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Calcium carbonate

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This product has been discontinued

Active ingredient
Calcium Carbonate 1250 mg/5 mL
Other brand names
Dosage form
Suspension
Route
Oral
Prescription status
OTC (over the counter)
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Marketed in the U.S.
Since 2004
Label revision date
July 8, 2021
Drug Information (PDF)
Prescribing information, PDF file
Active ingredient
Calcium Carbonate 1250 mg/5 mL
Other brand names
Dosage form
Suspension
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 2004
Label revision date
July 8, 2021
Manufacturer
PINNACLE PHARMA LLC
Registration number
part331
NDC root
81646-112
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

Calcium Carbonate Oral Suspension is a maximum strength antacid that provides relief from heartburn, acid indigestion, sour stomach, and upset stomach associated with these symptoms. Each 5 mL serving contains 1250 mg of calcium carbonate, which is equivalent to 500 mg of elemental calcium. This sugar-free, alcohol-free, and sodium-free formulation is designed to help soothe your stomach discomfort effectively.

Uses

If you're experiencing discomfort from heartburn, acid indigestion, sour stomach, or an upset stomach related to these symptoms, this medication can help relieve your discomfort. It’s designed to ease these common digestive issues, allowing you to feel more comfortable throughout your day.

Rest assured, there are no known teratogenic effects (which means it doesn't cause birth defects) associated with this medication, making it a safer option for those concerned about such risks.

Dosage and Administration

Before using the medication, make sure to shake the bottle well. This helps to mix the ingredients properly. When you're ready to take it, you can measure out 1 to 2 teaspoonfuls, which is equivalent to 5 to 10 milliliters (mL). You should take this dosage as your symptoms arise, or follow your doctor's specific instructions if they have provided any.

It's important to pay attention to how often you need to take the medication based on your symptoms. Always consult with your healthcare provider if you have any questions or concerns about your dosage.

What to Avoid

It's important to use this medication responsibly to ensure your safety and well-being. You should not take more than 6 teaspoonfuls (30 mL) within a 24-hour period, and avoid using the maximum dosage for longer than 2 weeks. Following these guidelines helps prevent potential issues related to misuse or dependence (a condition where your body becomes reliant on a substance). Always prioritize your health by adhering to these recommendations.

Side Effects

When using this product, it's important to be aware of potential side effects. Some individuals may experience adverse reactions, which can vary in severity. If you notice any unusual symptoms, it's best to consult with a healthcare professional.

Additionally, please remember not to exceed 6 teaspoonfuls (30 mL) in a 24-hour period, and avoid using the maximum dosage for more than 2 weeks. Always keep this product out of reach of children to ensure their safety.

Warnings and Precautions

Before using this product, it's important to consult with your doctor or pharmacist, especially if you are currently taking any prescription medications, as antacids can interact with them.

Be cautious not to exceed 6 teaspoonfuls (30 mL) in a 24-hour period, and avoid using the maximum dosage for more than 2 weeks. Always keep this product out of reach of children to ensure their safety. If you experience any unusual symptoms or side effects, stop using the product and contact your doctor immediately.

Overdose

If you suspect an overdose, it's important to stay calm and take immediate action. While there is no specific information available about the signs of overdose for this medication, general symptoms can include unusual drowsiness, confusion, or difficulty breathing. If you notice any of these signs, or if you are unsure, seek medical help right away.

In case of an overdose, contact your local emergency services or go to the nearest hospital. It's always better to be safe and get checked by a healthcare professional if you have any concerns about your health. Remember, timely intervention can make a significant difference.

Pregnancy Use

While the information provided does not specify any particular safety concerns or dosage modifications for pregnant individuals, it is always important to consult with your healthcare provider before taking any medication during pregnancy. They can offer personalized advice based on your health and circumstances.

Since there are no special precautions mentioned regarding use during pregnancy, maintaining open communication with your doctor about any medications you are considering is essential for your safety and the health of your baby.

Lactation Use

If you are breastfeeding, you can feel reassured that there are no specific warnings or recommendations regarding the use of Calcium Carbonate for nursing mothers. Additionally, the information available does not highlight any particular considerations or precautions related to lactation. This suggests that Calcium Carbonate is generally considered safe for use while breastfeeding. However, it's always a good idea to consult with your healthcare provider if you have any concerns or questions about medications during this time.

Pediatric Use

It's important to keep this medication out of reach of children to prevent accidental ingestion. The packaging is designed as a unit-dose, which means it contains a single dose, but it is not child-resistant. This means that children may be able to open it easily, so extra caution is necessary to ensure their safety. Always supervise and store medications securely to avoid any potential risks.

