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Extra Strength 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 2021
Label revision date
December 30, 2024
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 2021
Label revision date
December 30, 2024
Manufacturer
Better Living Brands LLC
Registration number
M002
NDC root
21130-317
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

Gas Relief is a medication designed to help alleviate the discomfort associated with pressure, bloating, and fullness that many people experience due to gas. It works by targeting the symptoms of gas, providing you with relief when you need it most. If you're feeling uncomfortable from gas, Gas Relief may be a helpful option to consider.

Uses

You can use this medication to help relieve the discomfort of pressure, bloating, and fullness that often comes from gas. It’s designed to make you feel more comfortable by addressing these common digestive issues.

Rest assured, there are no known teratogenic effects (which means it doesn’t cause birth defects) associated with this medication, making it a safer option for those who may be concerned about such risks.

Dosage and Administration

You can take this medication by swallowing 1 or 2 softgels with water after meals and at bedtime, depending on your needs. It's important to remember not to exceed 4 softgels in a 24-hour period unless your doctor advises you otherwise. Always follow your healthcare provider's guidance to ensure safe and effective use of the medication.

What to Avoid

You can feel confident using this medication, as there are no specific contraindications, controlled substance classifications, or concerns regarding abuse, misuse, or dependence mentioned. This means that, based on the information provided, there are no particular conditions or risks that you need to avoid when considering this treatment. Always remember to follow your healthcare provider's guidance and reach out if you have any questions or concerns about your medication.

Side Effects

It's important to keep this medication out of reach of children to prevent accidental ingestion. If you have any concerns about side effects or how to use this medication safely, please consult your healthcare provider for guidance.

Warnings and Precautions

It’s important to keep this medication out of reach of children to prevent accidental ingestion, which can be dangerous.

If you experience any unusual symptoms or side effects, stop using the medication and call your doctor immediately. Additionally, if you have any concerns about your health or the effects of this medication, don’t hesitate to reach out to your healthcare provider for guidance.

Overdose

If you suspect an overdose, it's important to stay calm and take immediate action. While the specific signs of an overdose are not detailed, common symptoms can include unusual drowsiness, confusion, or difficulty breathing. If you notice any of these signs, or if you are unsure, seek medical help right away.

In case of an overdose, contact your local emergency services or go to the nearest hospital. It's crucial to provide them with as much information as possible about the substance taken and the amount, if known. Remember, acting quickly can make a significant difference in your health and safety.

Pregnancy Use

When considering the use of Extra Strength Gas Relief (simethicone) during pregnancy, it's important to note that there is no specific information available about its safety, dosage adjustments, or any special precautions for pregnant individuals. This means that the effects of this medication on pregnancy have not been studied or documented.

If you are pregnant or planning to become pregnant, it's always best to consult with your healthcare provider before taking any medication, including over-the-counter products like simethicone. They can help you weigh the potential benefits and risks based on your individual health needs.

Lactation Use

If you are breastfeeding and considering using Extra Strength Gas Relief (simethicone), it's important to note that there is no specific information available about its effects on nursing mothers or lactation. This means that the safety and potential impact on your breast milk or your nursing infant are not well-studied.

As always, it's best to consult with your healthcare provider before taking any medication while breastfeeding. They can help you weigh the benefits and risks based on your individual situation.

Pediatric Use

It's important to keep this medication out of reach of children to ensure their safety. For adults, the recommended dosage is to swallow 1 or 2 softgels with water after meals and at bedtime, but you should not exceed 4 softgels in a 24-hour period unless directed by a doctor.

If you have any questions about using this medication for children or need specific guidance, it's best to consult with a healthcare professional. Always prioritize safety and follow the recommended guidelines.

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 the drug insert does not provide specific information about dosage adjustments, special monitoring, or precautions for your condition. This means that there are no tailored guidelines for how this medication may affect you if you have hepatic impairment (liver issues).

Always consult your healthcare provider for personalized advice and to discuss any concerns regarding your liver health and how it may relate to your treatment. They can help ensure that you receive the safest and most effective care.

Drug Interactions

It's great to know that there are no reported drug interactions or interactions with laboratory tests for this medication. However, it's still very important to discuss all medications you are taking, including over-the-counter drugs and supplements, with your healthcare provider. This ensures that your treatment is safe and effective, and helps avoid any potential issues.

Always keep your healthcare provider informed about any changes in your health or medications, as they can provide personalized advice tailored to your specific situation. Your safety and well-being are the top priority!

Storage and Handling

To ensure the best performance of your product, store it at a controlled room temperature between 20-25°C (68-77°F). It's important to keep it away from light, heat, and moisture, as these elements 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 safety and compliance. By taking these precautions, you can help ensure that the product remains safe and effective for use.

Additional Information

You should take this medication orally by swallowing 1 or 2 softgels with water after meals and at bedtime, as needed. It's important not to exceed 4 softgels in a 24-hour period unless directed by your doctor. Always follow your healthcare provider's advice regarding the use of this medication.

