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Titralac

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This product has been discontinued

Active ingredient
Calcium Carbonate 420 mg
Other brand names
Dosage form
Tablet
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
May 1, 2011
Drug Information (PDF)
Prescribing information, PDF file
Active ingredient
Calcium Carbonate 420 mg
Other brand names
Dosage form
Tablet
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
May 1, 2011
Manufacturer
iNova Pharmaceuticals Pty, Ltd
Registration number
part331
NDC root
55298-038
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

Titralac™ is an antacid that helps relieve discomfort caused by heartburn, sour stomach, and acid indigestion. It is calcium-rich, sugar-free, and contains very low levels of aluminum and sodium, making it a suitable option for those looking for a gentle way to manage their symptoms. Available in a refreshing spearmint flavor, Titralac™ has been providing fast relief since its introduction on May 1, 2011.

Uses

If you're experiencing discomfort from heartburn, a sour stomach, or acid indigestion, this medication can help relieve those symptoms. It works effectively to ease the burning sensation and discomfort that often accompany these digestive issues.

You can feel confident using this medication, as there are no known teratogenic effects (which means it doesn't cause birth defects) or nonteratogenic effects associated with it. This makes it a safe option for many individuals seeking relief from these common gastrointestinal problems.

Dosage and Administration

You can take this medication by chewing, swallowing, or letting two tablets dissolve in your mouth every two to three hours as needed for your symptoms or as your doctor advises. It's important to pay attention to how often you take it to avoid any issues.

Make sure not to exceed 19 tablets in a 24-hour period, and avoid using the maximum dosage for more than two weeks. Following these guidelines will help ensure you use the medication safely and effectively.

What to Avoid

It's important to be aware of certain guidelines when using this medication. While there are no specific contraindications or concerns about abuse, misuse, or dependence, you should stop using the medication and consult your doctor if your symptoms persist for more than two weeks. This ensures that you receive the appropriate care and support for your health needs. Always prioritize your well-being and seek professional advice when necessary.

Side Effects

Before using this medication, it's important to consult with your doctor or pharmacist, especially if you are currently taking any prescription drugs, as antacids can interact with them. If your symptoms persist for more than two weeks, you should stop using the medication and seek medical advice. Additionally, make sure to keep this product out of reach of children to ensure their safety.

Warnings and Precautions

Before using this medication, it's important to consult with your doctor or pharmacist, especially if you are currently taking any prescription drugs. Some antacids can interact with these medications, so it's best to ensure it's safe for you.

If your symptoms persist for more than two weeks, you should stop taking the medication and reach out to your doctor for further advice. While there are no specific emergency instructions provided, always seek immediate medical help if you experience severe or concerning symptoms.

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.

Pregnancy Use

When it comes to using TITRALAC (calcium carbonate tablet) during pregnancy, there is currently no specific information available about its safety, recommended dosage adjustments, or any special precautions you should take. This means that if you are pregnant or planning to become pregnant, it’s important to consult with your healthcare provider before using this medication. They can help you weigh the potential benefits and risks based on your individual health needs. Always prioritize open communication with your doctor regarding any medications you consider during pregnancy.

Lactation Use

If you are breastfeeding, you can feel reassured that there are no specific warnings or recommendations regarding nursing mothers or lactation in the information provided. This means that, based on the available data, there are no known risks associated with breastfeeding while using this medication. However, it's always a good idea to consult with your healthcare provider if you have any concerns or questions about your specific situation.

Pediatric Use

It's important to keep this medication out of reach of children. This precaution helps prevent accidental ingestion, which can be dangerous. Always store it in a safe place where children cannot access it, ensuring their safety at all times. If you have any concerns or questions about the medication, don't hesitate to reach out to your healthcare provider for guidance.

Geriatric Use

While there is no specific information about the use of TITRALAC (calcium carbonate tablet) 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 TITRALAC is 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 issues, it's important to know that there are no specific guidelines provided for dosage adjustments, special monitoring, or safety considerations related to your condition. This means that the information available does not outline any particular changes you may need to make regarding your treatment.

