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Mylanta Maximum Strength Classic Flavor Antacid and Anti Gas

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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
Liquid
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
July 19, 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
Liquid
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
July 19, 2023
Manufacturer
Lil' Drug Store Products, Inc.
Registration number
M001
NDC root
29485-8127
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, sour stomach, and upset stomach. It works quickly upon contact to soothe discomfort and alleviate pressure and bloating often associated with gas, making it effective for those who may experience these symptoms after overindulging in food and drink.

With its smooth, creamy taste and classic flavor, Mylanta is packaged in convenient single-dose pouches, allowing for easy use whenever you need relief.

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, as well as the pressure and bloating often associated with gas. Additionally, if you've overindulged in food or drink, this medication can provide relief from that discomfort too.

Dosage and Administration

When you need to take this medication, adults and children aged 12 years and older should take one 10 mL dose as needed or as directed by your doctor. It's important to remember that you should not exceed more than 60 mL, which is equivalent to 6 doses, within a 24-hour period. Additionally, you should avoid using the maximum dosage for more than 2 weeks to ensure your safety.

If you have a child under 12 years old, it's best to consult with a doctor before giving them this medication. This way, you can ensure that they receive the appropriate care and dosage for their age.

What to Avoid

There are no specific contraindications, controlled substance classifications, or concerns regarding abuse, misuse, or dependence associated with this medication. This means that, based on the available information, there are no particular situations or conditions under which you should avoid using it. Always consult with your healthcare provider for personalized advice and to ensure that this medication is appropriate for your individual health needs.

Side Effects

It's important to be aware of some warnings associated with this medication. If you have kidney disease or are on a magnesium-restricted diet, you should consult your doctor before using it. Additionally, if you are currently taking any prescription medications, it's advisable to speak with your doctor or pharmacist, as antacids can interact with certain drugs.

Always keep this medication out of reach of children. In the event of an overdose, seek medical help or contact a poison control center immediately. Your safety is a priority, so don't hesitate to ask questions if you're unsure about anything related to this medication.

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. Additionally, if you are currently taking any prescription drugs, check with your doctor or pharmacist first, since antacids can interact with certain medications.

Keep this product out of reach of children to ensure their safety. In the event of an overdose, seek medical help immediately or contact a poison control center for assistance.

Overdose

If you suspect an overdose, it’s crucial to seek medical help immediately or contact a poison control center. Signs of an overdose can vary, but they may include unusual drowsiness, confusion, or difficulty breathing.

Don’t wait for symptoms to worsen; getting prompt assistance can be vital. Always prioritize your safety and the safety of others by acting quickly in these situations.

Pregnancy Use

If you are pregnant or planning to become pregnant, it’s important to consult your doctor before using this product. While there are no specific warnings or contraindications noted for its use during pregnancy, seeking professional advice is always a wise choice to ensure your safety and that of your baby. Your healthcare provider can help you make informed decisions based on your individual health needs.

Lactation Use

If you are breastfeeding, you can feel reassured that there are no specific warnings or recommendations regarding the use of this product while nursing. Additionally, there is no information available about whether this product is excreted in breast milk or any potential risks it may pose to your infant. Always 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 you should consult a doctor before using it for children under 12 years old. This ensures that the treatment is safe and appropriate for their specific needs. Always prioritize your child's health by seeking professional advice when it comes to medications.

Geriatric Use

If you are an older adult or a caregiver, it's important to consult with a doctor before using this medication, especially if you have kidney disease or are on a magnesium-restricted diet. Kidney disease can affect how your body processes medications, and a magnesium-restricted diet means you need to be careful about the amount of magnesium you consume. Always prioritize safety and seek professional advice to ensure the best care for your health needs.

Renal Impairment

If you have kidney disease or are on a magnesium-restricted diet, it’s important to consult your doctor before using this medication. Your healthcare provider can help determine if this treatment is safe for you and may suggest necessary adjustments to your dosage or monitoring based on your kidney function. 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 need 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 drugs, 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 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 device, make sure to do so in a clean environment to maintain its integrity and safety. Always follow these guidelines to ensure optimal use and longevity of the product.

Additional Information

You will take this medication orally. There are no additional details available regarding laboratory tests, abuse potential, patient counseling, or postmarketing experiences. If you have any questions or concerns about your treatment, be sure to discuss them with your healthcare provider.

FAQ

What is Mylanta?

Mylanta is a maximum strength antacid and anti-gas medication that starts to work on contact, providing soothing fast relief from heartburn and other digestive discomforts.

What symptoms does Mylanta relieve?

Mylanta relieves heartburn, acid indigestion, sour stomach, upset stomach, pressure and bloating commonly referred to as gas, and symptoms due to overindulgence in food and drink.

How should adults and children over 12 use Mylanta?

Adults and children 12 years and over should take one 10 mL dose as needed, not exceeding 60 mL (6 doses) in any 24-hour period, and not using the maximum dosage for more than 2 weeks.

Is Mylanta safe for children under 12?

