Best Choice Extra Strength

Description

NDC# 63941-107-10. This product is a multi-symptom antacid and anti-gas tablet, formulated to provide fast relief from heartburn, gas pressure, bloating, discomfort, and acid indigestion. Each tablet is rich in calcium and magnesium and is available in a berry flavor, which is naturally and artificially flavored. The product is gluten-free and certified K Pareve. It is packaged in a bottle containing 100 chewable tablets. Best Choice® guarantees the quality of this product, which is proudly distributed by Valu Merchandisers, Co., located at 500 Kansan Ave., Kansas City, KS 66106. This product is not manufactured or distributed by Chattem Inc., the owner of the registered trademark ROLAIDS®. The packaging features a tamper-evident seal; do not use if the printed inner seal is broken or missing.

Uses and Indications

This drug is indicated for the relief of heartburn, acid indigestion, and the pressure, bloating, and discomfort commonly referred to as gas.

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

Dosage and Administration

Patients should chew 2 to 4 tablets completely as symptoms occur or as directed by a healthcare professional. It is important that the tablets are not swallowed whole to ensure proper administration and effectiveness.

Contraindications

There are no specified contraindications for this product. However, it is advised that patients do not exceed a maximum dosage of 8 tablets within a 24-hour period. Additionally, the maximum dosage should not be used for more than 2 weeks to mitigate potential risks associated with prolonged use.

Warnings and Precautions

Healthcare professionals should advise patients to consult a physician or pharmacist prior to using this product if they are currently taking any prescription medications, as antacids may interact with certain drugs.

When administering this product, it is crucial to adhere to the following precautions: patients should not exceed a maximum dosage of 8 tablets within a 24-hour period. Additionally, the maximum dosage should not be utilized for longer than 2 weeks to avoid potential adverse effects.

There are no specific laboratory tests recommended for monitoring the use of this product. However, healthcare providers should remain vigilant for any signs of adverse reactions or interactions, particularly in patients taking concurrent medications.

Side Effects

Patients should be aware of the potential for adverse reactions when using this product. It is important to consult a healthcare professional, such as a doctor or pharmacist, prior to use if currently taking any prescription medications, as antacids may interact with certain drugs.

While using this product, patients are advised not to exceed a maximum dosage of 8 tablets within a 24-hour period. Additionally, the maximum dosage should not be utilized for more than 2 weeks to minimize the risk of adverse effects.

To ensure safety, this product should be kept out of reach of children.

Drug Interactions

Antacids may interact with various prescription medications, potentially affecting their absorption and efficacy. It is advisable to monitor the timing of antacid administration in relation to other medications to minimize these interactions. Patients should be counseled to separate the dosing of antacids and other drugs by at least two hours when possible to ensure optimal therapeutic outcomes.

Packaging & NDC

Below are the non-prescription pack sizes of Best Choice Extra Strength (calcium carbonate, magnesium hydroxide, 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 symptomatic relief, children are directed to chew 2-4 tablets completely as symptoms occur or as directed by a healthcare professional. It is important to note that the tablets should not be swallowed whole.

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

The available data regarding the use of this product during pregnancy do not indicate any specific warnings, precautions, or dosage modifications. Additionally, the prescribing information does not specify whether the product is contraindicated in pregnancy or outline any potential risks to the fetus. As such, healthcare professionals should consider the lack of established risk data when prescribing this product to pregnant patients. It is advisable to weigh the potential benefits against any unknown risks, particularly in women of childbearing potential.

Lactation

There are no specific warnings or recommendations regarding the use of this product in lactating 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 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 overdosage, it is critical to adhere to the recommended dosage guidelines to prevent adverse effects. The maximum allowable dosage is eight tablets within a 24-hour period. Exceeding this limit may lead to serious health complications.

Healthcare professionals should be aware that the maximum dosage should not be utilized for more than two consecutive weeks. Prolonged use at this level increases the risk of toxicity and other associated health risks.

In cases of suspected overdosage, immediate medical attention is advised. Symptoms may vary depending on the specific circumstances and individual patient factors. Management procedures should include supportive care and symptomatic treatment as necessary. Monitoring of vital signs and laboratory parameters may be warranted to assess the extent of the overdosage and to guide further therapeutic interventions.

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.

Patient Counseling

Healthcare providers should advise patients to keep this product out of reach of children to prevent accidental ingestion.

When using this product, patients should be instructed not to exceed a maximum of 8 tablets within a 24-hour period. Additionally, it is important to inform patients that they should not use the maximum dosage for more than 2 weeks to avoid potential adverse effects.

Patients should also be encouraged to consult with their healthcare provider or pharmacist before using this product if they are currently taking any prescription medications. This is crucial as antacids may interact with certain prescription drugs, and professional guidance can help ensure safe and effective use.

Storage and Handling

The product is supplied in a configuration that ensures tamper evidence; it should not be used if the printed inner seal is broken or missing.

Storage conditions require the product to be kept at room temperature, with a specific emphasis on avoiding high humidity to maintain product integrity. Proper handling is essential to ensure the safety and efficacy of the product throughout its shelf life.

Additional Clinical Information

The product is administered orally. Clinicians should advise patients to consult a doctor or pharmacist prior to use if they are currently taking any prescription medications, as antacids may interact with certain drugs. Patients are instructed not to exceed 8 tablets within a 24-hour period and to avoid using the maximum dosage for more than 2 weeks. Additionally, it is important to keep the product out of reach of children.

Drug Information (PDF)

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

View product document (PDF)