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Pepto

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Active ingredient
Dimethicone 250 mg
Other brand names
Dosage form
Capsule, Liquid Filled
Route
Oral
Prescription status
OTC (over the counter)
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Marketed in the U.S.
Since 2025
Label revision date
October 1, 2025
Drug Information (PDF)
Prescribing information, PDF file
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
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Marketed in the U.S.
Since 2025
Label revision date
October 1, 2025
Manufacturer
The Procter & Gamble Manufacturing Company
Registration number
M002
NDC root
84126-368
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

Simethicone is a medication designed to provide relief from bloating, pressure, fullness, and the uncomfortable feeling often associated with gas. It works by breaking up gas bubbles in the stomach and intestines, making it easier for your body to eliminate them.

You can find simethicone in products like Pepto Gas + Bloating, which offers targeted relief for gas-related discomfort. This particular formulation comes in a maximum strength of 250 mg and is available in softgel form, making it easy to take when you need quick relief from gas.

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 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) associated with it. This makes it a safe option for many individuals looking to find relief from gas-related discomfort.

Dosage and Administration

You can take this medication if you are an adult or a child aged 12 years and older. Simply swallow 1 to 2 softgels when you need relief from your symptoms, either after a meal or at bedtime. It's important to remember not to exceed 2 softgels in a 24-hour period unless your doctor has specifically instructed you to do so.

Following these guidelines will help ensure you use the medication safely and effectively. If you have any questions or concerns about your dosage, be sure to consult with your healthcare provider.

What to Avoid

It's important to keep this medication out of reach of children to ensure their safety. There are no specific contraindications, risks of abuse or misuse, or concerns about dependence associated with this medication. Always follow the guidance provided by your healthcare professional and use the medication as directed.

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. Your health and the health of your baby are paramount, so getting expert advice is crucial.

Make sure to keep this medication out of reach of children to prevent any accidental ingestion. Always prioritize safety in your home. If you experience any unusual symptoms or have concerns while using this medication, don’t hesitate to 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 always important to be aware of the signs of an overdose, which can include unusual drowsiness, confusion, or difficulty breathing. If you suspect an overdose, it’s crucial to seek immediate medical help.

In case of an emergency, contact your local poison control center 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 swallow 1-2 softgels as needed, either after a meal or at bedtime. However, you should not exceed 2 softgels in a 24-hour period unless directed by a doctor. Always consult with a healthcare professional if you have any questions or concerns about using this medication for yourself or 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 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 there are no specific guidelines or dosage adjustments mentioned for your condition in the available information. This means that the standard recommendations apply, but you should always consult your healthcare provider for personalized advice. They can help determine the best approach for your treatment and monitor your liver function as needed.

Make sure to keep your doctor informed about your liver health, as they may want to conduct regular tests to ensure your safety while using any medication. Your well-being is a priority, and your healthcare team is there to support you.

Drug Interactions

It's important to have open conversations with your healthcare provider about any medications or tests you may be taking. Currently, there are no specific drug interactions or laboratory test interactions noted for this medication. However, every individual’s health situation is unique, and your provider can help ensure that your treatment is safe and effective.

Always discuss any other medications, supplements, or health conditions with your healthcare provider to avoid potential issues and to receive personalized advice tailored to your needs.

Storage and Handling

To ensure the best performance of your product, store it at room temperature, ideally between 20°-25°C (68°-77°F). It's also important to keep it protected from light, as exposure can affect its effectiveness.

When handling the product, make sure to do so in a clean environment to maintain its integrity. Always follow any additional safety instructions provided to ensure safe use and disposal.

Additional Information

You can take this medication orally by swallowing 1-2 softgels as needed, either after a meal or at bedtime. It's important not to exceed 2 softgels in a 24-hour period unless your doctor advises otherwise. This guidance applies to both adults and children aged 12 years and older.

Currently, there is no additional information available regarding laboratory tests, abuse potential, or postmarketing experiences related to this medication.

FAQ

What is Simethicone used for?

Simethicone is used to relieve bloating, pressure, fullness, and the stuffed feeling commonly referred to as gas.

What is the recommended dosage for adults and children over 12?

Adults and children 12 years and over should swallow 1-2 softgels as needed after a meal or at bedtime, not exceeding 2 softgels in 24 hours unless directed by a doctor.

Are there any contraindications for using Simethicone?

There are no contraindications listed for Simethicone in the provided information.

Can I use Simethicone if I am pregnant or breastfeeding?

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

How should Simethicone be stored?

Simethicone should be stored at room temperature between 20°-25°C (68°-77°F) and protected from light.

What is the strength of Simethicone in Pepto Gas + Bloating?

The strength of Simethicone in Pepto Gas + Bloating is 250 mg per softgel.

What packaging does Simethicone come in?

Simethicone is packaged in a bottle containing 50 softgels.

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 effects associated with this drug. Additionally, no nonteratogenic effects have been reported.

Dosage and Administration

Adults and children aged 12 years and older may take 1 to 2 softgels as needed, or as symptoms occur, after a meal or at bedtime. It is important not to exceed 2 softgels within a 24-hour period unless directed by a healthcare professional.

Contraindications

There are no specific contraindications listed for this product. However, it is advised to keep the product out of reach of children to prevent accidental ingestion or misuse.

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.

In the absence of specific laboratory tests or emergency medical protocols, healthcare professionals are advised to remain vigilant and monitor patients for any adverse effects. Should any concerning symptoms arise, it is crucial for patients to discontinue use and contact their healthcare provider for further guidance.

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 are no known 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 kept out of reach of children. For adolescents aged 12 years and older, the recommended dosage is 1-2 softgels as needed, either after a meal or at bedtime. It is important not to exceed 2 softgels in a 24-hour period unless directed by a healthcare professional.

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.

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 regarding the excretion of this medication in breast milk or its effects on breastfed infants. Therefore, caution is recommended when considering the use of this medication during lactation.

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

In the absence of specific overdosage information, it is essential for healthcare professionals to remain vigilant regarding the potential for overdose with this medication. In cases where an overdose is suspected, immediate medical attention should be sought.

Healthcare providers are advised to monitor patients closely for any signs or symptoms that may indicate an overdose. These may include, but are not limited to, altered mental status, cardiovascular instability, or gastrointestinal disturbances.

Management of an overdose should be guided by the clinical presentation of the patient. Supportive care is paramount, and symptomatic treatment should be initiated as necessary. Healthcare professionals should also consider contacting a poison control center for additional guidance on the management of overdose cases.

In summary, while specific overdosage information is not available, prompt recognition and appropriate management of potential overdose symptoms are critical in ensuring patient safety.

Nonclinical Toxicology

If pregnant or breastfeeding, it is advised to consult a health professional prior to use. There are no specific non-teratogenic effects or nonclinical toxicology details available. Additionally, no specific information regarding animal pharmacology and toxicology has been provided.

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 packaging that includes specific NDC numbers. It should be stored at room temperature, within the range of 20° to 25°C (68° to 77°F). Care must be taken to protect the product from light to ensure its integrity and efficacy.

Additional Clinical Information

The medication is administered orally. For adults and children aged 12 years and older, the recommended dosage is to swallow 1-2 softgels as needed, either after a meal or at bedtime. Patients should not exceed 2 softgels within a 24-hour period 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 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.