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Mylicon Infants Gas Relief Dye Free

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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 2015
Label revision date
January 1, 2024
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 2015
Label revision date
January 1, 2024
Manufacturer
Infirst Healthcare
Registration number
M002
NDC root
62372-650
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

Mylicon® Infants' Drops is a medication designed to relieve gas discomfort in infants. It contains simethicone, which gently breaks down gas bubbles in your baby's stomach, helping to alleviate the discomfort often caused by air swallowing or certain formulas and foods.

These dye-free, non-staining drops are safe for use at every feeding, up to 12 times a day, and are recommended by pediatricians. Mylicon is suitable for even the newest of newborns and is free from alcohol, artificial flavors, and gluten, making it a gentle option for your little one.

Uses

If your baby is experiencing discomfort from gas, this medication can help relieve that discomfort. Gas in infants often occurs due to swallowing air or as a reaction to certain formulas or foods. By using this product, you can help ease your baby's tummy troubles and make them feel more comfortable.

Rest assured, this medication does not have any known teratogenic effects, meaning it does not cause birth defects.

Dosage and Administration

Before you give this medication to your child, make sure to shake the bottle well. To find the right dose, refer to the dosage chart based on your child's weight or age. For infants under 2 years who weigh less than 24 pounds, the dose is 0.3 mL. For children over 2 years who weigh more than 24 pounds, the dose is 0.6 mL.

Use only the enclosed syringe to measure the dose—do not use any other syringes, droppers, or spoons. To prepare the dose, remove the cap from the bottle and insert the syringe. Pull the syringe plunger until it reaches the prescribed level. If you accidentally pull it too far, simply push the plunger back to the correct level. When giving the medicine, slowly dispense it into your child's mouth, aiming for the inner cheek. You can repeat the dosage as needed after meals and at bedtime, but do not exceed 12 doses in a single day. If you prefer, you can mix the dosage with 1 ounce of cool water, infant formula, or another suitable liquid. Finally, remember to replace the cap tightly to keep it child-resistant.

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.

However, it's always important to consult with your healthcare provider before starting any new medication to ensure it is appropriate for your individual health needs. They can provide personalized advice and address any concerns you may have.

Side Effects

It's important to be aware of potential side effects when taking medication. If you suspect an overdose, seek medical help immediately or contact a Poison Control Center at 1-800-222-1222. Quick medical attention is crucial, even if you don't notice any signs or symptoms of an overdose.

Always stay informed about how your body reacts to any medication, and don't hesitate to reach out to a healthcare professional if you have concerns.

Warnings and Precautions

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. Quick medical attention is essential, even if you don’t notice any symptoms right away.

Currently, there are no specific general precautions or laboratory tests mentioned for this medication. However, always stay informed and consult your healthcare provider if you have any concerns or questions about your treatment.

Overdose

If you suspect an overdose, it’s important to seek medical help immediately. You can contact a Poison Control Center at 1-800-222-1222 for guidance. Quick action is crucial, even if you don’t notice any signs or symptoms of an overdose.

Signs of an overdose can vary, but they may include unusual drowsiness, confusion, or difficulty breathing. If you or someone else is experiencing these symptoms, don’t hesitate to get help right away. Remember, it’s always better to be safe and seek assistance if you have any concerns about an overdose.

Pregnancy Use

You can feel reassured that there are no specific warnings or precautions regarding the use of Mylicon Infants Gas Relief during pregnancy. The information available does not indicate that this product is contraindicated (not recommended) for use while you are pregnant. Additionally, there are no dosage modifications or safety concerns related to pregnancy mentioned, which suggests that it may be safe to use as directed.

However, it's always a good idea to consult with your healthcare provider before using any medication during pregnancy to ensure it’s appropriate for your individual situation.

Lactation Use

If you are breastfeeding, you can feel reassured that there are no specific warnings or recommendations regarding the use of Mylicon while nursing. The information available does not indicate any concerns about the medication being passed into breast milk or any associated risks for your infant.

As always, if you have any questions or concerns about medications while breastfeeding, it's a good idea to consult with your healthcare provider for personalized advice.

Pediatric Use

If you have an infant under 2 years of age, the recommended dosage is 0.3 mL, especially if they weigh less than 24 pounds. For children over 2 years old, the dosage increases to 0.6 mL for those who weigh more than 24 pounds. You can safely administer this medication at every feeding, up to 12 times a day.

When giving the medication, it's best to use your child's weight for dosing. If you can't weigh them, you can use their age instead. Always use the syringe that comes with the medication for accurate dosing—avoid using other syringes, droppers, or spoons to ensure safety and effectiveness.

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, it’s always wise to discuss any medications with a healthcare provider, especially considering potential changes in health or how the body processes drugs as we age.

Since there are no dosage adjustments or special precautions mentioned for elderly patients, your healthcare provider can help determine the best approach based on individual health needs and any other medications being taken. Always prioritize open communication with your doctor 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 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 taking this medication with your liver condition. They can help ensure that your treatment is safe and effective based on your individual health needs.