Always consult with your healthcare provider for personalized advice and to ensure that your treatment plan is safe and effective for your kidney health. They can help you understand how your condition may affect your medication and what steps to take for your well-being.

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 may affect you differently due to your liver health.

Always consult your healthcare provider for personalized advice and to discuss any concerns you may have regarding your liver function and how it relates to your treatment. They can help ensure that your medication is safe and effective for you.

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 quality and safety of your product, store it at room temperature and keep it away from direct light. It's important to keep the bottle tightly closed when not in use to maintain its integrity. For your protection, you’ll notice a printed foil seal under the cap; this seal helps ensure that the product has not been tampered with before you use it.

By following these simple storage and handling guidelines, you can help ensure that the product remains effective and safe for your use.

Additional Information

You should take this medication orally, either by chewing, swallowing, or letting it melt in your mouth. The recommended dosage is two tablets every two to three hours as needed for symptoms, but be careful not to exceed 19 tablets in a 24-hour period. Additionally, do not use the maximum dosage for more than two weeks without consulting your physician.

FAQ

What is Titralac™?

Titralac™ is an antacid that is calcium-rich, sugar-free, low in aluminum, and very low in sodium.

What symptoms does Titralac™ relieve?

Titralac™ relieves heartburn, sour stomach, and acid indigestion.

How should I take Titralac™?

You should chew, swallow, or let melt in your mouth two tablets every two or three hours as symptoms occur or as directed by a physician.

What is the maximum dosage for Titralac™?

Do not take more than 19 tablets in a 24-hour period or use the maximum dosage for more than two weeks.

Are there any contraindications for using Titralac™?

No specific contraindications are mentioned for Titralac™.

Can I use Titralac™ if I am taking other prescription drugs?

You should ask a doctor or pharmacist before use if you are taking a prescription drug, as antacids may interact with certain medications.

Is Titralac™ safe to use during pregnancy or while nursing?

There is no specific information regarding the use of Titralac™ during pregnancy or nursing in the provided text.

What should I do if my symptoms last more than two weeks?

Stop use and ask a doctor if your symptoms last for more than two weeks.

How should I store Titralac™?

Store Titralac™ at room temperature, protect it from light, and keep the bottle tightly closed.

What flavor does Titralac™ come in?

Titralac™ is available in a spearmint flavor.

What is the packaging size of Titralac™?

Titralac™ is available in a bottle containing 100 tablets.

What should I do if I have children at home?

Keep Titralac™ out of reach of children.

Packaging Info

Below are the non-prescription pack sizes of Titralac (calcium carbonate). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Titralac.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

Titralac™ is an antacid formulation designed to provide fast relief from heartburn and indigestion. Each tablet is sugar-free, low in aluminum, and contains very low sodium, making it suitable for a variety of dietary needs. The product is enriched with calcium, contributing to its antacid properties. It is available in a convenient dosage form of 100 tablets, with a pleasant spearmint flavor. The National Drug Code (NDC) for this product is 055298-038-10.

Uses and Indications

This drug is indicated for the relief of heartburn, sour stomach, and acid indigestion.

There are no teratogenic effects associated with this drug, and no nonteratogenic effects have been reported.

Dosage and Administration

Patients should chew, swallow, or allow two tablets to melt in the mouth every two to three hours as symptoms occur or as directed by a physician. It is important to adhere to the maximum dosage limit of 19 tablets within a 24-hour period. Additionally, the maximum dosage should not be utilized for more than two consecutive weeks to avoid potential adverse effects.

Contraindications

There are no specified contraindications for this product. However, it is advised to discontinue use and consult a healthcare professional if symptoms persist for more than two weeks.

Warnings and Precautions

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

Patients should be advised to consult with a healthcare provider, such as a doctor or pharmacist, prior to use 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.

In cases where symptoms persist for more than two weeks, patients must be instructed to discontinue use and seek medical advice. Prolonged symptoms may indicate an underlying condition that requires further evaluation.

