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Mylanta Classic

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Active ingredients
  • Dimethicone 80 mg/10 mL
  • Calcium Carbonate 800 mg/10 mL
  • Magnesium Hydroxide 270 mg/10 mL
Other brand names
Drug classes
Blood Coagulation Factor, Calculi Dissolution Agent, Osmotic Laxative, Phosphate Binder
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 2024
Label revision date
February 5, 2024
Drug Information (PDF)
Prescribing information, PDF file
Active ingredients
  • Dimethicone 80 mg/10 mL
  • Calcium Carbonate 800 mg/10 mL
  • Magnesium Hydroxide 270 mg/10 mL
Other brand names
Drug classes
Blood Coagulation Factor, Calculi Dissolution Agent, Osmotic Laxative, Phosphate Binder
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 2024
Label revision date
February 5, 2024
Manufacturer
Infirst Healthcare Inc.
Registration number
M001
NDC root
62372-501
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 liquid medication that combines an antacid and an anti-gas agent to provide fast relief from various digestive discomforts. It is commonly used to alleviate symptoms such as heartburn, acid indigestion, sour stomach, and upset stomach. Additionally, Mylanta helps relieve pressure and bloating caused by gas, making it a helpful option if you've overindulged in food and drink.

With its classic flavor, Mylanta is designed to quickly soothe your stomach and ease the discomfort associated with these common digestive issues. Whether you're dealing with occasional heartburn or the discomfort of gas, Mylanta can offer you the relief you need.

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 pressure and bloating often associated with gas. Additionally, if you've overindulged in food and drink, this medication can provide relief from those uncomfortable feelings.

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) as needed. You can take it between meals, at bedtime, or as your doctor advises.

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

What to Avoid

Before using this medication, it's important to consult your doctor if you have kidney disease or if you are on a magnesium-restricted diet. These conditions may affect how the medication works for you.

Please remember to keep this medication out of reach of children. If you suspect an overdose, seek medical help immediately or contact a poison control center at 1-800-222-1222. Your safety is a priority, so follow these guidelines closely to avoid any potential risks.

Side Effects

It's important to be aware of potential side effects and warnings associated with this medication. Before using it, 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 medication 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. These conditions can affect how the medication works for you. Additionally, if you are currently taking any prescription drugs, check with your doctor or pharmacist first, as antacids may interact with them.

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 don’t hesitate to reach out for assistance if you need it.

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 if you believe you have taken too much of a medication, don’t hesitate to reach out for help right away. Your safety is the top priority.

Pregnancy Use

While the information provided does not specify any particular safety concerns or dosage modifications for pregnant individuals, it is always important to approach any medication with caution during pregnancy. Since there are no special precautions mentioned, it is advisable to consult with your healthcare provider before taking any medication if you are pregnant or planning to become pregnant. They can provide personalized guidance based on your health needs and circumstances.

Lactation Use

If you are breastfeeding or planning to breastfeed, it's important to consult your doctor before using this product. There is a possibility that it may be excreted in breast milk, which means it could potentially affect your baby. Since the effects on nursing infants have not been thoroughly studied, it's best to approach this with caution. Always prioritize your health and your baby's well-being by discussing any concerns with your healthcare provider.

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 10 mL and 20 mL, which can be taken as needed, either between meals or at bedtime, unless directed otherwise by a healthcare professional.

Be mindful of the maximum dosage, which should not exceed 60 mL (or 6 doses) in a 24-hour period. Additionally, if your child is using the maximum dosage, it should not be continued for more than 2 weeks. Always prioritize safety and consult with a healthcare provider if you have any questions or concerns.

Geriatric Use

If you are an older adult or caring for one, it's important to be cautious when using this medication. Before starting, consult with your doctor if you have kidney disease, as this can affect how the medication works in your body. Additionally, if you are currently taking any prescription medications, including antacids, check with your doctor or pharmacist to avoid any potential interactions.

For adults and children aged 12 and older, the recommended dose is between 10 mL and 20 mL (1-2 doses) as needed, taken between meals or at bedtime. However, do not exceed 60 mL (6 doses) in a 24-hour period, and avoid using the maximum dosage for more than two weeks. If the person is under 12 years old, please consult a doctor before use.

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 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 safety and effectiveness of your product, store it at a temperature between 20-25°C (68-77°F) and avoid freezing. This temperature range helps maintain the product's integrity.