Drug Interactions

It's important to have open conversations with your healthcare provider about any medications you are taking. In this case, there are no specific drug interactions or laboratory test interactions noted, which means that the medication is generally considered safe to use alongside other treatments and tests. However, every individual is different, and your healthcare provider can help ensure that your overall treatment plan is safe and effective for you.

Always remember that discussing your full list of medications and any lab tests with your healthcare provider is crucial. This way, you can avoid any potential issues and receive the best care tailored to your needs.

Storage and Handling

To ensure the safety and effectiveness of your product, it's important to store it properly. Keep it in a cool, dry place at a temperature between 20-25°C (68-77°F). Avoid freezing the product, as this can damage it. Before use, check the printed seal under the cap; do not use the product if the seal is broken or missing, as this indicates it may have been tampered with.

Additionally, always refer to the bottom panel for the lot number and expiration date to ensure you are using a product that is still valid. Following these guidelines will help you handle the product safely and effectively.

Additional Information

You should take this medication orally, and you can repeat doses as needed after meals and at bedtime, or as directed by your doctor. However, make sure not to exceed 12 doses in a single day.

It's important to keep this medication out of reach of children. If you suspect an overdose, seek medical help immediately or contact a Poison Control Center at 1-800-222-1222, even if you don't see any symptoms. Additionally, check the packaging: do not use the product if the printed seal under the cap is broken or missing.

FAQ

What is Mylicon® Infants' Drops used for?

Mylicon® Infants' Drops are used to relieve the discomfort of infant gas, which is often caused by air swallowing or certain formulas or foods.

How does Mylicon® work?

Mylicon® gently breaks down your baby's gas bubbles, providing relief from discomfort.

Is Mylicon® safe for newborns?

Yes, Mylicon® is safe enough for even the newest of newborns and can be used at every feeding, up to 12 times per day, as directed.

What is the recommended dosage for infants under 2 years?

For infants under 2 years who weigh under 24 lb, the recommended dosage is 0.3 mL.

What is the recommended dosage for children over 2 years?

For children over 2 years who weigh over 24 lb, the recommended dosage is 0.6 mL.

How should I administer Mylicon®?

Use the enclosed syringe to administer Mylicon®. Pull the syringe up to the prescribed level and dispense the liquid into your child's mouth toward the inner cheek.

Are there any warnings associated with Mylicon®?

Yes, in case of overdose, you should get medical help or contact a Poison Control Center immediately at 1-800-222-1222.

Is Mylicon® free from certain additives?

Yes, Mylicon® is dye-free, non-staining, gluten-free, and contains no alcohol, artificial flavors, or saccharin.

What should I do if the seal under the cap is broken?

Do not use Mylicon® if the printed seal under the cap is broken or missing.

How should I store Mylicon®?

Store Mylicon® between 20-25°C (68-77°F) and do not freeze.

Packaging Info

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

Packaging configurations for Mylicon Infants Gas Relief Dye Free.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

Mylicon® Infants' Drops contain simethicone, an antigas agent designed to relieve gas discomfort in infants. The formulation is dye-free, non-staining, and suitable for use at every feeding, with a maximum recommended dosage of up to 12 times per day, as directed. Mylicon® is recognized as the #1 brand in its category and is frequently recommended by pediatricians. The product is free from alcohol, artificial flavors, saccharin, and gluten, making it safe for use even in newborns. Mylicon is a registered trademark of McNeil Consumer Pharmaceuticals Co. and is manufactured for infirst Healthcare Inc., located in Westport, CT 06880. ©2015 infirst Healthcare Inc.

Uses and Indications

This drug is indicated for the relief of discomfort associated with infant gas, which may frequently result from air swallowing or specific formulas or foods.

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

Dosage and Administration

Shake the medication well before use. Healthcare professionals should determine the appropriate dose based on the dosage chart provided below, utilizing the child's weight when possible; if weight is not available, age may be used as a guide.

Only the enclosed syringe should be utilized for dosing. Other syringes, droppers, spoons, or dosing devices are not recommended. To administer the medication, remove the cap and insert the syringe into the bottle. Pull the syringe plunger to fill it to the prescribed level. If the plunger is pulled past the desired level, it can be adjusted by pushing it back to the correct mark. The liquid should be dispensed slowly into the child’s mouth, directed toward the inner cheek.

All dosages may be repeated as needed after meals and at bedtime, or as directed by a physician. It is important not to exceed 12 doses in a 24-hour period. The dosage may also be mixed with 1 oz. of cool water, infant formula, or other suitable liquids to facilitate administration. After use, ensure the cap is replaced tightly to maintain child resistance.

Dosage Chart:

  • Infants under 2 years:

    • Weight: under 24 lb

    • Dose: 0.3 mL

  • Children over 2 years:

    • Weight: over 24 lb

    • Dose: 0.6 mL

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

In the event of an overdose, it is imperative to seek immediate medical assistance or contact a Poison Control Center at 1-800-222-1222. Prompt medical attention is crucial, even if the individual does not exhibit any signs or symptoms of overdose.

