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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
Suspension
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
November 7, 2023
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
Suspension
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
November 7, 2023
Manufacturer
H E B
Registration number
M001
NDC root
37808-099
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

You may find that this medication is designed to help relieve discomfort associated with heartburn, sour stomach, acid indigestion, and gas. It works by addressing the excess stomach acid that can lead to these uncomfortable symptoms, providing you with relief when you need it most. If you're experiencing any of these issues, this medication could be a helpful option to consider.

Uses

If you're experiencing discomfort from heartburn, a sour stomach, or acid indigestion, this medication can help relieve those symptoms. It also addresses issues related to gas, providing you with some much-needed comfort.

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. This makes 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 and 20 mL (which is 1 to 2 doses) four times a day, unless your doctor advises otherwise. It's important not to exceed 80 mL (or 8 doses) in a 24-hour period, and you should not use the maximum dosage for more than two weeks.

If your child is under 12 years old, please consult a doctor before giving them this medication. Following these guidelines will help ensure that you use the medication safely and effectively.

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 mentioned in the provided information. This means that, based on the available details, there are no particular restrictions or warnings about taking or using this medication. Always remember to consult with your healthcare provider if you have any questions or concerns about your treatment.

Side Effects

It's important to be aware of potential side effects when using this medication. You should consult your doctor if you have kidney disease or are on a magnesium-restricted diet, as these conditions may affect how you can safely use the product. Additionally, if you are taking any prescription medications, it's wise to check with your doctor or pharmacist, since antacids can interact with certain drugs.

If your symptoms persist for more than two weeks, you should stop using the medication and seek medical advice. If you are pregnant or breastfeeding, please consult a healthcare professional before using this product to ensure it is safe for you and your baby.

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 taking any prescription medications, check with your doctor or pharmacist first, as antacids can interact with certain drugs.

If your symptoms persist for more than two weeks, you should stop using the medication and contact your doctor. If you are pregnant or breastfeeding, please seek advice from a healthcare professional before using this product.

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 effects of an overdose for this medication, you should be aware of general signs that may indicate a problem. These can include unusual drowsiness, confusion, or difficulty breathing.

If you notice any of these symptoms or if you believe you have taken too much of the medication, seek medical help right away. Contact your healthcare provider or go to the nearest emergency room. It's always better to be safe and get checked out if you have concerns about an overdose.

Pregnancy Use

If you are pregnant or breastfeeding, it’s important to consult with a healthcare professional before using this medication. They can provide guidance on whether it’s safe for you and your baby. Always prioritize your health and the health of your child by seeking expert advice.

Lactation Use

If you are pregnant or breastfeeding, it’s important to consult with a healthcare professional before using any medication. This ensures that you understand any potential risks and can make informed decisions about your health and the health of your baby. Always prioritize open communication with your doctor regarding your breastfeeding journey.

Pediatric Use

If you are considering this medication for your child, it's important to know that children under 12 years old should consult a doctor before use. For those aged 12 and older, the recommended dosage is between 10 mL to 20 mL (1-2 doses) taken four times a day, or as directed by a healthcare professional.

Be cautious not to exceed 80 mL (8 doses) in a 24-hour period, and avoid using the maximum dosage for more than two weeks. Always follow your doctor's guidance to ensure safe and effective use.

Geriatric Use

If you are an older adult or caring for one, it's important to consult with a doctor before using this medication, especially if there is a history of kidney disease (a condition where the kidneys do not function properly). Additionally, if you or the person you are caring for is taking any prescription medications, it's wise to check with a doctor or pharmacist to avoid any potential interactions.

For adults and children aged 12 and older, the recommended dosage is between 10 mL to 20 mL (1-2 doses) taken four times a day, unless directed otherwise by a healthcare professional. Be careful not to exceed 80 mL (8 doses) in a 24-hour period, and avoid using the maximum dosage for more than two weeks. If the person is under 12 years old, please consult a doctor for appropriate guidance.

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 your kidney health and follow your doctor's guidance closely.

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 treatments, 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 room temperature. It's important to avoid freezing, as this can damage the device. Always keep the container tightly closed when not in use to maintain its integrity and safety. Following these simple guidelines will help you use the product effectively and safely.

Additional Information

You should take this medication orally. For adults and children aged 12 years and older, the recommended dose is 10 mL to 20 mL (1-2 doses) four times a day, or as directed by your doctor. It's important not to exceed 80 mL (8 doses) in a 24-hour period, and you should not use the maximum dosage for more than 2 weeks. If the patient is under 12 years old, consult a doctor for appropriate dosing.

FAQ

What symptoms does this drug relieve?

This drug relieves heartburn, sour stomach, acid indigestion, and symptoms referred to as gas.

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

Adults and children 12 years and older should take 10 mL to 20 mL (1-2 doses) four times a day or as directed by a doctor.

What is the maximum dosage you should not exceed?

Do not exceed 80 mL (8 doses) in a 24-hour period or use the maximum dosage for more than 2 weeks.

What should you do if symptoms last more than 2 weeks?

Stop use and ask a doctor if symptoms last more than 2 weeks.

Are there any warnings for people with specific health conditions?

