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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 2023
Label revision date
October 3, 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 2023
Label revision date
October 3, 2025
Manufacturer
Heartland Pharma Co.
Registration number
M002
NDC root
80136-859
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

Heartland® is an over-the-counter medication designed to provide relief from the discomfort associated with gas, including pressure, bloating, and fullness. Each chewable tablet contains 125 mg of simethicone, which works by breaking up gas bubbles in the stomach and intestines, helping to alleviate these uncomfortable symptoms.

You can take Heartland® chewable tablets by chewing or crushing them completely before swallowing. This product is comparable to Gas-X® Extra Strength, offering a similar approach to managing gas-related discomfort.

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 you feel 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, controlled substance classifications, or concerns regarding abuse, misuse, or dependence associated with it. This means that, based on the available information, there are no known reasons that would prevent you from taking this medication safely. Always remember to follow your healthcare provider's guidance and reach out if you have any questions or concerns about your treatment.

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. Always store it in a safe place where children cannot access it.

If you experience any unusual symptoms or side effects, stop using the medication and call your doctor immediately. Your health and safety are the top priority, so don’t hesitate to seek help if you have concerns.

Overdose

It appears that there is no specific information available regarding overdosage for this medication. However, it’s important to be aware of the general signs of an overdose, which can include symptoms like extreme drowsiness, confusion, or difficulty breathing. If you suspect an overdose, it’s crucial to seek immediate medical help.

In case of an emergency, call your local emergency number or go to the nearest hospital. Always keep medications out of reach of children and follow the prescribed dosage to minimize the risk of an overdose. If you have any concerns or questions about your medication, don’t hesitate to reach out to your healthcare provider for guidance.

Pregnancy Use

If you are pregnant or planning to become pregnant, it's important to know that the safety of simethicone has not been established. There are no adequate studies in pregnant women, so the potential risks to your baby are unknown. Before using simethicone, you should consult your doctor to discuss whether it is necessary for you.

If your healthcare provider determines that you can use it, be aware that there are no specific dosage adjustments recommended for pregnant women. Always prioritize open communication with your healthcare team 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 simethicone for nursing mothers. Additionally, there is no information indicating that simethicone is excreted in breast milk or that it poses any risk to your infant. This means you can use simethicone 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 reach of children to ensure their safety. If your child is under 12 years old, you should consult a doctor before giving them this medication. For those aged 12 and older, the recommended dosage is 1 or 2 chewable tablets after meals and at bedtime, but be careful not to exceed 4 chewable tablets in a 24-hour period unless directed by a doctor. Always follow these guidelines to ensure safe use.

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 there are no specific guidelines or dosage adjustments mentioned for your condition in the available information. This means that the standard recommendations for the medication do not change based on renal impairment. However, it’s always best to discuss your individual situation with your healthcare provider, as they can offer personalized advice and monitor your health closely.

Make sure to keep your doctor informed about your kidney health, as they may need to consider this when prescribing medications or adjusting dosages in the future. Regular check-ups and open communication are key to managing your health effectively.

Hepatic Impairment

If you have liver 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 standard recommendations apply, and there are no special monitoring or precautions outlined for patients with liver issues.

Always consult your healthcare provider for personalized advice and to ensure that any medications you take are safe for your liver health. They can provide guidance tailored to your specific situation.

Drug Interactions

It's important to have open conversations with your healthcare provider about any medications or tests you may be taking. While there are no specific drug interactions or laboratory test interactions noted for this medication, your healthcare provider can help ensure that everything you are taking works well together and is safe for you. Always share your complete list of medications and any health conditions you have to receive the best care possible.

Storage and Handling

To ensure the best performance of your product, store it at a temperature of 25°C (77°F). It’s acceptable for the temperature to vary between 15°-30°C (59°-86°F) occasionally, but try to keep it as close to the recommended temperature as possible. Make sure to protect the product from moisture, as this can affect its quality. Always check the expiration date on the package and use the product before that date to ensure safety and effectiveness.

Additional Information

You can take this medication orally. 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 chewable tablets in a 24-hour period unless your doctor advises otherwise. If the patient is under 12 years old, consult a doctor for appropriate dosing.

FAQ

What is Heartland® used for?

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

How should I take Heartland®?

