Infants Gas Relief Drops

Description

The product is identified by the code 51945-4 and is associated with the root ID b47b37a1-bab6-f32e-e053-2995a90a723c. The effective date of this labeling is June 7, 2012. The package label includes a principal display panel, which is visually represented by an image file named "REL INFANT.jpg." The media type for this image is JPEG.

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 medication.

Dosage and Administration

Shake the bottle well before each use. The recommended dosages may be repeated as needed, after meals and at bedtime, or as directed by a physician. It is essential to use only the enclosed dropper for accurate dosing. The maximum allowable dosage is 12 doses per day.

For administration, fill the enclosed dropper to the recommended dosage level and dispense the liquid slowly into the baby’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 administration. After each use, clean the dropper thoroughly and replace the original cap on the bottle to maintain product integrity.

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 a poison control center should be contacted without delay.

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 should be sought, or a poison control center should be contacted without delay.

No specific general precautions or laboratory tests have been identified for this medication. However, healthcare professionals should remain vigilant and monitor patients for any adverse effects or unusual symptoms that may arise during treatment.

In cases of overdose, prompt action is crucial; therefore, healthcare providers should ensure that patients and caregivers are aware of the need to seek emergency medical help or contact a poison control center immediately.

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 no specific drug interactions identified for this medication. Additionally, no laboratory test interactions have been reported. 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 Drops (simethicone). 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 aged 2 years and older, weighing 24 lbs and above, 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 essential to use only the enclosed dropper for accurate dosing and to ensure that the maximum limit of 12 doses per day is not exceeded. The liquid should be dispensed slowly into the child’s mouth, directed toward the inner cheek. Additionally, the dosage may 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, 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. It is advisable to monitor these patients closely for any adverse effects or changes in efficacy, given the lack of targeted data for this population.

Pregnancy

There is no specific information available regarding the use of this medication during pregnancy, including safety concerns, dosage modifications, or special precautions that should be taken. Healthcare professionals should consider the lack of data when prescribing this medication to pregnant patients and weigh the potential risks and benefits. Women of childbearing potential should be counseled on the absence of established safety data and the importance of discussing any plans for pregnancy or potential exposure during treatment.

Lactation

There is no specific information available regarding the use of this medication in nursing mothers or its effects on lactation. Additionally, data on excretion in breast milk and potential effects on breastfed infants are not provided. Healthcare professionals should consider the lack of information 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. Prompt intervention is crucial to mitigate potential adverse effects associated with the overdose.

Healthcare professionals should be aware that the specific symptoms of an overdose may vary depending on the substance involved. Therefore, a thorough assessment of the patient's condition is essential to determine the appropriate course of action.

Management of an overdose typically involves supportive care and symptomatic treatment. Continuous monitoring of the patient's vital signs and clinical status is recommended. In cases where the specific substance is known, targeted therapies may be employed as indicated.

It is essential for healthcare providers to remain vigilant and act swiftly in the management of overdose situations to ensure optimal patient outcomes.

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

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 crucial to emphasize the importance of safety in the home environment, particularly for households with young children.

In the event of an overdose, healthcare providers should instruct patients to seek medical help immediately or contact a poison control center. Patients should be made aware of the signs of overdose and the urgency of obtaining assistance to ensure their safety and well-being.

Storage and Handling

The product is supplied in a tamper-evident container. It should not be used if the foil seal under the cap is broken or missing.

For optimal storage, the product must be kept at a temperature range of 20°-25°C (68°-77°F). It is important to avoid freezing the product.

Healthcare professionals should refer to the bottom panel of the container for the lot number and expiration date to ensure product integrity and safety.

Additional Clinical Information

The medication is administered orally, with all dosages potentially repeatable as needed, after meals and at bedtime, or as directed by a physician. There is no additional information available regarding laboratory tests, abuse potential, patient counseling, or postmarketing experience.

Drug Information (PDF)

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

View product document (PDF)