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Mylanta One Antacid/Anti-Gas

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Active ingredients
  • Dimethicone 80 mg
  • Calcium Carbonate 1000 mg
  • Magnesium Hydroxide 270 mg
Other brand names
Drug classes
Blood Coagulation Factor, Calculi Dissolution Agent, Osmotic Laxative, Phosphate Binder
Dosage form
Tablet, Chewable
Route
Oral
Prescription status
OTC (over the counter)
Marketed in the U.S.
Since 2021
Label revision date
December 11, 2023
Active ingredients
  • Dimethicone 80 mg
  • Calcium Carbonate 1000 mg
  • Magnesium Hydroxide 270 mg
Other brand names
Drug classes
Blood Coagulation Factor, Calculi Dissolution Agent, Osmotic Laxative, Phosphate Binder
Dosage form
Tablet, Chewable
Route
Oral
Prescription status
OTC (over the counter)
CSA schedule
Not a scheduled drug
Marketed in the U.S.
Since 2021
Label revision date
December 11, 2023
Manufacturer
Infirst Healthcare Inc.
Registration number
M001
NDC root
62372-552

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Drug Overview

Mylanta One is a chewable tablet that combines the benefits of an antacid and an anti-gas medication to help relieve various stomach discomforts. It is designed to provide quick relief from heartburn, acid indigestion, sour stomach, and upset stomach, as well as pressure and bloating often associated with gas. This product is particularly useful after overindulging in food and drink, offering a smooth and soothing taste in a convenient Berry Ginger flavor.

With 50 single-dose tablets in each package, Mylanta One features three powerful ingredients that work together to address your digestive discomforts effectively. Whether you're dealing with occasional heartburn or the discomfort of gas, Mylanta One aims to provide you with 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 the pressure and bloating often associated with gas. Additionally, if you've overindulged in food and drink, this medication can provide relief from that discomfort too.

Dosage and Administration

If you are an adult or a child aged 12 years and older, you can take this medication by chewing 1 tablet whenever you experience symptoms, or as your doctor advises. However, it's important not to exceed 6 tablets in a 24-hour period. Additionally, you should not use the maximum dosage for more than 2 weeks to avoid potential complications.

For children under 12 years of age, it's essential to consult a doctor before giving them this medication. Always follow your healthcare provider's instructions to ensure safe and effective use.

What to Avoid

You can feel confident using this medication, as there are no specific contraindications, controlled substance classifications, or concerns regarding abuse, misuse, or dependence associated with it. This means that, based on the available information, there are no known reasons to avoid taking this medication. Always remember to follow your healthcare provider's guidance and reach out if you have any questions or concerns about your treatment.

Side Effects

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

While specific side effects are not detailed here, it's always a good practice to monitor how you feel after starting a new medication and report any unusual symptoms to your healthcare provider.

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.

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 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, or if you are unsure, seek medical help right away.

In case of an overdose, contacting your local emergency services or going to the nearest hospital is crucial. Always keep the medication packaging with you, as it can help healthcare professionals understand what you've taken. Remember, it's better to be safe and get checked out if you have any concerns about an overdose.

Pregnancy Use

You can use Mylanta One Antacid/Anti-Gas during pregnancy, as there are no specific warnings, precautions, or dosage changes mentioned in the product information. The insert does not indicate whether the product is contraindicated (not recommended) for pregnant individuals or if there are any risks to the developing fetus.

However, it's always a good idea to consult with your healthcare provider before taking any medication during pregnancy to ensure it’s safe for you and your baby.

Lactation Use

If you are breastfeeding, you can use Mylanta One Antacid/Anti-Gas without specific warnings or recommendations mentioned for nursing mothers. The information provided does not indicate any concerns about the medication being present in breast milk or any risks to your infant.

However, as always, it's a good idea to consult with your healthcare provider if you have any questions or concerns about medications while breastfeeding. They can provide personalized advice based on your situation.

Pediatric Use

If you have a child under 12 years old, it's important to consult with a doctor before using this medication. For children aged 12 and older, they can chew 1 tablet when symptoms arise, or as directed by a healthcare professional.

Keep in mind that the maximum dosage for anyone is 6 tablets within a 24-hour period, and this maximum dosage should not be used for more than 2 weeks. Always follow these guidelines to ensure your child's safety and well-being.

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 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 dosage is to chew one tablet when symptoms arise, or as directed by your doctor. However, do not exceed six tablets 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 you may have regarding your liver health and medication use. They can help ensure that you receive the safest and most effective treatment based on your individual needs.

Drug Interactions

It's important to be aware that antacids, which are commonly used to relieve heartburn and indigestion, can interact with some prescription medications. This means that taking antacids at the same time as certain drugs may affect how well those medications work.

To ensure your safety and the effectiveness of your treatment, always discuss any medications you are taking, including over-the-counter products like antacids, with your healthcare provider. They can help you understand potential interactions and adjust your treatment plan if necessary.

Storage and Handling

To ensure the best performance of your product, store it at a temperature between 20-25°C (68-77°F). This temperature range helps maintain the integrity and effectiveness of the device.

When handling the product, be sure to do so with care to avoid any damage. Always follow any specific instructions provided for use to ensure safety and effectiveness. If you have any questions about disposal or further handling, please refer to the guidelines provided with your 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 One?

Mylanta One is an antacid and anti-gas medication that works in one tablet, available in a Berry Ginger flavor.

What symptoms does Mylanta One relieve?

