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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 medication that combines an antacid and an anti-gas agent to provide fast relief from heartburn, acid indigestion, sour stomach, and upset stomach. It also helps alleviate pressure and bloating commonly associated with gas, making it useful for those who may have overindulged in food and drink. With its smooth, creamy taste, Mylanta is designed for on-the-go relief, ensuring you can feel better quickly.

Uses

If you're experiencing discomfort from heartburn, acid indigestion, or a sour stomach, this medication can help relieve those symptoms. It also addresses upset stomachs caused by these issues, providing you with much-needed comfort.

In addition, if you're feeling pressure and bloating, often referred to as gas, this medication can alleviate that as well. It's also effective for those times when you've overindulged in food and drink, helping you feel better after a heavy meal.

Dosage and Administration

Before you use 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 has given you different instructions. However, be careful not to exceed 12 tsp, or 6 doses, in a 24-hour period, and avoid using the maximum dosage for more than 2 weeks.

If you are considering this medication for a child under 12 years old, it’s important to consult with a doctor first to ensure it’s safe and appropriate for them.

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 you.

Side Effects

Before using this medication, it's important to consult with 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 certain medications. This will 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. These conditions can affect how your body processes the medication and may lead to complications.

If you suspect an overdose, seek emergency medical help immediately or contact a Poison Control Center at 1-800-222-1222. It's crucial to act quickly in such situations to ensure your safety.

Overdose

It appears that there is no specific information available regarding overdosage for this medication. However, it's important to be aware of the general signs of an overdose, which can include symptoms like extreme drowsiness, confusion, or difficulty breathing. If you suspect an overdose, it is crucial to seek immediate medical help.

In case of an emergency, you should call your local emergency number or go to the nearest hospital. Always keep your medications in a safe place and follow the prescribed dosage to prevent any potential risks. If you have any concerns or questions about your medication, don’t hesitate to reach out to your healthcare provider for guidance.

Pregnancy Use

When it comes to using this medication during pregnancy, the information provided does not specify any explicit safety concerns or special precautions. There are also no recommended dosage modifications for pregnant individuals.

While the absence of specific warnings may suggest a lower risk, it's always best to consult with your healthcare provider before starting or continuing any medication during pregnancy. They can provide personalized advice based on your health and circumstances.

Lactation Use

When it comes to breastfeeding, there is currently no specific information available regarding the use of this medication for nursing mothers or its effects during lactation (the process of producing breast milk). This means that if you are breastfeeding, it’s important to consult with your healthcare provider for personalized advice and to discuss any potential risks or considerations related to your situation. Always prioritize your health and the well-being of your baby when making decisions about medication use while nursing.

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 doctor.

Be cautious not to exceed 12 teaspoons (6 doses) in a 24-hour period, and avoid using the maximum dosage for more than 2 weeks. If you suspect an overdose, seek medical help immediately or contact a Poison Control Center at 1-800-222-1222.

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 2 to 4 teaspoons (1 to 2 doses) taken between meals or at bedtime, unless directed otherwise by a healthcare professional.

Be mindful not to exceed 12 teaspoons (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 appropriate 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 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 have open conversations with your healthcare provider about any medications or tests you may be taking. While there are no specific drug interactions or laboratory test interactions noted for this medication, your healthcare provider can help ensure that everything you are taking works well together and is safe for you.

Always feel free to ask questions and share your complete list of medications and any lab tests you may be undergoing. This way, you can receive the best possible care tailored to your needs.

Storage and Handling

To ensure the best performance 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 device. When handling the product, make sure to do so in a clean environment to maintain its integrity and safety. Always follow any specific disposal instructions provided to ensure safe and responsible disposal of the product.

Additional Information

It's important to be aware that if you are currently taking a prescription medication, antacids (medications that help neutralize stomach acid) may interact with it. This means that taking antacids could affect how well your prescription works or increase the risk of side effects. Always consult with your healthcare provider or pharmacist before adding any new medications, including over-the-counter products like antacids, to your routine.

FAQ

What is Mylanta?

Mylanta is an antacid and anti-gas medication that provides fast relief from heartburn, acid indigestion, sour stomach, and gas.

