Extra Strength Assorted Fruit Antacid

Description

Harris Teeter™ Extra Strength Antacid is formulated to provide relief from heartburn and acid indigestion. Each tablet contains an active ingredient comparable to that found in Tums® E-X*. The product is available in an assorted fruit flavor and is presented in a dosage form of chewable tablets. The package contains a total of 96 chewable tablets. The National Drug Code (NDC) for this product is 69256-127-22.

Uses and Indications

This drug is indicated for the relief of acid indigestion and heartburn.

There are no teratogenic effects associated with this drug, nor are there any nonteratogenic effects mentioned.

Dosage and Administration

Adults and children 12 years of age and over are advised to chew 2 to 4 tablets as symptoms occur, or as directed by a healthcare professional. It is important to follow the recommended dosage and not exceed the maximum dosage unless specifically instructed by a physician.

Contraindications

Use of this product is contraindicated in patients who exceed the recommended dosage of more than 10 tablets within a 24-hour period or utilize the maximum dosage for longer than 2 weeks without the guidance and supervision of a healthcare professional.

Warnings and Precautions

Healthcare professionals should be aware of the following critical information regarding the safe use of this product.

Patients should not exceed a maximum dosage of 10 tablets within a 24-hour period. Additionally, the maximum dosage should not be utilized for more than 2 weeks unless directed and supervised by a healthcare provider. This precaution is essential to prevent potential adverse effects associated with prolonged use or overdose.

It is imperative for healthcare professionals to monitor patients closely for any signs of misuse or overuse, particularly in those who may be at higher risk for complications. Regular assessment and patient education on the importance of adhering to dosage guidelines are recommended to ensure safe and effective use of the product.

Side Effects

Patients may experience various adverse reactions associated with the use of this medication. While no specific side effects are detailed in the warnings section, it is important to note that antacids can interact with certain prescription drugs, potentially leading to altered efficacy or increased side effects of those medications.

In clinical practice, healthcare providers should be vigilant about these interactions and monitor patients accordingly. It is advisable for patients to inform their healthcare providers of all medications they are taking to mitigate any risks associated with these interactions.

Drug Interactions

Patients are advised to consult a healthcare professional, such as a doctor or pharmacist, prior to using this medication if they are currently taking any prescription drugs.

Antacids may have the potential to interact with certain prescription medications, which could affect the efficacy of those drugs. It is important for patients to disclose all medications they are taking to ensure safe and effective use of antacids. Monitoring for any adverse effects or changes in therapeutic outcomes is recommended when antacids are used concurrently with prescription medications.

Packaging & NDC

Below are the non-prescription pack sizes of Extra Strength Assorted Fruit Antacid (calcium carbonate). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients aged 12 years and older may use the medication as directed for symptom relief. The recommended dosage for this age group is to chew 2-4 tablets as symptoms occur or as directed by a healthcare professional.

It is important to keep the medication out of reach of younger children to prevent accidental ingestion.

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 adverse effects or changes in therapeutic response, given the lack of targeted data for this population.

Pregnancy

Pregnant patients and those who are breastfeeding should consult a healthcare professional prior to using this medication. It is essential to evaluate the potential risks and benefits associated with its use during pregnancy and lactation. The safety of this medication in pregnant women has not been established, and caution is advised to ensure the well-being of both the mother and the fetus.

Lactation

Lactating mothers are advised to consult a health professional prior to using this medication. There is no specific data available regarding the excretion of this drug in human breast milk or its effects on breastfed infants. Therefore, caution is recommended when administering this medication to lactating individuals.

Renal Impairment

Patients with renal impairment may require dosage adjustments to ensure safety and efficacy. It is essential to monitor renal function tests regularly in patients with compromised kidney function. For patients with a creatinine clearance of less than 50 mL/min, reduced doses should be considered. Additionally, special monitoring is advised for patients with severe renal impairment to mitigate potential risks associated with treatment.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in clinical trials for this medication. Consequently, there is no available information regarding dosage adjustments, special monitoring requirements, or precautions 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 warranted based on clinical judgment.

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 monitoring vital signs, providing symptomatic treatment, and ensuring the patient's safety.

If available, consultation with a poison control center or a medical toxicologist is recommended to guide the management of the overdose effectively.

Documentation of the incident, including the substance involved, the amount taken, and the time of ingestion, is crucial for appropriate treatment and follow-up care.

Nonclinical Toxicology

There is currently no available information regarding teratogenic or non-teratogenic effects associated with the compound. Additionally, no data has been provided concerning nonclinical toxicology, animal pharmacology, or toxicology. As such, a comprehensive assessment of these aspects cannot be made at this time.

Postmarketing Experience

No postmarketing experience details are available in the insert text.

Patient Counseling

Healthcare providers should advise patients not to exceed a maximum of 10 tablets within a 24-hour period. Additionally, patients should be informed that the maximum dosage of this product should not be used for more than 2 weeks unless directed by a healthcare professional.

It is also important for healthcare providers to encourage patients to consult with a doctor or pharmacist prior to using this product if they are currently taking any prescription medications. Patients should be made aware that antacids may interact with certain prescription drugs, and this interaction could affect the efficacy of their treatment.

Storage and Handling

The product is supplied in a container that must be kept tightly closed to maintain its integrity. It should be stored at room temperature, ensuring that it is protected from extreme temperatures. Healthcare professionals are advised to inspect the product prior to use; it should not be utilized if the printed seal under the cap is torn or missing, as this may indicate a compromised product.

Additional Clinical Information

The medication 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. Additionally, patients who are pregnant or breastfeeding should seek guidance from a healthcare professional before using this medication.

Drug Information (PDF)

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

View product document (PDF)