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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)
Marketed in the U.S.
Since 2021
Label revision date
November 7, 2023
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
Marketed in the U.S.
Since 2021
Label revision date
November 7, 2023
Manufacturer
KROGER COMPANY
Registration number
M001
NDC root
30142-639

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Drug Overview

You may be experiencing discomfort from heartburn, a sour stomach, acid indigestion, or gas. This medication is designed to help relieve these symptoms, providing you with comfort and relief. It works by addressing the excess stomach acid that can lead to these uncomfortable feelings, allowing you to feel more at ease. If you're looking for a solution to these common digestive issues, this medication could be a helpful option for you.

Uses

You can use this medication to help relieve several uncomfortable digestive issues. It effectively alleviates heartburn, which is that burning sensation in your chest, and it can also help with a sour stomach and acid indigestion, both of which can cause discomfort after eating. Additionally, if you're experiencing symptoms related to gas, this medication can provide relief from that as well.

Rest assured, there are no known 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 (which is about 1 to 2 doses) four times a day, unless your doctor advises otherwise. For children under 12 years, it’s important to consult a doctor for the appropriate dosage.

When measuring your dose, use the dosing cup that comes with the medication to ensure accuracy. Remember, 1 mL is equal to one milliliter, which is a standard unit of measurement for liquid medications. Following these instructions will help you use the medication safely and effectively.

What to Avoid

There are no specific contraindications, controlled substance classifications, or risks of abuse or misuse associated with this medication. Additionally, there are no concerns regarding dependence (a condition where the body becomes reliant on a substance).

Since there are no explicit "do not take" or "do not use" instructions, it is important to consult with your healthcare provider for personalized advice and to ensure this medication is appropriate for you. Always prioritize open communication with your doctor about any concerns or questions you may have regarding your treatment.

Side Effects

Taking this medication comes with some important considerations. You should not exceed 80 mL (8 doses) in a 24-hour period or use the maximum dosage for more than 2 weeks. 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, check with your doctor or pharmacist, as antacids can interact with certain drugs. If you are pregnant or breastfeeding, please seek advice from a healthcare professional before use.

Warnings and Precautions

It's important to use this medication safely. Do not exceed 80 mL (which is 8 doses) in a 24-hour period, and avoid using the maximum dosage for more than 2 weeks. If you have kidney disease or are on a magnesium-restricted diet, consult your doctor before using this product. Additionally, if you are currently taking any prescription medications, check with your doctor or pharmacist, as antacids can interact with some of these drugs.

If you are pregnant or breastfeeding, please speak with a healthcare professional before using this medication. Always seek emergency help if you experience severe side effects or an allergic reaction. If you notice any unusual symptoms or if your condition does not improve, stop using the medication and contact your doctor right away.

Overdose

Taking more than 80 mL (which is equivalent to 8 doses) in a 24-hour period, or using the maximum dosage for more than 2 weeks, can lead to an overdose. It's important to stick to the recommended dosage to avoid potential health risks.

If you suspect an overdose, look out for signs such as unusual drowsiness, confusion, or difficulty breathing. If you notice any of these symptoms, seek immediate medical help. Always prioritize your safety and consult a healthcare professional if you have any concerns about your medication use.

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 (which is 1 to 2 doses) taken four times a day, or as directed by a healthcare professional. Always follow your doctor's advice to ensure safe and effective use.

Geriatric Use

If you are an older adult or a caregiver, it's important to be cautious when considering this medication. Before using it, consult your doctor if you have kidney disease, as this condition can affect how your body processes the medication. Additionally, if you are currently taking any prescription drugs, it's wise to speak with your doctor or pharmacist first. Some antacids can interact with these medications, potentially leading to unwanted effects. Always prioritize safety and communication with your healthcare provider to ensure the best care.

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 should be used if you have hepatic impairment (liver issues).

Always consult your healthcare provider for personalized advice and to ensure that any medication you take is safe and appropriate for your liver health. They can help determine the best course of action based on your individual situation.

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 and protect it from freezing. It's important to keep the container tightly closed when not in use to maintain its integrity and effectiveness. Following these simple guidelines will help you handle the product safely and effectively.

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 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 to 2 doses) four times a day or as directed by a doctor.

What should I do if I am under 12 years old?

If you are under 12 years old, you should ask a doctor before use.

Are there any warnings I should be aware of?

Do not take more than 80 mL (8 doses) in a 24-hour period or use the maximum dosage for more than 2 weeks. Consult a doctor if you have kidney disease or are on a magnesium-restricted diet.

