Mylanta Maximum Strength Vanilla Caramel Flavor

Description

MYLANTA® is a maximum strength liquid formulation designed as an antacid and anti-gas agent. It contains active ingredients including aluminum hydroxide, magnesium hydroxide, and simethicone. The product is presented in a 12 fluid ounce (355 mL) volume and features a vanilla caramel flavor. MYLANTA® is characterized by its ability to provide multi-symptom relief, offering extra coating power while being paraben-free. The formulation is designed to be tough on heartburn yet gentle on the body, delivering a smooth, creamy taste. MYLANTA® is manufactured by Infirst Healthcare Inc., located in Westport, CT 06880, and is a registered trademark of McNeil Consumer Pharmaceuticals Co.

Uses and Indications

This drug is indicated for the relief of heartburn, pressure and bloating commonly referred to as gas, acid indigestion, sour stomach, and upset stomach associated with these symptoms. It is also indicated for the alleviation of symptoms resulting from overindulgence in food and drink.

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

Dosage and Administration

The medication should be shaken well before use. It is essential to measure the dose using the dosing cup provided to ensure accuracy.

For adults and children aged 12 years and older, the recommended dosage is 10 mL to 20 mL, which may be taken as 1 to 2 doses between meals, at bedtime, or as directed by a healthcare professional. The maximum allowable dosage should not exceed 60 mL (6 doses) within a 24-hour period. Furthermore, the maximum dosage should not be utilized for more than 2 consecutive weeks.

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

Contraindications

There are no specified contraindications for the use of this product. No conditions or situations have been identified that would warrant avoidance of use.

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, as these conditions may influence the safety and efficacy of the treatment.

It is advisable for individuals currently taking prescription medications to seek guidance from a doctor or pharmacist before initiating use. Antacids have the potential to interact with certain prescription drugs, which may necessitate adjustments in therapy or monitoring.

In the event of an overdose, immediate medical assistance should be sought. Patients or caregivers are encouraged to contact a poison control center at 1-800-222-1222 for prompt guidance and support.

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 currently taking prescription medications should seek advice from a healthcare professional or pharmacist, as antacids may interact with specific prescription drugs.

In the event of an overdose, immediate medical assistance should be sought, or the patient should contact a poison control center at 1-800-222-1222. It is crucial to keep this medication out of reach of children to prevent accidental ingestion.

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 various prescription medications, which could alter their effectiveness or lead to unintended side effects. It is essential for patients to disclose all medications they are taking to ensure safe and effective use of antacids alongside their prescribed therapies. Monitoring for any adverse effects or changes in therapeutic outcomes is recommended when antacids are used concurrently with prescription drugs.

Packaging & NDC

Below are the non-prescription pack sizes of Mylanta Maximum Strength Vanilla Caramel Flavor (antacid and anti gas aluminum hydroxide magnesium hydroxide and 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 (1-2 doses) between meals or at bedtime, or as directed by a healthcare provider. It is important to note that the maximum dosage should not exceed 60 mL (6 doses) within a 24-hour period, and the maximum dosage should not be used for more than 2 weeks.

Geriatric Use

Elderly patients should consult a healthcare provider prior to use if they have a history of kidney disease or are on a magnesium-restricted diet. For adults and children aged 12 years and older, the recommended dosage is 10 mL to 20 mL (1-2 doses) between meals, at bedtime, or as directed by a physician. It is important for geriatric patients not to exceed a maximum dosage of 60 mL (6 doses) within any 24-hour period. Additionally, the maximum dosage should not be utilized for more than 2 weeks.

For children under 12 years of age, it is advised to seek guidance from a healthcare provider before administration. Careful monitoring and adherence to these recommendations are essential to ensure the safety and efficacy of the treatment in elderly patients.

Pregnancy

Pregnant patients should consult a healthcare professional before using this medication, especially if they are currently taking any prescription drugs, as antacids may interact with certain medications. It is important to ensure that the use of this product does not pose any risk to fetal outcomes.

In the event of an overdose, immediate medical assistance should be sought, or the poison control center contacted at 1-800-222-1222. Additionally, this product should be kept out of reach of children to prevent accidental ingestion.

Lactation

There are no specific warnings or recommendations regarding the use of Mylanta Maximum Strength in lactating mothers. Additionally, there is no information available about the potential for excretion of this medication in breast milk or any associated risks to breastfed infants.

Renal Impairment

Patients with renal impairment should consult a healthcare professional prior to use, particularly if they have a history of kidney disease. Additionally, those on a magnesium-restricted diet are advised to seek medical guidance before initiating treatment. Monitoring and appropriate dosing adjustments may be necessary to ensure safety and efficacy in this population.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in relation to the use of this medication. Consequently, there are no 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 event of an overdose, it is imperative to seek immediate medical assistance or contact a poison control center without delay. Healthcare professionals are advised to call the National Capital Poison Center at 1-800-222-1222 for guidance.

Prompt intervention is crucial in managing overdose situations, as timely medical help can significantly influence outcomes. Symptoms of overdose may vary depending on the substance involved and the individual’s health status. Therefore, a thorough assessment and monitoring of the patient are essential.

Management procedures should be initiated as per established protocols, which may include supportive care and symptomatic treatment. It is essential for healthcare providers to remain vigilant and prepared to address any complications that may arise during the management of an overdose.

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 limits the assessment of potential risks associated with the use of the compound in these contexts.

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 at 1-800-222-1222 in the event of an overdose.

Patients should be encouraged to consult with their healthcare provider before using this medication if they have a history of kidney disease or are on a magnesium-restricted diet.

Additionally, it is important for patients to discuss their current medications with their healthcare provider or pharmacist prior to use, as antacids may interact with certain prescription drugs. This precaution helps ensure safe and effective use of the medication.

Storage and Handling

The product is supplied in a configuration that includes a dosing cup for accurate measurement. It is essential to store the product at a temperature range of 20-25°C (68-77°F) and to avoid freezing. Prior to use, the product must be shaken well to ensure proper consistency. For optimal results, the container should be kept in an upright position during storage.

Additional Clinical Information

The medication is administered orally. There are no additional details available regarding laboratory tests, abuse information, patient counseling, or postmarketing experience.

Drug Information (PDF)

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

View product document (PDF)