Mylanta Coat and Cool

Description

Mylanta® is a liquid formulation designed for the rapid relief of heartburn. It features a unique Coat & Cool™ technology that provides enhanced coating power, effectively working on contact to alleviate symptoms. The product is presented in a chocolate mint flavor, offering a smooth, chalky taste. Each bottle contains 12 fluid ounces (355 mL) of the solution. Mylanta® is manufactured for Infirst Healthcare Inc., located in Westport, CT 06880, and is a registered trademark of McNeil Consumer Pharmaceuticals Co. The product is tamper evident; do not use if the printed safety seal around or under the cap is broken or missing.

Uses and Indications

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

There are no teratogenic or nonteratogenic effects mentioned in the available data.

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 10-20 mL, which may be taken as 1-2 doses between meals, at bedtime, or as directed by a healthcare professional. The maximum allowable dosage should not exceed 60 mL within a 24-hour period. It is important to note that the maximum dosage should not be used for more than 2 weeks.

For children under 12 years of age, it is advised to consult a healthcare professional before administration.

Contraindications

There are no contraindications associated with the use of this product. It is deemed safe for use in the absence of specific conditions or situations that would warrant avoidance.

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 necessitate special consideration when using this product.

Additionally, it is advisable for patients to seek guidance from a doctor or pharmacist if they are currently taking any prescription medications. Antacids have the potential to interact with certain prescription drugs, which could affect their efficacy or safety.

This product should be stored out of reach of children to prevent accidental ingestion. In the event of an overdose, immediate medical assistance should be sought, or the Poison Control Center should be contacted at (1-800-222-1222).

Side Effects

Patients should be advised to consult a healthcare professional prior to use if they have kidney disease or are on a magnesium-restricted diet. Additionally, it is important for patients to seek guidance from a doctor or pharmacist if they are currently taking any prescription medications, as antacids may interact with certain drugs.

In the event of an overdose, immediate medical assistance should be sought, or the Poison Control Center should be contacted at (1-800-222-1222).

It is crucial to keep this medication out of reach of children to prevent accidental ingestion.

Drug Interactions

Patients with kidney disease should consult a healthcare professional prior to using this medication, as renal impairment may affect drug metabolism and excretion.

Additionally, individuals currently taking prescription medications are advised to seek guidance from a healthcare provider or pharmacist before initiating treatment. Antacids have the potential to interact with various prescription drugs, which may alter their effectiveness or increase the risk of adverse effects. Monitoring and possible dosage adjustments may be necessary based on the specific interactions identified.

Packaging & NDC

Below are the non-prescription pack sizes of Mylanta Coat and Cool (calcium carbonate, 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 children aged 12 years and older, the recommended dosage is 10-20 mL (1-2 doses) taken between meals, at bedtime, or as directed by a healthcare provider. The maximum dosage for this age group should not exceed 60 mL 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, as this may influence the safety and efficacy of the treatment. Additionally, it is 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 10-20 mL (1-2 doses) between meals, at bedtime, or as directed by a healthcare professional. It is important for elderly patients to adhere to the maximum dosage limit of 60 mL within a 24-hour period and to avoid using the maximum dosage for more than 2 weeks to mitigate potential risks.

For children under 12 years of age, consultation with a healthcare provider is necessary before administration. Careful monitoring and adherence to these guidelines are essential to ensure the safe use of the medication in geriatric patients.

Pregnancy

Pregnant patients may use this medication as no specific safety concerns regarding pregnancy have been detailed in the prescribing information. There are no dosage modifications recommended for pregnant individuals, and no special precautions regarding the use of this medication during pregnancy have been included in the text. Healthcare professionals should consider the overall clinical context when prescribing this medication to women of childbearing potential.

Lactation

There are no specific warnings or recommendations regarding the use of Mylanta Coat & Cool in lactating mothers. Additionally, there are no specific considerations or precautions related to lactation mentioned in the provided text.

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

There is no information available regarding the use of this medication in patients with hepatic impairment. Consequently, there are no dosage adjustments, special monitoring requirements, or precautions specified for individuals with compromised liver function. Healthcare professionals should exercise caution and consider the overall clinical context when prescribing this medication to patients with liver problems, as the absence of specific guidance necessitates careful evaluation of potential risks and benefits.

Overdosage

In the event of an overdose, it is imperative to seek immediate medical assistance. Healthcare professionals are advised to contact a Poison Control Center without delay. The national helpline for poison control can be reached at (1-800-222-1222).

Prompt intervention is crucial in managing overdose situations. Symptoms may vary depending on the substance involved, and healthcare providers should be prepared to assess and address any potential complications that may arise. It is essential to monitor the patient closely and provide supportive care as needed.

Management procedures should include a thorough evaluation of the patient's condition, including vital signs and any presenting symptoms. Depending on the severity of the overdose, treatment may involve decontamination, administration of antidotes, or other supportive measures as deemed appropriate by the medical team.

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 available in the insert text.

Patient Counseling

Patients should be advised to seek immediate medical assistance or contact a Poison Control Center at (1-800-222-1222) in the event of an overdose.

It is important for patients to consult with their healthcare provider before using this medication if they have a history of kidney disease. Additionally, patients on a magnesium-restricted diet should also seek guidance from their doctor prior to use.

Patients should be informed to discuss their current medications with their healthcare provider or pharmacist before starting this medication, as antacids may interact with certain prescription drugs. This precaution is essential to ensure safe and effective use of the medication.

Storage and Handling

The product is supplied in various package configurations, with specific NDC numbers available for identification. It is essential to store the product at a temperature range of 20-25°C (68-77°F). Freezing the product is strictly prohibited, as it may compromise its integrity and efficacy. Proper storage conditions must be maintained to ensure the product's quality and effectiveness throughout its shelf life.

Additional Clinical Information

The medication is administered orally. For adults and children aged 12 years and older, the recommended dosage is 10-20 mL (1-2 doses) taken between meals, at bedtime, or as directed by a healthcare professional. Patients should not exceed 60 mL within a 24-hour period and should not use the maximum dosage for more than two weeks. For children under 12 years, consultation with a doctor is advised before use.

Drug Information (PDF)

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

View product document (PDF)