Symptom checker
Select audience type

Switch between content for healthcare professionals (PRO) and general audience (GEN).

ADD CONDITION

items per page

Aluminum hydroxide/Magnesium hydroxide/Dimethicone

Last content change checked dailysee data sync status

Active ingredients
  • Dimethicone 120 mg/30 mL
  • Aluminum Hydroxide 1200 mg/30 mL
  • Magnesium Hydroxide 1200 mg/30 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 7, 2025
Drug Information (PDF)
Prescribing information, PDF file
Active ingredients
  • Dimethicone 120 mg/30 mL
  • Aluminum Hydroxide 1200 mg/30 mL
  • Magnesium Hydroxide 1200 mg/30 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 7, 2025
Manufacturer
Major Pharmaceuticals
Registration number
M001
NDC root
0904-7557
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

MAJOR® is a medication that combines three active ingredients: magnesium hydroxide, aluminum hydroxide, and simethicone. It is primarily used to provide relief from common digestive discomforts such as acid indigestion, heartburn, sour stomach, and upset stomach. Additionally, it helps alleviate pressure and bloating often associated with gas.

By working together, these ingredients help neutralize stomach acid and reduce gas buildup, making it easier for you to feel comfortable after meals. If you're experiencing these symptoms, MAJOR® may be a helpful option to consider for relief.

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 alleviating pressure and bloating often associated with gas.

You can rely on this treatment to ease your digestive discomfort and help you feel more comfortable throughout your day.

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 dosage is 2 to 4 teaspoonfuls taken four times a day, or as directed by your doctor. However, it's important not to exceed 16 teaspoonfuls 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 before administering the medication. This ensures that the dosage is safe and appropriate for their age and weight. Always follow your healthcare provider's instructions for the best results.

What to Avoid

It's important to keep this medication out of reach of children to ensure their safety. If your symptoms persist for more than two weeks, you should stop using the medication and consult your doctor for further guidance. This will help ensure that you receive the appropriate care and support for your health needs.

Side Effects

It's important to be aware of potential side effects when using this medication. You should not exceed 16 teaspoonfuls 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 using this product.

If your symptoms persist for more than 2 weeks, stop using the medication and seek medical advice. Always keep this medication 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 16 teaspoonfuls in a 24-hour period, and avoid using the maximum dosage for more than 2 weeks unless your doctor advises you to do so. 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 your symptoms persist for more than 2 weeks, stop using the medication and contact your doctor. Always keep this product out of reach of children to ensure their safety.

Overdose

Taking more than 16 teaspoonfuls of this medication in a 24-hour period can lead to an overdose. It's important to avoid using the maximum dosage for more than 2 weeks unless your doctor has specifically advised you to do so.

If you suspect an overdose, look for signs such as unusual drowsiness, confusion, or difficulty breathing (respiratory depression). If you notice any of these symptoms, seek immediate medical help. Always prioritize your safety and consult with a healthcare professional if you have any concerns about your medication use.

Pregnancy Use

If you are pregnant or planning to become pregnant, it's important to know that the safety of aluminum hydroxide, magnesium hydroxide, and simethicone during pregnancy has not been established. There may be potential risks to your fetus, so it's crucial to approach the use of these medications with caution. Always consult your physician before using these products to ensure they are appropriate for your situation.

Additionally, if you are prescribed these medications, be aware that dosage adjustments may be necessary during pregnancy. Your healthcare provider can give you the best guidance tailored to your needs.

Lactation Use

If you are breastfeeding, you can feel reassured that there are no specific warnings or recommendations regarding the use of Aluminum Hydroxide, Magnesium Hydroxide, and Simethicone Suspension. The information available does not indicate any concerns about these substances being passed into breast milk or posing risks to your infant.

However, since the insert does not provide details on potential effects on milk production or any special considerations for nursing mothers, it's always a good idea to consult with your healthcare provider if you have any questions or concerns about medications while breastfeeding.