FAQ

What is Gas Relief used for?

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

How should I take Gas Relief?

Adults should swallow 1 or 2 softgels with water as needed after meals and at bedtime. Do not exceed 4 softgels in 24 hours unless advised by a physician.

Are there any contraindications for Gas Relief?

No contraindications are listed for Gas Relief in the provided information.

Is Gas Relief safe to use during pregnancy?

There is no specific information regarding the use of Gas Relief during pregnancy.

Can I use Gas Relief while breastfeeding?

The provided information does not include specific details about the use of Gas Relief while breastfeeding.

What should I do if I have children at home?

Keep Gas Relief out of reach of children to ensure their safety.

What is the storage requirement for Gas Relief?

Store Gas Relief at a controlled room temperature of 20-25°C (68-77°F) and protect it from light, heat, and moisture.

Are there any known side effects of Gas Relief?

No side effects or drug interactions are mentioned in the provided information.

Packaging Info

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

Packaging configurations for Extra Strength Gas Relief.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

The product is identified by SPL Code 34089-3 and is formulated for gas relief. It is available in a package containing 50 count units.

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

Adults should swallow 1 or 2 softgels with water as needed after meals and at bedtime. The maximum recommended dosage is 4 softgels within a 24-hour period, unless otherwise directed by a physician. It is essential to adhere to this guideline to ensure safe and effective use of the medication.

Contraindications

There are no contraindications listed for this product. It is important to evaluate individual patient circumstances and consult relevant clinical guidelines when considering its use.

Warnings and Precautions

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

Healthcare professionals should remain vigilant regarding the potential risks associated with this medication. Regular monitoring of patients is recommended to ensure safety and efficacy during treatment. Specific laboratory tests may be necessary to assess the patient's response to therapy and to identify any adverse effects promptly.

In summary, adherence to these precautions is essential for the safe administration of this medication.

Side Effects

Patients should be advised to keep the medication out of reach of children. This precaution is essential to prevent accidental ingestion or misuse, which could lead to serious adverse reactions.

In clinical trials and postmarketing experiences, no specific adverse reactions were reported; however, the importance of safeguarding the medication from children cannot be overstated. It is crucial for patients and caregivers to be aware of this warning to ensure the safety and well-being of children.

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 Extra Strength Gas Relief (simethicone). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Extra Strength Gas Relief.
Details

Pediatric Use

Pediatric patients should be advised to keep this medication out of reach of children. The recommended dosage for adults is 1 or 2 softgels taken with water after meals and at bedtime, with a maximum of 4 softgels in a 24-hour period unless directed otherwise by a physician. There is no specific pediatric dosing information provided, and caution should be exercised when considering use in children.

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

There is no information available regarding the use of Extra Strength Gas Relief (simethicone) during pregnancy. Consequently, the safety of this medication in pregnant patients has not been established, and there are no specific dosage modifications or special precautions recommended for use in this population. Healthcare professionals should consider the lack of data when advising women of childbearing potential and weigh the potential benefits against any unknown risks when prescribing this medication during pregnancy.

Lactation

There is no specific information available regarding the use of Extra Strength Gas Relief (simethicone) in nursing mothers or its effects on lactation. Consequently, healthcare professionals should exercise caution when recommending this medication to lactating mothers, as the potential excretion of simethicone in breast milk and its effects on breastfed infants have not been established.

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 information regarding overdosage, healthcare professionals are advised to exercise caution and consider the potential risks associated with excessive administration of the medication.

It is essential to monitor patients closely for any signs or symptoms that may arise from an overdose. Symptoms of overdosage can vary widely depending on the medication involved and may include, but are not limited to, increased severity of known side effects, altered mental status, cardiovascular instability, or gastrointestinal disturbances.

In the event of suspected overdosage, immediate medical intervention is recommended. Healthcare providers should initiate supportive care and symptomatic treatment as necessary. It is advisable to contact a poison control center or consult the relevant medical literature for guidance on specific management protocols tailored to the medication in question.

Documentation of the incident, including the amount ingested and the time of exposure, is crucial for effective management and follow-up care. Continuous monitoring of the patient's vital signs and clinical status is also recommended until they are stabilized.

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 in these areas limits the understanding of the compound's potential effects in nonclinical settings.

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 various package configurations, with specific NDC numbers available upon request. It should be stored at a controlled room temperature of 20-25°C (68-77°F). Care must be taken to protect the product from light, heat, and moisture to ensure its integrity and efficacy.

Additional Clinical Information

The medication is administered orally, with adults advised to swallow 1 or 2 softgels with water after meals and at bedtime. Patients should not exceed a total of 4 softgels within a 24-hour period unless directed by a physician. There is no additional information available regarding laboratory tests, abuse potential, patient counseling, or postmarketing experiences.

Drug Information (PDF)

This file contains official product information for Extra Strength 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 Extra Strength 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.