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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)
Marketed in the U.S.
Since 2021
Label revision date
December 30, 2024
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
Marketed in the U.S.
Since 2021
Label revision date
December 30, 2024
Manufacturer
RITE AID CORPORATION
Registration number
M002
NDC root
11822-1569

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Drug Overview

This medication is designed to relieve bloating, pressure, or fullness that is commonly associated with gas. It can help you feel more comfortable by addressing these uncomfortable symptoms. The product is available in a package labeled for gas relief, containing 24 tablets, making it easy to manage your discomfort when needed.

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.

Using this medication can make a significant difference in how you feel, allowing you to go about your day without the distraction of digestive discomfort.

Dosage and Administration

You should take one or two softgels after a meal. It's important not to exceed this amount, as 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 be aware of certain guidelines when using this medication. While there are no specific contraindications or concerns regarding abuse, misuse, or dependence, 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 your condition does not improve, it's important to stop using the medication and consult your doctor. Additionally, please ensure that this medication is kept out of reach of children to prevent any accidental ingestion.

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 emergency instructions provided, always prioritize your health and seek medical advice if you have any concerns or experience unusual symptoms. Your well-being is paramount, so don’t hesitate to reach out to a healthcare professional if needed.

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, 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

If you are pregnant or planning to become pregnant, it's important to be aware that there is no specific information available regarding the use of this medication during pregnancy. This means that safety concerns, dosage adjustments, or any special precautions have not been established.

Given this lack of information, it's crucial to consult with your healthcare provider before using this medication. They can help you weigh the potential risks and benefits based on your individual circumstances. Always prioritize open communication with your doctor about any medications you are considering 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. The information available does not indicate any particular considerations or precautions you need to take while using this medication during lactation (the period of breastfeeding).

Always consult with your healthcare provider if you have any concerns or questions about medications while breastfeeding, but based on the current information, simethicone appears to be safe for you to use.

Pediatric Use

It's important to keep this medication out of reach of children to ensure their safety. When it comes to dosage, you should not give more than two softgels in a 24-hour period unless a doctor has specifically advised you to do so. Always consult with a healthcare professional if you have any questions or concerns about using this medication for your child.

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 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 related to renal impairment (kidney issues) are not provided.

It's always best to discuss your individual situation with your healthcare provider, who can offer personalized advice and ensure that any medications you take are safe and effective for you.

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 dosing and monitoring practices apply, but you should always consult your healthcare provider for personalized advice. They can help ensure that any medications you take are safe and effective for your liver health.

Make sure to keep your doctor informed about your liver condition, as they may want to monitor your liver function regularly to ensure everything is working well. Your health and safety are the top priority, so don’t hesitate to ask questions or express any concerns you may have.

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 may 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 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

No further information is available.

FAQ

What is the purpose of this drug?

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

How should I take this medication?

You should swallow one or two softgels after a meal.

What is the maximum dosage I can take?

Do not exceed two softgels in 24 hours except under the advice and supervision of a physician.

What should I do if my condition persists?

Stop use and ask a doctor if your condition persists.

How should I store this medication?

Store at room temperature between 59-86°F (15-30°C).

Is there any specific information for nursing mothers?

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

Are there any contraindications for this drug?

No contraindications are listed for this drug.

What should I do to keep this medication safe?

Keep 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 SPL Code 34089-3 and is available in a carton containing 24 units. It is specifically labeled for gas relief, indicating its intended therapeutic use. The packaging is designed to facilitate the distribution and identification of the product for healthcare professionals.

Uses and Indications

This drug is indicated for the relief of bloating, pressure, or fullness commonly associated with 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 within a 24-hour period. Exceeding this dosage should only occur under the guidance and supervision of a physician.

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

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 physician. Continuous monitoring of the patient's symptoms is essential to ensure appropriate management and intervention if necessary.

While no specific warnings or general precautions have been outlined, healthcare providers should remain vigilant and assess the patient's response to treatment regularly. This proactive approach will help in identifying any potential issues early and facilitate timely adjustments to the treatment plan.

Side Effects

Patients should be advised to stop use and consult a doctor if their condition persists. It is important to keep this product 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, no interactions with laboratory tests have been identified. Therefore, no specific recommendations for dosage adjustments or monitoring 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 important to note that the maximum recommended dosage for pediatric patients is two softgels in a 24-hour period, unless otherwise directed by a physician. Caregivers should ensure that this dosage limit is not exceeded to avoid potential adverse effects.

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 efficacy, 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 that should be taken. Healthcare professionals should consider the lack of data when prescribing this medication to pregnant patients and weigh the potential risks and benefits. Women of childbearing potential should be counseled on the absence of established safety data and the importance of discussing any potential pregnancy with their healthcare provider.

Lactation

There are no specific warnings or recommendations regarding the use of simethicone in lactating mothers. Additionally, there are no specific considerations or precautions related to lactation mentioned in the provided text. Therefore, healthcare professionals may consider the use of simethicone in nursing mothers without specific concerns for breastfed infants.

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 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 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 warranted based on clinical judgment.

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 initiate supportive care, which may include maintaining airway patency, providing supplemental oxygen, and monitoring vital signs.

If the substance involved is known, specific antidotes or treatments may be indicated, and healthcare professionals should refer to established guidelines for the management of overdose related to that substance.

In all cases, contacting a poison control center or a medical toxicologist for guidance is recommended to ensure appropriate management and intervention.

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 keep the medication out of reach of children to prevent accidental ingestion. It is important for patients to understand that if their condition persists, they should stop using the medication 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 59-86°F (15-30°C). Proper storage conditions are crucial to ensure the integrity and efficacy of the product. No special handling requirements are noted; however, adherence to the specified temperature range is recommended for optimal storage.

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.

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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.