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Gas Relief

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This product has been discontinued

Active ingredient
Dimethicone 180 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 2009
Label revision date
March 22, 2016
Drug Information (PDF)
Prescribing information, PDF file
Active ingredient
Dimethicone 180 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 2009
Label revision date
March 22, 2016
Manufacturer
We Care Distributor Inc.
Registration number
part332
NDC root
70005-019
Drug Information (PDF)
Prescribing information, PDF file
Packaging Info (3 NDCs)
Packaging & NDC Codes (3)

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

Simethicone Softgels, 80 mg, are a medication designed to help relieve discomfort caused by pressure, bloating, and fullness that is commonly associated with gas. This product works by breaking up gas bubbles in the stomach and intestines, making it easier for your body to eliminate them.

Typically available in pouches containing two softgels each, Simethicone is comparable to the active ingredients found in Gas-X Ultra Strength, providing effective relief for those experiencing gas-related discomfort.

Uses

You can use this medication to help relieve discomfort caused by pressure, bloating, and fullness that is often associated with gas. It’s designed to make you feel more comfortable when you experience these common digestive issues.

Rest assured, there are no known teratogenic effects (which means it doesn’t cause birth defects) or nonteratogenic effects (which refers to other types of harmful effects) associated with this medication.

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 not to exceed 2 softgels in a 24-hour period unless your doctor advises you to do so.

Make sure to take the softgels orally (by mouth) and always drink water with them to help with swallowing. Remember, you can use this medication as needed, but keep track of how many softgels you take to stay within the recommended limit.

What to Avoid

It's important to be aware of certain precautions when using this medication. While there are no specific contraindications or risks of abuse, misuse, or dependence associated with it, you should take immediate action if you suspect an overdose. In such cases, seek medical help or contact a Poison Control Center right away to ensure your safety. Always prioritize your health and well-being by following these guidelines.

Side Effects

It's important to be aware of some key warnings associated with this medication. If you are pregnant or breastfeeding, you should consult a healthcare professional before using it. Additionally, keep this medication out of reach of children. In the event of an overdose, seek medical help or contact a Poison Control Center immediately.

Taking these precautions can help ensure your safety and the safety of those around you.

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 ensure their safety.

In the event of an overdose, seek medical help immediately or contact a Poison Control Center. Your health and safety are paramount, so don’t hesitate to get assistance if you think you may have taken too much.

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 are more severe than what you would typically experience with the medication.

Always err on the side of caution—if you notice anything concerning, don’t hesitate to reach out for 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 suspect that your child has taken too much, seek medical help immediately or contact a Poison Control Center for guidance. Always prioritize safety and be vigilant about where medications are stored.

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 (issues with liver function).

Always consult your healthcare provider for personalized advice and to discuss any concerns 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 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 new medications you start. Open communication is key to managing your health effectively.

Storage and Handling

To ensure the best performance of your product, store it at a controlled room temperature between 20° and 25°C (68° and 77°F). It's important to keep it away from moisture, as this 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 instructions provided for safe use and disposal to ensure your safety and the product's effectiveness.

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 2 softgels in a 24-hour period unless directed by your doctor. Always follow your physician's advice for safe use.

FAQ

What is Simethicone Softgels used for?

Simethicone Softgels are used for relief of pressure, bloating, and fullness commonly referred to as gas.

How should I take Simethicone Softgels?

You should swallow 1 or 2 softgels with water as needed after meals and at bedtime, without exceeding 2 softgels in 24 hours unless advised by a physician.

Are there any contraindications for using Simethicone Softgels?

There are no contraindications listed for Simethicone Softgels.

What should I do in case of an overdose?

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

Can I use Simethicone Softgels if I am pregnant or breastfeeding?

If you are pregnant or breastfeeding, you should ask a health care professional before using Simethicone Softgels.

How should I store Simethicone Softgels?

Store Simethicone Softgels at controlled room temperature between 20°-25°C (68°-77°F) and protect them from moisture.

Are there any side effects associated with Simethicone Softgels?

No specific side effects are mentioned in the provided information.

Packaging Info

Below are the non-prescription pack sizes of Gas Relief (simethicone 180 mg). 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

Simethicone Softgels contain 80 mg of simethicone per softgel. The product is packaged in 25 pouches, with each pouch containing 2 softgels.

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 are instructed to swallow 1 or 2 softgels with water as needed after meals and at bedtime. The maximum dosage should not exceed 2 softgels within a 24-hour period, unless directed and supervised by a physician.

The route of administration is oral, and the method involves swallowing the softgels with water. It is essential to adhere to the specified frequency of administration, which is as needed after meals and at bedtime.

Contraindications

There are no specific contraindications listed for this product. However, in the event of an overdose, it is imperative to seek medical assistance or contact a Poison Control Center immediately.

Warnings and Precautions

Healthcare professionals are advised to exercise caution when prescribing this medication to pregnant or breastfeeding patients. It is imperative that patients consult with their healthcare provider prior to use to ensure safety for both the mother and child.

This medication should be stored securely and kept out of reach of children to prevent accidental ingestion or misuse.

In the event of an overdose, immediate medical assistance is crucial. Healthcare providers should instruct patients to seek medical help or contact a Poison Control Center without delay to mitigate potential risks associated with overdose.

Side Effects

Patients should be advised of the following warnings regarding the use of this medication. It is important to consult a healthcare professional if pregnant or breastfeeding before use. Additionally, the medication should be kept out of reach of children. In the event of an overdose, patients or caregivers should seek medical assistance or contact a Poison Control Center immediately.

These precautions are essential to ensure the safety and well-being of patients and to mitigate potential risks associated with the medication.

Drug Interactions

There are no documented 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 180 mg). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Gas Relief.
Details

Pediatric Use

Pediatric patients should be monitored closely, and the medication must be kept out of reach of children to prevent accidental ingestion. In the event of an overdose, it is crucial to seek medical assistance immediately or contact a Poison Control Center for guidance.

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 weighed, as the effects on fetal outcomes and lactation are not fully established. It is essential for women of childbearing potential to seek medical advice to ensure safe use during pregnancy and lactation.

Lactation

Lactating mothers are advised to consult a healthcare professional prior to using this medication. There is currently no available data on the excretion of this drug 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 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.

Nonclinical Toxicology

There is currently no available information regarding teratogenic or non-teratogenic effects associated with the compound. Additionally, no data has been provided concerning nonclinical toxicology, including animal pharmacology and toxicology.

Postmarketing Experience

No postmarketing experience details are available in the provided data.

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 and well-being.

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° to 25°C (68° to 77°F). Care must be taken to protect the product from 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 as needed after meals and at bedtime. It is important for patients not to exceed 2 softgels within a 24-hour period unless advised and supervised by a physician. No additional information is available regarding laboratory tests, abuse potential, 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.