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Extra Strength

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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
October 14, 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
October 14, 2025
Manufacturer
Raritan Pharmaceuticals Inc
Registration number
M002
NDC root
68163-700
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

NuRelief™ is an extra-strength liquid medication designed to relieve gas, bloating, and abdominal discomfort. It contains simethicone (125 mg), which works by alleviating the pressure, bloating, and fullness commonly associated with gas. This product is dye and sugar-free, naturally flavored with a tropical fruit taste, and comes in an 8 fluid ounce bottle, providing you with 48 doses for fast relief.

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) or nonteratogenic effects associated with this medication. This makes it a safe option for those looking to alleviate gas-related discomfort.

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; do not use this cup for any other medications. For adults, you can take either 5 mL or 10 mL after meals and at bedtime, but remember not to exceed 20 mL in a 24-hour period unless your doctor advises otherwise.

If you prefer soft gels, you can take up to 4 in a 24-hour period, but again, only do this if your doctor has instructed 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 medication 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 don't 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 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 children, do not exceed a dosage of 20 mL in any 24-hour period unless directed by a physician (a medical doctor). Always follow your healthcare provider's advice to ensure your child's safety and well-being.

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 always a good idea to discuss any medications with a healthcare provider. They can help ensure that the treatment is safe and appropriate, considering any unique health needs or conditions.

Since there are no dosage adjustments or special precautions mentioned for elderly patients, your healthcare provider will be the best resource for personalized advice. Always keep them informed about any other medications or health issues to help manage your care effectively.

Renal Impairment

If you have kidney issues, it's important to know that there are no specific guidelines, dosage adjustments, or monitoring requirements mentioned for your condition in the provided information. This means that the standard recommendations for medication use may apply to you without any special considerations. However, always consult your healthcare provider for personalized advice and to ensure your treatment is safe and effective based on your kidney health.

Hepatic Impairment

If you have liver problems, it's important to know that there are no specific guidelines, dosage adjustments, or special monitoring instructions provided for your condition in the available information. This means that the medication may not have been studied in depth for its effects on individuals with liver impairment.

Always consult your healthcare provider for personalized advice and to discuss any concerns you may have regarding your liver health and medication use. They can help ensure that your treatment is safe and effective based on your individual health needs.

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. It's important not to refrigerate it, as this can affect its effectiveness. Additionally, keep the product protected from light, heat, and moisture, as these elements can also compromise its quality.

When handling the product, make sure to do so in a clean environment to maintain its integrity. Following these storage and handling guidelines will help you use the product safely and effectively.

Additional Information

You should take this medication orally. If you are pregnant or breastfeeding, it's important to consult a healthcare professional before using it. Always keep this medication 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 medical attention is crucial even if you don't notice any symptoms.

FAQ

What is NuRelief™ used for?

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

What is the active ingredient in NuRelief™?

The active ingredient in NuRelief™ is Simethicone, which is used for anti-gas relief.

How should I take NuRelief™?

You 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 NuRelief™?

If you are pregnant or breastfeeding, you should ask a health professional before use. Additionally, keep it 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 right away at 1-800-222-1222.

Is NuRelief™ safe for children?

You should keep NuRelief™ out of reach of children, and it is important to consult a health professional for use in children.

How should I store NuRelief™?

Store NuRelief™ at room temperature, away from light, heat, and moisture. Do not refrigerate.

Does NuRelief™ have any contraindications?

There are no contraindications listed for NuRelief™.

What is the flavor of NuRelief™?

NuRelief™ is naturally flavored with a tropical fruit flavor.

How many doses are in a bottle of NuRelief™?

A bottle of NuRelief™ contains 48 doses.

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 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 or nonteratogenic effects associated with this drug.

Dosage and Administration

The product should be shaken well before use. Adults are advised to take either 5 mL or 10 mL using the dosing cup provided, as needed after meals and at bedtime. It is important to measure the dosage only with the dosing cup included with the product and not to use this cup with any other products.

The maximum recommended dosage is 20 mL within a 24-hour period, unless otherwise directed by a physician. Additionally, adults should not exceed 4 soft gels in a 24-hour period unless specifically instructed by a healthcare professional.

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 use 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 medication out of the reach of children to prevent accidental ingestion or misuse.

In the event of an overdose, immediate medical assistance is crucial. Patients 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 the patient does not exhibit any signs or symptoms of overdose.

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 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 are apparent.

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 necessary 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 is essential; caregivers are advised to contact a Poison Control Center at 1-800-222-1222, as prompt attention is critical even if no signs or symptoms are present.

For pediatric dosing, it is important not to exceed 20 mL within any 24-hour period unless directed by a physician. This precaution helps to mitigate potential risks associated with excessive intake in children.

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. It is important to assess the potential risks and benefits, as well as any available data regarding fetal outcomes and maternal health. 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 renal impairment, dosage adjustments, special monitoring, or safety considerations for patients with reduced kidney function. Healthcare professionals should exercise caution and consider individual patient factors when treating patients with renal impairment, as the absence of specific guidance necessitates careful clinical judgment.

Hepatic Impairment

There is no information available regarding the use of this medication in patients with hepatic impairment. Consequently, there are no dosage adjustments, special monitoring requirements, or precautions specified for individuals with compromised liver function. Healthcare professionals should exercise caution and consider the lack of data when prescribing this medication to patients with liver problems.

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 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 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 various package configurations, with specific NDC numbers available for identification. It is essential to store the product at room temperature, ensuring that it is not subjected to refrigeration. Care should be taken to protect the product from light, heat, and moisture to maintain its integrity and efficacy. Proper handling and storage conditions are crucial for optimal performance.

Additional Clinical Information

The medication is administered orally. Clinicians should advise patients who are pregnant or breastfeeding to consult a health professional prior to use. It is essential to keep the medication out of reach of children. In the event of an overdose, patients should seek immediate medical assistance or contact a Poison Control Center at 1-800-222-1222, as prompt medical attention is crucial, even if no symptoms are apparent.

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.