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Mylanta Maximum Strength Classic Flavor

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Active ingredients
  • Dimethicone 80 mg/10 mL
  • Aluminum Hydroxide 800 mg/10 mL
  • Magnesium Hydroxide 800 mg/10 mL
Other brand names
Drug classes
Calculi Dissolution Agent, Osmotic Laxative
Dosage form
Suspension
Route
Oral
Prescription status
OTC (over the counter)
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Marketed in the U.S.
Since 2016
Label revision date
December 11, 2024
Drug Information (PDF)
Prescribing information, PDF file
Active ingredients
  • Dimethicone 80 mg/10 mL
  • Aluminum Hydroxide 800 mg/10 mL
  • Magnesium Hydroxide 800 mg/10 mL
Other brand names
Drug classes
Calculi Dissolution Agent, Osmotic Laxative
Dosage form
Suspension
Route
Oral
Prescription status
OTC (over the counter)
CSA schedule
Not a scheduled drug
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Marketed in the U.S.
Since 2016
Label revision date
December 11, 2024
Manufacturer
Infirst Healthcare Inc.
Registration number
M001
NDC root
62372-500
Drug Information (PDF)
Prescribing information, PDF file
Packaging Info (3 NDCs)
Packaging & NDC Codes (3)

If you are a healthcare professional or from the pharmaceutical industry please visit this version.

If you are a consumer or patient please visit this version.

Drug Overview

Mylanta® is a maximum strength antacid and anti-gas medication designed to provide quick relief from heartburn, acid indigestion, and gas symptoms. It works by neutralizing stomach acid and soothing the digestive tract, helping to alleviate discomfort caused by overindulgence in food and drink. With its smooth, creamy texture and classic flavor, Mylanta is gentle on your body while effectively tackling the source of your symptoms.

The active ingredients in Mylanta include aluminum hydroxide, magnesium hydroxide, and simethicone (a medication that helps reduce gas). This combination offers multi-symptom relief, making it a convenient option for those experiencing pressure, bloating, or upset stomach. You can use Mylanta as directed every day to help manage these common digestive issues.

Uses

If you're experiencing discomfort from heartburn, pressure, or bloating, this medication can help relieve those symptoms. It works effectively to ease acid indigestion and a sour stomach, making it a good choice for when you're feeling upset due to these issues.

Additionally, if you've overindulged in food and drink, this medication can provide relief from the resulting discomfort. It's designed to help you feel better and get back to enjoying your day.

Dosage and Administration

Before you use this medication, make sure to shake the bottle well. When measuring your dose, use the dosing cup that comes with the medication for accuracy. If you are an adult or a child aged 12 years and older, you can take between 10 mL and 20 mL (which is about 1 to 2 doses) either between meals, at bedtime, or as your doctor has instructed.

It's important not to exceed 60 mL (or 6 doses) in a 24-hour period, and you should avoid using the maximum dosage for more than 2 weeks. If you are considering this medication for a child under 12 years old, please consult a doctor first for guidance.

What to Avoid

There are no specific contraindications, controlled substance classifications, or risks of abuse, misuse, or dependence associated with this medication. Additionally, there are no particular instructions indicating that you should not take or use this medication. Always consult with your healthcare provider for personalized advice and to ensure this medication is appropriate for you.

Side Effects

Before using this medication, it's important to consult your doctor if you have kidney disease or are on a magnesium-restricted diet, as these conditions may affect how the medication works for you. Additionally, if you are currently taking any prescription drugs, speak with your doctor or pharmacist, as antacids can interact with certain medications.

Keep this product out of reach of children. In the event of an overdose, seek medical help immediately or contact a poison control center at 1-800-222-1222.

Warnings and Precautions

Before using this medication, it's important to consult your doctor if you have kidney disease or are on a magnesium-restricted diet. Additionally, if you are currently taking any prescription medications, check with your doctor or pharmacist first, as antacids can interact with certain drugs.

In the event of an overdose, seek emergency medical help immediately or contact a poison control center at 1-800-222-1222. Your safety is a priority, so please take these precautions seriously.

Overdose

If you suspect an overdose, it’s crucial to seek medical help immediately. You can contact a poison control center at 1-800-222-1222 for guidance. Signs of an overdose can vary, but they may include unusual drowsiness, confusion, or difficulty breathing.

Always take overdosing seriously. If you notice any of these symptoms or have concerns about your health, don’t hesitate to reach out for help right away. Your safety is the top priority.

Pregnancy Use

If you are pregnant or planning to become pregnant, it's important to know that there is no specific information available about the use of Mylanta Maximum Strength during pregnancy. This means that safety concerns, dosage adjustments, or any special precautions have not been clearly outlined.

