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Gadavyt

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This product has been discontinued

Active ingredient
Magnesium Citrate 1.745 g/29.6 mL
Other brand names
Dosage form
Liquid
Route
Oral
Prescription status
OTC (over the counter)
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Marketed in the U.S.
Since 2012
Label revision date
October 15, 2012
Drug Information (PDF)
Prescribing information, PDF file
Active ingredient
Magnesium Citrate 1.745 g/29.6 mL
Other brand names
Dosage form
Liquid
Route
Oral
Prescription status
OTC (over the counter)
CSA schedule
Not a scheduled drug
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Marketed in the U.S.
Since 2012
Label revision date
October 15, 2012
Manufacturer
Gadal Laboratories Inc
Registration number
part334
NDC root
53113-101
Drug Information (PDF)
Prescribing information, PDF file
Packaging Info
Packaging & NDC Codes

If you are a healthcare professional or from the pharmaceutical industry please visit this version.

If you are a consumer or patient please visit this version.

Drug Overview

This medication contains sodium and magnesium, which are essential minerals that play important roles in various bodily functions. Sodium helps maintain fluid balance and supports nerve and muscle function, while magnesium is crucial for energy production, muscle contraction, and overall cellular health.

You may find this medication useful for replenishing these minerals in your body, especially if you have a deficiency or need additional support for your health. Always consult with a healthcare professional to understand how this medication can best serve your needs.

Uses

It seems that there are no specific uses or indications provided for this medication. Additionally, there are no mentions of teratogenic effects (which refer to substances that can cause developmental abnormalities in a fetus) or nonteratogenic effects (which do not affect fetal development). If you have any questions or need further information about this medication, please consult your healthcare provider for personalized advice.

Dosage and Administration

If you are an adult or a child aged 12 years and older, you can take between half to a full bottle (10 fluid ounces) of the medication. It's important to drink a full 8-ounce glass of liquid with each dose. You can take this medication either as a single dose once a day or split it into smaller doses throughout the day.

For children aged 6 to under 12 years, the recommended dosage is one-third to one-half of a bottle, also taken with a full 8-ounce glass of liquid. If your child is under 6 years old, it's essential to consult a doctor before giving them this medication to ensure it's safe and appropriate for their age.

What to Avoid

If you experience rectal bleeding or do not have a bowel movement after using this product, it’s important to stop using it and consult your doctor, as these symptoms could indicate a serious health issue. Additionally, if you find that you need to use a laxative for more than one week, you should also stop use and seek medical advice. Taking these precautions helps ensure your safety and well-being.

Side Effects

Before using this product, it's important to consult your doctor if you have kidney disease, follow a magnesium or sodium-restricted diet, experience stomach pain, nausea, or vomiting, or have noticed a sudden change in your bowel habits lasting more than a week. Additionally, if you are currently taking any prescription medications, please check with your doctor or pharmacist first.

While using this product, be sure not to exceed the maximum recommended daily dosage within a 24-hour period to avoid potential adverse effects.

Warnings and Precautions

Before using this product, it's important to consult your doctor if you have kidney disease, are on a magnesium or sodium-restricted diet, are experiencing stomach pain, nausea, or vomiting, or if you've noticed a sudden change in your bowel habits lasting more than a week. Additionally, if you are currently taking any prescription medications, check with your doctor or pharmacist before use. Always follow the recommended dosage and do not exceed the maximum daily limit.

You should stop using this product and call your doctor if you experience rectal bleeding, have no bowel movement after use, or if you find that you need to use a laxative for more than a week, as these could indicate a serious health issue.

In the event of an accidental overdose, seek emergency medical help immediately or contact a Poison Control Center at 1-800-222-1222. Your health and safety are important, so please take these precautions seriously.

Overdose

Taking more than the maximum recommended daily dosage of a medication can lead to serious health risks. It's important to stick to the prescribed amount to avoid potential overdose. If you suspect that you or someone else has taken too much, look for signs such as unusual drowsiness, confusion, or difficulty breathing (respiratory depression).

If you notice any of these symptoms or have concerns about an overdose, seek immediate medical help. Always remember, it's better to be safe and consult a healthcare professional if you're unsure about the dosage or experience any adverse effects.

