Mylanta Vanilla Caramel

Description

Mylanta® is a liquid antacid and anti-gas formulation designed to provide rapid relief from heartburn, acid indigestion, and discomfort associated with gas. The product is presented in a 12 fluid ounce (355 mL) container and features a vanilla caramel flavor. Its mechanism of action is effective upon contact, ensuring prompt alleviation of symptoms.

Uses and Indications

This drug is indicated for the relief of heartburn, acid indigestion, sour stomach, and upset stomach associated with these symptoms. It is also effective in alleviating 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 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.

For adults and children aged 12 years and older, the recommended dosage is 10 mL to 20 mL, which may be taken as needed. Dosing can occur between meals or at bedtime, or as directed by a healthcare professional. It is important not to exceed a total of 60 mL (equivalent to 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

Use is contraindicated in patients with kidney disease due to the potential for exacerbating renal impairment. Additionally, the product should not be used in individuals on a magnesium-restricted diet, as it may lead to adverse effects related to magnesium levels.

It is essential to keep the product out of reach of children. In the event of an overdose, immediate medical assistance should be sought, or contact a poison control center at 1-800-222-1222.

Warnings and Precautions

Healthcare professionals should exercise caution when recommending this product to patients with specific health conditions. It is imperative to consult a physician prior to use in individuals with kidney disease or those adhering to a magnesium-restricted diet, as these conditions may influence the safety and efficacy of the treatment.

Additionally, it is advisable for patients to seek guidance from a healthcare provider or pharmacist if they are currently taking any prescription medications. Antacids have the potential to interact with certain prescription drugs, which could lead to diminished therapeutic effects or increased risk of adverse reactions.

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.

No specific laboratory tests have been identified for monitoring during the use of this product. However, ongoing assessment of the patient's overall health status and medication regimen is recommended to ensure safe and effective use.

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 patients 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 specific prescription medications, which could alter the effectiveness of those drugs. It is essential for patients to disclose all medications they are taking to ensure safe and effective use of antacids. Monitoring for any changes in therapeutic effects or side effects is recommended when antacids are used concurrently with prescription medications.

Packaging & NDC

Below are the non-prescription pack sizes of Mylanta Vanilla Caramel (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 aged 12 years and older, the recommended dosage is 10 mL to 20 mL (1-2 doses) as needed, to be taken between meals, 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. Additionally, 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 kidney disease, as this may affect the safety and efficacy of the treatment. Additionally, it is advisable for geriatric patients to seek guidance from a doctor or pharmacist before using this medication if they are currently taking any prescription drugs. This is particularly important because antacids may interact with certain prescription medications, potentially leading to adverse effects or reduced therapeutic efficacy. Careful monitoring and consideration of these factors are essential to ensure the safe use of this medication in the elderly population.

Pregnancy

There are no specific statements regarding the use of Mylanta Vanilla Caramel during pregnancy in the available data. Additionally, no safety concerns or contraindications related to pregnancy have been identified. There are no recommended dosage modifications for pregnant individuals, nor are there any special precautions regarding its use during pregnancy. Healthcare professionals should consider the absence of data when advising pregnant patients about the use of this product.

Lactation

There are no specific warnings or recommendations regarding the use of Mylanta Vanilla Caramel in lactating mothers. Additionally, there are no specific considerations or precautions related to lactation mentioned in the provided text. Therefore, healthcare professionals may consider the use of this product in nursing mothers without specific concerns.

Renal Impairment

Patients with renal impairment should consult a healthcare professional prior to use, particularly if they have kidney disease. It is also advisable 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. Monitoring and appropriate dosing adjustments may be necessary based on the patient's renal function.

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 expert guidance.

Prompt intervention is crucial in managing overdose situations effectively. 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 soon as possible, which may include supportive care and symptomatic treatment. Healthcare providers should remain vigilant for any signs of adverse reactions and be prepared to implement appropriate therapeutic measures based on the clinical presentation of the patient.

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

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. 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.

Patients should be encouraged to consult with their healthcare provider before using the medication if they have kidney disease or are on a magnesium-restricted diet. Additionally, it is important for patients to discuss any current prescription medications with their doctor or pharmacist prior to use, as antacids may interact with certain prescription drugs.

Storage and Handling

The product is supplied in a tamper-evident container. It is essential to inspect the printed seal under the cap; do not use the product if the seal is broken or missing.

For optimal storage, the product should be maintained at a temperature range of 20-25°C (68-77°F). Freezing is not permitted, as it may compromise the integrity of the product.

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

View product document (PDF)