Mylanta New Tonight Soothing Honey Chamomile

Description

Mylanta® is a liquid formulation indicated for the relief of heartburn and gas. It is designed to provide fast relief of heartburn, particularly after dinner, when symptoms are most prevalent in adults. The product is presented in a 12 FL OZ (355 mL) volume and features a soothing honey chamomile flavor, offering a smooth and creamy taste.

The active ingredients include calcium carbonate, magnesium hydroxide, and simethicone, contributing to its calcium-rich formula. Mylanta® is paraben-free and formulated to be non-drowsy, allowing for use at any time of the day. The product is packaged with a tamper-evident seal, ensuring safety and integrity. Mylanta is a registered trademark of McNeil Consumer Pharmaceuticals Co., and is manufactured by Infirst Healthcare Inc., located in Westport, CT 06880. Copyright © 2017 Infirst Healthcare Inc. For more information, visit Mylanta.com.

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 relief of discomfort 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. It is important not to exceed a total of 60 mL (6 doses) within a 24-hour period. Additionally, 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 specified contraindications for the use of this product. No conditions or situations have been identified in which the product should not be used.

Warnings and Precautions

Healthcare professionals should exercise caution when recommending this medication. It is imperative to advise patients to consult a physician 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.

Additionally, patients should be encouraged 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 lead to adverse effects or diminished therapeutic outcomes.

In the event of an overdose, immediate medical assistance is crucial. Patients should be instructed to contact a poison control center or seek emergency medical help without delay, using the number 1-800-222-1222.

No specific laboratory tests are recommended for monitoring during the use of this medication. However, healthcare providers should remain vigilant and assess the overall health status of patients, particularly those with pre-existing conditions or those taking concurrent medications.

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 advice from a doctor or pharmacist if they are currently taking any prescription medications, as antacids may interact with specific drugs.

In the event of an overdose, it is crucial to seek immediate medical assistance or contact a poison control center at 1-800-222-1222. Furthermore, this product should be kept 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 antacids if they are currently taking any prescription medications. Antacids have the potential to interact with various prescription drugs, which may alter the effectiveness of the medications or lead to unintended side effects.

It is essential for healthcare providers to evaluate the specific medications a patient is taking to determine the risk of interaction and to consider appropriate dosage adjustments or monitoring strategies as necessary.

Packaging & NDC

Below are the non-prescription pack sizes of Mylanta New Tonight Soothing Honey Chamomile (calcium carbonate, 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 patients 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.

The maximum dosage for this age group 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 to adhere to the maximum dosage limit of 60 mL (6 doses) within a 24-hour period and to avoid using the maximum dosage 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 consideration of individual health status are essential when prescribing this medication to elderly patients.

Pregnancy

Pregnant patients should be aware that there are no specific safety concerns or dosage modifications associated with the use of this medication during pregnancy. Additionally, no special precautions regarding its use in pregnant individuals have been identified. As such, healthcare professionals should consider the overall clinical context when prescribing this medication to women of childbearing potential. It is advisable to monitor for any potential effects on fetal outcomes, although no specific data has been provided in the prescribing information.

Lactation

There are no specific warnings or recommendations regarding the use of Mylanta Tonight Soothing Honey Chamomile in lactating mothers. Additionally, the insert does not provide any statements concerning the potential for excretion of the product in breast milk or any associated risks to breastfed infants during lactation.

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

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 clinical judgment when considering the use of this medication in patients with liver problems, as the absence of data necessitates careful evaluation of potential risks and benefits.

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 expert guidance.

Prompt intervention is crucial in managing overdose situations, as timely medical support can significantly influence patient 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 understanding of potential risks associated with the compound in nonclinical settings.

Postmarketing Experience

Postmarketing experience has identified the following adverse reactions reported voluntarily or through surveillance programs: allergic reactions, which include anaphylaxis, angioedema, and urticaria.

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 healthcare providers to remind patients to discuss any current prescription medications with their doctor 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, it 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 New Tonight Soothing Honey Chamomile, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)