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Regular Strength Antacid Mint

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Active ingredients
  • Dimethicone 40 mg/10 mL
  • Aluminum Hydroxide 400 mg/10 mL
  • Magnesium Hydroxide 400 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 40 mg/10 mL
  • Aluminum Hydroxide 400 mg/10 mL
  • Magnesium Hydroxide 400 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
36800-582
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 regular strength antacid that provides fast relief from various digestive discomforts. It is designed to help alleviate symptoms such as acid indigestion, heartburn, sour stomach, and upset stomach, including gas and bloating. The product works by neutralizing stomach acid, which can help reduce pressure and discomfort associated with these symptoms.

This antacid is available in a mint flavor and comes in a 12 FL OZ (355 mL) size. It contains a small amount of alcohol (0.4% v/v), which is important to note for those who may be sensitive to alcohol consumption.

Uses

You can use this medication to help relieve discomfort from several common digestive issues. It is effective for alleviating acid indigestion, heartburn, and sour stomach. If you're experiencing an upset stomach or gas related to these symptoms, this medication can also provide relief.

It's important to note that there are no reported teratogenic effects (which means it doesn't cause birth defects) associated with this medication, making it a safer option for those who may be concerned about such risks.

Dosage and Administration

Before you use this medication, make sure to shake the bottle well. If you are an adult or a child aged 12 years and older, you should take between 10 mL to 20 mL four times a day, unless your doctor has given you different instructions.

For children under 12 years old, it’s important to consult a doctor before giving them this medication to ensure it’s safe and appropriate for their age. Remember, 1 mL is equal to one milliliter, which is a common measurement for liquid medications.

What to Avoid

It's important to be aware of certain guidelines when using this medication. While there are no specific contraindications or concerns about abuse, misuse, or dependence, you should stop using the medication and consult your doctor if your symptoms persist for more than two weeks. This ensures that you receive the appropriate care and support for your health needs. Always prioritize your well-being and seek professional advice when necessary.

Side Effects

It's important to be aware of potential side effects when using this product. You should not exceed 80 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, as these conditions may affect your use of the medication. 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 80 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, stop using the product and consult your doctor for further guidance. While there are no specific emergency instructions provided, always seek immediate medical help if you experience severe or concerning symptoms.

Overdose

Taking more than 80 mL of this product in a 24-hour period, or using the maximum dosage for more than 2 weeks without a doctor's guidance, can lead to an overdose. Signs of an overdose may include unusual symptoms that could affect your health. If you suspect an overdose, it’s important to seek immediate medical help.

If you experience any concerning symptoms or if you have taken too much, contact your healthcare provider or go to the nearest emergency room right away. Always prioritize your safety and well-being by following dosage instructions carefully.

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, you should consult with your healthcare provider before taking any medication to ensure it is safe for you and your baby. Your healthcare provider can offer personalized advice based on your specific situation and health needs.

Lactation Use

If you are breastfeeding, you can feel reassured that there are no specific warnings or recommendations regarding the use of this product while nursing. This means that, according to the information available, it is considered safe for you to use without concerns about potential effects on your milk production or the nursing infant.

Additionally, there are no indications that this product is excreted in breast milk, which further supports its use during lactation. Always consult with your healthcare provider if you have any questions or concerns 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 four times 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 four times a day, or as directed by your healthcare provider. If the patient 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 there are no specific guidelines or dosage adjustments mentioned for your condition in the available information. This means that the usual recommendations for monitoring or safety considerations related to renal impairment (kidney issues) are not provided.

Always consult your healthcare provider for personalized advice and to ensure that any medications you take are safe and appropriate for your kidney health. They can help you understand how your condition may affect your treatment plan.

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 monitor your liver function and make any necessary adjustments to your 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 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 maintain a clean environment to avoid contamination. Always follow any specific instructions provided for safe use and disposal to ensure your safety and the effectiveness of the product.

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 four times 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 a regular strength antacid that provides advanced antacid and antigas properties for fast relief.

What symptoms does Topcare Health relieve?

It relieves acid indigestion, heartburn, sour stomach, upset stomach, and gas associated with these symptoms.

What is the recommended dosage for adults and children 12 years and older?

You should take 10 mL to 20 mL four times a day, or as directed by a doctor.

What should children under 12 do before using Topcare Health?

Children under 12 years should consult a doctor before use.

Are there any contraindications for using Topcare Health?

No specific contraindications are mentioned for this product.

