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Gas Relief

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This product has been discontinued

Active ingredient
Dimethicone 125 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 2013
Label revision date
October 26, 2012
Drug Information (PDF)
Prescribing information, PDF file
Active ingredient
Dimethicone 125 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 2013
Label revision date
October 26, 2012
Manufacturer
Navarro Discount Pharmacies, LLC
Registration number
part332
NDC root
59970-078
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

You may be experiencing discomfort from bloating, pressure, fullness, or a stuffed feeling often associated with gas. This medication is designed to help relieve these symptoms, providing you with comfort and ease. It works by addressing the underlying causes of these sensations, helping to restore a sense of normalcy in your digestive system. If you're looking for relief from these common issues, this medication could be a supportive option for you.

Uses

If you're experiencing discomfort from bloating, pressure, fullness, or that stuffed feeling often associated with gas, this medication can help provide relief. It’s designed specifically to address these common digestive issues, making it easier for you to feel comfortable and at ease.

You can trust that this medication does not have any teratogenic effects, meaning it does not cause developmental problems in a fetus if taken during pregnancy. This makes it a safer option for those who may be expecting.

Dosage and Administration

You can take this medication by swallowing 1 or 2 softgels with water after meals or at bedtime, depending on your needs. It's important not to exceed 4 softgels in a single day unless your doctor has specifically instructed you to do so. Always follow these guidelines to ensure safe and effective use of the medication.

What to Avoid

It's important to be aware of certain guidelines when using this medication. You should not take it if your condition persists, as this may indicate that the treatment is not effective for you. Always consult with your healthcare provider if you have any concerns or if your symptoms continue.

Currently, there are no specific contraindications, controlled substance classifications, or noted risks of abuse, misuse, or dependence associated with this medication. However, staying informed and communicating openly with your doctor is essential for your safety and well-being.

Side Effects

If you experience any persistent symptoms while using this medication, it's important to stop using it and consult your doctor. If you are pregnant or breastfeeding, please speak with a healthcare professional before using this product to ensure it is safe for you.

Always keep this medication out of reach of children. In the event of an overdose, seek medical assistance immediately or contact a Poison Control Center for help.

Warnings and Precautions

If you are pregnant or breastfeeding, it’s important to consult with a healthcare professional before using this medication to ensure it’s safe for you and your baby.

In the event of an overdose, seek emergency medical help or contact a Poison Control Center immediately. Additionally, if your condition does not improve or continues to persist, stop taking the medication and reach out to your doctor for further guidance.

Overdose

If you suspect an overdose, it’s crucial to seek medical help immediately or contact a Poison Control Center. Signs of an overdose can vary, but they may include unusual symptoms that require prompt attention.

Always err on the side of caution—if you think you or someone else may have taken too much of a medication, don’t hesitate to reach out for professional assistance. Your health and safety are the top priority.

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 professional 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 healthcare provider regarding your breastfeeding journey.

Pediatric Use

It's important to keep this medication out of reach of children to prevent accidental ingestion. If you are pregnant or breastfeeding, it's advisable to consult with a healthcare professional before using this medication to ensure it's safe for you and your child. Always prioritize safety and seek guidance if you have any concerns.

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 kidney function might affect the use of this medication.

Always consult your healthcare provider for personalized advice and to ensure that any treatment plan is safe and effective for your specific condition. They can help determine the best approach 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. In this case, there are no known drug interactions or interactions with laboratory tests for the medication in question. However, always ensure that your healthcare provider is aware of all the medications you are using, as well as any tests you may undergo, to ensure your safety and the effectiveness of your treatment. This way, you can avoid any potential issues and receive the best care possible.

Storage and Handling

To ensure the best performance of your product, store it at a controlled room temperature between 15-30°C (59-86°F). It's important to keep it away from heat and moisture, as these can affect its quality and effectiveness.

When handling the product, make sure to do so in a clean environment to maintain its integrity. Always follow any specific disposal instructions provided to ensure safe and responsible disposal. By following these guidelines, you can help ensure the product remains safe and effective for use.

Additional Information

You can take this medication orally by swallowing 1 or 2 softgels with water after meals or at bedtime, as needed. It's important not to exceed 4 softgels in a day unless your doctor advises otherwise. If you have any questions about how to use this medication, be sure to consult your healthcare provider for guidance.

FAQ

What is this drug used for?

This drug is used for the relief of bloating, pressure, fullness, and the stuffed feeling commonly referred to as gas.

How should I take this medication?

You should swallow 1 or 2 softgels with water as needed after meals or at bedtime. Do not exceed 4 softgels per day unless directed by a doctor.

Are there any contraindications for this drug?

There are no contraindications listed for this drug.

What should I do if my condition persists?

You should stop use and ask a doctor if your condition persists.