Geriatric Use

While there is no specific information about the use of Calcium Carbonate Oral Suspension in older adults, it’s important to approach any medication with caution. Since the drug insert does not mention dosage adjustments or safety concerns for elderly patients, you should consult with a healthcare provider before starting this medication. They can help determine if it’s appropriate for you or your loved one, considering any unique health needs or conditions. 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 the information provided does not include specific guidelines for dosage adjustments, special monitoring, or safety considerations related to renal impairment (kidney issues). This means that there are no tailored recommendations for how your treatment may need to change based on your kidney function.

Always consult your healthcare provider for personalized advice and to ensure that your treatment plan is safe and effective for your specific situation. They can help monitor your kidney health and make any necessary adjustments to your medications.

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 course of action 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 be aware that antacids, which are commonly used to relieve heartburn and indigestion, can interact with some prescription medications. This means that taking antacids at the same time as certain drugs may affect how well those medications work.

To ensure your safety and the effectiveness of your treatment, always discuss any medications you are taking, including over-the-counter products like antacids, with your healthcare provider. They can help you understand potential interactions and adjust your treatment plan if necessary.

Storage and Handling

To ensure the best performance of your product, store it at a temperature between 20° and 25°C (68° and 77°F). It's important to keep it away from freezing temperatures, as freezing can damage the product.

When handling the product, make sure to do so in a clean environment to maintain its integrity. Always follow any specific instructions provided for safe use and disposal to ensure your safety and the product's effectiveness.

Additional Information

You should take this medication orally, using 1 to 2 teaspoonfuls (5 to 10 mL) as needed for your symptoms or as directed by your doctor. There are no additional details available regarding laboratory tests, abuse potential, or patient counseling.

FAQ

What is Calcium Carbonate Oral Suspension used for?

Calcium Carbonate Oral Suspension is an antacid that relieves heartburn, acid indigestion, sour stomach, and upset stomach associated with these symptoms.

What is the usual dosage for Calcium Carbonate Oral Suspension?

You should take 1 to 2 teaspoonfuls (5 to 10 mL) as symptoms occur, or as directed by a doctor. Do not exceed 6 teaspoonfuls (30 mL) in a 24-hour period or use the maximum dosage for more than 2 weeks.

Are there any contraindications for using Calcium Carbonate Oral Suspension?

No specific contraindications are mentioned for Calcium Carbonate Oral Suspension.

Is Calcium Carbonate Oral Suspension safe to use during pregnancy?

The provided information does not specify any safety concerns or dosage modifications for pregnant individuals.

Can Calcium Carbonate Oral Suspension be used by nursing mothers?

There are no specific warnings or recommendations regarding the use of Calcium Carbonate in nursing mothers mentioned.

What precautions should I take when using Calcium Carbonate Oral Suspension?

Keep out of reach of children, and ask a doctor or pharmacist before use if you are taking a prescription drug, as antacids may interact with certain medications.

How should I store Calcium Carbonate Oral Suspension?

Store the suspension at 20° - 25°C (68° - 77°F) and do not freeze.

What should I do before using Calcium Carbonate Oral Suspension?

Shake well before use and ensure you do not exceed the recommended dosage.

Packaging Info

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

Packaging configurations for Calcium Carbonate.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

Calcium Carbonate Oral Suspension is a maximum strength formulation containing 1250 mg of calcium carbonate per 5 mL, which is equivalent to 500 mg of elemental calcium. This product is sugar-free, alcohol-free, and sodium-free, serving as an antacid. It is packaged in a unit-dose format consisting of 10 x 5 mL cups. The suspension requires shaking before use and is not child-resistant. It should be stored at a temperature range of 20° - 25°C (68° - 77°F). The product is manufactured by Pinnacle Pharma LLC, located in Charlotte, NC 28217.

Uses and Indications

This drug is indicated for the relief of heartburn, acid indigestion, sour stomach, and upset stomach associated with these symptoms.

There are no teratogenic or nonteratogenic effects associated with this drug.

Dosage and Administration

Healthcare professionals are advised to instruct patients to shake the product well before use. The recommended dosage is 1 to 2 teaspoonfuls (5 to 10 mL) to be taken as symptoms occur, or as directed by a physician. It is essential to follow the prescribed dosing regimen to ensure optimal therapeutic outcomes.

Contraindications

There are no specified contraindications for this product. However, it is advised that patients do not exceed a dosage of 6 teaspoonfuls (30 mL) within a 24-hour period or use the maximum dosage for more than 2 weeks to avoid potential adverse effects.

Warnings and Precautions

It is imperative that healthcare professionals advise patients to consult with a physician or pharmacist prior to using this product if they are currently taking any prescription medications, as antacids may interact with certain drugs, potentially altering their efficacy or safety.

In terms of general precautions, it is essential to adhere to the recommended dosage guidelines. Patients should not exceed 6 teaspoonfuls (30 mL) within a 24-hour period, and the maximum dosage should not be utilized for longer than 2 weeks. This is crucial to prevent potential adverse effects associated with overuse.

Additionally, it is vital to ensure that this product is stored out of reach of children to prevent accidental ingestion, which could lead to serious health risks.