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, are on a magnesium-restricted diet, or are taking prescription drugs, as antacids may interact with them.

Can I use Mylanta during pregnancy?

You should consult a healthcare professional before using Mylanta if you are pregnant or planning to become pregnant, although no specific warnings are listed regarding its use during pregnancy.

What should I do in case of an overdose?

In case of overdose, get medical help or contact a poison control center right away.

How should Mylanta be stored?

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

Packaging Info

Below are the non-prescription pack sizes of Mylanta Maximum Strength Classic Flavor Antacid and Anti Gas (aluminum hydroxide, magnesium hydroxide, and dimethicone). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Mylanta Maximum Strength Classic Flavor Antacid and Anti Gas.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

Mylanta® Maximum Strength is an antacid and anti-gas formulation designed to provide rapid relief from heartburn and gas discomfort. The product is presented in single-dose pouches, each containing 0.3 fluid ounces (10 mL) of the solution. Mylanta® features a smooth, creamy texture and is available in a classic flavor. The formulation contains 0.2% alcohol, contributing to its efficacy. The active ingredients work on contact, delivering soothing relief for gastrointestinal distress.

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

Adults and children aged 12 years and over are advised to take one 10 mL dose as needed or as directed by a healthcare professional. The maximum allowable dosage is 60 mL, which equates to six doses, within any 24-hour period. It is important to note that the maximum dosage should not be utilized for more than two consecutive weeks.

For children under 12 years of age, consultation with a healthcare professional is recommended prior to 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 before prescribing.

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. Additionally, it is 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, potentially leading to adverse effects.

To ensure safety, this product should be stored out of reach of children to prevent accidental ingestion.

In the event of an overdose, immediate medical assistance should be sought, or the local poison control center should be contacted without delay to mitigate potential health risks.

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. It is also recommended that patients seek guidance from a doctor or pharmacist if they are currently taking any prescription medications, as antacids may interact with certain drugs.

In addition, it is crucial to keep this product out of the reach of children. In the event of an overdose, patients should seek immediate medical assistance or contact a poison control center.

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 to evaluate the necessity of dosage adjustments or increased monitoring when antacids are used concurrently with other medications.

Packaging & NDC

Below are the non-prescription pack sizes of Mylanta Maximum Strength Classic Flavor Antacid and Anti Gas (aluminum hydroxide, magnesium hydroxide, and dimethicone). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Mylanta Maximum Strength Classic Flavor Antacid and Anti Gas.
Details

Pediatric Use

Pediatric patients under 12 years of age should consult a healthcare professional prior to use. It is important for caregivers to seek medical advice to ensure the safety and appropriateness of treatment for this age group.

Geriatric Use

Elderly patients should consult a healthcare provider prior to using this medication, particularly if they have a history of kidney disease or are on a magnesium-restricted diet. Special consideration is warranted in this population due to the potential for altered pharmacokinetics and increased sensitivity to the effects of the medication. Monitoring for adverse effects and appropriate dose adjustments may be necessary to ensure safety and efficacy in geriatric patients.

Pregnancy

Pregnant patients or those planning to become pregnant should consult a healthcare professional before using this product. While there are no specific warnings or contraindications associated with the use of this product during pregnancy, it is essential for women of childbearing potential to seek medical advice to ensure safety for both the mother and the developing fetus. Healthcare professionals can provide guidance based on individual circumstances and the potential risks involved.

Lactation

There are no specific warnings or recommendations regarding the use of this product in nursing 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 kidney disease or are on a magnesium-restricted diet. It is essential to assess renal function and consider potential dosing adjustments or monitoring requirements based on the patient's specific condition.

Hepatic Impairment

There is no information available regarding the use of this medication in patients with hepatic impairment. Consequently, there are no dosage adjustments, special monitoring requirements, or precautions specified for individuals with compromised liver function. Healthcare professionals should exercise clinical judgment when considering the use of this medication in patients with liver problems, as the absence of data necessitates careful evaluation of potential risks and benefits.

Overdosage

In the event of an overdose, it is imperative to seek immediate medical assistance or contact a poison control center without delay. Prompt intervention is crucial to mitigate potential adverse effects associated with the overdose.

Healthcare professionals should be vigilant in monitoring for symptoms that may arise from an overdose. While specific symptoms are not detailed in the provided information, it is essential to remain alert to any signs of toxicity or adverse reactions that may develop.

Management of an overdose should be guided by established protocols, which may include supportive care and symptomatic treatment as necessary. The healthcare provider should ensure that the patient is stabilized and that appropriate measures are taken to address any complications that may arise from the 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 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.

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 or contact a poison control center immediately.

Patients should be encouraged to consult with their healthcare provider before using the medication if they have a history of kidney disease or are on a magnesium-restricted diet. It is also 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. This precaution helps ensure safe and effective use of the medication.

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 throughout its shelf life.

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 Maximum Strength Classic Flavor Antacid and Anti Gas, 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 Antacid and Anti Gas, 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.