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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 2015
Label revision date
December 5, 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 2015
Label revision date
December 5, 2024
Manufacturer
CVS
Registration number
M001
NDC root
69842-355
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

You may find this medication helpful if you experience discomfort from heartburn, sour stomach, acid indigestion, or gas. It is designed to relieve these common digestive issues, providing you with some much-needed comfort. If you're looking for a solution to these symptoms, this medication could be a suitable option for you.

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

If you are an adult or a child aged 12 years and older, you should take between 10 mL and 20 mL of the medication, which is equivalent to 1 to 2 doses. This should be done two times a day, or as your doctor advises.

For children under 12 years of age, it’s important to consult with 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 concerns regarding abuse, misuse, or dependence associated with this medication. Additionally, there are no explicit instructions indicating that you should not take or use this medication. Always consult with your healthcare provider for personalized advice and to ensure this medication is appropriate for you.

Side Effects

Taking this medication comes with some important considerations regarding side effects and interactions. You should not exceed 80 mL (or 8 doses) in a 24-hour period, and it's advised not to use 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 medication. Additionally, if you are currently taking any prescription drugs, it's essential to check with your doctor or pharmacist, as antacids can interact with certain medications. 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 take more than 80 mL (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 drugs.

If you are pregnant or breastfeeding, please speak with a healthcare professional before using this medication. Always keep it out of reach of children to ensure their safety. If you experience any severe reactions or have concerns, seek emergency help immediately or stop use and contact your doctor.

Overdose

Taking more than 80 mL (which is equivalent to 8 doses) of this medication within a 24-hour period, or using the maximum dosage for longer than 2 weeks, can lead to an overdose. Signs of an overdose may include unusual symptoms that could affect your health, so it's important to be aware of how much you are taking.

If you suspect an overdose, you should seek immediate medical help. It's always better to be safe and consult a healthcare professional if you have any concerns about your dosage or experience any unusual symptoms. Remember, following the recommended dosage is crucial for your safety and well-being.

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 have a child under 12 years old, it's important to consult with a doctor before using this medication. For children aged 12 and older, the recommended dosage is between 10 mL to 20 mL, which can be taken two 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 consult with a doctor before using this medication, especially if you have kidney disease. Kidney disease can affect how your body processes medications, so your doctor may need to adjust your dosage or monitor you more closely.

Additionally, if you are currently taking any prescription medications, including antacids, be sure to talk to your doctor or pharmacist. Some antacids can interact with prescription drugs, which may affect their effectiveness or cause unwanted side effects. Always prioritize open communication with your healthcare providers to ensure safe and effective treatment.

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 may affect you differently due to your liver health.

Always consult your healthcare provider for personalized advice and to discuss any concerns you may have regarding your liver function and how it relates to your treatment. They can help ensure that your medication is safe and effective for you.

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 room temperature in a tightly closed container. It's important to keep it away from freezing temperatures, as freezing can damage the product and affect its effectiveness.

When handling the product, always make sure to keep the container closed when not in use to maintain its integrity. Following these simple storage and handling guidelines will help you use the product safely and effectively.

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 to 2 doses) two times a day, or as directed by your doctor. If the patient is under 12 years of age, it’s important to consult a doctor for the appropriate dosage.

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 of age and older should take 10 mL to 20 mL (1 to 2 doses) two times a day or as directed by a doctor.

What should children under 12 years of age do before using this drug?

Children under 12 years of age should ask a doctor before use.

Are there any warnings associated with this drug?

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 this drug interact with other medications?

Yes, antacids may interact with certain prescription drugs, so ask a doctor or pharmacist before use if you are currently taking any.

What should I do if I am pregnant or breastfeeding?

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

How should this drug be stored?

Store at room temperature tightly closed and do not freeze.

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

No relevant information is available for SPL code 34089-3.

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

Adults and children 12 years of age and older are advised to take 10 mL to 20 mL, which corresponds to 1 to 2 doses, two times a day or as directed by a healthcare professional. For children under 12 years of age, it is recommended to consult a doctor for appropriate dosing guidance.

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 before prescribing.

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 imperative for patients to 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 recommended before use to assess potential risks to the mother and child.

Finally, to ensure safety, this medication should be stored out of reach of children to prevent accidental ingestion.

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, and the maximum dosage should not 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 patient and the 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. Specifically, antacids should be taken at least 2 hours apart from other drugs to ensure optimal therapeutic effects. 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 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 and children aged 12 years and older, the recommended dosage is 10 mL to 20 mL (1 to 2 doses) taken twice daily 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 this population, necessitating careful consideration of potential dosage adjustments and monitoring.

Additionally, it is advisable for geriatric patients to seek guidance from a doctor or pharmacist if they are currently taking any prescription medications. This is important as antacids may interact with certain prescription drugs, which could lead to adverse effects or diminished therapeutic efficacy. Close monitoring and appropriate adjustments may be required to ensure the safety and effectiveness of treatment in elderly patients.

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 the safety of both the mother and the developing fetus or nursing infant.

Lactation

Lactating mothers are advised to consult a health professional prior to using this medication. There is no specific data available regarding the excretion of this medication in 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 may lead to potential toxicity and associated complications.

Healthcare professionals should be vigilant in monitoring patients who may have exceeded the recommended dosage. Symptoms of overdosage can vary and may include, but are not limited to, gastrointestinal disturbances, neurological effects, or other systemic reactions.

Management of overdosage should involve immediate assessment of the patient's condition. If an overdosage is suspected, it is advisable to initiate supportive care and symptomatic treatment as necessary. Continuous monitoring of vital signs and clinical status is essential. In cases where the maximum dosage has been utilized for more than 2 weeks, healthcare providers should evaluate the patient for any signs of chronic toxicity and consider appropriate interventions.

Prompt recognition and management of overdosage are crucial to mitigate potential risks and ensure patient safety.

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 this medication out of reach of children to prevent accidental ingestion or misuse. It is important for patients to understand the potential risks associated with improper access to the medication by young individuals. Providers should emphasize the necessity of storing the medication in a secure location, away from children's sight and reach, to ensure safety.

Storage and Handling

The product is supplied in a tightly closed container and should be stored at room temperature. It is essential to ensure that the product is not exposed to freezing temperatures, as this may compromise its integrity. Proper handling and storage conditions are crucial 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 (1 to 2 doses) 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 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.