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Childrens Mylicon Tummy Relief for Kids

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Active ingredients
  • Dimethicone 40 mg
  • Calcium Carbonate 400 mg
Other brand names
Drug classes
Blood Coagulation Factor, Phosphate Binder
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 2018
Label revision date
December 1, 2023
Drug Information (PDF)
Prescribing information, PDF file
Active ingredients
  • Dimethicone 40 mg
  • Calcium Carbonate 400 mg
Other brand names
Drug classes
Blood Coagulation Factor, Phosphate Binder
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 2018
Label revision date
December 1, 2023
Manufacturer
Infirst Healthcare Inc.
Registration number
M002
NDC root
62372-400
Drug Information (PDF)
Prescribing information, PDF file
Packaging Info (2 NDCs)
Packaging & NDC Codes (2)

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

Children's MYLICON® Antacid/Antigas is a chewable tablet designed specifically for kids aged 2 to 11. These great-tasting cherry-flavored tablets provide quick relief for upset tummies caused by bloating, gas, and discomfort from acid indigestion and overeating. They help alleviate symptoms such as heartburn, sour stomach, and pressure associated with gas, making them a convenient option for multi-symptom tummy relief.

By targeting these common digestive issues, Children's MYLICON® Antacid/Antigas aims to soothe your child's discomfort and restore their tummy to a more comfortable state.

Uses

If you're experiencing discomfort from acid indigestion, heartburn, or a sour stomach, this medication can help relieve those symptoms. It’s also effective for upset stomachs that come with these issues, as well as the pressure and bloating often associated with gas. If you've overindulged in food and drink, this medication can provide relief from that discomfort too.

Rest assured, there are no known teratogenic effects (which means it doesn't cause birth defects) associated with this medication, making it a safer option for those concerned about such risks.

Dosage and Administration

When it comes to taking this medication, it's important to follow the dosage instructions based on your child's age and weight. If your child weighs under 24 pounds and is under 2 years old, you should consult a doctor before giving them any medication. For children aged 2 to 5 years who weigh between 24 and 47 pounds, you can give them 1 tablet, but make sure they do not take more than 3 tablets in a 24-hour period.

For children aged 6 to 11 years who weigh between 48 and 95 pounds, the recommended dosage is 2 tablets, with a maximum of 6 tablets in a 24-hour period. You can repeat the dosage as needed, but remember not to use the maximum dosage for more than two weeks unless a doctor advises you to do so. Always ensure you are following these guidelines to keep your child safe and healthy.

What to Avoid

There are no specific contraindications, controlled substance classifications, or concerns regarding abuse, misuse, or dependence associated with this medication. Additionally, there are no explicit instructions indicating that you should not take or use this medication. Always consult with your healthcare provider for personalized advice and to ensure this medication is appropriate for you.

Side Effects

It's important to be aware of potential side effects when taking this medication. In the event of an overdose, you should seek medical help immediately or contact a poison control center at 1-800-222-1222.

Always monitor how you feel while on this medication, and if you experience any unusual symptoms, consult your healthcare provider for guidance. Your safety is a priority, so don't hesitate to reach out for help if needed.

Warnings and Precautions

Before using this medication, it's important to consult with your doctor or pharmacist, especially if your child is currently taking any prescription drugs, as antacids can interact with certain medications. Always keep this product out of reach of children to ensure their safety.

In the event of an overdose, seek medical help immediately or contact a poison control center at 1-800-222-1222. Your health and safety are paramount, so please take these precautions seriously.

Overdose

If you suspect an overdose, it’s crucial to seek medical help immediately. You can contact a poison control center at 1-800-222-1222 for guidance. Signs of an overdose can vary, but they may include unusual drowsiness, confusion, or difficulty breathing.

Always err on the side of caution—if you notice any concerning symptoms or if you’re unsure, don’t hesitate to get help right away. Your health and safety are the top priority.

Pregnancy Use

If you are pregnant or planning to become pregnant, it's important to know that there is no specific information available about the use of Children's Mylicon Tummy Relief for Kids during pregnancy. This means that safety concerns, dosage adjustments, or any special precautions have not been clearly outlined.

Before using this product, you should consult with your healthcare provider to discuss any potential risks and to ensure that you are making the best choice for your health and your baby's health. Always prioritize open communication with your doctor regarding any medications you consider during pregnancy.

Lactation Use

If you are breastfeeding or planning to breastfeed, it's important to talk to your healthcare professional before using this product. There is a possibility that the ingredients could pass into your breast milk, so caution is advised.

The effects on your nursing infant have not been thoroughly studied, which means you should carefully weigh the potential risks against the benefits of using this product while breastfeeding. Your healthcare provider can help you make an informed decision that is best for you and your baby.

