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Sunmark Infants Gas Relief Drops

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This product has been discontinued

Active ingredient
Dimethicone 20 mg/0.3 mL
Other brand names
Dosage form
Emulsion
Route
Oral
Prescription status
OTC (over the counter)
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Marketed in the U.S.
Since 2003
Label revision date
September 10, 2012
Drug Information (PDF)
Prescribing information, PDF file
Active ingredient
Dimethicone 20 mg/0.3 mL
Other brand names
Dosage form
Emulsion
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 2003
Label revision date
September 10, 2012
Manufacturer
McKesson
Registration number
part332
NDC root
49348-577
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 gas relief drop specifically designed for infants. It helps relieve the discomfort caused by gas, which can often result from swallowing air or certain formulas and foods. This product provides fast relief from gas symptoms, making it a supportive option for parents looking to ease their baby's discomfort. Sunmark is alcohol and saccharin free and contains no artificial flavors, ensuring a gentle solution for your little one.

Uses

If you're experiencing discomfort from gas, this medication can help relieve those symptoms. Gas can often be caused by swallowing air or by certain foods and formulas you consume. By taking this medication, you can find some relief from the bloating and discomfort associated with gas, allowing you to feel more comfortable in your daily activities.

Dosage and Administration

Before you use this medication, make sure to shake the bottle well. For infants under 2 years old (weighing less than 24 pounds), the recommended dosage is 0.3 mL, while for children over 2 years old (weighing more than 24 pounds), the dosage increases to 0.6 mL. You can fill the enclosed dropper to the recommended level for accurate dosing.

When giving the medication, dispense the liquid slowly into your baby's mouth, aiming for the inner cheek to make it easier for them to swallow. If you prefer, you can mix the medication with 1 ounce of cool water, infant formula, or another suitable liquid to help with administration. You can repeat the dosage as needed after meals and at bedtime. Remember to clean the dropper after each use and put the original cap back on to keep it safe.

What to Avoid

It's important to use this medication responsibly. You should not exceed 12 doses in a single day, as taking more than this can lead to potential health risks. While there are no specific contraindications or concerns about abuse, misuse, or dependence associated with this medication, always follow the recommended guidelines to ensure your safety and well-being. If you have any questions or concerns about your treatment, please consult your healthcare provider.

Side Effects

When using this product, it's important not to exceed 12 doses per day to avoid potential health risks. Always keep it out of the reach of children to ensure their safety. If you experience any unusual symptoms or side effects, please consult your healthcare provider for guidance.

Warnings and Precautions

It's important to follow the recommended dosage for this medication, which should not exceed 12 doses per day. Taking more than this can lead to serious health risks.

Make sure to keep this medication out of the reach of children to prevent accidental ingestion. If you have any concerns or experience unusual symptoms, it's best to stop taking the medication and consult your doctor for further guidance. Always prioritize your safety and well-being when using any medication.

Overdose

If you suspect an overdose, it's important to stay calm and take immediate action. While there is no specific information available about the signs of overdose for this medication, general symptoms can include unusual drowsiness, confusion, or difficulty breathing. If you notice any of these signs, seek medical help right away.

In case of an overdose, contact your local emergency services or go to the nearest hospital. It's always better to err on the side of caution when it comes to your health. Remember, 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 be aware that there is no specific information available about 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 regarding any medications you may be considering during pregnancy.

Lactation Use

If you are breastfeeding or planning to breastfeed, it's important to be aware that there is no specific information available regarding the effects of this medication on nursing mothers or lactation (the process of producing breast milk). Since there are no guidelines or data provided, it’s advisable to consult with your healthcare provider to discuss any potential risks or concerns related to your situation. They can help you make informed decisions about your health and your baby's well-being.

Pediatric Use

When it comes to giving this medication to children, it's important to follow the recommended dosages based on their age and weight. For infants under 2 years old who weigh less than 24 pounds, the suggested dose is 0.3 mL. For children over 2 years old and weighing more than 24 pounds, the recommended dose increases to 0.6 mL. You can repeat these dosages as needed, but it's best to do so after meals and at bedtime.

Always remember to keep this medication out of reach of children to ensure their safety. If you have any questions or concerns about administering this medication, don't hesitate to consult your healthcare provider.

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 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 function 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 condition. 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 (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, which is between 59°F and 86°F (15°C to 30°C). This temperature range helps maintain the product's effectiveness and safety.

When handling the product, make sure to do so in a clean environment to avoid contamination. Always follow any specific instructions provided with the product for safe use and disposal. Keeping these guidelines in mind will help you use the product safely and effectively.

Additional Information

You can take this medication orally, and you may repeat the dosage as needed after meals and at bedtime. If you have any questions about how to take it or its effects, be sure to consult your healthcare provider for guidance.

FAQ

What is Sunmark used for?

Sunmark is used to relieve the symptoms of gas in infants, often caused by air swallowing or certain formulas or foods.

How should I use Sunmark?

Shake well before using. Fill the enclosed dropper to the recommended dosage level and dispense the liquid slowly into your baby's mouth, toward the inner cheek.

What is the recommended dosage for infants and children?

For infants under 2 years old and weighing under 24 lbs, the recommended dose is 0.3 mL. For children over 2 years old and weighing over 24 lbs, the recommended dose is 0.6 mL.

How often can I give Sunmark?

All dosages may be repeated as needed, after meals and at bedtime, but do not exceed 12 doses per day.

Are there any warnings for using Sunmark?

Yes, do not exceed 12 doses per day and keep the product out of the reach of children.

Does Sunmark contain any artificial ingredients?

No, Sunmark is alcohol and saccharin free and contains no artificial flavor.

