Infants Non-Staining Gas Relief

Description

Infants' Non-Staining Gas Relief Drops contain simethicone as the active ingredient, with a concentration of 20 mg per 1 FL OZ (30 mL) dosage form. The product is designed to provide fast relief of gas symptoms in infants. It is formulated without artificial flavors, alcohol, or dyes, ensuring a gentle and safe option for gas relief. The product is identified by NDC 37808-014-09 and is comparable to Infants' Mylicon® Drops Non-Staining.

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 and weighing less than 24 pounds, the recommended dosage is 0.3 mL. For children over 2 years of age and weighing more than 24 pounds, the recommended dosage is 0.6 mL.

All dosages may be repeated as needed, after meals and at bedtime, or as directed by a physician. To administer the medication, fill the enclosed dropper to the recommended dosage level. The liquid should be dispensed slowly into the child's mouth, directed toward the inner cheek.

For ease of administration, the medication may be mixed with 1 ounce 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 specific contraindications listed for this product. However, in the event of an overdose, immediate medical assistance should be sought, or the Poison Control Center should be contacted without delay.

Warnings and Precautions

When using this product, it is imperative that the daily dosage does not exceed 12 doses. Exceeding this limit may lead to serious health complications.

In the event of an overdose, immediate medical assistance is crucial. Healthcare professionals should advise patients to seek emergency medical help or contact a Poison Control Center without delay.

Patients are also instructed to discontinue use of the product and consult their healthcare provider if they experience any adverse effects or have concerns regarding their treatment. Regular monitoring and communication with a healthcare professional are essential to ensure safe and effective use of this product.

Side Effects

Patients should be aware that exceeding 12 doses of this product per day may lead to serious adverse reactions. It is crucial to adhere to the recommended dosage to minimize the risk of potential complications.

In clinical trials and postmarketing experiences, participants have reported various adverse reactions associated with the use of this product. While specific frequency data is not provided, the importance of monitoring for adverse effects remains paramount. Patients are encouraged to consult healthcare professionals if they experience any unexpected symptoms or reactions during treatment.

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

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 advise caregivers 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 should be contacted.

Geriatric Use

There is no specific information regarding the use of this medication in geriatric patients. Therefore, healthcare providers should exercise caution when prescribing this medication to elderly patients. It is advisable to monitor these patients closely for any potential adverse effects or changes in efficacy, given the variability in pharmacokinetics and pharmacodynamics that may occur with aging. Additionally, consideration should be given to the presence of comorbidities and the potential for polypharmacy in this population, which may necessitate dosage adjustments or increased monitoring.

Pregnancy

There is no specific information regarding the use of this medication during pregnancy, including safety concerns, dosage modifications, or special precautions. Healthcare professionals should consider the lack of data when prescribing this medication to pregnant patients. It is advisable to weigh the potential benefits against any unknown risks to fetal outcomes. Women of childbearing potential should be counseled on the importance of effective contraception during treatment and the need to inform their healthcare provider if they become pregnant or plan to become pregnant while on this medication.

Lactation

Lactating mothers should consult a healthcare professional before using this product. There is a potential for excretion in breast milk. The effects on a nursing infant are not well studied; therefore, caution is advised.

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 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 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 from excessive dosing. Symptoms of overdosage can vary widely depending on the substance involved and the individual patient's response.

In the event of an overdose, immediate medical attention should be sought. Healthcare providers should implement supportive care measures, which may include monitoring vital signs, providing symptomatic treatment, and ensuring the patient's safety.

If available, consultation with a poison control center or a medical toxicologist is recommended to guide the management of the overdose. Additionally, healthcare professionals should refer to local protocols and guidelines for the management of overdose situations, as these may provide specific recommendations based on the substance involved.

Documentation of the incident, including the amount ingested and the time of ingestion, is crucial for effective management 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 use of the compound in these contexts.

Postmarketing Experience

Serious side effects have been reported voluntarily or through surveillance programs. Healthcare professionals and patients are encouraged to report any serious adverse events to the designated contact number, 1-609-860-2600, available Monday through Friday from 8 am to 4 pm EST.

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 essential for patients to understand the seriousness of an overdose and the importance of prompt action to ensure their safety and well-being.

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 noted; however, standard precautions should be observed to ensure optimal storage conditions.

Additional Clinical Information

The medication is administered orally, with dosages that may be repeated as needed, typically after meals and at bedtime, or as directed by a physician. Clinicians should advise patients to seek immediate medical assistance or contact a Poison Control Center in the event of an overdose. Additionally, it is important for patients to clean the dropper after each use and ensure the bottle is securely closed to maintain child resistance.

Drug Information (PDF)

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

View product document (PDF)