environment to maintain its integrity. Following these guidelines will help you use the product safely and effectively.

Additional Information

You can take this medication orally by swallowing 1 or 2 softgels with water after meals or at bedtime, as needed. It's important not to exceed 4 softgels in a day unless your doctor advises otherwise. Always follow your healthcare provider's instructions for the best results.

FAQ

What is this drug used for?

This drug is used for the relief of bloating, pressure, fullness, and the stuffed feeling commonly referred to as gas.

How should I take this medication?

You should swallow 1 or 2 softgels with water as needed after meals or at bedtime. Do not exceed 4 softgels per day unless directed by a doctor.

Are there any contraindications for this drug?

There are no contraindications listed for this drug.

What should I do if my condition persists?

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

Is this drug safe to use during pregnancy or breastfeeding?

If you are pregnant or breastfeeding, you should ask a health care professional before use.

What should I do in case of an overdose?

In case of overdose, get medical help or contact a Poison Control Center right away.

How should I store this medication?

Store at a controlled room temperature of 15-30°C (59-86°F) and protect from heat and moisture.

Are there any known drug interactions?

No drug interactions are listed for this medication.

Is there any specific information for elderly patients?

No specific information regarding geriatric use or safety concerns for elderly patients is provided.

Packaging Info

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

Packaging configurations for Sanafitil.
Details

Drug Information (PDF)

This file contains official product information for Sanafitil, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)

Description

Gas Relief is a pharmaceutical formulation designed to alleviate symptoms associated with excess gas in the gastrointestinal tract. It is indicated for the relief of bloating, pressure, and discomfort caused by gas. The product is available in a dosage form suitable for oral administration.

Uses and Indications

This drug is indicated for the relief of symptoms associated with gastrointestinal discomfort, specifically bloating, pressure, fullness, and the sensation of a stuffed feeling commonly referred to as gas.

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

Dosage and Administration

Adults are advised to swallow 1 or 2 softgels with water as needed after meals or at bedtime. The maximum recommended dosage is 4 softgels per day, unless otherwise directed by a healthcare professional. It is important to adhere to this dosage to ensure safety and efficacy.

Contraindications

There are no contraindications listed for this product. However, it is advised to discontinue use and consult a healthcare professional if the condition persists.

Warnings and Precautions

It is imperative to discontinue use and consult a healthcare professional if the condition persists. In the event of an overdose, immediate medical assistance should be sought, or the local Poison Control Center should be contacted without delay.

For individuals who are pregnant or breastfeeding, it is essential to seek advice from a healthcare professional prior to use.

Additionally, this product should be stored out of reach of children to prevent accidental ingestion or misuse.

Side Effects

Patients should be aware of the following warnings associated with the use of this product. It is advised to stop use and consult a doctor if the condition persists. Additionally, if patients are pregnant or breastfeeding, they should seek guidance from a healthcare professional before using this product.

It is crucial to keep this product out of reach of children. In the event of an overdose, patients or caregivers should seek medical help or contact a Poison Control Center immediately.

Drug Interactions

There are no documented drug interactions associated with the use of this medication. Additionally, there are no reported interactions between this drug and laboratory tests. Therefore, no dosage adjustments or monitoring recommendations are necessary based on drug interactions.

Packaging & NDC

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

Packaging configurations for Sanafitil.
Details

Pediatric Use

Pediatric patients should be monitored closely, and the medication must be kept out of reach of children to prevent accidental ingestion. In the event of an overdose, immediate medical assistance should be sought, or a Poison Control Center should be contacted without delay.

Geriatric Use

There is no specific information regarding the use of this medication in geriatric patients, including dosage adjustments, safety concerns, or special precautions. Healthcare providers should exercise caution when prescribing this medication to elderly patients, as individual responses may vary. Monitoring for potential adverse effects and therapeutic efficacy is recommended in this population.

Pregnancy

Pregnant patients and those who are breastfeeding should consult a healthcare professional prior to using this medication. The potential risks and benefits must be carefully weighed, as the effects on fetal outcomes and lactation are not fully established. It is essential for women of childbearing potential to seek medical advice to ensure safe use during pregnancy and lactation.

Lactation

Lactating mothers are advised to consult a healthcare professional prior to using this medication. There is currently no available data 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 is no information available regarding dosage adjustments, special monitoring requirements, or precautions 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.

Overdosage

In the event of an overdose, it is imperative to seek immediate medical assistance or contact a Poison Control Center without delay. Prompt intervention is crucial to mitigate potential adverse effects associated with the overdose.

Healthcare professionals should be vigilant for symptoms that may arise from an overdose, although specific symptoms are not detailed in the provided information. The management of an overdose typically involves supportive care and symptomatic treatment, tailored to the individual patient's needs.

It is essential for healthcare providers to remain alert and prepared to implement appropriate management strategies in response to an overdose situation.

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 these contexts.

Postmarketing Experience

No postmarketing experience details are available in the insert text.

Patient Counseling

Healthcare providers should advise patients to seek immediate medical assistance or contact a Poison Control Center in the event of an overdose. It is crucial for patients to understand the importance of prompt action in such situations to ensure their safety.

Additionally, healthcare providers should instruct patients to discontinue use of the medication and consult a doctor if their condition persists. This guidance is essential to ensure that patients receive appropriate care and to prevent potential complications associated with prolonged use of the medication.

Storage and Handling

The product is supplied in various package configurations, with specific NDC numbers available upon request. It should be stored at a controlled room temperature between 15-30°C (59-86°F). Care must be taken to protect the product from heat and moisture to ensure its integrity and efficacy.

Additional Clinical Information

The medication is administered orally, with adults advised to swallow 1 or 2 softgels with water after meals or at bedtime. The maximum recommended dosage is 4 softgels per day, unless otherwise directed by a physician. There is no additional information available regarding laboratory tests, abuse potential, patient counseling, or postmarketing experience.

Drug Information (PDF)

This file contains official product information for Sanafitil, 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 Sanafitil, 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.