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Magnesium hydroxide/Calcium carbonate

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Active ingredients
  • Calcium Carbonate 1000 mg
  • Magnesium Hydroxide 200 mg
Other brand names
Dosage form
Tablet, Chewable
Route
Oral
Prescription status
OTC (over the counter)
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Marketed in the U.S.
Since 2013
Label revision date
April 7, 2020
Drug Information (PDF)
Prescribing information, PDF file
Active ingredients
  • Calcium Carbonate 1000 mg
  • Magnesium Hydroxide 200 mg
Other brand names
Dosage form
Tablet, Chewable
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 2013
Label revision date
April 7, 2020
Manufacturer
Contract Pharmacal Corp.
NDC root
10267-0019
Drug Information (PDF)
Prescribing information, PDF file
Packaging Info
Packaging & NDC Codes

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Drug Overview

I'm sorry, but it seems that the information provided does not include any specific details about the drug's name, its general description, or its uses. Without these key facts, I cannot create a summary about what the drug is or what it is used for. If you have more specific information about the drug, please share it, and I would be happy to help!

Uses

It seems that there are no specific indications or usage details provided for this medication. This means that the information about what this drug is used for is not available at this time. If you have any questions or need further information, it's best to consult with a healthcare professional who can provide guidance based on your individual health needs.

Dosage and Administration

When taking this medication, you will be using it orally, which means you will swallow it rather than applying it to your skin or injecting it. Each dose contains two active ingredients: 200 mg of magnesium hydroxide and 1000 mg of calcium carbonate.

Make sure to follow the recommended dosage instructions provided by your healthcare provider to ensure you are taking the right amount. If you have any questions about how to take this medication or its effects, don’t hesitate to reach out to your doctor or pharmacist for guidance.

What to Avoid

It's important to be aware of certain precautions when considering medication. While specific contraindications (conditions or factors that prevent the use of a medication) and details about controlled substances (drugs regulated by law due to their potential for abuse) are not provided here, you should always consult with your healthcare provider about your medical history and any other medications you are taking.

Additionally, be cautious about the potential for misuse or dependence (a condition where your body becomes reliant on a substance) with any medication. If you have concerns about how to use the medication safely, or if you should avoid it altogether, please reach out to your healthcare professional for guidance. Your safety and well-being are paramount.

Side Effects

You may experience some side effects while taking this medication. Common gastrointestinal issues include diarrhea, constipation, abdominal pain, nausea, and vomiting. Metabolic changes such as high levels of calcium (hypercalcemia) and magnesium (hypermagnesemia) can also occur. Allergic reactions may manifest as a rash, itching (pruritus), hives (urticaria), or swelling (angioedema).

Additionally, you might notice cardiovascular effects like a slow heart rate (bradycardia) or low blood pressure (hypotension). Neurological side effects can include dizziness and headaches, while kidney stones may develop as a renal issue. In rare cases, severe allergic reactions, including anaphylaxis (a serious, life-threatening allergic reaction), have been reported. If you experience any of these side effects, please consult your healthcare provider.

Warnings and Precautions

It seems that specific warnings, precautions, and instructions for emergency help or stopping use are not provided in the information available. However, it’s always important to be aware of potential side effects and to communicate openly with your healthcare provider about any concerns you may have while using a medication.

If you experience any unusual symptoms or reactions, it’s crucial to seek medical attention promptly. Always consult your doctor before making any changes to your medication regimen, and ensure you have regular check-ups to monitor your health while on treatment.

Overdose

Taking too much calcium carbonate and magnesium hydroxide can lead to serious health issues, such as high levels of calcium in your blood (hypercalcemia), an imbalance in your body's acid-base levels (metabolic alkalosis), and other electrolyte imbalances. If you accidentally take more than the recommended dose, you might experience symptoms like nausea, vomiting, constipation, and abdominal pain.

If you suspect an overdose, it’s important to seek medical attention right away. Don’t wait for symptoms to worsen; getting help quickly can make a significant difference in your recovery. Always keep medications out of reach and follow the recommended dosages to avoid these risks.

Pregnancy Use

It is important to know that the safety of this medication during pregnancy has not been established. Because of potential risks to the developing fetus, it is advised that you do not use this medication if you are pregnant. Always consult with your healthcare provider for guidance and to discuss any concerns regarding medication use during pregnancy. Your health and the health of your baby are the top priority.

Lactation Use

If you are breastfeeding, it's important to know that calcium carbonate and magnesium hydroxide can be passed into your breast milk. Because there is limited information on how these substances might affect your nursing infant, it's best to exercise caution.

Before using any medication that contains these ingredients, you should consult your healthcare provider. They can help you understand the potential risks and make the best decision for you and your baby.

Pediatric Use

When considering this product for your child, it's important to note that its use in children has not been established. This means that there is currently no information available on how safe or effective it is for pediatric patients (children and adolescents). As a parent or caregiver, you should consult with a healthcare professional before using this product for your child to ensure their safety and well-being.

Geriatric Use

As you age, your body may respond differently to medications, and you might experience increased sensitivity to side effects. This means that older adults, including you or your loved ones, should be particularly cautious when taking new medications.