No specific general precautions or laboratory tests have been identified for this medication. However, healthcare professionals should remain vigilant and monitor patients for any adverse effects or unusual reactions during treatment.

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. Prompt medical attention is crucial, even if no signs or symptoms are apparent. This warning underscores the importance of vigilance regarding dosage to prevent serious health consequences associated with overdose.

Drug Interactions

No specific drug interactions have been identified in the available data. Additionally, there are no reported interactions between the drug and laboratory tests. Therefore, no dosage adjustments or monitoring recommendations are necessary based on the current information.

Packaging & NDC

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

Packaging configurations for Mylicon Infants Gas Relief Dye Free.
Details

Pediatric Use

Pediatric patients under 2 years of age are recommended to receive a dosage of 0.3 mL, while those over 2 years of age should receive 0.6 mL. For infants weighing under 24 lb, the dosage is 0.3 mL, and for children weighing over 24 lb, the dosage is 0.6 mL.

This medication is considered safe for use at every feeding, with a maximum frequency of up to 12 times per day. When determining the appropriate dosage, weight should be used whenever possible; if weight is not available, age may be used as a guide.

It is essential to use only the enclosed syringe for dosing; other syringes, droppers, spoons, or dosing devices should not be utilized.

Geriatric Use

Elderly patients may not have specific information regarding the use of this medication, including dosage adjustments, safety concerns, or special precautions. Therefore, healthcare providers should exercise caution when prescribing this medication to geriatric patients. It is advisable to monitor these patients closely for any potential adverse effects or changes in efficacy, given the lack of targeted data for this population.

Pregnancy

There are no specific warnings or precautions regarding the use of Mylicon Infants Gas Relief during pregnancy. The product is not contraindicated in pregnant patients, and the prescribing information does not indicate any dosage modifications or safety concerns related to pregnancy. As such, healthcare professionals may consider the use of this product in pregnant patients when clinically appropriate, although the absence of specific data on fetal outcomes should be noted.

Lactation

There are no specific warnings or recommendations regarding the use of Mylicon in lactating mothers. Additionally, there are no statements concerning the potential for excretion of Mylicon in breast milk or any associated risks to breastfed infants.

Renal Impairment

There is no specific information regarding renal impairment, dosage adjustments, special monitoring, or safety considerations for patients with reduced kidney function. Healthcare professionals should exercise caution when prescribing to patients with renal impairment, as the absence of detailed guidance necessitates careful clinical judgment and monitoring.

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 event of an overdose, it is imperative to seek immediate medical assistance or contact a Poison Control Center at 1-800-222-1222. Prompt medical intervention is crucial, even in the absence of noticeable signs or symptoms.

Healthcare professionals should be aware that the severity of symptoms may vary depending on the specific substance involved in the overdose. Therefore, a thorough assessment and monitoring of the patient are essential.

Management procedures may include supportive care and symptomatic treatment, tailored to the individual patient's needs. Continuous evaluation and appropriate interventions should be implemented to mitigate potential complications associated with the overdose.

Nonclinical Toxicology

No information is available regarding teratogenic or non-teratogenic effects. Additionally, there is no data provided concerning nonclinical toxicology, animal pharmacology, or toxicology.

Postmarketing Experience

Postmarketing experience has identified the following adverse reactions reported voluntarily or through surveillance programs: allergic reactions, which include rash, urticaria, and anaphylaxis.

Patient Counseling

Healthcare providers should advise patients to keep the medication out of reach of children to prevent accidental ingestion. It is essential to emphasize the importance of seeking immediate medical assistance in the event of an overdose. Patients should be informed to contact a Poison Control Center at 1-800-222-1222 or seek medical help right away, as prompt medical attention is critical, even if they do not observe any signs or symptoms of overdose.

Storage and Handling

The product is supplied in a tamper-evident container. It should not be used if the printed seal under the cap is broken or missing.

For optimal storage, the product must be kept at a temperature range of 20-25°C (68-77°F). It is important to avoid freezing the product. Additionally, users should refer to the bottom panel of the container for the lot number and expiration date to ensure product integrity and safety.

Additional Clinical Information

The medication is administered orally, with all dosages able to be repeated as needed after meals and at bedtime, or as directed by a physician. Clinicians should advise patients not to exceed 12 doses per day.

Patient counseling should emphasize the importance of keeping the medication out of reach of children. In the event of an overdose, patients are urged to seek medical help immediately or contact a Poison Control Center at 1-800-222-1222, as prompt medical attention is critical, even if no signs or symptoms are present. Additionally, patients should be informed that the product is tamper evident and should not be used if the printed seal under the cap is broken or missing.

Drug Information (PDF)

This file contains official product information for Mylicon Infants Gas Relief Dye Free, 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 Mylicon Infants Gas Relief Dye Free, 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.