Pregnancy Use

If you are pregnant or breastfeeding, it’s important to consult with a healthcare professional before using this medication. They can provide guidance on whether it’s safe for you and your baby. Always prioritize your health and the health of your child by seeking expert advice.

Lactation Use

If you are pregnant or breastfeeding, it’s important to consult with a healthcare professional before using any medication. This ensures that you understand any potential risks and can make informed decisions about your health and the health of your baby. Always prioritize open communication with your doctor regarding your breastfeeding journey.

Pediatric Use

When it comes to giving this medication to children, it's important to follow specific guidelines. For children aged 6 to under 12 years, you can give them between 1/3 to 1/2 of a bottle mixed with a full 8-ounce glass of liquid. This helps ensure they receive the right dosage for their age.

If your child is under 6 years old, it's crucial to consult a doctor before administering the medication. This precaution helps ensure their safety and that they receive appropriate care tailored to their needs. Always prioritize your child's health by following these recommendations.

Geriatric Use

When it comes to using this medication in older adults, there is no specific information available about dosage adjustments, safety concerns, or special precautions. This means that the drug insert does not provide guidelines tailored for elderly patients.

If you are caring for an older adult, it's important to consult with a healthcare professional for personalized advice. They can help determine the best approach to using this medication safely and effectively, considering any unique health needs or conditions that may be present.

Renal Impairment

If you have kidney disease, it's important to consult your doctor before using this medication. Your healthcare provider can help determine if it's safe for you and if any adjustments to your dosage are necessary. Always prioritize open communication with your doctor regarding your kidney health to ensure the best care.

Hepatic Impairment

If you have liver problems, it's important to know that there are no specific guidelines or dosage adjustments mentioned for your condition in the available information. This means that the standard recommendations apply, but you should always consult your healthcare provider for personalized advice. They can help monitor your liver function and determine the best approach for your treatment.

Make sure to keep your doctor informed about your liver health, as they may need to conduct regular tests to ensure your safety while using any medication. Your well-being is a priority, so don't hesitate to ask questions or express any concerns you may have.

Drug Interactions

It's important to talk to your doctor or pharmacist before using this medication, especially if you are currently taking any prescription drugs. This conversation helps ensure that all your medications work well together and that you avoid any potential interactions that could affect your health. Always prioritize your safety by discussing your full list of medications with your healthcare provider.

Storage and Handling

To ensure the best performance of your product, store it at room temperature, away from excessive heat and freezing conditions. This helps maintain its effectiveness and safety.

Once opened, remember to discard any unused product within 24 hours. This is important to prevent any potential contamination or loss of effectiveness. By following these simple storage and handling guidelines, you can help ensure the product remains safe and effective for your use.

Additional Information

You should take this medication orally. For adults and children aged 12 and older, the recommended dose is between half to one full bottle (10 fl. oz.), taken with a full 8 oz glass of liquid. This can be done as a single daily dose or divided into smaller doses throughout the day. For children aged 6 to under 12 years, the dose is one-third to half a bottle, also with a full 8 oz glass of liquid. If your child is under 6 years old, it's important to consult a doctor before giving this medication.

If you are pregnant or breastfeeding, be sure to consult a healthcare professional before using this medication to ensure it is safe for you.

FAQ

What is the recommended dosage for adults and children 12 years and older?

The recommended dosage is 1/2 to 1 bottle (10 fl. oz.), taken with a full 8 oz glass of liquid. This can be taken as a single daily dose or in divided doses.

What should children aged 6 to under 12 years take?

Children aged 6 to under 12 years should take 1/3 to 1/2 bottle with a full 8 oz glass of liquid.

What should I do if my child is under 6 years old?

If your child is under 6 years of age, you should consult a doctor for guidance.

How should I store this product?

Store the product at room temperature, protecting it from excessive heat and freezing.

What should I do with unused product?

Discard any unused product within 24 hours of opening.

Are there any warnings I should be aware of?

Yes, ask a doctor before use if you have kidney disease, a magnesium or sodium restricted diet, stomach pain, nausea, vomiting, or a sudden change in bowel habits lasting more than 1 week.

