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Gas Relief

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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 2021
Label revision date
May 10, 2025
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 2021
Label revision date
May 10, 2025
Manufacturer
United Natural Foods, Inc. dba UNFI
Registration number
M002
NDC root
41163-408
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

EQUALINE® is an extra strength gas relief medication available in chewable tablet form, containing 125 mg of simethicone (a substance that helps reduce gas in the digestive tract). It is designed to provide relief from pressure, bloating, and discomfort commonly associated with gas.

These cherry-flavored tablets work by breaking up gas bubbles in your stomach and intestines, making it easier for your body to eliminate them. If you're experiencing uncomfortable feelings of fullness or bloating, EQUALINE® may help you find relief.

Uses

If you're experiencing discomfort from pressure, bloating, or a feeling of fullness often associated with gas, this medication can help provide relief. It's designed specifically to address these common digestive issues, making your day-to-day life more comfortable.

Rest assured, there are no known teratogenic effects (which means it doesn't cause birth defects) or nonteratogenic effects associated with this medication. This makes it a safe option for those looking to alleviate gas-related discomfort.

Dosage and Administration

When using this medication, it's important to follow the instructions carefully. You should not take more than the recommended amount. If you're using chewable tablets, make sure to chew or crush them completely before swallowing; do not swallow them whole.

For adults and children aged 12 years and older, you can take 1 or 2 chewable tablets as needed after meals and at bedtime. However, be cautious not to exceed 4 chewable tablets in a 24-hour period unless your doctor advises otherwise. If the patient is a child under 12 years old, it's best to consult a doctor before giving them this medication.

What to Avoid

You can feel confident using this medication, as there are no specific contraindications (conditions that would prevent you from taking it) or concerns about abuse, misuse, or dependence (a condition where your body becomes reliant on a substance). Additionally, there are no particular instructions indicating that you should avoid taking or using this medication under any circumstances. Always remember to follow your healthcare provider's guidance for the best results.

Side Effects

It's important to keep this medication out of reach of children to prevent accidental ingestion. Always ensure that it is stored safely and securely. If you have any concerns about side effects or how to use this medication, 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. Always consult your healthcare provider if you have any questions or concerns about your treatment.

Overdose

If you suspect an overdose, it's important to stay calm and take immediate action. While there are no specific signs or symptoms of overdose mentioned, you should be aware that an overdose can lead to serious health issues. Common signs of overdose may include unusual drowsiness, confusion, or difficulty breathing.

If you or someone you know may have taken too much of a medication, seek medical help right away. Contact your healthcare provider or go to the nearest emergency room. It's always better to be safe and get professional assistance in these situations.

Pregnancy Use

When it comes to using this medication during pregnancy, there is no specific information available about its safety, recommended dosage adjustments, or any special precautions you should take. This means that if you are pregnant or planning to become pregnant, it’s important to consult with your healthcare provider before starting or continuing this medication. They can help you weigh the potential risks and benefits based on your individual situation. Always prioritize open communication with your doctor to ensure the best care for you and your baby.

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 is no information available about whether this product is excreted in breast milk or any potential risks to your infant. Always consult with your healthcare provider if you have any concerns or questions about medications while breastfeeding.

Pediatric Use

It's important to keep this medication out of reach of children to ensure their safety. For adults and children aged 12 years and older, the recommended dosage is 1 or 2 chewable tablets after meals and at bedtime, but you should not exceed 4 tablets in a 24-hour period unless directed by a doctor.

If your child is under 12 years old, it's essential to consult with a doctor before giving them this medication. Always prioritize their health and safety by following these guidelines closely.

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, it’s important to consult with a healthcare provider before starting the medication. 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 there are no specific guidelines or dosage adjustments mentioned for your condition in the available information. This means that the usual recommendations for monitoring or safety considerations related to renal impairment (kidney issues) are not provided.

It's always best to consult with your healthcare provider about your individual situation, as they can offer personalized advice and ensure that any medications you take are safe and effective for you.

Hepatic Impairment

If you have liver problems, it's important to know that the information provided does not include specific guidelines for dosage adjustments, special monitoring, or precautions related to your condition. This means that there are no tailored recommendations for how the medication may affect you differently due to your liver health.

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 liver function and overall health.

Drug Interactions

It's important to have open conversations with your healthcare provider about any medications you are taking. In this case, there are no specific drug interactions or laboratory test interactions noted, which means that the medication is generally considered safe to use with other drugs and tests. However, every individual is different, and your healthcare provider can help ensure that your treatment plan is safe and effective for you.

Always discuss any changes in your medications or upcoming lab tests with your healthcare provider to avoid any potential issues and to get the best care possible.

Storage and Handling

To ensure the best performance and safety of your product, store it at room temperature, ideally around 25°C (77°F). It’s acceptable for the temperature to vary between 15°-30°C (59°-86°F), but make sure to keep it away from moisture. Always check the outer packaging before use; if the package is opened or if the blister is torn or broken, do not use the product. Additionally, remember to look at the end flap for important information like the expiration date and lot number, which are crucial for your safety.

Additional Information

You can take this medication orally by chewing or crushing the tablets completely before swallowing. For adults and children aged 12 and over, the recommended dose is 1 or 2 chewable tablets as needed after meals and at bedtime, but do not exceed 4 tablets in a 24-hour period unless directed by a doctor. If the patient is under 12 years old, consult a doctor for appropriate dosing.

