Symptom checker
Select audience type

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

ADD CONDITION

items per page

Dimethicone

Last content change checked dailysee data sync status

Active ingredient
Dimethicone 250 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 2016
Label revision date
November 25, 2024
Drug Information (PDF)
Prescribing information, PDF file
Active ingredient
Dimethicone 250 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 2016
Label revision date
November 25, 2024
Manufacturer
Humanwell PuraCap Pharmaceutical (Wuhan) Co. , Ltd
Registration number
M002
NDC root
53345-032
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

Simethicone Capsules 250 mg are designed to help relieve bloating, pressure, or fullness that is commonly associated with gas. This medication works by breaking up gas bubbles in the stomach and intestines, making it easier for your body to eliminate them.

If you're experiencing discomfort from gas, Simethicone can provide you with relief, allowing you to feel more comfortable in your daily activities.

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.

You can use this medication without worrying about any teratogenic effects, which means it doesn't cause birth defects. Overall, it’s a straightforward option for managing gas-related discomfort.

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 keep this medication out of reach of children to ensure their safety. If your condition does not improve or continues to persist, please stop using the medication and consult your doctor for further guidance.

There are no specific contraindications, controlled substance classifications, or concerns regarding abuse, misuse, or dependence associated with this medication. Always prioritize your health and safety by following these instructions.

Side Effects

If you experience any persistent symptoms while using this medication, it's important to stop using it and consult your doctor. Additionally, make sure to keep this medication out of reach of children to ensure their safety.

Warnings and Precautions

It's important to be cautious when using this medication. If your condition does not improve or if it persists, you should stop using the medication and consult your doctor for further advice.

Additionally, make sure to keep this medication out of the reach of children to prevent any accidental ingestion. Always prioritize safety and seek medical help if you have any concerns.

Overdose

If you suspect an overdose, it's important to stay calm and take immediate action. While the specific signs of an overdose are not detailed, common 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 crucial to provide them with as much information as possible about the substance taken and the amount, if known. Remember, acting quickly can make a significant difference in your health and safety.

Pregnancy Use

You can use Simethicone during pregnancy without specific warnings or dosage changes noted in the available information. There are no indications that it is contraindicated (not recommended) for pregnant individuals, nor are there any identified risks to the fetus. However, as with any medication, it's always a good idea to consult with your healthcare provider before starting any new treatment during pregnancy.

Lactation Use

If you are breastfeeding, you can feel reassured that there are no specific warnings or recommendations regarding the use of Simethicone for nursing mothers. Additionally, the information available does not indicate any concerns about Simethicone being passed into breast milk or posing risks to your infant. This means you can use it without worrying about potential effects on your milk production or your baby's health.

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 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 for patients with 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 there are no specific guidelines or dosage adjustments mentioned for your condition in the available information. This means that the standard recommendations apply, and there are no special monitoring requirements or precautions outlined for patients with liver impairment.

Always consult your healthcare provider for personalized advice and to ensure that any medications you take are safe for your liver health. They can provide guidance based on your individual situation and help monitor your liver function as needed.

Drug Interactions

It's important to have open conversations with your healthcare provider about any medications or tests you may be taking. In this case, there are no known drug interactions or laboratory test interactions associated with the medication. However, always ensure that your healthcare provider is aware of all the medications you are using, as this helps them provide the best care tailored to your needs.

By discussing your full medical history and any other treatments, you can help prevent potential issues and ensure your safety.

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 product's effectiveness and safety.

When handling the product, make sure to do so in a clean environment to avoid contamination. Always follow any specific instructions provided with the product for safe use and disposal. Keeping these guidelines in mind will help you use the product safely and effectively.

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 in a 24-hour period unless your doctor advises otherwise. Always follow your healthcare provider's guidance to ensure safe and effective use.

FAQ

What is Simethicone used for?

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

How should I take Simethicone?

You should swallow one or two softgels after a meal and not exceed two softgels per 24 hours unless advised by a physician.

Are there any contraindications for using Simethicone?

There are no contraindications listed for Simethicone.

Is Simethicone safe to use during pregnancy?

The insert does not provide specific information regarding the use of Simethicone during pregnancy or any risks to the fetus.

Can I use Simethicone while breastfeeding?

There are no specific warnings or recommendations regarding the use of Simethicone in nursing mothers mentioned in the insert.

What should I do if my condition persists while using Simethicone?

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

How should I store Simethicone?