Pediatric Use

If you have a child under 12 years old, it's important to consult a physician (doctor) before using this medication. For children aged 12 years and older, the recommended dosage is 2 to 4 teaspoonfuls taken four times a day, or as directed by a physician. Always follow your healthcare provider'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 can help determine if this treatment is safe for you. Additionally, if you are currently taking any prescription medications, including antacids, it's wise to check with your doctor or pharmacist to avoid any potential interactions.

For adults and children aged 12 and older, the recommended dosage is 2 to 4 teaspoonfuls taken four times a day, or as directed by your physician. If the person you are caring for is under 12 years old, please consult a physician for appropriate guidance. Always prioritize safety and communication with healthcare professionals when managing medications.

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, be sure to discuss this with your doctor or pharmacist, as antacids may interact with certain drugs you are using. 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 liver function tests (which check how well your liver is working) to ensure your safety while using any medication.

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 treatments, 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 a controlled room temperature between 20° and 25°C (68° and 77°F). This temperature range is important for maintaining the product's effectiveness. Additionally, be sure to protect it from freezing, as extreme cold can damage the product.

When handling the product, always do so with care to maintain its integrity. Following these storage and handling guidelines will help ensure that 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 dosage is 2 to 4 teaspoonfuls four times a day, 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 MAJOR® used for?

MAJOR® is used for the relief of acid indigestion, heartburn, sour stomach, upset stomach due to these symptoms, and pressure and bloating commonly referred to as gas.

What are the active ingredients in MAJOR®?

Each 30 mL of MAJOR® contains Magnesium Hydroxide (1200 mg), Aluminum Hydroxide (1200 mg), and Simethicone (120 mg).

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

Adults and children 12 years and older should take 2 to 4 teaspoonfuls four times a day or as directed by a physician.

Are there any precautions for children under 12 years?

Children under 12 years should consult a physician before use.

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

You should stop use and ask a doctor if symptoms last more than 2 weeks.

Can I take MAJOR® if I have kidney disease?

You should ask a doctor before use if you have kidney disease.

Is MAJOR® safe to use during pregnancy?

The safety of MAJOR® during pregnancy has not been established, and there may be potential risks to the fetus; consult a physician before use.

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

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

What are the storage conditions for MAJOR®?

Store MAJOR® at controlled room temperature between 20° - 25°C (68° - 77°F) and protect it from freezing.

What are the warnings associated with MAJOR®?

Do not take more than 16 teaspoonfuls in a 24-hour period or use the maximum dosage for more than 2 weeks without physician supervision.

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

Each 30 mL of the formulation contains 1200 mg of Magnesium Hydroxide, 1200 mg of Aluminum Hydroxide, and 120 mg of Simethicone. The combination of these active ingredients is designed to provide antacid and anti-foaming properties. The product is presented in a liquid dosage form, suitable for oral administration.

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 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 four times a day, or as directed by a physician. It is important not to exceed a total of 16 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 physician for appropriate dosing recommendations.

Contraindications

Use is contraindicated in the following situations:

  • The product should be kept out of reach of children to prevent accidental ingestion or misuse.

  • If symptoms persist for more than 2 weeks, discontinue use and consult a healthcare professional for further evaluation.

Warnings and Precautions

Patients should not exceed a maximum dosage of 16 teaspoonfuls within a 24-hour period, nor should they utilize the maximum dosage for longer than 2 weeks without the guidance and supervision of a physician.

Healthcare professionals are advised to recommend that patients consult a physician prior to use if they have a history of kidney disease or are on a magnesium-restricted diet. These conditions may necessitate special consideration regarding the safety and efficacy of the treatment.

Additionally, it is crucial for patients to seek advice from a doctor or pharmacist before initiating use if they are currently taking any prescription medications. Antacids have the potential to interact with certain prescription drugs, which could lead to adverse effects or diminished therapeutic efficacy.

