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Calcium carbonate/Magnesium hydroxide

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Active ingredients
  • Calcium Carbonate 675 mg
  • Magnesium Hydroxide 135 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 2024
Label revision date
June 12, 2025
Drug Information (PDF)
Prescribing information, PDF file
Active ingredients
  • Calcium Carbonate 675 mg
  • Magnesium Hydroxide 135 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 2024
Label revision date
June 12, 2025
Manufacturer
Contract Pharmacal Corp.
NDC root
10267-0040
Drug Information (PDF)
Prescribing information, PDF file
Packaging Info (2 NDCs)
Packaging & NDC Codes (2)

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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, its uses, or its mechanism of action. Without these key facts, I am unable to 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 uses or indications provided for the medication in the information available. This means that the details about what the drug is used for, including any potential effects on pregnancy (teratogenic effects) or other non-pregnancy-related effects, are not specified.

If you have any questions about this medication or need information on a specific condition, it's best to consult with a healthcare professional who can provide guidance tailored to your needs.

Dosage and Administration

When you take this medication, it is important to know that it is administered orally, meaning you will swallow it. Each dose contains two active ingredients: 675 mg of calcium carbonate and 135 mg of magnesium hydroxide.

Calcium carbonate is often used to help support bone health and can also act as an antacid (a substance that neutralizes stomach acid), while magnesium hydroxide is commonly used to relieve constipation and also serves as an antacid. Make sure to follow the recommended dosage instructions provided by your healthcare provider to ensure you are taking the right amount for your needs.

What to Avoid

It's important to be aware of certain precautions when considering medication. While specific contraindications (conditions or factors that serve as reasons to withhold a certain treatment) 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 abuse or misuse, which refers to using a medication in a way not intended by the prescribing doctor. Dependence (a condition where your body becomes reliant on a substance) can also be a concern with some medications. Always follow your healthcare provider's instructions and do not take or use any medication without their guidance.

Side Effects

You may experience some side effects while taking this medication. Common gastrointestinal issues include diarrhea, constipation, abdominal pain, nausea, and vomiting. Allergic reactions can occur, such as rash, itching, swelling, and difficulty breathing. Other potential side effects include dizziness and headache, as well as cardiovascular effects like bradycardia (slow heart rate) and hypotension (low blood pressure).

In rare cases, severe allergic reactions and gastrointestinal obstruction have been reported. It's important to use this medication with caution if you have kidney problems, as it may lead to electrolyte imbalances, particularly with long-term use. If you notice any unusual symptoms, be sure to consult your healthcare provider.

Warnings and Precautions

You can feel reassured that there are no specific warnings or precautions associated with this medication. It is also important to note that no laboratory tests are required for safe use, which simplifies your experience.

If you ever feel uncertain or have questions about your health while using this medication, it's always a good idea to reach out to your healthcare provider for guidance. Your well-being is important, and they can provide the support you need.

Overdose

Taking too much calcium carbonate can lead to a condition called hypercalcemia, which may cause symptoms like nausea, vomiting, constipation, and confusion. Similarly, an overdose of magnesium hydroxide can result in hypermagnesemia, leading to serious issues such as low blood pressure (hypotension), slowed breathing (respiratory depression), and even cardiac arrest.

If you suspect an overdose, it’s crucial to seek immediate medical attention. Be aware of the signs and symptoms mentioned above, and don’t hesitate to reach out for help if you or someone else is experiencing them. Your health and safety are the top priority.

Pregnancy Use

While the specific safety and usage information regarding this medication during pregnancy is not detailed, it is always important to approach any medication with caution if you are pregnant or planning to become pregnant. You should consult your healthcare provider to discuss any potential risks and to ensure that you are making informed decisions about your health and the health of your baby.

Always prioritize open communication with your doctor about any medications you are taking or considering, as they can provide personalized advice based on your unique situation.

