Infants Gas Relief

Description

Simethicone is presented in a dosage of 20 mg per dose, formulated as a nonstaining solution. 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 package contains a total of 200 doses, provided in two 1 FL OZ (30 mL) bottles, amounting to a total volume of 2 FL OZ (60 mL). This formulation is comparable to Infants' Mylicon®.

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 bottle well before use. The recommended dosage for infants under 2 years of age (weighing less than 24 lb) is 0.3 mL, while for children over 2 years of age (weighing more than 24 lb), the dosage is 0.6 mL. All doses may be repeated as needed after meals and at bedtime, or as directed by a physician. However, the total daily dosage should not exceed 12 doses.

Administration should be performed using only the enclosed syringe. Other syringes, droppers, spoons, or dosing devices are not recommended. To administer the medication, remove the cap and insert the syringe into the hole at the top of the bottle. Turn the bottle upside down and pull back the plunger of the syringe until it is filled slightly above the prescribed level. Return the bottle to its original position and gently push the plunger back until the liquid reaches the prescribed level. Withdraw the syringe from the bottle and dispense the liquid slowly into the child’s mouth, aiming for the inner cheek.

For optimal results, the dosage may be mixed with 1 oz. of cool water, infant formula, or other suitable liquids. It is advisable to clean the syringe after each use and replace the original cap to maintain hygiene and ensure proper dosing.

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 at 1-800-222-1222 for guidance on managing the situation effectively.

Side Effects

Patients should be aware that in the event of an overdose, immediate medical assistance is necessary. It is advised to contact a Poison Control Center without delay at 1-800-222-1222. This warning underscores the importance of adhering to prescribed dosages to mitigate the risk of serious adverse reactions associated with overdose.

Drug Interactions

There are currently no specific drug interactions or drug and laboratory test interactions identified for the medication. As such, no dosage adjustments or monitoring recommendations are necessary at this time. Healthcare professionals should continue to assess the patient's overall medication regimen and clinical status to ensure safe and effective use of the medication.

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 old (weighing less than 24 lbs) should receive a dose of 0.3 mL, while those over 2 years old (weighing more than 24 lbs) should receive a dose of 0.6 mL. The dosage can be mixed with 1 oz. of cool water, infant formula, or other suitable liquids to facilitate administration.

Healthcare professionals should advise caregivers to keep the product out of reach of children. In the event of an overdose, immediate medical assistance should be sought, or the Poison Control Center should be contacted without delay.

Geriatric Use

There is no specific information regarding the use of Infant's Gas Relief (dimethicone liquid) in geriatric patients. Therefore, healthcare providers should exercise caution when considering this medication for elderly patients. It is advisable to monitor for any potential adverse effects or interactions, particularly in those who may have multiple comorbidities or are taking other medications. As there are no established dosage adjustments or safety considerations specifically for this population, clinical judgment should guide the use of this product in geriatric patients.

Pregnancy

Pregnant patients should be aware that the safety of this medication during pregnancy has not been established. There are no available data regarding the potential risks or fetal impacts associated with its use in pregnant individuals. Healthcare professionals are advised to consider the lack of information when prescribing this medication to women of childbearing potential and to weigh the benefits against any potential risks. It is recommended that patients discuss their pregnancy status and any plans for pregnancy with their healthcare provider prior to initiating treatment.

Lactation

There is no specific information available regarding the use of this medication in lactating mothers or its effects on breastfed infants. Healthcare professionals should consider the lack of data when advising lactating mothers about the use of this medication.

Renal Impairment

Patients with renal impairment have not been specifically addressed in the available prescribing information. There are no dosage adjustments, special monitoring requirements, or safety considerations outlined for individuals with reduced kidney function. Healthcare professionals should exercise caution and consider the lack of data when prescribing to this patient population.

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 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 mitigate potential adverse effects. Symptoms of overdose may vary depending on the substance involved, and healthcare providers should be prepared to assess and manage these symptoms accordingly.

Management procedures may include supportive care, monitoring of vital signs, and specific antidotal treatments if applicable. It is essential for healthcare professionals to remain vigilant and act swiftly to ensure patient safety in cases of suspected 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 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 a container that must not be used if the preprinted seal around the bottle is torn or missing. 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. Clinicians should advise patients to keep the medication out of reach of children and to seek medical assistance or contact a Poison Control Center immediately in the event of an overdose (1-800-222-1222). Patients are also instructed not to use the product if the preprinted seal around the bottle is torn or missing. Proper storage conditions include keeping the medication at room temperature and avoiding freezing.

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)