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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
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
February 1, 2023
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
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
February 1, 2023
Manufacturer
Infirst Healthcare Inc.
Registration number
part331
NDC root
62372-500
Drug Information (PDF)
Prescribing information, PDF file
Packaging Info
Packaging & NDC Codes

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 fast relief from heartburn, acid indigestion, and gas symptoms. It works by coating the stomach and neutralizing excess acid on contact, helping to soothe discomfort effectively. With its smooth, creamy texture and classic flavor, Mylanta® is gentle on the body and can be used daily as directed.

The active ingredients in Mylanta® include aluminum hydroxide, magnesium hydroxide, and simethicone (a medication that helps reduce gas). This combination not only targets the source of your symptoms but also offers multi-symptom relief, making it a convenient option for those seeking comfort from 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 that uncomfortable feeling as well. It's designed to help you feel better and get back to enjoying your day.

Dosage and Administration

Before using this medication, make sure to shake the bottle well. If you are an adult or a child aged 12 years and older, you can take between 2 teaspoons (tsp) to 4 tsp, which is 1 to 2 doses, between meals or at bedtime, unless your doctor advises otherwise. However, it's important not to exceed 12 tsp (6 doses) in a 24-hour period, and you should avoid using the maximum dosage for more than 2 weeks.

If the patient is a child under 12 years old, it’s best to consult a doctor before administering the medication. Always follow these guidelines to ensure safe and effective use.

What to Avoid

There are no specific contraindications, controlled substance classifications, or concerns regarding abuse, misuse, or dependence associated with this medication. Additionally, there are no explicit 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 your situation.

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, please speak with your doctor or pharmacist first, since antacids can interact with some medications.

Being aware of these factors can help ensure your safety and the effectiveness of your treatment.

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, as these conditions may affect how the medication works for you.

If you suspect an overdose, seek emergency medical help immediately or contact a poison control center at 1-800-222-1222. Additionally, if you are currently taking any prescription medications, stop using this product and call your doctor, as antacids can interact with certain drugs.

Overdose

If you suspect an overdose, it's important to stay calm and take immediate action. While there is no specific information available about the signs of overdose for this medication, general symptoms can include unusual drowsiness, confusion, or difficulty breathing. If you notice any of these signs, seek medical help right away.

In case of an overdose, contact your local emergency services or go to the nearest hospital. It's always better to be safe and get checked by a healthcare professional if you have any concerns about your health.

Pregnancy Use

If you are pregnant or planning to become pregnant, you may be wondering about the safety of using Mylanta Maximum Strength Classic Flavor. The information available does not specify any risks or contraindications for using this product during pregnancy, meaning there are no known dangers to the fetus associated with its use. Additionally, there are no recommended dosage changes for pregnant individuals, and no special precautions are noted.

As always, it's a good idea to consult with your healthcare provider before using any medication during pregnancy to ensure it’s appropriate for your specific situation.

Lactation Use

If you are breastfeeding, you can use Mylanta Maximum Strength Classic Flavor without specific warnings or recommendations against it. The information available does not indicate any concerns about the product being passed into breast milk or any risks to your infant while you are nursing.

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

Pediatric Use

If you are considering this medication for your child, it's important to know that children under 12 years old should consult a doctor before use. For those aged 12 and older, the recommended dosage is between 2 teaspoons to 4 teaspoons (1-2 doses) taken between meals or at bedtime, unless directed otherwise by a healthcare professional.

Be mindful of the maximum dosage: no more than 12 teaspoons (6 doses) should be taken in a 24-hour period, and this maximum dosage should not be used for more than 2 weeks. Always prioritize your child's safety by following these guidelines closely.

Geriatric Use

While there is no specific information available about the use of this medication in older adults, it’s important to approach any new treatment with caution. Since older adults may have different health needs and may be taking multiple medications, it’s always a good idea to consult with a healthcare provider before starting any new medication. They can help ensure that the treatment is safe and appropriate for your individual health situation.

If you or a loved one is an older adult, be sure to discuss any concerns about potential side effects or interactions with other medications you may be taking. Your healthcare provider can provide guidance tailored to your specific needs.

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 to your dosage are necessary. Always prioritize open communication with your doctor regarding your kidney health to ensure the best care.

Hepatic Impairment

If you have liver problems, it's important to know that the drug insert does not provide specific information about dosage adjustments, special monitoring, or precautions for your condition. This means that there are no tailored guidelines for how this medication may affect you if you have hepatic impairment (liver issues).

Always consult your healthcare provider for personalized advice and to discuss any concerns regarding your liver health and how it may relate to your treatment. They can help ensure that you receive the safest and most effective care.

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 performance and safety of your product, store it at a temperature between 20-25°C (68-77°F). It's important to avoid freezing, as this can damage the product. When handling the product, always check the tamper-evident seal under the cap. If the seal is broken or missing, do not use the product, as this indicates it may not be safe for use.

By following these simple storage and handling guidelines, you can help maintain the product's integrity and ensure your safety.

Additional Information

You can take this medication orally, with the recommended dosage for adults and children aged 12 years and older being 2 to 4 teaspoons (1-2 doses) between meals or at bedtime, or as directed by your doctor. It's important not to exceed 12 teaspoons (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 for appropriate guidance.

FAQ

What is Mylanta®?

Mylanta® is an 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 2 to 4 teaspoons (1-2 doses) between meals or at bedtime, as directed by a doctor.

What is the maximum dosage for Mylanta®?

Do not take more than 12 teaspoons (6 doses) in any 24-hour period, and do not use the maximum dosage for more than 2 weeks.

