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Aluminum hydroxide/Magnesium hydroxide/Dimethicone, unspecified

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Active ingredients
  • Dimethicone, Unspecified 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 2025
Label revision date
July 15, 2025
Drug Information (PDF)
Prescribing information, PDF file
Active ingredients
  • Dimethicone, Unspecified 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 2025
Label revision date
July 15, 2025
Manufacturer
American Health Packaging
Registration number
M002
NDC root
60687-888
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 relief from these symptoms, this suspension may be a suitable choice for you.

Uses

You can use this medication to help relieve several uncomfortable digestive issues. It is effective for easing acid indigestion, heartburn, and a sour stomach. If you're experiencing an upset stomach due to these symptoms, this medication can provide relief. Additionally, it helps with the pressure and bloating that often come with gas.

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 concerned about such risks.

Dosage and Administration

Before you use this medication, make sure to shake the bottle well. For adults and children aged 12 years and older, the recommended dose is 30 mL (which is one unit dose cup) taken one to two times a day, unless your doctor advises otherwise. However, it's important not to exceed 2 unit dose cups (60 mL) in a 24-hour period, and you should not use the maximum dosage for more than two weeks.

If the patient is a child under 12 years old, it's essential to consult a physician (doctor) for the appropriate dosage. Always follow these guidelines 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 listed, you should stop using the medication and consult your doctor if your symptoms persist for more than two weeks. This is crucial to ensure your safety and to determine if further medical evaluation is needed.

Always use medications as directed and be mindful of any changes in your health. If you have any concerns about your treatment or experience unexpected effects, reach out to your healthcare provider for guidance.

Side Effects

It's important to be aware of potential side effects when using this medication. You should not take more than 2 unit dose cups (60 mL) in a 24-hour period or use the maximum dosage for more than 2 weeks unless directed by your doctor. If you have kidney disease or are on a magnesium-restricted diet, consult your doctor before use. 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 seek medical advice. Always keep this product out of reach of children to ensure their safety.

Warnings and Precautions

It's important to use this medication safely. Do not take more than 2 unit dose cups (60 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, check with your doctor or pharmacist if you are currently taking any prescription medications, as antacids can interact with some of them. If your symptoms persist for more than 2 weeks, stop using the medication and contact your doctor for further guidance.

Overdose

Taking more than 2 unit dose cups (60 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 or someone else has taken too much, contact your healthcare provider or local emergency services right away. Always follow the recommended dosage guidelines to ensure your safety and well-being.

Pregnancy Use

When it comes to using this medication during pregnancy, there are no specific safety concerns or special precautions mentioned. Additionally, there are no dosage modifications required for pregnant individuals. While the information provided does not highlight any risks, it's always best to consult with your healthcare provider before starting any new medication if you are pregnant or planning to become pregnant. They can offer personalized advice based on your health and circumstances.

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 (a medical doctor) before using this medication. For adults and children aged 12 years and older, the recommended dosage is 30 mL (one unit dose cup) taken one to two times daily, 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 one to two times daily, or as directed by your healthcare provider. If the patient is under 12 years old, please consult a physician for appropriate guidance. Always prioritize safety and seek professional advice when it comes to medication 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 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 (issues with liver function).

Before starting any new medication, including this one, you should discuss your liver health with your healthcare provider. They can help determine the best approach for your treatment and ensure your safety.

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 drugs, 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, make sure to do so in a clean environment to maintain its integrity. Always follow any specific instructions provided for safe use and disposal to ensure your safety and the product's effectiveness.

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 one to two times daily, or as directed by your doctor. If the patient is under 12 years old, it's important to consult a physician for appropriate dosing 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.

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

The usual dosage is 30 mL (one unit dose cup), taken one to two times daily, or as directed by a doctor.

Are there any restrictions on how much I can take?

Do not take more than 2 unit dose cups (60 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?

Stop use and ask a doctor if your symptoms last more than 2 weeks.

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.

Is this medication safe to use during pregnancy?

The provided text does not mention specific safety concerns regarding use during pregnancy.

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

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

How should I store this medication?

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

Is this medication sugar-free?

Yes, this medication is sugar-free.

What should I do before using this medication if I have children under 12?

Consult a physician before use if the patient is a child under 12 years.

Packaging Info

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

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

Drug Information (PDF)

This file contains official product information for Aluminum Hydroxide, Magnesium Hydroxide, and Dimethicone, 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 2400 mg of Magnesium Hydroxide, 2400 mg of Aluminum Hydroxide, and 240 mg of Simethicone. This product is sugar-free and requires shaking well 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. This formulation is intended for institutional use only.