How should I store Sunmark?

Store Sunmark at room temperature, between 59°F and 86°F.

Is there any information on using Sunmark during pregnancy or while nursing?

No specific information is provided regarding the use of Sunmark during pregnancy or lactation.

Packaging Info

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

Packaging configurations for Sunmark Infants Gas Relief Drops.
Details

Drug Information (PDF)

This file contains official product information for Sunmark Infants Gas Relief Drops, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)

Description

Sunmark gas relief drops are formulated for infants and contain an active ingredient comparable to that found in Mylicon® Infant drops. These drops provide fast relief from gas symptoms in infants. The product is alcohol and saccharin free and does not contain artificial flavors. Each bottle contains 1 fluid ounce (30 mL), providing a total of 100 doses.

Uses and Indications

This drug is indicated for the relief of symptoms associated with gas, which may frequently result from air swallowing or the consumption of certain formulas or foods.

Dosage and Administration

The medication should be shaken well before each use. Dosages may be repeated as needed, following meals and at bedtime.

For administration, healthcare professionals should fill the enclosed dropper to the recommended dosage level. The liquid should be dispensed slowly into the patient's mouth, directed toward the inner cheek. It is permissible to mix the medication with 1 ounce of cool water, infant formula, or other suitable liquids to facilitate administration.

After each use, the dropper must be cleaned thoroughly, and the original cap should be replaced to maintain product integrity.

Dosage by Age and Weight:

  • For infants under 2 years of age (weighing less than 24 pounds), the recommended dosage is 0.3 mL.

  • For children over 2 years of age (weighing more than 24 pounds), the recommended dosage is 0.6 mL.

Contraindications

Use of this product is contraindicated in patients who exceed 12 doses per day. Exceeding this dosage may lead to potential adverse effects. No other contraindications have been identified.

Warnings and Precautions

Exceeding the recommended dosage of this medication can lead to serious adverse effects. It is imperative that healthcare professionals advise patients not to exceed 12 doses per day to ensure safety and efficacy.

In addition to dosage considerations, it is crucial to maintain general precautions regarding the storage and accessibility of the medication. Healthcare providers should emphasize the importance of keeping this medication out of the reach of children to prevent accidental ingestion and potential harm.

Currently, there are no specific laboratory tests or monitoring parameters provided for the safe use of this medication. However, healthcare professionals should remain vigilant and assess the patient's overall health and response to treatment during follow-up consultations.

In the event of any concerning symptoms or adverse reactions, patients should be instructed to stop taking the medication and seek medical advice promptly.

Side Effects

Patients should be aware of the potential adverse reactions associated with this product. It is important to adhere to the recommended dosage guidelines, specifically not exceeding 12 doses per day, to minimize the risk of adverse effects.

In clinical practice, there have been warnings regarding the safety of this product, emphasizing the necessity of proper usage. Additionally, it is crucial to keep this product out of the reach of children to prevent accidental ingestion and potential harm.

While specific adverse reactions were not detailed in the provided information, healthcare professionals should remain vigilant and monitor patients for any unexpected effects during treatment.

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 Infants Gas Relief Drops (simethicone). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Sunmark Infants Gas Relief Drops.
Details

Pediatric Use

Pediatric patients under 2 years of age and weighing less than 24 lbs are recommended to receive a dose of 0.3 mL. For children over 2 years of age and weighing more than 24 lbs, the recommended dose is 0.6 mL. All dosages may be repeated as needed, following meals and at bedtime.

It is important to keep this medication out of the reach of children to ensure safety.

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 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 available regarding the use of this medication in nursing mothers or lactation considerations. Healthcare professionals should exercise caution and consider the potential risks and benefits when prescribing this medication to lactating mothers. Further research may be necessary to fully understand the implications for breastfed infants.

Renal Impairment

Patients with renal impairment may not have specific dosage adjustments, special monitoring, or safety considerations outlined in the prescribing information. Therefore, healthcare professionals should exercise caution when prescribing this medication to patients with reduced kidney function, as the lack of data necessitates careful clinical judgment. Regular monitoring of renal function is advisable to ensure patient safety and therapeutic efficacy.

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 absence of specific information regarding overdosage, healthcare professionals are advised to exercise caution when administering the medication. It is essential to monitor patients closely for any signs of adverse effects or symptoms that may arise from excessive dosing.

In the event of suspected overdosage, immediate medical attention should be sought. Healthcare providers should implement supportive measures as necessary, which may include symptomatic treatment and monitoring of vital signs.

Due to the lack of detailed overdosage information, it is recommended that healthcare professionals refer to established clinical guidelines and protocols for managing overdose situations relevant to the specific medication in question. Additionally, contacting a poison control center may provide further guidance on appropriate management strategies.

Continued vigilance and patient assessment are crucial in mitigating potential risks associated with overdosage.

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 the medication out of the reach of children to prevent accidental ingestion. It is important to emphasize the necessity of adhering to the recommended dosage guidelines, specifically not to exceed 12 doses per day. Patients should be informed about the potential risks associated with exceeding the recommended dosage and encouraged to contact their healthcare provider if they have any questions or concerns regarding their treatment.

Storage and Handling

The product is supplied in various package configurations, with specific NDC numbers available for identification. It is essential to store the product at room temperature, maintaining a range of 59°F to 86°F (15°C to 30°C). Proper storage conditions are crucial to ensure the integrity and efficacy of the product.

Additional Clinical Information

The medication is administered orally, with all dosages able to be repeated as needed, following meals and at bedtime. 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 Infants Gas Relief Drops, 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 Infants Gas Relief Drops, 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

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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.