Before using this medication, you should consult with your healthcare provider to discuss any potential risks and to ensure that it is safe for you and your baby. Always prioritize open communication with your doctor regarding any medications you consider taking during pregnancy.

Lactation Use

If you are breastfeeding, you can use Mylanta Maximum Strength Classic Flavor without specific warnings or recommendations against it. Currently, there is no information available about whether this medication passes into breast milk or if it poses any risk to your nursing infant.

As always, it's a good idea to consult with your healthcare provider if you have any concerns or questions about medications while breastfeeding.

Pediatric Use

If you are considering this medication for your child, it's important to know that it is not recommended for children under 12 years old without consulting a doctor first. Always reach out to your child's healthcare provider to discuss any concerns or questions you may have regarding their treatment. This ensures that your child receives the safest and most effective care tailored to their age and health needs.

Geriatric Use

If you are an older adult or caring for one, it's important to consult a doctor before using this medication, especially if there are any concerns about kidney disease or if you are on a magnesium-restricted diet. For adults and children aged 12 and older, the recommended dosage is between 10 mL and 20 mL (1-2 doses) taken between meals or at bedtime, as directed by a healthcare professional.

Be mindful not to exceed 60 mL (6 doses) in a 24-hour period, and avoid using the maximum dosage for more than two weeks. If the person you are caring for is under 12 years old, please consult a doctor for guidance.

Renal Impairment

If you have kidney disease, it’s important to consult your doctor before using this medication. Your healthcare provider can help determine if it’s safe for you and if any adjustments are needed. Additionally, if you are on a magnesium-restricted diet, you should also speak with your doctor before starting this medication to ensure it aligns with your dietary needs. Always prioritize your health by seeking professional advice tailored to your specific situation.

Hepatic Impairment

If you have liver problems, it's important to know that there are no specific guidelines or dosage adjustments mentioned for your condition in the available information. This means that the standard recommendations apply, but you should always consult your healthcare provider for personalized advice. They can help determine the best approach for your treatment and monitor your liver function as needed.

Make sure to keep your doctor informed about your liver health, as they may want to conduct regular tests to ensure your safety while using any medication. Your well-being is a priority, so don't hesitate to ask questions or express any concerns you may have.

Drug Interactions

It's important to talk to your doctor or pharmacist before using this medication, especially if you are currently taking any prescription drugs. Some medications, like antacids, can interact with your prescription medications, potentially affecting how well they work or increasing the risk of side effects.

Always keep your healthcare provider informed about all the medications you are taking to ensure your treatment is safe and effective. This way, you can avoid any unexpected interactions and get the best possible care.

Storage and Handling

To ensure the best results, store the product at a temperature between 20-25°C (68-77°F) and avoid freezing it. Before using, make sure to shake the container well to mix the contents thoroughly. When measuring your dose, use the dosing cup provided to ensure accuracy.

It's important to check the product for safety before use. If the printed seal under the cap is broken or missing, do not use the product, as this indicates it may have been tampered with. Following these guidelines will help you use the product safely and effectively.

Additional Information

You can take this medication orally, with adults and children aged 12 and over typically using 10 mL to 20 mL (1-2 doses) between meals or at bedtime, unless your doctor advises otherwise. It's important not to exceed 60 mL (6 doses) in a 24-hour period and to avoid using the maximum dosage for more than 2 weeks. If the patient is under 12 years old, consult a doctor before use.

FAQ

What is Mylanta?

Mylanta is a maximum strength antacid and anti-gas medication that helps relieve heartburn, acid indigestion, and gas symptoms.

What are the active ingredients in Mylanta?

The active ingredients in Mylanta are Aluminum hydroxide, Magnesium hydroxide, and Simethicone.

How should I take Mylanta?

Adults and children 12 years and over should take 10 mL-20 mL (1-2 doses) between meals or at bedtime, and not exceed 60 mL (6 doses) in 24 hours.

Can children under 12 use Mylanta?

Children under 12 years should ask a doctor before using Mylanta.

Are there any warnings for using Mylanta?

You should ask a doctor before use if you have kidney disease or a magnesium-restricted diet, and if you are taking any prescription drugs.

What should I do in case of an overdose?

In case of overdose, get medical help or contact a poison control center immediately at 1-800-222-1222.

Is Mylanta safe to use during pregnancy or while nursing?

The insert does not provide specific information regarding the use of Mylanta during pregnancy or nursing.

How should I store Mylanta?

Store Mylanta between 20-25°C (68-77°F) and do not freeze. Ensure the seal under the cap is intact before use.

