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Aluminum hydroxide/Magnesium hydroxide/Dimethicone, unspecified

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Active ingredients
  • Dimethicone, Unspecified 20 mg/5 mL
  • Aluminum Hydroxide 200 mg/5 mL
  • Magnesium Hydroxide 200 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 2025
Label revision date
May 30, 2025
Drug Information (PDF)
Prescribing information, PDF file
Active ingredients
  • Dimethicone, Unspecified 20 mg/5 mL
  • Aluminum Hydroxide 200 mg/5 mL
  • Magnesium Hydroxide 200 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 2025
Label revision date
May 30, 2025
Manufacturer
American Health Packaging
Registration number
M001
NDC root
60687-877
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

Magnesium Hydroxide, Aluminum Hydroxide, and Simethicone Suspension is an antacid and antigas medication designed to provide relief from various digestive discomforts. It helps alleviate symptoms such as acid indigestion, heartburn, sour stomach, and upset stomach. Additionally, it addresses pressure and bloating commonly associated with gas.

This combination of ingredients works together to neutralize stomach acid and reduce gas buildup, making it a helpful option for those experiencing these common gastrointestinal issues. If you're looking for a solution to ease your digestive discomfort, this suspension may be a suitable choice.

Uses

If you're experiencing discomfort from acid indigestion, heartburn, or a sour stomach, this medication can help provide relief. It’s also effective for upset stomachs caused by these symptoms, as well as for pressure and bloating often associated with gas.

You can use this medication to ease these common digestive issues and improve your overall comfort.

Dosage and Administration

Before using 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 one unit dose cup (30 mL) between meals and at bedtime, or follow your doctor's instructions. It's important not to exceed 4 unit dose cups (120 mL) in a 24-hour period, and you should not use the maximum dosage for more than 2 weeks.

If you are caring for a child under 12 years old, please consult a physician for appropriate guidance on dosage. Always follow these instructions carefully to ensure safe and effective use of the medication.

What to Avoid

It's important to be aware of certain guidelines when using this medication. While there are no specific contraindications or concerns about abuse, misuse, or dependence, you should stop using the medication and consult your doctor if your symptoms persist for more than two weeks. This ensures that you receive the appropriate care and support for your health needs. Always prioritize your well-being and seek professional advice when necessary.

Side Effects

It's important to be aware of potential side effects when using this medication. You should not exceed 4 unit dose cups (120 mL) in a 24-hour period or use the maximum dosage for more than 2 weeks without consulting your doctor. If you have kidney disease or are on a magnesium-restricted diet, it's advisable to speak with your doctor before using this product.

If your symptoms persist for more than 2 weeks, you should stop using the medication and consult a doctor. Additionally, if you are currently taking any prescription medications, check with your doctor or pharmacist, as antacids can interact with certain drugs.

Warnings and Precautions

It's important to use this medication safely. Do not take more than 4 unit dose cups (120 mL) in a 24-hour period, and avoid using the maximum dosage for more than 2 weeks unless your doctor advises you to do so.

Before using this medication, consult your doctor if you have kidney disease or are on a magnesium-restricted diet. Additionally, if you are currently taking any prescription medications, check with your doctor or pharmacist, as antacids can interact with certain drugs.

If your symptoms persist for more than 2 weeks, stop using the medication and contact your doctor for further guidance.

Overdose

Taking more than 4 unit dose cups (120 mL) in a 24-hour period or using the maximum dosage for more than 2 weeks without a doctor's guidance can lead to an overdose. Signs of an overdose may include unusual symptoms that you should be aware of. If you suspect an overdose, it’s important to seek immediate medical help.

If you find yourself in this situation, contact your healthcare provider or go to the nearest emergency room right away. Always remember to follow the recommended dosage guidelines to ensure your safety and well-being.