When handling the product, check the tamper-evident seal under the cap. If this seal is broken or missing, do not use the product, as it may not be safe. Following these guidelines will help you use the product safely and effectively.

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 used for?

Mylanta is a liquid antacid and anti-gas medication that relieves heartburn, acid indigestion, sour stomach, upset stomach, and bloating due to gas.

How should I take Mylanta?

Adults and children 12 years and over should take 10 mL-20 mL (1-2 doses) as needed, between meals, or at bedtime. Do not exceed 60 mL (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 a magnesium-restricted diet. Antacids may also interact with certain prescription drugs.

Can children use Mylanta?

Children under 12 years should ask a doctor before use.

What should I do in case of an overdose?

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

Is Mylanta safe to use during pregnancy?

The insert does not provide specific information regarding the use of Mylanta during pregnancy, so consult a doctor for advice.

What should nursing mothers know about Mylanta?

Nursing mothers should consult a doctor before using Mylanta, as there is potential for excretion in breast milk and effects on nursing infants are not well studied.

How should Mylanta be stored?

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

Packaging Info

Below are the non-prescription pack sizes of Mylanta Classic (calcium carbonate, magnesium hydroxide, simethicone). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Mylanta Classic.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

Mylanta® is a liquid antacid and anti-gas formulation designed to provide rapid relief from heartburn, acid indigestion, and painful gas upon contact. The product is presented in a classic flavor and is available in a 12 fluid ounce (355 mL) container.

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 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.

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 of this product is contraindicated in patients with kidney disease and those on a magnesium-restricted diet. Due to potential adverse effects, individuals with these conditions should consult a healthcare professional prior to use.

Additionally, this product should be kept 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

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 influence the safety and efficacy of the treatment.

It is advisable for patients to seek guidance from a doctor or pharmacist before using this product if they are currently taking any prescription medications. 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 without delay at 1-800-222-1222 for further instructions and support.

Side Effects

Patients should be aware of certain warnings associated with the use of this medication. It is advised to consult a doctor before use if there is a history of kidney disease or if the patient is on a magnesium-restricted diet. Additionally, patients should seek guidance from a doctor or pharmacist if they are currently taking any prescription medications, as antacids may interact with specific drugs.

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

Drug Interactions

Patients are advised to consult a healthcare professional, such as a doctor or pharmacist, prior to using antacids if they are currently taking any prescription medications. Antacids have the potential to interact with various prescription drugs, which may alter the effectiveness of the medications or lead to unintended side effects.

It is essential for healthcare providers to evaluate the specific medications involved to determine the need for dosage adjustments or enhanced monitoring during concurrent use.

Packaging & NDC

Below are the non-prescription pack sizes of Mylanta Classic (calcium carbonate, magnesium hydroxide, simethicone). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Mylanta Classic.
Details

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 allowable dosage for this age group is 60 mL (6 doses) within a 24-hour period. It is important to note that this maximum dosage should not be used for more than 2 weeks.

Geriatric Use

Elderly patients should consult a healthcare provider prior to use, particularly if they have a history of kidney disease, as this may influence the safety and efficacy of the treatment. Additionally, it is advisable for geriatric patients to seek guidance from a doctor or pharmacist if they are currently taking any prescription medications, as antacids may interact with certain drugs.

For adults and children 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 professional. It is important for elderly patients to adhere to the maximum dosage limit of 60 mL (6 doses) within a 24-hour period and to avoid using the maximum dosage for more than 2 weeks without medical supervision.

For children under 12 years of age, consultation with a healthcare provider is necessary before administration. Careful monitoring and adherence to these guidelines are essential to ensure the safe use of this medication in geriatric patients.

Pregnancy

Pregnant patients may use this medication as no specific safety concerns regarding pregnancy have been detailed in the prescribing information. There are no dosage modifications recommended for pregnant individuals, and no special precautions regarding the use of this medication during pregnancy have been included. Healthcare professionals should continue to evaluate the benefits and risks when prescribing this medication to women of childbearing potential.

Lactation

Nursing mothers should consult a doctor before using this product. There is a potential for excretion in breast milk, and the effects on nursing infants are not well studied; therefore, caution is advised when considering the use of this product during lactation.

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

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 be initiated as per established protocols, which may include supportive care and symptomatic treatment. It is vital for healthcare providers to remain vigilant and prepared to address any complications that may arise during the management of an 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 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 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 a history of 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 configuration that ensures tamper evidence; it should not be used if the printed seal under the cap 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 efficacy.

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 Classic, 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 Classic, 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.