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Maximum Strength Antacid Mint

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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
Drug classes
Calculi Dissolution Agent, Osmotic Laxative
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 2020
Label revision date
December 26, 2024
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
Drug classes
Calculi Dissolution Agent, Osmotic Laxative
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 2020
Label revision date
December 26, 2024
Manufacturer
Topco Associates, LLC
Registration number
M001
NDC root
36800-342
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

Topcare Health is a maximum strength antacid and anti-gas medication designed to provide fast relief from common digestive discomforts. It helps alleviate symptoms such as acid indigestion, heartburn, sour stomach, and upset stomach, including gas associated with these issues.

With a pleasant mint flavor, Topcare Health offers a soothing option for those seeking quick relief from uncomfortable stomach sensations.

Uses

If you're experiencing discomfort from acid indigestion, heartburn, or a sour stomach, this medication can help relieve those symptoms. It is also effective for an upset stomach and gas that may accompany these issues.

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

Before you use this medication, make sure to shake the bottle well. For adults and children aged 12 years and older, the recommended dose is between 10 mL to 20 mL, taken two times a day. However, it's important to follow your doctor's specific instructions if they provide different guidance.

If you have a child under 12 years old, please consult a doctor before giving them this medication to ensure it's safe and appropriate for their age. Remember, 1 mL (milliliter) is a small measurement, so be sure to use the correct amount for effective treatment.

What to Avoid

It's important to be aware of certain guidelines when using this medication. If your symptoms persist for more than two weeks, you should stop using the product and consult your doctor. This is crucial to ensure your health and safety.

Currently, there are no specific contraindications, controlled substance classifications, or concerns regarding abuse, misuse, or dependence associated with this medication. However, always prioritize your well-being by following the recommended usage instructions.

Side Effects

It's important to be aware of potential side effects and warnings when using this product. You should not exceed 60 mL in a 24-hour period or use the maximum dosage for more than two weeks without consulting your doctor. If your symptoms persist for more than two weeks, stop using the product and seek medical advice.

Before using this product, talk to your doctor if you have kidney disease or are on a magnesium-restricted diet. Additionally, if you are currently taking any prescription medications, consult with your doctor or pharmacist, as antacids can interact with certain drugs.

Warnings and Precautions

It's important to use this product safely. You should not take more than 60 mL in a 24-hour period, and you should not use the maximum dosage for more than two weeks unless your doctor advises you to do so.

If your symptoms persist for more than two weeks, please stop using the product and consult your doctor. While there are no specific emergency instructions provided, always seek immediate medical help if you feel you need it. Remember, your health and safety are the top priority.

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, contact your local emergency services or go to the nearest hospital. It's always better to be safe and get checked by a healthcare professional if you have any concerns about your health.

Pregnancy Use

While the information provided does not specify any particular safety concerns or precautions for use during pregnancy, it is important to approach any medication with care. There are no dosage modifications recommended for pregnant individuals, which suggests that the standard dosing may be considered safe. However, always consult with your healthcare provider before starting or continuing any medication during pregnancy to ensure it is appropriate for your specific situation. Your health and the health of your baby are the top priority, so open communication with your doctor is essential.

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 to your infant. Always consult with your healthcare provider if you have any concerns or questions about medications while breastfeeding.

Pediatric Use

If you have a child under 12 years old, it's important to consult a doctor before using this medication. For children aged 12 and older, the recommended dosage is between 10 mL to 20 mL taken twice a day, or as directed by a healthcare professional. Always follow your doctor's advice to ensure the safety and effectiveness of the treatment for your child.

Geriatric Use

If you are an older adult or caring for one, it's important to be cautious when using this medication. Before starting, you should 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, it's wise to check with your doctor or pharmacist first, since antacids can interact with some of these drugs.

For adults and children aged 12 and older, the typical dosage is 10 mL to 20 mL taken twice a day, or as directed by your healthcare provider. If the person you are caring for is under 12 years old, please consult a doctor for appropriate guidance. Always prioritize safety and communication with healthcare professionals when managing medications.

Renal Impairment

If you have kidney problems, it's important to know that the information provided does not include specific guidelines for dosage adjustments, special monitoring, or safety considerations related to renal impairment (kidney issues). This means that there are no tailored recommendations for how your treatment may need to change based on your kidney function.

Always consult your healthcare provider for personalized advice and to ensure that your treatment plan is safe and effective for your specific situation. They can help monitor your kidney health and make any necessary adjustments to your medications.

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 antacids can interact with these medications, which may affect how well they work or increase the risk of side effects.

