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Maximum Strength Antacid

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Active ingredients
  • Dimethicone 40 mg/5 mL
  • Aluminum Hydroxide 400 mg/5 mL
  • Magnesium Hydroxide 400 mg/5 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 2014
Label revision date
November 6, 2023
Drug Information (PDF)
Prescribing information, PDF file
Active ingredients
  • Dimethicone 40 mg/5 mL
  • Aluminum Hydroxide 400 mg/5 mL
  • Magnesium Hydroxide 400 mg/5 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 2014
Label revision date
November 6, 2023
Manufacturer
Chain Drug Marketing Association
Registration number
M001
NDC root
63868-715
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 this medication helpful if you experience discomfort from heartburn, sour stomach, acid indigestion, or an upset stomach related to these symptoms. It is designed to relieve these common digestive issues, including the discomfort associated with gas. By addressing these symptoms, the medication aims to provide you with relief and improve your overall comfort.

Uses

If you're experiencing discomfort from heartburn, sour stomach, or acid indigestion, this medication can help relieve those symptoms. It also addresses upset stomach caused by these issues and can alleviate the discomfort associated with gas.

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.

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 2 to 4 teaspoonfuls of the medication between meals or at bedtime, unless your doctor has given you different instructions. It's important not to exceed 12 teaspoonfuls in a 24-hour period, and you should not use the maximum dosage for more than 2 weeks.

If the patient is a child under 12 years old, you should consult a doctor before giving them this medication. Always follow the guidance provided by your healthcare professional to ensure safe and effective use.

What to Avoid

It's important to keep this medication, as well as all other drugs, out of the reach of children to ensure their safety. While there are no specific contraindications or concerns about abuse, misuse, or dependence mentioned, always use medications responsibly and as directed. If you have any questions or concerns about your medication, don't hesitate to reach out to your healthcare provider for guidance.

Side Effects

Before using this medication, it's important to consult with 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, as antacids can interact with some of these 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.

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, as antacids can interact with certain drugs. If your symptoms persist for more than two weeks, stop using the medication and contact your doctor.

Always keep this and all medications out of the reach of children. If you are pregnant or breastfeeding, 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 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 2 to 4 teaspoonfuls taken between meals or at bedtime, unless directed otherwise by a healthcare professional.

Be cautious not to exceed 12 teaspoonfuls in a 24-hour period, and avoid using the maximum dosage for more than two weeks. Always prioritize your child's safety by following these guidelines and seeking medical advice when necessary.

Geriatric Use

If you are an older adult or caring for one, it's important to be cautious when using this medication. Before starting, consult with your doctor, especially if you have kidney disease (a condition where your kidneys do not function properly) or if you are taking any other prescription medications.

For adults and children aged 12 and older, the recommended dosage is 2 to 4 teaspoonfuls between meals or at bedtime, unless your doctor advises otherwise. However, do not exceed 12 teaspoonfuls in a 24-hour period, and avoid using the maximum dosage for more than two weeks. If the person you are caring for is under 12 years old, please consult a doctor before use.

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 there are no specific guidelines or dosage adjustments mentioned for your condition in the available information. This means that the standard recommendations for the medication do not change based on liver impairment. However, it’s always a good idea to discuss your liver health with your healthcare provider, as they can offer personalized advice and monitor your condition effectively.

Make sure to keep your doctor informed about any liver issues you may have, as they can help ensure that your treatment is safe and appropriate 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 your other medications could affect how well those medications work.

To ensure your treatment is safe and effective, always discuss any medications, 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 avoid exposing it to freezing temperatures. This helps maintain its effectiveness and safety. After each use, make sure to close the cap tightly to prevent contamination and preserve the integrity of the contents.

By following these simple storage and handling guidelines, you can help ensure that your product remains safe and effective for your needs.

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, upset stomach due to these symptoms, and gas.

What should I do before using this drug?

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.

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

You should take 2 to 4 teaspoonfuls between meals, at bedtime, or as directed by a doctor, but do not exceed 12 teaspoonfuls in 24 hours 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 your symptoms last more than 2 weeks.

Can children under 12 years use this drug?

Children under 12 years should ask a doctor before use.

What precautions should I take if I am pregnant or breastfeeding?

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

How should I store this drug?

Store at room temperature and avoid freezing. Make sure to close the cap tightly after use.

What should I do if I accidentally take too much?

Do not take more than the recommended dosage, and if you suspect an overdose, seek medical advice.

Is there any specific instruction for use?

Shake well before use.

What should I keep in mind regarding children and this drug?

Keep this and all drugs out of the reach of children.

Packaging Info

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

Packaging configurations for Maximum Strength Antacid.
Details

Drug Information (PDF)

This file contains official product information for Maximum Strength Antacid, 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 upset stomach associated with these symptoms. Additionally, it provides relief from symptoms commonly referred to as 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 2 to 4 teaspoonfuls taken between meals, at bedtime, or as directed by a healthcare professional. It is important not to exceed a maximum of 12 teaspoonfuls within a 24-hour period, and the maximum dosage should not be used for more than 2 weeks.

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

Contraindications

There are no specific contraindications listed for this product. However, it is essential to keep this and all medications out of the reach of children to prevent accidental ingestion or misuse.

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

Patients should be instructed to discontinue use and contact a healthcare professional if their symptoms persist for more than two weeks. Additionally, it is crucial for pregnant or breastfeeding individuals to consult a health professional before using this product.

To ensure safety, all medications should be stored out of the reach of children to prevent accidental ingestion.

Side Effects

Patients should be aware of certain warnings associated with the use of this medication. It is advised to consult a doctor before use if there is a history of kidney disease or if the patient is on a magnesium-restricted diet. Additionally, patients should seek guidance from a doctor or pharmacist if they are currently taking any prescription medications, as antacids may interact with specific drugs.

In the event that symptoms persist for more than two weeks, patients are instructed to discontinue use and consult a doctor. Furthermore, pregnant or breastfeeding individuals should seek advice from a health professional prior to using this medication.

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 Maximum Strength Antacid (aluminum hydroxide, magnesium hydroxide, dimethicone). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Maximum Strength Antacid.
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 2 to 4 teaspoonfuls taken between meals, at bedtime, or as directed by a healthcare provider.

It is important to note that no more than 12 teaspoonfuls should be taken 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. Additionally, it is advisable for geriatric patients to seek guidance from a doctor or pharmacist if they are currently taking any prescription medications, as potential interactions may occur.

For adults and children aged 12 years and older, the recommended dosage is 2 to 4 teaspoonfuls taken between meals, at bedtime, or as directed by a healthcare professional. It is crucial for elderly patients to adhere to the maximum dosage limit of 12 teaspoonfuls within a 24-hour period and to avoid using the maximum dosage for more than 2 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 is particularly important in the geriatric population, where careful monitoring and dose adjustments may be necessary to ensure safety and efficacy.

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 regarding the excretion of this medication 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 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 standard 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 exposure, is crucial for effective management and follow-up care.

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 and all other drugs out of the reach of children. It is essential to emphasize the importance of proper storage to prevent accidental ingestion or misuse. Patients should be informed about the potential risks associated with improper access to medications by children and encouraged to take necessary precautions to ensure safety in their home environment.

Storage and Handling

The product is supplied in various package configurations, with specific NDC numbers available for identification. It is essential to store the product at room temperature, ensuring that it is kept away from freezing conditions. After each use, the cap must be closed tightly to maintain the integrity of the product. Proper handling and storage are crucial to ensure the product remains effective and safe for 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 Maximum 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 Maximum 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.