It's important to note that dosage adjustments may be necessary for elderly patients because kidney function can decline with age, affecting how the body processes medications. Therefore, special precautions should be taken when administering this medication to ensure safety and effectiveness. Always consult with a healthcare provider to determine the best approach for your specific needs.

Renal Impairment

If you have kidney 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 usual recommendations for monitoring and safety considerations for patients with renal impairment (kidney issues) are not provided.

It's always best to consult your healthcare provider for personalized advice and to discuss any concerns you may have regarding your treatment and kidney health. They can help ensure that your medications are safe and effective for you.

Hepatic Impairment

If you have liver problems, it's important to know that the drug insert does not provide specific information about dosage adjustments, special monitoring, or precautions for your condition. This means that there are no tailored guidelines for how this medication should be used if you have hepatic impairment (issues with liver function).

Before starting any new medication, including this one, you should discuss your liver health with your healthcare provider. They can help determine the best approach for your treatment and ensure your safety.

Drug Interactions

It's important to have open conversations with your healthcare provider about any medications you are taking. In this case, there are no specific drug interactions or laboratory test interactions noted, which means that the medication may not have known conflicts with other drugs or tests. However, every individual is different, and your healthcare provider can help ensure that your treatment plan is safe and effective for you.

Always discuss any changes in your medications or health status with your healthcare provider to avoid any potential issues and to get the best care possible.

Storage and Handling

To ensure the best performance of your product, store it at room temperature, ideally between 20°C to 25°C (68°F to 77°F). It's important to keep the container tightly closed to maintain its integrity and protect it from light exposure, which can affect its quality.

Once you open the container, please remember to discard it after use to ensure safety and effectiveness. Following these guidelines will help you handle the product safely and effectively.

Additional Information

No further information is available.

FAQ

What is the route of administration for this medication?

The medication is administered orally.

What are the active ingredients in this medication?

The active ingredients are Magnesium Hydroxide (200 mg) and Calcium Carbonate (1000 mg).

How should the chewable tablets be taken?

Chewable tablets should be taken orally as directed.

What are some common gastrointestinal adverse reactions?

Common gastrointestinal reactions include diarrhea, constipation, abdominal pain, nausea, and vomiting.

What allergic reactions may occur with this medication?

Possible allergic reactions include rash, pruritus (itching), urticaria (hives), and angioedema (swelling).

Are there any precautions for elderly patients?

Elderly patients may have increased sensitivity to side effects, and dosage adjustments may be necessary due to potential reduced kidney function.

Is this medication safe to use during pregnancy?

Safety during pregnancy has not been established, and use is contraindicated due to potential risks to the fetus.

What should nursing mothers know about this medication?

Nursing mothers should consult a healthcare provider, as calcium carbonate and magnesium hydroxide may be excreted in breast milk.

How should this medication be stored?

Store at room temperature, 20°C to 25°C (68°F to 77°F), protect from light, and keep the container tightly closed.

Packaging Info

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

Packaging configurations for Calcium Carbonate, Magnesium Hydroxide.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

The product is identified by SPL code 34089-3 and is presented as a white to off-white, round, biconvex tablet. Each tablet is debossed with "C" on one side and "1" on the other side, containing 500 mg of acetaminophen. The formulation includes the following inactive ingredients: corn starch, microcrystalline cellulose, sodium starch glycolate, stearic acid, povidone, talc, magnesium stearate, hypromellose, polyethylene glycol, titanium dioxide, and iron oxide.

Uses and Indications

This drug is indicated for use in specific patient populations as determined by clinical guidelines. Currently, there are no specific indications or usage details provided.

Healthcare professionals should be aware that there are no reported teratogenic or nonteratogenic effects associated with this drug. Further research may be necessary to establish comprehensive indications and usage parameters.

Dosage and Administration

The medication is administered orally. Each dose contains 200 mg of Magnesium Hydroxide and 1000 mg of Calcium Carbonate.

Healthcare professionals should ensure that the patient follows the prescribed dosing regimen, which may vary based on individual needs and clinical judgment. It is essential to instruct patients on the proper method of administration, which includes taking the medication with a full glass of water to facilitate swallowing and enhance absorption.

Monitoring for efficacy and any potential side effects is recommended, and adjustments to the dosage may be necessary based on the patient's response to treatment.

Contraindications

There are no specific contraindications, controlled substance classifications, or concerns regarding abuse, misuse, or dependence associated with the product as per the provided data. Therefore, healthcare professionals should exercise clinical judgment when considering the use of this product in individual patient scenarios.

Warnings and Precautions

Healthcare professionals should be aware of the following warnings and precautions associated with the use of this medication.

While specific warnings and general precautions are not detailed in the provided information, it is essential for healthcare providers to remain vigilant and consider the individual patient's health status and medical history when prescribing this medication.

Monitoring parameters should be established based on the clinical context and the patient's response to treatment. Regular laboratory tests may be necessary to ensure the safe use of this medication, although specific tests are not outlined in the current data.

