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Dimethicone

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This product has been discontinued

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 2020
Label revision date
October 20, 2020
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 2020
Label revision date
October 20, 2020
Manufacturer
H-E-B
Registration number
part332
NDC root
37808-788
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 relieve bloating, pressure, or fullness that you may experience due to gas. It works by addressing the discomfort associated with these symptoms, helping you feel more at ease. If you're dealing with the uncomfortable sensations of 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 can take this medication by swallowing one or two softgels when you start to feel symptoms. It's important to remember that you should not take more than two softgels in a 24-hour period 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 keep this medication out of reach of children to ensure their safety. There are no specific contraindications, controlled substance classifications, or concerns regarding abuse, misuse, or dependence mentioned in the provided information. Always follow these guidelines to use the medication safely and effectively.

Side Effects

It's important to be aware of potential side effects when using this medication. You should stop using it and consult a doctor if your condition does not improve. If you are pregnant or breastfeeding, please speak with a healthcare professional before using this product. Additionally, keep it out of reach of children to ensure their safety.

Warnings and Precautions

If your condition does not improve, it's important to stop using the product and consult your doctor for further advice. If you are pregnant or breastfeeding, please speak with a healthcare professional before using this product to ensure it is safe for you and your baby.

Always keep this product out of reach of children to prevent accidental ingestion or misuse. If you suspect that a child has taken it, seek emergency help immediately. Your safety and well-being are the top priority, so don’t hesitate to reach out to a healthcare provider with any concerns.

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, contacting your healthcare provider or local poison control center is crucial. They can provide guidance on what steps to take next. Always remember that when in doubt, it's better to err on the side of caution and seek professional assistance.

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 expert 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. 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 about how to manage medications in your home, don't hesitate to ask 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 standard recommendations for the medication do not include special monitoring or safety considerations tailored for patients with renal impairment (kidney issues).

Always consult your healthcare provider for personalized advice and to ensure that any medication you take is safe and appropriate for your kidney health. They can provide guidance based on your individual situation.

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 differently due to your liver health.

Always consult your healthcare provider for personalized advice and to discuss any concerns you may have regarding your liver condition and the use of this medication. They can help ensure that you receive the safest and most effective treatment based on your individual health needs.

Drug Interactions

It's great to know that there are no reported drug interactions or interactions with laboratory tests for 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 room temperature, ideally between 20-25°C (68-77ºF). It's important to keep it away from heat, humidity, and light, as these factors can affect its quality.

When handling the product, be sure to check the tamper-evident seal under the cap. If the seal is cut, torn, or missing, do not use the product, as this indicates it may not be safe. Following these guidelines will help you use the product safely and effectively.

Additional Information

No further information is available.

FAQ

What does this drug relieve?

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 as symptoms occur, but do not exceed 2 softgels per 24 hours unless advised by a physician.

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.

Can I use this drug if I am pregnant or breastfeeding?

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

How should I store this drug?

Store the drug at room temperature between 20-25°C (68-77ºF) and protect it from heat, humidity, and light.

What should I do if the seal under the cap is damaged?

Do not use the drug if the printed seal under the cap is cut, torn, or missing.

Is there any information regarding use in elderly patients?

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

Are there any known drug interactions?

No drug interactions are listed for this drug.

What precautions should I take regarding children?

Keep this drug out of reach of children.

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

The product is identified by the SPL code 34089-3. No specific description details are provided in the text.

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 as symptoms occur. The maximum dosage should not exceed two softgels within a 24-hour period, unless directed otherwise by a physician. It is important for healthcare professionals to monitor patients for adherence to this dosing regimen and to provide guidance as necessary.

Contraindications

There are no specific contraindications listed for this product. However, it is advised to keep the product out of reach of children to prevent accidental ingestion or misuse.

Warnings and Precautions

Healthcare professionals should advise patients to discontinue use and consult a physician if the condition persists. This precaution is essential to ensure that any underlying issues are appropriately addressed.

In cases where patients are pregnant or breastfeeding, it is imperative to seek guidance from a healthcare professional prior to use. This recommendation is crucial to safeguard both maternal and infant health.

Additionally, it is important to keep the product out of reach of children to prevent accidental ingestion or misuse. This measure is vital for ensuring the safety of pediatric patients.

Side Effects

Patients should be advised to discontinue use and consult a healthcare professional if their condition persists. It is important for individuals who are pregnant or breastfeeding to seek guidance from a health professional prior to using this product. Additionally, the product should be kept out of reach of children to prevent accidental ingestion or misuse.

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 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. It is essential to ensure that children do not have access to the medication to prevent accidental ingestion or misuse.

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

Pregnant patients and those who are breastfeeding should consult a healthcare professional prior to using this medication. It is essential to evaluate the potential risks and benefits associated with its use during pregnancy and lactation.

Lactation

Lactating mothers are advised to consult a health professional prior to using this medication. There is currently no available data regarding the excretion of this medication 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 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 necessitates careful clinical judgment and monitoring of these patients.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in relation to the use of this medication. Consequently, there are no 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 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, immediate medical attention should be sought. Healthcare providers should implement supportive care measures, which may include maintaining airway patency, providing supplemental oxygen, and monitoring vital signs.

Additionally, it is recommended to consult local poison control centers or relevant toxicology resources for guidance on specific management protocols and antidotes, if applicable.

Documentation of the incident, including the amount and timing of the substance taken, is crucial for effective treatment 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 limits the assessment of potential risks associated with the compound in these areas.

Postmarketing Experience

No postmarketing experience details are available in the insert text.

Patient Counseling

Healthcare providers should advise patients to keep this medication out of reach of children to prevent accidental ingestion or misuse. It is important to emphasize the necessity of proper storage and handling to ensure the safety of young individuals.

Storage and Handling

The product is supplied in a configuration that includes specific NDC numbers, which are essential for identification and inventory management. It is crucial to store the product at room temperature, maintaining a range between 20-25°C (68-77ºF).

To ensure the integrity of the product, it must be protected from heat, humidity, and light. Additionally, the packaging features a tamper-evident seal; therefore, it should not be used if the printed seal under the cap is cut, torn, or missing. Proper adherence to these storage and handling guidelines is essential for maintaining product efficacy and safety.

Additional Clinical Information

No further data are available.

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.