What should I do if I experience rectal bleeding or no bowel movement after use?

Stop taking the product and call your doctor, as these could be signs of a serious condition.

Is it safe to use this product if I am pregnant or breastfeeding?

If you are pregnant or breastfeeding, you should ask a health professional before use.

What should I do in case of an accidental overdose?

In case of accidental overdose, seek professional assistance or contact a Poison Control Center immediately at 1-800-222-1222.

Packaging Info

Below are the non-prescription pack sizes of Gadavyt (magnesium citrate). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Gadavyt.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

No relevant information is available for SPL code 34089-3.

Uses and Indications

This drug is indicated for use in patients as determined by the prescribing healthcare professional. Currently, there are no specific indications or usage details provided.

There are no known teratogenic or nonteratogenic effects associated with this drug. Healthcare professionals should consider the absence of these effects when evaluating treatment options for their patients.

Dosage and Administration

Adults and children 12 years of age and older may be administered a dosage of 1/2 to 1 bottle (10 fl. oz.). Each dose should be accompanied by a full 8 oz glass of liquid. These doses can be taken as a single daily dose or divided into multiple doses throughout the day.

For children aged 6 to under 12 years, the recommended dosage is 1/3 to 1/2 bottle, also taken with a full 8 oz glass of liquid.

For children under 6 years of age, it is advised to consult a doctor prior to administration.

Contraindications

Use is contraindicated in patients who experience rectal bleeding or have not had a bowel movement after use, as these may indicate a serious underlying condition. Additionally, the use of this product is contraindicated in individuals who require laxative use for more than one week, necessitating medical consultation.

Warnings and Precautions

Healthcare professionals should 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, a sodium-restricted diet, stomach pain, nausea, or vomiting. Additionally, individuals who have experienced a sudden change in bowel habits lasting more than one week should seek medical advice before using this product.

It is also important to recommend that patients consult with a doctor or pharmacist if they are currently taking any prescription medications, as interactions may occur. During the use of this product, patients must not exceed the maximum recommended daily dosage within a 24-hour period to avoid potential adverse effects.

Patients should be instructed to discontinue use and contact their healthcare provider if they experience rectal bleeding or if there is no bowel movement following use, as these symptoms may indicate a serious underlying condition. Furthermore, if a laxative is required for more than one week, medical consultation is necessary.

In the event of an accidental overdose, immediate professional assistance should be sought, or the Poison Control Center (1-800-222-1222) should be contacted for guidance.

Side Effects

Patients should be aware of several important warnings associated with the use of this product. It is advised that individuals consult a healthcare professional prior to use if they have a history of kidney disease, are on a magnesium-restricted or sodium-restricted diet, are experiencing stomach pain, nausea, or vomiting, or have noticed a sudden change in bowel habits lasting more than one week. Additionally, patients currently taking a prescription medication should seek guidance from a doctor or pharmacist before using this product.

When utilizing this product, it is crucial for patients to adhere to the recommended dosage guidelines and not exceed the maximum daily dosage within a 24-hour period. Failure to follow these recommendations may lead to adverse reactions or complications.

Drug Interactions

Patients are advised to consult a healthcare professional, such as a doctor or pharmacist, prior to using this medication if they are currently taking any prescription drugs. This precaution is essential to identify potential drug interactions that may affect the efficacy or safety of the treatment.

It is important to monitor for any adverse effects or changes in therapeutic outcomes when combining this medication with other prescription therapies. Adjustments to dosage or treatment regimens may be necessary based on the specific interactions identified during consultation.

Packaging & NDC

Below are the non-prescription pack sizes of Gadavyt (magnesium citrate). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Gadavyt.
Details

Pediatric Use

Pediatric patients aged 6 to under 12 years may be administered 1/3 to 1/2 bottle of the product, mixed with a full 8 oz glass of liquid. For children under 6 years of age, it is advised to consult a doctor prior to use.

Geriatric Use

There is no specific information regarding the use of this medication in geriatric patients, including dosage adjustments, safety concerns, or special precautions. Healthcare providers should exercise caution when prescribing this medication to elderly patients, as individual responses may vary. Monitoring for potential adverse effects and therapeutic efficacy is recommended in this population.

