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Infants Gas Relief

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Active ingredient
Dimethicone 20 mg/0.3 mL
Other brand names
Dosage form
Solution/ Drops
Route
Oral
Prescription status
OTC (over the counter)
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Marketed in the U.S.
Since 2013
Label revision date
December 26, 2024
Drug Information (PDF)
Prescribing information, PDF file
Active ingredient
Dimethicone 20 mg/0.3 mL
Other brand names
Dosage form
Solution/ Drops
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 2013
Label revision date
December 26, 2024
Manufacturer
Topco Associates, LLC
Registration number
M002
NDC root
36800-119
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

Topcare health is a medication that contains simethicone (20 mg), which is designed to help relieve the discomfort of gas in infants. It works by gently breaking down gas bubbles in your baby's stomach, making it easier for them to pass gas. This product is safe to use at every feeding, providing a gentle solution for common gas-related issues that may arise from air swallowing or certain formulas and foods.

Additionally, Topcare health is non-staining and dye-free, ensuring that it is gentle on your baby's sensitive system. It comes in a convenient 1 FL OZ (30 mL) bottle, making it easy to administer as needed.

Uses

You can use this medication to help relieve the discomfort caused by gas, which often results from swallowing air or consuming certain foods or formulas. It’s designed to ease the symptoms associated with this common issue, making you feel more comfortable.

Rest assured, there are no known teratogenic effects (which means it doesn’t cause birth defects) associated with this medication, so it is considered safe in that regard.

Dosage and Administration

Before using the 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 appropriate level for your child's age and weight.

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. Remember, you can repeat the dosage as needed after meals and at bedtime. After each use, clean the dropper thoroughly and securely close the bottle to keep it safe for your child.

What to Avoid

You can feel reassured that there are no specific contraindications, controlled substance classifications, or risks of abuse or misuse associated with this medication. Additionally, there are no concerns regarding dependence (a condition where the body becomes reliant on a substance).

Since there are no "do not take" or "do not use" instructions provided, it suggests that this medication is generally safe for use as directed. However, always consult with your healthcare provider for personalized advice and to ensure it’s appropriate for your individual health needs.

Side Effects

When using this product, it's important to not exceed 12 doses per day to avoid potential complications. Currently, there are no specific side effects or adverse reactions reported. However, always stay informed and consult with your healthcare provider if you have any concerns while using this medication.

Warnings and Precautions

When using this product, it’s important not to exceed 12 doses in a single day to avoid potential harm. If you think you may have taken too much, seek emergency medical help or contact a Poison Control Center immediately.

While there are no specific general precautions or lab tests mentioned, always stay alert to how your body responds to any medication. If you experience any unusual symptoms or have concerns, don’t hesitate to reach out to your healthcare provider for guidance.

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, or if you are unsure, 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 be safe and get checked by a healthcare professional if you have any concerns about your health. Remember, timely action can make a significant difference.

Pregnancy Use

The safety of simethicone during pregnancy has not been established, meaning that there is limited information on how it may affect you or your developing baby. Currently, there are no specific contraindications (reasons not to use it) or special precautions mentioned for pregnant individuals. Additionally, no dosage modifications are required if you are pregnant, and there is no information available regarding potential risks to the fetus.

As always, it's important to consult with your healthcare provider before using any medication during pregnancy to ensure it is safe for you and your baby.

Lactation Use

If you are breastfeeding, you can feel reassured that there are no specific warnings or recommendations regarding nursing mothers in the information provided. Additionally, there are no particular considerations or precautions mentioned for lactation. This suggests that the use of the medication may not pose significant risks to you or your nursing infant. However, it's always a good idea to consult with your healthcare provider about any medications you are taking while breastfeeding to ensure the best care for you and your baby.

Pediatric Use

When giving this medication to your child, 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 recommended dose is 0.3 mL. For children over 2 years old and weighing more than 24 pounds, the recommended dose is 0.6 mL. Make sure not to exceed 12 doses in a single day.

Always keep this medication out of reach of children to prevent accidental ingestion. If you suspect an overdose, seek medical help immediately or contact a Poison Control Center for assistance.

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. If you or a loved one is an older adult, be sure to discuss any potential risks or concerns with your healthcare provider. They can help determine the best approach for your individual health needs, especially since older adults may have different responses to medications compared to younger individuals. Always keep an open line of communication with your doctor about any changes in health or medication effects.

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.

Always consult your healthcare provider for personalized advice and to ensure that any medications you take are safe and appropriate for your kidney health. They can help you understand how your condition may affect your treatment plan.

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 discuss any concerns you may have about your liver condition and how it relates to your treatment. They can help ensure that your care is safe and effective.

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, always ensure that your healthcare provider is aware of all the medications you are using, as this helps them provide the best care tailored to your needs.

By discussing your full medical history and any other treatments, you can help prevent potential issues and ensure your safety.

Storage and Handling

To ensure the best performance of your product, store it at room temperature. This helps maintain its effectiveness and safety. When handling the product, be sure to follow any specific instructions provided to avoid contamination or damage. Always keep the product in a clean environment to ensure it remains safe for use.

If you have any components that come with the product, make sure to understand their role and how to handle them properly. Proper storage and careful handling are key to ensuring your product works as intended.

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 Topcare health?

Topcare health is a product that compares to Mylicon® non-staining infants' drops, containing the active ingredient simethicone.

What does simethicone do?

Simethicone relieves the symptoms of gas frequently caused by air swallowing or certain formulas or foods by gently breaking down gas bubbles.

