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Mag-Al Plus

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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 2004
Label revision date
November 12, 2024
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 2004
Label revision date
November 12, 2024
Manufacturer
PAI Holdings, LLC dba PAI Pharma
Registration number
M002
NDC root
0121-1762
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

MAG-AL PLUS XS is a liquid medication that contains magnesium hydroxide, aluminum hydroxide, and simethicone. It is designed 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 combining these ingredients, MAG-AL PLUS XS works to neutralize stomach acid and reduce gas, making it a helpful option for those experiencing these uncomfortable symptoms. If you're dealing with digestive issues, this medication may offer you the relief you need.

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 many people refer to as 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 dosage is 2 to 4 teaspoonfuls taken twice a day, or as directed by your doctor. However, it's important not to exceed 8 teaspoonfuls in a 24-hour period, and you should not use the maximum dosage for more than 2 weeks.

If you have a child under 12 years old, please consult a 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 use this medication responsibly to ensure your safety and well-being. You should not take more than 8 teaspoonfuls in a 24-hour period, and you should avoid using the maximum dosage for more than 2 weeks unless your doctor advises you to do so. Following these guidelines helps prevent potential issues related to misuse or dependence (a condition where your body becomes reliant on a substance). Always consult with your healthcare provider if you have any questions or concerns about your medication.

Side Effects

It's important to be aware of certain warnings before using this medication. If you have kidney disease or are on a magnesium-restricted diet, you should consult your doctor first. Additionally, if your symptoms persist for more than two weeks while using this medication, you should stop using it and seek medical advice.

Taking these precautions can help ensure your safety and well-being while using the medication.

Warnings and Precautions

It's important to use this medication safely. Do not exceed 8 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.

Before starting 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 some drugs.

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

Overdose

Taking more than 8 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 this product during pregnancy has not been established. You should consult your physician before using it, as there may be potential risks to your fetus, although these risks are not specifically detailed.

While there are no specific dosage modifications provided for pregnant individuals, it is crucial to seek guidance from your healthcare provider regarding its use. Always discuss any medications or products you are considering with your doctor to ensure the best care 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 Mag-AL Plus XS while nursing. The information available does not indicate any concerns about the medication being passed into breast milk or any potential risks 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. This ensures that it is safe and appropriate for your child's specific needs. For adults and children aged 12 years and older, the recommended dosage is 2 to 4 teaspoonfuls taken twice a day, or as directed by a physician. 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 be cautious when using this medication. Before starting, consult your doctor if you have kidney disease, as this can affect how the medication works in your body. Additionally, if you are currently taking any prescription medications, including antacids, check with your doctor or pharmacist to avoid any potential interactions.

For adults and children aged 12 and older, the typical dosage is 2 to 4 teaspoonfuls taken twice a day, or as directed by your physician. If the user is under 12 years old, it's essential to consult a physician for appropriate guidance. Always prioritize safety and communication with healthcare providers 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, 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 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).

Always consult your healthcare provider for personalized advice and to ensure that any medication you take is safe and appropriate for your liver health. They can help you understand how to manage your treatment effectively.

Drug Interactions

It's important to 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 safety and the effectiveness of your treatment.

Storage and Handling

To ensure the safety and effectiveness 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 integrity. Additionally, be sure to protect it from freezing, as extreme cold can damage the product.

When handling the product, always do so with clean hands and in a clean environment to avoid contamination. Following these guidelines will help you use the product safely and effectively.

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 is MAG-AL PLUS XS used for?

MAG-AL PLUS XS 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 MAG-AL PLUS XS?

Each 30 mL of MAG-AL PLUS XS contains 2400 mg of Magnesium Hydroxide, 2400 mg of Aluminum Hydroxide, and 240 mg of Simethicone.

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 two times a day or as directed by a physician.

Are there any dosage restrictions for MAG-AL PLUS XS?

Do not take more than 8 teaspoonfuls in a 24-hour period or use the maximum dosage for more than 2 weeks without a physician's advice.

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

Stop using MAG-AL PLUS XS and ask a doctor if your symptoms last more than 2 weeks.

Is MAG-AL PLUS XS safe to use during pregnancy?

The safety of MAG-AL PLUS XS during pregnancy has not been established, so consult a physician if you are pregnant or planning to become pregnant.

Can I use MAG-AL PLUS XS if I have kidney disease?

You should ask a doctor before using MAG-AL PLUS XS if you have kidney disease.

What should I do before taking MAG-AL PLUS XS if I am on prescription medication?