Are there any warnings for using Mylanta®?

Yes, ask a doctor before use if you have kidney disease or a magnesium-restricted diet, and if you are taking a prescription drug, as antacids may interact with certain medications.

Can I use Mylanta® during pregnancy?

The insert does not provide specific information regarding the use of Mylanta® during pregnancy, and there are no known teratogenic effects.

Is Mylanta® safe for nursing mothers?

There are no specific warnings or recommendations regarding the use of Mylanta® in nursing mothers mentioned in the insert.

How should I store Mylanta®?

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

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.

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 Maximum Strength Classic Flavor is a liquid formulation containing the active ingredients aluminum hydroxide, magnesium hydroxide, and simethicone. This product is designed to provide relief from symptoms associated with excess stomach acid. The formulation includes 0.2% alcohol and is presented in a dosage form of 10 fluid ounces (296 mL). Mylanta is a registered trademark of McNeil Consumer Pharmaceuticals Co. The product is manufactured for Infirst Healthcare Inc., located in Westport, CT 06880. All rights reserved © 2021 Infirst Healthcare Inc.

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. For adults and children aged 12 years and older, the recommended dosage is 2 teaspoons to 4 teaspoons (1 to 2 doses) taken between meals, at bedtime, or as directed by a healthcare professional. It is important not to exceed a maximum of 12 teaspoons (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. It is important to evaluate individual patient circumstances and consult relevant clinical guidelines when considering treatment options.

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 affect the safety and efficacy of the treatment.

In the event of an overdose, it is imperative to seek emergency medical assistance immediately. Healthcare providers and patients can contact a poison control center at 1-800-222-1222 for guidance.

Patients are advised to discontinue use and contact their healthcare provider if they are currently taking any prescription medications. Antacids have the potential to interact with certain prescription drugs, which may lead to adverse effects or reduced therapeutic efficacy. Regular monitoring and consultation with a healthcare professional are recommended to ensure safe 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, 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. Antacids have the potential to interact with certain prescription drugs, which could lead to adverse effects or reduced therapeutic efficacy.

Monitoring for these interactions and contraindications is essential to ensure patient safety and optimal treatment outcomes.

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 various prescription medications, which could alter their effectiveness or lead to unintended side effects. It is essential for patients to disclose all medications they are taking to ensure safe and effective use of antacids alongside their prescribed treatments. Monitoring for any adverse effects or changes in therapeutic outcomes is recommended when these interactions are possible.

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. For adolescents and children aged 12 years and older, the recommended dosage is 2 teaspoons to 4 teaspoons (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 12 teaspoons (6 doses) within a 24-hour period. Additionally, the maximum dosage should not be used for more than 2 weeks.

Geriatric Use

There is no specific information regarding the use of this medication in geriatric patients, including dosage adjustments, safety concerns, or special precautions. Healthcare providers should exercise caution when prescribing this medication to elderly patients, as they may have altered pharmacokinetics and pharmacodynamics. Close monitoring is recommended to ensure safety and efficacy in this population.

Pregnancy

There are no specific statements regarding the use of Mylanta Maximum Strength Classic Flavor during pregnancy. The available information does not indicate any contraindications or risks to the fetus associated with the use of this product during pregnancy. Additionally, no dosage modifications for pregnant individuals are provided. The insert does not include any special precautions regarding the use of this product during pregnancy. As with any medication, healthcare professionals should consider the overall clinical context when advising pregnant patients.

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 of this product 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. It is essential to assess renal function and consider potential dosing adjustments or monitoring requirements based on the degree of impairment.

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 absence of specific information regarding overdosage, healthcare professionals are advised to exercise caution and adhere to general principles of management in cases of suspected overdose.

It is essential to monitor the patient closely for any potential symptoms that may arise, as the clinical presentation can vary depending on the substance involved and the individual patient's response. Common symptoms of overdose may include, but are not limited to, altered mental status, cardiovascular instability, respiratory distress, and gastrointestinal disturbances.

In the event of an overdose, immediate medical attention should be sought. Healthcare providers should initiate supportive care, which may include maintaining airway patency, providing supplemental oxygen, and monitoring vital signs. The use of activated charcoal may be considered if the patient presents within a suitable timeframe and is deemed appropriate based on clinical judgment.

Additionally, it is crucial to consult local poison control centers or toxicology experts for guidance on specific management protocols and antidotes, if applicable. Continuous assessment and supportive measures should be implemented until the patient stabilizes or further treatment is determined.

Documentation of the incident, including the substance involved, estimated dose, time of ingestion, and any symptoms observed, is vital for ongoing management and potential reporting requirements.

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 seek immediate medical assistance or contact a poison control center at 1-800-222-1222 in the event of an overdose. It is crucial for patients to understand the importance of prompt action in such situations.

Additionally, healthcare providers should encourage patients to consult with their doctor or pharmacist prior to 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 it is essential to ensure safe and effective use.

Storage and Handling

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

For optimal storage, the product must be kept at a temperature range of 20-25°C (68-77°F). It is crucial to avoid freezing the product to maintain its integrity and effectiveness.

Additional Clinical Information

The medication is administered orally, with the recommended dosage for adults and children aged 12 years and older being 2 to 4 teaspoons (1-2 doses) between meals or at bedtime, or as directed by a healthcare professional. Patients should not exceed 12 teaspoons (6 doses) within a 24-hour period and should not use the maximum dosage for more than 2 weeks. For children under 12 years of age, 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.

Learn more in our Editorial Policy

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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.