Is Topcare health safe for infants?

Yes, it is safe enough to use at every feeding when used as directed.

What is the recommended dosage for infants under 2 years?

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

What is the recommended dosage for children over 2 years?

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

How should I administer Topcare health?

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

Can I mix Topcare health with other liquids?

Yes, you may mix it with 1 oz. of cool water, infant formula, or other suitable liquids.

Are there any warnings for using Topcare health?

Do not exceed 12 doses per day when using this product.

What should I do in case of overdose?

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

Is Topcare health safe to use during pregnancy?

The safety of simethicone during pregnancy has not been established, but there are no specific contraindications mentioned.

Is there any information regarding nursing mothers?

There are no specific warnings or recommendations regarding nursing mothers in the provided text.

How should I store Topcare health?

Store Topcare health at room temperature and keep it out of reach of children.

Packaging Info

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

Packaging configurations for Infants Gas Relief.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

Topcare Health offers a formulation that compares to Mylicon®, designed as non-staining infants' gas relief drops. The active ingredient, simethicone, is present at a concentration of 20 mg per 1 fluid ounce (30 mL) of solution. This product is dye-free and specifically formulated to gently break down gas bubbles in infants, providing effective anti-gas relief. It is safe for use at every feeding, ensuring comfort for infants experiencing gas discomfort.

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.

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

Dosage and Administration

The medication should be shaken well before use. For infants under 2 years of age (weighing less than 24 lb), the recommended dosage is 0.3 mL. For children over 2 years of age (weighing more than 24 lb), the recommended dosage is 0.6 mL.

All dosages may be repeated as needed, with administration recommended after meals and at bedtime. To administer, fill the enclosed dropper to the appropriate dosage level. The liquid should be dispensed slowly into the child's mouth, directed toward the inner cheek to facilitate swallowing.

For ease of administration, the medication may be mixed with 1 oz. of cool water, infant formula, or other suitable liquids. It is essential to clean the dropper after each use and securely close the bottle to maintain child resistance.

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. Additionally, there are no specific instructions indicating that the product should not be taken or used under any circumstances.

Warnings and Precautions

When using this product, it is imperative that the maximum dosage does not exceed 12 doses per day to avoid potential adverse effects.

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 of the situation.

Currently, there are no specific general precautions or laboratory tests outlined in the product insert. Therefore, healthcare providers should exercise clinical judgment and consider individual patient circumstances when prescribing this product.

Side Effects

Patients should be advised not to exceed 12 doses of this product per day, as doing so may lead to potential adverse reactions. However, no specific side effects or adverse reactions have been documented in clinical trials or postmarketing experiences. It is important for healthcare providers to monitor patients for any unexpected effects during the use of this product, given the absence of detailed adverse reaction data.

Drug Interactions

No drug interactions or drug and laboratory test interactions have been identified in the available data. Therefore, no specific recommendations for dosage adjustments or monitoring are necessary at this time.

Packaging & NDC

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

Packaging configurations for Infants Gas Relief.
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. It is important to note that the total daily dosage should not exceed 12 doses.

Healthcare professionals should ensure that the product is kept out of reach of children. In the event of an overdose, immediate medical assistance should be sought, or a Poison Control Center should be contacted.

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. 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. Currently, there are no specific contraindications for its use in pregnant patients. Additionally, there is no information available regarding potential risks to the fetus associated with simethicone. No dosage modifications for pregnant individuals are specified, and no special precautions regarding its use during pregnancy are mentioned. Healthcare professionals should consider the lack of established safety data when advising pregnant patients on the use of simethicone.

Lactation

There are no specific warnings or recommendations regarding nursing mothers. Additionally, there are no specific considerations or precautions mentioned related to lactation. Therefore, healthcare professionals may not need to take special precautions when prescribing this medication to lactating mothers.

Renal Impairment

Patients with renal impairment have not been specifically addressed in the available data regarding dosage adjustments, special monitoring, or safety considerations. Therefore, healthcare professionals should exercise caution when prescribing this medication to patients with reduced kidney function, as the lack of information necessitates careful clinical judgment and monitoring.

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 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, as the clinical presentation can vary depending on the substance involved. Common symptoms of overdose may include, but are not limited to, altered mental status, cardiovascular instability, and respiratory distress.

In the event of an overdose, immediate medical intervention is recommended. Healthcare providers should initiate supportive care, which may include maintaining airway patency, providing supplemental oxygen, and monitoring vital signs.

If the substance involved is known, specific antidotes or treatments should be administered as appropriate. Consultation with a poison control center or toxicology expert may be beneficial in guiding the management of the overdose.

Documentation of the incident, including the substance, amount ingested, and time of ingestion, is crucial for effective treatment 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 compound in these areas.

Postmarketing Experience

No postmarketing experience details are available in the insert text.

Patient Counseling

Healthcare providers should advise patients to seek immediate medical assistance or contact a Poison Control Center in the event of an overdose. It is important for patients to understand the seriousness of an overdose and the necessity of prompt action to ensure their safety. Providers should encourage patients to keep emergency contact information readily available and to be aware of the signs of overdose.

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 to maintain its integrity and efficacy. No special handling requirements are necessary beyond standard storage practices.

Additional Clinical Information

The medication is administered orally, with all dosages available for repetition as needed, following meals and at bedtime. There is no additional information regarding laboratory tests, abuse potential, patient counseling, or postmarketing experience.

Drug Information (PDF)

This file contains official product information for Infants 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 Infants 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.