Infants Gas Relief

Description

Simethicone is presented in a dosage form of 20 mg per dose, contained within a nonstaining formula. The product is free from alcohol, saccharin, and artificial flavors, ensuring a straightforward composition. It features a newly designed dosing syringe for improved administration. Each container holds 1 fluid ounce (30 mL) and provides a total of 100 doses.

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

Healthcare professionals should instruct caregivers to shake the medication well before use. The dosing regimen allows for all doses to be repeated as needed, following meals and at bedtime, or as directed by a physician. It is imperative that the total daily dosage does not exceed 12 doses.

The enclosed syringe must be utilized exclusively for administering this medication; caregivers should not use any other syringe, dropper, spoon, or dosing device. To prepare the dose, caregivers should remove the cap and insert the syringe into the hole at the top of the bottle, then turn the bottle upside down. The plunger of the syringe should be pulled back until it is filled slightly above the prescribed level. After returning the bottle to its original position, the caregiver should gently push the plunger back until the correct dosage is reached. The syringe should then be removed from the bottle, and the liquid should be dispensed slowly into the child’s mouth, directed toward the inner cheek.

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. The dosage may be mixed with 1 ounce of cool water, infant formula, or other suitable liquids to facilitate administration.

For optimal results, caregivers should clean the syringe after each use and replace the original cap securely on the bottle.

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. The national Poison Control Center can be reached at 1-800-222-1222 for guidance and support in managing overdose situations.

Side Effects

Patients should be advised to keep the medication out of reach of children. In the event of an overdose, it is crucial to seek medical assistance or contact a Poison Control Center immediately.

No specific adverse reactions have been reported in clinical trials or postmarketing experiences beyond the warnings provided. It is essential for healthcare providers to monitor patients for any unexpected effects and to report them as necessary.

Drug Interactions

There are currently no specific drug interactions identified for the medication. Additionally, no interactions with laboratory tests have been reported. Therefore, no dosage adjustments or monitoring recommendations are necessary at this time.

Packaging & NDC

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

Pediatric Use

Pediatric patients under 2 years of age and weighing less than 24 lbs should 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. Doses may be repeated as needed, after meals and at bedtime, or as directed by a physician, with a maximum of 12 doses per day.

It is essential to use only the enclosed syringe for dosing; other syringes, droppers, spoons, or dosing devices should not be used when administering this medication to children.

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 closely monitor this population for any potential adverse effects or changes in drug efficacy, as age-related physiological changes may influence drug metabolism and response. Additionally, consideration should be given to the presence of comorbidities and polypharmacy, which are common in geriatric patients and may necessitate dosage adjustments or increased vigilance in monitoring.

Pregnancy

There is no specific information available 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 should be informed of the absence of established safety data in pregnancy.

Lactation

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

Renal Impairment

Patients with renal impairment may not have specific dosage adjustments, special monitoring, or safety considerations outlined in the prescribing information. Therefore, healthcare professionals should exercise caution when prescribing this medication to patients with reduced kidney function, as the absence of detailed guidance necessitates careful clinical judgment and individualized patient assessment. Regular monitoring of renal function is advisable to ensure patient safety and therapeutic efficacy.

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. Healthcare professionals should advise patients or caregivers to call the Poison Control Center at 1-800-222-1222 for guidance.

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 are encouraged to remain vigilant and prepared to provide supportive care, which may include monitoring vital signs, administering activated charcoal if indicated, and employing other necessary medical interventions as dictated by the clinical scenario.

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 in these areas limits the understanding of the compound's potential effects in nonclinical settings.

Postmarketing Experience

No postmarketing experience details are available in the insert text.

Patient Counseling

Healthcare providers should advise patients to keep this medication out of reach of children to prevent accidental ingestion. It is important to inform patients that in the event of an overdose, they should seek medical help immediately or contact a Poison Control Center. The national Poison Control Center can be reached at 1-800-222-1222, and patients should be encouraged to have this number readily available.

Storage and Handling

The product is supplied in configurations that include specific NDC numbers, which can be referenced for identification. It is essential to store the product at room temperature, ensuring that it is kept away from freezing conditions.

Healthcare professionals should be aware that the integrity of the product is crucial; therefore, it must not be used if the neck wrap imprinted with "Safety Seal" is broken or missing. For traceability, the lot number and expiration date can be found on the bottom panel of the packaging. Proper handling and storage are vital to maintain the product's efficacy and safety.

Additional Clinical Information

The medication is administered orally. Clinicians should advise patients to keep the product out of reach of children and to seek immediate medical assistance or contact a Poison Control Center (1-800-222-1222) in the event of an overdose. Patients should not use the product if the neck wrap imprinted with "Safety Seal" is broken or missing. Additionally, it is important to store the medication at room temperature and avoid freezing. No further information is available regarding laboratory tests, abuse potential, or postmarketing experience.

Drug Information (PDF)

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

View product document (PDF)