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Gas Relief

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Active ingredient
Dimethicone 80 mg
Other brand names
Dosage form
Tablet, Chewable
Route
Oral
Prescription status
OTC (over the counter)
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Marketed in the U.S.
Since 1999
Label revision date
December 17, 2018
Drug Information (PDF)
Prescribing information, PDF file
Active ingredient
Dimethicone 80 mg
Other brand names
Dosage form
Tablet, Chewable
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 1999
Label revision date
December 17, 2018
Manufacturer
Advance Pharmaceutical Inc.
Registration number
part332
NDC root
17714-019
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

This medication is designed to relieve bloating, pressure, and discomfort caused by gas, which can result from certain foods or swallowing air. It works by alleviating the discomfort associated with gas, helping you feel more comfortable after meals or during times when gas buildup occurs.

If you experience gas-related discomfort, this product may provide the relief you need to feel better.

Uses

If you're experiencing bloating, pressure, or discomfort due to gas, this medication can help provide relief. These symptoms can often arise from certain foods you eat or from swallowing air. By taking this medication, you can find comfort and ease from these uncomfortable feelings.

It's important to note that this medication does not have any known harmful effects on developing babies (teratogenic effects), making it a safer option for those who may be pregnant.

Dosage and Administration

You can take 1 to 2 tablets of this medication as needed after meals and at bedtime. It's important to chew the tablets thoroughly to ensure they work effectively. However, be mindful not to exceed 6 tablets in a single day unless your doctor has specifically instructed you to do so. Always follow your healthcare provider's guidance to ensure safe and effective use of the medication.

What to Avoid

There are no specific contraindications, controlled substance classifications, or risks of abuse or misuse associated with this medication. Additionally, there are no concerns regarding dependence (a condition where the body becomes reliant on a substance).

Since there are no explicit "do not take" or "do not use" instructions, it is important to consult with your healthcare provider for personalized advice and to ensure this medication is appropriate for you. Always prioritize your health and safety by discussing any concerns or questions with a medical professional.

Side Effects

It's important to be aware of potential side effects when considering medication. If you are pregnant or breastfeeding, you should consult a healthcare professional before using this medication to ensure it is safe for you and your baby.

Always keep an eye out for any unusual reactions and discuss any concerns with your doctor. Your health and safety are the top priority.

Warnings and Precautions

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 be aware of your health and any changes you may experience while using this medication. If you notice any unusual symptoms or have concerns, don’t hesitate to stop using the medication and contact your doctor for advice. Your safety is the top priority.

Overdose

If you suspect an overdose, it's important to stay calm and take immediate action. While there is no specific information available about the signs of overdose for this medication, general 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 always better to be safe and get checked by a healthcare professional if you have any concerns about your health.

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. This precaution helps prevent accidental ingestion, which can be dangerous. Always store it in a safe place where children cannot access it, ensuring their safety at all times. If you have any concerns about how to manage medications in your home, don't hesitate to ask your healthcare provider for guidance.

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 differently due to your liver health.

Always consult your healthcare provider for personalized advice and to discuss any concerns you may have regarding your liver function and how it relates to your treatment. They can help ensure that your medication is safe and effective for you.

Drug Interactions

It's important to have open conversations with your healthcare provider about any medications you are taking, even if there are no known drug interactions or laboratory test interactions associated with them. This ensures that your treatment plan is safe and effective for your individual health needs.

Always keep your healthcare team informed about all the medications and supplements you use, as well as any lab tests you may undergo. This way, they can provide the best care tailored to you.

Storage and Handling

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

When handling the product, check the safety seal under the cap. If the seal is broken or missing, do not use the product, as this indicates it may have been tampered with. Following these guidelines will help you use the product safely and effectively.

Additional Information

You should take this medication orally by chewing 1 to 2 tablets as needed after meals and at bedtime. It's important not to exceed 6 tablets 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 the primary use of this drug?

This drug relieves bloating, pressure, and discomfort caused by gas, which can result from certain foods or swallowing air.

