Infants Gas Relief

Description

This product is a dye-free formulation designed for infants' gas relief, containing simethicone as the active ingredient, comparable to that found in INFANTS’ MYLICON® DROPS. The non-staining formula gently breaks down gas bubbles in infants, providing effective relief without the use of alcohol, artificial colors, or flavors. Each bottle contains 1 fluid ounce (30 mL) and delivers 100 doses. The product is distributed by The Kroger Co., located in Cincinnati, Ohio, 45202. It is important to note that this product is not manufactured or distributed by Infirst Healthcare Inc., the distributor of INFANTS’ MYLICON® DROPS, and Infirst Healthcare Inc. is not affiliated with The Kroger Co. or this product. The National Drug Code (NDC) for this product is 30142-171-01.

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. Healthcare professionals should determine the appropriate dosage based on the patient's weight; if weight is not available, age may be used as a guide. The following dosage recommendations apply:

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

All dosages may be repeated as needed after meals and at bedtime, or as directed by a physician. It is important not to exceed 12 doses in a 24-hour period.

To administer the medication, fill the enclosed dropper or syringe to the recommended dosage level. Dispense the liquid slowly into the child’s mouth, directing it toward the inner cheek. It is crucial to use only the provided dropper or syringe for dosing; do not substitute with other devices such as spoons or different syringes.

The dosage may also be mixed with 1 ounce of cool water, infant formula, or other suitable liquids to facilitate administration. After each use, the dropper should be cleaned thoroughly, and the bottle should be recapped with the original cap to maintain integrity.

Contraindications

There are no specific contraindications listed for this product. However, it is advised 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.

Warnings and Precautions

It is imperative to keep this medication out of reach of children to prevent accidental ingestion. In the event of an overdose, immediate medical assistance is essential. Healthcare professionals should advise patients to contact a Poison Control Center at 1-800-222-1222 or seek emergency medical help without delay, even if no signs or symptoms are apparent. Prompt intervention is crucial in such situations to mitigate potential health risks.

Currently, there are no specific general precautions or laboratory tests associated with the use of this medication. However, the emphasis on overdose management remains a critical component of patient safety and care.

Side Effects

In the event of an overdose, patients are advised to seek immediate medical assistance or contact a Poison Control Center at 1-800-222-1222. Prompt medical attention is crucial, even if no signs or symptoms are apparent. This warning underscores the importance of vigilance regarding dosage to prevent serious health consequences.

Drug Interactions

There are no specific drug interactions identified for this medication. Additionally, no laboratory test interactions have been noted in the available data. Therefore, no dosage adjustments or monitoring recommendations are necessary based on drug or laboratory test interactions.

Packaging & NDC

Below are the non-prescription pack sizes of Infants Gas Relief (simethicone antigas). 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. All dosages may be repeated as needed after meals and at bedtime, or as directed by a physician. It is important not to exceed 12 doses per day.

When determining the appropriate dosage, weight should be used if possible; otherwise, age may be utilized. The recommended dosage should be dispensed slowly into the infant's mouth, directed toward the inner cheek, using the enclosed dropper or syringe filled to the indicated level. Alternatively, the dosage can be mixed with 1 oz. of cool water, infant formula, or other suitable liquids to facilitate administration.

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, given the physiological changes associated with aging that may affect drug metabolism and response. Additionally, consideration should be given to the possibility of altered pharmacokinetics and pharmacodynamics in geriatric patients, which may necessitate dosage adjustments or increased monitoring.

Pregnancy

The available prescribing information does not provide specific data regarding the use of this product during pregnancy, including safety concerns, dosage modifications, or special precautions. Therefore, healthcare professionals are advised to exercise caution when prescribing this product to pregnant patients. The potential risks and benefits should be carefully considered, and alternative therapies may be explored in consultation with the patient. Women of childbearing potential should be informed of the lack of data and encouraged to discuss any concerns with their healthcare provider.

Lactation

There is no specific information available regarding the use of this medication in nursing mothers or any lactation considerations. Healthcare professionals should exercise caution and consider the potential risks and benefits when prescribing this medication to lactating mothers. Further research may be necessary to fully understand the implications for breastfed infants.

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 these patients to ensure safety and 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 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 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 of an overdose 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 information is available regarding teratogenic or non-teratogenic effects. Additionally, there is no data provided concerning nonclinical toxicology, animal pharmacology, or toxicology.

Postmarketing Experience

No postmarketing experience details are available in the insert text.

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. Healthcare professionals are advised not to use the product if the printed seal under the cap is broken or missing.

Storage conditions require the product to be maintained at room temperature. It is imperative to avoid freezing the product to ensure its integrity and efficacy. 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 immediate medical assistance or contact a Poison Control Center at 1-800-222-1222 in the event of an overdose, as prompt medical attention is crucial even if no symptoms are apparent.

Patients may mix the dosage with 1 oz. of cool water, infant formula, or other suitable liquids for administration. It is also important to clean the dropper thoroughly after each use and to recap the bottle with the original cap to maintain product integrity.

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)