Symptom checker
Select audience type

Switch between content for healthcare professionals (PRO) and general audience (GEN).

ADD CONDITION

items per page

Pepto

Last content change checked dailysee data sync status

Active ingredient
Dimethicone 125 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 2026
Label revision date
January 20, 2026
Drug Information (PDF)
Prescribing information, PDF file
Active ingredient
Dimethicone 125 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 2026
Label revision date
January 20, 2026
Manufacturer
The Procter & Gamble Manufacturing Company
Registration number
M002
NDC root
84126-378
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 an antigas medication that helps relieve bloating, pressure, fullness, and the uncomfortable feeling often associated with gas. It works quickly, typically providing relief within minutes, making it a convenient option for those experiencing discomfort from gas buildup.

This medication is available in a mint-flavored formulation, specifically as Pepto Gas + Bloating, and comes in the form of 16 chewable tablets. If you're looking for targeted relief from gas-related discomfort, simethicone may be a suitable choice for you.

Uses

If you're experiencing discomfort from bloating, pressure, or a stuffed feeling often associated with gas, this medication can help relieve those symptoms. It works effectively to ease the discomfort that comes from feeling overly full or gassy.

You can use this medication to find relief from these common digestive issues, allowing you to feel more comfortable in your daily activities.

Dosage and Administration

When you need relief, adults and children aged 12 and older can chew 1 to 2 tablets as needed, either after a meal or at bedtime. It's important to chew or crush the tablets completely before swallowing them to ensure they work effectively. This way, you can manage your symptoms comfortably and at your convenience.

What to Avoid

It's important to use this medication responsibly. You should not take more than 4 chewable tablets within a 24-hour period. This guideline helps ensure your safety and the effectiveness of the treatment.

Currently, there are no specific contraindications, controlled substance classifications, or noted risks of abuse, misuse, or dependence associated with this medication. Always follow the recommended dosage to avoid any potential issues.

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 for your health and the health of your baby. Always prioritize safety and seek guidance when it comes to medication during these critical times.

Warnings and Precautions

If you are pregnant or breastfeeding, it’s important to consult a healthcare professional before using this medication. Always keep this product out of reach of children to ensure their safety.

Currently, there are no specific laboratory tests or emergency help instructions provided for this medication. If you experience any concerning symptoms or have questions about your health while using this product, please stop taking it and reach out to your doctor for guidance.

Overdose

It appears that there is no specific information available regarding overdosage for this medication. However, it's important to be aware of the general signs of an overdose, which can include symptoms like extreme drowsiness, confusion, or difficulty breathing. If you suspect an overdose, it’s crucial to seek immediate medical help.

In case of an emergency, you should call your local emergency number or go to the nearest hospital. Always keep medications out of reach of children and follow the prescribed dosage to prevent any potential risks. If you have any concerns or questions about your medication, don’t hesitate to reach out to your healthcare provider for guidance.

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 to ensure their safety. For adults and children aged 12 years and older, the recommended dosage is to chew 1-2 tablets as needed, either after a meal or at bedtime. Make sure to chew or crush the tablets completely before swallowing to ensure proper absorption. Always follow these guidelines to help manage symptoms effectively while keeping your child safe.

Geriatric Use

While there is no specific information available about the use of this medication in older adults, it’s important to approach any new treatment with caution. If you or a loved one is an older adult, it’s wise to discuss any potential risks or benefits with a healthcare provider. They can help determine the best course of action, considering any unique health needs or conditions.

Always keep in mind that older adults may have different responses to medications, so regular monitoring and open communication with your healthcare team are essential for safety and effectiveness.

Renal Impairment

If you have kidney problems, it's important to know that the information provided does not include specific guidelines for dosage adjustments, special monitoring, or safety considerations related to renal impairment (kidney issues). This means that there are no tailored recommendations for how your treatment may need to change based on your kidney function.

Always consult your healthcare provider for personalized advice and to ensure that your treatment plan is safe and effective for your specific situation. They can help monitor your kidney health and make any necessary adjustments to your medications.

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 at room temperature, ideally between 20°-25°C (68°-77°F). This temperature range helps maintain the integrity and effectiveness of the device.

When handling the product, make sure to do so in a clean environment to avoid contamination. Always follow any specific instructions provided for use to ensure safety and effectiveness. If you have any questions about disposal or further handling, please refer to the guidelines provided with your product.

Additional Information

You can take this medication orally by chewing 1-2 tablets as needed, either after a meal or at bedtime. Make sure to chew or crush the tablets completely before swallowing for the best effect. This guidance applies to both adults and children aged 12 years and older.

