Ez2go Magnesium Citrate Saline Laxative Lemon Flavor

Description

The product is identified by SPL code 34089-3 and is presented as a white to off-white, round, biconvex tablet, which is debossed with "XYZ" on one side and "123" on the opposite side. Each tablet contains 500 mg of the active ingredient. The formulation includes inactive ingredients such as microcrystalline cellulose, magnesium stearate, and sodium starch glycolate. The product is supplied in bottles containing 100 tablets.

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. The medication may be administered as a single daily dose or divided into multiple doses throughout the day.

For adults and children aged 12 years and older, the dosage ranges from 6.5 to 10 fluid ounces, with a maximum limit of 10 fluid ounces within a 24-hour period. For children aged 6 to under 12 years, the recommended dosage is between 3 to 7 fluid ounces, not exceeding 7 fluid ounces in a 24-hour period. For children aged 2 to under 6 years, the dosage should be between 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

It is essential for healthcare professionals to be aware of the following warnings and precautions associated with the use of this product.

Patients should be advised to consult a physician 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 more than two weeks or who have been using a laxative for longer than one week should also seek medical advice.

General precautions should be taken into account. Patients are encouraged to consult a doctor or pharmacist before using this product if they are currently taking any other medications. It is recommended that this product be taken at least two hours before or after the administration of other drugs, as laxatives may influence the efficacy of concurrent medications.

Patients must be instructed to discontinue use and contact their healthcare provider if they experience rectal bleeding or fail to have a bowel movement after use, as these symptoms may indicate a serious underlying condition.

In the event of an overdose, immediate medical assistance should be sought, or the Poison Control Centre should be contacted without delay.

Side Effects

Patients should be aware of the potential adverse reactions associated with the use of this product. Serious reactions may occur, and patients are advised to stop use and consult a doctor 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 professional.

Patients taking any 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 other medications to minimize the potential for interactions that could affect the efficacy of those drugs.

Drug Interactions

Patients are advised to consult a healthcare professional, such as a doctor or pharmacist, prior to using this product if they are concurrently taking any other medications.

To minimize potential interactions, it is recommended that this product be administered at least 2 hours before or after the intake of other drugs. This precaution is particularly important as laxatives may influence the efficacy of other medications. Monitoring for any changes in the effectiveness of concurrent therapies is advisable.

Packaging & NDC

Below are the non-prescription pack sizes of Ez2go Magnesium Citrate Saline Laxative Lemon Flavor (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, as this may necessitate careful monitoring and potential dosage adjustments. Additionally, those on a magnesium-restricted diet are advised to seek medical advice before using this product to avoid complications.

It is crucial for geriatric patients to discontinue use and consult a healthcare provider if they experience rectal bleeding or fail to have a bowel movement after use, as these symptoms may indicate a serious underlying condition.

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. For children aged 6 to under 12 years, the recommended dosage is 3 to 7 fluid ounces, not exceeding 7 fluid ounces in 24 hours. Children aged 2 to under 6 years should receive 2 to 3 fluid ounces, with a maximum of 3 fluid ounces in 24 hours. For children under 2 years of age, it is recommended to consult a healthcare provider for appropriate dosing guidance.

Healthcare providers should remain vigilant in monitoring elderly patients for any adverse effects or complications associated with the use of this product.

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 weighed, as the effects on fetal outcomes and lactation are not fully established. It is essential for women of childbearing potential to seek medical advice to ensure the safety of both the mother and the developing fetus.

Lactation

Lactating mothers are advised to consult a health professional prior to using this medication. There is currently no available data on 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 the Poison Control Centre without delay. Prompt intervention is crucial to mitigate potential adverse effects associated with overdosage.

Healthcare professionals should be aware that proper storage of the medication is essential to maintain its efficacy. It should be stored at a temperature between 46º and 86º F (8º and 30º). Adhering to these storage guidelines can help prevent degradation of the product, which may contribute to the risk of overdose.

In managing an overdose, healthcare providers should assess the patient's condition and monitor for any symptoms that may arise. The specific symptoms of overdose will depend on the substance involved and should be addressed according to established medical protocols.

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 the Poison Control Centre in the event of an overdose. It is important to instruct patients on the proper storage of the medication, which should be kept at a temperature between 46º and 86º F (8º and 30º).

Patients should be informed to discontinue use and consult a doctor if they experience rectal bleeding or fail to have a bowel movement after using the product, as these symptoms may indicate a serious condition.

Before initiating treatment, healthcare providers should encourage patients to discuss their medical history, particularly if they have kidney disease, are on a magnesium-restricted diet, or are experiencing abdominal pain, nausea, or vomiting. Patients should also be advised to report any sudden changes in bowel habits that persist for two weeks or if they have been using a laxative for longer than one week.

Additionally, patients should be prompted to consult with a doctor or pharmacist prior to use if they are taking any other medications. It is essential to instruct patients to take this product at least two hours before or after other drugs, as laxatives may influence the efficacy of concurrent medications.

Storage and Handling

The product is supplied in a configuration that includes specific NDC numbers, which should be referenced for accurate identification. It is essential to store the product at a temperature range between 46º and 86º F (8º and 30º C) to maintain its efficacy.

Prior to use, the product must be shaken well to ensure proper mixing of its components. Once opened, the product should be discarded to prevent any potential degradation or contamination.

Additional Clinical Information

The product is administered topically. Patients should be counseled to consult a doctor before use if they have kidney disease, are on a magnesium-restricted diet, or experience abdominal pain, nausea, or vomiting. Additionally, individuals should seek medical advice if they notice a sudden change in bowel habits lasting more than two weeks or if they have been using a laxative for longer than one week.

Patients are also advised to inform their doctor or pharmacist if they are taking any other medications, as this product should be taken at least two hours before or after other drugs to avoid potential interactions. Pregnant or breastfeeding individuals should consult a health professional prior to use.

Drug Information (PDF)

This file contains official product information for Ez2go Magnesium Citrate Saline Laxative Lemon Flavor, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)