Supreme Antacid

Description

Supreme Antacid is a calcium-rich formulation designed to provide fast relief from heartburn and acid indigestion. It is presented in a mint crème flavor and is packaged in a 12 fluid ounce (355 mL) container. The product contains an alcohol content of 0.4% v/v. This formulation is comparable to the active ingredients found in MYLANTA® Supreme.

Uses and Indications

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

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

Dosage and Administration

Healthcare professionals are advised to instruct patients to shake the product well before use.

For adults and children aged 12 years and older, the recommended dosage is 2 to 4 teaspoonfuls taken two times a day, or as directed by a physician.

For children under 12 years of age, it is essential to consult a healthcare provider for appropriate dosing recommendations.

Contraindications

Use is contraindicated in patients whose symptoms persist for more than two weeks. Prolonged symptoms may indicate an underlying condition that requires further evaluation and management.

Warnings and Precautions

Patients should not exceed a maximum dosage of 18 teaspoonfuls within a 24-hour period. Additionally, the maximum dosage should not be utilized for more than two weeks unless directed and supervised by a healthcare professional.

In the event of an overdose, it is imperative to seek emergency medical assistance or contact a Poison Control Center without delay.

Patients are advised to discontinue use and consult their healthcare provider if symptoms persist beyond two weeks. Monitoring for prolonged symptoms is essential to ensure appropriate management and intervention.

Side Effects

Patients should be aware of the potential adverse reactions associated with this product. It is crucial to adhere to the recommended dosage guidelines, which state that no more than 18 teaspoonfuls should be taken within a 24-hour period, and the maximum dosage should not be used for more than two weeks unless under the advice and supervision of a healthcare professional.

In the event that symptoms persist for more than two weeks, patients are advised to discontinue use and consult a doctor.

Before using this product, individuals should seek medical advice if they have a history of kidney disease or are on a magnesium-restricted diet, as these conditions may influence the safety and efficacy of the treatment. Additionally, patients currently taking prescription medications should consult with a doctor or pharmacist prior to use, as antacids may interact with certain prescription drugs, potentially leading to adverse effects.

Monitoring for these reactions is essential to ensure patient safety and effective management of their health conditions.

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. Specifically, antacids should be taken at least 2 hours apart from other drugs to ensure optimal therapeutic effects and to avoid diminished efficacy of the prescribed treatments.

Packaging & NDC

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

Pediatric Use

Pediatric patients under 12 years of age should consult a healthcare professional before use. For adolescents and adults aged 12 years and older, the recommended dosage is 2 to 4 teaspoonfuls taken twice daily, or as directed by a physician.

It is essential to keep this medication out of reach of children. In the event of an overdose, immediate medical assistance should be sought, or contact a Poison Control Center.

Geriatric Use

Elderly patients should exercise caution when using this medication, particularly those aged 65 and older. It is advisable for geriatric patients to consult a healthcare provider before use if they have a history of kidney disease, as this may influence the safety and efficacy of the treatment.

Additionally, elderly patients are encouraged to seek guidance from a doctor or pharmacist prior to using this medication if they are currently taking any prescription drugs. This is important because antacids may interact with certain prescription medications, potentially leading to adverse effects or reduced therapeutic efficacy.

For dosing, adults and children aged 12 years and older are recommended to take 2 to 4 teaspoonfuls two times a day, or as directed by a healthcare professional. For children under 12 years of age, it is essential to consult a doctor for appropriate dosing recommendations.

Monitoring and dose adjustments may be necessary for geriatric patients to ensure safe and effective use of the medication.

Pregnancy

The safety of this product during pregnancy has not been established. Pregnant patients or those planning to become pregnant should consult a healthcare professional before use. While potential risks to the fetus are not specified, caution is advised when considering the use of this product in pregnant individuals. There are no specific dosage modifications for pregnant patients; therefore, it is essential to seek guidance from a healthcare professional regarding appropriate use during pregnancy.

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

There is no specific information available regarding dosage adjustments, special monitoring, or safety considerations for patients with renal impairment. Healthcare professionals should exercise caution when prescribing to patients with reduced kidney function, as the absence of detailed guidance necessitates careful clinical judgment. Regular monitoring of renal function may be advisable in 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 cases of overdosage, it is critical to adhere to the recommended dosage guidelines to prevent adverse effects. The maximum allowable intake is 18 teaspoonfuls within a 24-hour period. Exceeding this limit may lead to significant health risks. Furthermore, the maximum dosage of this product should not be utilized for more than 2 weeks unless directed and monitored by a healthcare professional.

Healthcare providers should be vigilant for symptoms that may arise from overdosage, although specific symptoms are not detailed in the provided information. In the event of suspected overdosage, immediate medical attention is advised.

Management of overdosage should involve supportive care and symptomatic treatment as necessary. It is essential for healthcare professionals to evaluate the patient's condition and implement appropriate interventions based on clinical judgment and the specific circumstances of the overdosage incident.

Nonclinical Toxicology

No information is available regarding teratogenic or non-teratogenic effects. Additionally, there is no data provided concerning nonclinical toxicology, animal pharmacology, or toxicology.

Postmarketing Experience

No postmarketing experience details are provided in the insert.

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 important for patients to be informed that they should discontinue use and consult a doctor if their symptoms persist for more than two weeks.

Patients should be encouraged to consult with their healthcare provider before using this medication if they have a history of kidney disease or if they are on a magnesium-restricted diet. Additionally, healthcare providers should recommend that patients speak with their doctor or pharmacist prior to use if they are currently taking any prescription medications, as antacids may interact with certain drugs.

Storage and Handling

The product is supplied in various package configurations, with specific NDC numbers available upon request. It should be stored at a controlled room temperature of 20ºC to 25ºC (68ºF to 77ºF). Freezing is not permitted, as it may compromise the integrity of the product. Proper handling and storage conditions are essential to maintain the product's efficacy and safety.

Additional Clinical Information

The medication is administered orally. For adults and children aged 12 years and older, the recommended dosage is 2 to 4 teaspoonfuls taken twice daily, or as directed by a healthcare professional. For children under 12 years of age, it is advised to consult a doctor for appropriate dosing guidance.

There is no additional information available regarding laboratory tests, abuse potential, patient counseling, or postmarketing experiences.

Drug Information (PDF)

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

View product document (PDF)