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 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 2011
Label revision date
October 30, 2017
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 2011
Label revision date
October 30, 2017
Manufacturer
Richmond Pharmaceuticals, Inc.
Registration number
part332
NDC root
54738-518
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 comes in the form of chewable tablets and is designed to help relieve bloating, pressure, and discomfort caused by gas. Gas can result from certain foods or from swallowing air, and this product aims to provide you with relief from these uncomfortable sensations.

By targeting the symptoms associated with gas, this medication can help improve your overall comfort, allowing you to feel more at ease after meals or during times when you might experience digestive discomfort.

Uses

If you're experiencing bloating, pressure, or discomfort due to gas, this medication can help provide relief. These symptoms can often arise from certain foods you eat or from swallowing air. By taking this medication, you can find comfort and ease from these uncomfortable feelings, allowing you to go about your day more comfortably.

Rest assured, this medication does not have any known teratogenic effects, meaning it does not cause harm to a developing fetus.

Dosage and Administration

You can take 1 to 2 tablets of this medication as needed after meals and at bedtime. It's important to chew the tablets thoroughly to ensure they work effectively.

Make sure not to exceed 6 tablets in a single day unless your doctor has specifically instructed you to do so. Following these guidelines will help you use the medication safely and effectively.

What to Avoid

There are no specific contraindications, controlled substance classifications, or concerns regarding abuse, misuse, or dependence associated with this medication. This means that, based on the available information, there are no particular situations or conditions under which you should avoid using it. Always consult with your healthcare provider for personalized advice and to ensure that this medication is appropriate for you.

Side Effects

It's important to be aware of potential side effects when considering this medication. If you are pregnant or breastfeeding, you should consult a healthcare professional before using it to ensure safety for you and your baby.

Always keep an open line of communication with your doctor about any concerns or side effects you may experience while taking this medication. Your health and well-being are the top priority.

Warnings and Precautions

If you are pregnant or breastfeeding, it’s important to consult with a healthcare professional before using this medication. They can help you understand any potential risks and benefits for you and your baby.

Always be aware of how your body responds to the medication. If you experience any unusual symptoms or side effects, stop using the medication and contact your doctor for guidance. Your health and safety are the top priority, so don’t hesitate to seek help if you have 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, 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 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. 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 Simethicone, there is no specific information available about how it should be used by older adults. This means that there are no special dosage adjustments, safety concerns, or precautions outlined for elderly patients.

If you are an older adult or a caregiver, it's always a good idea to consult with a healthcare professional before starting any new medication, including Simethicone. They can provide personalized advice based on individual health needs and conditions.

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 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 regarding your liver health and how it may relate to your treatment. They can help ensure that you receive the safest and most effective care.

Drug Interactions

It's great to know that there are no reported interactions between this medication and other drugs or laboratory tests. 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.

Always keep your healthcare provider informed about any changes in your health or new medications you start. Open communication helps prevent any potential issues and supports your overall well-being.

Storage and Handling

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

When handling the product, check the safety seal under the cap. If the seal is broken or missing, do not use the product, as this indicates it may have been tampered with. Following these guidelines will help you use the product safely and effectively.

Additional Information

You should take this medication orally by chewing 1 to 2 tablets as needed after meals and at bedtime. It's important not to exceed 6 tablets in a day unless your doctor advises otherwise. If you have any questions or concerns about how to use this medication, be sure to consult your healthcare provider for guidance.

FAQ

What is the main use of this drug?

This drug relieves bloating, pressure, and discomfort of gas caused by certain foods or air swallowing.

How should I take this medication?

You should chew thoroughly 1 to 2 tablets as needed after meals and at bedtime, but do not exceed 6 tablets per day unless directed by a doctor.

Are there any warnings for pregnant or breastfeeding women?

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

What should I do if I have children?

Keep this medication out of reach of children.

What are the storage instructions for this drug?

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

Are there any known drug interactions?

No drug interactions were mentioned in the provided information.

Is there any information on geriatric use?

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

What should I do if the safety seal is broken?

Do not use the medication if the imprinted safety seal under the cap is broken or missing.

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 National Drug Code (NDC) 54738-518-01. It is formulated as a dosage form of 100 chewable tablets.

Uses and Indications

This drug is indicated for the relief of bloating, pressure, and discomfort associated with gas, which may result from the consumption of certain foods or from air swallowing.

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

Dosage and Administration

Patients are advised to chew thoroughly 1 to 2 tablets as needed after meals and at bedtime. The maximum recommended dosage is 6 tablets per day, unless otherwise directed by a healthcare professional. It is important for patients to adhere to this guideline to avoid potential adverse effects associated with exceeding the recommended dosage.

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.

Warnings and Precautions

Healthcare professionals should advise patients to consult with a healthcare provider if they are pregnant or breastfeeding prior to using this medication. This precaution is essential to ensure the safety of both the mother and the child, as potential risks may be associated with the use of the medication during these periods.

It is imperative that healthcare providers remain vigilant in assessing the appropriateness of this medication for patients who are pregnant or nursing, taking into consideration the potential benefits and risks involved.

Side Effects

Patients should be advised to consult a health professional if they are pregnant or breastfeeding before using this medication. This precaution is essential to ensure the safety of both the patient and the developing fetus or nursing infant.

No additional adverse reactions have been reported in clinical trials or postmarketing experiences. It is important for healthcare providers to monitor patients for any unexpected reactions and to report them as necessary.

Drug Interactions

No drug interactions or drug and laboratory test interactions have been identified in the available data. Therefore, no specific recommendations for dosage adjustments or monitoring are necessary at this time.

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. There are no specific age ranges, dosage differences, or study outcomes provided for pediatric use in the available data. Caution is advised when administering this medication to ensure safety in the pediatric population.

Geriatric Use

Elderly patients may not have specific dosage adjustments, safety concerns, or special precautions outlined in the drug insert for Simethicone. As there is no dedicated information regarding geriatric use, healthcare providers should exercise clinical judgment when prescribing this medication to elderly patients. It is advisable to monitor these patients closely for any potential adverse effects, given the general considerations for medication use in this population.

Pregnancy

Pregnant patients and those who are breastfeeding should consult a healthcare professional prior to using this medication. It is important to evaluate the potential risks and benefits associated with the use of this drug during pregnancy and lactation. Healthcare providers should consider the available data and individual patient circumstances when advising on the use of this medication in these populations.

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

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 lack of data necessitates careful clinical judgment in these cases.

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 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 monitoring vital signs, providing symptomatic treatment, and ensuring the patient's safety.

If available, consultation with a poison control center or a medical toxicologist is recommended to guide the management of the overdose effectively.

Documentation of the incident, including the substance involved, the amount taken, and the time of ingestion, is crucial for appropriate 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 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 this medication out of reach of children to prevent accidental ingestion or misuse. It is important to emphasize the necessity of proper storage to ensure the safety of young individuals.

Storage and Handling

The product is supplied in a configuration that includes a tamper-evident seal. It is essential to inspect the safety seal under the cap; the product should not be used if the seal is broken or missing.

For optimal storage, the product must be kept at room temperature, specifically within the range of 15-30 °C (59-86 °F). It is crucial to protect the product from moisture to maintain its integrity and effectiveness.

Additional Clinical Information

The medication is administered orally, with the recommended directions for use being to chew thoroughly 1 to 2 tablets as needed after meals and at bedtime. Patients should not exceed 6 tablets per day unless directed by a healthcare professional.

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.