Store Simethicone at room temperature between 59°F and 86°F (15°C and 30°C), and protect it from heat, humidity, and light.

Is there any information about drug interactions with Simethicone?

No drug interactions were listed in the provided text.

What is the packaging information for Simethicone?

Simethicone is available in 250 mg capsules, with 12 capsules per blister and 124 blisters per box.

What precautions should I take when using Simethicone?

Keep Simethicone out of reach of children and follow the dosage instructions carefully.

Packaging Info

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

Packaging configurations for Simethicone.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

Simethicone Capsules contain 250 mg of simethicone per capsule. The product is identified by NDC 53345-032-02 and is packaged with 12 capsules per blister, with a total of 124 blisters per box. It is essential to inspect the product immediately upon receipt. This formulation is intended for bulk shipment and is designated for further manufacturing, processing, or repackaging. The capsules should be protected from heat, humidity, and light, and must not be refrigerated. Recommended storage conditions are between 15-30°C (59-86°F).

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 should swallow one or two softgels after a meal. The maximum recommended dosage is two softgels within a 24-hour period, unless otherwise directed by a physician. It is important for healthcare professionals to advise patients not to exceed this dosage without appropriate medical supervision.

Contraindications

There are no specific contraindications listed for this product. However, it is advised to keep the product out of reach of children. Additionally, if the condition persists, discontinue use and consult a healthcare professional.

Warnings and Precautions

Healthcare professionals should be aware of the following important considerations regarding the safe use of this product.

It is imperative to discontinue use and consult a physician if the condition persists. This precaution is essential to ensure that any underlying issues are appropriately addressed and managed.

Additionally, it is crucial to keep this product out of the reach of children to prevent accidental ingestion or misuse. Ensuring proper storage is a key aspect of safeguarding pediatric patients.

Side Effects

Patients should be advised to stop use and consult a doctor if their condition persists. It is also important to keep the product out of reach of children to prevent accidental ingestion or misuse.

No specific adverse reactions have been reported in clinical trials or postmarketing experiences; however, the warnings provided should be taken seriously to ensure patient safety.

Drug Interactions

There are no documented drug interactions associated with the use of this medication. Additionally, no interactions with laboratory tests have been identified. Therefore, no specific dosage adjustments or monitoring recommendations are necessary based on drug interactions.

Packaging & NDC

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

Packaging configurations for Simethicone.
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 caution is advised when administering this medication to 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 are no specific warnings, precautions, or dosage modifications regarding the use of Simethicone during pregnancy. The prescribing information does not indicate whether Simethicone is contraindicated in pregnant patients or if there are any associated risks to the fetus. As such, healthcare professionals should consider the absence of data when advising women of childbearing potential regarding the use of Simethicone during pregnancy.

Lactation

There are no specific warnings or recommendations regarding the use of Simethicone in lactating mothers. Additionally, the insert does not provide information on the potential for excretion of Simethicone in breast milk or any associated risks to breastfed infants. Therefore, healthcare professionals may consider the use of Simethicone in nursing mothers on a case-by-case basis, as no significant concerns have been documented.

Renal Impairment

There is no specific information available regarding dosage adjustments, special monitoring, or safety considerations for patients with renal impairment. Healthcare professionals should exercise caution when prescribing to patients with reduced kidney function, as the absence of detailed guidance necessitates careful clinical judgment. Regular monitoring of renal function may be advisable in these patients to ensure safety and efficacy.

Hepatic Impairment

There is no information available regarding hepatic impairment, including dosage adjustments, special monitoring requirements, or precautions for patients with compromised liver function. Therefore, no specific recommendations can be made for the use of this medication in patients with hepatic impairment. It is advised that healthcare professionals exercise clinical judgment when considering treatment options for this patient population.

Overdosage

In the absence of specific information regarding overdosage, healthcare professionals are advised to exercise caution and adhere to 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, the following management procedures are recommended:

  1. Assessment: Conduct a thorough assessment of the patient's clinical status, including vital signs and level of consciousness.

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

  3. Consultation: Engage with a poison control center or a medical toxicologist for guidance on specific interventions and antidotes, if applicable.

  4. Documentation: Document all findings, interventions, and the patient's response to treatment meticulously.

Healthcare professionals should remain vigilant and prepared to implement these measures in the event of an overdose, despite the lack of specific overdosage information.

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 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 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

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 within a 24-hour period unless directed by a physician. No additional information is available regarding laboratory tests, abuse potential, patient counseling, or postmarketing experience.

Drug Information (PDF)

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