While no specific emergency medical instructions are provided, healthcare professionals should remain vigilant and prepared to address any adverse reactions or complications that may arise during treatment.

Currently, there are no specific general precautions or laboratory tests indicated for monitoring in relation to this medication. However, it is advisable to maintain a comprehensive understanding of the patient's overall health status and any concurrent medications to ensure safe and effective use.

Side Effects

Patients should be advised to consult a doctor or pharmacist prior to use if they are currently taking any prescription medications, as antacids may interact with certain prescription drugs.

In the event that symptoms persist for more than two weeks, patients are instructed to discontinue use and seek medical advice.

Additionally, it is crucial to keep this medication out of reach of children to prevent accidental ingestion.

Drug Interactions

Antacids may interact with various prescription medications, potentially affecting their absorption and efficacy. It is advisable to monitor the timing of antacid administration in relation to other medications to minimize these interactions. Specifically, antacids should be taken at least 2 hours apart from other drugs to ensure optimal therapeutic outcomes.

Packaging & NDC

Below are the non-prescription pack sizes of Titralac (calcium carbonate). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Titralac.
Details

Pediatric Use

Pediatric patients should be advised to keep this medication out of reach of children. Safety and efficacy in pediatric populations have not been established, and caution is advised when considering its use in this demographic.

Geriatric Use

There is no specific information regarding the use of TITRALAC (calcium carbonate tablet) 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 is advisable, given the lack of targeted data for this population.

Pregnancy

There is no specific information available regarding the use of TITRALAC (calcium carbonate tablet) during pregnancy. As such, the safety of this medication in pregnant patients has not been established, and there are no known dosage modifications or special precautions recommended for use during pregnancy. Healthcare professionals should weigh the potential benefits against any unknown risks when considering the use of TITRALAC in women of childbearing potential. It is advisable to monitor pregnant patients closely and to discuss any concerns regarding the use of this medication during pregnancy with them.

Lactation

There are no specific warnings or recommendations regarding the use of this medication in nursing mothers. Additionally, there are no specific warnings or recommendations related to lactation. Healthcare professionals should consider the absence of data when advising lactating mothers on the use of this medication.

Renal Impairment

Patients with renal impairment have not been specifically addressed in the available data regarding dosage adjustments, special monitoring, or safety considerations. Therefore, healthcare professionals should exercise caution when prescribing this medication to patients with reduced kidney function, as the lack of information necessitates careful clinical judgment and monitoring.

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 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.

If available, specific antidotes or treatments should be administered as indicated based on the clinical scenario and the substance involved. Consultation with a poison control center or a medical toxicologist may also be beneficial in guiding the management of the overdose.

Documentation of the incident, including the substance involved, the amount ingested, and the time of ingestion, is crucial for effective treatment 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 these contexts.

Postmarketing Experience

No postmarketing experience details are available in the insert text.

Patient Counseling

Healthcare providers should advise patients to keep the medication out of reach of children to prevent accidental ingestion.

Patients should be informed to discontinue use and consult a doctor if their symptoms persist for more than two weeks, as this may indicate a need for further evaluation or alternative treatment options.

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

Storage and Handling

The product is supplied in a bottle that must be stored at room temperature. It is essential to protect the bottle from light exposure to maintain product integrity. The bottle should always be kept tightly closed when not in use to prevent contamination. For added safety, the bottle is equipped with a printed foil seal under the cap, which serves as a protective measure.

Additional Clinical Information

The medication is administered orally, with patients instructed to chew, swallow, or allow two tablets to melt in the mouth every two to three hours as symptoms occur or as directed by a physician. It is important for patients not to exceed 19 tablets within a 24-hour period or to use the maximum dosage for more than two weeks.

No additional information is available regarding laboratory tests, abuse potential, patient counseling, or postmarketing experience.

Drug Information (PDF)

This file contains official product information for Titralac, 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 Titralac, 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.