Pediatric Use

When considering this medication for your child, it's important to follow specific dosage guidelines based on their weight and age. For children under 24 pounds (under 2 years old), you should consult a doctor before use. If your child weighs between 24 and 47 pounds (ages 2 to 5), they can take 1 tablet, but no more than 3 tablets in a 24-hour period. For children weighing 48 to 95 pounds (ages 6 to 11), the recommended dosage is 2 tablets, with a maximum of 6 tablets in 24 hours.

Always check with a doctor or pharmacist before giving this medication if your child is currently taking any prescription drugs, as it may interact with certain medications. Keep the medication out of reach of children, and in case of an overdose, seek medical help immediately or contact a poison control center at 1-800-222-1222.

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 for personalized advice. 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.

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 and what steps to take for your safety.

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 (issues with liver function).

Always consult your healthcare provider for personalized advice and to ensure that any medication you take is safe and appropriate for your liver health. They can help monitor your condition and make any necessary adjustments to your treatment plan.

Drug Interactions

It's important to talk to your doctor or pharmacist before giving your child any new medication, especially if they are currently taking a prescription drug. Some over-the-counter medications, like antacids, can interact with prescription drugs, potentially affecting how well they work.

Always ensure that your healthcare provider is aware of all medications your child is taking to avoid any unwanted interactions and to keep their treatment safe and effective.

Storage and Handling

To ensure the best performance and safety of your product, store it in a cool, dry place at a temperature between 20-25°C (68-77°F). This temperature range helps maintain the product's effectiveness.

When handling the product, be sure to check the safety seal under the cap. If the seal is broken or missing, do not use the product, as this indicates it may have been tampered with. Following these guidelines will help you use the product safely and effectively.

Additional Information

You should take this medication orally. If your child is currently on any prescription drugs, it's important to consult with a doctor or pharmacist before use, as antacids can interact with some medications. Always keep this medication out of reach of children. In the event of an overdose, seek medical assistance immediately or contact a poison control center at 1-800-222-1222.

FAQ

What is Children's MYLICON® Antacid/ Antigas used for?

Children's MYLICON® Antacid/ Antigas is used to relieve symptoms such as acid indigestion, heartburn, sour stomach, and upset stomach associated with these symptoms, as well as pressure and bloating commonly referred to as gas.

What age group can use Children's MYLICON®?

Children's MYLICON® is suitable for kids aged 2 to 11 years.

What is the recommended dosage for children aged 2-5 years?

For children aged 24-47 lbs (2-5 years), the recommended dosage is 1 tablet, not more than 3 tablets in 24 hours.

What should I do in case of an overdose?

In case of overdose, get medical help or contact a poison control center right away at 1-800-222-1222.

Can I use Children's MYLICON® if my child is taking other medications?

You should ask a doctor or pharmacist before use if your child is presently taking a prescription drug, as antacids may interact with certain medications.

Is there any information about using Children's MYLICON® during pregnancy?

The insert does not provide specific information regarding the use of Children's MYLICON® during pregnancy.

What flavor does Children's MYLICON® come in?

Children's MYLICON® comes in a great tasting cherry flavor.

How should I store Children's MYLICON®?

Store Children's MYLICON® between 20-25°C (68-77°F) and keep it out of reach of children.

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

Do not use Children's MYLICON® if the imprinted safety seal under the cap is broken or missing.

Packaging Info

Below are the non-prescription pack sizes of Childrens Mylicon Tummy Relief for Kids (antacid and antigas). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Childrens Mylicon Tummy Relief for Kids.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

Children's MYLICON® Antacid/Antigas is formulated to provide multi-symptom relief for upset tummies in children aged 2 to 11. This product is designed to quickly alleviate discomfort associated with bloating, gas, and acid indigestion, often resulting from overeating. Each package contains 24 chewable tablets, flavored with cherry. MYLICON is a registered trademark of McNeil Consumer Pharmaceuticals Co. The product is manufactured for Infirst Healthcare Inc, located in Westport, CT 06880. The packaging includes a tamper-evident safety seal; do not use if the seal under the cap is broken or missing.

Uses and Indications

This drug is indicated for the relief of symptoms associated with acid indigestion, heartburn, sour stomach, and upset stomach. It is also effective in alleviating pressure and bloating commonly referred to as gas, as well as discomfort resulting from overindulgence in food and drink.

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

Dosage and Administration

Dosing recommendations are based on the patient's age and weight. For patients under 24 lbs (under 2 years of age), consultation with a healthcare professional is advised prior to administration.

For children weighing between 24 to 47 lbs (ages 2 to 5 years), the recommended dosage is 1 tablet, with a maximum of 3 tablets allowed within a 24-hour period.

For children weighing between 48 to 95 lbs (ages 6 to 11 years), the recommended dosage is 2 tablets, with a maximum of 6 tablets permitted in a 24-hour period.

Dosing may be repeated as necessary; however, it is important to note that the maximum dosage should not be utilized for more than two weeks unless under the guidance and supervision of a healthcare provider.

