Extra Strength Smooth Assorted Fruit Antacid

Description

This product is an extra strength smooth antacid tablet formulated to provide fast relief from heartburn, sour stomach, acid indigestion, and upset stomach. It is available in assorted fruit flavors and is packaged in a bottle containing 60 tablets. The product is comparable to the active ingredient in TUMS® Smoothies™ E-X*. The National Drug Code (NDC) for this formulation is 53943-173-23. It is distributed by Discount Drug Mart and Food Fair.

Uses and Indications

This drug is indicated for the relief of symptoms associated with acid indigestion, heartburn, sour stomach, and upset stomach.

There are no teratogenic effects associated with this drug, and no nonteratogenic effects have been reported.

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 10 tablets within a 24-hour period or who utilize the maximum dosage for more than 2 weeks without the advice and supervision of a healthcare professional.

Warnings and Precautions

Healthcare professionals should be aware of the following precautions associated with the use of this product.

General precautions must be observed to ensure patient safety. It is imperative that patients do 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 specifically advised and monitored by a healthcare provider. This limitation is crucial to prevent potential adverse effects associated with prolonged use or excessive dosage.

No specific laboratory tests have been identified for monitoring during the use of this product. However, healthcare professionals should remain vigilant and assess the patient's overall health and response to treatment regularly.

In the absence of specific emergency medical help instructions or directives to discontinue use, healthcare providers are encouraged to maintain open communication with patients regarding any unusual symptoms or concerns that may arise during treatment.

Side Effects

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

Healthcare providers should be aware of these interactions and monitor patients accordingly to ensure safe and effective use of concomitant therapies. As with any medication, patients should be advised to report any unexpected symptoms or reactions to their healthcare provider.

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 Extra Strength Smooth Assorted Fruit Antacid (calcium carbonate). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients aged 12 years and older may chew 2-4 tablets as symptoms occur, or as directed by a healthcare professional. It is important to keep this medication out of reach of younger children to ensure safety.

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. The potential risks and benefits must be carefully considered, as the effects on fetal outcomes and lactation are not fully established. It is essential for women of childbearing potential to seek medical advice to ensure safe use during pregnancy and breastfeeding.

Lactation

Lactating mothers are advised to consult a health professional prior to using this medication. There is currently no available data on 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 a reduced dose of the medication. Dosage adjustments should be based on creatinine clearance to ensure appropriate therapeutic levels while minimizing the risk of adverse effects. Regular renal function tests are recommended to monitor kidney function in patients receiving this medication. Additionally, special monitoring may be necessary for patients with severe renal impairment to ensure safety and efficacy.

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, as the clinical presentation can vary depending on the substance involved and the individual patient's response. Common symptoms of overdose may include, but are not limited to, altered mental status, cardiovascular instability, respiratory distress, and gastrointestinal disturbances.

In the event of an overdose, immediate medical intervention is recommended. Healthcare providers should initiate supportive care, which may include maintaining airway patency, providing supplemental oxygen, and ensuring adequate circulation. The use of activated charcoal may be considered if the patient presents within a suitable timeframe and if the ingestion was recent.

Furthermore, it is crucial to consult local poison control centers or toxicology experts for guidance on specific management protocols and antidotes, if applicable. Continuous monitoring of vital signs and laboratory parameters may be necessary to assess the patient's condition and guide further treatment decisions.

In summary, while specific overdosage information is not available, healthcare professionals should remain vigilant and prepared to implement standard overdose management strategies to ensure patient safety and optimal outcomes.

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, including animal pharmacology and 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 total 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 physician.

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 to ensure optimal stability and efficacy.

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 the medication.

Drug Information (PDF)

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

View product document (PDF)