Simethicone Infant

Description

No description information is available for the specified drug.

Uses and Indications

This drug is indicated for the relief of symptoms associated with gas.

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

Dosage and Administration

Shake the product well before use. The recommended dosages may be repeated as needed, particularly during meals and at bedtime, or as directed by a physician. It is important not to exceed 12 doses in a 24-hour period.

For administration, fill the enclosed dropper to the recommended dosage level. Dispense the liquid slowly into the baby's mouth, directing it toward the inner cheek to facilitate swallowing. Alternatively, the dosage may be mixed with 1 oz. of cool water, infant formula, or other suitable liquids to enhance palatability.

Dosage by Age and Weight:

• Infants (under 2 years): For infants weighing under 24 lbs, the recommended dose is 0.3 mL.

• Children (2 years and over): For children weighing 24 lbs and over, the recommended dose is 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 without delay.

Warnings and Precautions

It is imperative to keep this medication out of reach of children to prevent accidental ingestion and potential harm.

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 and intervention.

Side Effects

In the event of an overdose, patients should seek medical assistance or contact a Poison Control Center immediately. This warning is critical to ensure prompt and appropriate care in such situations.

No additional adverse reactions have been reported in clinical trials or postmarketing experiences. It is essential for healthcare providers to monitor patients for any signs of overdose and to educate them on the importance of adhering to prescribed dosages.

Drug Interactions

There are currently no documented drug interactions associated with the use of this medication. Additionally, there is no information available regarding interactions with laboratory tests. As such, no specific recommendations for dosage adjustments or monitoring are warranted at this time.

Packaging & NDC

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

Pediatric Use

Pediatric patients under 2 years of age are recommended to receive a dose of 0.3 mL if they weigh less than 24 lbs. For children aged 2 years and older, the recommended dose is 0.6 mL for those weighing 24 lbs and above.

Administration should be performed by filling the enclosed dropper to the recommended dosage level and dispensing the liquid slowly into the child's mouth, directing it toward the inner cheek. Alternatively, the dosage may be mixed with 1 oz. of cool water, infant formula, or other suitable liquids to facilitate ingestion.

It is crucial to keep this medication out of reach of children. In the event of an overdose, immediate medical assistance should be sought, or contact a Poison Control Center without delay.

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 adverse effects or changes in therapeutic response, given the lack of targeted data for this population.

Pregnancy

There is no specific information available regarding the use of Simethicone Infant Gas Relief Drops during pregnancy. As such, safety concerns, dosage modifications, or special precautions for pregnant patients have not been established. Healthcare professionals should consider the lack of data when advising women of childbearing potential and weigh the potential benefits against any unknown risks when recommending this product during pregnancy.

Lactation

There are no specific warnings or recommendations regarding the use of Simethicone Infant Gas Relief Drops in lactating mothers. Additionally, there is no information available about the potential for excretion of the drug in breast milk or any associated risks to breastfed infants.

Renal Impairment

There is no information available regarding dosage adjustments, special monitoring, or safety considerations for patients with renal impairment. Healthcare professionals should exercise caution and consider the lack of specific guidance when prescribing to patients with reduced kidney function.

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 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 without delay. Prompt intervention is crucial to mitigate potential adverse effects associated with the overdose.

Healthcare professionals should be vigilant in monitoring for symptoms that may arise from an overdose. While specific symptoms are not detailed in the provided information, it is essential to be aware that they can vary based on the substance involved and the individual patient’s response.

Management of an overdose typically involves supportive care and symptomatic treatment. Healthcare providers are advised to follow established protocols for overdose management, which may include decontamination, monitoring vital signs, and administering specific antidotes if applicable.

In summary, timely medical intervention and appropriate management strategies are critical in addressing overdose situations effectively.

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

Postmarketing experience has identified additional adverse reactions reported voluntarily or through surveillance programs. Healthcare professionals and patients are encouraged to report any suspected adverse reactions to the FDA at 1-800-FDA-1088 or via the website https://www.fda.gov/medwatch/report.htm. This reporting contributes to the ongoing assessment of the safety profile of the product.

Patient Counseling

Healthcare providers should advise patients to keep this medication out of reach of children to prevent accidental ingestion. It is important for patients to understand the potential risks associated with overdose. In the event of an overdose, patients should be instructed to seek medical help immediately or contact a Poison Control Center for assistance. This information is crucial for ensuring patient safety and promoting responsible use of the medication.

Storage and Handling

The product is supplied in a configuration that includes a printed seal under the cap, which must remain intact; do not use the product if this seal is broken or punctured. It should be stored at room temperature, ensuring that it is not exposed to freezing conditions. For reference, the lot number and expiration date can be found on the bottom panel of the container.

Additional Clinical Information

The medication is administered orally, with dosages that may be repeated as needed, adjusted around 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.

For reporting suspected adverse reactions, patients and healthcare professionals are encouraged to contact the FDA at 1-800-FDA-1088 or visit https://www.fda.gov/medwatch/report.htm. No additional information is available regarding laboratory tests, abuse potential, or patient counseling.

Drug Information (PDF)

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

View product document (PDF)