Infants Gas Relief

Description

CVS pharmacy® Infants' Gas Relief is a non-staining formula containing simethicone as the active ingredient, comparable to that found in Infants' MYLICON® Drops*. This product is designed to provide relief from gas discomfort in infants. It is formulated without alcohol, saccharin, or artificial flavors. Each bottle contains 1 fluid ounce (30 mL) and provides 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 and 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.

Doses 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 to the recommended dosage level and dispense the liquid slowly into the baby's mouth, directing it toward the inner cheek. The dosage may also be mixed with 1 oz. of cool water, infant formula, or other suitable liquids to facilitate administration.

For optimal hygiene and to maintain the integrity of the product, the dropper should be cleaned after each use, and the original cap should be replaced securely.

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

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 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.

No additional adverse reactions, including serious or common reactions, have been specified in the provided data. Therefore, healthcare professionals should monitor patients for any unexpected effects and report them as necessary.

Drug Interactions

No specific drug interactions have been identified for the product. Additionally, there are no reported interactions with laboratory tests. 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 (dimethicone). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients under 2 years of age and weighing less than 24 pounds should 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. Dosing 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 keep this medication out of reach of children. In the event of an overdose, immediate medical assistance should be sought, or contact a Poison Control Center without delay.

Geriatric Use

There is no specific information regarding the use of Infant's Gas Relief Non-Staining Formula (dimethicone liquid) in geriatric patients. As such, healthcare providers should exercise caution when considering this product for elderly patients. Due to the lack of clinical data, it is advisable to monitor for any adverse effects or unusual responses in this population. Additionally, healthcare providers may consider dose adjustments based on individual patient needs and overall health status, particularly in those aged 65 and older.

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 the use of this medication in pregnant individuals. Healthcare professionals are advised to consider the lack of information when prescribing this medication to women of childbearing potential and to discuss the potential risks and benefits with their patients. It is essential to exercise caution and to monitor any developments closely in pregnant patients who may require treatment.

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 nursing infants 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 individuals with reduced kidney function, as the lack of data necessitates careful clinical judgment. 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 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 symptoms 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 procedures may include supportive care and symptomatic treatment, tailored to the specific symptoms presented. Continuous monitoring of the patient's vital signs and overall clinical status is recommended until the individual is stabilized.

Healthcare providers are encouraged to familiarize themselves with the specific antidotes or treatments available for the substance involved in the overdose, as this knowledge can significantly impact 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 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 configuration that includes a printed foil seal under the cap. It is imperative that the product is not used if this seal is torn or missing, as this may compromise the integrity of the product.

Storage conditions require that the product be kept at room temperature. It is essential to avoid freezing, as this may adversely affect the product's efficacy. For traceability, the lot number and expiration date can be found on the bottom panel of the container.

Additional Clinical Information

The medication is administered orally, with all doses potentially repeatable as needed, after meals and at bedtime, or as directed by a physician. Clinicians should ensure that patients do not exceed 12 doses per day. No further information is available regarding laboratory tests, abuse potential, patient counseling, 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)