Symptom checker
Select audience type

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

ADD CONDITION

items per page

Extra Strength

Last content change checked dailysee data sync status

Active ingredient
Dimethicone, Unspecified 125 mg/5 mL
Other brand names
Dosage form
Liquid
Route
Oral
Prescription status
OTC (over the counter)
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Marketed in the U.S.
Since 2020
Label revision date
December 19, 2025
Drug Information (PDF)
Prescribing information, PDF file
Active ingredient
Dimethicone, Unspecified 125 mg/5 mL
Other brand names
Dosage form
Liquid
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 2020
Label revision date
December 19, 2025
Manufacturer
KRAMER LABORATORIES
Registration number
M002
NDC root
55505-225
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

Kaopectate® is an extra strength gas relief liquid that contains simethicone (125 mg), a medication designed to help alleviate discomfort caused by gas. It works quickly, often providing relief from pressure, bloating, and fullness within minutes. This product is sugar-free and dye-free, making it a suitable option for those looking for a gentle solution to gas-related issues.

Uses

If you're experiencing discomfort from pressure, bloating, or a feeling of fullness often associated with gas, this medication can help provide relief. It's designed specifically to address these common digestive issues, making your day-to-day life more comfortable.

Rest assured, there are no known teratogenic effects (which means it doesn't cause birth defects) associated with this medication, so it is considered safe in that regard.

Dosage and Administration

Before using this medication, make sure to shake the bottle well. It's important to measure your dose accurately using the dosing cup that comes with the product. You should not use this cup for any other products to avoid confusion.

For adults, the recommended dose is either 5 mL or 10 mL, taken as needed after meals and at bedtime. However, be cautious not to exceed 20 mL in a 24-hour period unless your doctor has specifically advised you to do so. Always follow these guidelines 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 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 a healthcare professional before using this medication. Additionally, keep this product out of reach of children. In the event of an overdose, seek medical help immediately or contact a Poison Control Center at 1-800-222-1222, as prompt attention is crucial even if you do not notice any symptoms.

Warnings and Precautions

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

In the event of an overdose, seek medical help immediately or contact a Poison Control Center at 1-800-222-1222. Quick medical attention is crucial, even if you do not notice any signs or symptoms of an overdose.

Overdose

If you suspect an overdose, it’s important to seek medical help immediately. You can contact a Poison Control Center at 1-800-222-1222 for guidance. Quick action is crucial, even if you don’t notice any signs or symptoms of an overdose.

Signs of an overdose can vary, but they may include unusual drowsiness, confusion, or difficulty breathing. If you or someone else is experiencing these symptoms, don’t hesitate to get help right away. Remember, acting quickly can make a significant difference in the outcome.

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 prevent accidental ingestion. If you suspect an overdose, seek medical help immediately or contact a Poison Control Center at 1-800-222-1222. Quick action is crucial, even if your child shows no signs or symptoms of overdose.

For safety, ensure that your child does not take more than 20 mL in a 24-hour period unless directed by a doctor. Always follow your healthcare provider's advice regarding dosage and supervision when it comes to administering this medication to children.

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 for personalized advice. 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 is safe and effective for your specific condition. They can help determine the best approach for managing your health, especially if you have concerns about your kidneys.

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 feel free to ask questions and share your complete list of medications and any lab tests you may be undergoing. This way, you can receive the best possible care tailored to your needs.

Storage and Handling

To ensure the best performance of your product, store it at room temperature between 20° and 25°C (68° and 77°F). It's important not to refrigerate the product, as this can affect its effectiveness. Additionally, make sure to protect it from light, heat, and moisture, as these elements can also compromise its quality.

When handling the product, always do so in a clean environment to maintain its integrity. Following these storage and handling guidelines will help ensure that the product remains safe and effective for your use.

Additional Information

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

FAQ

What is Kaopectate® used for?

Kaopectate® is used for the relief of pressure, bloating, and fullness commonly referred to as gas.

What is the active ingredient in Kaopectate®?

The active ingredient in Kaopectate® is Simethicone, which is an anti-gas agent at a dosage of 125mg.

How quickly does Kaopectate® work?

Kaopectate® starts to work in minutes to relieve gas fast.

What is the recommended dosage for adults?

Adults should take 5 mL or 10 mL in the dosing cup provided as needed after meals and at bedtime, but do not exceed 20 mL in any 24-hour period unless advised by a physician.

Are there any warnings for using Kaopectate®?

If you are pregnant or breastfeeding, you should ask a health professional before use. Keep out of reach of children.

