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Simethicone 80mg

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Active ingredient
Dimethicone 80 mg
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 2022
Label revision date
January 8, 2024
Drug Information (PDF)
Prescribing information, PDF file
Active ingredient
Dimethicone 80 mg
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 2022
Label revision date
January 8, 2024
Manufacturer
Gendose Pharmaceuticals, LLC
Registration number
M002
NDC root
77333-812
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 is a medication commonly used to relieve gas distress, bloating, and discomfort in the digestive system. It works by breaking up gas bubbles in the stomach and intestines, making it easier for your body to eliminate them.

Available in 80 mg tablets, simethicone can help you feel more comfortable after meals or during times when you experience excessive gas. If you're looking for relief from these uncomfortable symptoms, simethicone may be a helpful option for you.

Uses

If you're experiencing gas distress, bloating, or discomfort, this medication can help relieve those symptoms. It's designed to ease the discomfort associated with excess gas in your digestive system, making you feel more comfortable.

You can use this medication without worrying about teratogenic effects (which are harmful effects on a developing fetus), as none have been reported. This means it's considered safe in that regard.

Dosage and Administration

You can take this medication by chewing 1 or 2 tablets completely after meals and at bedtime, depending on your needs. It's important not to swallow the tablets whole, as they are designed to be chewed for proper effectiveness.

Make sure you do not exceed 6 tablets in a 24-hour period unless your doctor has advised you otherwise. Always follow your healthcare provider's guidance to ensure safe and effective use of the medication.

What to Avoid

You can feel reassured that there are no specific contraindications, controlled substance classifications, or risks of abuse or misuse associated with this medication. Additionally, there are no concerns regarding dependence (a condition where the body becomes reliant on a substance).

Since there are no explicit "do not take" or "do not use" instructions, it is important to follow your healthcare provider's guidance and use the medication as directed. Always consult with your doctor if you have any questions or concerns about your treatment.

Side Effects

If you experience any serious side effects, it’s important to seek medical help right away or contact a poison control center at 1-800-222-1222. This ensures you receive the appropriate care and guidance. Always be aware of how your body responds to medication, and don’t hesitate to reach out for assistance if you have concerns.

Warnings and Precautions

It's important to be aware of certain warnings and precautions when using this medication. If you experience any severe side effects or symptoms that concern you, seek medical help right away or contact a poison control center at 1-800-222-1222.

Additionally, if you notice any unusual changes in your health or if you have specific medical conditions, it's crucial to stop using the medication and call your doctor for further guidance. Always prioritize your health and safety by staying informed and proactive about any potential risks associated with your treatment.

Overdose

If you suspect an overdose, it’s crucial to get medical help right away. You can contact a poison control center at 1-800-222-1222 for immediate assistance. Signs of an overdose can vary, but they may include unusual drowsiness, confusion, or difficulty breathing.

If you notice any of these symptoms or if you believe you have taken too much of a medication, do not hesitate to seek help. Your safety is the top priority, so act quickly to ensure you receive the care you need.

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.

Before taking any medication, including this one, you should consult with your healthcare provider to discuss potential risks and benefits. Your doctor can help you make informed decisions that prioritize your health and the health of your baby.

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, there is no information indicating that simethicone is excreted in breast milk or that it poses any risk to your infant. This means you can use simethicone without concern for its 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 and ensure that your child cannot access it. If you have any concerns about the medication or its effects, consult your healthcare provider for guidance. Your child's safety is the top priority.

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 related to 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 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 (issues with liver function).

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

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 specific drug interactions or laboratory test interactions noted, which means that, based on the available information, this medication is not known to interfere with other drugs or tests. However, every individual is different, and your healthcare provider can help ensure that your treatment plan is safe and effective for you. Always share your complete list of medications and any tests you may undergo to avoid any potential issues.

Storage and Handling

To ensure the best performance of your product, store it at room temperature. This means keeping it in a place that is neither too hot nor too cold, typically between 68°F and 77°F (20°C to 25°C).

When handling the product, make sure to do so with clean hands or while using gloves to maintain a safe and sterile environment. Always follow any specific disposal instructions provided to ensure safety and compliance.

Additional Information

You should take this medication orally by chewing 1 or 2 tablets completely as needed after meals and at bedtime. It's important not to swallow the tablets whole. Make sure you do not exceed 6 tablets in a 24-hour period unless your doctor advises otherwise. Always follow your healthcare provider's guidance for safe use.

FAQ

What is Simethicone used for?

Simethicone is used to relieve gas distress, bloating, and discomfort.

How should I take Simethicone?

Adults should chew 1 or 2 tablets completely as needed after meals and at bedtime. Do not swallow the tablets whole.

What is the maximum dosage of Simethicone I can take?