Pregnancy Use

You can feel reassured that there are no specific warnings or precautions regarding the use of Aluminum Hydroxide, Magnesium Hydroxide, and Simethicone during pregnancy. The information available does not indicate that these medications are contraindicated (not recommended) for pregnant individuals, nor does it mention any risks to the fetus. Additionally, there are no dosage modifications or special precautions outlined for those who are pregnant.

As always, it's a good idea to consult with your healthcare provider before taking any medication during pregnancy to ensure it’s safe for you and your baby.

Lactation Use

If you are breastfeeding, you can feel reassured that there are no specific warnings or recommendations regarding the use of this medication while nursing. Currently, there is no information available about whether this medication passes into breast milk or if it poses any risk to your infant.

As always, it's a good idea to discuss any medications you are considering with your healthcare provider to ensure they are safe for you and your baby.

Pediatric Use

If you have a child under 12 years old, it's important to consult a physician (doctor) before using this medication. For adults and children aged 12 years and older, the recommended dosage is 30 mL, which is one unit dose cup, taken between meals and at bedtime, or as directed by your doctor. Always follow your healthcare provider's instructions 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 are any concerns about kidney disease or if you are following a magnesium-restricted diet. These conditions can affect how the medication works in your body.

For adults and children aged 12 and older, the recommended dosage is 30 mL (one unit dose cup) taken between meals and at bedtime, or as directed by a healthcare professional. If the user is under 12 years old, please consult a physician for appropriate guidance. Always prioritize safety and seek medical advice tailored to individual health needs.

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. Additionally, if you are currently taking any prescription medications, including antacids, be sure to discuss this with your doctor or pharmacist, as these can interact with your other medications. Taking these precautions can help ensure your safety and the effectiveness of your treatment.

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 apply, but you should always consult your healthcare provider for personalized advice. They can help determine the best approach for your treatment and monitor your liver function as needed.

Make sure to keep your doctor informed about your liver health, as they may want to conduct regular tests to ensure your safety while using any medication. Your well-being is a priority, so don't hesitate to ask questions or express any concerns you may have.

Drug Interactions

It's important to talk to your doctor or pharmacist before using this medication, especially if you are currently taking any prescription drugs. Some medications, like antacids, can interact with your prescription medications, potentially affecting how well they work or increasing the risk of side effects.

Always keep your healthcare provider informed about all the medications you are taking to ensure your treatment is safe and effective. This way, you can avoid any unexpected interactions and get the best possible care.

Storage and Handling

To ensure the best performance of your product, store it at a temperature between 20° and 25°C (68° to 77°F), which is considered a controlled room temperature. It's important to keep the product away from freezing temperatures, as this can damage it.

When handling the product, always do so with care to maintain its integrity and effectiveness. Following these storage and handling guidelines will help ensure your product remains safe and effective for use.

Additional Information

You should take this medication orally. For adults and children aged 12 years and older, the recommended dose is 30 mL (one unit dose cup) taken between meals and at bedtime, or as directed by your doctor. If the patient is under 12 years old, it's important to consult a physician for appropriate guidance.

FAQ

What is Magnesium Hydroxide, Aluminum Hydroxide, and Simethicone Suspension used for?

It is an antacid/antigas used for the relief of acid indigestion, heartburn, sour stomach, upset stomach, and gas-related pressure and bloating.

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

The usual dosage is 30 mL (one unit dose cup) taken between meals and at bedtime, or as directed by a doctor.

Are there any specific warnings for using this medication?

Do not take more than 4 unit dose cups (120 mL) in a 24-hour period or use the maximum dosage for more than 2 weeks without a doctor's advice.

What should I do if my symptoms last more than 2 weeks?

You should stop using the medication and consult a doctor if symptoms persist for more than 2 weeks.

Is this medication safe to use during pregnancy?

The insert does not specify any contraindications or risks associated with using this medication during pregnancy.

Can I use this medication if I have kidney disease?

You should ask a doctor before use if you have kidney disease or are on a magnesium-restricted diet.