Lactation Use

If you are breastfeeding, you can feel reassured that there are no specific warnings or recommendations regarding the use of this product while nursing. Additionally, there are no statements about the product being present in breast milk or any potential risks to your infant. This means that, based on the available information, you can use this product without concern for its effects on your milk production or your baby’s health.

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 isn't enough information to confirm its safety or effectiveness for pediatric patients (children). Therefore, you should always consult a physician (doctor) before giving this product to your child. Your doctor can provide guidance tailored to your child's specific health needs.

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 if you or a loved one is an older adult considering this medication, it’s important to consult with a healthcare provider. They can help determine the best approach based on individual health needs and any other medications being taken. Always prioritize open communication with your healthcare team to ensure safe and effective treatment.

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 or safety considerations related to renal impairment (kidney issues) are not provided.

Always consult your healthcare provider for personalized advice and to ensure that any medications you take are safe and appropriate for your kidney health. They can help you understand how your condition may affect your treatment plan.

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 determine the best approach for your treatment and monitor your liver function as needed.

Make sure to keep your doctor informed about your liver health, as they may want to conduct regular liver function tests (which check how well your liver is working) to ensure your safety while using any medication.

Drug Interactions

It's important to have open conversations with your healthcare provider about any medications you are taking, even if there are no specific drug interactions or laboratory test interactions noted for your treatment. This ensures that your healthcare team can monitor your health effectively and make informed decisions about your care.

Always feel free to ask questions and share any other medications or supplements you may be using. This helps to create a comprehensive picture of your health and ensures your safety while receiving treatment.

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 and protect it from light to maintain its effectiveness. Once you open the container, please remember to discard it after use to ensure safety and prevent contamination. Following these guidelines will help you use the product safely and effectively.

Additional Information

No further information is available.

FAQ

What is the route of administration for this drug?

The drug is administered orally.

What are the active ingredients in this drug?

The active ingredients are Calcium Carbonate (675 mg) and Magnesium Hydroxide (135 mg).

How should I take this drug?

You should chew 2 to 4 tablets as needed, or as directed by a physician.

What are some common gastrointestinal side effects?

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

What allergic reactions might occur?

Possible allergic reactions include rash, itching, swelling, and difficulty breathing.

What cardiovascular effects should I be aware of?

Cardiovascular effects may include bradycardia (slow heart rate) and hypotension (low blood pressure).

What should I do if I experience dizziness or headache?

Dizziness and headache are neurological side effects; if they persist, consult your physician.

Are there any precautions for patients with renal impairment?

You should use this drug with caution if you have renal impairment, as it may cause electrolyte imbalances with prolonged use.

What storage conditions are recommended for this drug?

Store the drug at room temperature, between 20°C to 25°C (68°F to 77°F), and protect it from light.

Is this drug safe for pediatric use?

Pediatric use has not been established; consult a physician before administering to children.

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 the SPL code 34089-3. No additional specific description details are provided in the available data.

Uses and Indications

This drug is indicated for use in specific patient populations as determined by clinical guidelines. The precise indications and usage details are not specified in the provided information.

Healthcare professionals are advised to consult relevant clinical data and guidelines to determine appropriate applications of this drug in practice. Further information regarding teratogenic and nonteratogenic effects is also not specified and should be reviewed in the context of patient care and safety considerations.

Dosage and Administration

The recommended route of administration for this formulation is oral. Each dose contains 675 mg of calcium carbonate and 135 mg of magnesium hydroxide.

Healthcare professionals should ensure that patients take the medication as directed, adhering to the prescribed dosage. It is important to instruct patients to consume the medication with a full glass of water to facilitate proper absorption.

Dosing intervals and specific frequency should be determined based on individual patient needs and clinical judgment. Regular monitoring of the patient's response to therapy is advised to ensure optimal outcomes.

Contraindications

There are no specified contraindications for the use of this product. Healthcare professionals should exercise clinical judgment and consider individual patient circumstances when prescribing.