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, and not exceed 12 teaspoons (6 doses) in a 24-hour period.

Are there any warnings for using Mylanta?

Yes, you should ask a doctor before use if you have kidney disease or are on a magnesium-restricted diet.

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.

Can children under 12 use Mylanta?

Children under 12 years should ask a doctor before use.

Is there any information about Mylanta's use during pregnancy?

The provided text does not mention any specific information regarding Mylanta's use during pregnancy.

What is the storage requirement for Mylanta?

Mylanta should be stored between 20-25°C (68-77°F) and should not be frozen.

What are the main benefits of using Mylanta?

Mylanta relieves heartburn, acid indigestion, sour stomach, upset stomach, and bloating due to gas, especially after overindulgence in food and drink.

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

No description information is available for the specified drug.

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 symptoms, as well as relieving pressure and bloating commonly referred to as gas. Additionally, this drug provides relief from discomfort due to 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 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 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. These conditions may necessitate special consideration and monitoring to ensure safe use of the medication.

In the event of an overdose, it is imperative to seek emergency medical assistance immediately. Patients or caregivers should contact a Poison Control Center at 1-800-222-1222 for guidance and support.

If any adverse effects or unusual symptoms occur, patients are advised to discontinue use and contact their healthcare provider for further evaluation and management.

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 prescription drugs, potentially leading to adverse effects or diminished therapeutic outcomes.

Drug Interactions

There are currently no documented drug interactions associated with this medication. Additionally, there are no known interactions with laboratory tests. As such, no specific recommendations for dosage adjustments or monitoring are warranted at this time.

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, at bedtime, or as directed by a physician. It is important to note that the maximum dosage should not exceed 12 teaspoons (6 doses) within a 24-hour period, and this maximum dosage should not be utilized for more than 2 weeks. In the event of an overdose, immediate medical assistance should be sought, or contact a Poison Control Center at 1-800-222-1222.

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 2 teaspoons to 4 teaspoons (1-2 doses) between meals or at bedtime, or as directed by a physician. It is important for geriatric patients to adhere to the maximum dosage limit of 12 teaspoons (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 professional before administration. Careful monitoring and consideration of individual health status are essential when prescribing this medication to elderly patients.

Pregnancy

Pregnant patients may use this medication as no specific safety concerns regarding pregnancy have been detailed in the available data. There are no dosage modifications recommended for pregnant individuals, nor are there any special precautions regarding its use during pregnancy. Healthcare professionals should continue to evaluate the benefits and risks when prescribing this medication to women of childbearing potential.

Lactation

There is no specific information available regarding the use of this medication in nursing mothers or its effects during lactation. Healthcare professionals should consider the lack of data when advising lactating mothers about the use of this medication. It is recommended to weigh the potential benefits against any unknown 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 clinical trials for this medication. Consequently, there is no available information regarding 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 warranted based on clinical judgment.

Overdosage

There is currently no specific information available regarding overdosage for this medication. In the absence of documented overdosage data, healthcare professionals are advised to exercise caution and monitor patients closely for any unusual symptoms or adverse effects that may arise following administration.

In the event of suspected overdosage, it is recommended that healthcare providers initiate supportive care and symptomatic treatment as necessary. Monitoring of vital signs and laboratory parameters may be warranted to assess the patient's condition and guide further management.

Healthcare professionals should remain vigilant for potential symptoms that could indicate an overdosage scenario, although specific symptoms have not been detailed. If any adverse reactions or unexpected clinical presentations occur, appropriate medical intervention should be sought immediately.

For further guidance, healthcare providers are encouraged to consult local poison control centers or relevant medical authorities to obtain the most current recommendations for managing suspected overdosage cases.

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 provided in the insert.

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 various package configurations, with specific NDC numbers available for identification. It is essential to store the product at a temperature range of 20-25°C (68-77°F). Freezing the product is strictly prohibited, as it may compromise its integrity and efficacy. Proper storage conditions must be maintained to ensure the product's quality and effectiveness.

Additional Clinical Information

No further data are available.

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

Last AI update:

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.