Can I use this drug if I am pregnant or breastfeeding?

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

How should I store this drug?

Store the drug at room temperature, protect it from freezing, and keep it tightly closed.

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

You should ask a doctor or pharmacist before use, as antacids may interact with certain prescription drugs.

Is there any information on teratogenic effects?

No teratogenic effects are mentioned for this drug.

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 additional specific description details are provided in the available data.

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

The medication should be shaken well before use to ensure proper mixing of the formulation.

For adults and children aged 12 years and older, the recommended dosage is 10 mL to 20 mL, which may be taken as 1 to 2 doses, 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 recommendations.

Dosing should be measured using the dosing cup provided to ensure accuracy.

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 not exceed a maximum dosage of 80 mL (equivalent to 8 doses) within a 24-hour period, nor should they utilize the maximum dosage for a duration exceeding 2 weeks. Adherence to these guidelines is essential to prevent potential adverse effects associated with overuse.

Prior to initiating treatment, individuals with kidney disease or those adhering to a magnesium-restricted diet are advised to consult a healthcare professional. This precaution is critical to ensure the safe use of the medication in these populations.

Additionally, it is recommended that patients seek guidance from a doctor or pharmacist if they are currently taking any prescription medications. Antacids may interact with certain prescription drugs, which could lead to diminished efficacy or increased risk of side effects.

For pregnant or breastfeeding individuals, consultation with a healthcare professional is imperative before use. This step is necessary to evaluate the potential risks and benefits associated with the medication during these sensitive periods.

Side Effects

Patients should be aware of the following warnings and precautions associated with the use of this medication. It is advised not to exceed a dosage of 80 mL (8 doses) within a 24-hour period, nor should the maximum dosage be used for more than 2 weeks.

Individuals with kidney disease or those on a magnesium-restricted diet should consult a healthcare professional prior to use. Additionally, patients currently taking prescription medications should seek advice from a doctor or pharmacist, as antacids may interact with certain drugs.

For pregnant or breastfeeding individuals, it is recommended to consult a health professional before using this product to ensure safety for both the mother and the child.

Drug Interactions

Antacids may interact with various prescription medications, potentially affecting their absorption and efficacy. It is advisable to separate the administration of antacids and other medications by at least two hours to minimize the risk of interaction. Monitoring for therapeutic effectiveness of the affected drugs is recommended when antacids are used concurrently.

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 to 2 doses) four times a day, or as directed by a healthcare provider.

Geriatric Use

Elderly patients should consult a healthcare provider prior to using this medication, particularly if they have a history of kidney disease. The renal function may be compromised in geriatric patients, which could necessitate careful monitoring and potential dosage adjustments.

Additionally, it is advisable for elderly patients to seek guidance from a doctor or pharmacist before initiating this medication if they are currently taking any prescription drugs. There is a possibility of interactions between antacids and certain prescription medications, which could affect the safety and efficacy of treatment. Therefore, thorough medication reconciliation and monitoring are recommended to mitigate any risks associated with polypharmacy in this population.

Pregnancy

Pregnant patients and those who are breastfeeding should consult a healthcare professional prior to using this medication. The potential risks and benefits must be carefully weighed, as the effects on fetal outcomes and lactation are not fully established. It is essential for women of childbearing potential to seek medical advice to ensure safe use during pregnancy and lactation.

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 event of overdosage, it is critical to adhere to the recommended dosage guidelines to prevent adverse effects. The maximum allowable dosage is 80 mL, which equates to 8 doses within a 24-hour period. Exceeding this limit or utilizing the maximum dosage for a duration exceeding 2 weeks may lead to potential complications.

Healthcare professionals should be vigilant for symptoms that may arise from overdosage, although specific symptoms were not detailed in the provided information. It is advisable to monitor patients closely for any signs of adverse reactions.

In cases of suspected overdosage, immediate medical attention should be sought. Management procedures may include supportive care and symptomatic treatment as necessary. It is essential to provide the patient with appropriate medical evaluation and intervention based on their clinical presentation.

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 in these areas limits the understanding of the compound's potential effects in nonclinical settings.

Postmarketing Experience

No postmarketing experience details have been reported in the available data.

Patient Counseling

Healthcare providers should advise patients to keep the 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 children.

Storage and Handling

The product is supplied in a configuration that ensures optimal handling and storage. It must be stored at room temperature, away from extreme temperatures, and protected from freezing. To maintain the integrity of the product, it is essential to keep the container tightly closed when not in use.

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 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

Last AI update:

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.