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Sunmark Gas Relief

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This product has been discontinued

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 2004
Label revision date
April 10, 2014
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 2004
Label revision date
April 10, 2014
Manufacturer
McKesson
Registration number
part332
NDC root
49348-509
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

Sunmark is a medication designed to provide fast relief from the pressure, bloating, and discomfort associated with gas. Its active ingredient, simethicone (a substance that helps break up gas bubbles in the stomach and intestines), works to alleviate these uncomfortable symptoms. Sunmark comes in a peppermint cream formulation and is available in chewable tablet form, making it easy to take when you need relief.

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 confident using this medication, as it has no known teratogenic effects (which means it doesn't cause birth defects) or nonteratogenic effects. This makes it a safe option for managing these common digestive issues.

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 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, misuse, or dependence associated with this medication. This means that, based on the available information, there are no particular situations or conditions under which you should avoid using it. 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 keep this medication out of reach of children. If an overdose occurs, seek medical help or contact a Poison Control Center right away.

While specific side effects are not detailed here, always be aware of how your body responds to any medication and consult your healthcare provider if you experience any unusual symptoms.

Warnings and Precautions

It's important to keep this medication out of 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 healthcare provider's instructions and discuss any concerns you may have about this medication. If you experience any unusual symptoms or side effects, stop using the medication and call your doctor for guidance. Your safety is a priority, so don't hesitate to reach out for help if needed.

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 safety and the safety of others by acting quickly in these situations.

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 clearly outlined.

Before taking any medication, including this one, you should consult with your healthcare provider to discuss potential risks and benefits. They can help you make informed decisions that prioritize your health and the health of your baby.

Lactation Use

If you are breastfeeding and considering using Sunmark Gas Relief (dimethicone), it's important to note that the drug insert does not provide specific information about its effects on nursing mothers or lactation. This means there are no established guidelines or known risks associated with its use while breastfeeding.

As always, it's a good idea to consult with your healthcare provider before taking any medication to ensure it is safe for you and your baby. They can help you weigh the benefits and any potential concerns 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 or contact a Poison Control Center right away. Being aware of these precautions can help ensure your child's safety.

Geriatric Use

While there is no specific information about how this medication should be used by older adults, it’s important to approach any new treatment with caution. If you or a loved one is an older adult, it’s always a good idea to discuss any medications with a healthcare provider. They can help ensure that the treatment is safe and appropriate, considering any unique health needs or conditions that may be present.

Remember, even if there are no specific dosage adjustments or safety concerns mentioned, your healthcare provider can offer personalized advice based on individual health status and any other medications being taken. Always prioritize open communication with your healthcare team to ensure the best care.

Renal Impairment

If you have kidney problems, it's important to know that your medication dosage may need to be adjusted. This is because your kidneys may not process the medication as effectively, which can affect how well it works for you. Your healthcare provider will likely monitor your renal function tests, which are tests that check how well your kidneys are working.

If you have decreased creatinine clearance (a measure of kidney function), your doctor may recommend a reduced dose of your medication. This helps ensure that you receive the right amount of the drug without putting extra strain on your kidneys. Always follow your healthcare provider's guidance regarding your treatment plan.

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 (liver issues).

Always consult your healthcare provider for personalized advice and to discuss any concerns regarding your liver health and how it may relate to your treatment. They can help ensure that you receive the safest and most effective care.

Drug Interactions

It's important to have open conversations with your healthcare provider about any medications or tests you may be taking. In this case, there are no known drug interactions or laboratory test interactions associated with the medication. However, every individual is different, and your healthcare provider can help ensure that your treatment is safe and effective for you. Always feel free to ask questions and share your complete list of medications and any tests you may be undergoing.

Storage and Handling

To ensure the best performance of your product, store it at room temperature, away from high humidity and excessive heat. It's important to keep it below 40°C (104°F) to maintain its integrity.

