Symptom checker
Select audience type

Switch between content for healthcare professionals (PRO) and general audience (GEN).

ADD CONDITION

items per page

Gas Relief

Last content change checked dailysee data sync status

Active ingredient
Dimethicone 125 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 2015
Label revision date
January 8, 2016
Drug Information (PDF)
Prescribing information, PDF file
Active ingredient
Dimethicone 125 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 2015
Label revision date
January 8, 2016
Manufacturer
Safeway
Registration number
part332
NDC root
21130-135
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

Simethicone is an extra strength gas relief medication designed to help alleviate discomfort caused by gas, pressure, and bloating in your digestive system. The active ingredient, simethicone (125 mg per tablet), works by breaking up gas bubbles, making it easier for your body to eliminate them.

This product is available in a pleasant peppermint flavor and comes in a package containing 18 chewable tablets, making it a convenient option for those seeking quick relief from gas-related discomfort.

Uses

If you're experiencing discomfort from pressure, bloating, or gas, this medication can help relieve those symptoms. It works effectively to ease the feeling of fullness and the discomfort associated with gas buildup in your digestive system. You can feel more comfortable and at ease after using it, allowing you to go about your day without the distraction of these uncomfortable sensations.

Dosage and Administration

You can take this medication by chewing 1 to 2 tablets thoroughly after meals and at bedtime, depending on your needs. It's important to remember not to exceed 4 tablets 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

There are no specific contraindications, controlled substance classifications, or risks of abuse, misuse, or dependence associated with this medication. This means that, based on the available information, you can use it without concerns about these particular issues. However, always consult with your healthcare provider for personalized advice and to ensure that this medication is appropriate for your individual health needs.

Side Effects

It's important to be aware of potential side effects when using this medication. You should keep it out of the reach of children to prevent accidental ingestion. In the event of an overdose, seek medical help or contact a poison control center right away.

While specific side effects are not detailed here, always monitor for any unusual reactions and consult your healthcare provider if you have concerns. Your safety is a priority, so staying informed is key.

Warnings and Precautions

It's important to keep this medication out of the reach of children to prevent accidental ingestion. If you suspect an overdose, seek medical help or contact a poison control center right away.

Always follow your doctor's instructions and let them know if you experience any unusual symptoms. If you have any concerns or questions about your treatment, don't hesitate to reach out to your healthcare provider for guidance.

Overdose

If you suspect an overdose, it’s crucial to seek medical help right away or contact a poison control center. Signs of an overdose can vary, but they may include unusual drowsiness, confusion, or difficulty breathing.

Don’t wait for symptoms to worsen; getting prompt assistance can be vital. Always prioritize your health and safety by reaching out for help if you think an overdose has occurred.

Pregnancy Use

If you are pregnant or planning to become pregnant, it's important to be aware that there is no specific information available regarding the use of this medication during pregnancy. This means that safety concerns, dosage adjustments, or any special precautions have not been established.

Before taking this medication, you should consult with your healthcare provider to discuss any potential risks and to ensure that you are making informed decisions for your health and the health of your baby. Always prioritize open communication with your doctor about any medications you are considering during pregnancy.

Lactation Use

If you are breastfeeding, you can feel reassured that there are no specific warnings or recommendations regarding the use of this product while nursing. Additionally, there are no statements about the product being excreted in breast milk or any associated risks for your infant. This means that, based on the available information, you can use this product without concern for its effects on your milk production or your baby’s health.

Pediatric Use

It's important to keep this medication out of the reach of children. If you suspect that a child has taken too much, seek medical help or contact a poison control center right away. Being aware of this precaution can help ensure your child's safety. Always supervise the use of medications and follow the recommended guidelines to prevent any accidental ingestion.

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. Since older adults may have different health needs and responses to medications, you should always consult with a healthcare provider before starting any new medication. They can help determine the right dosage and monitor for any potential side effects, ensuring that the treatment is safe and effective for you or your loved one.

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. This means that there are no tailored recommendations for how your kidney condition 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 situation. 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 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 ensure that any medication you take is safe and appropriate for your liver health. They can help monitor your condition and make any necessary adjustments to your treatment plan.

Drug Interactions

It's great to know that there are no reported drug interactions or laboratory test interactions with this medication. However, it's still very important to discuss all the 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 may start. Open communication is key to managing your health effectively.

Storage and Handling

To ensure the safety and effectiveness of your product, always check that none of the individual blister units are broken or open before use. Store the product at room temperature, and be mindful to keep it away from high humidity and excessive heat, which can be harmful if temperatures exceed 40°C (104°F).

By following these simple storage and handling guidelines, you can help maintain the quality of the product and ensure it works as intended.