Ask a doctor or pharmacist before use if you are presently taking a prescription drug, as antacids may interact with certain medications.

How should I store MAG-AL PLUS XS?

Store MAG-AL PLUS XS at controlled room temperature between 20° - 25°C (68° - 77°F) and protect it from freezing.

What is the NDC for MAG-AL PLUS XS?

The National Drug Code (NDC) for MAG-AL PLUS XS is 0121-1762-30.

Packaging Info

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

Packaging configurations for Mag-Al Plus.
Details

Drug Information (PDF)

This file contains official product information for Mag-Al Plus, 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 2400 mg of Magnesium Hydroxide, 2400 mg of Aluminum Hydroxide, and 240 mg of Simethicone. The product is manufactured by Pharmaceutical Associates, Inc., located in Greenville, SC 29605. The packaging is not child-resistant.

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. It is also 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 formulation should be shaken well before each use to ensure proper mixing of the ingredients.

For adults and children aged 12 years and older, the recommended dosage is 2 to 4 teaspoonfuls administered twice daily, or as directed by a physician. It is important not to exceed a total of 8 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 patients who exceed 8 teaspoonfuls within a 24-hour period or who utilize the maximum dosage for more than 2 weeks without the advice and supervision of a physician. This limitation is essential to prevent potential adverse effects associated with prolonged high dosage.

Warnings and Precautions

The maximum recommended dosage should not exceed 8 teaspoonfuls within a 24-hour period, and the maximum dosage should not be utilized for more than 2 weeks unless directed and monitored by a physician.

Healthcare professionals should advise patients to consult a doctor prior to use if they have a history of kidney disease or are on a magnesium-restricted diet. Additionally, it is important to recommend that patients 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 beyond 2 weeks.

Side Effects

Patients should be aware of certain warnings associated with the use of this medication. It is advised that individuals consult a healthcare professional prior to use if they have a history of kidney disease or are on a magnesium-restricted diet.

In the event that symptoms persist for more than two weeks, patients are instructed to discontinue use and seek medical advice. This precaution is essential to ensure the safety and well-being of individuals using 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 certain prescription medications, which could affect the efficacy of those drugs. It is important for patients to disclose all medications they are taking to ensure safe and effective use of antacids. Monitoring for any adverse effects or changes in therapeutic outcomes is recommended when these medications are used concurrently.

Packaging & NDC

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

Packaging configurations for Mag-Al Plus.
Details

Pediatric Use

Pediatric patients under 12 years of age should consult a physician prior to use. For adolescents and children aged 12 years and older, the recommended dosage is 2 to 4 teaspoonfuls taken twice daily 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 two 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.

Healthcare providers should closely monitor elderly patients for any potential interactions or complications, particularly in those with pre-existing conditions or those taking multiple medications.

Pregnancy

The safety of this product during pregnancy has not been established. Pregnant patients or those planning to become pregnant should consult a physician before use. While potential risks to the fetus are not specified, caution is advised. There are no specific dosage modifications for pregnant individuals; therefore, it is essential to seek guidance from a healthcare provider regarding appropriate use. It is recommended that the use of this product be discussed with a healthcare provider if the patient is pregnant.

Lactation

There are no specific warnings or recommendations regarding the use of Mag-AL Plus XS in lactating mothers. Additionally, there is no information available concerning the potential for excretion of Mag-AL Plus XS 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 prescription 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 this medication. 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 cases of overdosage, it is critical to adhere to the recommended dosage guidelines to prevent adverse effects. The maximum allowable dosage is 8 teaspoonfuls within a 24-hour period. Exceeding this limit or utilizing the maximum dosage for more than 2 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 the event of suspected overdosage, 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 following dosage recommendations to mitigate the risk of overdosage and its associated complications.

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 question.

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. It is important to inform patients not to exceed a maximum dosage of 8 teaspoonfuls within a 24-hour period and to avoid using the maximum dosage for more than 2 weeks unless directed by a physician.

Patients should be instructed to discontinue use and consult a doctor if their symptoms persist for more than 2 weeks. Additionally, healthcare providers should encourage patients to seek medical advice before using the medication if they have kidney disease or are on a magnesium-restricted diet.

Furthermore, patients should be advised 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.

Storage and Handling

The product is supplied in various package configurations, with specific NDC numbers available upon request. It should be stored at a controlled room temperature of 20° to 25°C (68° to 77°F), in accordance with USP Controlled Room Temperature guidelines. It is essential to protect the product from freezing to maintain its integrity and efficacy.

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 Mag-Al Plus, 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 Mag-Al Plus, 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.