Mylanta One relieves heartburn, acid indigestion, sour stomach, upset stomach, pressure and bloating from gas, and overindulgence in food and drink.

How should adults and children 12 years and over use Mylanta One?

Adults and children 12 years and over should chew 1 tablet as symptoms occur, or as directed by a doctor, without exceeding 6 tablets in 24 hours.

Are there any warnings for using Mylanta One?

Yes, ask a doctor before use if you have kidney disease or a magnesium-restricted diet, and consult a doctor or pharmacist if you are taking prescription drugs, as antacids may interact with them.

Is Mylanta One safe to use during pregnancy?

The insert does not provide specific information regarding the use of Mylanta One during pregnancy or any risks to the fetus.

Can nursing mothers use Mylanta One?

There are no specific warnings or recommendations regarding the use of Mylanta One in nursing mothers mentioned in the provided text.

What is the maximum dosage for Mylanta One?

Do not take more than 6 tablets in 24 hours, and do not use the maximum dosage for more than 2 weeks.

How should Mylanta One be stored?

Store Mylanta One between 20-25°C (68-77°F).

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 One Antacid/Anti-Gas (calcium carbonate, magnesium hydroxide, dimethicone). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Mylanta One Antacid/Anti-Gas.
Details

Drug Information (PDF)

This file contains official product information for Mylanta One Antacid/Anti-Gas, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)

Description

Mylanta One Antacid/Anti-Gas chewable tablets are formulated to provide relief from heartburn and gas discomfort. Each tablet combines three active ingredients to deliver both antacid and anti-gas effects in a single dose. The tablets are presented in a berry ginger flavor, designed for a smooth and soothing taste experience. The product is packaged in a plastic bottle containing 50 single-dose chewable tablets, ensuring convenient access for users.

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 older are instructed to chew 1 tablet as symptoms occur, or as directed by a healthcare professional. The maximum allowable dosage is 6 tablets within a 24-hour period. It is important to note that the maximum dosage should not be utilized for more than 2 consecutive weeks.

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

Contraindications

There are no contraindications associated with the use of this product. It is deemed safe for use in the absence of specific conditions or situations that would warrant avoidance.

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 during treatment.

It is also advisable 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 affect their efficacy or lead to adverse effects.

In the event of an overdose, immediate medical assistance should be sought. Patients are encouraged to contact a poison control center without delay at 1-800-222-1222 for further instructions and support.

Patients should remain vigilant for any adverse reactions and discontinue use if they experience any concerning symptoms, subsequently contacting their healthcare provider for further evaluation.

Side Effects

Patients should be aware of potential adverse reactions associated with the use of this medication. It is important to consult a healthcare professional before use if there is a history of kidney disease or if the patient is on a magnesium-restricted diet, as these conditions may influence the safety and efficacy of the treatment.

Additionally, patients are advised 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 may lead to altered therapeutic effects or increased risk of adverse reactions.

While specific side effects were not detailed in the provided information, the importance of monitoring for any unexpected reactions during treatment cannot be overstated. Patients should report any unusual symptoms or concerns to their healthcare provider promptly.

Drug Interactions

Antacids may interact with various prescription medications, potentially affecting their absorption and efficacy. It is advisable to monitor the timing of antacid administration in relation to other medications to minimize these interactions. Specifically, antacids should be taken at least 2 hours apart from other drugs to ensure optimal therapeutic outcomes.

Packaging & NDC

Below are the non-prescription pack sizes of Mylanta One Antacid/Anti-Gas (calcium carbonate, magnesium hydroxide, dimethicone). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Mylanta One Antacid/Anti-Gas.
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 to chew 1 tablet as symptoms occur or as directed by a healthcare provider.

The maximum dosage for this age group is 6 tablets 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 if they have kidney disease, as this may affect 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 to chew 1 tablet as symptoms occur or as directed by a healthcare professional. It is important for elderly patients to adhere to the maximum dosage limit of 6 tablets within a 24-hour period and to avoid using the maximum dosage for more than 2 weeks. For children under 12 years of age, consultation with a healthcare provider is necessary before use.

Healthcare providers should closely monitor geriatric patients for any adverse effects or interactions, particularly in those with pre-existing conditions or those taking multiple medications.

Pregnancy

There are no specific warnings, precautions, or dosage modifications associated with the use of Mylanta One Antacid/Anti-Gas during pregnancy. The prescribing information does not indicate whether the product is contraindicated in pregnant patients or if there are any known risks to the fetus. As such, healthcare professionals should consider the absence of data when advising women of childbearing potential regarding the use of this product during pregnancy.

Lactation

There are no specific warnings or recommendations regarding the use of Mylanta One Antacid/Anti-Gas in lactating mothers. The available information does not address the potential for excretion in breast milk, the risk to breastfed infants, or any special considerations for 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 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 from an overdose. Symptoms can vary widely depending on the substance involved and the individual patient's response.

In the event of an overdose, immediate medical attention should be sought. Healthcare providers should implement supportive care measures, which may include maintaining airway patency, providing supplemental oxygen, and monitoring vital signs.

Additionally, it is recommended to consult local poison control centers or relevant toxicology resources for guidance on specific management protocols and antidotes, if applicable.

Documentation of the incident, including the substance involved, estimated dose, and time of exposure, is crucial for effective management and follow-up care.

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 compound in these areas.

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 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) to maintain its integrity and efficacy. Proper storage conditions must be adhered to, ensuring that the product is kept within the specified temperature limits to prevent degradation.

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 One Antacid/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 One Antacid/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.

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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.