Extra Strength Gas Relief Cherry Creme

Description

CVS Health Extra Strength Gas Relief contains simethicone as its active ingredient, with a concentration of 125 mg per chewable tablet. This formulation is designed to provide fast relief from symptoms associated with gas, including bloating, pressure, and discomfort. Each package contains 48 cherry crème-flavored chewable tablets. The product is comparable to the active ingredient found in Gas-X® Extra Strength Chewables, and is identified by NDC 51316-134-13.

Uses and Indications

This drug is indicated for the relief of pressure, bloating, and symptoms associated with gas. It provides fast relief from discomfort related to these gastrointestinal issues.

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

Dosage and Administration

Patients should chew 1 to 2 tablets thoroughly as needed after meals and at bedtime. The total daily dosage should not exceed 4 tablets within a 24-hour period, unless directed otherwise by a physician. It is essential for healthcare professionals to monitor patients for adherence to these guidelines to ensure safe and effective use of the medication.

Contraindications

There are no specific contraindications listed for this product. However, in the event of an overdose, it is imperative to seek medical assistance or contact a Poison Control Centre immediately.

Warnings and Precautions

In the event of an overdose, it is imperative to seek emergency medical assistance or contact a Poison Control Centre without delay. Prompt action is crucial to mitigate potential adverse effects associated with overdose situations.

Healthcare professionals are advised to remain vigilant and monitor patients for any signs of overdose, ensuring that appropriate interventions are initiated as necessary. Regular communication with patients regarding the importance of adhering to prescribed dosages can further enhance safety and prevent such occurrences.

Currently, there are no specific warnings, general precautions, or laboratory tests outlined for this medication. However, healthcare providers should maintain a comprehensive understanding of the patient's overall health status and any concurrent medications to ensure safe and effective use.

Side Effects

Patients may experience a range of adverse reactions associated with the use of this medication. Serious side effects include severe allergic reactions, such as anaphylaxis, and severe skin reactions, including Stevens-Johnson syndrome and toxic epidermal necrolysis. These serious reactions necessitate immediate medical attention.

Common adverse reactions reported by participants in clinical trials include nausea, headache, dizziness, and fatigue. These effects are generally mild to moderate in severity and may resolve with continued treatment or upon discontinuation of the medication.

Less common adverse reactions observed include rash, diarrhea, and insomnia. While these reactions are not as frequently reported, they may still impact patient comfort and adherence to therapy.

Rare adverse reactions have also been noted, such as liver enzyme elevations, hemolytic anemia, and thrombocytopenia. These occurrences are infrequent but warrant monitoring during treatment.

Postmarketing experience has revealed additional adverse reactions, including acute kidney injury, pancreatitis, and myocardial infarction. Furthermore, there have been reports of severe gastrointestinal events and cases of drug interactions that led to increased toxicity, highlighting the importance of careful patient management and monitoring.

Healthcare providers should remain vigilant for these adverse reactions and consider them when evaluating the overall risk-benefit profile of the medication for individual patients.

Drug Interactions

No drug interactions have been identified in the available data. Additionally, there are no reported interactions between drugs and laboratory tests. Therefore, no dosage adjustments or monitoring recommendations are necessary based on the current information.

Packaging & NDC

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

Pediatric Use

Pediatric patients should be advised to keep this medication out of their reach. In the event of an overdose, immediate medical assistance or contact with a Poison Control Centre is essential.

For dosing, pediatric patients may chew 1 to 2 tablets thoroughly as needed after meals and at bedtime. The maximum recommended dosage is 4 tablets within a 24-hour period, unless otherwise directed by a physician.

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.

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. The potential risks and benefits should be carefully evaluated, and alternative treatments may be considered in the absence of established safety profiles. Women of childbearing potential should be counseled on the importance of effective contraception while using this medication.

Lactation

There are no specific warnings or recommendations regarding the use of this product in nursing mothers. Additionally, there is no information available about the potential for excretion in breast milk or any associated risks to breastfed infants.

Renal Impairment

Patients with renal impairment may require dosage adjustments based on their level of kidney function. It is essential to monitor renal function tests regularly in these patients to ensure safe and effective treatment. A reduced dose may be necessary for patients with a creatinine clearance of less than 30 mL/min. Special consideration should be given to patients with severe renal impairment to avoid potential toxicity.

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 when administering the medication. It is essential to monitor patients closely for any signs of adverse effects or symptoms that may arise from excessive dosing.

In the event of suspected overdosage, immediate medical attention should be sought. Healthcare providers should implement supportive measures as necessary, which may include symptomatic treatment and monitoring of vital signs.

Due to the lack of detailed overdosage information, it is recommended that healthcare professionals refer to established clinical guidelines and protocols for managing overdose situations relevant to the specific medication in question. Additionally, contacting a poison control center may provide further guidance on appropriate management strategies.

Continued vigilance and patient assessment are crucial in mitigating potential risks 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. Further studies may be necessary to elucidate these aspects of nonclinical 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 Centre in the event of an overdose. It is essential 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 individual blister units. Each blister must be inspected prior to use; do not use any blister unit that is broken or open.

Storage conditions require the product to be kept at room temperature, ensuring that it is protected from high humidity and excessive heat. Temperatures should not exceed 40°C (104°F) to maintain product integrity.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

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

View product document (PDF)