Pregnancy

Pregnant patients and those who are breastfeeding should consult a healthcare professional prior to using this medication. It is important to evaluate the potential risks and benefits associated with the use of this drug during pregnancy and lactation. Healthcare providers should consider the available data and individual patient circumstances when advising on the use of this medication in these populations.

Lactation

Lactating mothers are advised to consult a health professional prior to using this medication. There is currently no available data regarding the excretion of this medication 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 the use of 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 information.

Overdosage

In cases of overdosage, it is critical to adhere to the maximum recommended daily dosage to prevent adverse effects. Exceeding this dosage may lead to serious health complications.

Recommended Actions Healthcare professionals should monitor patients closely for any signs of overdosage. If an overdose is suspected, immediate medical attention is warranted. It is essential to assess the patient's condition and provide supportive care as necessary.

Potential Symptoms Symptoms of overdosage may vary depending on the specific medication involved. Common manifestations can include, but are not limited to, gastrointestinal disturbances, neurological symptoms, and cardiovascular irregularities.

Management Procedures Management of an overdose should be tailored to the individual patient and the specific circumstances of the overdose. Supportive measures, including the administration of activated charcoal if appropriate, may be considered. Continuous monitoring of vital signs and symptomatic treatment should be implemented as needed.

In all cases, consultation with a poison control center or a medical toxicologist is recommended to ensure optimal management of the overdosage 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 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 provided data.

Patient Counseling

Healthcare providers should advise patients to keep this medication and all other drugs out of the reach of children to prevent accidental ingestion.

In the event of an accidental overdose, it is crucial for patients to seek professional assistance immediately. They should be informed to contact a Poison Control Center at 1-800-222-1222 for guidance and support.

Storage and Handling

The product is supplied in configurations that include specific NDC numbers. It should be stored at room temperature, ensuring protection from excessive heat and freezing conditions. Healthcare professionals are advised to discard any unused product within 24 hours of opening to maintain safety and efficacy.

Additional Clinical Information

The medication is administered orally, with specific dosing guidelines based on age. For adults and children aged 12 years and older, the recommended dose is between 1/2 to 1 bottle (10 fl. oz.), taken with a full 8 oz glass of liquid. This can be administered as a single daily dose or divided into multiple doses. For children aged 6 to under 12 years, the dose is 1/3 to 1/2 bottle, also accompanied by a full 8 oz glass of liquid. For children under 6 years of age, consultation with a healthcare professional is advised.

Clinicians should counsel patients to seek advice from a health professional if they are pregnant or breastfeeding before using the medication. No additional information is available regarding laboratory tests, abuse potential, or postmarketing experiences.

Drug Information (PDF)

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

View product document (PDF)

Data Generation & Sources

This page was automatically generated and is maintained by the AllDrugs AI Data-Science Team. It was built from the FDA Structured Product Label (DailyMed) for Gadavyt, retrieved by a validated AI data-extraction workflow.

All FDA-listed dosage forms and strengths are shown in the Packaging & NDC Codes section above. Regulatory status appears in the Summary Information panel above and was verified in the FDA National Drug Code directory and the NSDE NDC Directory daily file.

Note: an automated daemon monitors NSDE checksums; when the record for this NDC changes, the new file is pulled instantly and this page is refreshed.

No human clinician has reviewed this version.

Learn more in our Editorial Policy

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Primary FDA sources:

Orange Book data shown on this page are limited to Regulatory Status (Rx), Established Pharmacologic Class (EPC), and Mechanism of Action (MoA).

Regulatory data notice: Information on this page is reproduced verbatim from FDA public databases (NSDE, Orange Book, Purple Book, DailyMed SPL). NDA/ANDA drugs are FDA-approved, BLA biologics are FDA-licensed. Inclusion alone does not guarantee current market availability or imply FDA endorsement.

Medical disclaimer: This AI-generated content is provided for educational purposes only and does not constitute medical advice. Always consult a licensed healthcare professional for diagnosis or treatment decisions.