Always keep your healthcare provider informed about all the medications you are taking, including over-the-counter products, to ensure your safety and the effectiveness of your treatment.

Storage and Handling

To ensure the best performance of your product, store it at a controlled room temperature between 20ºC and 25ºC (68ºF to 77ºF). It's important to keep it away from freezing temperatures, as freezing can damage the product.

When handling the product, make sure to do so in a clean environment to maintain its integrity. Always follow any additional safety instructions provided to ensure safe use and disposal.

Additional Information

You should take this medication orally. For adults and children aged 12 years and older, the recommended dose is between 10 mL to 20 mL, taken twice a day, or as directed by your doctor. If the patient is under 12 years old, it's important to consult a doctor for the appropriate dosage.

FAQ

What is Topcare Health?

Topcare Health is an advanced antacid and antigas product that provides maximum strength relief for acid indigestion, heartburn, sour stomach, and upset stomach associated with gas.

How should I take Topcare Health?

Adults and children 12 years and older should take 10 mL to 20 mL two times a day, or as directed by a doctor. Children under 12 years should consult a doctor before use.

What are the indications for using Topcare Health?

Topcare Health is indicated for relieving acid indigestion, heartburn, sour stomach, and upset stomach and gas associated with these symptoms.

Are there any warnings associated with Topcare Health?

Do not take more than 60 mL in a 24-hour period or use the maximum dosage for more than 2 weeks without a doctor's advice. If symptoms last more than two weeks, stop use and consult a doctor.

Can I use Topcare Health if I have kidney disease?

You should ask a doctor before using Topcare Health if you have kidney disease, as it may not be suitable for you.

Is there any information about using Topcare Health during pregnancy?

The provided information does not specify any concerns regarding the use of Topcare Health during pregnancy.

What should I do if I am taking other prescription drugs?

You should consult a doctor or pharmacist before using Topcare Health, as antacids may interact with certain prescription medications.

What is the flavor of Topcare Health?

Topcare Health comes in a mint flavor.

How should I store Topcare Health?

Store Topcare Health at controlled room temperature between 20ºC-25ºC (68º-77ºF) and do not freeze.

Packaging Info

Below are the non-prescription pack sizes of Maximum Strength Antacid Mint (aluminum hydroxide, magnesium hydroxide, simethicone). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Maximum Strength Antacid Mint.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

Topcare Health offers a maximum strength antacid and antigas formulation, designed for fast relief. This product is comparable to the active ingredients found in Mylanta® Maximum Strength. Each 12 fluid ounce (355 mL) bottle contains an alcohol concentration of 0.2% v/v and is flavored with mint. The National Drug Code (NDC) for this product is 36800-342-40.

Uses and Indications

This drug is indicated for the relief of symptoms associated with acid indigestion, heartburn, sour stomach, and upset stomach, including gas related to these conditions.

There are no teratogenic or nonteratogenic effects associated with this drug.

Dosage and Administration

Healthcare professionals are advised to instruct patients to shake the product well before use.

For adults and children aged 12 years and older, the recommended dosage is 10 mL to 20 mL administered two times a day, or as directed by a physician.

For children under 12 years of age, it is essential to consult a healthcare provider for appropriate dosing recommendations.

All dosages are to be measured in milliliters (mL).

Contraindications

There are no specified contraindications for the use of this product. However, it is advised to discontinue use and consult a healthcare professional if symptoms persist for more than two weeks.

Warnings and Precautions

Exceeding a daily dosage of 60 mL is contraindicated, and the maximum dosage of this product should not be utilized for longer than two weeks unless directed and monitored by a healthcare professional. Adherence to this guideline is essential to prevent potential adverse effects associated with prolonged use.

Patients are advised to discontinue use and consult a physician if symptoms persist beyond a two-week period. This precaution is critical to ensure appropriate evaluation and management of the underlying condition.

While no specific emergency medical instructions are provided, it is imperative for healthcare professionals to remain vigilant and prepared to address any unforeseen complications that may arise during treatment.

Currently, there are no laboratory tests specified for monitoring; however, healthcare providers should consider appropriate clinical assessments based on individual patient needs and treatment responses.

Side Effects

Patients should be aware of the potential adverse reactions associated with this product. Serious adverse reactions may occur, particularly if the product is used inappropriately. It is crucial not to exceed a dosage of 60 mL within a 24-hour period or to use the maximum dosage for more than two weeks without the advice and supervision of a healthcare professional.

