Mylanta

Description

Mylanta® is a multi-symptom antacid and anti-gas formulation designed to provide fast relief from heartburn, gas, and upset stomachs. This product is suitable for use by adults and children aged 6 years and older. It is presented in a mixed berry flavor and is available in a 16 fluid ounce (473 mL) dosage form.

Uses and Indications

This drug is indicated for the relief of heartburn, acid indigestion, and sour stomach. It is also effective in alleviating upset stomach associated with these conditions, as well as relieving pressure and bloating commonly referred to as gas. Additionally, this drug provides relief from 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 dosage using the dosing cup provided to ensure accuracy. The medication may be taken as needed, between meals, at bedtime, or as directed by a healthcare professional.

For children aged 6 to 11 years, the recommended dosage is 10 mL, with a maximum limit of 30 mL within a 24-hour period. For adults and children aged 12 years and older, the dosage range is 10 to 20 mL, not to exceed 60 mL in a 24-hour period.

It is important to note that the maximum dosage should not be used for more than 2 weeks.

Contraindications

There are no specific contraindications identified for this product. However, it is advised to keep the product out of reach of children to prevent accidental ingestion. In the event of an overdose, immediate medical assistance should be sought, or contact a poison control center at 1-800-222-1222. Additionally, individuals currently taking prescription medications should consult a healthcare professional prior to use, as antacids may interact with certain prescription drugs.

Warnings and Precautions

Patients should consult a healthcare professional, such as a doctor or pharmacist, prior to using this product if they are currently taking any prescription medications. It is important to note that antacids may interact with certain prescription drugs, potentially affecting their efficacy or safety.

To ensure safety, this product must be kept out of the reach of children. In the event of an overdose, immediate medical assistance is required. Patients or caregivers should contact a poison control center without delay at 1-800-222-1222 for guidance.

In cases of overdose, it is critical to seek emergency medical help promptly. The same contact number for the poison control center, 1-800-222-1222, should be utilized for further instructions and support.

No specific instructions for discontinuation of use and consultation with a healthcare provider have been provided in the insert.

Side Effects

Patients should be aware of the potential adverse reactions associated with the use of this medication. It is important to consult a healthcare professional, such as a doctor or pharmacist, before use, especially if currently taking a prescription drug, as antacids may interact with certain medications.

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

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.

Packaging & NDC

Below are the non-prescription pack sizes of Mylanta (calcium carbonate, simethicone). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients aged 6 to 11 years are recommended to receive a dosage of 10 mL. The total daily dosage should not exceed 30 mL within a 24-hour period.

It is essential to keep this medication out of reach of children. In the event of an overdose, immediate medical assistance should be sought, or a poison control center should be contacted.

Geriatric Use

Elderly patients may not have specific information regarding the use of this medication, including dosage adjustments, safety concerns, or special precautions. Therefore, healthcare providers should exercise caution when prescribing this medication to geriatric patients. It is advisable to monitor these patients closely for any adverse effects or changes in therapeutic response, given the lack of targeted data for this population.

Pregnancy

There are no specific statements regarding the use of Mylanta All-Family Multi Symptom Stomach Remedy during pregnancy. The available prescribing information does not mention any safety concerns, contraindications, or special precautions related to the use of this product in pregnant patients. Additionally, no dosage modifications for pregnant individuals are provided. Healthcare professionals should consider the absence of data when advising women of childbearing potential and weigh the benefits against any potential risks when recommending this product during pregnancy.

Lactation

There are no specific warnings or recommendations regarding the use of Mylanta in lactating mothers. Additionally, there are no statements concerning the potential for excretion of Mylanta in breast milk or any associated risks to breastfed infants.

Renal Impairment

Patients with renal impairment have not been specifically addressed in the available data regarding dosage adjustments, special monitoring, or safety considerations. Therefore, healthcare professionals should exercise caution when prescribing this medication to patients with reduced kidney function, as the lack of information necessitates careful clinical judgment and monitoring of these patients.

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 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 vital 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 available in the insert text.

Patient Counseling

Healthcare providers should advise patients to keep the medication out of reach of children. In the event of an overdose, patients should be instructed to seek medical help immediately or contact a poison control center at 1-800-222-1222.

Additionally, it is important for healthcare providers to remind patients to consult with a doctor or pharmacist before using this medication if they are currently taking any prescription drugs. Patients should be made aware that antacids may interact with certain prescription medications, and this interaction could affect the efficacy or safety of their treatment.

Storage and Handling

The product is supplied in a container that requires careful handling to ensure its integrity and effectiveness. It should be stored at a temperature range of 20-25°C (68-77°F) and must not be frozen. Prior to use, the product should be shaken well to ensure proper mixing.

For accurate dosing, it is essential to measure the product using the dosing cup provided. Once opened, the product should be discarded after use to maintain safety and efficacy. Additionally, the container features a tamper-evident seal; therefore, it should not be used if the printed seal under the cap is broken or missing.

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, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)