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Dimethicone

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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 2004
Label revision date
November 17, 2025
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 2004
Label revision date
November 17, 2025
Manufacturer
Geri-Care Pharmaceuticals, Corp
Registration number
M002
NDC root
57896-791
Drug Information (PDF)
Prescribing information, PDF file
Packaging Info (2 NDCs)
Packaging & NDC Codes (2)

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

You may find relief from discomfort caused by gas with this medication, which is designed to alleviate pressure, bloating, and fullness. It is commonly used to help you feel more comfortable when experiencing these symptoms, making daily activities easier and more enjoyable.

Uses

If you're experiencing discomfort from pressure, bloating, or a feeling of fullness often associated with gas, this medication can help relieve those symptoms. It's designed to ease the discomfort that can come from excess gas in your digestive system.

You can feel confident using this medication, as there are no known teratogenic effects (which means it doesn't cause birth defects) or other harmful effects noted. This makes it a safe option for managing your gas-related discomfort.

Dosage and Administration

To take this medication, start by chewing or crushing the tablet completely before swallowing it. If you are an adult or a child aged 12 years and older, you can take 1 to 2 tablets as needed after meals and at bedtime. However, it's important not to exceed 6 tablets in a 24-hour period unless your doctor has advised you otherwise.

If the patient is a child under 12 years old, you should consult a doctor before giving them this medication. Always follow these guidelines to ensure safe and effective use.

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 your individual health needs.

Side Effects

If you are pregnant or breastfeeding, it’s important to consult with a healthcare professional before using this medication. This ensures that you receive the best advice tailored to your specific situation. Always prioritize your health and the health of your baby when considering any medication.

Warnings and Precautions

If you are pregnant or breastfeeding, it’s important to consult with a healthcare professional before using this medication. This ensures that you understand any potential risks to you or your baby.

Always keep this medication out of reach of children to prevent accidental ingestion or misuse. If you suspect that a child has taken this medication, seek emergency help immediately.

Overdose

It appears that there is no specific information available regarding overdosage for this medication. However, it's always important to be aware of the signs of an overdose, which can include unusual drowsiness, confusion, or difficulty breathing. If you suspect that you or someone else may have taken too much of a medication, it’s crucial to seek immediate medical help.

In case of an overdose, contact your local emergency services or go to the nearest hospital. Having the medication packaging or information on hand can help medical professionals provide the best care. Always remember that when it comes to medications, it's better to be safe and get help if you have any concerns.

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

If you are considering this medication for your child, it's important to know that children under 12 years old should consult a doctor before use. For adults and children aged 12 years and older, the recommended dosage is 1 to 2 tablets as needed, taken after meals and at bedtime. Always follow your healthcare provider's advice to ensure safe and effective use.

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

It appears that there is no specific information regarding renal impairment (kidney problems) in the provided text. Therefore, there are no dosage adjustments, special monitoring, or safety considerations to discuss for patients with kidney issues. If you have concerns about how your kidney health may affect your medication or treatment, it's important to consult your healthcare provider for personalized advice and guidance.

Hepatic Impairment

If you have liver problems, it's important to know that the information provided does not include specific guidelines for dosage adjustments, special monitoring, or precautions related to your condition. This means that there are no tailored recommendations for how the medication may affect you differently due to your liver health.

Always consult your healthcare provider for personalized advice and to ensure that any treatment plan is safe and effective for your specific situation. They can help determine the best approach based on your liver function and overall health.

Drug Interactions

It's important to have open conversations with your healthcare provider about any medications or tests you may be taking. While there are no specific drug interactions or laboratory test interactions noted for this medication, your healthcare provider can help ensure that everything you are taking works well together and is safe for you. Always share your complete list of medications and any health conditions you have to receive the best care possible.

Storage and Handling

To ensure the best performance of your product, store it in a cool, dry place at a temperature between 20°-25°C (68°-77°F). It’s acceptable for the temperature to occasionally range from 15°-30°C (59°-86°F), but try to keep it within the recommended limits. Make sure to protect the product from moisture, as this can affect its quality.

When handling the product, check that the imprinted seal under the cap is intact. If the seal is missing or broken, do not use the product, as this could compromise its safety and effectiveness. Following these guidelines will help you use the product safely and effectively.

Additional Information

You will take this medication orally. There are no additional details available regarding laboratory tests, abuse potential, or patient counseling information. If you have any questions or concerns about your treatment, be sure to discuss them with your healthcare provider.

