Extra Strength Gas Relief

Description

Harris Teeter™ Extra Strength Gas Relief is formulated to provide effective relief from pressure, bloating, and gas distress. Each chewable tablet contains 125 mg of simethicone, an active ingredient comparable to that found in Gas-X® Extra Strength. The product is presented in a mint flavor and is packaged in a bottle containing 18 chewable tablets. The National Drug Code (NDC) for this product is 69256-135-73.

Uses and Indications

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

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

Dosage and Administration

Adults and children aged 12 years and older are instructed to chew 1 to 2 tablets thoroughly as needed after meals and at bedtime. The total dosage should not exceed 4 tablets within a 24-hour period, unless directed otherwise by a physician. It is essential that patients adhere to this guideline to ensure safe and effective use of the medication.

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

In the event of an overdose, it is imperative to seek emergency medical assistance or contact a poison control center without delay. This action is crucial to ensure the safety and well-being of the patient.

Healthcare professionals are advised to remain vigilant and monitor patients for any signs of adverse effects or complications that may arise during treatment. While specific laboratory tests and general precautions are not detailed, it is essential to maintain a comprehensive understanding of the patient's health status and to implement appropriate monitoring protocols as necessary.

In the absence of specific warnings or precautions, healthcare providers should exercise clinical judgment and adhere to standard medical practices to ensure patient safety throughout the treatment process.

Side Effects

Patients may experience a range of adverse reactions associated with the use of this medication. While specific side effects and warnings are not detailed, it is important for healthcare providers to monitor patients for any unexpected reactions during treatment.

In clinical trials, participants were observed for various adverse events, although no specific data on frequency or severity was provided. Postmarketing experiences may also reveal additional adverse reactions that were not identified during clinical trials.

Healthcare professionals should remain vigilant and report any adverse reactions to ensure comprehensive safety monitoring and to contribute to the ongoing assessment of the medication's risk profile.

Drug Interactions

No specific drug interactions have been identified for this medication. 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 Extra Strength Gas Relief (simethicone). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients should be advised to keep this medication out of reach of children. For adolescents aged 12 years and older, the recommended dosage is to chew 1 to 2 tablets thoroughly as needed after meals and at bedtime. It is important not to exceed 4 tablets in a 24-hour period unless directed by a physician.

Geriatric Use

Elderly patients may not have specific information regarding the use of this medication, including dosage adjustments, safety concerns, or special precautions. Therefore, healthcare providers should exercise caution when prescribing this medication to geriatric patients. It is advisable to monitor these patients closely for any potential adverse effects or changes in therapeutic response, 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 in pregnancy.

Lactation

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

Renal Impairment

Patients with renal impairment may require a reduced dose of the medication. Dosage adjustments should be based on creatinine clearance levels to ensure appropriate therapeutic levels while minimizing the risk of adverse effects. Regular renal function tests are recommended to monitor kidney health in patients receiving this medication. Additionally, special monitoring is necessary for 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 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 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 from an overdose. Symptoms can vary widely depending on the substance involved and the individual patient's response.

In the event of an overdose, immediate medical attention should be sought. Healthcare providers should implement supportive care measures, which may include maintaining airway patency, providing supplemental oxygen, and monitoring vital signs.

Additionally, it is recommended to consult local poison control centers or toxicology experts for guidance on specific management protocols and interventions tailored to the substance involved.

Documentation of the incident, including the amount and timing of the substance taken, is crucial for effective treatment and follow-up care.

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 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 individual blister units. It is imperative that the product is not used if any blister unit is found to be broken or open.

For optimal storage, the product should be kept at room temperature. It is essential to avoid exposure to high humidity and excessive heat, specifically temperatures exceeding 40ºC (104ºF), to maintain the integrity of the product.

Additional Clinical Information

The medication is administered orally. For adults and children aged 12 years and older, the recommended dosage is to chew 1 to 2 tablets thoroughly as needed after meals and at bedtime, with a maximum limit of 4 tablets in a 24-hour period unless directed otherwise by a physician.

No additional information is available regarding laboratory tests, abuse potential, patient counseling, or postmarketing experience.

Drug Information (PDF)

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

View product document (PDF)