Additional Information

You should take this medication orally by chewing 1 to 2 tablets thoroughly as needed after meals and at bedtime. It's important not to exceed 4 tablets in a 24-hour period unless directed by your doctor. Always follow your physician's advice for safe use.

FAQ

What is Simethicone used for?

Simethicone is used for extra strength gas relief, helping to relieve symptoms of gas discomfort, pressure, and bloating.

How should I take Simethicone?

You should chew 1 to 2 tablets thoroughly as needed after meals and at bedtime, but do not exceed 4 tablets in a 24-hour period unless advised by a physician.

Are there any contraindications for using Simethicone?

There are no contraindications listed for using Simethicone.

What should I do in case of an overdose?

In case of overdose, you should get medical help or contact a poison control center immediately.

Is Simethicone safe to use during pregnancy or while nursing?

There are no specific warnings or recommendations regarding the use of Simethicone during pregnancy or by nursing mothers.

What are the storage instructions for Simethicone?

Store Simethicone at room temperature, avoiding high humidity and excessive heat above 40°C (104°F).

What flavor does Simethicone come in?

Simethicone is available in a peppermint flavor.

How many tablets are in a package of Simethicone?

Each package of Simethicone contains 18 chewable tablets.

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

Simethicone is presented in a dosage form of chewable tablets, with each tablet containing 125 mg of simethicone. The product is flavored with peppermint to enhance palatability. It is indicated for the relief of symptoms associated with gas discomfort, pressure, and bloating. The product is supplied in a package containing 18 chewable tablets.

Uses and Indications

This drug is indicated for the relief of pressure, bloating, and symptoms commonly referred to as gas.

There are no teratogenic effects associated with this drug, and no nonteratogenic effects have been reported.

Dosage and Administration

Patients are advised to chew 1 to 2 tablets thoroughly as needed after meals and at bedtime. The maximum recommended dosage should not exceed 4 tablets within a 24-hour period, unless directed otherwise by a physician. It is essential for healthcare professionals to monitor patients for 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.

Warnings and Precautions

It is imperative to keep this medication out of the reach of children to prevent accidental ingestion and potential harm.

In the event of an overdose, immediate medical assistance should be sought. Healthcare professionals are advised to contact a poison control center without delay to ensure appropriate management and intervention.

Side Effects

Patients should be advised to keep this medication out of the reach of children. In the event of an overdose, it is crucial to seek medical assistance or contact a poison control center immediately.

No specific adverse reactions have been reported in clinical trials or postmarketing experiences; however, the importance of adhering to safety guidelines cannot be overstated.

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). 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. In the event of an overdose, it is crucial to seek medical assistance or contact a poison control center immediately.

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. It is advisable to monitor these patients closely for any adverse effects or changes in efficacy.

Pregnancy

There is no specific information regarding the use of this medication during pregnancy, including safety concerns, dosage modifications, or special precautions. Healthcare professionals should consider the lack of data when prescribing this medication to pregnant patients. It is advisable to weigh the potential benefits against any unknown risks to fetal outcomes. Women of childbearing potential should be counseled on the importance of effective contraception during treatment and should be informed of the need to discuss any plans for pregnancy with their healthcare provider.

Lactation

There are no specific warnings or recommendations regarding the use of this product by nursing mothers. Additionally, there are no statements concerning the potential for excretion in breast milk or any associated risks to breastfed infants.

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 medical assistance or contact a poison control center without delay. Prompt intervention is crucial to mitigate potential adverse effects associated with excessive intake of the medication.

Healthcare professionals should be vigilant for symptoms that may arise from an overdose, although specific symptoms are not detailed in the provided information. The management of an overdose typically involves supportive care and symptomatic treatment, tailored to the individual patient's needs.

It is essential for healthcare providers to remain informed about the appropriate protocols for managing overdose situations, ensuring that patients receive timely and effective care.

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 keep this medication out of the reach of children to prevent accidental ingestion or misuse. It is important for patients to understand the potential risks associated with improper access to the medication by young children. Providers should emphasize the necessity of storing the medication in a secure location, away from children's sight and reach, to ensure safety.

Storage and Handling

The product is supplied in individual blister units. It is imperative that the product is not used if any blister unit is found to be broken or open.

For optimal storage, the product should be kept at room temperature. It is essential to avoid exposure to high humidity and excessive heat, specifically temperatures exceeding 40°C (104°F), to maintain the integrity of the product.

Additional Clinical Information

The medication is administered orally, with the recommended direction for patients to chew 1 to 2 tablets thoroughly as needed after meals and at bedtime. Patients should not exceed 4 tablets within a 24-hour period unless advised and supervised by a physician. There is no additional information 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.