How should I store this medication?

Store it at 20° to 25°C (68° to 77°F) and protect it from freezing.

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

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

What is the dosage for children under 12 years?

Consult a physician before using this medication for children under 12 years.

What should I do before using this medication?

Shake well before using and follow the instructions provided.

Packaging Info

Below are the non-prescription pack sizes of Aluminum Hydroxide, Magnesium Hydroxide, and Simethicone. Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Aluminum Hydroxide, Magnesium Hydroxide, and Simethicone.
Details

Drug Information (PDF)

This file contains official product information for Aluminum Hydroxide, Magnesium Hydroxide, and Simethicone, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)

Description

Magnesium Hydroxide, Aluminum Hydroxide, and Simethicone Suspension is an antacid and antigas formulation. Each 30 mL dose contains 1200 mg of Magnesium Hydroxide, 1200 mg of Aluminum Hydroxide, and 120 mg of Simethicone. This product is sugar-free and requires shaking before use. It should be stored at a temperature range of 20° to 25°C (68° to 77°F) in accordance with USP Controlled Room Temperature guidelines and must be protected from freezing.

Uses and Indications

This drug is indicated for the relief of acid indigestion, heartburn, sour stomach, and upset stomach associated with these symptoms. It is also indicated for the alleviation of pressure and bloating commonly referred to as gas.

There are no teratogenic effects associated with this drug. Additionally, no nonteratogenic effects have been reported.

Dosage and Administration

The medication should be shaken well before use. For adults and children aged 12 years and older, the recommended dosage is 30 mL (one unit dose cup) taken between meals and at bedtime, or as directed by a healthcare professional. It is important not to exceed 4 unit dose cups (120 mL) 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, consultation with a physician is advised prior to administration.

Contraindications

There are no specified contraindications for this product. However, it is advised to discontinue use and consult a healthcare professional if symptoms persist for more than two weeks.

Warnings and Precautions

Patients should not exceed a maximum of 4 unit dose cups (120 mL) within a 24-hour period. Additionally, the maximum dosage should not be utilized for more than 2 weeks unless directed and monitored by a physician.

Healthcare professionals are advised to exercise caution and recommend that patients consult a physician prior to use if they have a history of kidney disease or are on a magnesium-restricted diet. Furthermore, it is essential to advise patients to seek guidance from a doctor 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 their healthcare provider if symptoms persist for more than 2 weeks. This precaution is critical to ensure appropriate management of any underlying conditions that may require further evaluation.

Side Effects

Patients should be aware of the following warnings and recommendations regarding the use of this medication. It is advised not to exceed 4 unit dose cups (120 mL) within a 24-hour period or to use the maximum dosage for more than 2 weeks unless under the guidance and supervision of a physician.

Before using this medication, patients with kidney disease or those on a magnesium-restricted diet should consult a doctor. Additionally, individuals currently taking prescription medications should seek advice from a healthcare professional or pharmacist, as antacids may interact with certain prescription drugs.

Patients are also advised to discontinue use and consult a doctor if symptoms persist for more than 2 weeks. These precautions are essential to ensure safe and effective use of the medication.

Drug Interactions

Patients are advised to consult a healthcare professional, such as a doctor or pharmacist, prior to using this medication if they are currently taking any prescription drugs.

Antacids may have the potential to interact with various prescription medications, which could alter their effectiveness or lead to unintended side effects. It is essential for patients to disclose all medications they are taking to ensure safe and effective use of antacids alongside their prescribed treatments. Monitoring for any adverse effects or changes in therapeutic outcomes is recommended when these interactions are possible.

Packaging & NDC

Below are the non-prescription pack sizes of Aluminum Hydroxide, Magnesium Hydroxide, and Simethicone. Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Aluminum Hydroxide, Magnesium Hydroxide, and Simethicone.
Details

Pediatric Use

Pediatric patients under 12 years of age should consult a physician before use. For adolescents and children aged 12 years and older, the recommended dosage is 30 mL, administered using one unit dose cup, between meals and at bedtime, or as directed by a healthcare professional.