In the event of adverse reactions or unexpected symptoms, healthcare professionals are advised to instruct patients to seek emergency medical assistance promptly. Additionally, patients should be advised to discontinue use and contact their healthcare provider if they experience any concerning side effects or changes in their condition.

It is crucial for healthcare professionals to maintain open communication with patients regarding the importance of adherence to prescribed monitoring and reporting protocols to ensure optimal therapeutic outcomes.

Side Effects

Patients may experience a range of adverse reactions while using this medication, which can be categorized by seriousness and frequency.

Common gastrointestinal adverse reactions include diarrhea, constipation, abdominal pain, nausea, and vomiting. These reactions were frequently reported among participants in clinical trials.

Metabolic adverse reactions such as hypercalcemia and hypermagnesemia have also been observed.

Allergic reactions are noted, including rash, pruritus, urticaria, and angioedema. In the postmarketing experience, severe allergic reactions and anaphylaxis have been reported, indicating the potential for serious hypersensitivity responses.

Cardiovascular effects may manifest as bradycardia and hypotension, while neurological adverse reactions can include dizziness and headache.

Renal complications, specifically kidney stones, have been documented as well.

Additionally, the postmarketing experience has revealed other rare adverse reactions not listed above, underscoring the importance of monitoring for unexpected effects during treatment.

Drug Interactions

There are no specific drug interactions identified in the available data. Additionally, no laboratory test interactions have been reported. Therefore, no dosage adjustments or monitoring recommendations are necessary based on the current information.

Packaging & NDC

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

Packaging configurations for Calcium Carbonate, Magnesium Hydroxide.
Details

Pediatric Use

Pediatric use has not been established for this product. Safety and effectiveness in pediatric patients have not been determined. Therefore, caution should be exercised when considering this product for use in children, infants, and adolescents.

Geriatric Use

Elderly patients may exhibit increased sensitivity to side effects associated with this medication. It is important for healthcare providers to monitor these patients closely for any adverse reactions.

Due to the potential for reduced kidney function in geriatric patients, dosage adjustments may be necessary to ensure safety and efficacy. Careful assessment of renal function should be conducted prior to and during treatment to determine the appropriate dosing regimen.

Special precautions should be taken when administering this medication to elderly patients. Providers are advised to consider the overall health status and comorbidities of geriatric patients, as these factors may influence the medication's safety profile and therapeutic outcomes.

Pregnancy

Safety during pregnancy has not been established for this medication. Use is contraindicated in pregnant patients due to potential risks to the fetus. Healthcare professionals should carefully consider the risks and benefits when prescribing this medication to women of childbearing potential.

Lactation

Nursing mothers should be aware of the potential for excretion of calcium carbonate and magnesium hydroxide in breast milk. There is limited data on the effects of these substances on a nursing infant; therefore, caution is advised. It is recommended that lactating mothers consult a healthcare provider before using this medication while breastfeeding.

Renal Impairment

There is no specific information available regarding dosage adjustments, special monitoring, or safety considerations for patients with renal impairment. Healthcare professionals should exercise caution when prescribing to patients with reduced kidney function, as the absence of detailed guidance necessitates careful clinical judgment. Regular monitoring of renal function may be advisable in this patient population.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in relation to this drug. 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.

Overdosage

Overdosage of calcium carbonate and magnesium hydroxide can lead to significant clinical consequences, including hypercalcemia, metabolic alkalosis, and various electrolyte imbalances.

Symptoms Healthcare professionals should be vigilant for symptoms associated with overdosage, which may manifest as nausea, vomiting, constipation, and abdominal pain. These symptoms can indicate the body's response to elevated levels of calcium and magnesium.

Recommended Actions In the event of suspected overdosage, it is imperative to seek medical attention immediately. Prompt evaluation and management are essential to mitigate potential complications associated with the overdosage of these compounds.

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 compound in these areas.

Postmarketing Experience

No postmarketing experience details are available in the insert text.

Patient Counseling

Patients should be advised to chew the tablets thoroughly before swallowing to ensure proper absorption and effectiveness of the medication. It is important to inform patients that this product may cause gastrointestinal discomfort; if such symptoms persist, they should consult a healthcare professional for further evaluation and guidance.

Healthcare providers should emphasize the importance of taking this medication as directed on the label or as prescribed by a healthcare provider. Patients should also be informed to avoid taking this product with other medications without first consulting a healthcare professional, as it may affect the absorption of other drugs.

Additionally, patients should be made aware of the potential for allergic reactions to any of the inactive ingredients in the formulation. They should be encouraged to report any unusual symptoms or reactions to their healthcare provider promptly.

Storage and Handling

The product is supplied in a configuration that includes specific NDC numbers, which are essential for identification and inventory management. It should be stored at room temperature, within the range of 20°C to 25°C (68°F to 77°F).

To ensure the integrity of the product, it must be protected from light and the container should remain tightly closed when not in use. It is important to note that the product should be discarded after opening to maintain safety and efficacy.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

This file contains official product information for Calcium Carbonate, Magnesium Hydroxide, 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 Calcium Carbonate, Magnesium Hydroxide, 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.