Mag-Al Plus Xs

Description

MAG-AL PLUS XS is a pharmaceutical product identified by the National Drug Code (NDC) 55154-9422-5. It is presented in a dosage form of a 30 mL bag, containing a total of 2400 mg of magnesium and 2400 mg of aluminum, along with 240 mg of an additional active ingredient. The product is packaged in a quantity of 5 cups.

Uses and Indications

This drug is indicated for the relief of acid indigestion, heartburn, sour stomach, and upset stomach associated with these symptoms. Additionally, it provides relief from 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 administered twice daily, or as directed by a physician. It is important not to exceed 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

Healthcare professionals should be aware of the following warnings and precautions associated with the use of this medication.

Dosage Limitations Patients must not exceed 8 teaspoonfuls within a 24-hour period. Additionally, the maximum dosage should not be utilized for more than 2 weeks unless under the guidance and supervision of a physician.

Pre-existing Conditions Prior to administration, it is essential to consult a physician if the patient has a history of kidney disease or is on a magnesium-restricted diet. These conditions may necessitate special consideration and monitoring.

Drug Interactions Healthcare providers should advise patients to seek guidance from a doctor or pharmacist before using this medication if they are currently taking any prescription drugs. Antacids have the potential to interact with certain medications, which could affect therapeutic outcomes.

Duration of Use Patients should discontinue use and consult a physician if symptoms persist for more than 2 weeks. Prolonged symptoms may indicate an underlying condition that requires further evaluation.

Safety Precautions This medication should be kept out of reach of children to prevent accidental ingestion and potential harm.

Side Effects

Patients should be aware of the following adverse reactions associated with the use of this medication. It is crucial to adhere to the recommended dosage guidelines, as exceeding 8 teaspoonfuls in a 24-hour period or using the maximum dosage for more than 2 weeks without the advice and supervision of a physician may lead to serious complications.

Patients with kidney disease or those on a magnesium-restricted diet should consult a doctor prior to use, as these conditions may increase the risk of adverse reactions. Additionally, individuals currently taking prescription medications should seek advice from a healthcare professional or pharmacist, as antacids may interact with certain drugs, potentially leading to adverse effects.

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

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 treatment.

Packaging & NDC

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

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 two times a day, or as directed by a physician.

Geriatric Use

Elderly patients may not have specific information regarding the use of this medication, including dosage adjustments, safety concerns, or special precautions. Therefore, healthcare providers should exercise caution when prescribing this medication to geriatric patients. It is advisable to monitor these patients closely for any potential adverse effects or changes in efficacy, given the lack of targeted data for this population.

Pregnancy

Pregnant patients and those who are breastfeeding should consult a healthcare professional before using this medication. The safety of this drug during pregnancy has not been established, and potential risks to fetal outcomes are not fully known. Therefore, it is essential for women of childbearing potential to discuss their individual circumstances with their healthcare provider to weigh the benefits and risks associated with the use of this medication during pregnancy and lactation.

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 about 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 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 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 prescribing 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 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 associated with overdosage, which may vary depending on the specific substance involved. In cases of suspected overdosage, immediate medical evaluation is advised to assess the patient's condition and initiate appropriate management procedures.

Management of overdosage may include supportive care and symptomatic treatment, tailored to the individual patient's needs. Continuous monitoring and assessment are essential to ensure patient safety and to mitigate any potential complications arising from the 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 in these areas limits the understanding of the compound's potential effects in nonclinical settings.

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 reminded 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 for identification. 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. Proper handling and storage conditions must be adhered to in order to ensure optimal product performance.

Additional Clinical Information

The medication is administered orally, with the recommended dosage for adults and children aged 12 years and older being 2 to 4 teaspoonfuls taken twice daily, or as directed by a physician. For children under 12 years, consultation with a physician is advised prior to use.

Clinicians should counsel patients not to exceed 8 teaspoonfuls within a 24-hour period and to avoid using the maximum dosage for more than 2 weeks unless under medical supervision. Patients with kidney disease or those on a magnesium-restricted diet should seek medical advice before use. Additionally, it is important for patients to consult a doctor or pharmacist if they are currently taking prescription medications, as antacids may interact with certain drugs. Patients are advised to discontinue use and consult a physician if symptoms persist beyond 2 weeks.

Drug Information (PDF)

This file contains official product information for Mag-Al Plus Xs, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)