Geriatric Use

Elderly patients should consult a healthcare provider prior to use if they have a history of kidney disease or if they are on a magnesium-restricted diet.

For adults and children aged 12 years and older, the recommended dosage is 30 mL (one unit dose cup) to be taken between meals and at bedtime, or as directed by a physician. It is important for geriatric patients to adhere to this dosage unless otherwise instructed by their healthcare provider.

For children under 12 years of age, it is advised to consult a physician before administration. Careful monitoring and consideration of individual health status are essential when prescribing this medication to elderly patients.

Pregnancy

The available data regarding the use of Aluminum Hydroxide, Magnesium Hydroxide, and Simethicone during pregnancy do not indicate specific warnings or precautions. The prescribing information does not state whether the drug is contraindicated in pregnant patients or if there are any associated risks to the fetus. Additionally, there are no recommendations for dosage modifications or special precautions for individuals who are pregnant. Healthcare professionals should consider the lack of specific data when advising pregnant patients and weigh the potential benefits against any unknown risks.

Lactation

There are no specific warnings or recommendations regarding the use of this medication in nursing mothers. Additionally, there is no information available about the potential for excretion in breast milk or any associated risks to breastfed infants.

Renal Impairment

Patients with renal impairment should consult a healthcare professional prior to use, particularly if they have kidney disease. It is also advisable 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. Monitoring and appropriate dosing adjustments may be necessary based on individual renal function.

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 intake is four unit dose cups (120 mL) within a 24-hour period. Exceeding this limit or utilizing the maximum dosage for more than two weeks should only occur under the guidance and supervision of a qualified physician.

Healthcare professionals should be vigilant for potential symptoms associated with overdosage, which may vary depending on the specific circumstances and individual patient factors. Immediate assessment and monitoring of the patient are essential to identify any adverse reactions.

Management of overdosage should involve supportive care and symptomatic treatment as necessary. It is advisable to consult a poison control center or a medical toxicologist for further guidance on the appropriate management strategies tailored to the specific situation.

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 specific postmarketing experience details are available. As such, there are no additional adverse events or rare case reports to summarize at this time.

Patient Counseling

Healthcare providers should advise patients to keep the medication out of reach of children to prevent accidental ingestion. Patients should be instructed to stop using the medication and consult a doctor if their symptoms persist for more than two weeks, as this may indicate a need for further evaluation.

It is important for healthcare providers to encourage patients to seek medical advice before using the medication if they have a history of kidney disease or are on a magnesium-restricted diet. Additionally, patients should be informed to consult with their doctor or pharmacist prior to use if they are currently taking any prescription medications, as antacids may interact with certain drugs. This precaution helps ensure safe and effective use of the medication.

Storage and Handling

The product is supplied in accordance with the National Drug Code (NDC) specifications. It should be stored at a temperature range of 20° to 25°C (68° to 77°F), adhering to the guidelines set forth by the United States Pharmacopeia (USP) for Controlled Room Temperature. It is essential to protect the product from freezing to maintain its integrity and efficacy. Proper handling and storage conditions must be observed to ensure optimal product performance.

Additional Clinical Information

The medication is administered orally. For adults and children aged 12 years and older, the recommended dosage is 30 mL, taken using one unit dose cup, between meals and at bedtime, or as directed by a healthcare professional. For children under 12 years of age, it is advised to consult a physician for appropriate dosing guidance.

There is no additional information available regarding laboratory tests, abuse potential, patient counseling, or postmarketing experiences.

Drug Information (PDF)

This file contains official product information for Aluminum Hydroxide, Magnesium Hydroxide, and Simethicone, 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 Aluminum Hydroxide, Magnesium Hydroxide, and Simethicone, 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.

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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.