Magnesium citrate

Description

NDC 46122-740-38, GOOD NEIGHBOR PHARMACY® Magnesium Citrate is a dye-free and sugar-free saline laxative formulated as an oral solution. This product contains a lemon flavor and has an alcohol content of 0.025% derived from flavoring. Each bottle contains 10 fluid ounces (296 mL). It is imperative to note that the product should not be used if the tamper-evident twist-off cap is missing, broken, or separated from the neck ring.

Uses and Indications

This drug is indicated for the relief of occasional constipation (irregularity). It generally produces a bowel movement within 1/2 to 6 hours following administration.

Dosage and Administration

The medication should be shaken well before use. It is recommended that patients drink a full glass (8 ounces) of liquid with each dose to ensure proper administration.

For adults and children aged 12 years and older, the dosage may be administered as a single daily dose or divided into multiple doses, with a recommended range of 6.5 to 10 fluid ounces. The maximum allowable dosage for this age group is 10 fluid ounces within a 24-hour period.

For children aged 6 to under 12 years, the dosage ranges from 3 to 7 fluid ounces, with a maximum of 7 fluid ounces in a 24-hour period.

For children aged 2 to under 6 years, the recommended dosage is 2 to 3 fluid ounces, with a maximum of 3 fluid ounces in a 24-hour period.

For children under 2 years of age, it is advised to consult a physician for appropriate dosing recommendations.

Contraindications

There are no specific contraindications identified for this product. However, it is advised to discontinue use and consult a healthcare professional if rectal bleeding occurs or if there is a failure to have a bowel movement after use, as these may indicate a serious underlying condition.

Warnings and Precautions

Patients should consult a healthcare professional prior to use if they have any of the following conditions: kidney disease, a magnesium-restricted diet, abdominal pain, nausea, or vomiting. Additionally, individuals who have experienced a sudden change in bowel habits persisting for two weeks or longer, or those who have used a laxative for more than one week, should seek medical advice before proceeding with this product.

It is advisable for patients to discuss their current medications with a healthcare provider or pharmacist before using this product. This is particularly important for those taking other drugs, as laxatives may influence the efficacy of concurrent medications. To minimize potential interactions, it is recommended that this product be taken at least two hours before or after the administration of other drugs.

Patients should discontinue use and contact a healthcare professional if they experience rectal bleeding or fail to have a bowel movement after using the product, as these symptoms may indicate a serious underlying condition.

In the event of an overdose, immediate medical assistance should be sought, or the patient should contact a Poison Control Center without delay.

Side Effects

Patients should be aware of the potential adverse reactions associated with the use of this product. Serious adverse reactions may occur, and patients are advised to stop use and consult a healthcare professional if they experience rectal bleeding or failure to have a bowel movement after use, as these symptoms could indicate a serious underlying condition.

Before using this product, patients should seek medical advice if they have a history of kidney disease, are on a magnesium-restricted diet, or are experiencing abdominal pain, nausea, or vomiting. Additionally, a sudden change in bowel habits that persists for more than two weeks or the prolonged use of a laxative for more than one week warrants consultation with a healthcare provider.

Patients taking other medications should also consult a doctor or pharmacist prior to use, as this product may interact with other drugs. It is recommended that this product be taken at least two hours before or after the administration of other medications to minimize potential interactions.

Drug Interactions

Taking magnesium citrate may influence the efficacy of concurrent medications. It is recommended that magnesium citrate be administered at least 2 hours before or after other drugs to minimize potential interactions.

Patients are advised to consult with a healthcare professional, such as a doctor or pharmacist, prior to using magnesium citrate if they are currently taking any other medications. This precaution helps ensure safe and effective use while avoiding unintended drug interactions.

Packaging & NDC

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

Pediatric Use

Pediatric patients aged 12 years and older may receive a dosage of 6.5 to 10 fl oz, with a maximum limit of 10 fl oz in a 24-hour period. For children aged 6 to under 12 years, the recommended dosage ranges from 3 to 7 fl oz, not exceeding 7 fl oz in 24 hours. In children aged 2 to under 6 years, the dosage is 2 to 3 fl oz, with a maximum of 3 fl oz in 24 hours. For infants and children under 2 years of age, it is advised to consult a doctor before administration.

Geriatric Use

Elderly patients should consult a healthcare provider prior to use if they have a history of kidney disease or if they are on a magnesium-restricted diet.

For dosing, adults and children aged 12 years and older may take between 6.5 to 10 fluid ounces, with a maximum limit of 10 fluid ounces within a 24-hour period. In pediatric populations, the following dosing guidelines apply: children aged 6 to under 12 years may receive 3 to 7 fluid ounces, with a maximum of 7 fluid ounces in 24 hours; children aged 2 to under 6 years may take 2 to 3 fluid ounces, with a maximum of 3 fluid ounces in 24 hours. For children under 2 years of age, it is advised to consult a healthcare provider before administration.

Careful monitoring and consideration of these guidelines are essential to ensure the safety and efficacy of treatment in geriatric patients.

Pregnancy

Pregnant patients and those who are breastfeeding should consult a healthcare professional prior to using this medication. It is important to assess the potential risks and benefits associated with its use during pregnancy and lactation. The safety of this medication in pregnant women has not been established, and caution is advised to ensure the well-being of both the mother and the fetus.

Lactation

Lactating mothers are advised to consult a healthcare professional prior to using this medication. There is currently no available data regarding the excretion of this drug in human breast milk or its effects on breastfed infants. Therefore, caution is recommended when administering this medication to lactating individuals.

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 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 an overdose, it is imperative to seek immediate medical assistance or contact a Poison Control Center without delay. Prompt intervention is crucial to mitigate potential adverse effects associated with the overdose.

Healthcare professionals should be vigilant in monitoring for symptoms that may arise from an overdose. While specific symptoms are not detailed in the provided information, it is essential to be aware that they can vary based on the substance involved and the individual patient’s response.

Management of an overdose typically involves supportive care and symptomatic treatment. The healthcare provider should assess the patient's condition and implement appropriate measures based on the severity of the overdose and the symptoms presented. Continuous monitoring and evaluation are recommended to ensure patient safety and effective management of the situation.

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 insert text.

Patient Counseling

Healthcare providers should advise patients to seek immediate medical assistance or contact a Poison Control Center in the event of an overdose. It is important for patients to be aware of the signs that warrant discontinuation of the product and consultation with a doctor, such as rectal bleeding or failure to have a bowel movement after use, as these may indicate a serious underlying condition.

Patients should be encouraged to consult with their healthcare provider prior to use if they have any of the following conditions: kidney disease, a magnesium-restricted diet, abdominal pain, nausea, or vomiting. Additionally, patients should report any sudden changes in bowel habits that persist for more than two weeks or if they have been using a laxative for longer than one week.

Furthermore, patients should be instructed to speak with their doctor or pharmacist before using this product if they are currently taking any other medications. It is essential to take this laxative at least two hours before or after other medications, as it may influence the effectiveness of those drugs.

Storage and Handling

The product is supplied in various package configurations, with specific NDC numbers available for identification. It is essential to store the product at temperatures ranging from 46° to 86°F (8° to 30°C) to maintain its integrity and efficacy. Proper container requirements must be adhered to, ensuring that the product is kept in a suitable environment. Special handling needs should be observed to prevent any compromise to the product's quality during storage and transportation.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

This file contains official product information for Magnesium Citrate, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)