It's important to remember not to swallow the tablets whole, as they need to be chewed or crushed for proper effectiveness.

FAQ

What is EQUALINE®?

EQUALINE® is an extra strength gas relief chewable tablet that helps relieve pressure, bloating, and fullness commonly referred to as gas.

What is the active ingredient in EQUALINE®?

The active ingredient in EQUALINE® is simethicone, which is present at a strength of 125 mg per tablet.

How should I take EQUALINE®?

You should chew or crush the tablets completely before swallowing. Do not swallow the tablets whole.

What is the recommended dosage for adults and children over 12?

Adults and children 12 years and over can take 1 or 2 chewable tablets as needed after meals and at bedtime, but should not exceed 4 tablets in 24 hours unless directed by a doctor.

Is EQUALINE® safe for children under 12?

For children under 12 years, you should ask a doctor before use.

What flavors does EQUALINE® come in?

EQUALINE® is available in a cherry flavor.

Are there any warnings associated with EQUALINE®?

Yes, keep EQUALINE® out of reach of children and do not use if the package is opened or if the blister unit is torn, broken, or shows any signs of tampering.

What should I do if I have questions about EQUALINE®?

You can contact customer service at 855-423-2630 for any questions regarding EQUALINE®.

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

NDC 41163-408-44. EQUALINE® Extra Strength is a gas relief formulation containing simethicone 125 mg per chewable tablet. The product is designed to alleviate symptoms of bloating, pressure, and discomfort associated with gas. Each tablet is cherry-flavored and intended for oral administration, requiring complete chewing or crushing before swallowing; whole tablets should not be swallowed. The package contains 18 chewable tablets. The product is tamper evident; do not use if the package is opened or if the blister unit is torn, broken, or shows any signs of tampering. This product is not manufactured or distributed by GSK Consumer Healthcare S.A., the owner of the registered trademark Gas-X® Extra Strength.

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

Patients should adhere strictly to the recommended dosage and administration guidelines. For adults and children aged 12 years and older, the recommended dose is 1 to 2 chewable tablets taken as needed after meals and at bedtime. It is imperative that patients do not exceed 4 chewable tablets within a 24-hour period unless specifically directed by a healthcare professional.

For optimal efficacy, patients must chew or crush the tablets completely before swallowing; swallowing the tablets whole is not advised.

For children under 12 years of age, it is essential to consult a healthcare provider for appropriate dosing recommendations.

Contraindications

There are no contraindications listed for the use of this product. It is important to evaluate each patient's individual circumstances and medical history when considering treatment options.

Warnings and Precautions

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

Healthcare professionals should ensure that patients are informed about the importance of proper storage and handling of the medication. This precaution is essential to safeguard against potential adverse effects that may arise from unintentional exposure in pediatric populations.

In addition, healthcare providers are encouraged to monitor patients for any signs of misuse or adverse reactions, particularly in vulnerable populations. Regular follow-up and patient education on the safe use of this medication are recommended to mitigate risks associated with its administration.

Side Effects

Patients should be advised to keep this medication out of reach of children. This warning is critical to prevent accidental ingestion or exposure, 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 remains a priority to ensure patient safety.

Drug Interactions

No specific drug interactions have been identified in the available data. Additionally, there are no reported interactions between the drug and laboratory tests. Therefore, no dosage adjustments or monitoring recommendations are necessary based on the current information.

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. For adults and children aged 12 years and older, the recommended dosage is 1 or 2 chewable tablets as needed after meals and at bedtime, with a maximum of 4 chewable tablets in a 24-hour period unless otherwise directed by a healthcare professional.

For children under 12 years of age, it is advised to consult a doctor before use.

Geriatric Use

There is no specific information available 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 specific information available regarding the use of this medication during pregnancy, including safety concerns, dosage modifications, or special precautions that should be taken. Healthcare professionals should consider the lack of data when prescribing this medication to pregnant patients and weigh the potential risks and benefits. Women of childbearing potential should be counseled on the absence of established safety data and the importance of discussing any potential pregnancy with their healthcare provider.

Lactation

There are no specific warnings or recommendations regarding the use of this product in nursing mothers. Additionally, there is no information provided about the potential for excretion in breast milk or any associated risk 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 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 substance involved, estimated dose, and time of exposure, is crucial for effective management and follow-up 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 question. Further studies may be necessary to elucidate these aspects of nonclinical toxicology.

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 and handling to ensure the safety of young individuals.

Storage and Handling

The product is supplied in a tamper-evident package. Healthcare professionals should ensure that the outer package remains unopened and that the blister is intact; do not use if the package is opened or the blister is torn or broken.

Storage conditions require the product to be maintained at a temperature of 25°C (77°F), with permissible excursions between 15°-30°C (59°-86°F). It is essential to protect the product from moisture. For reference, the expiration date and lot number can be found on the end flap of the packaging.

Additional Clinical Information

The medication is administered orally. For adults and children aged 12 years and older, the recommended dosage is 1 or 2 chewable tablets taken as needed after meals and at bedtime, with a maximum of 4 chewable tablets in a 24-hour period unless otherwise directed by a physician. For children under 12 years, consultation with a doctor is advised.

Patients should be counseled to chew or crush the tablets completely before swallowing, as swallowing them whole is not recommended. No additional information is available regarding laboratory tests, abuse potential, or postmarketing experiences.

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.