Do not exceed 6 tablets in a 24-hour period unless advised by a physician.

Are there any contraindications for using Simethicone?

No contraindications are listed for Simethicone.

Is Simethicone safe to use during pregnancy?

There are no specific safety concerns or recommendations regarding the use of Simethicone during pregnancy.

Can I use Simethicone while breastfeeding?

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

What should I do in case of an emergency?

Get medical help or contact a poison control center immediately at 1-800-222-1222.

How should I store Simethicone?

Store Simethicone at room temperature and keep it out of reach of children.

Packaging Info

Below are the non-prescription pack sizes of Simethicone 80mg (simethicone). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Simethicone 80mg.
Details

Drug Information (PDF)

This file contains official product information for Simethicone 80mg, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)

Description

Simethicone is presented in a dosage form of 80 mg per tablet, with a total of 100 tablets per container. The active ingredient, simethicone, is a silicone-based compound used to relieve symptoms of excess gas in the gastrointestinal tract. Each tablet is formulated to provide effective gas relief, contributing to patient comfort. The product is intended for oral administration.

Uses and Indications

This drug is indicated for the relief of gas distress, bloating, and discomfort.

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

Dosage and Administration

Adults should chew 1 or 2 tablets completely as needed after meals and at bedtime. It is important to note that the tablets must not be swallowed whole.

The maximum recommended dosage is 6 tablets within a 24-hour period, unless otherwise directed by a physician. Healthcare professionals should ensure that patients are aware of this limit to prevent potential overdose.

Contraindications

There are no contraindications associated with the use of this product. It is not classified as a controlled substance, and there are no known risks of abuse, misuse, or dependence. Additionally, there are no specific instructions indicating that the product should not be taken or used under any circumstances.

Warnings and Precautions

Healthcare professionals should be aware of the critical need for immediate medical intervention in the event of an overdose or adverse reaction. It is imperative to seek medical assistance or contact a poison control center without delay. The national poison control hotline can be reached at 1-800-222-1222 for guidance and support in managing such situations.

In addition to immediate actions, healthcare providers should remain vigilant regarding the monitoring of patients for any potential side effects or complications associated with the use of this medication. Regular assessments and appropriate laboratory tests may be necessary to ensure patient safety and to mitigate risks effectively.

Side Effects

Patients should be aware that in the event of an adverse reaction, immediate medical assistance is crucial. It is recommended to contact a medical professional or a poison control center at 1-800-222-1222 without delay. This guidance is essential for ensuring prompt and appropriate care in the case of serious reactions.

Drug Interactions

No specific drug interactions have been identified in the available data. Additionally, there are no reported interactions between the drug and laboratory tests. Therefore, no dosage adjustments or monitoring recommendations are necessary based on the current information.

Packaging & NDC

Below are the non-prescription pack sizes of Simethicone 80mg (simethicone). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Simethicone 80mg.
Details

Pediatric Use

Pediatric patients should be advised to keep this medication out of reach of children. It is essential to ensure that the medication is stored safely to prevent accidental ingestion or misuse by pediatric populations.

Geriatric Use

There is no specific information available 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. It is advisable to monitor these patients closely for any 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 during pregnancy.

Lactation

There are no specific warnings or recommendations regarding the use of simethicone in lactating mothers. Additionally, there is no information available about the potential for excretion of simethicone in breast milk or any associated risks to breastfed infants.

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 clinical trials for this medication. Consequently, there is no available information 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. Regular monitoring of liver function may be warranted based on clinical judgment.

Overdosage

In the event of an overdosage, it is imperative to seek immediate medical assistance. Healthcare professionals are advised to contact a poison control center without delay. The national poison control hotline can be reached at 1-800-222-1222 for guidance and support.

Prompt intervention is crucial in managing potential symptoms associated with overdosage. Symptoms may vary depending on the substance involved and the amount ingested. Therefore, a thorough assessment and appropriate management strategies should be implemented as soon as possible to mitigate any adverse effects.

Healthcare providers should ensure that they are familiar with the specific management protocols relevant to the substance in question, as these may include supportive care, monitoring of vital signs, and symptomatic treatment.

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 to emphasize the potential risks associated with unauthorized access to the medication by young individuals. Providers should encourage patients to store the medication in a secure location and to be vigilant about monitoring its use.

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 to maintain its integrity and efficacy. No special handling requirements are noted; however, standard precautions should be observed to ensure optimal storage conditions.

Additional Clinical Information

The medication is administered orally, with adults instructed to chew 1 or 2 tablets completely as needed after meals and at bedtime. It is important that patients do not swallow the tablets whole and do not exceed 6 tablets within a 24-hour period unless advised and supervised 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 80mg, 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 80mg, 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.