Packaging Info

Below are the non-prescription pack sizes of Mylanta Maximum Strength Classic Flavor (antacid and anti gas aluminum hydroxide magnesium hydroxide and simethicone). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Mylanta Maximum Strength Classic Flavor.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

Mylanta contains the active ingredients aluminum hydroxide, magnesium hydroxide, and simethicone. This formulation is paraben-free and contains 0.2% alcohol. The product is presented in a liquid dosage form, with a volume of 12 fluid ounces (355 mL). It is characterized by a smooth, creamy taste and a classic flavor profile. Mylanta is a registered trademark of McNeil Consumer Pharmaceuticals Co. and is manufactured for Infirst Healthcare Inc., located in Westport, CT 06880.

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 is 60 mL (6 doses) 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 for appropriate dosing recommendations.

Contraindications

There are no specified contraindications for the use of this product. It is important to evaluate each patient's individual circumstances and medical history to ensure safe and appropriate 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 using this product. Antacids have the potential to interact with certain prescription drugs, which may affect therapeutic outcomes.

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 advised to consult a healthcare professional prior to use if they have kidney disease or are on a magnesium-restricted diet, as these conditions may influence the safety and efficacy of the treatment. 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 certain prescription medications, which could affect the efficacy of those drugs. It is important for patients to disclose all medications they are taking to ensure safe and effective use of antacids. Monitoring for any adverse effects or changes in therapeutic outcomes is recommended when these medications are used concurrently.

Packaging & NDC

Below are the non-prescription pack sizes of Mylanta Maximum Strength Classic Flavor (antacid and anti gas aluminum hydroxide magnesium hydroxide and simethicone). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Mylanta Maximum Strength Classic Flavor.
Details

Pediatric Use

Pediatric patients under 12 years of age should consult a healthcare professional before use. It is important to assess the appropriateness of treatment and dosage for this age group, as specific recommendations may vary based on individual health needs and conditions.

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 crucial 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

The safety of Mylanta Maximum Strength during pregnancy has not been established, as the prescribing information does not provide specific data regarding its use in this population. Consequently, healthcare professionals should exercise caution when considering this medication for pregnant patients. There are no available studies or risk categories to inform potential fetal impacts or necessary dosage modifications. It is advisable for women of childbearing potential to discuss the use of Mylanta Maximum Strength with their healthcare provider to weigh the benefits and risks before initiating treatment during pregnancy.

Lactation

There are no specific warnings or recommendations regarding the use of Mylanta Maximum Strength Classic Flavor in lactating mothers. Additionally, there is no information available about the potential for excretion 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 established dosage adjustments, special monitoring requirements, or precautions 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 considered as part of standard clinical practice.

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 include supportive care and symptomatic treatment as necessary. Healthcare providers should remain vigilant for any signs of adverse reactions and be prepared to implement appropriate interventions based on the clinical presentation.

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 in these areas limits the understanding of the compound's potential effects in nonclinical settings.

Postmarketing Experience

No postmarketing experience details are available in the insert text.

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. It is important for patients to understand the seriousness of an overdose and the necessity of prompt action to ensure their safety.

Storage and Handling

The product is supplied in a container 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.

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, with a recommended dosage for adults and children aged 12 years and older being 10 mL to 20 mL (1-2 doses) between meals or at bedtime, or as directed by a healthcare professional. Patients should not exceed 60 mL (6 doses) within a 24-hour period and should not use the maximum dosage for more than 2 weeks. For children under 12 years, consultation with a doctor is advised before use.

No additional information is available regarding laboratory tests, abuse potential, patient counseling, or postmarketing experiences.

Drug Information (PDF)

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

View product document (PDF)

Data Generation & Sources

This page was automatically generated and is maintained by the AllDrugs AI Data-Science Team. It was built from the FDA Structured Product Label (DailyMed) for Mylanta Maximum Strength Classic Flavor, retrieved by a validated AI data-extraction workflow.

All FDA-listed dosage forms and strengths are shown in the Packaging & NDC Codes section above. Regulatory status appears in the Summary Information panel above and was verified in the FDA National Drug Code directory and the NSDE NDC Directory daily file.

Note: an automated daemon monitors NSDE checksums; when the record for this NDC changes, the new file is pulled instantly and this page is refreshed.

No human clinician has reviewed this version.

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Primary FDA sources:

Orange Book data shown on this page are limited to Regulatory Status (Rx), Established Pharmacologic Class (EPC), and Mechanism of Action (MoA).

Regulatory data notice: Information on this page is reproduced verbatim from FDA public databases (NSDE, Orange Book, Purple Book, DailyMed SPL). NDA/ANDA drugs are FDA-approved, BLA biologics are FDA-licensed. Inclusion alone does not guarantee current market availability or imply FDA endorsement.

Medical disclaimer: This AI-generated content is provided for educational purposes only and does not constitute medical advice. Always consult a licensed healthcare professional for diagnosis or treatment decisions.