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Regular Strength Antacid

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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 2015
Label revision date
October 31, 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 2015
Label revision date
October 31, 2023
Manufacturer
CVS
Registration number
M001
NDC root
69842-286
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

This medication is designed to relieve discomfort associated with heartburn, sour stomach, acid indigestion, and gas. If you experience these symptoms, this drug can help provide you with relief, allowing you to feel more comfortable throughout your day.

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 it has no known teratogenic effects (which means it doesn't cause birth defects) or nonteratogenic effects. This makes it a safe option for many individuals seeking relief from these common digestive issues.

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 can take between 10 mL to 20 mL (which is 1 to 2 doses) as needed, either between meals or at bedtime, unless your doctor has given you different instructions.

It's important not to exceed 120 mL (or 12 doses) in a 24-hour period, and you should not use the maximum dosage for more than 2 weeks. If you have a child under 12 years old, please consult a doctor before giving them this medication.

What to Avoid

It's important to keep this medication out of reach of children to ensure their safety. There are no specific contraindications, controlled substance classifications, or concerns regarding abuse, misuse, or dependence associated with this medication. Always follow safety guidelines to use it responsibly.

Side Effects

It's important to be aware of potential side effects and interactions when using this medication. You should consult your doctor before using it if you have kidney disease or are on a magnesium-restricted diet. Additionally, if you are taking any prescription medications, it's wise to check with your doctor or pharmacist, as 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.

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 some drugs.

If your symptoms persist for more than two weeks, stop using the medication and contact your doctor. If you are pregnant or breastfeeding, seek advice from a healthcare professional before use. Always keep this medication out of reach of children to ensure their safety.

Overdose

If you suspect an overdose, it's important to stay calm and take immediate action. While the specific signs of an overdose are not detailed, common 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 crucial to provide them with as much information as possible about the substance taken and the amount, if known. Remember, acting quickly can make a significant difference in your health and safety.

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 can be taken as needed between meals or at bedtime, or as directed by a healthcare professional.

Be cautious not to exceed 120 mL (which is 12 doses) in a 24-hour period, and avoid using the maximum dosage for more than two weeks. Always prioritize safety and consult with a healthcare provider if you have any questions or concerns about your child's health.

Geriatric Use

When it comes to using this medication in older adults, there is no specific information available about dosage adjustments, safety concerns, or special precautions. This means that if you or a loved one is an older adult considering this medication, it’s important to consult with a healthcare provider. They can help determine the best approach based on individual health needs and any other medications being taken. Always prioritize open communication with your healthcare team 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 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 you understand how to manage your treatment effectively.

Drug Interactions

It's important to be aware that antacids can interact with some prescription medications. This means that if you are taking any prescription drugs, you should consult with your doctor or pharmacist before using antacids. They can help ensure that your medications work effectively and safely together. Always prioritize open communication about all the medications and supplements you are taking to avoid any potential issues.

Storage and Handling

To ensure the best performance of your product, store it at room temperature. It's important to protect it from freezing, as extreme cold can damage it. 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 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) between meals as needed, at bedtime, or as directed by a doctor.

What is the maximum dosage I should not exceed?

Do not exceed 120 mL (12 doses) in a 24-hour period or use the maximum dosage for more than 2 weeks.

What should I 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 I should be aware of?

Ask a doctor before use if you have kidney disease or a magnesium-restricted diet, and consult a doctor or pharmacist if you are taking a prescription drug.

Is this drug safe to use during pregnancy or breastfeeding?

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

What should I do if I have children under 12 years?

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

How should I store this drug?

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

What should I do before using this drug?

Shake well before use and keep out of reach of children.

Are there any contraindications for this drug?

No contraindications are listed for this drug.

Packaging Info

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

Packaging configurations for Regular Strength Antacid.
Details

Drug Information (PDF)

This file contains official product information for Regular Strength Antacid, 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 and consists of a combination of active and inactive ingredients. The active ingredients are not specified in the provided information. Similarly, the inactive ingredients are also unspecified. The product is formulated in a dosage form that is not detailed in the text. Additionally, the physical characteristics of the product are not described.

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. 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 between meals as needed, at bedtime, or as directed by a healthcare professional.

It is important not to exceed a total of 120 mL (12 doses) within a 24-hour period, and the maximum dosage should not be used for more than 2 consecutive weeks. For children under 12 years of age, it is advised to consult a healthcare professional for appropriate dosing recommendations.

Contraindications

Use of this product is contraindicated in individuals who are unable to keep it out of reach of children. This precaution is essential to prevent accidental ingestion or misuse by pediatric patients. No other contraindications have been identified.

Warnings and Precautions

Patients should consult a healthcare professional prior to use if they have a history of kidney disease or are on a magnesium-restricted diet. It is also advisable to seek guidance from a doctor or pharmacist if the patient is currently taking any prescription medications, as antacids may interact with certain drugs.

In the event that symptoms persist for more than two weeks, the patient should discontinue use and consult a healthcare provider for further evaluation. Additionally, pregnant or breastfeeding individuals are encouraged to seek advice from a health professional before using this product.

To ensure safety, this product should be kept out of reach of children.

Side Effects

Patients should be advised to consult a healthcare professional prior to use if they have kidney disease or are on a magnesium-restricted diet. Additionally, it is important for patients to seek guidance from a doctor or pharmacist if they are currently taking any prescription medications, 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 healthcare provider. Pregnant or breastfeeding individuals should also seek advice from a health professional before using this product.

Drug Interactions

Antacids may interact with certain prescription medications, potentially affecting their efficacy. It is advisable for patients to consult with a healthcare professional, such as a doctor or pharmacist, prior to using antacids if they are currently taking any prescription drugs. This precaution helps to ensure safe and effective use of both antacids and prescribed therapies, minimizing the risk of adverse interactions.

Packaging & NDC

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

Packaging configurations for Regular Strength Antacid.
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) between meals as needed, at bedtime, or as directed by a healthcare provider.

It is important to note that the maximum dosage should not exceed 120 mL (12 doses) within a 24-hour period, and the maximum dosage should not be used for more than 2 weeks.

Geriatric Use

Elderly patients may not have specific information regarding the use of this medication, including dosage adjustments, safety concerns, or special precautions. Therefore, healthcare providers should exercise caution when prescribing this medication to geriatric patients. It is advisable to monitor these patients closely for any adverse effects or changes in efficacy, given the lack of targeted data for 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 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 absence of specific information regarding overdosage, healthcare professionals are advised to exercise caution and adhere to general principles of management in cases of suspected overdose.

It is essential to monitor the patient closely for any potential symptoms that may arise from an overdose. Symptoms can vary widely depending on the substance involved and the individual patient's response.

In the event of an overdose, immediate medical attention should be sought. Healthcare providers should implement supportive care measures, which may include maintaining airway patency, providing supplemental oxygen, and monitoring vital signs.

Additionally, it is recommended to consult local poison control centers or relevant toxicology resources for guidance on specific management protocols and antidotes, if applicable.

Documentation of the incident, including the substance involved, estimated dose, and time of ingestion, is crucial for effective management and treatment planning.

Nonclinical Toxicology

There is currently no available information regarding teratogenic effects, non-teratogenic effects, or any specific findings in nonclinical toxicology studies. Additionally, no data has been provided concerning animal pharmacology and toxicology.

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 to emphasize the necessity of proper storage to ensure the safety of young individuals.

Storage and Handling

The product is supplied in configurations that include specific NDC numbers. It should be stored at room temperature, ensuring that it is protected from freezing conditions. Additionally, it is essential to keep the container tightly closed to maintain the integrity of the product.

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, 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, 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.