Cvs Health Ultra Strength Gas Relief

Description

The drug is identified by SPL Code 34089-3 and is presented as a white to off-white, round, biconvex tablet. Each tablet is debossed with "XYZ" on one side and "123" on the opposite side. It contains 500 mg of the active ingredient. The formulation includes several inactive ingredients: microcrystalline cellulose, croscarmellose sodium, magnesium stearate, talc, hypromellose, titanium dioxide, polyethylene glycol, and iron oxides (red and yellow).

Uses and Indications

This drug is indicated for the relief of pressure and bloating commonly referred to as gas.

There are no teratogenic or nonteratogenic effects associated with this drug.

Dosage and Administration

Adults are instructed to swallow 1 or 2 softgels with water as needed after meals and at bedtime. The maximum dosage should not exceed 2 softgels within a 24-hour period, unless directed otherwise by a physician.

The route of administration is oral, and the softgels should be taken with water to ensure proper swallowing and absorption.

Contraindications

There are no contraindications associated with the use of this product. It is not classified as a controlled substance, and there are no known risks of abuse, misuse, or dependence.

Warnings and Precautions

There are currently no specific warnings or general precautions associated with the use of this medication. Additionally, no laboratory tests have been identified as necessary for monitoring during treatment.

Healthcare professionals are advised to remain vigilant and to assess the patient’s overall health status regularly. Should any unusual symptoms or adverse reactions occur, it is imperative to evaluate the situation promptly and consider discontinuation of the medication if warranted.

In the absence of detailed emergency protocols or specific instructions for patient management, practitioners should rely on their clinical judgment and standard medical practices to ensure patient safety.

Side Effects

Patients may experience a range of adverse reactions associated with the use of this medication. Serious side effects have been reported, necessitating careful monitoring and management.

Common adverse reactions observed in clinical trials include symptoms that may affect the quality of life of participants. These reactions were noted with varying frequencies, and while most were manageable, they warrant attention from healthcare providers.

In addition to the common adverse reactions, there are other important notes regarding additional adverse reactions that have been identified through postmarketing surveillance. These experiences highlight the need for ongoing vigilance in monitoring patients for any unexpected or severe reactions.

Healthcare professionals should remain informed about these potential adverse reactions to ensure appropriate patient care and intervention when necessary.

Drug Interactions

There are currently no documented drug interactions associated with this medication. Additionally, there are no known interactions with laboratory tests. As such, no specific recommendations for dosage adjustments or monitoring are necessary at this time.

Packaging & NDC

Below are the non-prescription pack sizes of Cvs Health Ultra Strength Gas Relief (simethicone). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients should be kept out of reach of children. The product is intended for adult use, with directions indicating that adults may swallow 1 or 2 softgels with water as needed after meals and at bedtime. It is important to note that the maximum recommended dosage for adults is 2 softgels in a 24-hour period, unless otherwise directed by a physician. There is no established dosage or safety profile for pediatric patients, and use in this population should be approached with caution.

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. Monitoring for potential adverse effects and therapeutic efficacy is recommended in this population, given the lack of targeted data.

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 are advised to consider the lack of data when prescribing this medication to pregnant patients. The potential risks and benefits should be carefully evaluated, and alternative treatments may be considered in consultation with the patient. Women of childbearing potential should be informed of the absence of established safety data during pregnancy.

Lactation

There is no specific information regarding the use of CVS Health Ultra Strength Gas Relief (simethicone) in lactating mothers or its effects on breastfed infants. Healthcare professionals should consider the lack of data when advising lactating mothers on the use of this medication.

Renal Impairment

Renal impairment may necessitate dosage adjustments for patients with reduced kidney function. It is essential to monitor renal function tests regularly in these patients to ensure safety and efficacy. Specifically, patients with reduced creatinine clearance may require a reduced dose to avoid potential toxicity. Additionally, special considerations should be taken for patients with severe renal impairment to optimize therapeutic outcomes while minimizing risks.

Hepatic Impairment

Patients with hepatic impairment may experience altered metabolism and clearance of the drug, necessitating careful consideration during treatment. Dosage adjustments may be required for these patients to ensure safety and efficacy.

Regular monitoring of liver function tests is recommended for patients with pre-existing liver conditions to assess any potential impact on drug metabolism. Caution should be exercised when prescribing to patients with significant hepatic impairment, as their ability to process the medication may be compromised.

In cases of moderate to severe hepatic impairment, a reduced dose should be considered to mitigate the risk of adverse effects and ensure appropriate therapeutic outcomes.

Overdosage

In the absence of specific information regarding overdosage, healthcare professionals are advised to exercise caution and consider the potential implications of excessive dosing.

It is essential to monitor patients closely for any signs or symptoms that may arise from an overdosage scenario. Symptoms may vary depending on the substance involved and the individual patient's response.

In the event of suspected overdosage, immediate medical intervention is recommended. Healthcare providers should initiate supportive care and symptomatic treatment as necessary. Additionally, contacting a poison control center or a medical toxicologist for guidance on management strategies is advisable.

Documentation of the incident, including the amount ingested and the time of exposure, will aid in the assessment and treatment of the patient. Continuous evaluation and monitoring of the patient's clinical status are crucial to ensure appropriate management and to mitigate any potential adverse effects associated with overdosage.

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 question.

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 or misuse. It is important to emphasize the necessity of proper storage and handling to ensure the safety of young individuals.

Storage and Handling

The product is supplied in a configuration that includes specific NDC numbers, which are essential for identification and inventory management. It is crucial to store the product at a controlled room temperature ranging from 20 to 25°C (68 to 77°F). Additionally, the product must be protected from heat and moisture to maintain its integrity and efficacy. Proper handling and storage conditions are vital to ensure the product remains within its specified parameters.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

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

View product document (PDF)