How should I take this medication?

You should chew thoroughly 1 to 2 tablets as needed after meals and at bedtime, but do not exceed 6 tablets per day unless directed by a physician.

Are there any warnings for pregnant or breastfeeding women?

Yes, if you are pregnant or breastfeeding, you should ask a health professional before use.

What should I do if I have children?

Keep this medication out of reach of children.

What are the storage instructions for this drug?

Store at room temperature between 15-30 °C (59-86 °F) and protect from moisture.

Are there any contraindications for this medication?

No specific contraindications are listed for this drug.

Is there any information regarding drug interactions?

No specific drug interactions are mentioned for this medication.

What should I do if the safety seal is broken?

Do not use the medication if the imprinted safety seal under the cap is broken or missing.

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

The product is identified by the National Drug Code (NDC) 17714-019-01 and is available in a dosage form of 100 chewable tablets.

Uses and Indications

This drug is indicated for the relief of bloating, pressure, and discomfort associated with gas, which may result from the consumption of certain foods or from air swallowing.

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

Dosage and Administration

Patients are advised to chew thoroughly 1 to 2 tablets as needed after meals and at bedtime. The maximum recommended dosage is 6 tablets per day, unless otherwise directed by a physician. It is important for healthcare professionals to monitor patient adherence to these guidelines to ensure safe and effective use of the medication.

Contraindications

There are no contraindications associated with the use of this product. It is not classified as a controlled substance, and there are no known risks of abuse, misuse, or dependence. Additionally, there are no specific instructions indicating that the product should not be taken or used under any circumstances.

Warnings and Precautions

Healthcare professionals should advise patients to consult with a healthcare provider if they are pregnant or breastfeeding prior to using this medication. This precaution is essential to ensure the safety of both the mother and the child, as potential risks may be associated with the use of the medication during these periods.

It is imperative that healthcare providers remain vigilant in assessing the appropriateness of this medication for individuals in these sensitive populations. Regular monitoring and open communication regarding any concerns or side effects should be encouraged to promote safe usage.

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 developing fetus or nursing infant.

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

No specific drug interactions have been identified for this medication. Additionally, there are no reported interactions with laboratory tests. Therefore, no dosage adjustments or monitoring recommendations are necessary based on drug or laboratory test 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 advised to keep this medication out of reach of children. Safety and efficacy in pediatric populations have not been established, and caution is advised when administering this medication to younger individuals.

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. The potential risks and benefits must be carefully considered, as the effects on fetal outcomes and breastfeeding infants 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 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 adhere to general principles of management in cases of suspected overdose.

It is essential to monitor the patient closely for any potential symptoms that may arise from an overdose. Symptoms can vary widely depending on the substance involved and the individual patient's response.

In the event of an overdose, immediate medical attention should be sought. Healthcare providers should implement supportive care measures, which may include maintaining airway patency, providing supplemental oxygen, and monitoring vital signs.

Additionally, it is recommended to consult local poison control centers or relevant toxicology resources for guidance on specific management protocols and antidotes, if applicable.

Documentation of the incident, including the amount and timing of the substance taken, is crucial for effective treatment and follow-up care.

Nonclinical Toxicology

There is currently no available information regarding teratogenic effects, non-teratogenic effects, or any relevant nonclinical toxicology data. Additionally, no details are provided concerning animal pharmacology and toxicology.

Postmarketing Experience

No postmarketing experience details are available in the insert.

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 and handling to ensure the safety of young individuals.

Storage and Handling

The product is supplied in a configuration that includes a tamper-evident seal. It is essential to inspect the safety seal under the cap; do not use the product if the seal is broken or missing.

For optimal storage, the product should be kept at room temperature, specifically within the range of 15-30 °C (59-86 °F). It is crucial to protect the product from moisture to maintain its integrity and effectiveness.

Additional Clinical Information

The medication is administered orally, with the recommended directions for use being to chew thoroughly 1 to 2 tablets as needed after meals and at bedtime. Patients should not exceed 6 tablets 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.