Maximum Strength Antacid

Description

Harris Teeter™ Maximum Strength Antacid is formulated to provide relief from heartburn, acid indigestion, pressure, and bloating. This antacid and antigas liquid is designed for effective symptom management and is comparable to the active ingredients found in Mylanta® Maximum Strength. The product is presented in a mint-flavored liquid dosage form, contained in a 12 FL OZ (355 mL) bottle. The formulation includes an alcohol content of 0.2% v/v. The National Drug Code (NDC) for this product is 69256-517-05.

Uses and Indications

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

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

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 10 mL to 20 mL administered twice daily, 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.

All dosages are to be measured in milliliters (mL).

Contraindications

There are no specific contraindications listed for this product. However, it is advised to discontinue use and consult a healthcare professional if symptoms persist for more than two weeks.

Warnings and Precautions

Patients should not exceed a maximum dosage of 60 mL within a 24-hour period. Additionally, the maximum dosage should not be used for more than two weeks unless directed and supervised by a healthcare professional. Adherence to these guidelines is crucial to prevent potential adverse effects associated with excessive use.

If symptoms persist beyond two weeks, it is imperative to discontinue use and consult a healthcare provider for further evaluation and management. This precaution is essential to ensure that any underlying conditions are appropriately addressed.

In the event of severe or concerning symptoms, patients are advised to seek emergency medical assistance. While specific emergency instructions are not provided, the importance of timely medical intervention cannot be overstated.

No specific laboratory tests are recommended for monitoring during the use of this product. However, healthcare professionals should remain vigilant for any signs of complications or adverse reactions that may necessitate further investigation.

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 60 mL 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. Additionally, individuals with kidney disease or those on a magnesium-restricted diet should seek medical advice before using this product.

Furthermore, patients currently taking prescription medications should consult with a doctor or pharmacist prior to use, as antacids may interact with certain prescription drugs. These precautions are essential to ensure the safe and effective use of the product.

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 outcomes. Healthcare professionals should consider this timing when prescribing medications that may be affected by antacids.

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 aged 12 years and older, the recommended dosage is 10 mL to 20 mL taken twice daily, or as directed by a healthcare provider.

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 renal function may be compromised in this population, potentially affecting drug metabolism and excretion.

Additionally, elderly patients are encouraged to seek guidance from a doctor or pharmacist prior to initiating therapy if they are currently taking any prescription medications. This is important due to the potential for interactions between antacids and certain prescription drugs, which may necessitate dose adjustments or alternative therapies.

For adults and children aged 12 years and older, the recommended dosage is 10 mL to 20 mL taken two times a day, or as directed by a healthcare professional. Careful monitoring and adherence to prescribed dosages are essential to ensure safety and efficacy in geriatric patients.

Pregnancy

The available data regarding the use of this medication during pregnancy do not indicate specific safety concerns. There are no documented dosage modifications required for pregnant individuals, nor are there any special precautions outlined for use during pregnancy. Healthcare professionals should consider the overall clinical context when prescribing this medication to pregnant patients, as individual circumstances may vary. It is advisable to monitor for any potential effects on fetal outcomes, although no specific risks have been identified in the available information.

Lactation

There are no specific warnings or recommendations regarding the use of this product by lactating mothers. Additionally, there are no specific warnings or recommendations related to lactation in the provided information. Therefore, healthcare professionals may consider the use of this product in nursing mothers on a case-by-case basis, taking into account the overall clinical context.

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 cases of overdosage, it is critical to adhere to the recommended dosage guidelines to prevent adverse effects. The maximum allowable dosage is 60 mL within a 24-hour period. Additionally, the product should not be used at its maximum dosage for more than 2 weeks unless directed by a healthcare professional.

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

Management of overdosage should involve supportive care and symptomatic treatment as necessary. Continuous monitoring of the patient’s condition is essential, and healthcare professionals should consider consulting a poison control center for further guidance on management strategies.

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 text.

Patient Counseling

Healthcare providers should advise patients to keep the medication out of reach of children to prevent accidental ingestion. Patients should be instructed to stop using the medication and consult a doctor if their symptoms persist for more than two weeks, as this may indicate a need for further evaluation.

It is important for patients to seek medical advice before using the medication if they have a history of kidney disease or are on a magnesium-restricted diet. Additionally, patients should be encouraged to discuss their current medications with their healthcare provider or pharmacist, particularly if they are taking any prescription drugs, as antacids may interact with certain medications. This precaution helps ensure safe and effective use of the product.

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 ranging from 20ºC to 25ºC (68ºF to 77ºF). It is imperative to avoid freezing the product to maintain its integrity and efficacy. Proper handling and storage conditions are essential to ensure the product remains within the specified temperature range.

Additional Clinical Information

The medication is administered orally. For adults and children aged 12 years and older, the recommended dosage is 10 mL to 20 mL 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.

No additional information is available regarding laboratory tests, abuse potential, patient counseling, or postmarketing experience.

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)