Magnesium citrate

Description

Foster Thrive™ is an oral solution containing magnesium citrate, classified as a saline laxative. The product is formulated with a lemon flavor and has an alcohol content of 0.025% derived from flavoring. Each bottle contains 10 fluid ounces (296 mL) of the solution. The National Drug Code (NDC) for this product is 70677-1111-1.

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

Use is contraindicated in patients experiencing rectal bleeding or failure to have a bowel movement after use, as these symptoms may indicate a serious underlying condition. In such cases, it is essential to seek medical advice promptly.

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 treatment.

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 other medications.

Patients should discontinue use and contact a healthcare professional if they experience rectal bleeding or if there is a failure 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, individuals who have noticed a sudden change in bowel habits that persists for more than two weeks or who have been using a laxative for longer than one week should also consult a healthcare provider.

It is important for patients to inform their doctor or pharmacist if they are taking any other medications, as the use of this product may affect the efficacy of other drugs. To minimize potential interactions, patients should take this product at least two hours before or after administering other medications.

Drug Interactions

The administration of this product should be separated from other medications by a minimum of two hours. This precaution is particularly important as laxatives may influence the efficacy of concomitantly administered drugs.

Healthcare professionals are advised to monitor patients for potential alterations in the therapeutic effects of other medications when used in conjunction with this product. Adjustments to dosages of other drugs may be necessary based on clinical response and the timing of administration.

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 is 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 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 adverse effects or changes in therapeutic response, given the lack of targeted data for this population.

Pregnancy

Pregnant patients and those who are breastfeeding should consult a healthcare professional prior to using this medication. The potential risks and benefits must be carefully evaluated in these populations to ensure maternal and fetal safety.

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 for symptoms that may arise from an overdose, although specific symptoms are not detailed in the provided information. The management of an overdose typically involves supportive care and symptomatic treatment, tailored to the individual patient's needs.

It is essential for healthcare providers to remain alert and prepared to implement appropriate management strategies in response to an overdose scenario.

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.

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 crucial for patients to stop using the product and consult a doctor if they experience rectal bleeding or fail to have a bowel movement after use, as these symptoms may indicate a serious underlying condition.

Patients should be encouraged to consult with their healthcare provider before using the product if they have any of the following conditions: kidney disease, a magnesium-restricted diet, abdominal pain, nausea, or vomiting. Additionally, patients should be informed that a sudden change in bowel habits persisting for more than two weeks or the use of a laxative for longer than one week warrants a discussion with their doctor.

Furthermore, patients should be instructed to consult a doctor or pharmacist prior to use if they are currently taking any other medications. It is important to emphasize that this product should be taken at least two hours before or after other drugs, as laxatives may influence the effectiveness of concurrent medications.

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 efficacy and integrity. Proper storage conditions must be adhered to, ensuring that the product is kept within the specified temperature range to prevent degradation.

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)