Infants Gas Relief

Description

Harris Teeter™ Infants' Gas Relief Drops contain 20 mg of simethicone as the active ingredient, indicated for the fast relief of gas symptoms in infants. The formulation is designed as non-staining drops, with a total volume of 1 FL OZ (30 mL). This product is characterized by the absence of artificial flavors, alcohol, and dyes, ensuring a gentle and safe option for infants. It is comparable to the active ingredient found in Mylicon®.

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

All dosages may be repeated as needed, with administration recommended after meals and at bedtime. To administer, fill the enclosed dropper to the appropriate dosage level. The liquid should be dispensed slowly into the child's mouth, directed toward the inner cheek to facilitate swallowing.

For ease of administration, the medication may be mixed with 1 oz. 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 contraindications associated with the use of this product. It is deemed safe for use in the absence of specific conditions or situations that would warrant avoidance.

Warnings and Precautions

Healthcare professionals should be aware of the following warnings and precautions when administering this product.

It is imperative that the recommended dosage is strictly adhered to; do not exceed 12 doses per day. Exceeding this limit may lead to serious adverse effects.

In the event of an overdose, immediate medical assistance is crucial. Healthcare providers should instruct patients or caregivers to seek medical help or contact a Poison Control Center without delay. Prompt action is essential to mitigate potential health risks associated with overdose.

Side Effects

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

In clinical trials and postmarketing experiences, participants have reported various adverse reactions, although specific data on the frequency and nature of these reactions were not provided. Continuous monitoring and adherence to dosing guidelines are essential for ensuring patient safety.

Drug Interactions

There are currently no specific drug interactions identified for this medication. Additionally, no interactions with laboratory tests have been documented. As such, routine monitoring or dosage adjustments based on drug interactions are not necessary.

Packaging & NDC

Below are the non-prescription pack sizes of Infants 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 pounds are recommended to receive a dose of 0.3 mL. For children over 2 years of age and weighing more than 24 pounds, the recommended dose is 0.6 mL. It is important to note that the total daily dose should not exceed 12 doses.

Healthcare professionals should ensure that the product is kept 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 available regarding the use of this medication in geriatric patients, including dosage adjustments, safety concerns, or special precautions. Healthcare providers should exercise caution when prescribing this medication to elderly patients, as individual responses may vary. Monitoring for potential adverse effects and therapeutic efficacy is recommended in this population.

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

There is no specific information available regarding the use of this medication in nursing mothers or 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

Patients with renal impairment may require dosage adjustments to ensure safety and efficacy. It is essential to monitor renal function tests in individuals with kidney problems to assess their condition accurately. Additionally, a reduced dose should be considered for patients with decreased creatinine clearance to mitigate the risk of adverse effects associated with impaired renal function.

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, as the clinical presentation can vary depending on the substance involved and the individual patient's response. Common symptoms of overdose may include, but are not limited to, altered mental status, cardiovascular instability, respiratory distress, and gastrointestinal disturbances.

In the event of an overdose, immediate medical intervention is recommended. Healthcare providers should initiate supportive care, which may include maintaining airway patency, providing supplemental oxygen, and ensuring adequate circulation. The use of activated charcoal may be considered if the patient presents within a suitable timeframe and is deemed appropriate based on clinical judgment.

Additionally, it is crucial to consult local poison control centers or toxicology experts for guidance on specific management protocols and antidotes, if applicable. Continuous monitoring of vital signs and laboratory parameters may be necessary to assess the patient's condition and guide further treatment decisions.

In summary, while specific overdosage information is not available, healthcare professionals should remain vigilant and prepared to implement standard overdose management strategies to ensure patient safety and optimal outcomes.

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 seek immediate medical assistance or contact a Poison Control Center in the event of an overdose. It is crucial for patients to understand the importance of prompt action in such situations 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 necessary beyond standard storage practices.

Additional Clinical Information

The medication is administered orally, with all dosages able to be repeated as needed after meals and at bedtime. Clinicians should advise patients that in the event of an overdose, immediate medical assistance or contact with a Poison Control Center is essential. Additionally, patients are instructed to clean the dropper after each use and ensure the bottle is closed to maintain child resistance.

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)