Mag-Al Plus

Description

Each 30 mL of the formulation contains 1200 mg of Aluminum Hydroxide, 1200 mg of Magnesium Hydroxide, and 120 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 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 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 four times a day, or as directed by a physician. It is important to note that the maximum dosage should not exceed 16 teaspoonfuls within a 24-hour period, and this 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 unless under the guidance and supervision of 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. Additionally, it is prudent 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 beyond 2 weeks. This precaution is essential to ensure appropriate management of their condition and to prevent potential complications.

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 in 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 should consult a healthcare professional if they have kidney disease or are on a magnesium-restricted diet, as these conditions may affect the safety and efficacy of the medication.

Patients are also advised to discontinue use and seek medical advice if symptoms persist for more than 2 weeks. Additionally, it is crucial to keep this medication out of reach of children to prevent accidental ingestion.

Furthermore, patients should consult a doctor or pharmacist prior to use if they are currently taking any prescription medications, as antacids may interact with certain drugs, potentially leading to adverse effects.

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 (aluminum hydroxide, magnesium hydroxide, and 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 four times a day or as directed by a physician.

Geriatric Use

Elderly patients should consult a physician prior to use if they have kidney disease or are on a magnesium-restricted diet. It is important for healthcare providers to consider these factors when prescribing treatment to geriatric patients, as renal function may be compromised in this population, potentially affecting drug metabolism and excretion.

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 advised to consult a physician for appropriate dosing recommendations.

Healthcare providers should closely monitor elderly patients for any adverse effects or complications, particularly those related to renal function and dietary restrictions.

Pregnancy

Pregnant patients or those planning to become pregnant should consult a healthcare professional before using Mag-AL Plus. Currently, there are no specific warnings or contraindications associated with the use of Mag-AL Plus during pregnancy as indicated in the available prescribing information. However, it is essential for healthcare providers to evaluate the potential benefits and risks when considering treatment options for pregnant patients.

Lactation

There is no specific information available regarding the use of this medication in nursing mothers or any lactation considerations. Healthcare professionals should exercise caution and consider the potential risks and benefits when prescribing this medication to lactating mothers. Further research may be necessary to fully understand the implications for 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 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 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 associated with overdosage, which may vary depending on the specific substance involved. Immediate assessment and intervention may be necessary to mitigate any adverse effects.

Management of overdosage should include supportive care and symptomatic treatment as required. It is advisable to consult a poison control center or seek emergency medical assistance for further evaluation and management strategies tailored to the individual case.

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 understanding of potential risks associated with the compound in nonclinical settings. Further studies may be necessary to elucidate these aspects.

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 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). Care must be taken to protect the product from freezing to ensure 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)