What should I do in case of an overdose?

In case of overdose, get medical help or contact a Poison Control Center immediately at 1-800-222-1222.

How should I store Kaopectate®?

Store Kaopectate® at 20° – 25°C (68° – 77°F) and protect it from light, heat, and moisture. Do not refrigerate.

Does Kaopectate® contain any sugar or dye?

Kaopectate® is sugar-free and dye-free.

How many doses are in a bottle of Kaopectate®?

A bottle of Kaopectate® contains 48 doses.

Who distributes Kaopectate®?

Kaopectate® is distributed by Kramer Laboratories, Inc., located in Bridgewater, NJ.

Packaging Info

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

Packaging configurations for Extra Strength.
Details

Drug Information (PDF)

This file contains official product information for Extra Strength, 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 referred to as gas.

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

Dosage and Administration

Healthcare professionals should instruct patients to shake the product well before use. The recommended dosage for adults is either 5 mL or 10 mL, administered using the dosing cup provided, as needed after meals and at bedtime.

It is imperative that patients do not exceed a maximum of 20 mL in any 24-hour period unless advised and supervised by a physician. The dosing cup provided should be used exclusively for this product and not with any other products to ensure accurate measurement.

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 should advise patients to consult with a health professional prior to using this product if they are pregnant or breastfeeding. This precaution is essential to ensure the safety of both the patient and the developing fetus or nursing infant.

It is imperative to keep this product out of the reach of children to prevent accidental ingestion or misuse.

In the event of an overdose, immediate medical assistance is crucial. Patients or caregivers should be instructed to seek medical help or contact a Poison Control Center at 1-800-222-1222 without delay. Quick medical attention is critical, even if no signs or symptoms of overdose are apparent.

Side Effects

Patients should be advised to consult a health professional if they are pregnant or breastfeeding before using this medication. It is essential to keep this product out of the reach of children to prevent accidental ingestion.

In the event of an overdose, immediate medical assistance should be sought, or the Poison Control Center should be contacted at 1-800-222-1222. Quick medical attention is critical, even if no signs or symptoms of overdose are apparent.

Drug Interactions

There are currently no documented drug interactions associated with the use of 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 Extra Strength (simethicone). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Extra Strength.
Details

Pediatric Use

Pediatric patients should be closely monitored to ensure that the medication is kept out of reach of children. In the event of an overdose, immediate medical assistance should be sought, and caregivers are advised to contact a Poison Control Center at 1-800-222-1222. Prompt medical attention is crucial, even if no signs or symptoms are apparent.

It is important to note that pediatric patients should not exceed a dosage of 20 mL within a 24-hour period unless directed and supervised by a physician. This precaution helps to mitigate the risk of potential adverse effects associated with higher dosages.

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

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 considered, as the effects on fetal outcomes and lactation are not fully established. It is essential for women of childbearing potential to discuss their individual circumstances with a healthcare provider 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 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 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 overdose, it is imperative to seek immediate medical assistance or contact a Poison Control Center at 1-800-222-1222. Prompt medical intervention is crucial, even in the absence of noticeable signs or symptoms. Healthcare professionals should be aware that early recognition and management of an overdose can significantly impact patient outcomes.

It is essential to monitor the patient closely for any potential symptoms that may arise following an overdose. The specific manifestations can vary depending on the substance involved and the amount ingested. Therefore, a thorough assessment and appropriate supportive care should be initiated as soon as possible.

In summary, the key steps in managing an overdose include rapid medical evaluation, contacting poison control, and vigilant monitoring for symptoms, ensuring that the patient receives the necessary care without delay.

Nonclinical Toxicology

If pregnant or breast-feeding, 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 on the importance of seeking immediate medical assistance in the event of an overdose. Patients should be informed to contact a Poison Control Center at 1-800-222-1222 without delay. It is crucial to emphasize that prompt medical attention is necessary, even if the patient does not exhibit any signs or symptoms of an overdose. This information is vital for ensuring patient safety and effective management of potential overdose situations.

Storage and Handling

The product is supplied in packaging that ensures its integrity during storage. It should be stored at a temperature range of 20° to 25°C (68° to 77°F). Refrigeration is not recommended, as the product must be kept at room temperature. Additionally, it is essential to protect the product from light, heat, and moisture to maintain its efficacy and safety. Proper handling and storage conditions are crucial to preserving the quality of the product throughout its shelf life.

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 Extra Strength, 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 Extra Strength, 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.