When handling the product, check each individual blister unit carefully. If you find any that are broken or open, do not use them, as this could compromise safety and effectiveness. 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 thoroughly as needed after meals and at bedtime. It's important not to exceed 6 tablets in a day unless your doctor advises otherwise. Always follow your healthcare provider's instructions for safe use.

FAQ

What is Sunmark used for?

Sunmark is used to relieve pressure, bloating, and discomfort associated with gas.

What is the active ingredient in Sunmark?

The active ingredient in Sunmark is SIMETHICONE, with a strength of 80 mg.

How should I take Sunmark?

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

Are there any contraindications for using Sunmark?

There are no contraindications listed for using Sunmark.

What should I do in case of an overdose?

In case of overdose, get medical help or contact a Poison Control Center immediately.

Can I use Sunmark if I have kidney problems?

If you have renal impairment, you may require dosage adjustments and should monitor renal function tests.

Is Sunmark safe to use during pregnancy?

There is no specific information regarding the use of Sunmark during pregnancy.

How should I store Sunmark?

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

What is the formulation of Sunmark?

Sunmark comes in a peppermint creme formulation and is available in 36 chewable tablets.

Are there any known side effects of Sunmark?

No specific side effects are mentioned in the provided information.

Packaging Info

Below are the non-prescription pack sizes of Sunmark Gas Relief (dimethicone). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Sunmark Gas Relief.
Details

Drug Information (PDF)

This file contains official product information for Sunmark 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 80 mg of simethicone. The product is formulated with a peppermint creme flavor, enhancing palatability. Each bottle contains a total of 36 chewable tablets, designed for ease of administration.

Uses and Indications

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

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

Dosage and Administration

Patients are advised to chew 1 to 2 tablets thoroughly as needed after meals and at bedtime. The total daily dosage should not exceed 6 tablets 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 deemed safe for use in the absence of specific conditions or situations that would warrant avoidance.

Warnings and Precautions

It is imperative to keep this medication out of 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 the 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.

Drug Interactions

There are no reported 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 Sunmark Gas Relief (dimethicone). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Sunmark 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. 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 are advised to consider the lack of data when prescribing this medication to pregnant patients. The potential risks and benefits should be carefully evaluated, and alternative treatments may be considered in consultation with the patient. Women of childbearing potential should be informed of the absence of established safety data during pregnancy.

Lactation

There is no specific information regarding the use of Sunmark Gas Relief (dimethicone) in lactating mothers or lactation considerations. The prescribing information does not provide data on the excretion of dimethicone in breast milk or its effects on breastfed infants. Healthcare professionals should consider this lack of information when advising lactating mothers on the use of this product.

Renal Impairment

Patients with renal impairment may require dosage adjustments to ensure safety and efficacy. It is essential to monitor renal function tests in these patients to assess their kidney status. Additionally, a reduced dose should be considered for patients with decreased creatinine clearance to mitigate the risk of adverse effects associated with impaired renal function.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in clinical trials for this medication. Consequently, there is no available information regarding 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 warranted based on clinical judgment.

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 aware that the specific symptoms of an overdose may vary depending on the substance involved. Therefore, a thorough assessment of the patient's condition is essential to determine the appropriate course of action.

Management of an overdose typically involves supportive care and symptomatic treatment. Continuous monitoring of the patient's vital signs and clinical status is recommended. In cases where the specific substance is known, targeted therapies may be employed as indicated.

It is essential for healthcare providers to remain vigilant and prepared to implement emergency protocols in the event of an overdose, ensuring the best possible outcomes for affected individuals.

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 in these areas limits the understanding of the compound's potential effects in nonclinical settings.

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 safeguarding the medication to ensure the safety of young individuals.

Storage and Handling

The product is supplied in individual blister units. Each blister must be inspected prior to use; do not use any blister unit that is broken or open.

Storage conditions require the product to be kept at room temperature, ensuring that it is protected from high humidity and excessive heat. Temperatures should not exceed 40°C (104°F) to maintain product integrity.

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 6 tablets per day unless directed 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 Sunmark 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 Sunmark 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.