Side Effects

When using this product, patients should adhere to the recommended dosage guidelines, which specify not to exceed 6 teaspoonfuls (30 mL) in a 24-hour period or to use the maximum dosage for more than 2 weeks. Failure to follow these instructions may lead to adverse reactions.

It is crucial to keep this product out of reach of children to prevent accidental ingestion, which could result in serious health consequences.

The potential adverse reactions associated with this product have not been explicitly detailed in the provided information. However, it is important for patients to be aware of the risks associated with exceeding the recommended dosage and to monitor for any unusual symptoms or reactions during use.

Drug Interactions

Antacids may interact with various prescription medications, potentially affecting their absorption and efficacy. It is advisable to separate the administration of antacids and other medications by at least two hours to minimize the risk of interaction. Monitoring for therapeutic effectiveness of the affected medications is recommended when antacids are used concurrently.

Packaging & NDC

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

Packaging configurations for Calcium Carbonate.
Details

Pediatric Use

Pediatric patients should be advised to keep this medication out of reach of children. It is important to note that the unit-dose package is not child-resistant, which may pose a risk of accidental ingestion. Healthcare professionals should ensure that caregivers are aware of these safety considerations to prevent potential harm to pediatric patients.

Geriatric Use

Elderly patients may not have specific dosage adjustments, safety concerns, or special precautions outlined in the drug insert for Calcium Carbonate Oral Suspension. As such, healthcare providers should exercise clinical judgment when prescribing this medication to geriatric patients, considering the individual health status and potential comorbidities that may influence treatment outcomes. Regular monitoring may be warranted to ensure safety and efficacy in this population, given the absence of targeted data.

Pregnancy

Pregnant patients may use this medication as no specific safety concerns regarding pregnancy have been detailed in the prescribing information. There are no dosage modifications recommended for pregnant individuals, nor are there any special precautions regarding its use during pregnancy. Healthcare professionals should continue to evaluate the benefits and risks when prescribing this medication to women of childbearing potential.

Lactation

There are no specific warnings or recommendations regarding the use of Calcium Carbonate in lactating mothers. Additionally, there are no specific considerations or precautions related to lactation mentioned in the provided text. Therefore, healthcare professionals may consider the use of Calcium Carbonate in nursing mothers without specific concerns related to breastfeeding.

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

There is no information available regarding the use of this medication in patients with hepatic impairment. Consequently, there are no dosage adjustments, special monitoring requirements, or precautions specified for individuals with compromised liver function. Healthcare professionals should exercise clinical judgment when considering the use of this medication in patients with liver problems, as the absence of data may necessitate careful monitoring and assessment of liver function.

Overdosage

In the absence of specific information regarding overdosage, healthcare professionals are advised to exercise caution and adhere to general principles of management in cases of suspected overdose.

It is essential to monitor the patient closely for any potential symptoms that may arise from an overdose. Symptoms can vary widely depending on the substance involved and the individual patient's response.

In the event of an overdose, immediate medical attention should be sought. Healthcare providers should implement supportive care measures, which may include maintaining airway patency, providing supplemental oxygen, and monitoring vital signs.

Additionally, it is recommended to consult local poison control centers or relevant toxicology resources for guidance on specific management protocols and antidotes, if applicable.

Documentation of the incident, including the substance involved, estimated dose, and time of exposure, is crucial for effective management and follow-up care.

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 question. Further studies may be necessary to elucidate these aspects of nonclinical toxicology.

Postmarketing Experience

Serious side effects have been reported voluntarily or through surveillance programs. Healthcare professionals and patients are encouraged to report any serious adverse events to the designated phone number for further evaluation and monitoring.

Patient Counseling

Healthcare providers should advise patients to keep this product out of reach of children to prevent accidental ingestion.

Patients should be informed about the importance of adhering to the recommended dosage guidelines. Specifically, they should not exceed 6 teaspoonfuls (30 mL) within a 24-hour period and should avoid using the maximum dosage for more than 2 weeks.

Additionally, it is crucial for patients to consult with their healthcare provider or pharmacist before using this product if they are currently taking any prescription medications. This is particularly important as antacids may interact with certain prescription drugs, potentially affecting their efficacy or safety.

Storage and Handling

The product is supplied in various package configurations, with specific NDC numbers available upon request. It should be stored at a temperature range of 20° to 25°C (68° to 77°F). Freezing is not permitted, as it may compromise the integrity of the product. Proper container requirements must be adhered to, ensuring that the product is kept in a suitable environment to maintain its efficacy. Special handling needs should be observed to prevent any damage or degradation during storage.

Additional Clinical Information

The medication is administered orally, with a recommended dosage of 1 to 2 teaspoonfuls (5 to 10 mL) taken as symptoms occur or as directed by a healthcare professional. There are no additional details available regarding laboratory tests, abuse information, patient counseling, or postmarketing experience.

Drug Information (PDF)

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