FAQ

What is the primary use of this drug?

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

How should I take this medication?

Adults and children 12 years and over should take 1-2 tablets as needed after meals and at bedtime. Chew or crush the tablet completely before swallowing.

What is the maximum dosage I can take in a day?

Do not exceed 6 tablets in 24 hours unless advised and supervised by a doctor.

Can children use this medication?

Children under 12 years should ask a doctor before use.

Are there any warnings for pregnant or breastfeeding women?

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

How should I store this medication?

Store at 20°-25°C (68°-77°F) and protect from moisture. Do not use if the imprinted seal under the cap is missing or broken.

Are there any contraindications for this drug?

No contraindications are listed for this drug.

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

No description information is available for the specified drug.

Uses and Indications

This drug is indicated for the relief of pressure, bloating, and fullness commonly associated with gas.

There are no teratogenic or nonteratogenic effects reported for this medication.

Dosage and Administration

Patients should chew or crush the tablet completely before swallowing to ensure proper absorption. For adults and children aged 12 years and older, the recommended dosage is 1 to 2 tablets taken as needed after meals and at bedtime. It is important not to exceed 6 tablets within a 24-hour period unless directed by a healthcare professional.

For children under 12 years of age, it is advised to consult a doctor before administration.

Contraindications

There are no contraindications associated with the use of this product. It is deemed safe for use in the absence of specific conditions or situations that would warrant avoidance.

Warnings and Precautions

Healthcare professionals are advised to exercise caution when prescribing this medication to pregnant or breastfeeding patients. It is imperative that patients consult with a healthcare professional prior to use in these circumstances to ensure safety and appropriateness of treatment.

Additionally, this medication should be stored securely and kept out of reach of children to prevent accidental ingestion or misuse. Proper storage practices are essential to safeguard against potential risks associated with pediatric exposure.

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

There are currently no documented drug interactions associated with this medication. Additionally, there is no information available regarding interactions with laboratory tests. As such, no specific recommendations for dosage adjustments or monitoring are warranted 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 under 12 years of age should consult a healthcare professional before use. For adolescents aged 12 years and older, the recommended dosage is 1-2 tablets taken as needed after meals and at bedtime.

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 efficacy, 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 important to assess the potential risks and benefits, as well as any available data regarding fetal outcomes and lactation. Healthcare providers can offer guidance tailored to individual circumstances, ensuring the safety of both the patient and the developing fetus or nursing infant.

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 information available regarding dosage adjustments, special monitoring, or safety considerations for patients with renal impairment. Healthcare professionals should exercise caution and consider the lack of specific guidance when prescribing to patients with reduced kidney function.

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 overdosage information, it is essential for healthcare professionals to remain vigilant and prepared for potential scenarios involving overdose.

Healthcare providers should be aware that the clinical presentation of an overdose may vary depending on the substance involved and the individual patient’s characteristics. Symptoms of overdose can range from mild to severe and may include altered mental status, cardiovascular instability, respiratory distress, and gastrointestinal disturbances.

In the event of suspected overdosage, immediate medical evaluation is recommended. Healthcare professionals should assess the patient's vital signs and conduct a thorough clinical examination. Supportive care should be initiated as necessary, which may include airway management, intravenous fluids, and monitoring of vital parameters.

If specific antidotes or treatments are available for the substance involved, they should be administered according to established protocols. Consultation with a poison control center or toxicology expert may also be warranted to guide management decisions.

It is crucial to document all findings and interventions in the patient's medical record and to report any adverse events to the appropriate regulatory authorities as required.

Nonclinical Toxicology

There is currently no available information regarding teratogenic effects, non-teratogenic effects, or any relevant nonclinical toxicology data. Additionally, no details are provided concerning animal pharmacology and toxicology.

Postmarketing Experience

No postmarketing experience details are available in the insert.

Patient Counseling

Healthcare providers should advise patients to keep this medication out of the reach of children to prevent accidental ingestion or misuse. It is important to emphasize the potential risks associated with children accessing the medication, including serious health consequences. Patients should be encouraged 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 upon request. It should be stored at a temperature range of 20°-25°C (68°-77°F), with permissible excursions between 15°-30°C (59°-86°F).

To ensure product integrity, it is essential to protect the product from moisture. Additionally, the product must not be used if the imprinted seal under the cap is missing or broken, as this may compromise safety and efficacy.

Additional Clinical Information

The medication is administered orally. There are no additional details available regarding laboratory tests, abuse information, 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.