Patients should be instructed to discontinue use and consult a physician if symptoms persist beyond 2 weeks.

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

Side Effects

Patients should be aware of the following warnings and recommendations regarding the use of this medication. It is advised not to exceed 16 teaspoonfuls within a 24-hour period or to use the maximum dosage for more than 2 weeks without the guidance and supervision of a physician.

Before initiating treatment, patients with kidney disease or those on a magnesium-restricted diet should consult a healthcare professional.

In the event that symptoms persist for more than 2 weeks, patients are advised to discontinue use and seek medical advice.

Additionally, this medication should be kept out of reach of children to prevent accidental ingestion.

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 and to avoid diminished efficacy of the prescribed treatments.

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 2 to 4 teaspoonfuls taken four times a day or as directed by a physician.

Geriatric Use

Elderly patients should consult a healthcare provider prior to use if they have a history of kidney disease, as this may influence the safety and efficacy of the treatment. Additionally, it is advisable for geriatric patients to seek guidance from a doctor or pharmacist if they are currently taking any prescription medications, as antacids may interact with certain drugs, potentially leading to adverse effects.

For dosing, adults and children aged 12 years and older are recommended to take 2 to 4 teaspoonfuls four times a day or as directed by a physician. However, for children under 12 years of age, it is essential to consult a physician before administration to ensure appropriate dosing and safety.

Close monitoring of elderly patients is recommended, particularly in the context of concurrent medications and existing health conditions, to mitigate risks and ensure optimal therapeutic outcomes.

Pregnancy

The safety of aluminum hydroxide, magnesium hydroxide, and simethicone during pregnancy has not been established. Pregnant patients or those planning to become pregnant should consult a physician before use, as there may be potential risks to the fetus. Therefore, the use of these agents should be approached with caution. Additionally, dosage adjustments may be necessary for pregnant individuals; healthcare providers should be consulted for appropriate guidance regarding dosage modifications.

Lactation

There are no specific warnings or recommendations regarding the use of Aluminum Hydroxide, Magnesium Hydroxide, and Simethicone Suspension in lactating mothers. The available information does not address the potential for excretion of these components in breast milk, the risk to breastfed infants, or any special considerations for nursing mothers.

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 prescription drugs. Monitoring and appropriate dosing adjustments may be necessary based on individual renal function and concurrent medications.

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 16 teaspoonfuls 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 of overdosage, which may arise from excessive intake. In cases where overdosage is suspected, immediate medical evaluation is advised. Management procedures may include supportive care and symptomatic treatment, tailored to the specific symptoms presented by the patient.

It is essential for healthcare providers to educate patients on the importance of adhering to prescribed dosages and to monitor for any signs of overdosage, ensuring timely intervention if necessary.

Nonclinical Toxicology

No teratogenic or non-teratogenic effects were identified in the available data. Additionally, there are no details regarding nonclinical toxicology or animal pharmacology and toxicology provided in the text.

Postmarketing Experience

No postmarketing experience details are available in the insert text.

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 with kidney disease to seek medical advice before using this medication, as it may not be suitable for their condition. Additionally, those on a magnesium-restricted diet should also consult a healthcare professional prior to use to ensure safety.

Patients should be encouraged to discuss any current prescription medications with their doctor or pharmacist before starting this medication, as antacids may interact with certain prescription drugs, potentially affecting their efficacy or safety.

Storage and Handling

The product is supplied in accordance with the National Drug Code (NDC) specifications. It should be stored at a controlled room temperature of 20° to 25°C (68° to 77°F), as defined 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 adhered to in order to ensure the product's quality and safety.

Additional Clinical Information

The medication is administered orally. For adults and children aged 12 years and older, the recommended dosage is 2 to 4 teaspoonfuls taken four times a day, or as directed by a physician. For children under 12 years, it is advised to consult a physician before use.

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 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.

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.