Mylicon Infants Gas Relief Original

Description

Infants' Mylicon® is a simethicone-based antigas formulation designed for gas relief in infants. The product is presented in a liquid dosage form, specifically as original drops, and is non-staining. Each 1 fluid ounce (30 mL) bottle contains sufficient doses for up to 100 administrations. Mylicon® is free from alcohol, artificial flavors, and saccharin, and is gluten-free, making it suitable for use even in the newest of newborns when used as directed. The product is recommended by pediatricians and is recognized as the #1 brand in its category. It is manufactured for infirst Healthcare Inc., located in Westport, CT 06880. Mylicon is a registered trademark of McNeil Consumer Pharmaceuticals Co. Important: Keep this carton for future reference on full labeling. ©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 used for administration. 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 until it is filled to the prescribed level. If the plunger is pulled past the desired level, push it back to reach the correct dosage. Slowly dispense the liquid into the child’s mouth, directing it toward the inner cheek.

All dosages may be repeated as needed after meals and at bedtime, or as directed by a physician. The total daily dosage should not exceed 12 doses. The medication can 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 specific contraindications listed for this product. However, it is essential to keep the product out of reach of children to prevent accidental ingestion. In the event of an overdose, immediate medical assistance should be sought, or contact a Poison Control Center at 1-800-222-1222, as prompt medical attention is critical even in the absence of noticeable signs or symptoms.

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 symptoms that may arise during treatment.

Side Effects

Patients should be aware of the potential for overdose associated with this medication. In the event of an overdose, it is imperative to seek medical assistance immediately or contact a Poison Control Center at 1-800-222-1222. Quick medical attention is critical, even if no signs or symptoms are initially apparent.

Healthcare providers should monitor patients for any signs of overdose and educate them on the importance of prompt action in such situations.

Drug Interactions

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

Packaging & NDC

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

Pediatric Use

Pediatric patients under 2 years of age and those over 2 years of age may be treated with this medication. For infants under 2 years (weighing less than 24 lbs), the recommended dosage is 0.3 mL. For children over 2 years (weighing more than 24 lbs), the dosage is 0.6 mL.

All dosages can be administered as needed, following meals and at bedtime, or as directed by a physician. It is important not to exceed 12 doses per day. The medication is considered safe for use at every feeding, allowing for administration up to 12 times daily. Pediatricians recommend this medication for use in the specified age groups.

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

There are no specific warnings or precautions regarding the use of Mylicon (simethicone) during pregnancy. The prescribing information does not indicate whether the drug is contraindicated in pregnant patients or if there are any associated risks to the fetus. Additionally, no dosage modifications or special precautions for pregnant individuals are provided in the insert. Healthcare professionals should consider the absence of data when advising women of childbearing potential and weigh the benefits against any potential risks when recommending this medication during pregnancy.

Lactation

Nursing mothers should consult a healthcare professional before using this product. There is a potential for excretion in breast milk, and the safety of this product during lactation has not been established. Caution is advised when administering this product to nursing mothers.

Renal Impairment

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

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in clinical trials for this medication. Consequently, there is no available information regarding dosage adjustments, special monitoring requirements, or precautions for individuals with compromised liver function. It is recommended that healthcare providers exercise caution when prescribing this medication to patients with hepatic impairment, given the lack of data on its safety and efficacy in this population. Regular monitoring of liver function may be warranted based on clinical judgment.

Overdosage

In the event of an overdose, it is imperative to seek immediate medical assistance or contact a Poison Control Center 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 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 these contexts.

Postmarketing Experience

No postmarketing experience details are available in the insert.

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 without delay, 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.

Healthcare professionals are advised to check 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 potentially repeatable as needed, after meals and at bedtime, or as directed by a physician. Clinicians should ensure that patients do not exceed a total of 12 doses per day. 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 Mylicon Infants Gas Relief Original, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

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