Is this drug safe to use during pregnancy or breastfeeding?

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

What should I do in case of an overdose?

In case of overdose, get medical help or contact a Poison Control Center right away.

How should I store this medication?

Store at a controlled room temperature of 15-30°C (59-86°F) and protect from heat and moisture.

Is there any information regarding drug interactions?

No drug interactions are listed for this medication.

Can children use this medication?

Keep this medication out of reach of children.

Packaging Info

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

Packaging configurations for Gas Relief.
Details

Drug Information (PDF)

This file contains official product information for Gas Relief, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)

Description

This product is identified by the code 51945-4 and is associated with the package label principal display panel. The effective date of this labeling is October 26, 2012. The product is represented visually by an image in JPEG format, referenced as "Gas Relief.nav.jpg." The labeling includes a multimedia component that provides an image description relevant to the product.

Uses and Indications

This drug is indicated for the relief of symptoms associated with gastrointestinal discomfort, specifically bloating, pressure, fullness, and the sensation of being stuffed, commonly referred to as gas.

There are no teratogenic or nonteratogenic effects associated with this drug.

Dosage and Administration

Adults are advised to swallow 1 or 2 softgels with water as needed after meals or at bedtime. The maximum recommended dosage is 4 softgels per day, unless otherwise directed by a healthcare professional. It is important to adhere to this dosage to ensure safety and efficacy.

Contraindications

There are no specific contraindications listed for this product. However, it is advised that the product should not be used if the condition persists.

Warnings and Precautions

Healthcare professionals should exercise caution when prescribing this medication, particularly in specific populations.

Pregnant or breastfeeding patients should consult a healthcare professional prior to use to ensure safety for both the mother and child.

In the event of an overdose, immediate medical assistance is crucial. Patients or caregivers should contact a Poison Control Center or seek emergency medical help without delay.

Additionally, if the patient's condition does not improve or persists, it is imperative to discontinue use and consult a physician for further evaluation and management.

Side Effects

Patients should be advised to stop use and consult a doctor if their condition persists. It is important for individuals who are pregnant or breastfeeding to seek guidance from a healthcare professional prior to use. Additionally, the product should be kept out of reach of children. In the event of an overdose, immediate medical assistance should be sought, or contact with a Poison Control Center is recommended.

Drug Interactions

There are no known drug interactions associated with the use of this medication. Additionally, no interactions with laboratory tests have been identified. Therefore, no dosage adjustments or monitoring recommendations are necessary based on drug interactions.

Packaging & NDC

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

Packaging configurations for Gas Relief.
Details

Pediatric Use

Pediatric patients should be kept out of reach of children to prevent accidental ingestion. Additionally, it is advised that individuals who are pregnant or breastfeeding consult a healthcare professional prior to use.

Geriatric Use

There is no specific information 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. Monitoring for potential adverse effects and therapeutic efficacy is recommended in 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 healthcare 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 mothers.

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

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 without delay. Prompt intervention is crucial to mitigate potential adverse effects associated with the overdose.

Healthcare professionals should be vigilant in monitoring for symptoms that may arise from an overdose. While specific symptoms are not detailed in the provided information, it is essential to assess the patient for any signs of toxicity or distress.

Management of an overdose should be guided by the severity of the symptoms and the clinical judgment of the healthcare provider. Supportive care and symptomatic treatment may be necessary, and the involvement of poison control experts can provide additional guidance on the appropriate management strategies.

In summary, timely medical intervention and thorough assessment are critical components in the management of overdose cases.

Nonclinical Toxicology

No teratogenic or non-teratogenic effects have been reported in the available nonclinical studies. Additionally, there is no information regarding animal pharmacology and toxicology. The absence of data limits the assessment of potential risks associated with the use of the compound in these contexts.

Postmarketing Experience

No postmarketing experience details are available in the insert text.

Patient Counseling

Healthcare providers should advise patients to seek immediate medical assistance or contact a Poison Control Center in the event of an overdose. It is crucial for patients to understand the importance of prompt action in such situations to ensure their safety.

Additionally, healthcare providers should instruct patients to discontinue use of the medication and consult a doctor if their condition persists. This guidance is essential to ensure that patients receive appropriate care and to prevent potential complications associated with prolonged use of the medication.

Storage and Handling

The product is supplied in various package configurations, with specific NDC numbers available for identification. It should be stored at a controlled room temperature between 15-30°C (59-86°F). Care must be taken to protect the product from heat and moisture to ensure its integrity and efficacy.

Additional Clinical Information

The medication is administered orally, with adults instructed to swallow 1 or 2 softgels with water after meals or at bedtime, not exceeding 4 softgels per day unless directed by a physician. 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 Gas Relief, 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 Gas Relief, 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.