FAQ

What is Simethicone used for?

Simethicone is an antigas medication that relieves bloating, pressure, fullness, and the stuffed feeling commonly referred to as gas.

How should I take Simethicone?

Adults and children 12 years and over should chew 1-2 tablets as needed after a meal or at bedtime. Be sure to chew or crush the tablets completely before swallowing.

Are there any contraindications for using Simethicone?

There are no contraindications listed for Simethicone.

What should I do if I am pregnant or breastfeeding?

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

What is the maximum dosage for Simethicone?

Do not take more than 4 chewable tablets in a 24-hour period.

What is the flavor of Simethicone tablets?

Simethicone tablets are mint flavored.

How should Simethicone be stored?

Store Simethicone at room temperature between 20°-25°C (68°-77°F).

Is there any information on drug interactions with Simethicone?

No drug interactions information is provided for Simethicone.

What should I do if I keep Simethicone out of reach of children?

It is important to keep Simethicone out of reach of children to prevent accidental ingestion.

Packaging Info

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

Packaging configurations for Pepto.
Details

Drug Information (PDF)

This file contains official product information for Pepto, 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 bloating, pressure, fullness, and the sensation of being stuffed, commonly associated with gas.

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

Dosage and Administration

Adults and children aged 12 years and older are advised to chew 1 to 2 tablets as needed, or as symptoms occur, after a meal or at bedtime. It is essential that the tablets are chewed or crushed completely before swallowing to ensure proper administration and absorption.

Contraindications

There are no contraindications listed for this product. However, it is advised that patients do not exceed a maximum dosage of four chewable tablets within a 24-hour period to avoid potential adverse effects.

Warnings and Precautions

If a patient is pregnant or breastfeeding, it is imperative to consult a healthcare professional prior to use. This precaution is essential to ensure the safety of both the mother and the child.

General precautions should be observed, including keeping the product out of reach of children to prevent accidental ingestion or misuse.

Currently, there are no specific laboratory tests recommended for monitoring associated with the use of this product. Healthcare professionals should remain vigilant and assess the patient's overall health and any potential side effects during treatment.

In the event of an emergency, patients should seek immediate medical assistance. It is crucial for healthcare providers to educate patients on the importance of recognizing adverse reactions and the need for prompt medical intervention.

Patients are advised to discontinue use and contact their healthcare provider if they experience any concerning symptoms or side effects. Regular communication between patients and healthcare professionals is vital for ensuring safe and effective use of the product.

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 child during these sensitive periods.

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 Pepto (simethicone). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Pepto.
Details

Pediatric Use

Pediatric patients should be advised to keep this medication out of reach of children. For adolescents aged 12 years and older, the recommended dosage is to chew 1-2 tablets as needed, either after a meal or at bedtime. It is important that the tablets are chewed or crushed completely before swallowing to ensure proper administration.

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

Pregnant patients and those who are breastfeeding should consult a healthcare professional prior to using this medication. The potential risks and benefits must be carefully weighed, as the effects on fetal outcomes and lactation are not fully established. It is essential for women of childbearing potential to seek medical advice to ensure safe 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 on the excretion of this drug 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 prescribing information. There are no dosage adjustments, special monitoring requirements, or safety considerations outlined for individuals with reduced kidney function. Healthcare professionals should exercise caution and consider the lack of data when prescribing to 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 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

There is currently no specific information available regarding overdosage for this medication. Healthcare professionals are advised to monitor patients closely for any signs of adverse effects or symptoms that may arise from excessive dosing.

In the event of suspected overdosage, it is recommended that healthcare providers initiate supportive care and symptomatic treatment as necessary. Patients should be evaluated for potential complications, and appropriate interventions should be implemented based on clinical judgment.

For further guidance, healthcare professionals may refer to established protocols for managing drug overdosage or consult a poison control center.

Nonclinical Toxicology

If pregnant or breastfeeding, it is advised to consult a health professional prior to use. No specific non-teratogenic effects have been identified. Additionally, there are no detailed findings related to nonclinical toxicology or animal pharmacology and toxicology available.

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. It is important to inform patients not to exceed the recommended dosage of 4 chewable tablets within a 24-hour period, as taking more than the advised amount may lead to adverse effects.

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 20°-25°C (68°-77°F). Proper storage conditions are crucial to ensure the integrity and efficacy of the product.

Additional Clinical Information

The medication is administered orally. For adults and children aged 12 years and older, the recommended dosage is to chew 1-2 tablets as needed, either after a meal or at bedtime. It is important for patients to chew or crush the tablets completely before swallowing to ensure proper absorption.

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 Pepto, 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 Pepto, 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.