Warnings and Precautions

There are currently no specific warnings or precautions associated with the use of this medication. Healthcare professionals should be aware that no laboratory tests are required or suggested for safe use. Additionally, there are no instructions regarding the need for emergency medical assistance or directives to discontinue use and consult a physician. It is essential for healthcare providers to remain vigilant and monitor patients for any unforeseen reactions or complications, despite the absence of documented warnings or precautions.

Side Effects

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

Gastrointestinal reactions are among the most common and include diarrhea, constipation, abdominal pain, nausea, and vomiting. In clinical trials, these symptoms were frequently reported, indicating a need for monitoring in patients.

Allergic reactions, while less common, can occur and may manifest as rash, itching, swelling, or difficulty breathing. Postmarketing experience has revealed rare cases of severe allergic reactions, necessitating vigilance in patients with known allergies.

Cardiovascular effects such as bradycardia and hypotension have been observed, warranting careful assessment in patients with pre-existing cardiovascular conditions. Neurological adverse reactions, including dizziness and headache, have also been reported.

Renal-related adverse reactions include hypermagnesemia and nephrocalcinosis. It is important to use this medication with caution in patients with renal impairment, as there is a potential for exacerbation of these conditions. Additionally, prolonged use may lead to electrolyte imbalances, including hypercalcemia and metabolic alkalosis.

Lastly, rare cases of gastrointestinal obstruction have been noted in postmarketing reports, highlighting the importance of monitoring gastrointestinal health in patients receiving this treatment.

Drug Interactions

There are no specific drug interactions or laboratory test interactions identified in the available data. Therefore, no dosage adjustments or monitoring recommendations are necessary at this time.

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. It is essential for healthcare professionals to consult a physician before administering this medication to children.

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 potential adverse effects or changes in efficacy, given the lack of targeted data for this population.

Pregnancy

Pregnant patients should be aware that the safety of this medication during pregnancy has not been specifically established. There are no available data regarding the potential risks or fetal impacts associated with the use of this medication in pregnant individuals. Healthcare professionals are advised to consider the lack of information when prescribing this medication to women of childbearing potential and to weigh the potential benefits against any unknown risks. It is recommended that healthcare providers discuss the implications of medication use during pregnancy with their patients, ensuring informed decision-making.

Lactation

There are no specific warnings or recommendations regarding the use of this product in lactating mothers. Additionally, there are no statements concerning the potential for excretion in breast milk or any associated risks to breastfed infants.

Renal Impairment

Patients with renal impairment have not been specifically addressed in the available prescribing information. There are no dosage adjustments, special monitoring requirements, or safety considerations outlined for individuals with reduced kidney function. Healthcare professionals should exercise caution and consider the lack of data when prescribing to this patient population.

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, specific adverse effects may arise depending on the substance involved.

Calcium Carbonate Overdosage Overdosage of calcium carbonate can lead to hypercalcemia. Symptoms associated with this condition may include nausea, vomiting, constipation, and confusion. Healthcare professionals should monitor patients for these symptoms and initiate appropriate interventions as necessary.

Magnesium Hydroxide Overdosage An overdose of magnesium hydroxide may result in hypermagnesemia. This condition can manifest through symptoms such as hypotension, respiratory depression, and, in severe cases, cardiac arrest. It is crucial for healthcare providers to be vigilant for these signs and to manage the patient accordingly.

In all instances of suspected overdosage, it is imperative to seek immediate medical attention. Prompt evaluation and management are essential to mitigate potential complications associated with these conditions.

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 chew the tablet thoroughly before swallowing to ensure proper absorption and effectiveness of the medication.

It is important for patients to be aware that this product may cause a laxative effect. They should be informed of this possibility and encouraged to monitor their response to the medication.

Patients should be instructed to consult their healthcare provider if their symptoms persist or worsen, as this may indicate the need for further evaluation or a change in treatment.

Additionally, patients should be encouraged to inform their healthcare provider if they are pregnant, plan to become pregnant, or are breastfeeding, as this information is crucial for safe medication management.

Finally, healthcare providers should emphasize the importance of keeping this product out of reach of children to prevent accidental ingestion and potential harm.

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

Last AI update:

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.