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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)
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Marketed in the U.S.
Since 2021
Label revision date
December 11, 2023
Drug Information (PDF)
Prescribing information, PDF file
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
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Marketed in the U.S.
Since 2021
Label revision date
December 11, 2023
Manufacturer
Infirst Healthcare Inc.
Registration number
M001
NDC root
62372-551
Drug Information (PDF)
Prescribing information, PDF file
Packaging Info (2 NDCs)
Packaging & NDC Codes (2)

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 One is a combination antacid and anti-gas medication designed to provide relief from various stomach discomforts. It contains three powerful ingredients that work together to alleviate heartburn, acid indigestion, sour stomach, and upset stomach. Additionally, it helps relieve pressure and bloating commonly associated with gas, making it a helpful option for those who experience discomfort after eating or drinking too much.

Available in a smooth, soothing Lemon Mint flavor, Mylanta One comes in chewable tablet form, with each package containing 50 single-dose tablets. This convenient product is designed to work effectively in just one tablet, providing quick relief from the discomforts of overindulgence.

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.

You can feel confident using this medication, as there are no known teratogenic effects (which means it doesn't cause birth defects) associated with it.

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

There are no specific contraindications, controlled substance classifications, or risks of 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 you.

Side Effects

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

By taking these precautions, you can help ensure your safety while using 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. Additionally, if you are currently taking any prescription medications, check with your doctor or pharmacist first, as antacids can interact with certain drugs.

In the event of an overdose, seek emergency medical help immediately or contact a poison control center at 1-800-222-1222. While there are no specific instructions to stop taking this medication, always stay in touch with your healthcare provider regarding any concerns or unusual symptoms you may experience.

Overdose

If you suspect an overdose, it's important to stay calm and take immediate action. While the specific signs of an overdose are not detailed, common symptoms can include extreme 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 crucial to provide them with as much information as possible about the substance taken and the amount, if known. Remember, acting quickly can make a significant difference in your health and safety.

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, the safety and effectiveness of this product in pregnant women have not been established. Always prioritize your health and the health of your baby by seeking professional medical advice.

Lactation Use

If you are breastfeeding, you can use Mylanta One Antacid/Anti-Gas 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 using it during lactation.

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

Pediatric Use

If your child is under 12 years old, it's important to consult a doctor before using this medication. For those aged 12 and older, you can give them 1 tablet to chew when symptoms arise, or as directed by their doctor. However, make sure they do not exceed 6 tablets in a 24-hour period, and avoid using the maximum dosage for more than 2 weeks. Always prioritize safety and follow these guidelines to ensure your child's well-being.

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. If you or a loved one is an older adult, it’s wise to discuss any potential risks or concerns with your healthcare provider. They can help determine the best approach, considering any unique health needs or conditions.

Always ensure that your doctor is aware of all medications being taken, as older adults may be more sensitive to certain drugs. Regular check-ins with your healthcare team can help monitor for any side effects or changes in health.

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 information provided does not include specific guidelines for dosage adjustments, special monitoring, or precautions related to your condition. This means that there are no tailored recommendations for how the medication may affect you differently due to your liver health.

Always consult your healthcare provider for personalized advice and to ensure that any treatment plan is safe and effective for your specific situation. They can help determine the best approach based on your liver function and overall health.

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 its effectiveness and safety.

When handling the product, be sure to do so with clean hands and in a clean environment to avoid contamination. Proper storage and careful handling are essential for your safety and the product's reliability.

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 contains three powerful ingredients in one, available as chewable tablets in Lemon Mint flavor.

What symptoms does Mylanta One relieve?

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

How should I take Mylanta One?

Adults and children 12 years and over should chew 1 tablet as symptoms occur, or as directed by a doctor. Do not take more than 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.

Can I use Mylanta One if I am pregnant?

You should ask a doctor before using Mylanta One if you are pregnant or planning to become pregnant, as safety and efficacy in pregnant women have not been established.

Is Mylanta One safe for children?

Children under 12 years of age 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.

How should I store Mylanta One?

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

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 with three active ingredients to provide dual action as an antacid and anti-gas agent. Each tablet is designed to deliver effective relief in a single dose. The product is presented in a plastic bottle containing 50 chewable tablets, flavored with a lemon mint taste for a smooth and soothing experience.

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 to ensure safe use of the medication.

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 at 1-800-222-1222 for prompt guidance 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 the 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 could lead to adverse effects or reduced therapeutic efficacy.

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

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. Healthcare professionals should consider this timing when prescribing medications that may be affected by antacids.

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. It is important to note that no more than 6 tablets should be taken within a 24-hour period. Additionally, the maximum dosage should not be used for more than 2 weeks.

Geriatric Use

Elderly patients may not have specific information regarding the use of this medication, including dosage adjustments, safety concerns, or special precautions. Therefore, healthcare providers should exercise caution when prescribing this medication to geriatric patients. It is advisable to monitor these patients closely for any potential adverse effects or changes in therapeutic response, given the lack of targeted data for this population.

Pregnancy

Pregnant patients or those planning to become pregnant should consult a healthcare professional before using this product. Currently, there are no specific warnings or contraindications associated with the use of this product during pregnancy. However, safety and efficacy in pregnant women have not been established. Therefore, healthcare providers should weigh the potential benefits against any unknown risks when considering this product for use in pregnant patients.

Lactation

There are no specific warnings or recommendations regarding the use of Mylanta One Antacid/Anti-Gas 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 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 absence of specific information regarding overdosage, healthcare professionals are advised to exercise caution when administering the medication. It is essential to monitor patients closely for any signs of adverse effects or symptoms that may arise from excessive dosing.

In the event of suspected overdosage, immediate medical attention should be sought. Healthcare providers should implement supportive measures as necessary, which may include symptomatic treatment and monitoring of vital signs.

Due to the lack of detailed overdosage information, it is recommended that healthcare professionals refer to established clinical guidelines and protocols for managing overdose situations relevant to the specific medication in question. Additionally, contacting a poison control center may provide further guidance on appropriate management strategies.

Continued vigilance and patient assessment are crucial in mitigating potential risks associated with overdosage.

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 controlled 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.

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.