Contraindications

There are no specified contraindications 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 consult a healthcare professional, such as a doctor or pharmacist, prior to administration if the patient is currently taking any prescription medications. This is particularly crucial as antacids may interact with certain prescription drugs, potentially leading to adverse effects.

To ensure safety, this product should be stored out of reach of children. This precaution is essential to prevent accidental ingestion and potential harm.

In the event of an overdose, immediate medical assistance is required. Healthcare providers should instruct patients or caregivers to contact a poison control center without delay at 1-800-222-1222 for guidance and support.

No specific instructions for discontinuation of use and consultation with a healthcare provider have been provided in the insert.

Side Effects

In the event of an overdose, patients are advised to seek immediate medical assistance or contact a poison control center at 1-800-222-1222. It is crucial for healthcare providers and patients to be aware of this warning to ensure prompt intervention and management of potential overdose situations.

Drug Interactions

Patients should consult a healthcare professional prior to using this medication if they are currently taking any prescription drugs.

Antacids may have the potential to interact with specific prescription medications, which could alter the effectiveness of those drugs. It is advisable to monitor for any changes in therapeutic outcomes or side effects when antacids are used concurrently with prescription medications. Adjustments to dosages or additional monitoring may be necessary based on the specific interactions identified.

Packaging & NDC

Below are the non-prescription pack sizes of Childrens Mylicon Tummy Relief for Kids (antacid and antigas). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Childrens Mylicon Tummy Relief for Kids.
Details

Pediatric Use

Pediatric patients under 24 lbs (under 2 years) should not use this medication without consulting a doctor. For children weighing 24-47 lbs (ages 2-5 years), the recommended dosage is 1 tablet, with a maximum of 3 tablets in a 24-hour period. For those weighing 48-95 lbs (ages 6-11 years), the dosage is 2 tablets, not to exceed 6 tablets in 24 hours.

Healthcare professionals should advise caregivers to consult a doctor or pharmacist before administering this medication if the child is currently taking any prescription drugs, as antacids may interact with certain medications. It is crucial to keep this product out of reach of children. In the event of an overdose, immediate medical assistance should be sought, or the poison control center should be contacted at 1-800-222-1222.

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

The safety of Children's Mylicon Tummy Relief for Kids during pregnancy has not been established, as the prescribing information does not provide specific data regarding its use in pregnant patients. Consequently, there are no known safety concerns, dosage modifications, or special precautions outlined for this population. Healthcare professionals should exercise caution and consider the lack of data when advising women of childbearing potential regarding the use of this product during pregnancy. It is recommended that pregnant patients consult their healthcare provider before using this medication.

Lactation

Lactating mothers should consult a healthcare professional before using this product. There is a potential for excretion in breast milk; therefore, caution is advised when administering to nursing mothers. The effects on a nursing infant are not well studied; thus, the risks versus benefits should be considered.

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 and consider individual patient factors when prescribing to patients with reduced kidney function, as the absence of specific guidance necessitates careful clinical judgment.

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 event of an overdose, it is imperative to seek immediate medical assistance. Healthcare professionals are advised to contact a poison control center without delay. The national poison control hotline can be reached at 1-800-222-1222 for guidance and support.

Prompt intervention is crucial in managing overdose situations, as timely medical help can significantly influence outcomes. Symptoms of overdose may vary depending on the substance involved and the individual’s health status. Therefore, a thorough assessment and appropriate management strategies should be implemented based on the specific circumstances of the overdose.

Healthcare providers should ensure that they are familiar with the recommended protocols for managing overdose cases, including potential symptomatic treatment and supportive care measures.

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 understanding of potential risks associated with the compound 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.

In the event of an overdose, patients should be instructed to seek medical help immediately or contact a poison control center at 1-800-222-1222 for assistance.

Additionally, it is important for healthcare providers to recommend that patients consult with a doctor or pharmacist before using this medication if their child is currently taking any prescription drugs. This is crucial as antacids may interact with certain prescription medications, and ensuring safety is paramount.

Storage and Handling

The product is supplied in a configuration that ensures tamper evidence; it should not be used if the imprinted safety seal under the cap is broken or missing.

For optimal storage, the product must be maintained at a temperature range of 20-25°C (68-77°F). Proper handling and storage conditions are essential to ensure the integrity and efficacy of the product.

Additional Clinical Information

The medication is administered orally. Clinicians should advise patients or caregivers to consult a doctor or pharmacist prior to use if the patient is currently taking any prescription medications, as antacids may interact with certain drugs. It is crucial to keep the medication out of reach of children. In the event of an overdose, immediate medical assistance should be sought, or a poison control center contacted at 1-800-222-1222.

Drug Information (PDF)

This file contains official product information for Childrens Mylicon Tummy Relief for Kids, 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 Childrens Mylicon Tummy Relief for Kids, 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.