Yes, ask a doctor before use if you have kidney disease or a magnesium-restricted diet.

Can this drug interact with other medications?

Yes, antacids may interact with certain prescription drugs, so consult a doctor or pharmacist before use.

What should you do if you are pregnant or breastfeeding?

If pregnant or breastfeeding, ask a health professional before use.

What should you do for children under 12 years?

For children under 12 years, ask a doctor before use.

How should this drug be stored?

Store at room temperature, avoid freezing, and keep tightly closed.

What should you do before using this drug?

Shake well before each use.

Packaging Info

Below are the non-prescription pack sizes of Regular Strength Antacid Mint (aluminum hydroxide, magnesium hydroxide, dimethicone). 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

The product is identified by the SPL code 34089-3. No specific description details are provided in the available information.

Uses and Indications

This drug is indicated for the relief of heartburn, sour stomach, acid indigestion, and symptoms associated with gas.

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

Dosage and Administration

Healthcare professionals should instruct patients to shake the medication well before each 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. It is important to note that the total daily dosage should not exceed 80 mL (equivalent to 8 doses) within a 24-hour period, and the maximum dosage should not be utilized for more than 2 weeks.

For children under 12 years of age, it is advised to consult a physician for appropriate dosing recommendations.

Contraindications

There are no contraindications listed for the use of this product. It is important to evaluate each patient's individual circumstances and medical history when considering treatment options.

Warnings and Precautions

Healthcare professionals should advise patients to consult a physician prior to use if they have a history of kidney disease or are on a magnesium-restricted diet. These conditions may affect the safety and efficacy of the treatment.

It is also essential for patients to seek guidance from a healthcare provider or pharmacist if they are currently taking any prescription medications, as antacids may interact with certain drugs, potentially leading to adverse effects.

Patients should be instructed to discontinue use and contact a healthcare professional if symptoms persist for more than two weeks. This precaution is critical to ensure that any underlying conditions are appropriately addressed.

For individuals who are pregnant or breastfeeding, it is imperative to consult a health professional before initiating use, as the safety of the product in these populations has not been fully established.

Side Effects

Patients should be aware of several important warnings associated with the use of this medication. It is advised to consult a doctor prior to use if there is a history of kidney disease or if the patient is on a magnesium-restricted diet. Additionally, patients taking prescription medications should seek guidance from a healthcare professional, as antacids may interact with certain drugs.

In the event that symptoms persist for more than two weeks, patients are instructed to discontinue use and consult a doctor. Pregnant or breastfeeding individuals should also seek advice from a health professional before using this product to ensure safety for both the mother and child.

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. Healthcare professionals should consider advising patients to space the administration of antacids and other medications to ensure optimal therapeutic outcomes.

Packaging & NDC

Below are the non-prescription pack sizes of Regular Strength Antacid Mint (aluminum hydroxide, magnesium hydroxide, dimethicone). 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 (1-2 doses) four times a day, or as directed by a healthcare provider. It is important to note that the maximum dosage should not exceed 80 mL (8 doses) within a 24-hour period, and the 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 a history of kidney disease, as this may influence the safety and efficacy of the treatment. Additionally, it is advisable for geriatric patients to seek guidance from a doctor or pharmacist if they are currently taking any prescription medications, to avoid potential drug interactions.

For adults and children aged 12 years and older, the recommended dosage is 10 mL to 20 mL (1-2 doses) administered four times a day, or as directed by a healthcare professional. It is critical for elderly patients to adhere to the maximum dosage limit of 80 mL (8 doses) within a 24-hour period and to refrain from using the maximum dosage for more than two weeks to mitigate the risk of adverse effects.

For children under 12 years of age, it is essential to consult a healthcare provider before administration. This precaution ensures that appropriate dosing and safety measures are considered for this population.

Pregnancy

Pregnant patients and those who are breastfeeding should consult a healthcare professional prior to using this medication. It is important to assess the potential risks and benefits, as well as any available data regarding fetal outcomes and lactation. Healthcare providers can offer guidance tailored to individual circumstances, ensuring the safety of both the patient and the developing fetus or nursing infant.

Lactation

Lactating mothers are advised to consult a health professional prior to using this medication. There is currently no available data on the excretion of this drug in human breast milk or its effects on breastfed infants. Therefore, caution is recommended when administering this medication to lactating individuals.

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 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 use of the compound in these contexts.

Postmarketing Experience

No postmarketing experience details are available in the insert.

Patient Counseling

Healthcare providers should advise patients to keep this medication out of reach of children to prevent accidental ingestion or misuse. It is important to emphasize the necessity of proper storage to ensure the safety of young individuals.

Storage and Handling

The product is supplied in a configuration that ensures optimal handling and storage. It should be stored at room temperature, with a specific emphasis on avoiding freezing conditions. To maintain the integrity of the product, it is essential to keep the container tightly closed at all times.

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 (1-2 doses) taken four times a day, or as directed by a healthcare professional. Patients should not exceed a total of 80 mL (8 doses) within a 24-hour period, nor should they use the maximum dosage for more than two weeks. For children under 12 years of age, it is advised to consult a doctor for appropriate dosing.

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.

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.