You should chew or crush the tablets completely before swallowing. Adults and children 12 years and over can take 1 or 2 chewable tablets as needed after meals and at bedtime, not exceeding 4 tablets in 24 hours unless directed by a doctor.

Is Heartland® safe to use during pregnancy?

The safety of simethicone, the active ingredient in Heartland®, during pregnancy has not been established. Consult a doctor before use if you are pregnant or planning to become pregnant.

What should I do if I have children under 12 years?

If you have children under 12 years, you should ask a doctor before giving them Heartland®.

What are the storage instructions for Heartland®?

Store Heartland® at 25°C (77°F), with excursions permitted between 15°-30°C (59°-86°F). Protect from moisture and use by the expiration date on the package.

What should I do if the safety seal is broken or missing?

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

Who manufactures Heartland®?

Heartland® is manufactured by Pharma Co.

How can I contact the distributor of Heartland®?

You can contact the distributor, Northeast Pharma, at www.heartlandpharmaco.com or by calling 1-800-383-0648.

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

No description information is available.

Uses and Indications

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

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

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 the tablets are chewed or crushed completely before swallowing; they should not be swallowed whole.

The maximum allowable dosage for this population is 4 chewable tablets within a 24-hour period, unless otherwise directed by a healthcare professional. For children under the age of 12, it is advised to consult a doctor before administration.

Contraindications

There are no contraindications associated with the use of this product. It is not classified as a controlled substance, and there are no identified 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

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

Healthcare professionals should ensure that patients are informed about the importance of proper storage and handling of the medication. In addition, it is recommended that patients be advised to monitor for any adverse effects and to report them promptly. Regular follow-up appointments may be necessary to assess the patient's response to treatment and to make any necessary adjustments to the therapeutic regimen.

In summary, safeguarding this medication from children and maintaining open communication regarding its use and potential side effects are critical components of patient safety and effective treatment management.

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.

No specific adverse reactions have been reported in clinical trials or postmarketing experiences. However, it is essential for healthcare providers to monitor patients for any unexpected effects and to report them as necessary.

Drug Interactions

There are currently no documented drug interactions associated with this medication. Additionally, there is no information available regarding interactions with laboratory tests. As such, no specific recommendations for dosage adjustments or monitoring are warranted at this time.

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

For adolescents 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.

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

The safety of simethicone during pregnancy has not been established. There are no adequate and well-controlled studies in pregnant women; therefore, the potential risks to the fetus are unknown. Pregnant patients or those planning to become pregnant should consult a healthcare provider before use. Simethicone should only be used if clearly needed and after a thorough discussion with a healthcare professional. No specific dosage modifications are provided for pregnant women.

Lactation

There are no specific warnings or recommendations regarding the use of simethicone in lactating mothers. Additionally, there is no information available about the potential for excretion of simethicone in breast milk or any associated risks to breastfed infants.

Renal Impairment

There is no information available regarding dosage adjustments, special monitoring, or safety considerations for patients with renal impairment. Healthcare professionals should exercise caution and consider the lack of specific guidance when prescribing to patients with reduced kidney function.

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 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 overdosage information, it is essential for healthcare professionals to remain vigilant regarding the potential for overdose with this medication. In cases where an overdose is suspected, immediate medical attention should be sought.

Healthcare providers are advised to monitor patients closely for any signs or symptoms that may indicate an overdose. These may include, but are not limited to, increased severity of known side effects, unusual behavioral changes, or any other atypical clinical manifestations.

Management of an overdose should be guided by the clinical presentation of the patient. Supportive care is paramount, and symptomatic treatment should be initiated as necessary. It is recommended that healthcare professionals consult local poison control centers or relevant toxicology resources for specific guidance on the management of overdose cases.

In summary, while specific overdosage information is not available, healthcare professionals should exercise caution, monitor for symptoms, and provide appropriate supportive care in the event of an overdose.

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 the 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 children.

Storage and Handling

The product is supplied in packaging that includes specific NDC numbers. It should be stored at a controlled room temperature of 25°C (77°F), with permissible excursions between 15°C and 30°C (59°F and 86°F). It is essential to protect the product from moisture to maintain its integrity. Users are advised to adhere to the expiration date indicated on the package to ensure optimal efficacy.

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 of age, it is advised to consult a doctor for appropriate dosing guidance.

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.