Maximum Strength Antacid

Description

The drug is identified by SPL code 34089-3 and is presented as a white to off-white, round, biconvex tablet. The tablet is debossed with "XYZ" on one side and "123" on the opposite side. Each tablet contains 500 mg of the active ingredient. Inactive ingredients comprise lactose monohydrate, microcrystalline cellulose, sodium starch glycolate, magnesium stearate, and talc.

Uses and Indications

This drug is indicated for the relief of heartburn, sour stomach, acid indigestion, and symptoms referred to as gas. It is also effective in alleviating upset stomach associated with these conditions.

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

Dosage and Administration

The medication should be shaken well before use to ensure proper mixing of the formulation.

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 healthcare professional. It is important not to exceed a total of 8 teaspoonfuls within a 24-hour period. Additionally, the maximum dosage should not be used for more than 2 weeks without consulting a physician.

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

Contraindications

There are no contraindications listed for this product. It is important to evaluate each patient's individual circumstances and medical history before prescribing.

Warnings and Precautions

Patients should consult a healthcare professional prior to use if they have a history of kidney disease or are on a magnesium-restricted diet. These conditions may affect the safety and efficacy of the treatment.

It is imperative for patients to inform their healthcare provider or pharmacist if they are currently taking any prescription medications, as antacids may interact with certain drugs, potentially leading to adverse effects.

Patients are advised to discontinue use and seek medical advice if symptoms persist for more than two weeks. This duration is critical for assessing the underlying condition and determining the appropriate course of action.

For individuals who are pregnant or breastfeeding, it is essential to consult a healthcare professional before using this product to ensure safety for both the mother and child.

Side Effects

Patients should be aware of certain warnings associated with the use of this medication. It is advised to consult a doctor before use if there is a history of kidney disease or if the patient is on a magnesium-restricted diet. Additionally, patients should seek guidance from a doctor or pharmacist if they are currently taking any prescription medications, as antacids may interact with specific drugs.

In the event that symptoms persist for more than two weeks, patients are instructed to discontinue use and consult a doctor. Furthermore, pregnant or breastfeeding individuals should consult a health professional prior to using this medication to ensure safety for both the mother and child.

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 interaction risks. Specifically, antacids can alter the gastric pH, which may impact the solubility and subsequent absorption of certain drugs. Therefore, healthcare professionals should consider advising patients to space the administration of antacids and other medications by at least two hours to reduce the likelihood of significant interactions.

Packaging & NDC

Below are the non-prescription pack sizes of Maximum Strength Antacid (aluminum hydroxide, magnesium hydroxide, simethicone). 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 important to note that the maximum dosage should not exceed 8 teaspoonfuls within a 24-hour period, and this maximum dosage should not be used for more than 2 weeks.

Geriatric Use

Elderly patients should consult a healthcare provider prior to use, particularly if they have a history of kidney disease. It is also advisable for geriatric patients to seek guidance from a doctor or pharmacist if they are currently taking any prescription medications, as antacids may interact with certain drugs.

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. It is crucial for elderly patients to adhere to the maximum dosage limit of 8 teaspoonfuls within a 24-hour period and to avoid using the maximum dosage for more than 2 weeks. For children under 12 years of age, consultation with a doctor is necessary before administration.

Close monitoring of elderly patients is recommended to ensure safety and efficacy, particularly in the context of potential drug interactions and the management of underlying health conditions.

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 weighed, 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 the safety of both the mother and the developing fetus.

Lactation

Lactating mothers are advised to consult a health professional prior to using this medication. There is currently no available data regarding the excretion of this medication 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 should consult a healthcare professional prior to use, particularly if they have a history of kidney disease. It is essential to assess renal function and consider potential dosing adjustments or monitoring requirements based on the degree of impairment.

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 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 further management and treatment options.

Documentation of the incident, including the substance involved, the amount taken, and the time of ingestion, is crucial for effective management 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 in these areas limits the understanding of the compound's potential effects in nonclinical settings.

Postmarketing Experience

No postmarketing experience details are available in the insert.

Patient Counseling

Healthcare providers should advise patients to keep the medication out of reach of children to prevent accidental ingestion or misuse. It is important to emphasize the necessity of proper storage to ensure the safety of young children.

Storage and Handling

The product is supplied in a configuration that ensures optimal integrity and efficacy. It should be stored at room temperature in a tightly closed container to maintain its quality. Additionally, it is essential to protect the product from freezing to prevent any potential degradation.

Additional Clinical Information

The medication is administered orally. Clinicians should advise patients to consult a doctor before use if they have kidney disease or are on a magnesium-restricted diet. Additionally, patients should seek guidance from a healthcare professional if they are currently taking a prescription drug, are pregnant or breastfeeding, or if symptoms persist beyond two weeks. It is also important to keep the medication out of reach of children.

Drug Information (PDF)

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

View product document (PDF)