What should you do if symptoms last more than two weeks?

You should stop use and ask a doctor if symptoms last more than two weeks.

Is there any alcohol in Topcare Health?

Yes, Topcare Health contains 0.4% v/v alcohol.

What precautions should you take if you have kidney disease?

You should ask a doctor before use if you have kidney disease.

Can Topcare Health interact with prescription drugs?

Yes, you should ask a doctor or pharmacist before use if you are presently taking a prescription drug, as antacids may interact with certain medications.

How should Topcare Health be stored?

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

Packaging Info

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

Packaging configurations for Regular Strength Antacid Mint.
Details

Drug Information (PDF)

This file contains official product information for Regular 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 Regular Strength Antacid & Antigas is formulated to provide fast relief from symptoms associated with excess stomach acid and gas. This advanced antacid solution contains 0.4% v/v alcohol and is presented in a 12 fluid ounce (355 mL) dosage form. The product is characterized by its mint flavor, enhancing palatability for users. The National Drug Code (NDC) for this formulation is 36800-582-40.

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 four 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 taken orally, and the volume is measured in milliliters (mL).

Contraindications

There are no specified contraindications for 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

Patients should not exceed a maximum dosage of 80 mL within a 24-hour period. Additionally, the maximum dosage should not be used for more than two weeks unless directed and supervised by a healthcare professional.

If symptoms persist beyond two weeks, it is imperative to discontinue use and consult a physician for further evaluation and guidance.

There are no specific laboratory tests recommended for monitoring during the use of this product. However, healthcare professionals should remain vigilant for any adverse effects or prolonged symptoms in patients.

Side Effects

Patients should be aware of the potential adverse reactions associated with this product. It is crucial to adhere to the recommended dosage guidelines, which state that no more than 80 mL should be taken within a 24-hour period, and the maximum dosage should not be used for more than 2 weeks unless under the advice and supervision of a healthcare professional.

In the event that symptoms persist for more than two weeks, patients are advised to discontinue use and consult a doctor. 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 with 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 Regular Strength Antacid Mint (aluminum hydroxide, magnesium hydroxide, simethicone). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Regular 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 four times a day, 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 this may influence the safety and efficacy of the treatment.

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, potentially leading to adverse effects or reduced therapeutic efficacy.

For dosing, the recommended administration for adults and children aged 12 years and older is 10 mL to 20 mL four 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.

Overall, careful monitoring and appropriate dose modifications may be necessary for geriatric patients to ensure safe and effective use of this medication.

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

There are no specific warnings or recommendations regarding the use of this product by lactating mothers. Additionally, there is no information available concerning the potential for excretion in breast milk or any effects on breastfed infants.

Renal Impairment

There is no specific information available regarding dosage adjustments, special monitoring, or safety considerations for patients with renal impairment. Healthcare professionals should exercise caution when prescribing to patients with reduced kidney function, as the absence of detailed guidance necessitates careful clinical judgment. Regular monitoring of renal function may be advisable in 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

Exceeding the recommended dosage of this product can lead to serious health risks. It is imperative that healthcare professionals advise patients not to take more than 80 mL within a 24-hour period. Additionally, the maximum dosage should not be utilized for longer than 2 weeks unless under the guidance and supervision of a qualified healthcare provider.

In the event of an overdosage, patients may experience a range of symptoms, which can vary based on individual factors and the extent of the overdose. Healthcare professionals should be vigilant in monitoring for any adverse effects and be prepared to implement appropriate management strategies.

Recommended actions in the case of suspected overdosage include immediate assessment of the patient's condition and initiation of supportive care as necessary. It is crucial to consult with a poison control center or medical toxicologist for further guidance on the management of overdosage and to determine if additional interventions are required.

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 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 the medication if they have a history of kidney disease or are on a magnesium-restricted diet. Additionally, patients should be encouraged to discuss their current medications with their healthcare provider or pharmacist, particularly if they are taking any prescription drugs, as antacids may interact with certain medications. This precaution helps ensure safe and effective use of the product.

Storage and Handling

The product is supplied in various package configurations, with specific NDC numbers available upon request. It should be stored at a temperature range of 20ºC to 25ºC (68ºF to 77ºF). Freezing is not permitted, as it may compromise the integrity of the product. Proper 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 four times a day, or as directed by a healthcare professional. For children under 12 years of age, it is advised to consult a doctor for appropriate dosing guidance.

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 Regular 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 Regular 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.