Patients are advised to discontinue use and consult a doctor if symptoms persist for more than two weeks. Additionally, individuals with kidney disease or those on a magnesium-restricted diet should seek medical advice before using this product.

Furthermore, patients currently taking prescription medications should consult a doctor or pharmacist prior to use, as antacids may interact with certain prescription drugs. These precautions are essential to ensure the safe and effective use of the product.

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 certain prescription medications, which could affect the efficacy of those drugs. It is important for patients to disclose all medications they are taking to ensure safe and effective use of antacids. Monitoring for any adverse effects or changes in therapeutic outcomes is recommended when antacids are used concurrently with prescription medications.

Packaging & NDC

Below are the non-prescription pack sizes of Maximum Strength Antacid Mint (aluminum hydroxide, magnesium hydroxide, simethicone). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Maximum Strength Antacid Mint.
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 taken twice daily, or as directed by a healthcare provider.

Geriatric Use

Elderly patients should exercise caution when using this medication, particularly those aged 65 and older. It is advisable for geriatric patients to consult a healthcare provider before use if they have a history of kidney disease, as renal function may be compromised in this population, potentially affecting drug metabolism and excretion.

Additionally, elderly patients are encouraged to seek guidance from a doctor or pharmacist prior to using this medication if they are currently taking any prescription drugs. This is important because antacids may interact with certain prescription medications, which could lead to adverse effects or reduced efficacy of treatment.

For dosing, the recommended administration for adults and children aged 12 years and older is 10 mL to 20 mL taken two times a day, or as directed by a healthcare professional. For children under 12 years of age, it is essential to consult a doctor for appropriate dosing recommendations.

Close monitoring and appropriate dose adjustments may be necessary to ensure safety and efficacy 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, 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 are no specific warnings or recommendations regarding the use of this product in nursing mothers. Additionally, there is no information available concerning the potential for excretion in breast milk or any associated risks to breastfed infants.

Renal Impairment

Patients with renal impairment have not been specifically addressed in the available prescribing information. There are no dosage adjustments, special monitoring requirements, or safety considerations outlined for individuals with reduced kidney function. Healthcare professionals should exercise caution and consider the lack of data when prescribing to this patient population.

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 in the provided sections of the Summary of Product Characteristics (SPL), healthcare professionals are advised to exercise caution and adhere to general principles of management in cases of suspected overdosage.

Recommended Actions In the event of an overdosage, it is essential for healthcare providers to assess the patient's clinical status and initiate appropriate supportive care. Monitoring of vital signs and symptomatic treatment should be implemented as necessary.

Potential Symptoms While specific symptoms of overdosage are not detailed, healthcare professionals should remain vigilant for any unusual or severe reactions that may arise, given the pharmacological profile of the medication.

Management Procedures In the absence of specific antidotes or treatment protocols, the management of overdosage should focus on supportive care and symptomatic relief. Healthcare professionals are encouraged to consult local poison control centers or toxicology experts for guidance tailored to the individual case.

It is imperative that healthcare providers document any instances of overdosage and report them to the appropriate regulatory authorities to contribute to the ongoing assessment of the medication's safety profile.

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. Patients should be informed to discontinue use and consult a doctor if their symptoms persist for more than two weeks, as this may indicate a need for further evaluation.

It is important for patients to seek medical advice before using this medication if they have a history of kidney disease, as this condition may affect the safety and efficacy of the treatment. Additionally, patients on a magnesium-restricted diet should also consult their healthcare provider prior to use to ensure it is appropriate for their dietary restrictions.

Furthermore, healthcare providers should encourage patients to discuss any current prescription medications they are taking with their doctor or pharmacist before starting this treatment. Antacids may interact with certain prescription drugs, and it is crucial for patients to be aware of potential interactions to avoid adverse effects.

Storage and Handling

The product is supplied in various package configurations, with specific NDC numbers available upon request. It should be stored at a controlled room temperature of 20ºC to 25ºC (68ºF to 77ºF). Freezing is not permitted, as it may compromise the integrity of the product. Proper handling and storage conditions are essential to maintain the product's efficacy and safety.

Additional Clinical Information

The medication is administered orally. For adults and children aged 12 years and older, the recommended dosage is 10 mL to 20 mL taken twice daily, or as directed by a healthcare professional. For children under 12 years of age, it is advised to consult a doctor for appropriate dosing.

No additional information is available regarding laboratory tests, abuse potential, patient counseling, or postmarketing experiences.

Drug Information (PDF)

This file contains official product information for Maximum Strength Antacid Mint, 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 Maximum Strength Antacid Mint, 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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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.