Uses and Indications

This drug is indicated for the relief of symptoms associated with acid indigestion, heartburn, sour stomach, and upset stomach due to these conditions. Additionally, it is effective in alleviating pressure and bloating 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. For adults and children aged 12 years and older, the recommended dosage is 30 mL (one unit dose cup) taken one to two times daily, or as directed by a healthcare professional. It is important not to exceed 2 unit dose cups (60 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 the use of 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 dosage of 2 unit dose cups (60 mL) within a 24-hour period. Additionally, the maximum dosage should not be used for more than 2 weeks unless directed and supervised 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 inform 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 their condition and to prevent potential complications.

Side Effects

Patients should be aware of the following adverse reactions associated with the use of this medication. It is important to adhere to the recommended dosage guidelines, which state that no more than 2 unit dose cups (60 mL) should be taken within a 24-hour period, and the maximum dosage should not be used for more than 2 weeks unless under the advice and supervision of a physician.

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

If symptoms persist for more than 2 weeks, patients are advised to discontinue use and consult a doctor. It is also crucial to keep this medication out of reach of children to prevent accidental ingestion.

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. The specific mechanisms of these interactions can vary, and the clinical effects may depend on the particular drugs involved. Therefore, it is essential to assess the need for dosage adjustments or increased monitoring when antacids are used concurrently with other medications.

Packaging & NDC

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

Packaging configurations for Aluminum Hydroxide, Magnesium Hydroxide, and Dimethicone.
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 (one unit dose cup) taken one to two times daily, 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, as this may affect the safety and efficacy of the treatment. Additionally, those on a magnesium-restricted diet are advised to seek medical advice before initiating therapy.

For adults and children aged 12 years and older, the recommended dosage is 30 mL (one unit dose cup) taken one to two times daily, or as directed by a healthcare professional. It is important for geriatric patients to adhere to this dosing guideline and to consult their physician for any necessary adjustments based on individual health status.

For children under 12 years of age, it is essential to consult a physician for appropriate dosing recommendations. Careful monitoring and consideration of the specific health needs of elderly patients are crucial to ensure safe and effective use of the medication.

Pregnancy

Pregnant patients should be informed that there are no specific safety concerns or dosage modifications associated with the use of this medication during pregnancy. Additionally, no special precautions regarding its use in pregnant individuals have been identified. As such, healthcare professionals should consider the overall clinical context when prescribing this medication to women of childbearing potential. It is advisable to weigh the potential benefits against any risks, although current data does not indicate known fetal impacts.

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 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 this drug. Consequently, there are no 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 prescribing information.

Overdosage

In the event of overdosage, it is critical to adhere to the recommended dosage guidelines to prevent adverse effects. Patients should not exceed 2 unit dose cups (60 mL) within a 24-hour period. Furthermore, the maximum dosage should not be utilized for more than 2 weeks unless under the guidance and supervision of a qualified physician.

Healthcare professionals are advised to monitor for potential symptoms of overdosage, which may include but are not limited to gastrointestinal disturbances, central nervous system effects, or other systemic reactions. In cases of suspected overdosage, immediate medical attention should be sought.

Management of overdosage should involve supportive care and symptomatic treatment. It is essential to assess the patient's condition and provide appropriate interventions based on the severity of symptoms. Continuous monitoring and evaluation are recommended to ensure patient safety and effective management of any adverse effects that may arise from overdosage.

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 use of the compound in these contexts.

Postmarketing Experience

No postmarketing experience details are available in the provided data.

Patient Counseling

Healthcare providers should advise patients to keep the medication out of reach of children to prevent accidental ingestion.

Patients should be informed to discontinue use 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 patients to seek medical advice before using this medication if they have a history of kidney disease, as this condition may affect the safety and efficacy of the treatment.

Additionally, patients on a magnesium-restricted diet should be encouraged to consult with their healthcare provider prior to use to ensure it is appropriate for their dietary restrictions.

Healthcare providers should also recommend that patients speak with their doctor or pharmacist if they are currently taking any prescription medications, as antacids may interact with certain drugs, potentially altering their effectiveness or increasing the risk of side effects.

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), in compliance with USP Controlled Room Temperature guidelines. It is essential to protect the product from freezing to maintain its integrity and efficacy. Proper handling and storage conditions are critical to ensure the product's quality and effectiveness.

Additional Clinical Information

The medication is administered orally. For adults and children aged 12 years and older, the recommended dosage is 30 mL (one unit dose cup) taken one to two times daily, or as directed by a physician. For children under 12 years, it is advised to consult a physician for appropriate dosing guidance.

No additional information is available regarding laboratory tests, abuse potential, patient counseling, or postmarketing experience.

Drug Information (PDF)

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

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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.